chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus started in right ear approximately 2 weeks after 3rd vaccine. It has not gone away.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Dec2021 15:15 (Lot number: FD0810) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Only Graves Disease" (unspecified if ongoing); "covid-19" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP7533, Location of injection: Arm Left, Vaccine Administration Time: 13:30), administration date: 09Apr2021, when the patient was 61 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534, Location of injection: Arm Left, Vaccine Administration Time: 13:45), administration date: 19Mar2021, when the patient was 61 years old, for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset 26Dec2021, outcome "not recovered", described as "Tinnitus started in right ear approximately 2 weeks after 3rd vaccine. It has not gone away.". The event "tinnitus started in right ear approximately 2 weeks after 3rd vaccine. it has not gone away." was evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus.  Additional information: The most recent COVID-19 vaccine was administered at Pharmacy or drug store facility. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Nature Thyroid as other medications within 2 weeks of vaccination. Since the vaccination, patient had not tested for COVID-19. The seriousness was reported as non-serious.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pancreatic disorder, Renal disorder, Vision blurred
Clinical narrative: blurry vision; Experiencing issues with pancreas/kidneys; Experiencing issues with pancreas/kidneys; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative.  An elderly female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 Immunization. The following information was reported: VISION BLURRED (non-serious), outcome "not recovered", described as "blurry vision"; PANCREATIC DISORDER (non-serious), RENAL DISORDER (non-serious), outcome "not recovered" and all described as "Experiencing issues with pancreas/kidneys".  Additional Information: Prior to vaccination, the patient was diagnosed with COVID-19. Unknown if the patient been tested for COVID-19, Since the vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: first dose she had severe pains in the left side of her neck; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 11:00 (Lot number: EN6202) at the age of 77 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Swine flu vaccine (Couldn't use her legs), for she couldn't use her legs. The following information was reported: NECK PAIN (non-serious) with onset Feb2021, outcome "not recovered", described as "first dose she had severe pains in the left side of her neck".  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had a terrible reaction to the Swine flu vaccine years ago and she couldn't use her legs, has no product information for this vaccine she had the reaction to. States she is otherwise very healthy, states she has never drank or smoked and exercises and eats healthy.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200510888 Same patient and product, different dose;US-PFIZER INC-202200510889 Same patient and product, different dose
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: has severe pain in her arm and feels that she can no longer more,; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, unknown manufacturer), for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "has severe pain in her arm and feels that she can no longer more,".  Additional information: My mother was vaccinated with her vaccine against covid, and it has been 7 months since the second dose. Lately my mother has severe pain in her arm and feels that she can no longer more, the pain you feel in your arm is very intense and I need your prompt help, please.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test date=26Nov2021 / covid test result=Positive; covid test date=26Nov2021 / covid test result=Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Feb2021 (Lot number: el8987) at the age of 69 years as dose 2, single and administration date 29Jan2021 (Lot number: EL9266) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: trees" (unspecified if ongoing); "Meniere's ear" (unspecified if ongoing), notes: 20 years ago. Concomitant medication(s) included: LEVOXYL. There was no other vaccine in four weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Nov2021, outcome "unknown" and all described as "covid test date=26Nov2021 / covid test result=Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Nov2021) positive, notes: Nasal swab.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test result=Positive; covid test result=Positive; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 46 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 29Oct2021 (Lot number: FF2589) at the age of 45 years as dose 3 (booster), single, administration date 17Feb2021 (Lot number: EL3247) as dose 2, single and administration date 27Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No covid prior vaccine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Apr2022, outcome "unknown" and all described as "covid test result=Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Mar2022) negative; (01Apr2022) positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Tuesday evening started to get sick fatigue Ag test neg - then Ag test positive Friday 01Apr as not feeling well and tested positive. No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event covid test result=Positive and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Nausea, SARS-CoV-2 test, Vomiting
Clinical narrative: massive nausea; headache; vomiting; diarrhea; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Oct2021 (Batch/Lot number: unknown) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; WELLBUTRIN. Past drug history included: Known allergies: reglan, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right), administration date: 18Jan2021, when the patient was 46 years old, for Covid-19 immunization, reaction(s): "Massive nausea", "Headache", "Low grade fever"; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), for Covid-19 immunization, reaction(s): "Headache", "Massive nausea". The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "massive nausea"; HEADACHE (non-serious), outcome "unknown", described as "headache"; VOMITING (non-serious), outcome "unknown", described as "vomiting"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nausea, headache, vomiting, diarrhoea.  Additional Information: Patient occupation other health professional. Lot number was unable to locate or read the details. Facility type vaccine reported as hospital. It was unknown if other vaccine in four weeks. Adverse event reported as first dose, massive nausea and headache, second dose same, with low grade fever, third dose same, with nausea, vomiting and diarrhea. Have had daily headaches since first dose. No if covid prior vaccination. Covid was tested post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: long-lasting headache; 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 female patient received bnt162b2 (COMIRNATY), administration date 31Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "long-lasting headache".  Additional information: Caller states that she has experienced long-lasting headache ever since she got the second dose of the Pfizer-BioNTech COVID-19 Vaccine. She had the second shot on 31Mar2021. Somewhere around May or June, She started getting these unrelenting headaches. They're always there. The salient difference in every other routine was the vaccine. There was nothing else that changed". She never had issues with headaches. She read somewhere, some abstracts, that the Moderna vaccine can cause something similar. Do you have information on sustained headaches caused by the Pfizer vaccine. Headache has been reported, but there's no info on how long it lasts (e.g. long-lasting headache). She was asking Were booster shots the same formulation as the other vaccines. It's been almost a year since she got the second dose. Do she need to start over or should she just get the booster dose. First, she was curious if there were any reported effects of the Pfizer Covid vaccine regarding headaches starting a substantial amount of time after the vaccine maybe a month or two later. How can she access that information. Caller states this was based on her experience however she was not sure if there was a connection. Caller states her second question, she had both vaccines, the last one was 31Mar2021, caller states she has not been boosted, her question was can she get a booster now or does she need to get the first and second dose again. Caller states she does not have a ton of time, just wants to make clear she does not have any clear connection between the vaccine and her experience, states she did find a report on the Moderna vaccine but it was all medical jumble, states there may have been a connection there. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, SARS-CoV-2 test
Clinical narrative: massive nausea; headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; WELLBUTRIN. Past drug history included: Reglan, reaction(s): "known allergies: Reglan". The following information was reported: NAUSEA (non-serious) with onset 29Dec2020, outcome "not recovered", described as "massive nausea"; HEADACHE (non-serious) with onset 29Dec2020, outcome "not recovered", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nausea, headache.  Additional information: Facility type vaccine: Hospital. If other vaccine in four weeks: Unknown. First dose, massive nausea and headache. Have had daily headaches since first dose. If covid prior vaccination: No. If covid tested post vaccination: Yes. Known allergies: Reglan. Other medical history: Hypothyroidism  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: massive nausea; headache; low grade fever; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Jan2021 (Batch/Lot number: unknown) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; WELLBUTRIN. Past drug history included: Reglan, reaction(s): "Allergies". Vaccination history included: Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer,, Prev dose brand unknown=False,, Previous dose lot unknown: True,, Previous dose Lot unknown reason: Unable to locate or read the details,, Prev dose number=1, Prev dose vaccine location: Left Arm,), for COVID-19 Immunization, reaction(s): "massive nausea"; Bnt162b2 (Prev dose brand=Pfizer,, Prev dose brand unknown=False,, Previous dose lot unknown: True,, Previous dose Lot unknown reason: Unable to locate or read the details,, Prev dose number=1, Prev dose vaccine location: Left Arm,), for COVID-19 Immunization, reaction(s): "headache".  The following information was reported: NAUSEA (non-serious), outcome "not recovered", described as "massive nausea"; HEADACHE (non-serious), outcome "not recovered", described as "headache"; PYREXIA (non-serious), outcome "not recovered", described as "low grade fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nausea, headache, pyrexia.  Additional information: Vaccine was administered at hospital. First dose, massive nausea and headache, second dose same, with low grade fever, third dose same, with nausea, vomiting and diarrhea. Have had daily headaches since first dose. AE did not result in emergency room or physician office visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: cold-like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program (174529). The reporter is the parent.  A 30-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold-like symptoms".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: Elevetated blood pressure; 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), administration date 31Mar2022 (Batch/Lot number: unknown) as dose 4 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN, No side effects), for COVID-19 Immunization, reaction(s): "No side effects"; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN, No side effects), for COVID-19 Immunization, reaction(s): "No side effects"; Covid-19 vaccine (Dose 3, MANUFACTURER UNKNOWN, No side effects), for COVID-19 Immunization, reaction(s): "No side effects". The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 31Mar2022, outcome "not recovered", described as "Elevetated blood pressure". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient declined to complete a reporter, he doesn't even know if this is a side effect from the vaccine, he had the other 3 and had no side effects, but this one he just noticed when he took his blood pressure it was elevated. Patient just got the 2nd Booster shot yesterday, and he noticed last night that he had an elevated blood pressure and the same thing this morning. Patient stated he would just like to talk to someone who could tell him if this was related to the vaccine. Additional details and clarifications unable to be obtained.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: Sweaty; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CRESTOR. 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. The following information was reported: HYPERHIDROSIS (non-serious), outcome "unknown", described as "Sweaty".  Additional information: Patient mentioned that she started taking "-statin, which is a generic for Crestor" after the third dose; however, patient cannot verify the exact date as she mentioned she cannot exactly remember it but she also mentioned that she was taking "5mg and was increased to 10mg before the first booster." Patient also mentioned "November" but she cannot confirm this information. Patient wanted to know if taking "statin" was related to the COVID vaccine. Patient stated that she feel a little better, but she was sweaty and just wanted to let Pfizer know that she experienced this. After providing response about the potential interaction of "Crestor and/or -statins", patient mentioned that it was just a minor side effect and it was probably too early to know if there are reported side effects from the second booster dose. Patient also stated that she had already read information about the side effect from the internet.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Feeling abnormal
Clinical narrative: didn't feel good after 2nd dose of Pfizer Covid19 vaccine, his blood pressure went up after he had both doses; didn't feel good after 2nd dose of Pfizer Covid19 vaccine, his blood pressure went up after he had both doses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 52 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, My husband (52yr old) didn't feel good after 2nd dose of Pfizer Covid19 vaccine, his blood pressure went up after he had both doses.), for COVID-19 immunization, reaction(s): "blood pressure went up". The following information was reported: FEELING ABNORMAL (non-serious), outcome "not recovered", BLOOD PRESSURE INCREASED (non-serious), outcome "unknown" and all described as "didn't feel good after 2nd dose of Pfizer Covid19 vaccine, his blood pressure went up after he had both doses". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She has a consumer on the line who is calling on behalf of mother.  She got the Pfizer COVID 19 first dose and on her 2nd dose, she got sinus infection and when she received 3rd dose about a month ago, she came out with shingles and liver was swollen. Wants to know what can be done with it.  While reporting for her mother, caller stated that her husband had the Pfizer and won't get another one and does not feel well since.  She did not wish to create report for him and stated he would need to call himself. This report is to capture information for her husband.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Pain, Pain in extremity
Clinical narrative: body ache; chills; dizzy; arm was a little sore; Joint pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2022 11:00 (Lot number: FJ5682) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (ongoing), notes: Blood pressure high Diagnosed years ago; "allergic to penicillin" (unspecified if ongoing), notes: allergic to penicillin. Concomitant medication(s) included: NORVASC. The following information was reported: DIZZINESS (non-serious) with onset 24Mar2022, outcome "recovered" (24Mar2022), described as "dizzy"; PAIN (non-serious) with onset 26Mar2022 07:00, outcome "recovering", described as "body ache"; CHILLS (non-serious) with onset 26Mar2022 07:00, outcome "unknown", described as "chills"; ARTHRALGIA (non-serious) with onset Mar2022, outcome "unknown", described as "Joint pain"; PAIN IN EXTREMITY (non-serious) with onset 23Mar2022, outcome "recovered" (23Mar2022), described as "arm was a little sore". Therapeutic measures were taken as a result of arthralgia.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Blood thyroid stimulating hormone, C-reactive protein, Echocardiogram, Electrocardiogram
Clinical narrative: developed myocarditis after a second dose of the Pfizer mRNA COVID-19 vaccine; This is a literature report for the following literature source(s): "RECOGNIZING AND MANAGING MYOCARDITIS FOLLOWING COVID-19 VACCINATION: MITIGATING RISK OF SUDDEN CARDIAC DEATH IN ATHLETES", Journal of the College of Cardiology, 2022; Vol:79 (9), pgs:2397, DOI:10.1016/S0735-1097%2822%2903388-5.  A 19 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19 infection" (unspecified if ongoing), notes: 6-8 months prior; with symptoms that included rhinorrhea, cough, anosmia, ageusia, and mild chest pain. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st single dose), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (medically significant, life threatening), outcome "recovering", described as "developed myocarditis after a second dose of the Pfizer mRNA COVID-19 vaccine". The event "developed myocarditis after a second dose of the pfizer mrna covid-19 vaccine" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: angiogram: normal; blood thyroid stimulating hormone: normal; c-reactive protein: normal; echocardiogram: normal left ventricular systolic function, notes: normal wall motion, and no pericardial effusion; electrocardiogram: 0.5-1mm st segment elevation in the inferior and, notes: and lateral leads; full blood count: normal; magnetic resonance imaging: minimal t2 signal elevation, but did reveal late, notes: gadolinium enhancement of 25-75 percentage of the inferior and lateral walls; metabolic function test: normal; physical examination: normal; sars-cov-2 test: positive; troponin: 3.61 ng/ml, notes: elevated and peaked; vital signs measurement: normal. Therapeutic measures were taken as a result of myocarditis included ibuprofen and beta blocker.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events MYOCARDITIS Cannot be 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
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Magnetic resonance imaging, Metabolic function test, Myocarditis, Physical examination
Clinical narrative: developed myocarditis after a second dose of the Pfizer mRNA COVID-19 vaccine; This is a literature report for the following literature source(s): "RECOGNIZING AND MANAGING MYOCARDITIS FOLLOWING COVID-19 VACCINATION: MITIGATING RISK OF SUDDEN CARDIAC DEATH IN ATHLETES", Journal of the College of Cardiology, 2022; Vol:79 (9), pgs:2397, DOI:10.1016/S0735-1097%2822%2903388-5.  A 19 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19 infection" (unspecified if ongoing), notes: 6-8 months prior; with symptoms that included rhinorrhea, cough, anosmia, ageusia, and mild chest pain. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st single dose), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (medically significant, life threatening), outcome "recovering", described as "developed myocarditis after a second dose of the Pfizer mRNA COVID-19 vaccine". The event "developed myocarditis after a second dose of the pfizer mrna covid-19 vaccine" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: angiogram: normal; blood thyroid stimulating hormone: normal; c-reactive protein: normal; echocardiogram: normal left ventricular systolic function, notes: normal wall motion, and no pericardial effusion; electrocardiogram: 0.5-1mm st segment elevation in the inferior and, notes: and lateral leads; full blood count: normal; magnetic resonance imaging: minimal t2 signal elevation, but did reveal late, notes: gadolinium enhancement of 25-75 percentage of the inferior and lateral walls; metabolic function test: normal; physical examination: normal; sars-cov-2 test: positive; troponin: 3.61 ng/ml, notes: elevated and peaked; vital signs measurement: normal. Therapeutic measures were taken as a result of myocarditis included ibuprofen and beta blocker.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events MYOCARDITIS Cannot be 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
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Troponin, Vital signs measurement
Clinical narrative: developed myocarditis after a second dose of the Pfizer mRNA COVID-19 vaccine; This is a literature report for the following literature source(s): "RECOGNIZING AND MANAGING MYOCARDITIS FOLLOWING COVID-19 VACCINATION: MITIGATING RISK OF SUDDEN CARDIAC DEATH IN ATHLETES", Journal of the College of Cardiology, 2022; Vol:79 (9), pgs:2397, DOI:10.1016/S0735-1097%2822%2903388-5.  A 19 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19 infection" (unspecified if ongoing), notes: 6-8 months prior; with symptoms that included rhinorrhea, cough, anosmia, ageusia, and mild chest pain. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st single dose), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (medically significant, life threatening), outcome "recovering", described as "developed myocarditis after a second dose of the Pfizer mRNA COVID-19 vaccine". The event "developed myocarditis after a second dose of the pfizer mrna covid-19 vaccine" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: angiogram: normal; blood thyroid stimulating hormone: normal; c-reactive protein: normal; echocardiogram: normal left ventricular systolic function, notes: normal wall motion, and no pericardial effusion; electrocardiogram: 0.5-1mm st segment elevation in the inferior and, notes: and lateral leads; full blood count: normal; magnetic resonance imaging: minimal t2 signal elevation, but did reveal late, notes: gadolinium enhancement of 25-75 percentage of the inferior and lateral walls; metabolic function test: normal; physical examination: normal; sars-cov-2 test: positive; troponin: 3.61 ng/ml, notes: elevated and peaked; vital signs measurement: normal. Therapeutic measures were taken as a result of myocarditis included ibuprofen and beta blocker.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events MYOCARDITIS Cannot be 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
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: Ringing in ears started after injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Oct2021 13:00 (Lot number: FE3590) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Seasonal allergies" (unspecified if ongoing), notes: Other medical history: Seasonal allergies; "Known allergies: Sulfur" (unspecified if ongoing); "Known allergies: metals" (unspecified if ongoing). Concomitant medication(s) included: AMOXICILLIN. Past drug history included: Nubain, reaction(s): "Known allergies: Nubain". Vaccination history included: Bnt162b2 (previous dose product: COVID 19, brand: Pfizer , lot number: EW0150, administration time: 02:00 PM, dose number: 2, dose vaccine location: Left arm), administration date: 09Apr2021, when the patient was 61 years old, for Covid-19 Immunization; Bnt162b2 (previous dose product: COVID 19, brand: Pfizer Covid Vaccine, lot number: ER8727 , dose administration time: 03:45 PM, dose number: 1, dose vaccine location: Left arm), administration date: 19Mar2021, when the patient was 61 years old, for Covid-19 Immunization.  The following information was reported: TINNITUS (non-serious) with onset 09Oct2021 12:00, outcome "not recovered", described as "Ringing in ears started after injection". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus.  Additional information: Facility type vaccine was reported as Pharmacy or Drug Store. Patient did not receive any other vaccines in four weeks. Ringing in ears started 30 hrs after injection. Patient had no covid prior vaccination and post vaccination patient tested covid. Covid test type post vaccination: Nasal Swab, Covid test name post vaccination: PCR. Covid test date: 30Nov2021 with unknown result. Event was assessed as non-serious.  Follow-up attempts completed. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling, SARS-CoV-2 test
Clinical narrative: Pain in left arm; fluid built up on muscle; loss of mobility was back; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Jan2022 14:00 (Batch/Lot number: unknown) at the age of 50 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. Past drug history included: Aspirin [acetylsalicylic acid], reaction(s): "Drug hypersensitivity", notes: Known allergies: Aspirin. Vaccination history included: Covid-19 vaccine (Primary immunization complete. Unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 03Jan2022, out-come "not recovered", described as "Pain in left arm"; PERIPHERAL SWELLING (non-serious) with on-set 03Jan2022, outcome "not recovered", described as "fluid built up on muscle"; MOBILITY DE-CREASED (non-serious) with onset 2022, outcome "not recovered", described as "loss of mobility was back". The events "pain in left arm", "fluid built up on muscle" and "loss of mobility was back" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, peripheral swelling, mobility decreased.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Serious, Seriousness criteria-Results in death, Seriousness criteria-Life threatening, Seriousness criteria-Caused/prolonged hospitalization, Seriousness criteria-Disabling/Incapacitating, Seriousness criteria-Congenital anomaly/birth defect all were reported as no. Facility where the most recent COVID-19 vaccine was administered: (withheld). Reported Event: Booster shot on 03Jan pain in left arm after a month still pain and fluid built up on muscle.  Dr. Gave a topical gel and that didn't help, than I was given an oral steroid for 5 days felt better for a week than pain and loss of mobility was back now on 29Mar a steroid injection into the muscle. Hospitalization Prolonged: No. What treatment received for the adverse event? Topical gel, oral steroids, and now shot in muscle  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Left hand paresthesias; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Mar2022 (Lot number: Fk9895) at the age of 16 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Covid diagnosed between 2nd vaccine and booster" (unspecified if ongoing); "known allergies: Tree nuts" (unspecified if ongoing), notes: known allergies: Tree nuts. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Fc3182), administration date: 21Aug2021, when the patient was 16 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0186), administration date: 21Jun2021, when the patient was 15 years old, for COVID-19 Immunization. The following information was reported: PARAESTHESIA (non-serious) with onset 07Mar2022, outcome "not recovered", described as "Left hand paresthesias". The event "left hand paresthesias" was evaluated at the physician office visit. Therapeutic measures were taken as a result of paresthesia.  Additional information: Report was about COVID vaccine. Yes other vaccine in four weeks. Adverse event: I have been experiencing extreme hair loss since my second dose of the Pfizer Vaccine, AE resulted in: [Doctor or other healthcare professional office/clinic visit] AE: treatment Physical therapy had been ordered, Known allergies : Tree nuts, Yes had COVID prior vaccination.  Follow-Up (05Apr2022): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: fever; aches; headache; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 57 year-old male patient received bnt162b2 (BNT162B2), administration date 31Mar2022 08:00 (Batch/Lot number: unknown) at the age of 57 years as dose 4 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATENOLOL. Vaccination history included: Covid-19 vaccine (DOSE 1,2,3; MANUFACTUERER UNKNOWN), for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 2022, outcome "recovering", described as "fever"; PAIN (non-serious) with onset 2022, outcome "recovering", described as "aches"; HEADACHE (non-serious) with onset 2022, outcome "recovering", described as "headache"; NAUSEA (non-serious) with onset 2022, outcome "recovering", described as "nausea". Therapeutic measures were not taken as a result of pyrexia, pain, headache, nausea.  Additional information: Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: atenolol. Prior to vaccination, was the patient diagnosed with COVID-19?:No. Since the vaccination, has the patient been tested for COVID-19?:No. Device Date : 01Apr2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Lethargy
Clinical narrative: Fatigue - feeling drained of all energy, very tired; Very lethargic; Chills; Chills - randomly getting sensations of being cold, even though on average I tend to always feel like I'm on the warmer side.; This is a spontaneous report from a contactable reporter (Other healthcare professional). The reporter is the patient.  A 30-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in left arm, administration date 24Dec2021 (Lot number: FJ1611) at the age of 30 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Appendectomy" (unspecified if ongoing), notes: Appendectomy and "Normal birth" (unspecified if ongoing), notes: natural birth of healthy daughter. Concomitant medications included: GENERIC ALLEGRA; ASHWAGANDHA, FISH OIL and THE MANE CHOICE HEALTHY HAIR VITAMIN MANETABOLISM PLUS.  The following information was reported: FATIGUE (non-serious) with onset 25Dec2021, outcome "recovered", described as "Fatigue - feeling drained of all energy, very tired"; LETHARGY (non-serious) with onset 25Dec2021, outcome "recovered", described as "Very lethargic"; CHILLS (non-serious) with onset 25Dec2021, outcome "recovered", described as "Chills"; FEELING COLD (non-serious) with onset 25Dec2021, outcome "recovered", described as "Chills - randomly getting sensations of being cold, even though on average I tend to always feel like I'm on the warmer side". Therapeutic measures were not taken as a result of fatigue, lethargy, chills and feeling cold.  Additional information: Body weight was reported as 280ish and height 72". It was reported that the patient had no other medical anything. Known allergies was reported as 'none known'. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The patient also received bnt162b2 (BNT162B2), intramuscular, administered in left arm, administration date 22Jan2022 (Lot number: FJ6369) at the age of 30 years as dose 2, single for COVID-19 immunisation.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: Pulsatile tinnitus in one ear; This is a spontaneous report from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 60-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 20Mar2021 (Lot number: EP7534) at the age of 59 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EN6198, Anatomical location: Left arm), administration date: 27Feb2021, when the patient was 59 years old, for COVID-19 immunisation.  The following information was reported: TINNITUS (non-serious) with onset 03Dec2021, outcome "recovered", described as "Pulsatile tinnitus in one ear". The event "Pulsatile tinnitus in one ear" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.