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vaers-outcomes

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Information has been received from a 67 year old female registered Nurse with chronic mucitis and an allergy to ampicillin and a history of sinus infection, calcium in breast and cholecystectomy (removed in past) who on 10/6/06 was vaccinated SC with a dose of Varicella Zoster vaccine. Concomitant therapy included Claritin, Lisinopril, Vitamins unspecified, calcium unspec vitamin D unspec, Synthroid, baby aspirin and Cortisone gel. On 10/10/06 at 16:00, the pt developed nausea, vertigo and loss of balance. She felt better lying down and closing her eyes. She felt like the room was spinning. No vomiting or diarrhea was noted. She had not taken her temp, but if she has a fever it is low grade. The pt currently has an abscess in her mouth currently which she has an appointment to be seen on 10/11/06. She reported that her blood pressure had been stable and she dose not have diabetes. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2006. Information has been received from a 67 year old female Registered Nurse with "chronic mucitis", anxiety disorder and an allergy to ampicillin and a history of sinus infections, calcium in breasts and cholecystectomy (removed in past) who on 06-OCT-2006 was vaccinated SC with a first dose of VARIVAX (Merck) (lot # 652965/0622F). Concomitant therapy included CLARITIN, lisinopril (manufacturer unknown), vitamins (unspecified), calcium (unspecified) (+) vitamin D (unspecified), SYNTHROID, baby aspirin and "cortizone gel". On 10-OCT-2006 at 16:00, the patient developed nausea, vertigo and loss of balance. She felt better lying down and closing her eyes. She felt like the room was spinning. No vomiting or diarrhea was noted. She had not taken her temperature, but if she had a fever "it is low grade". The patient currently has an abcess in her mouth currently which she has an appointment to be seen on 11-OCT-2006. She reported that her blood pressure had been stable and she does not have diabetes. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information from the physician indicated that the patient was vaccinated at a pharmacy. No significant problems were noted in the patient's chart. The patient's symptoms were reported resolved on 30-OCT-2006. The physician reported that it was unclear whether related to the vaccine. Laboratory tests included an office visit on 30-OCT-2006 for a "blood issue". No further information is expected.

1ER_VISIT

About one minute after receiving Pfizer Tris immunization, patient slumped backwards in her chair and stiffened. Her eyes were open, but she was unresponsive to verbal talking for approximately 10 seconds. After 10 seconds she slowly relaxed and was able to respond to verbal commands. She said she felt normal at this point. She refused our offer to call emergency. We advised to stay seated for at least 15 minutes. We checked on her every few minutes and she said she felt normal every time. After 15 minutes she tried standing up and said it felt normal. She was with her grandmother during this whole time. The patient called her mother who advised her to remain at the store until she got there. When the mother arrived we explained what had happened, we said it could have been a vasovagal response. The mother said she was taking her daughter to the ER just to be safe.

1ER_VISIT

Fever (100.4) Extreme Fatigue Muscle Aches (whole body) Joint pain (whole body) Weakness

0No event

Non-arousable, sleepy, slight fever for 8 hrs duration; Onset approx 12 hrs post inject; when seen in Er was stable;

1ER_VISIT

Dose administered after 30-day Use By Date and Date the vial was initially stored in the refrigerator was 14-Apr-2023; No adverse event; HCP confirms that 3 additional patients received expired dose on 18-May-2023 from the same lot number; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP confirms that 3 additional patients received expired dose on 18-May-2023 from the same lot number), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date and Date the vial was initially stored in the refrigerator was 14-Apr-2023) and NO ADVERSE EVENT (No adverse event) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis. No Medical History information was reported. On 23-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-May-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 18-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP confirms that 3 additional patients received expired dose on 18-May-2023 from the same lot number). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date and Date the vial was initially stored in the refrigerator was 14-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP confirms that 3 additional patients received expired dose on 18-May-2023 from the same lot number), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date and Date the vial was initially stored in the refrigerator was 14-Apr-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (HCP confirms that 3 additional patients received expired dose on 18-May-2023 from the same lot number) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date and Date the vial was initially stored in the refrigerator was 14-Apr-2023). Concomitant medication of the patient was not reported. Vial size was reported as 2.5mL. The vial did not undergo any temperature excursions. Treatment medication of the patient was not reported. This case was linked to US-MODERNATX, INC.-MOD-2023-725148 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 18-May-2023: Upon live follow up patient details and dose information was updated.; Sender's Comments: US-MODERNATX, INC.-MOD-2023-725148:Patient 1 out of 4 patients

0No event

came down with Bells Paulsi; This serious case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced bell's palsy (Verbatim: came down with Bells Paulsi) (serious criteria GSK medically significant). The outcome of the bell's palsy was not resolved. It was unknown if the reporter considered the bell's palsy to be related to Shingles vaccine. It was unknown if the company considered the bell's palsy to be related to Shingles vaccine. Additional Information: GSK receipt date: 23-MAR-2023 The case was received from the patient via interactive digital media. The patient stated that he/she had the Shingles shot and came down with Bells Paulsi for the rest of his/her life. The follow-up could not be possible as no contact details were available.

0No event

no other AE reported; expired VAQTA inadvertently given to a patient; This spontaneous report was received from a registered nurse and refers to a 37-year-old female patient. Her pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 04-DEC-2020, the patient was inadvertently vaccinated with an expired Hepatitis A vaccine, inactivated (VAQTA) lot # S025258, expiration date 05-NOV-2020 (formulation, anatomical location, exact dose and route of administration were not provided) for prophylaxis. There was no prior temperature excursion for Hepatitis A vaccine, inactivated (VAQTA). No other adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S025258; expirationdate: 05-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability

0No event

This spontaneous report as received from a certified medical assistant refers to multiple patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA, lot # L009445, expiration date: 01-JUN-2017, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. The certified medical assistant was unable to provide exact temperatures at the time of reporting, but stated they "went to 32 degrees Fahrenheit or lower" and they were out of range for "15 minute increments, 40 times". No specified cumulative time was reported. The temperatures were recorded by a data logger and according to the reporter they were back in range at the time of report. There were no prior excursions reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of three reports received from the same reporter. Additional information has been requested.

0No event

Blood clot in left arm caused a stroke

1ER_VISIT

6 cm x 6 cm red raised area with punctate needle mark in the center

0No event

Patient complained of injection site pain, swelling, redness. She also had loss of appetite, insomnia, fatigue, and difficulty moving her arm.

1ER_VISIT

C/O dizziness at 3am. Awoke in bed turned to side. Noticed dizziness. Mild dizziness continued states she feels well as of 1p 12/2/03-less dizziness, stuffy nose. Pt returned to work, feels improved.

0No event

pt recv vax in 7/98 & in 8/98 pt exp chickenpox w/15 lesions which were described as red little blister w/a white center.

0No event

Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration

0No event

Moderna covid vaccine found to be out of date after administration on 8/APR/2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna covid vaccine found to be out of date after administration on 8/APR/2021) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. No Medical History information was reported. On 08-Apr-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna covid vaccine found to be out of date after administration on 8/APR/2021). On 08-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Moderna covid vaccine found to be out of date after administration on 8/APR/2021) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. The patient was notified and opted not to repeat the vaccine. No adverse events were reported as a result of the event.

0No event

severe headache with 'excruciating left foot pain shooting up her leg. no swelling : reported at approximately 12pm called patient back at 4pm and she reported the headache feeling much better, eating and zero foot and leg pain at this point.

0No event

This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 16-JUN-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot# M006141, expiry date 28-MAY-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two separate temperature excursion (dates unspecified): one lasting for 72 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (-1.11 degrees Celsius) and the second one lasting for 32 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (-0.56 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.

0No event

[PFIZDER BIONTECH COVID VACCINE] use for COVID-19 under Emergency Use Authorization (EUA):Pfizer Biotech Vaccine \ I am concerned the doctor may have directed someone to give me the vaccine booster without my consent even though I had adverse reaction to the first and second dose of the Pfizer BIONTECH COVID Vaccine. He the refused to diagnose myocarditis and then prescribed medications claiming the hypertension and high lipids were naturally occurring and not the result of vaccine reaction. I now believe that Dr. enrolled me in a myocarditis study without my consent, and directed others to take actions, which made my symptoms persist. It has been ongoing since last year. He refused to diagnose and prescribed relevant medication for another purpose.

4HOSPITAL

Patient was administered vaccine at 11:00 AM in the left deltoid muscle IM. Patient reported feeling chest tightness, heaviness as if someone was sitting on her chest, pressure on her chest, and found it a little hard to breath at 11:10 am. Patient had a history of congestive heart failure and suffers from anxiety, but wasn't sure if the chest pain was due to her past medical history or the vaccine. At 11:17 am the chest pain remained the same. At 11:30 she was still feeling chest pressure and her right arm was feeling weak. At 11:30 Heart rate was 56, Blood Pressure was 138/72, and respiratory rate was 12. EMS was called at 11:35. Patient was taken to the hospital once EMS arrived.

1ER_VISIT

LIGHTHEADED, METALLIC TASTE IN MOUTH, MILD ITCHING ON LEFT SIDE, HEAVINESS IN CHEST AND GUT. NO SHORTNESS OF BREATH. TWO SYNCOPAL EPISODES, NO IMPROVEMENT IN SYMPTOMS AFTER 10 MINUTES, TRANSPORTED TO HOSPITAL.

1ER_VISIT

Dizzy, fast heart rate , pain in arm for weeks not days, sweaty all the time , blurred vision , Short moments of confusion randomly for no reason

0No event

Site Pain beginning evening of April 27 Swelling and soreness in left supraclavicular nodes beginning upon waking the morning of April 28th and reducing in size to date. Swelling still present today, May 8th. Postmenopausal spotting, hot flashes, nigh sweats. Fatigue

0No event

Fever, with rash developing over the next 3 days. Started on the head, covered the body over 3 days. Some crusted.

0No event

mild arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020L20A) for COVID-19 vaccination. no medical history was provided by the reporter. Concomitant products included ATORVASTATIN for Cholesterol, LISINOPRIL for Hypertension, LEVOTHYROXINE for Parathyroid tumour. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. treatment medication: tylenol Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Caller returning call from Safety, concomitant medication was updated

0No event

Vaccine administered beyond the Best Used Date but before expiration date.

0No event

My arm was sore; Gave daughter some Tylenol and in the morning she woke up and it was worse; Severe muscle pain around whole body; Last night she had only in the arm, but this morning she has around the whole body; She has severe muscle pain in all her body/ This morning she woke up with severe pain in all her muscles, all muscles are in pain; Arm was sore; pain in her arm where the vaccination site was; Fever; This is a spontaneous report from a contactable consumer. This consumer (patients mother) reported for a 36 year old female patient. A 36-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; Batch/Lot Number: EW0185), via an unspecified route of administration, administered in right arm on 26May2021 at 11:00 am (at the age of 36-year-old) as 2nd dose, single dose for covid-19 immunization. The patient's medical history included Autism spectrum, Asperger syndrome in the childhood, when she was a child, from an unknown date and unknown if it is ongoing. The patient's concomitant medication included Risperidone (RISPERDAL) for autism spectrum 2 mg, at bedtime, Diphenhydramine hydrochloride (BENADRYL) 25 mg at night for anticholinergic syndrome, Gabapentin (GABAPENTIN) 200 in the afternoon and 500 at night, Clonazepam (CLONAZEPAM) for autism spectrum disorder, 2 mg morning and 1 mg at night. The patient stated that Neurontin or Gabapentin the same 200 in the afternoon and 500 at night." (Not clarified if taking the brand or the generic). The patient had first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; Batch/Lot Number: EW0175), via an unspecified route of administration, administered in right arm on 05May2021 (at the age of 36-year-old) as single dose for covid-19 immunization. On 26May2021, the patient arm was sore, so she gave her daughter some Tylenol and then in the morning she said she woke up and it was worse. The patient had pain in her arm where the vaccination site was, where they gave the vaccination on her arm and it was sore the day of and then the next she was saying my arm was sore, so the mother gave her some Tylenol to help it. The patient developed the pain in the arm like all of us did, especially by night. The patient got the injection last morning on the 26may in the morning like about 11 O clock by night she developed pain in the arm and she took the Tylenol. On 27May2021, morning, she woke up with severe pain in all her muscles, she can't exactly to move (not clear nor clarified), all muscles are in pain. On 27May2021, Severe muscle pain around whole body. Last night she had only in the arm, but this morning she has around the whole body, in morning she woke up with severe pain in all her muscles, all muscles are in pain. The patient said when she woke up in the morning it was worse. The reporter stated that her daughter received the Pfizer Covid 19 vaccine on 26May2021 and today she has a bad reaction, she has severe muscle pain in all her body and a fever. The reporter asked What percentage of patients reported this side effect. Reporter stated, that she want to report, and wanted to get some medical advice what to do. The events were reported as non-serious. The patient underwent lab tests which included covid-19: Negative on 23Apr2021 and on 29Apr2021. The patient took Tylenol as a treatment for the event. The outcome of the events for unknown. QR Comment: This case might be split as reporter stated, "We got the injection last morning on the 26th in the morning like about 11 O' clock by night she developed pain in the arm like all of us did." However, it was not clarified further nor split was made by call handler

0No event

DTAP given instead of TDAP. PC to mother to inform - will need Tdap - in 6 months ok for school till then. Public Health Nurse informed.

0No event

vaccine vial was not diluted and patient was administered 0.3 ml of undiluted product.

0No event

Noticed Swelling and redness of left arm below shoulder and in the inside of arm very warm to the touch

0No event

My iWatch was showing that my heart rate was over the suggested number. I was experiencing edema in the leg and ankle right afterward. I thought this might be due to my Femara as it can do it. I stopped the Femara for a couple weeks but did not see a difference in the edema. Then my iWatch started to set off alarms of elevated heart rates, starting 8/1/2022 on a daily basis. I then purchased a blood pressure cuff. With my first reading I was 200/120. I then set up a virtual appointment with my doctor on 8/16/2022. She then placed me on HCTZ to see if that would help. It did help to some extent but have changed the medicine to Lisinopril/HCTZ and now seems to help keep under control.

0No event

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Additional Details: Patient fainted for few seconds few minutes after getting the shot , and had dizziness for few minutes afterwards, pt also stated that he has mild nausea

0No event

This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (in 15F for cold temperature and in 51F for warm temperature) doses of GARDASIL 9 (dose, route of administration, lot # an expiration date were not reported. The call was made because of the data logger. No previous excursion and no adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.

0No event

Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.

0No event

Syncope x 2.

0No event

Patient reporting pressure behind both of her eyes and some mild eye pain with extraocular movements. Patient also had generalized myalgias, arm soreness where vaccine was administered along with some chills.

0No event

24 hours post shot, muscle aches, fever, chills, nausea, vomiting, headache. 48 hours post shot still mild muscle aches and headache.

0No event

Patient felt like something was in his throat, tongue felt thick, dizziness/lightheadness, and tremors

0No event

Gardasil #1 (1423X) given in right arm on 4/23/09. Adverse reactions symptoms began 4/24/09 exhibited by: dizziness, headache, stomach pain, nausea, chest pains, shortness of breath, pins/needle sensations to feet, burning of skin, nerve pain to right elbow, fatigue, muscle weakness to legs, nausea, swollen lymph nodes to neck. Physician contacted 4/28/09 because this was felt to be in direct relation to the vaccine. She felt it was viral. 6/03/09 Same physician seen due to symptoms becoming more severe. Lab work drawn to rule out Mono due to swollen lymph nodes. 6/08/09 Pediatric Neurologist seen who confirmed that the symptoms were directly related to the Gardasil injection. Diagnosed peripheral neuropathy. 6/17/09 Medical and immunization records received DOS 4/23/09 to 6/3/09. Assessment: Pain & tingling, fatigue, lymphadenopathy. Patient presented with fatigue, headache, dizzy, chest pain, tingly feeling in arms and legs, pale, tender cervical lymph nodes. Referral to neurologist. LABS and DIAGNOSTICS: Planned CBC, ESR, CRP, Electrolytes, EBV, IgG, IgM. 8/3/09 Consultant medical records received DOS 12/12/08 to 6/29/09. Assessment: New onset symptoms after Gardasil. Patient presents with dizziness and waves of nausea. Chest pain, shortness of breath, and intermittent bifrontal headaches. Tingling of feet and hands with associated pain. Burning sensation in hands and quadraceps muscles. Off balance. Back pain. EB Virus pending. Neuropathic type pain - ulnar region. Allodynic pain. Tender in C2 to C6. Heart rate 74 and standing heart rate 100. Flat affect and dysphoric mood.

1ER_VISIT

Dizziness, Headache, Arthralgia, Fever, ErythemaMultiform, UrticariaPruritus, NauseaVomiting, chills Narrative:

0No event

covid positive pt, admitted to hospital, vaccinated X2

4HOSPITAL

Narrative: Patient with very complex medical history. First Covid 19 vaccine administered 2/16/2021, Second vaccine administered 3/10/2021. PHM involves: Stem Cell transplant Feb 2016, with mild AGVHD. ALL Relapse Oct 2017. CAR-T cell treatment Jan 2018. MDS diagnosis 8/2019. Patient had stopped Acyclovir and Bactrim Prophylaxis therapy March 2021. Hospitalization May 2021 for Herpes Zoster Ophthalmicus affecting right face above eyebrown. ADR entered for Covid-19 vaccine after patient refusal for additional vaccine. Administration dates of Covid 19 vaccine unlikely related to shingles occurrence

1ER_VISIT

vomiting, nausea, feeling bad.

0No event

The right arm where my daughter received the unknown 2 of the 3 vaccines started to form a red lump and swell around 6:30pm, 4 hours after the vaccines were applied. After we got home around 5pm she went to lay down in her bed with immense pain on her right shoulder which was swelling and hot. She developed a small fever around 7:00pm and could not move or lightly touch the right arm without feeling immense pain. Around 8:00pm she developed a swelling and bruised feeling in her top right shoulder socket and right clavicle and side of the neck. It has been almost 48 hours and her right arm is still swollen. The fever and swelling clavicle has gone down but she still feels a bruised feeling in her clavicle.

0No event

within 2 hours of vaccine got nauseous, vomiting, dizzy and not able to walk. Had to call 911 adn hospitalized for 2 days

4HOSPITAL

PNEUMOVAX23 was indicated for prevention of pneumococcal disease by the 23 serotypes contained in the vaccine. Despite its extensive use, relatively few cases of severe hypersensitivity reactions have been reported. This literature marketed report as received from a health care professional refers to a 24 year old female patient with a history of persistent asthma, allergic rhinitis. It was assumed that patient had been vaccinated with PREVENAR previously. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (dose, dose number, lot no and route of administration unknown). Concomitant therapies included Tdap. The patient had been vaccinated with both vaccines for school enrollment. One day after the immunizations she developed a 10 cm induration and erythema at the PNEUMOVAX injection site and a fever of 104.3 F, fatigue, dizziness, headache and nausea. She was admitted to the hospital for presumed erysipelas versus a vaccine allergic reaction. Relevant laboratory values on admission were leukocytosis (19,100/uL) with 86% granulocytes. There was no eosinophilia. She was treated with intravenous antibiotics for two days with improvement and was discharged on antibiotics. Two months later, an allergy clinic follow up visit revealed very high titers against Streptococcus pneumoniae (serotype 14- 223.0 mcg/ml; serotype 5 > 100 mcg/ml; and elevated but normal range protective titers for all other serotypes). Anti Tdap antigen titers were only moderately elevated (tetanus toxoid-5.34 IU/ml; diphtheria-2.67 IU/ml; and pertussis-12 IU/ml). Total serum IgE was elevated (317.6 IU/ml), but quantitative serum immunoglobulin levels were normal. She had a history of gelatin intolerance which caused nausea. None of the two vaccines she received contained gelatin but porcine gelatin-specific serum IgE levels were minimally elevated. It was concluded that the severe delayed systemic reaction associated with very high anti-pneumococcal antibody levels, suggested a type 3 (immune complex mediated) hypersensitivity (hospitalization). Highest antibody titers after the PNEUMOVAX were against two serotypes (5 and 14) that were contained in the 13 serotype PREVENAR. The outcome of Type 3 immune complex mediated reaction was reported as recovering. The event Type 3 immune complex mediated reaction was reported to be related to the suspect product. This case suggested that caution should be used when immunizing younger individuals with PNEUMOVAX, especially if they have previously been immunized with PREVENAR. Additional information has been requested.

2ER_VISIT, HOSPITAL

A report was received from a health care professional on 11/07/03, concerning a vaccinee of unknown demography who experienced pain at the injection site for more than 2 days after receiving Fluvirin vaccine on 11/03/03. The outcome of the event was not reported. There was insufficient information to determine the reporters causality assessment. Follow up pending.

0No event

Post menopausal bleeding (54 at last period, no issues like this since) started a couple of weeks after vaccination. Symptoms started with very painful abdominal cramping. Used an electric hot pad to ease pain. The bleeding started the day after the cramping. One sanitary pad was used per day for 5 days. At the time of report patient says that the bleeding has reduced significantly and "almost ended."

0No event

After injection (flu) - arm swelled some and rash appeared - (slight red, raised rash). Throat sore and became sweaty and glands on neck swelled. Took vitals and had pt sit down and relax for a while. Felt better.

0No event

Pt received Td booster on 7/30/02. On 8/5/02 pt contacted health dept to report pain on left arm since receiving vaccine. Seemed OK on 7/631/02; then has had pain since 8/1/02. Has tried OTC pain relievers, ice packs, without relief.

1ER_VISIT

It was reported that a 15 y.o. female PT received a Rabies Imovax IM series starting in July 00. Reportedly after the 2nd dose on day 3, the PT developed systemic immune-complex like side effect such as headache, nausea, flu-like symptoms with joint discomfort in back and shoulders. It is now 6 months since the series and she still has nausea and fatigue and problems with her back and joints. This event was classified as medically significant by AVP US on 4/25/01. From follow-up #1 mailed correspondence received on 7/2/01 additional PT, vaccine and vaccine administrator info. was provided.

0No event

5 hrs post DTP dose the baby ran a fever to 103 - turned limp and pale - eyes rolled back episode lasted approx l min.

0No event

stroke; She had blood clots in her heart up until her brain; hand went numb and tingling; hand went numb and tingling; she has not had energy/she feels weak/dizzy; she has not had energy/she feels weak; Dizzy; This is a spontaneous report from a contactable consumer. This consumer reported for a 91-Year-old female patient that patient received first dose of bnt162b2 (BNT162B2; Formulation: Solution for injection) via unknown route of administration from unknown date in Mar2021(at the age of 91-Years) on unknown location for COVID-19 immunization. No prior Vaccinations (within 4 weeks). No AEs following prior vaccinations. Patient's Medical History (including any illness at time of vaccination) was reported as None. Patient's family medical history was not reported. Concomitant medications were not reported. It was reported that patient experienced stroke (required emergency Room, and physician office visit and patient was hospitalized, for two nights and three days.), she had blood clots in her heart up until her brain (required emergency Room, and physician office visit and patient was hospitalized, for two nights and three days.), hand went numb and tingling (required emergency Room, and physician office visit and patient was hospitalized, for two nights and three days). Her mother's first shot was in March, her second shot was in April. She has been perfectly healthy up until this point. Ever since she got the shot in April, she has not had energy, she feels weak, and she has been dizzy worsened, no treatment received, and the same doctor tells her to rest. She has not had energy, no treatment received, and she has went to doctor she has been resting more. A week ago, yesterday she was standing at the pantry and her right hand went numb and tingling so she rushed over and took her to the urgent care and the doctor said he thinks she is having a stroke and she took her to hospital, and they found out on the second day they did an MRI and cat scan and an ultrasound of the heart. The MRI showed she had two strokes. So, they kept her in the hospital she had blood clots in her heart up until her brain. She got the covid vaccine and now she has two blood clots. The outcome of the events for stroke, she had blood clots in her heart up until her brain, hand went numb and tingling was unknown, and for she has not had energy/she feels weak, Dizzy was not recovered. Information on the lot/ batch number has been requested.

2ER_VISIT, HOSPITAL

My left upper arm was itchy and swollen; My left upper arm was itchy and swollen; lethargic; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient. A 34-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Generalised anxiety disorder" (unspecified if ongoing); "known allergies: Tree nuts" (unspecified if ongoing), notes: known allergies: Tree nuts. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; FLUOXETINE; PRENATAL VITAMINS [ASCORBIC ACID;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;ERGOCALCIFEROL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL PALMITATE;RIBOFLAVIN;THIAMINE MONONITRATE]. Vaccination history included: Covid-19 vaccine (Dose:1, unknown manufacture), for COVID-19 immunization; Covid-19 vaccine (Dose:2, unknown manufacture), for COVID-19 immunization; Covid-19 vaccine (Dose:3, unknown manufacture), for COVID-19 immunization; Covid-19 vaccine (Dose:4, unknown manufacture), for COVID-19 immunization. The following information was reported: PRURITUS (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 14Oct2023, outcome "recovered" (17Oct2023) and all described as "My left upper arm was itchy and swollen"; LETHARGY (non-serious) with onset 14Oct2023, outcome "recovered" (Oct2023), described as "lethargic". Therapeutic measures were not taken as a result of pruritus, peripheral swelling, lethargy. Additional information: Patient reported, "My left upper arm was itchy and swollen starting the day after I received the vaccine and the swelling and itching lasted for four days. I also felt very lethargic the day after receiving the vaccine, which happened with the other doses but the arm swelling and itching was new this time". The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.

0No event

a little harder to breathe afterwards (dyspnoea); Information has been received from an other company on 14-SEP-2023. This spontaneous report was received from a consumer referring to a 75 years old female patient. The patient's concurrent condition included primary pulmonary arterial hypertension. The patient's medical history and concomitant therapy were not reported. On an unknown date in 2023 (reported as "a couple weeks ago"), the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) for immunization (strength, dose and route of administration were unknown; lot number and expiration date were not reported). After the vaccination, the patient found a little harder to breathe (dyspnoea). At the reporting time, the outcome of the event was unknown. The causal relationship between zoster vaccine live (ZOSTAVAX) and the event of dyspnoea was reported as possibly related.

0No event

Fever that peaked at 107 °F, body aches, stuffy nose, headache.

1ER_VISIT

This case was reported by a pharmacist via call center representative and described the occurrence of varicella-like rash in a adult female patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 2 days after receiving Shingrix, the patient experienced varicella-like rash. On an unknown date, the outcome of the varicella-like rash was unknown. It was unknown if the reporter considered the varicella-like rash to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The healthcare professional stated, the patient was given Shingrix and developed a few isolated spot two days later that resembled chicken pox. The healthcare professional did not have vaccine information.

0No event

Headache, extreme body aches, chills, slight fever, slight nausea all began approximately 9 hours after receiving the vaccine. and lasted approximately 72 hours. Within 48 hours site became sore and red. this lasted 5 days after receiving the vaccine.

0No event

0.25ML GIVEN. NO ADVERSE EVENTS NOTED

0No event

Received MMR 3/19/03 and on 3/22/03 developed 101 deg fever which continued thru 3/25/03. Also c/o joint pain, developing rash on arms, leg, torso that is itching and large welts with blisters (hives). ER staff told client she probably had allergic reaction to hives. Went to ER on 3/25/03 - given Tylenol & Benadryl.

1ER_VISIT

Narrative: 77yo M patient w/ALS and was declining. He was hospitalized x2 07/2021 for respiratory distress/failure and it was decided during hospitalization the pt/family wanted home hospice care. PMH includes ALS, respiratory failure, untreat OSA, COPD, HTN, dyspnea, spasms BLE, constipation, seasonal allergies, increased oral secretions. Pt admitted to home hospice on 8/17/2021. Pt died at home with home hospice on 9/11/21. Pt had received covid vaccines on 4/1/21 & 4/30/21. This death is likely not related to the vaccinations due to comorbidities, age, and length of time from vaccine administration.

7ER_VISIT, DIED

Pt. reported redness, swelling, tenderness and heat to injection site (left subcutaneous tissue). Pt. arrived to clinic to report symptoms x 2 days. Pt. denies fevers. Pt. given at home care instructions.

0No event

Tingling on her mouth; Body ache; Fatigue; Chills; Throat and mouth felt weird; Shaky; Brain fog; Throat and mouth felt weird; Rapid heart beat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (Throat and mouth felt weird), NERVOUSNESS (Shaky), FEELING ABNORMAL (Brain fog), ORAL DISCOMFORT (Throat and mouth felt weird) and TACHYCARDIA (Rapid heart beat) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Graves' disease, Vitamin D deficiency and Latex allergy. Concomitant products included THIAMAZOLE (TAPAZOLE), VITAMIN D3 and LORATADINE (CLARITINE) for an unknown indication. On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2020, the patient experienced OROPHARYNGEAL DISCOMFORT (Throat and mouth felt weird), NERVOUSNESS (Shaky), FEELING ABNORMAL (Brain fog), ORAL DISCOMFORT (Throat and mouth felt weird), TACHYCARDIA (Rapid heart beat), MYALGIA (Body ache), FATIGUE (Fatigue) and CHILLS (Chills). On 31-Dec-2020, the patient experienced PARAESTHESIA ORAL (Tingling on her mouth). On 31-Dec-2020, OROPHARYNGEAL DISCOMFORT (Throat and mouth felt weird), NERVOUSNESS (Shaky), FEELING ABNORMAL (Brain fog), ORAL DISCOMFORT (Throat and mouth felt weird) and TACHYCARDIA (Rapid heart beat) had resolved. In January 2021, MYALGIA (Body ache), FATIGUE (Fatigue) and CHILLS (Chills) had resolved. At the time of the report, PARAESTHESIA ORAL (Tingling on her mouth) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2020, Heart rate: (High) 150 beats per minute. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow-up added on 27-APR-2021, medical history provided, vaccine date updated, second dose details added, new events added

0No event

Patient is under age 12 but was given the COVID vaccine for ages 12+. When this was discovered, the parent was called to check in on on the patient. Parent reported arm redness/swelling and more fatigue than previous vaccines. Vaccine was administered on 10/19/23. As of 10/22/23, mom reports the patient is better and symptoms had resolved.

0No event

PT HAS BEEN COMPLAING OF CHILS AND BOYACHES AND CONTINUOUS FATIGUE WHICH HAS LASTED UNTIL TODAY

0No event

TEMPERATURE EXCURSION WITH VACCINE ADMINISTERED , OUTCOME UNKNOWN

0No event

None stated

0No event

Error: Wrong Dose of Vaccine - Too High

0No event

Suddenly had a fever over 99 degrees and developed hives significant in size. The hives would disappear and then reappear on another part of his body, but the hives appeared all over him at once. A single hive could reach the size of one half of his entire leg from hip to ankle.

1ER_VISIT

Pt.'s wife states 06/29/2021 husband received Phizer vaccine 10:00am and then was notified of receiving 6x the normal dosage required @ 11:00am. No known symptoms presently presently (currently under supervision).

0No event

Light headache, dizziness, low blood pressure (100/64 mmHg)

0No event

Bright red cheeks; Throbbing; Bad ear ache; had a little bit of a headache; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Bright red cheeks), PAIN (Throbbing), EAR PAIN (Bad ear ache) and HEADACHE (had a little bit of a headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The patient's past medical history included Trigeminal neuralgia since an unknown date. Concurrent medical conditions included Drug allergy, Drug allergy, Drug allergy and Drug allergy. Concomitant products included INSULIN DEGLUDEC (TRESIBA), SEMAGLUTIDE (OZEMPIC), SOTALOL, APIXABAN (ELIQUIS), HYDROCODONE, ATORVASTATIN, CENTRUM SILVER +50 and VALACICLOVIR HYDROCHLORIDE (VALTREX) for an unknown indication. On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced ERYTHEMA (Bright red cheeks), PAIN (Throbbing), EAR PAIN (Bad ear ache) and HEADACHE (had a little bit of a headache). At the time of the report, ERYTHEMA (Bright red cheeks), PAIN (Throbbing), EAR PAIN (Bad ear ache) and HEADACHE (had a little bit of a headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Body temperature: high Farad (High) Temperature of 101 F. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.

0No event

Noted soreness in RT shoulder am of 21st. Then developed 102 fever, body aches, swelling, noted shoulder size increased size of "baseball", redness developed - spreading down to RT elbow. Dev. nausea and vomited on 22nd. Felt fatigued/miserable. Used ice/head on shoulder as palpable "hard" spot. Noted evening 23rd area decrease 2 redness down to elbow. Returned to clinic on 24th with symptoms currently.

1ER_VISIT

AIDP, NMO, TM, DEVIC - symptoms started 12/2012 after flu vaccine. Immune therapy treatments is on going.

2ER_VISIT, HOSPITAL

1AUG91 1AM by mom's report pt awakened, tried to get up but couldn't; noticed exaggerated shaking; Lasted approx 2 min; Fell on floor getting out of bed;

1ER_VISIT

This case was reported by a nurse and described a 33 year old male patient who did not respond to the Hepatitis B vaccine recombinant immunization series. On an unspecified date in 2002 or 2003, the patient received the third dose of Engerix-B. Approximately 6 to 12 weeks later a Hepatitis B surface antibody titer was negative. The nurse stated that "All injections were given intramuscularly in the deltoid muscle with a 1 inch needle. All vaccine is refrigerated and the temperature is monitored daily. The nurse considered the event to be probably related to vaccination with Engerix-B.

0No event

Patient said she felt a nerve type when right after the shot. She stated the pain started in her neck and went into her head and then down her back and to her rectum and felt like it was pulling her down and her legs became very heavy.

0No event

This spontaneous report was received from a doctor of pharmacy refers to a 69-year-old male patient with no pertinent medical history and drug reactions/allergies. On 15-OCT-2012 the patient was vaccinated with 0.5 milliliter (ml) PNEUMOVAX 23 (lot # 1947AA), expiration date 20-OCT-2013) intramuscularly (IM). Concomitant medications included unspecified blood pressure medication. Patient experiencing stinging, soreness and pain at the injection site after receiving PNEUMOVAX 23 on 15-OCT-2012. Pharmacist also reported that the patient stated that he had been experiencing cramping in the left arm where he received the injection of PNEUMOVAX 23 and that the cramping moved down from his shoulder to his hand and is described as quick cramps or a twitching feeling. No treatment was given for the events. No lab diagnostic studies were performed. The patient sought medical attention by contacting the pharmacist. The events did not resolve at the time of this report. No further information is available. Additional information has been requested.

0No event

Patient was given a Men Bexero vaccination instead of intented MenQuadfi Vaccine.

0No event

(L) upper arm Cellulitis

0No event

PMR Polymyalgia Rheumatica-severe pain in arm and shoulder, neck, hips trouble walking at first, also extreme fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: penacyllin" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: DULOXETINE; HYDROCODONE; PRAVASTATIN; TRAZODONE. Patient was tested for COVID post vaccination (unknown results). Past drug history included: Immetrex, reaction(s): "Drug allergy". Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 2, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 3 (booster), manufacturer unknown), for COVID-19 immunization. The following information was reported: POLYMYALGIA RHEUMATICA (disability, medically significant) with onset 04Oct2022, outcome "recovered with sequelae", described as "PMR Polymyalgia Rheumatica-severe pain in arm and shoulder, neck, hips trouble walking at first, also extreme fatigue". The events "pmr polymyalgia rheumatica-severe pain in arm and shoulder, neck, hips trouble walking at first, also extreme fatigue" required physician office visit. Therapeutic measures were taken as a result of polymyalgia rheumatica which included steroids. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.

0No event

Member noted usual redness around the site of vaccination 26JAN10. On the eve of 27JAN10, noted his arm was red, itchy, and swollen with numbness in left hand. Seen in urgent care center @ Hospital. He was given IV fluids and Levaquin 500mg per IV. He did have Labs drawn (CBC,blood cultures, CK) He was released and sent back to training with followup in clinic next day.

1ER_VISIT

Mom stated child got very sick. Had fever of 100.3 with TYLENOL and MOTRIN. Had flu-like symptoms within 1 to 2 hrs of administration of vaccine-Saw MD next morning- did strep screen neg-.

1ER_VISIT

Acute pericarditis. Symptoms (pain on left side of chest, going up to shoulder) began evening of 10/10, three days after Pfizer booster. Went to urgent care on 10/11. They suggested I go to an ER.

1ER_VISIT

Myocarditis Managed with ibuprofen and monitoring Sx resolved in 1 day Trponins trended down in 3 days

4HOSPITAL

patient received vaccination at 1:00 pm patient called into pharmacy stating he was starting to have hives with 4 present. No respiratory difficulty. Patient was advised to go directly to the Emergency Department. Phone call to Emergency Department to notify them of patient's need to be seen at their facility.

1ER_VISIT

Redness on arm 50 mm and fever x 2 hrs.

0No event

Covid Pneumonia; covid virus/tested positive for the covid virus; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 15Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received, 1st dose Pfizer covid vaccine 15Feb2021, and in between 1st and 2nd dose, she got covid virus. The patient tested positive for the covid virus on 22Feb2021, went to ER on that Friday, found covid in her lungs, Diagnosed with Covid Pneumonia. The patient is scheduled on 08Mar2020, the patient wants some advice on pushing it back, and if and when she should get it. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

1ER_VISIT

Redness, swelling, itching, warmth.

0No event

Patient had vaccines 2/28/14 then 4 days later developed vomiting and diarrhea. Weight loss = 6 oz.

1ER_VISIT

Fainted in 3 mts after the vaccine administration. Tech helped the patient to sit.Then he was fine talking. He did mention that he did not eat anything before coming for the vaccine.Called 911.All vital signs were tested and were good.

0No event

From an initial report received on 12/4/00, it was reported that a 38 year old male was given Menomune A/C/Y/W-135 on 11/29/00. On 11/30/00, it was reported that the pt experienced "generalized red rash. Pt was evaluated in an ER and treated with Zantac and Prednisone pack. Rash is resolving at this time. The pt had been on religious fast and rash occurred after eating". Follow-up information received on 3/27/01, reported on "12/4/00 (pt) called and said that he started to develop a raised, reddened rash on Friday night (12/1/00) after he ate. This is the month of Ramadan and he is fasting every day. The rash started in the axilla area and spread down his torso and into his legs. He also complained of abdominal pain that started at the same time. He went to the ER and received Zantac and a dose-pak of Prednisone. The medication is helping but every night the symptoms, although lessening, reoccur after he has broken his fast of the day and eaten. He is concerned that this may be related to the meningococcal vaccine. On 12/8/00, I called (the pt) and the symptoms have completely subsided." Additional pt, responsible physician and vaccine information was provided. The date of vaccination is listed as 11/28/00. Reportedly, the pt recovered from this experience.

1ER_VISIT

Chills, shaking, sweating, severe headache

0No event

Swelling and soreness in the arm of the injection site on 04/16/2021. On 05/22/2021 severe knee pain and joint pain in the left knee. I saw Dr. on 05/25/2021, he thought it was arthritis. Pain medication- tramadol hcl 50 mg, every 6 hrs. as needed, cream Diclofenac sodium topical Gel 1 %. I had not had any pain prior to the vaccine. It could have been an underlying condition that was brought out by the vaccine. When the left knee first flared up I could hardly walk, but it has gotten better.

0No event

Headaches, Fatigue

0No event

Headaches and migraines

0No event

The evening of 03/20/2021 the left side of my mouth began feeling numb and my left eye was drooping slightly. The morning of 03/21/2021 I could not close my left eye or the left side of my mouth. I went to the ER that morning and was diagnosed with Bells Palsy. I was given Prednisone and Acyclovir tablets. As of today, 04/10/2021 I still have very slight paralysis on the left side of my face.

1ER_VISIT

pt recv vax 15MAY98 & the next day pt exp muscle aches on rt side of the body;

0No event

Friday morning I woke up with a headache. I then noticed my lymph node was swollen on my left side of my lower neck. My doctor prescribed me a Z pack. Headache still went on till Sunday. Saturday I noticed the rash on my left arm where I had the vaccine. Sunday it became bigger and started to tingly. Monday morning rash is still there and now it's itchy.

0No event

She maybe had a sore arm for 2 days, 3 days max with the second one/ arm hurt a little more; With the second one maybe a little tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (Batch/Lot number: unknown) as dose 2, single. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "She maybe had a sore arm for 2 days, 3 days max with the second one/ arm hurt a little more"; FATIGUE (non-serious), outcome "unknown", described as "With the second one maybe a little tired". Additional information: The patient maybe had a sore arm for 2 days, 3 days max with the second one. With the first one there was nothing to report. With the second one maybe a little tired and arm hurt a little more. The patient had the last shot on 16Mar so it was waning. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202101324789 Same patient and drug, different event separated in time

0No event

Vaccination failure; She tested positive for COVID, and She says that she was having very mild symptoms like congestion and achiness; Started having chest discomfort; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Started having chest discomfort), VACCINATION FAILURE (Vaccination failure) and COVID-19 (She tested positive for COVID, and She says that she was having very mild symptoms like congestion and achiness) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 013L20A) for COVID-19 vaccination. The patient's past medical history included Open heart surgery (when she was 5, but that issue was resolved and she has not had any problems in decades.). Concomitant products included MULTIVITAMIN [VITAMINS NOS], IRON and CALCIUM for an unknown indication. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced CHEST DISCOMFORT (Started having chest discomfort). On 06-Nov-2021, the patient experienced VACCINATION FAILURE (Vaccination failure) and COVID-19 (She tested positive for COVID, and She says that she was having very mild symptoms like congestion and achiness). On 19-Mar-2021, CHEST DISCOMFORT (Started having chest discomfort) had resolved. At the time of the report, VACCINATION FAILURE (Vaccination failure) and COVID-19 (She tested positive for COVID, and She says that she was having very mild symptoms like congestion and achiness) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Blood test: normal (normal) all test results came back as normal.. On 17-Mar-2021, Chest X-ray: normal (normal) all test results came back as normal.. On 17-Mar-2021, Electrocardiogram: normal (normal) all test results came back as normal.. On 17-Mar-2021, Exercise electrocardiogram: normal (normal) all test results came back as normal.. On 17-Mar-2021, Myocardial necrosis marker: normal (normal) all test results came back as normal.. On 06-Nov-2021, COVID-19: positive (Positive) Positive. Patient reported that started experiencing chest discomfort which prompted to go to the ER. describes it simply as chest discomfort and not pain Treatment information was not reported. Company Comment: This is an Spontaneous case concerning a 54-year-old female patient, with no relevant medical history reported, who experienced the non-serious unexpected AESI of COVID-19, approximately 9 months and 18 days after the administration of the second dose of the mRNA-1273 vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is an Spontaneous case concerning a 54-year-old female patient, with no relevant medical history reported, who experienced the non-serious unexpected AESI of COVID-19, approximately 9 months and 18 days after the administration of the second dose of the mRNA-1273 vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.

1ER_VISIT