Datasets:

chrisvoncsefalvay

/

vaers-outcomes

like 0

Local redness, warmth.

0No event

I started with a headache then went to awful body aches and fever. I had chills all night and massive sweating. I had to change my shirt. This went on thru the next day 3/23

0No event

I started with palpitations lasting for approximately half an hour reaching 122. I took Motrin 800 mg after I got the vaccine by that evening about 11 o?clock I started getting chills and I started spiking fevers very uncomfortable muscle muscle aches bodyaches frontal headache fatigue x 2 days. I still have body aches and joint pain with a mild frontal headache

0No event

Tingling in mouth within 5 mins of injection; after 3 hours tingling in tongue, mouth, numbness on the left side of the mouth and of the left side of the face ; resolved after 7 hours on its own.

0No event

Injection area has red bumps around it - left arm; Injection area itches - left arm; Injection area has red bumps around it - left arm; Arm was real sore for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was real sore for 3 days), VACCINATION SITE MASS (Injection area has red bumps around it - left arm), VACCINATION SITE PRURITUS (Injection area itches - left arm) and VACCINATION SITE ERYTHEMA (Injection area has red bumps around it - left arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. Concurrent medical conditions included Allergy (She had a reaction to some band aids.). Concomitant products included VITAMIN C [ASCORBIC ACID], VITAMIN D NOS and CALCIUM for an unknown indication. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was real sore for 3 days). On 26-Feb-2021, the patient experienced VACCINATION SITE MASS (Injection area has red bumps around it - left arm), VACCINATION SITE PRURITUS (Injection area itches - left arm) and VACCINATION SITE ERYTHEMA (Injection area has red bumps around it - left arm). The patient was treated with Physical therapy (Heating pad) for Pain in extremity; Physical therapy (Heating pad) for Vaccination site mass; Physical therapy (Heating pad) for Vaccination site pruritus and Physical therapy (Heating pad) for Vaccination site erythema. On 21-Feb-2021, PAIN IN EXTREMITY (Arm was real sore for 3 days) had resolved. At the time of the report, VACCINATION SITE MASS (Injection area has red bumps around it - left arm), VACCINATION SITE PRURITUS (Injection area itches - left arm) and VACCINATION SITE ERYTHEMA (Injection area has red bumps around it - left arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

0No event

No appetite; Fever of 101 F; Tired and could not get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (No appetite), PYREXIA (Fever of 101 F) and FATIGUE (Tired and could not get out of bed) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (no historical condition was reported). On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced DECREASED APPETITE (No appetite), PYREXIA (Fever of 101 F) and FATIGUE (Tired and could not get out of bed). On 18-Feb-2021, DECREASED APPETITE (No appetite), PYREXIA (Fever of 101 F) and FATIGUE (Tired and could not get out of bed) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 f. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

0No event

Vaccine expired 1/31/22

0No event

multifocal acquired demyelinating sensory and motor neuropathy; Hemolytic anemia; This literature-non-study case was reported in a literature article and describes the occurrence of CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (multifocal acquired demyelinating sensory and motor neuropathy) and HAEMOLYTIC ANAEMIA (Hemolytic anemia) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (multifocal acquired demyelinating sensory and motor neuropathy) (seriousness criterion medically significant) and HAEMOLYTIC ANAEMIA (Hemolytic anemia) (seriousness criterion medically significant). At the time of the report, CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (multifocal acquired demyelinating sensory and motor neuropathy) was resolving and HAEMOLYTIC ANAEMIA (Hemolytic anemia) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Alanine aminotransferase: 107 U/L Elevated after IVIg treatment. On an unknown date, Antibody test: anti-MAG antibodies-unremarkable. On an unknown date, Aspartate aminotransferase: 54 U/L Elevated after IVIg treatment. On an unknown date, Blood bilirubin unconjugated: 0.8 mg/dl elevated. On an unknown date, Blood grouping: AB negative, Rh negative.. On an unknown date, Blood lactate dehydrogenase: Normal. On an unknown date, CSF cell count: no pleocytosis. On an unknown date, CSF protein (15-45 mg/dl): 45 mg/dl borderline. On an unknown date, Coombs direct test: Negative. On an unknown date, Electroneuromyography: The needle electromyography portion of the electrodiagnostic study was normal. On an unknown date, Haemoglobin: 15 g/dL baseline, 12.3 g/dL five days after IVIg treatment and 10.6 g/dL eight days after IVIg treatment. On an unknown date, Haptoglobin: less than 8 mg/dL- Low. On an unknown date, Immunoelectrophoresis: unremarkable. On an unknown date, Immunology test: unremarkable. On an unknown date, Light chain analysis: unremarkable. On an unknown date, Nerve conduction studies: nerve conduction studies (NCS) showed normal sensory nerve action potentials (SNAP) in absolute terms, but amplitudes were asymmetric in two nerves (sural: right 11.6uV and left 21.5uV, median: right 18.4uV and left 41.0uV). Compound muscle action potentials (CMAP) had slowed conduction velocities in multiple nerves, several with associated conduction block. The peroneal extensor digitorum brevis CMAP had particularly slowed conduction velocities with conduction block. The left median and tibial F-wave latencies were prolonged. Although the NCS abnormalities were much more striking in motor nerves, the asymmetric SNAPs along with the patient's sensory symptoms and deficits on examination suggest sensorimotor involvement. Taken together, NCS demonstrated a generalized, non-length-dependent, sensorimotor, demyelinating polyneuropathy. On an unknown date, Neurological examination: notable for distal weakness of both upper and lower extremities, more pronounced on the left. Shoulder abduction, elbow extension and flexion, and wrist extension and flexion strength were graded 5/5 bilaterally using the Medical Research Council (MRC) scale, finger abduction (interosseous) and thumb abduction (abductor pollicis brevis) were 4/5 bilaterally, hip flexion, knee extension and flexion were 5/5 bilaterally, ankle dorsiflexion was 4/5 bilaterally, ankle plantarflexion was 5/5 bilaterally, toe extension was 1/5 on the left and 4/5 on the right, and toe flexion was 5/5 bilaterally. He could march on his toes but not on his heels. On an unknown date, Reflex test: absent throughout. On an unknown date, Reticulocyte count: 2.2 % elevated. On an unknown date, Romberg test: Romberg's sign were absent. On an unknown date, Skin test: Sensation to pinprick was decreased distally in both upper and lower extremities with 8 seconds timed vibration sensation at bilateral great toes, while proprioception was intact.. On an unknown date, Urine analysis: unremarkable. On an unknown date, Vascular endothelial growth factor assay: unremarkable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication not reported. The patient had received the Moderna vaccine booster dose and three days later noticed left thumb numbness and tingling that spread throughout his hand, followed a month later by sensory changes in both legs and left leg weakness. Previously patient was a lacrosse player and lost the ability to run after vaccination. Patient denied neck or low back pain and any preceding illness. The patient was presented with numbness, tingling, and weakness in his extremities progressing over four months. Patient underwent neurologic examination and nerve conduction studies (NCS). Patient's NCS met diagnostic criteria of Chronic inflammatory demyelinating polyneuropathy (CIDP) by Academy of Neurology. This was followed by laboratory studies corresponding to the differential diagnosis. The patient did not have toxic exposures, a contributory family history, or systemic symptoms suggestive of a plasma cell dyscrasia. Patient's neuropathy was best characterized as sensorimotor, asymmetric, and subacute. These elements were most consistent with a diagnosis of multifocal acquired demyelinating sensory and motor neuropathy (MADSAM). Patient received treatment with 2g per kg of intravenous immunoglobulins (IVIg) administered over two days. However, after noticing dark-colored urine and fatigue which suggested hemolytic anemia, the patient received high-dose steroids, and the long-term treatment was switched to subcutaneous immunoglobulin. Patient did not experience further adverse effects and had gradual improvement in motor strength and sensory symptoms. Author stated that there was possibility that a vaccination unmasks an underlying, previously asymptomatic autoimmune disorder rather than cause it. Company comment: This literature-non-study case concerns a male patient aged 23 years with no preceding illness reported, who experienced the unexpected serious (medically significant) events of Chronic inflammatory demyelinating polyradiculoneuropathy(CIDP) (reported as multifocal acquired demyelinating sensory and motor neuropathy(MADSAM) and AESI) and Haemolytic anaemia, after booster dose of mRNA-1273 vaccine in covid-19 vaccination series. Patient presented with numbness, tingling, and weakness in his extremities progressing over four months. He initially noticed left thumb numbness and tingling that spread throughout his hand, followed a month later by sensory changes in both legs and left leg weakness. He denied neck or low back pain and had received the Moderna vaccine booster three days prior to symptom onset. His initial neurologic examination was notable for distal weakness of both upper and lower extremities, more pronounced on the left. Sensation to pinprick was decreased distally in both upper and lower extremities, while proprioception was intact. Romberg's sign was absent. Reflexes were absent throughout. The combination of motor weakness, sensory abnormalities, and areflexia a disorder of the lower motor neurons, simultaneous upper and lower extremity involvement narrows the localization to the peripheral nerves, with a non-length-dependent pattern suggestive of an inflammatory polyneuropathy. Although the Nerve conduction study (NCS) abnormalities were much more striking in motor nerves, the asymmetric SNAPs along with the patient's sensory symptoms and deficits on examination suggest sensorimotor involvement. NCS demonstrated a generalized, non length-dependent, sensorimotor, demyelinating polyneuropathy. Patient's NCS met diagnostic criteria for multifocal CIDP in the 2021 revised Academy of Neurology/Peripheral Nerve Society guidelines. Patient did not have toxic exposures, a contributory family history, or systemic symptoms suggestive of a plasma cell dyscrasia. He had unremarkable serum electrophoresis (SPEP), immunofixation (IFE), free light chains, anti-MAG antibodies, and vascular endothelial growth factor. Given the non-contributory history and normal serum studies, CIDP or a CIDP variant was strongly considered. Cerebrospinal fluid (CSF) studies revealed a borderline protein of 45mg/dL with no pleocytosis. This patient's neuropathy was best characterized as sensorimotor, asymmetric, and subacute which was most consistent with a diagnosis of MADSAM. Patient was started on 2g/kg of intravenous immunoglobulins (IVIg) administered over two days. Three days after the initial dose, he noticed dark-colored urine and fatigue, five days after IVIg infusions, hemoglobin was 12.3g/dL (baseline of 15g/dL), which subsequently dropped to 10.6g/dL. Aspartate transaminase (AST) and alanine transaminase (ALT) were raised. Down trending hemoglobin following IVIg suggests hemolytic anemia, a rare complication which is most common in non-O blood group patients (patient-AB negative). An elevated reticulocyte index (2.2%), elevated indirect bilirubin (0.8mg/dL), and low haptoglobin supported the diagnosis. Direct antiglobulin test (DAT) was negative, a finding in 12.5% of cases of hemolytic anemia with unclear mechanism. Patient received high-dose steroids, and the long-term treatment was switched to subcutaneous immunoglobulin. He did not experience further adverse effects and had gradual improvement in motor strength and sensory symptoms. Author concludes that vaccination possibly unmasks an underlying, previously asymptomatic autoimmune disorder rather than cause it. The benefit-risk relationship of mRNA-1273 is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 04-Jan-2023: Live follow up received by safety on 04-Jan-2023 has email with full text article and contains significant information. Reporter information, Literature information, lab data, treatment drug and event details updated,; Sender's Comments: This literature-non-study case concerns a male patient aged 23 years with no preceding illness reported, who experienced the unexpected serious (medically significant) events of Chronic inflammatory demyelinating polyradiculoneuropathy(CIDP) (reported as multifocal acquired demyelinating sensory and motor neuropathy(MADSAM) and AESI) and Haemolytic anaemia, after booster dose of mRNA-1273 vaccine in covid-19 vaccination series. Patient presented with numbness, tingling, and weakness in his extremities progressing over four months. He initially noticed left thumb numbness and tingling that spread throughout his hand, followed a month later by sensory changes in both legs and left leg weakness. He denied neck or low back pain and had received the Moderna vaccine booster three days prior to symptom onset. His initial neurologic examination was notable for distal weakness of both upper and lower extremities, more pronounced on the left. Sensation to pinprick was decreased distally in both upper and lower extremities, while proprioception was intact. Romberg's sign was absent. Reflexes were absent throughout. The combination of motor weakness, sensory abnormalities, and areflexia a disorder of the lower motor neurons, simultaneous upper and lower extremity involvement narrows the localization to the peripheral nerves, with a non-length-dependent pattern suggestive of an inflammatory polyneuropathy. Although the Nerve conduction study (NCS) abnormalities were much more striking in motor nerves, the asymmetric SNAPs along with the patient's sensory symptoms and deficits on examination suggest sensorimotor involvement. NCS demonstrated a generalized, non length-dependent, sensorimotor, demyelinating polyneuropathy. Patient's NCS met diagnostic criteria for multifocal CIDP in the 2021 revised Academy of Neurology/Peripheral Nerve Society guidelines. Patient did not have toxic exposures, a contributory family history, or systemic symptoms suggestive of a plasma cell dyscrasia. He had unremarkable serum electrophoresis (SPEP), immunofixation (IFE), free light chains, anti-MAG antibodies, and vascular endothelial growth factor. Given the non-contributory history and normal serum studies, CIDP or a CIDP variant was strongly considered. Cerebrospinal fluid (CSF) studies revealed a borderline protein of 45mg/dL with no pleocytosis. This patient's neuropathy was best characterized as sensorimotor, asymmetric, and subacute which was most consistent with a diagnosis of MADSAM. Patient was started on 2g/kg of intravenous immunoglobulins (IVIg) administered over two days. Three days after the initial dose, he noticed dark-colored urine and fatigue, five days after IVIg infusions, hemoglobin was 12.3g/dL (baseline of 15g/dL), which subsequently dropped to 10.6g/dL. Aspartate transaminase (AST) and alanine transaminase (ALT) were raised. Down trending hemoglobin following IVIg suggests hemolytic anemia, a rare complication which is most common in non-O blood group patients (patient-AB negative). An elevated reticulocyte index (2.2%), elevated indirect bilirubin (0.8mg/dL), and low haptoglobin supported the diagnosis. Direct antiglobulin test (DAT) was negative, a finding in 12.5% of cases of hemolytic anemia with unclear mechanism. Patient received high-dose steroids, and the long-term treatment was switched to subcutaneous immunoglobulin. He did not experience further adverse effects and had gradual improvement in motor strength and sensory symptoms. Author concludes that vaccination possibly unmasks an underlying, previously asymptomatic autoimmune disorder rather than cause it. The benefit-risk relationship of mRNA-1273 is not affected by this report.

0No event

Sore arm; This is a spontaneous report from a contactable pharmacist (patient) via medical information team. A 69-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 24Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported) administered via an unspecified route of administration on 02Jan2021 at single dose for COVID-19 immunization. The patient experienced sore arm on an unspecified date. It was reported that the patient participated in a study where they did antibody testing after the being fully vaccinated and the patient's antibody test was negative for antibodies. The patient would like to know if there would be a chance that his antibodies wore off since it has been three months since he received the second dose of the vaccine. The patient would like to know should he receive a booster dose and stated that when he had the second dose, he did not have any side effects other than a sore arm. The outcome of the event was unknown. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.

0No event

Information has been received from a physician concerning a 12 year old (reported as 11 year old) male who on 23-DEC-1999 and 17-OCT-2002 was vaccinated with the first and second dose of MMR II respectively. On 18-JAN-2010 the patient experienced mumps. On 20-JAN-2010, the patient was diagnosed with mumps. The patient had right parotitis. His right cheek was swollen. There were no other symptoms. On 20-JAN-2010 1st blood work was performed and the results showed IgM <1:10, IgG 8.23 and serum amylase 379. The patient did not receive the 3rd dose of MMR II. At the time of the report, the outcome was unknown. No further information is available.

0No event

Fever of 103.4, complete inability to sleep or move due to severe nausea, suspected to have peaked at about a quarter past midnight on 2021/05/02. Roommate noticed (attempted) calls for help after ~10 minutes and administered ice water and 325mg acetaminophen. I?ve since recovered enough to fill out this form starting about 55 after midnight. Fever is down to 102.7 and nausea is reduced; dizzy spells that feel like ?skipping a moment? every minute or two, but reducing with the fever. Chronic cough following suspected covid case last year is significantly worsened, and I feel like stuff is trying to get into my lungs, but the coughs are unproductive. If the fever reverts, I will administer additional acetaminophen and my roommate will take me to urgent care. My primary care provider is closed at this time.

0No event

Absolutely feel so sick that I'm about to die I cannot breathe I cannot eat my throat is so sore I've got a headaches I am sick as a dog and I was doing fine before the shot I had had a month-long illness and got over it and started taking my shots and got sick again

0No event

Popping in both elbows; It has worsened over time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A male patient received BNT162b2 (BNT162B2), on 30Oct2021 as dose 2, single (Lot number: FF2590) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (First Dose: , Lot: 301358A), administration date: 09Oct2021, for COVID-19 immunization. The following information was reported: JOINT NOISE (non-serious), outcome "not recovered", described as "Popping in both elbows"; CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "It has worsened over time". Therapeutic measures were not taken as a result of joint noise, condition aggravated. Additional information: Caller would not provide any identifiers except phone number. Caller received the first dose of the Pfizer COVID-19 on 09Oct2021 and the second dose on 30Oct2021. He has noticed "popping in both elbows" since he received the vaccine and it has worsened over time. Caller would like to know if this is a side effect of the Pfizer COVID-19 vaccine and how long it may last. Caller clarifies that he does have popping in both elbows. Caller declines to provide any patient identifiers other than his phone number. Caller states it started whenever he got the vaccine shots, well not too long after he got his Pfizer Vaccine Shots. Caller later states he thinks it might have started after his second one and it has gotten worse. No follow-up attempts are possible. No further information is expected.

0No event

Large bumpy rash at injection (1 x 3 inches) for 3 weeks - went away - but severe pain in the arm when patient moves the arm still exists.

0No event

This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (After 5 day course of Paxlovid tested positive for Covid on day 7) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065k21a) for COVID-19 treatment. Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for an unknown indication. Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Dose number: 1, batch/Lot No: ER8729, location of injection: arm right and vaccine administration time: 02:00 PM) on 10-Apr-2021, Pfizer / BioNTech (Dose number: 2, batch/Lot No: EW0170, location of injection: arm right and vaccine administration time: 01:00 PM) on 01-May-2021, Pfizer / BioNTech (Dose number: 3, batch/Lot No: FG3527 and location of injection: arm right and vaccine administration time: 03:00 PM) on 04-Nov-2021. Past adverse reactions to the above products included No adverse event with Pfizer / BioNTech, Pfizer / BioNTech and Pfizer / BioNTech. Concurrent medical conditions included Penicillin allergy. On 12-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 02-Jul-2022, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On 02-Jul-2022 at 4:00 PM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (After 5 day course of Paxlovid tested positive for Covid on day 7). At the time of the report, COVID-19 (After 5 day course of Paxlovid tested positive for Covid on day 7) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive. The patient was not taking any other medications/products (concomitant) within 2 weeks of starting COVID-19 treatment. Treatment received for event was reported as no. Company comment: This Spontaneous case reported by a patient concerns a 66-year-old, male patient with no relevant medical history reported, who experienced the unexpected, non serious AESI of COVID-19 (After 5 day course of Paxlovid tested positive for Covid on day 7) about 2 months and 20 days after receiving the 4 dose of mRNA1273 Vaccine in the Covid 19 vaccination series. Patient previously received the 2 primary doses and the 3 dose with Pfizer vaccines, with no adverse events reported for Pfizer vaccines. Interchange of vaccine products was noted. No details on symptoms, comorbidities, other labs and diagnostic tests, and treatment details was provided. In June 2022, the patient was started on Nirmatrelvir, Ritonavir (PAXLOVID) at an unspecified dose, for an unknown indication. On 02-Jul-2022 patient experienced COVID-19. After 5 day course of Paxlovid, he was tested positive for Covid on day 7. On an unknown date SARS-CoV-2 test was positive. No treatment was received for the event. The event outcome was unknown. Ongoing Covid 19 pandemia and use of Paxlovid remain as confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events´ seriousness assessed as per medical judgement. Sender's Comments: This Spontaneous case reported by a patient concerns a 66-year-old, male patient with no relevant medical history reported, who experienced the unexpected, non serious AESI of COVID-19 (After 5 day course of Paxlovid tested positive for Covid on day 7) about 2 months and 20 days after receiving the 4 dose of mRNA1273 Vaccine in the Covid 19 vaccination series. Patient previously received the 2 primary doses and the 3 dose with Pfizer vaccines, with no adverse events reported for Pfizer vaccines. Interchange of vaccine products was noted. No details on symptoms, comorbidities, other labs and diagnostic tests, and treatment details was provided. In June 2022, the patient was started on Nirmatrelvir, Ritonavir (PAXLOVID) at an unspecified dose, for an unknown indication. On 02-Jul-2022 patient experienced COVID-19. After 5 day course of Paxlovid, he was tested positive for Covid on day 7. On an unknown date SARS-CoV-2 test was positive. No treatment was received for the event. The event outcome was unknown. Ongoing Covid 19 pandemia and use of Paxlovid remain as confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events´ seriousness assessed as per medical judgement.

0No event

Lower back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Lower back pain) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination. No Medical History information was reported. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced BACK PAIN (Lower back pain). At the time of the report, BACK PAIN (Lower back pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. The patient attributed the lower back pain might be due to poor sleeping position. On 12-Mar-2021, the patient received the second dose. No treatment information was provided.

0No event

Approximately 6 hours after the injection at 6 pm I began to experience right sided ankle pain and swelling and mild chills. The pain peaked about 2 hours later about a 5/10 and was constant. I took 200 mg of Ibuprofen and elevated my foot. The right ankle was visibly swollen and red compared to the left. Prior to going to bed the pain had mostly resolved. Upon waking up in the morning the pain had entirely resolved. There was some residual stiffness that resolved throughout the course of the day.

0No event

55 yo F reported rash with 2-3 cm wheel that first appeared 2-4 hours after 1st dose of Pfizer COVID vaccine. Rash first appeared on L palm, then right palm, then L foot. Rash cleared in approximately 1 week. She endorsed mild pruritis without dyspnea, swelling, wheezing.

0No event

Major allergic skin reaction - hives all over body along with swelling.

0No event

received the Covid-19 vaccine at 0705. She reports symptoms of some congestion on R side, in ears, eyes feel "popping" a bit; had this the first time. "I think it is my BP."; takes meds at night. Is drinking water. Denies issues breathing, able to swallow; no hives, itching. 0715 BP 138/84, pulse 78, p ox 100 %; will continue being monitored, resting, eyes closed. 0725 BP 138/86, pulse 70, p ox 98%; feels about the same/maybe a little better;no issues breathing. Continue monitoring. 0730 States still bit congested; feels like "eyes could cross" if let them, a bit dizzy; no vision changes, no issues breathing. Offered to contact Rapid Response for evaluation in ED; patient wants to give another 5 minutes or so. 0735 Patient feels better, less congestion; BP 122/84, p 70. Able to stand without dizziness; feels comfortable going. Brother lives close; may go there. Has papers on when to seek medical attention.

0No event

Suspected pneumonitis. Patient presented on day following vaccination as shortness of breath, nausea, and diarrhea were not abating with home management. They had started later in the day after the vaccination. At ER admission - SpO2 = 80% room air. Nasal cannula was applied and SpO2 recovered quickly. BNP was elevated so acute exacerbation of heart failure was suspected and treated. However, patient did not improve with diuresis. Viral workup and bacterial cause workup negative. No acute cardiac events discovered. Patient continued to decline. Transferred to ICU on 3-19-21 to use BiPAP with 65% FiO2 and able to take breaks to 15L nasal cannula. Borderline blood pressures at this time. Infectious disease, pulmonology, cardiology, nephrology, and critical care anesthesia services evaluated and ruled out multiple possible diagnoses and patient continued to decline. Diagnostic bronchoscopy on 3-22-21 with BAL lead to patient ventilator dependent with profound hypotension. Aggressive ICU management ensued. Bronchoscopy very clean with no real secretions - in line with CT evidence of pneumonitis. Despite aggressive care and maximized pressor support, patient expired on 3-29-21 when family chose to withdraw care as blood pressure declined again.

5ER_VISIT, HOSPITAL, DIED

Redness around shot area, swelling around shot area, fever, musclle/joint aches and nausea

0No event

RHEUMATOID ARTHRITIS - COURSE AS FOLLOWS: Immediate localized tenderness at injection site. Muscle pain within two weeks, attributed to injection and dismissed as minor by phone consultation w nurse. Bilaterial Carpel Tunnel Syndrome one month post injection - diagnosed during office visit. Tennis Elbow in left arm one month post injection - diagnosed during office visit. Rheumatoid arthritis flare 4 months post injection - diagnosed via blood test taken during emergency visit to doctor's office. Ongoing RA symptoms to current date, including one additional RA flare requiring ER visit. Current medication treatment: mevachor, relafen, norco, flexeril, calcium supplement, multivitamin, folic acid.

1ER_VISIT

Significant neck and upper back pain as soon as 1 hour post vaccine lasting until at least 24 hours - tylenol and heat/ice (no change) chills without fever overnight the night of - no treatment soreness in arm 1 hr post to up to its worst at 24 hours later when I could not abduct >90 degrees for 24 more hours

0No event

sore arms where got the shot.; 1st dose about 6 years ago; headache for 3 days; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (For tolerance of 1st dose, refer case US2022AMR123664). In August 2022, the patient received the 2nd dose of Shingles vaccine. In August 2022, less than a month after receiving Shingles vaccine, the patient experienced injection site pain, headache and drug dose administration interval too long. On an unknown date, the outcome of the injection site pain and drug dose administration interval too long were unknown and the outcome of the headache was recovered/resolved. It was unknown if the reporter considered the injection site pain and headache to be related to Shingles vaccine. Linked case(s) involving the same patient:US2022AMR123664 Additional Information: GSK Receipt Date: 22-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient just had his/her 2nd shingles vaccine a few days ago and the side effects of getting it was not also comfortable. The patient had a headache for about 3 days and sore arms where he/she got the shot. Additional Supportive Information: The patient received the 2nd dose of shingles vaccine later than the recommended schedule, which led to lengthening of vaccination schedule. The follow up would not possible as no contact details were available.; Sender's Comments: US-GSK-US2022AMR123664:Same reporter

0No event

pt recv vax 22AUG95 & 2APR96 or 3APR96 pt devel chicken pox;no further details were provided;

0No event

by the middle of the month of May of 2021 his voice began going away & he still does not have it back; This spontaneous case was reported by a consumer and describes the occurrence of APHONIA (by the middle of the month of May of 2021 his voice began going away & he still does not have it back) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 021C21A) for COVID-19 vaccination. No Medical History information was reported. On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced APHONIA (by the middle of the month of May of 2021 his voice began going away & he still does not have it back). At the time of the report, APHONIA (by the middle of the month of May of 2021 his voice began going away & he still does not have it back) had not resolved. No concomitant medications and no treatment medications were reported. It was reported that patient friend sent him an article about someone else who lost their voice after receiving 2nd dose.

0No event

Rash on extremities, maculopapular with erythema and pruritis. Taking Benadryl and topical Benadryl.

0No event

Visiting family over Christmas and began having scratchy throat. A family member tested positive so I tested and tested positive for COVID-19. Had cough, congestion, sore throat, headache, fatigue, runny nose, loss of appetite, upset stomach. Did x-ray and it was negative for pneumonia. PCP prescribe Paxlovid and it didn't provide any relief for me. Symptoms persisted for about 6 weeks before beginning to improve.

1ER_VISIT

Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 48-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications information was not reported. The reporter stated that because their facility has not been able to download the digital data logger, they have been put on hold by the State at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the State was made. There had been no power outages that would have impacted the Moderna vaccine. However, she reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. Reporter stated that no adverse reactions were reported by any patients. No treatment medication were provided.

0No event

Two days after taking the vaccination, the skin on the palms of my hands started peeling off. I have a Stevens-Johnson's Syndrome reaction to certain antibiotics. This experience was less severe but very similar in appearance.

0No event

This case was reported by a consumer via call center representative and described the occurrence of influenza in a 93-year-old female patient who received Influenza vaccine. Co-suspect products included ADVAIR DISKUS inhalation powder for difficulty breathing. Concurrent medical conditions included blood pressure high, leg syndrome and reflux esophagitis. Concurrent medications included unspecified heart medicine, unspecified blood pressure medicine, unspecified leg syndrome medicine, and unspecified reflux medication. Concomitant products included Pneumonia vaccine. In October 2014, the patient received Influenza vaccine. In 2014, the patient started ADVAIR DISKUS (inhaled) 250/50 ug 1 puff(s) twice daily (2 puff(s) daily). In February 2015, 122 days after receiving Influenza vaccine and several months after starting ADVAIR DISKUS, the patient experienced influenza, hoarseness and sputum increased. ADVAIR DISKUS was continued with no change. On an unknown date, the outcome of the influenza was recovering/resolving and the outcome of the hoarseness and sputum increased were not recovered/not resolved. It was unknown if the reporter considered the influenza, hoarseness and sputum increased to be related to Influenza vaccine. It was unknown if the reporter considered the influenza to be related to ADVAIR DISKUS. The reporter considered the hoarseness and sputum increased to be possibly related to ADVAIR DISKUS. Additional information was provided: The patient reported that she had been using ADVAIR for about 23 years, but just last year, in 2014 started using it consistently and twice daily for her breathing. She stated in October of last year she had the flu shot, but in February 2015 she got the flu. Also in February with the flu incident she noticed voice changes and her doctor informed her it probably was the ADVAIR use. She stated she rinses her mouth after each dose. She also added that she has had increased fluid/mucous that she has to spit out. She was referred to her physician for treatment recommendations for the hoarseness. She added that she had also received the pneumonia vaccine at some point.

0No event

Patient got extremely agitated and cried all the time for 2 weeks, he also had a fever of about 104 for 4 days and got a really bad cough 3 days after the shot.

1ER_VISIT

swelling in throat-mild difficulty swallowing; redness, puffiness, & dryness of eyes; no previous h/o allergy to eggs;

1ER_VISIT

Noticed lump in right arm, size of quarter, red and painful, approx. 6 cm below right deltoid. Had nausea and vomiting day before noticing the lump.

0No event

weak; Still don't feel back to normal, just feeling so terrible; had some depression; Cough issues; bruise on injection arm; temperatures of 99.1 after the second Covid Vaccine.; stomach flora was distrubed; His wife has a immunodeficiency; His wife has a immunodeficiency; Feeling Very Sick; Chills; Headache; body aches; Nausea; Diarrhea; Sore Arm; This is a spontaneous report from two contactable consumers. A 71-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EL9267, Expiration Date: 31May2021) via an unspecified route of administration administered in left arm on 17Feb2021 at 13:15 as single dose and first dose (Lot number :EL3302 or EL330Z) (at the age of 71-year-old) for COVID-19 immunization. The patient's medical history included immunodeficiency common variable from 2004 and ongoing. The patient's concomitant medications included immunoglobulin human normal (GAMMAGARD SD) taken for immunodeficiency common variable from 2004 and ongoing. Patient had a significant reaction a few days after the vaccine. Patient had second Covid Vaccine on 17Feb2021, which was a Wednesday. Patient got a very sore arm on 17Feb2021. And then Friday evening, patient was feeling very sick, had chills, headache, body aches, diarrhea, nausea. Patient stated she has not had an actual fever since diagnosis of COVID in 2004 and started Gammagard. Patient stated her temperature usually runs 97.4 to 97.7. Patient stated she had temperatures of 99.1 after the second Covid Vaccine. Patient continued through the weekend feeling sick. Thought she was feeling better on Monday but stated it all returned and lasted for about 10 days. It was reported that, second dose was about 2 inches to 2 1/2 inches further down and towards the back of her arm. Patient has bruise on injection arm, left arm. Patient stated she went to see her primary care provider when experiencing symptoms and was told her stomach flora was disturbed. Patient was struggling with intermittent nausea, and weak. Patient stated she was still not one hundred percent. Still did not felt back to normal, just feeling so terrible, and had some depression. It was really not a fun experience. Patient was having cough issues, but did not provide further details. Patient stated chills, headache, and body aches lasted about 10 days. Patient stated still having some nausea and diarrhea but that it was getting a lot better. It was a 10 day battle including Friday, about 9-10 days.The outcome of sore arm was not resolved and feeling very sick was recovering. The outcome of his wife has a immunodeficiency, chills, headache, body aches, nausea, diarrhea, weak, still don't feel back to normal, just feeling so terrible, had some depression, cough issues, bruise on injection arm, temperatures of 99.1 after the second covid vaccine, stomach flora was disturbed was unknown. Brief Complaint Description: PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE - EL9267- Lack Of Effect. No reasonably suggest device malfunction. Severity of harm not applicable. Suggest Device. IDC - Level 1: Quality. IDC - Level 2: Product Complaint. IDC - Level 3: Complaint - Complaint - Function / Therapeutic Properties. (Parent) Complaint Class: Product Use Attributes. (Parent) Complaint Sub-Class: Lack of Effect. (Parent) Brand/Trade-Name: Pfizer-Biontech Covid-19 Vaccine Injectable. (Parent) Product Family-API: BNT162B2. (Parent) Product-Description: Compound Bnt 162 Covid-19 Vaccine Suspension For Intramuscular 2ml. (Parent) Product-Type: RX. (Parent) Product-Category: Injectable. (Parent) Sterile-Product: Yes. (Parent) Combination-Product: No. (Parent) Medical-Device: No. (Parent) Combination-Product-Type: N/A. (Parent) Lot-: EL9267. (Parent) UDI-(if appl): N/A. (Parent) Batch-Expiry Year: 2021 (Parent) Batch-Expiry Month: May. (Parent) Batch-Expiry Day: 31. Fill Date: This is the date the formulation product is filled into the primary container 29Dec2020. Package Date: This is the start date when the finished product is packaged into the commercial presentation 31Dec2020. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL9267 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL9267, fill lot EL9258, and the formulated drug product lot EL9249. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. No follow-up attempts are possible. No further information is expected.

0No event

"Large area that was swollen Lump got as big as a football"

0No event

pt given vax & devel rash over chest face, ears, arms;

0No event

However found out today a friend's brother had the same issue after 1st shot. He also started feeling bad 5 days after 1st shot and broke out with Shingles at 10 days; feeling bad 5 days after 1st shot; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (friend's brother). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced shingles. It was reported by the consumer that Reporter found out today a friend's brother had the same issue after 1st shot. he also started feeling bad 5 days after 1st shot and broke out with shingles at 10 days. The outcome of the events were unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021265079 same reporter/product/event, different patient

0No event

Patient was admitted to hospital on 12/12/2013 as a transfer from an outside hospital with intussusception.

2ER_VISIT, HOSPITAL

SkinRash, Rash & UrticariaPruritus Narrative: Intermittent, body and facial rash with pruritis. She was evaluated by PCP on 1/5/21 and treated with Prednisone.

0No event

Pt. Refers to dizziness, malaise and presents paleness and sweating minutes after administering his third dose. Paramedic estimated vital: P: 72 B/P: 60/30 Sat: 97 Dextrose: 99 consultation with Dr. Oxygen is administered, he lay down with raised legs and observed for 30 minutes. Vitals were re-estimated P: 90 B/P: 115/70 Dextrose: 99 Patient reported feeling better and left.

0No event

Tdap ordered, tetanus vaccine given.

0No event

Myalgia Chills

0No event

This spontaneous report as received from a pharmacist refers to a patient unknown age. On 16-OCT-2013, the patient was vaccinated with ZOSTAVAX VIAL 19400 PFU (dose, route and lot number were not provided). No concomitant medications were reported. On 16-OCT-2013, the patient received less than full dose of ZOSTAVAX when the needle came loose from the syringe during administration and some of the ZOSTAVAX leaked out. No adverse symptoms reported. Additional information has been requested.

0No event

Rapid Response team called for C/o dizziness, lightheadedness, weakness and numbness in all 4 extremities. She was admitted to ED

1ER_VISIT

Pale, dizzy, almost fainted, use ice packs behind neck, got better in 10 min.

0No event

expired doses were administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses were administered) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses were administered). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired doses were administered) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was given by reporter. No treatment medication was given by reporter. This case was linked to MOD-2021-354462, MOD-2021-354659 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 15-Oct-2021: Follow-up received: Added Patient details.

0No event

Shoulder pain and loss of range of motion starting right after vaccine administration and still present after 1 month.

0No event

Flu like symptoms; Fever; Flu like symptoms; Fever; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of INFLUENZA LIKE ILLNESS (Flu like symptoms), the second episode of INFLUENZA LIKE ILLNESS (Flu like symptoms), the first episode of PYREXIA (Fever) and the second episode of PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis. No Medical History information was reported. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced the first episode of INFLUENZA LIKE ILLNESS (Flu like symptoms) and the first episode of PYREXIA (Fever). In August 2021, the patient experienced the second episode of INFLUENZA LIKE ILLNESS (Flu like symptoms) and the second episode of PYREXIA (Fever). In August 2021, last episode of INFLUENZA LIKE ILLNESS (Flu like symptoms) and the last episode of PYREXIA (Fever) had resolved. Concomitant medication was not reported. In 2021, patient received 1st dose COVID-19 vaccine manufactured by Moderna. In 2021, patient received 2nd dose COVID-19 vaccine manufactured by Moderna. On 18-Aug-2021, patient received 3rd dose COVID-19 vaccine manufactured by Moderna. The patient had Moderna twice a month apart in 2021 and stated that most of them with Rheumatoid arthritis taking a biologic qualify for the third booster as immune suppressed. The patient got a note from Rheumatoid arthritis doctor stating that and four days ago on 18-Aug-2021, the patient got their third Moderna booster. Symptoms experienced were like the second shot. The patient had flu like symptoms and a slight fever for 24 hours. The patient glad they did this and still were a mask when they were in crowds. Treatment details were unknown. It was unknown if patient was enrolled in a COVID-19 vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.

0No event

24OCT97 nausea, dizziness, thought process was inhibited, could not form complete sentences, disoriented, thought & coordination severely inhibited for day;

0No event

syncope; fell from standing; hit head on table; This is a spontaneous report from a contactable health professional. A 27-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EW0164), intramuscular in the left arm on 15Apr2021 (at the age of 27-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccinations within 4 weeks of the vaccine. On 15Apr2021, immediately after the vaccine, the patient experienced syncope due to which he fell. He fell from standing and hit his head on a table. There were no signs of soft tissue injury. The patient was brought into the emergency department from the vaccination room. The patient was not treated for the events. The clinical outcome of syncope, fell from standing and hit head on table was resolved on Apr2021.; Sender's Comments: A contributory role of BNT162B2 to the reported events cannot be excluded based on temporal association. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

1ER_VISIT

This spontaneous case was reported by a consumer and describes the occurrence of MYASTHENIA GRAVIS (Generalized myasthenia gravis exacerbated) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A, 036821A and 014M20A) for COVID-19 vaccination. Concurrent medical conditions included Ocular myasthenia (about finishing her treatment for ocular myasthenia.). On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced MYASTHENIA GRAVIS (Generalized myasthenia gravis exacerbated) (seriousness criteria hospitalization and medically significant). At the time of the report, MYASTHENIA GRAVIS (Generalized myasthenia gravis exacerbated) had not resolved. Medical Hx: Hx relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. Allergies were not provided. The patient did not have COVID + test or diagnosis. No concomitant medication were given. Height- 5'4''. It was reported that within three weeks of getting the 1st dose of the Moderna COVID 19 vaccine patient got generalized myasthenia gravis and It was then exacerbated after the 2nd and 3rd shot of the vaccine. Patient's doctors said they did not have an idea if the symptoms were related to the vaccine. The online reading suggested it might be due to the mRNA. Patient had been hospitalized for it. Patient got monthly infusion of IVIG at a cost of $12000 per month. Patient was assuming this was how it's going to be for the rest of the life. The patient received urgent care. Treatment medication included monthly infusion of IVIG. Company Comment: This spontaneous case concerns a 74-year-old, female patient with concurrent Ocular myasthenia, who experienced the unexpected, serious (Hospitalized, medically significant) AESI Myasthenia gravis (reported as Generalized myasthenia gravis exacerbated). The event occurred on an unspecified date after the third dose of mRNA-1273. The patient reported occurrence of generalized myasthenia gravis after the first dose with further exacerbation after the second and third doses. The event status was not provided in between doses to assume a positive rechallenge. Clinical course during hospitalization was not provided in the case although it was mentioned that the patient is being treated with monthly IVIg infusion. The patient's concurrent condition, given the usually progressive nature of the disease, remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2022-529242 (Patient Link).; Sender's Comments: This spontaneous case concerns a 74-year-old, female patient with concurrent Ocular myasthenia, who experienced the unexpected, serious (Hospitalized, medically significant) AESI Myasthenia gravis (reported as Generalized myasthenia gravis exacerbated). The event occurred on an unspecified date after the third dose of mRNA-1273. The patient reported occurrence of generalized myasthenia gravis after the first dose with further exacerbation after the second and third doses. The event status was not provided in between doses to assume a positive rechallenge. Clinical course during hospitalization was not provided in the case although it was mentioned that the patient is being treated with monthly IVIg infusion. The patient's concurrent condition, given the usually progressive nature of the disease, remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.

2ER_VISIT, HOSPITAL

No adverse reactions reported

0No event

Within 15-minutes of vaccination, the patient reported pruritus on their neck and chest.

0No event

hives lasting one day with persistant erythema at site of VZV vaccine

0No event

Lymph-node pain under arm (same as injected arm), radiated from underarm to under left breast; duration from 04-03-2021 through 04-07-2021 Metallic taste in mouth. Intermittent from day of injection to current date of this report (04-20-2021).

0No event

Varicella vaccine 10/12/95. Acute onset varicella with > 50 pox in first 24 hrs on 11/4/02.

0No event

Hot flashes; Diarrhea; Vaccine was administered too high in the upper arm; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flashes), DIARRHOEA (Diarrhea), PRODUCT ADMINISTRATION ERROR (Vaccine was administered too high in the upper arm), FATIGUE (Fatigue) and CHILLS (Chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. Concurrent medical conditions included Spinal disorder and Pain. Concomitant products included ETODOLAC (LODINE) for Pain. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced HOT FLUSH (Hot flashes), DIARRHOEA (Diarrhea), PRODUCT ADMINISTRATION ERROR (Vaccine was administered too high in the upper arm), FATIGUE (Fatigue) and CHILLS (Chills). On 12-Feb-2021, PRODUCT ADMINISTRATION ERROR (Vaccine was administered too high in the upper arm) had resolved. At the time of the report, HOT FLUSH (Hot flashes), DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medications were not provided by reporter. Reporter did not allow further contact

0No event

Fever; Initial information received on 11-Oct-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional. This case involves an adult patient (unknown age and gender) who had fever (pyrexia), after receiving INFLUENZA VACCINE. The patient had no medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious fever (pyrexia) (unknown latency) following the administration of INFLUENZA VACCINE. There were no laboratory data/results available. It was not reported if the patient received a corrective treatment. At time of reporting, the outcome was unknown for the reported event. There will be no information on the batch number for this case.

0No event

Patient contracted Covid

0No event

blood in stool with less amount; diarrhea (7-8 times) with signs of bright red blood; Lower abdominal cramping; extreme pain; severe abdominal pain/cramps; extremely tired/ little exhausted feeling comes and go; body weakness; slept all day; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA HAEMORRHAGIC (diarrhea (7-8 times) with signs of bright red blood), HAEMATOCHEZIA (blood in stool with less amount), ASTHENIA (body weakness), SOMNOLENCE (slept all day) and ABDOMINAL PAIN LOWER (Lower abdominal cramping) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure high and Prostatic disorder. Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy, LISINOPRIL for Blood pressure high, TAMSULOSIN for Prostatic disorder. On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced ASTHENIA (body weakness), SOMNOLENCE (slept all day) and FATIGUE (extremely tired/ little exhausted feeling comes and go). On 21-May-2021, the patient experienced DIARRHOEA HAEMORRHAGIC (diarrhea (7-8 times) with signs of bright red blood), ABDOMINAL PAIN LOWER (Lower abdominal cramping), PAIN (extreme pain) and ABDOMINAL PAIN (severe abdominal pain/cramps). On 22-May-2021, the patient experienced HAEMATOCHEZIA (blood in stool with less amount). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at a dose of OTC, 2mg. On 06-May-2021, ASTHENIA (body weakness), SOMNOLENCE (slept all day) and FATIGUE (extremely tired/ little exhausted feeling comes and go) had resolved. On 22-May-2021, PAIN (extreme pain) had resolved. At the time of the report, DIARRHOEA HAEMORRHAGIC (diarrhea (7-8 times) with signs of bright red blood), HAEMATOCHEZIA (blood in stool with less amount), ABDOMINAL PAIN LOWER (Lower abdominal cramping) and ABDOMINAL PAIN (severe abdominal pain/cramps) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. On 06May2021, patient got blood work done. No results was given. Patient was in an extreme pain from 7pm and it last all night This case is linked case to Original Case : MOD-2021-162193 Action taken with mRNA-1273 in response to the event was Not Applicable Very limited information regarding the events have been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the events have been provided at this time. Further information has been requested.

0No event

swelling where shot was given and could not lift my arm for 2 days. Nausea for 2 days and really tired.

0No event

Took unrefrigerated dose of Vivotif; Spontaneous report received on 06FEB2020. A male consumer reported that he "took unrefrigerated dose of Vivotif" (PT: Product storage error). He was receiving Vivotif for immunisation. The consumer finished his last dose of Vivotif but, the vaccine was exposed out of the refrigerator for a total cumulative time of 16 hours. He could not confirm the temperature. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown. Company Comment: A consumer took unrefrigerated dose of Vivotif (Product storage error). Vivotif was exposed out of a refrigerator for a cumulative time of 16 hours and Vivotif should always be stored inside refrigerator at recommended temperature. Considering the nature of the event, the causality of product storage error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took unrefrigerated dose of Vivotif (Product storage error). Vivotif was exposed out of a refrigerator for a cumulative time of 16 hours and Vivotif should always be stored inside refrigerator at recommended temperature. Considering the nature of the event, the causality of product storage error is assessed as not applicable to Vivotif.

0No event

Excruciating pain in right shoulder; zero mobility. Patient said, this is the worst pain I have ever experienced in my entire life. Improved slightly over 72 hours.

0No event

One day post vax, the pt experienced pain, redness and swelling. The pt described a raised area approximately 5-6 across. The second day the pt experienced a temp of 102. Pt took Tylenol but did not seek medical care. The pt also reported nausea.

0No event

Right thigh where she receive DPaT/IPV has been turning red and swollen some itching(?). Tenderness noted.

0No event

Information has been received from a medical assistant concerning a 17 year old female who on 16-JAN-2008 was vaccinated with a second dose of GARDASIL vaccine (yeast). The patient developed a rash, unspecified, after the second dose and went to an urgent care center but was not hospitalized. The doctor's office was notified of the rash when the patient was called by the doctor's office on 17-JUN-2008 to schedule her third vaccination. The doctor's office is awaiting records. At the time of the report, the outcome was unknown. Additional information has been requested.

1ER_VISIT

c/o severe burning in arm p/vax;2min later c/o chest pain;SOB, fainted shortly afterward;BP 90/56-P57;woke w/bad h/a that cont until the following day;

0No event

Pt started vomiting and complaining of severe abdomen pain. Was seen in the ER twice for abdomen pain. Dr.'s counldn't find anything wrong other than constipation. She was also seen twice by pediatrician who couldn't find anything wrong with her. Constipation problem was taken care of and pt still was screaming in pain. Pt didn't sleep for 2 weeks because of extreme pain. After 2 weeks a Dr. diagnosed her as having an allergic reaction to the MMR vaccine b/c of her previous egg allergy. She can no longer have eggs or milk b/c it causes severe pain and bloating.

1ER_VISIT

This case was reported by a healthcare professional via a sales representative and described the occurrence of bulging Fontanelle in a 4-month-old subject of unspecified gender who was vaccinated with PEDIARIX. Previous and/or concurrent vaccinations given on the same day as PEDIARIX included Haemophilius influenzae type B vaccine, manufacturer unspecified; pneumococcal vaccine, unspecified; manufacturer unspecified. On an unspecified date the subject received 2nd dose of PEDIARIX. At an unspecified time after vaccination with PEDIARIX, the subject experienced bulging Fontanelle. The subject required medical attention in the physician's office. It was unknown if the bulging Fontanelle was a congenital anomaly / birth defect. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event possibly related to vaccination with PEDIARIX. On 11 February 2008 follow-up was received via the healthcare professional. She reported that the 4 month old male subject received the first dose of PEDRIX on 16 October 2007 and the second dose of PEDIARIX on 07 January 2008. Concurrent vaccinations given on the same day as PEDIARIX included ROTATEQ, oral route, manufacturer unspecified, along with Haemophillus influenzae type B vaccine; manufacturer unspecified, pneumococcal vaccine, unspecified; manufacturer unspecified. On 07 January 2008, the subject experienced an inappropriate schedule of vaccine administered. Three days following vaccination with with PEDIARIX, on 10 January 2008, the subject experienced a bulging Fontanelle and an unspecified adverse reaction. The subject was seen by the physician. A spinal tap and unspecified laboratory tests were performed and all results were normal. The healthcare professional noted that the events were not serious and she considered that the bulging Fontanelle and unspecified adverse reaction were possibly related to the use of PEDIARIX. The healthcare professional noted that the bulging Fontanelle was not associated with medical history or concurrent illness, lack of efficacy, erroneous administration or suspected transmission of an infectious agent via medicinal product. On an unspecified date, the bulging Fontanelle and unspecified adverse reaction resolved.

1ER_VISIT

Beginning the day after the vaccination pt states her arm was sore and swollen. Pt continues to have soreness and a golf ball sized lump at the site of the vaccination one year later. Pt states physician recently prescribed Diclofenac sodium topical 1% gel and that has relieved the pain but not the swelling.

0No event

Patient states he had mild to moderate discomfort in my L arm (injection location), it has continued for approximately 12hrs, along with my hands feeling numb and cold, patient also felt a bit lightheaded.

0No event

Error: Improper Storage (ex. temp./location)-

0No event

This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. The reporter is the patient. A 73-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid after getting the booster shots". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: she's 73 y/o and she has Covid after getting the booster shots. Clinical course: Caller wants to know where she can get the medication Paxlovid. Was not able to transfer to PRIVATE, caller disconnected the call. Created a manual AE form. Medical Information (Live Operators Only): Were any unaddressed medical questions referred or forwarded to Medical Information: YES: Customer and/or medical inquiry forwarded or referred to MI. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.

0No event

vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.

0No event

Pt received Pzifer vaccine, and was seated in the waiting area, flagged down a nurse, and c/o feeling lightheaded, and stomach cramps. Pt moved to enclosed area, resting on stretcher, and vitals taken, initials vitals 90, 130/79, 97%. Declined N/V. pt stated that he had not eaten during the day. tolerated clears. Pt rested for 15 minutes, next set of vitals 69, 120/80, 99%. Pt denied the need to go to ED, and left for home.

0No event

Dosing Error

0No event

I had the Vaccine on 1/25/21, in my Right Arm. I started having symptoms on 1/26/21, I worked half a day and went home with Chills, Joint pain, Headache and missed work on 1/27. I had joint pain in my fingers and toes, but continued to work, I tried Tylenol with the pain, On 2/3/21 while at work I got the COVID Arm symptoms, Hot arm, Red rash, Huge hard knot, ( I put an Ice pack on the site while at work and took Tylenol) I also have had more joint pain in my Fingers and Toes causing me to stay home from work on 1/4 and 1/5 and again on 1/8 and 1/9. The Burning and Sharp pain in my fingers, toes (swelling in my toes on my Right foot) and wrist have not gone away. I have been woken up from the Sharp pain in my fingers and toes, it is uncomfortable wearing shoes. I still have the COVID Arm, the red rash the Hot and the swelling of my arm, the heat comes and goes in my arm, the red rash has been continuous since it first appeared, the knot has shrunk in size.

0No event

suicidal thoughts; depression; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (age at vaccination was 41 years) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand: Pfizer, lot: ER2613) in left arm on 17Mar2021 17: 00 at a single dose for COVID-19 immunization. Vaccine Facility type was hospital. Medical history was none. Allergies to medications, food, or other products was no. Patient was not pregnant at the time of vaccination. Concomitant medications included celecoxib (CELAXA) and rosuvastatin calcium (CRESTOR). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient reported that 2 days post shot on 19Mar2021 09:00, she began to have suicidal thoughts. She did suffer from depression, but she was not suicidal and have never been treated for this level of depression before. 2 1/2 weeks later her mood has improved. She did not harm herself. Events were considered non-serious. The outcome of the events was recovered. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient has not been tested for COVID 19.

0No event

Called 9/27/2012 reported palms of hands and bottom of feet itching. Denies any other rash. No fever. No shortness of breath - used topical cortisone and allergy med ALLEGRA x 1 resolved in 10 days.

0No event

This spontaneous report was received from a medical assistant, refers to a 4 year old patient of unknown gender. Medical history and current conditions were not reported. On 13-JUL-2017, the patient was vaccinated with improperly stored dose of PROQUAD (lot # M043306, exp. date: 24-APR-2018) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The vaccine was stored under temperature from -14 degree Celsius (C) to -10 C with timeframe of 6 hours 31 minutes. Previous temperature excursion included: -14 C to -10 C for 538 hours 52 minutes. No adverse effects were reported. Digital data logger was involved. No Product Quality Complaint (PQC) was involved. This is one of 11 reports received from the same reporter. Sender's Comments: US-009507513-1708USA001467: US-009507513-1708USA001338: US-009507513-1709USA006806: US-009507513-1709USA006807: US-009507513-1709USA006809: US-009507513-1709USA006813: US-009507513-1709USA006815: US-009507513-1709USA006816: US-009507513-1709USA006819: US-009507513-1709USA006820.

0No event

rash, vomiting, and eye swelling the night after vaccination

0No event

1324h COVID vaccine administered 1338h pt reported wheezing, difficulty breathing to nurse who notified MD 1339h pt reports h/o CHF, MD advised pt to take his nitro 5 mcg, pulse ox 88% 1341h no improvement of sx, MD administered EpiPen 0.3 mg/0.3 mL, L lateral thigh, 15L of 02 administered by rebreather mask, pulse ox 98% 1347h BP 148/84 1349 diphenhydramine 50mg IM administered by MD, L arm 1351h paramedics took over care of pt, transported by ambulance to nearest hospital

1ER_VISIT

This spontaneous report as received from a registered nurse refers to a currently 30 years old female patient. No information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was provided. On an unknown dates, the patient was vaccinated with unspecified number of doses of M-M-R II injection (dose, route, lot# and expiration date were not reported). On an unknown date, the patient underwent antibody test (titers) and she had low titers for rubella. The patient's rubella titer was "0.9 and it needs to be 0.99 to be positive". On 03-FEB-2016, the patient who was 30 years old received a dose of PROQUAD (Merck) injection, lot# L033692, expiration date 28-FEB-2017 (dose and route of vaccination were not reported). No adverse effects associated with this vaccination were reported. The outcome of low titers for rubella and the causality between low titers for rubella and doses of M-M-R II were not provided. Causality between low titers for rubella and PROQUAD (Merck) was assessed as not related as the vaccine was administered after low titers for rubella onset. Additional information has been requested.

0No event

fever to 106 Degree Fahrenheit by digital thermometer

0No event

Sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced sickness (Verbatim: Sick).The outcome of the sickness was resolved (duration 7 days). It was unknown if the reporter considered the sickness to be related to RSV vaccine. It was unknown if the company considered the sickness to be related to RSV vaccine. Additional Information: GSK Receipt Date: 28-SEP-2023 This case was reported by a patient via interactive digital media. The patient got the RSV vaccine and was very sick for seven days. The patient thought that he/she was doing better now. The patient would be afraid to recommend it but he/she guessed getting RSV would be worse. The follow up would not possible as no contact details were available.

0No event

seizures for 3 days in a row (Sat, Sun, and today, when he has not had any seizures for a few months. Had to administer emergency seizure medication (Lorazepam) as the seizures persisted past the 2 minute mark on 2 out of 3 of the days. He has had persistent fever from day after shot (6/24/22) to the present day (6/28/22). Consistently 101.8. Fever spiking at times to between 104.9 and 105.3 even after ibuprofen given. Has happened early in the morning, so it is unknown at point if it will continue to happen. If fever spikes high again doctor says to go to ER.

0No event

Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date during 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. The patient was diagnosed with shingles after being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of his shingles and associated injuries. On an unknown date in 2016, the patient was treated for vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.

0No event

Patient developed pruritus over body. Patient prescribed ATARAX and prednisone resulting subsequent shingle outbreak. Patient required 2 rounds of prednisone.

1ER_VISIT

Patient is not the appropriate age for the Janssen COVID vaccine at time of vaccination. She is currently 16 years old. No adverse reaction in the 15 minutes after administration. Pharmacist administering vaccine realized patient was underage when filling out vaccine card after administration.

0No event

This retrospective pregnancy case was reported by a consumer via call center representative and described the occurrence of hydrocele in a male infant exposed to BOOSTRIX (batch number 9M9AA, expiry date 23rd October 2016) in utero. The mother received the product. On 16th September 2014, the mother received BOOSTRIX. The mother's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The infant was exposed to BOOSTRIX during the third trimester of pregnancy. The infant was born via unknown delivery and weighed 2353 grams (5lbs 3oz) at birth. The infant was diagnosed with intrauterine growth retardation (serious criteria GSK medically significant). The infant experienced low birth weight. On an unknown date, the infant experienced hydrocele (serious criteria congenital anomaly), exotropia and maternal vaccine exposure. On an unknown date, the outcome of the hydrocele was recovered/resolved and the outcome of the intrauterine growth retardation, birth weight low and maternal vaccine exposure were unknown and the outcome of the exotropia was not recovered/not resolved. It was unknown if the reporter considered the hydrocele, intrauterine growth retardation, exotropia and birth weight low to be related to BOOSTRIX. Additional information was provided as follows: The mother received BOOSTRIX vaccine during her third trimester of pregnancy and her baby did not grow from that point. Less than a year after receiving the vaccination with BOOSTRIX, the patient had hydrocele which was noted between her patient's 2nd and 6th month check-up which resolved on its own and in 2015 during the infant's first year of life, several months after vaccination, exotropia was noted.

0No event

No additional AE; patient age 20 weeks received an initial dose of ROTATEQ on 9/19/2022; This spontaneous report was received from medical assistant and refers to a 20-week-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 19-SEP-2022, the patient was vaccinated with initial dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #W004502, expiration date: 09-OCT-2023, administered orally for prophylaxis (strength was not provided) (product administered to patient of inappropriate age). There was no adverse event reported.

0No event

Early the next morning after I notice my right arm was red, swellling and bruising from the shoulder to the elbow and developed a golf ball sized knot in my arm that was hot and very painful. It was so painful that I couldnt stand the touch. The nurses advised if it got any worse to go to the ER but I didnt. My arm was nearly unusable because of the pain and finally the pain stopped around 1/8 .

0No event

This spontaneous report was received from a physician refers to a 6 month old male patient. Patient's medical history and drug reactions/allergies were not reported. On and unknown date, the patient was vaccinated with the third dose of ROTATEQ 1 ml, oral (lot# was not reported). On 29-JUL-2014, after receiving the third dose of ROTATEQ the patient had hives surrounding his mouth. The physician reports that the hives resolved on their own within 40 minutes. The physician also reported that the patient had no adverse effects with pervious doses of ROTATEQ. No treatment was given for the adverse event. No lab diagnostics studies were performed. On an unknown date, the patient sought medical attention calling the physician's office. The outcome of hives surrounding his mouth was reported as recovered/resolved 29-JUL-2014. Additional information has been requested.

0No event

Headache

0No event

Swollen, tender gland in left armpit Welt and rash at injection site

0No event

covid/lung covid; covid/lung covid; Rheumatoid arthritis flare up; felt like allergies; sore arm; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4241673-00 (AbbVie Inc.). A 37 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Jan2021 (Batch/Lot number: unknown) at the age of 37 years as dose 1, single and intramuscular, administration date 29Jan2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "covid/lung covid"; RHEUMATOID ARTHRITIS (medically significant), outcome "recovered", described as "Rheumatoid arthritis flare up"; HYPERSENSITIVITY (non-serious), outcome "recovering", described as "felt like allergies"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "sore arm". The action taken for adalimumab was unknown. Clinical course: The reporter's assessment of the causal relationship of the event with the suspect products was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Causality for Humira (adalimumab) The reporter's causality for the event(s) of covid vaccine caused sore arm, covid/lung covid, rheumatoid arthritis flair up due to covid vaccine and felt like allergies was not provided. Concomitant Drugs and dates of administration (Exclude those used to treat event) Concomitant Drugs Not Reported. Other Relevant History Not reported. event abate after stopping drug NA. . PFIZER BIONTECH COVID-19 VACCINE (tozinameran) was also considered suspect. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and DRUG INEFFECTIVE, COVID-19 , RHEUMATOID ARTHRITIS , HYPERSENSITIVITY, VACCINATION SITE PAIN cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

0No event

BREAST CANCER; This spontaneous report received from a consumer concerned multiple patients. It concerned two females of unspecified age. The patients' height, and weight were not reported. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802070 expiry: UNKNOWN) dose was not reported, 1 total administered on 12-MAR-2021 for prophylactic vaccination. The patient received injection left deltoid and unknown for other patient. No concomitant medications were reported. On 09-JUL-2021, the patients experienced breast cancer on the same side they received the vaccine. The patients stated they were feeling like crap because they now had cancer. The diagnosis occurred about 1 week after the mammogram which was on 09-Jul-2021 and on unknown date, second patients mammogram showed more instances of enlarged lymph nodes. It was diagnosed by mammogram and an ultrasound, and biopsy. The diagnosis occurred about 1 week after the mammogram which was on 09-Jul-2021. On 14-Jul-2021, the one patient had biopsy done which confirmed cancer and unknown for other. On 28-Jul-2021, one patient had MRI of both breasts which showed that cancer was limited to the left breast. One patient had 16 consecutive days of radiation, and was currently taking medication which she would be on for 5 years and the other patient was also receiving radiation treatment at the same time as her who also recently had a covid-19 vaccine about 3-4 months ago. One patient also had a day surgery on 3-Aug-2021 at hospital. It was a lumpectomy and removal of 5 sentinel lymph nodes. The lymph nodes were clear but the actual lump showed cancer in it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of breast cancer was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220138438-covid-19 vaccine ad26.cov2.s-Breast cancer.This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

0No event

Initially soreness and metallic taste, reoccurrence of lower back pain identical to that which preceded diagnosis of CIDP, worsening of lower extremity weakness and numbness (worse on the left) which progressed rapidly in June 2022. I went from being able to walk continuously for miles to barely being able to walk 0.25 mile. Prior to that, except for an insurer caused interruption of therapy in September 2019, symptoms had been stable on IVIg since my diagnosis in 2012. I also developed new upper extremity interscapular paresthesias on the left.

0No event