chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 63-year-old patient received BNT162b2 (BNT162B2), on 05Apr2022 at 16:39 as dose 4 (booster), single (Lot number: FP4554, Expiration Date: 30Jul2022) at the age of 63 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Lung Cancer", start date: Oct2019 (unspecified if ongoing); "R lower Lobectomy", start date: Feb2020 (unspecified if ongoing), notes: R lower Lobectomy; "Cholesterol" (unspecified if ongoing); "Rash-Herpes" (unspecified if ongoing); "Rash-Herpes" (unspecified if ongoing). Concomitant medication(s) included: FAMVIR [FAMCICLOVIR] oral taken for herpes zoster, rash, start date: 1999 (ongoing); REPATHA subcutaneous taken for blood cholesterol, start date: 2021 (ongoing). Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); unknown manufacturer), for COVID-19 Immunization. The following information was reported: EAR PAIN (non-serious) with onset Apr2022, outcome "not recovered"; PAIN IN JAW (non-serious) with onset Apr2022, outcome "not recovered", described as "Jaw pain"; TOOTHACHE (non-serious) with onset Apr2022, outcome "not recovered", described as "Teeth pain". The events "teeth pain", "ear pain" and "jaw pain" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of toothache, ear pain, pain in jaw. Additional information: The patient did not receive prior vaccinations within four weeks. The patient underwent physical therapy in May2022 for jaw pain and acupuncture in Jun2022 for ear pain. The patient reported that pain started in Apr2022 and was still in pain. It was also reported that the patient went to physical therapy for ear, jaw, teeth pain and went to Chiropractor for acupuncture. The patient received treatment with steroids for the events.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 65 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 25Jun2022 as dose 4 (booster), single (Lot number: 058A222A) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Tested positive 5 days after Paxlovid course; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 29Mar2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 28Aug2022, outcome "not recovered", described as "Tested positive 5 days after Paxlovid course"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Tested negative for the last 4 days; (unspecified date) Negative, notes: Tested negative for the last 4 days; (unspecified date) Negative, notes: Tested negative for the last 4 days; (unspecified date) Negative, notes: Tested negative for the last 4 days; (28Aug2022) Positive, notes: Tested positive 5 days after Paxlovid course. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of disease recurrence. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "recovered", described as "Dizzy". Additional information: States that 2  days ago she had her 2nd Pfizer shot and her 26-year-old granddaughter said to go home and don't do anything, just to go home and relax and get a good nights sleep and that she hopes she doesn't get sick like she was. During report caller states she personally knows of 2 people that have experienced dizziness after the shot but theirs went away. They both have the Pfizer COVID shot. One lady is a receptionist for her son and her mother in law was dizzy with the shot. She was worse than the caller but came back perfectly after going through it worse. Caller declines to report. States both had the Pfizer COVID vaccine. Expiry Date of Pfizer COVID shot: Not Provided. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive for Covid; positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   A 56-year-old female patient received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Batch/Lot number: unknown), on 22Feb2021 as dose 2, single (Batch/Lot number: unknown), on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: She tested positive for Covid. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, SARS-CoV-2 test
Clinical narrative: got booster in Dec2021 and now still can't taste 9 months later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Dec2021 as dose number unknown booster, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization complete-unknown number of doses; Lot number: Unknown; Route of administration: Unspecified), for COVID-19 immunisation. The following information was reported: AGEUSIA (non-serious) with onset 2021, outcome "not recovered", described as "got booster in Dec2021 and now still can't taste 9 months later". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient would like to know why the patient got the COVID vaccination in May2021 and could not taste for 4 months, got booster in Dec2021 and now still cannot taste 9 months later. The patient had never had COVID and test if the patient had symptoms and all negative, when will the patient get taste back.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: so dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (hospitalization), outcome "unknown", described as "so dizzy". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201099490 same reporter/drug, different patient/event;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid 19 after 4 Doses of the Covid 19 Vaccine; Tested positive for Covid 19 after 4 Doses of the Covid 19 Vaccine; 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 65-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Aug2022, outcome "not recovered" and all described as "Tested positive for Covid 19 after 4 Doses of the Covid 19 Vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid (Lot number: 6D8819. (nirmatrelvir tablets; ritonavir tablets) 300 mg; 100 mg) started on 29Aug2022 3 pills in the morning and 3 pills in the evening.  Clinical course: Tested positive for Covid 19 after 4 Doses of the Covid 19 Vaccine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; SARS-CoV-2 infection; Symptoms returned and we tested Pos; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "SARS-CoV-2 infection"; DISEASE RECURRENCE (medically significant), outcome "unknown", described as "Symptoms returned and we tested Pos". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive again for covid despite receiving the BNT162B2 vaccines; Negative, notes: tested Neg; Positive, notes: tested Pos. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Reporter stated that, the same for my brother who lives with us. We all wake up with scratchy throats, had fever and headaches during the night. Took the test and were all pos, called our Drs. Took the Paxlovid for 5 days, tested Neg. Then 3 and 4 days later symptoms returned and we tested Pos.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201022236 Same reporter/vaccine/event, different patient;US-PFIZER INC-PV202200053462 Same reporter/vaccine/event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: threw up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 26-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "threw up". Additional information: States that 2 (name withheld) days ago she had her 2nd Pfizer shot and her 26 year old granddaughter said to go home and do not do anything, just to go home and relax and get a good nights sleep and that she hopes she does not get sick like she was. Caller declines to report on her granddaughter. States she threw up and she is good now and perfectly fine. She had the Pfizer Covid shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Batch/Lot number: unknown), on 29Mar2021 as dose 2, single (Batch/Lot number: unknown), on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 31Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation; ezetimibe (ZETIA), (Batch/Lot number: unknown); atorvastatin calcium (LIPITOR), (Batch/Lot number: unknown). The patient's relevant medical history included: "high cholesterol" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: LEVOTHYROXINE SODIUM. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Aug2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Aug2022) Positive, notes: first positive test; (24Aug2022) Negative, notes: Tested negative for Covid; (25Aug2022) Negative, notes: Tested negative for Covid; (30Aug2022) Positive, notes: Tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19.COVID 19 Treatment start date was 18Aug2022 and stop date was 23Aug2022 with antiviral drug.  Clinical course: Patient took other medications in two weeks. Ongoing (although somewhat improving) fatigue since first positive test result on 18Aug2022. Sore throat returned overnight on 27Aug2022 and 28Aug2022 but went away after getting up both mornings and drinking. No sore throat the next day, but nasal congestion increased markedly overnight on 29Aug2022. Fatigue getting better but still not back to pre-Covid energy. Tested negative for Covid on 24Aug2022 and 25Aug2022. Tested positive again on 30Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: PNC20
Symptoms: Arthralgia, Headache, Vaccination site pain
Clinical narrative: Slight headache; my shoulder is sore at the injection site; my shoulder is sore at the injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Slight headache"; ARTHRALGIA (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "my shoulder is sore at the injection site".  Additional information: The patient had slight headache, did not have the bad adverse reaction but had headache and shoulder was sore at the injection site.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Disease Recurrence; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 at 09:45 as dose 1, single (Lot number: EL3248), in left arm, on 23Mar2021 at 09:45 as dose 2, single (Lot number: EL3248), in left arm and on 30Nov2021 at 09:15 as dose 3 (booster), single (Lot number: FF8839) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing), notes: other medical history: Anxiety. The patient's concomitant medications were not reported. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 30Aug2022, outcome "not recovered"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Aug2022) Negative; (26Aug2022) Negative; (30Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course included patient was tested positive for COVID on an at-home rapid test on day 12 after two negative tests on day 7 and 8. Mild congestion on day 12 after no symptoms for at least 5 days.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Experienced pain on her right arm where she got the dose.; 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 55-year-old female patient received BNT162b2 (COMIRNATY), on 29Apr2021 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "Experienced pain on her right arm where she got the dose.". Additional Information: The patient was a 55-year-old female who was 55 years old at the time of her vaccination. The patient received her 1st dose of Comirnaty last 29Apr2021 and experienced pain on her right arm where she got the dose. The patient said until now it was still hurting.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase, Blood creatine phosphokinase MB, Body temperature, Brain natriuretic peptide, Chest X-ray
Clinical narrative: Acute Myopericarditis; headache; myalgias; numbness; tingling; emesis; This is a literature report.  A 15-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "history of fever of 38.8degreeC" (unspecified if ongoing), notes: 1-day history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1), for COVID-19 immunisation. The following information was reported: MYOPERICARDITIS (hospitalization, medically significant, life threatening), 3 days after the suspect product(s) administration, outcome "unknown", described as "Acute Myopericarditis"; HEADACHE (non-serious), 3 days after the suspect product(s) administration, outcome "unknown"; MYALGIA (non-serious), 3 days after the suspect product(s) administration, outcome "unknown", described as "myalgias"; HYPOAESTHESIA (non-serious), 3 days after the suspect product(s) administration, outcome "unknown", described as "numbness"; PARAESTHESIA (non-serious), 3 days after the suspect product(s) administration, outcome "unknown", described as "tingling"; VOMITING (non-serious), 3 days after the suspect product(s) administration, outcome "unknown", described as "emesis". The event "acute myopericarditis" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood creatine phosphokinase: 399 IU/l; Blood creatine phosphokinase MB: 19 ng/ml; 174 ng/ml; Body temperature: 38.8 Centigrade, notes: history of fever of 38.8degreeC; Brain natriuretic peptide: less than 10; Chest X-ray: normal; Echocardiogram: normal; Electrocardiogram: normal sinus rhythm; All work-up for other potential causes: Negative; returned to baseline normal values; Magnetic resonance imaging heart: acute myopericarditis with a small pericardial, notes: effusion. Mild patchy delayed subepicardial enhancement was also noted in the mid cavity and basal posterolateral wall (suggestive of postinflammatory scarring related to localized myocarditis); Troponin I: 3.18 ng/ml, notes: elevated; 26 ng/ml. Therapeutic measures were taken as a result of myopericarditis.; 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 MYOPERICARDITIS 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: Echocardiogram, Electrocardiogram, Headache, Hypoaesthesia, Investigation
Clinical narrative: Acute Myopericarditis; headache; myalgias; numbness; tingling; emesis; This is a literature report.  A 15-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "history of fever of 38.8degreeC" (unspecified if ongoing), notes: 1-day history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1), for COVID-19 immunisation. The following information was reported: MYOPERICARDITIS (hospitalization, medically significant, life threatening), 3 days after the suspect product(s) administration, outcome "unknown", described as "Acute Myopericarditis"; HEADACHE (non-serious), 3 days after the suspect product(s) administration, outcome "unknown"; MYALGIA (non-serious), 3 days after the suspect product(s) administration, outcome "unknown", described as "myalgias"; HYPOAESTHESIA (non-serious), 3 days after the suspect product(s) administration, outcome "unknown", described as "numbness"; PARAESTHESIA (non-serious), 3 days after the suspect product(s) administration, outcome "unknown", described as "tingling"; VOMITING (non-serious), 3 days after the suspect product(s) administration, outcome "unknown", described as "emesis". The event "acute myopericarditis" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood creatine phosphokinase: 399 IU/l; Blood creatine phosphokinase MB: 19 ng/ml; 174 ng/ml; Body temperature: 38.8 Centigrade, notes: history of fever of 38.8degreeC; Brain natriuretic peptide: less than 10; Chest X-ray: normal; Echocardiogram: normal; Electrocardiogram: normal sinus rhythm; All work-up for other potential causes: Negative; returned to baseline normal values; Magnetic resonance imaging heart: acute myopericarditis with a small pericardial, notes: effusion. Mild patchy delayed subepicardial enhancement was also noted in the mid cavity and basal posterolateral wall (suggestive of postinflammatory scarring related to localized myocarditis); Troponin I: 3.18 ng/ml, notes: elevated; 26 ng/ml. Therapeutic measures were taken as a result of myopericarditis.; 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 MYOPERICARDITIS 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: Magnetic resonance imaging heart, Myalgia, Myopericarditis, Paraesthesia, Troponin I
Clinical narrative: Acute Myopericarditis; headache; myalgias; numbness; tingling; emesis; This is a literature report.  A 15-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "history of fever of 38.8degreeC" (unspecified if ongoing), notes: 1-day history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1), for COVID-19 immunisation. The following information was reported: MYOPERICARDITIS (hospitalization, medically significant, life threatening), 3 days after the suspect product(s) administration, outcome "unknown", described as "Acute Myopericarditis"; HEADACHE (non-serious), 3 days after the suspect product(s) administration, outcome "unknown"; MYALGIA (non-serious), 3 days after the suspect product(s) administration, outcome "unknown", described as "myalgias"; HYPOAESTHESIA (non-serious), 3 days after the suspect product(s) administration, outcome "unknown", described as "numbness"; PARAESTHESIA (non-serious), 3 days after the suspect product(s) administration, outcome "unknown", described as "tingling"; VOMITING (non-serious), 3 days after the suspect product(s) administration, outcome "unknown", described as "emesis". The event "acute myopericarditis" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood creatine phosphokinase: 399 IU/l; Blood creatine phosphokinase MB: 19 ng/ml; 174 ng/ml; Body temperature: 38.8 Centigrade, notes: history of fever of 38.8degreeC; Brain natriuretic peptide: less than 10; Chest X-ray: normal; Echocardiogram: normal; Electrocardiogram: normal sinus rhythm; All work-up for other potential causes: Negative; returned to baseline normal values; Magnetic resonance imaging heart: acute myopericarditis with a small pericardial, notes: effusion. Mild patchy delayed subepicardial enhancement was also noted in the mid cavity and basal posterolateral wall (suggestive of postinflammatory scarring related to localized myocarditis); Troponin I: 3.18 ng/ml, notes: elevated; 26 ng/ml. Therapeutic measures were taken as a result of myopericarditis.; 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 MYOPERICARDITIS 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: Vomiting
Clinical narrative: Acute Myopericarditis; headache; myalgias; numbness; tingling; emesis; This is a literature report.  A 15-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "history of fever of 38.8degreeC" (unspecified if ongoing), notes: 1-day history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1), for COVID-19 immunisation. The following information was reported: MYOPERICARDITIS (hospitalization, medically significant, life threatening), 3 days after the suspect product(s) administration, outcome "unknown", described as "Acute Myopericarditis"; HEADACHE (non-serious), 3 days after the suspect product(s) administration, outcome "unknown"; MYALGIA (non-serious), 3 days after the suspect product(s) administration, outcome "unknown", described as "myalgias"; HYPOAESTHESIA (non-serious), 3 days after the suspect product(s) administration, outcome "unknown", described as "numbness"; PARAESTHESIA (non-serious), 3 days after the suspect product(s) administration, outcome "unknown", described as "tingling"; VOMITING (non-serious), 3 days after the suspect product(s) administration, outcome "unknown", described as "emesis". The event "acute myopericarditis" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood creatine phosphokinase: 399 IU/l; Blood creatine phosphokinase MB: 19 ng/ml; 174 ng/ml; Body temperature: 38.8 Centigrade, notes: history of fever of 38.8degreeC; Brain natriuretic peptide: less than 10; Chest X-ray: normal; Echocardiogram: normal; Electrocardiogram: normal sinus rhythm; All work-up for other potential causes: Negative; returned to baseline normal values; Magnetic resonance imaging heart: acute myopericarditis with a small pericardial, notes: effusion. Mild patchy delayed subepicardial enhancement was also noted in the mid cavity and basal posterolateral wall (suggestive of postinflammatory scarring related to localized myocarditis); Troponin I: 3.18 ng/ml, notes: elevated; 26 ng/ml. Therapeutic measures were taken as a result of myopericarditis.; 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 MYOPERICARDITIS 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: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I have long COVID even though I m vaccinated 3 times; I have long COVID even though I m vaccinated 3 times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "heart condition" (unspecified if ongoing), notes: So I have, and a heart condition. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I have long COVID even though I m vaccinated 3 times".  Clinical course: During the call, the patient stated that patient was sick, became disabled. Patient got covid and had long covid even though vaccinated 3 times. Patient was supposed to get vaccinated, get fourth shot yesterday for second booster and patient had a flare up again. So, it gave all kinds of weird symptoms when had long covid. Patient petrified of it that had long covid because just a couple of days ago on the news they were talking about long Covid and they gave another slew of symptoms that are associated with long Covid. If patient needed another thing to make scared to death about dementia. As needed anything else to tell, patient could potentially get dementia. The fear was real and then they said the long Covid was showing dementia, brain (inaudible). Those kinds of things. If patient hadn't been vaccinated 3 times, would have died from it for sure because patient had (inaudible) that are auto-immune related. Patient had a heart condition and so had no immune system virtually. Patient got it in the hospital, still got it (Covid).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200051652 master cases, dose 1;
Sex: U
Vaccine: COVID19
Symptoms: Symptom recurrence
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient. A 58-year-old patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; estrogens conjugated (PREMARIN). The patient's relevant medical history included: "heart condition" (unspecified if ongoing), notes: So I have, and a heart, condition, so I have no immune system virtually; "so I have no immune system virtually" (unspecified if ongoing), notes: So I have, and a heart, condition, so I have no immune system virtually. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown), for COVID-19 immunization, reaction(s): "I have long COVID even though I am vaccinated 3 times", "I have long COVID even though I am vaccinated 3 times"; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown), for COVID-19 immunization, reaction(s): "I have long COVID even though I am vaccinated 3 times", "I have long COVID even though I am vaccinated 3 times"; Bnt162b2 (Dose Number: 3, Batch/Lot No: Unknown), for COVID-19 immunization, reaction(s): "I have long COVID even though I am vaccinated 3 times", "I have long COVID even though I am vaccinated 3 times". The following information was reported: SYMPTOM RECURRENCE (non-serious), outcome "unknown", described as "I had a flare up again". The action taken for estrogens conjugated was unknown. Additional information: During the call, the patient stated, I am sick today. I became disabled. I was literally shocked when I went there yesterday to pick it up. It was 66 dollars. Do not get COVID. I got it and I have long COVID even though I am vaccinated 3 times. I was supposed to get vaccinated, get my fourth shot yesterday for my second booster and I had a flare up again. So, it gives all kinds of weird symptoms when you have long COVID. I am petrified of it that I have long COVID because just a couple of days ago on the news they were talking about long COVID and they gave another slew of symptoms that are associated with, uh, long COVID. If I needed another thing to make me scared to death about dementia. As I needed anything else to tell me I could potentially get dementia. The fear is real and then they said the long COVID is showing dementia, brain (inaudible). Those kinds of things. If I had not been vaccinated 3 times I would have died from it I am sure because I have (inaudible) that are auto-immune related. So I have, and a heart condition, so I have no immune system virtually. I got it in the hospital. I still got it. (COVID) Note: The patient/reporter did not specify which vaccination they received. Pfizer-BioNTech COVID-19 Vaccine is being reported out of an abundance of caution. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s) : PFIZER INC-PV202200051652 master case, Dose 1;
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Magnetic resonance imaging heart, Myopericarditis, Troponin
Clinical narrative: Myopericardit is After COVID-19 vaccine; This is a literature report.  A 16-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "admission" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; UNKNOWN MANUFACTURER), for COVID-19 immunisation. The following information was reported: MYOPERICARDITIS (hospitalization, medically significant, life threatening), 3 days after the suspect product(s) administration, outcome "recovered", described as "Myopericardit is After COVID-19 vaccine". The patient underwent the following laboratory tests and procedures: Electrocardiogram: showed mild diffuse ST segment elevations; obtained during the episode showed striking ST, notes: ST segment elevation in the inferolateral leads; normal; Magnetic resonance imaging heart: showed subepicardial enhancement without evidence, notes: of acute infarction; Troponin (3-57): 10819 ng/L, notes: High-sensitivity; downtrending, notes: discharged on hospital; Echocardiogram: Normal. Therapeutic measures were taken as a result of myopericarditis.  Clinical course: A 16 year old previously healthy male presented with two days of chest pain and subjective fevers three days after receiving the second dose of the Pfizer COVID-19 vaccine. High-sensitivity troponin I was 10,819 ng/L (reference range: 3-57), and ECG showed mild diffuse ST segment elevations (Image 1). He was admitted for suspected myopericarditis and treated with ketorolac, prednisone, and IVIG. Shortly after admission, he experienced sudden crushing, substernal chest pain. An ECG obtained during the episode showed striking ST segment elevation in the inferolateral leads. He was started on a nitroglycerin drip, supplemental oxygen, low dose aspirin and received 3 doses of morphine. The acute chest pain responded rapidly to these measures, and the nitroglycerin drip was stopped after 24 hours without recurrence of symptoms. An echocardiogram was normal. Cardiac MRI showed subepicardial enhancement without evidence of acute infarction. He was discharged on hospital day #4, chest pain free for 24 hours with downtrending troponin. Conclusion(s): This case highlights the importance of recognizing coronary vasospasm as a potential complication of COVID vaccine-induced myopericarditis.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: Polycystic ovaries
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient. A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "PMDD" (ongoing). The patient's concomitant medications were not reported. The following information was reported: POLYCYSTIC OVARIES (non-serious), outcome "unknown", described as "PCOS". Therapeutic measures were taken as a result of polycystic ovaries. Additional information: Patient stated, "As a patient with PMDD I spent three days on bedrest coping with PCOS I developed as a result of having gotten the COVID-19 vaccine from Pfizer, but I likely would have ruptured my ovaries if I had gotten Moderna's version of the vaccine. This is why I can ask that you please fare well during the lawsuit from Moderna knowing that your company is doing humane work. Thank you, from my heart." The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Hypoaesthesia, Limb discomfort, Movement disorder
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in May2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 2022, outcome "unknown", described as "Elevated blood pressure"; LIMB DISCOMFORT (non-serious) with onset 2022, outcome "not recovered", described as "My arm has been greatly effected/ it is getting worse"; HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 2022, outcome "not recovered" and all described as "Numbness and tingling is now all the way down in my fingers"; MOVEMENT DISORDER (non-serious), outcome "not recovered", described as "Effecting my left hand movements". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: It was reported that the patient received the booster back in May2022 and the patient's arm had been greatly effected ever since. There appeared to be no sign of improvement. To be more precise it was getting worse. As a piano player it had been effecting its left hand movements. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in May2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 2022, outcome "unknown", described as "Elevated blood pressure"; LIMB DISCOMFORT (non-serious) with onset 2022, outcome "not recovered", described as "My arm has been greatly effected/ it is getting worse"; HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 2022, outcome "not recovered" and all described as "Numbness and tingling is now all the way down in my fingers"; MOVEMENT DISORDER (non-serious), outcome "not recovered", described as "Effecting my left hand movements". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: It was reported that the patient received the booster back in May2022 and the patient's arm had been greatly effected ever since. There appeared to be no sign of improvement. To be more precise it was getting worse. As a piano player it had been effecting its left hand movements. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, Fatigue, Feeling abnormal
Clinical narrative: tested positive for Covid/Oropharyngeal Pain/Pyrexia/Cough; tested positive for Covid/Oropharyngeal Pain/Pyrexia/Cough; mental fogginess; stuffy nose; tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset 24Aug2022, outcome "unknown", described as "mental fogginess"; NASAL CONGESTION (non-serious) with onset 24Aug2022, outcome "unknown", described as "stuffy nose"; FATIGUE (non-serious) with onset 24Aug2022, outcome "unknown", described as "tiredness"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Aug2022, outcome "unknown" and all described as "tested positive for Covid/Oropharyngeal Pain/Pyrexia/Cough". The patient underwent the following laboratory tests and procedures: Body temperature: (24Aug2022) 101 Fahrenheit, notes: fever of 101F; SARS-CoV-2 test: (27Aug2022) Positive, notes: My sister tested positive for Covid on 27Aug2022.  Clinical course: The reporter's sister tested positive for Covid on 27Aug2022. Her symptoms started Wednesday night (24Aug2022) as a sore throat and progressed to a fever of 101F, stuffy nose, coughing, tiredness and mental fogginess. She received two Pfizer Covid-19 vaccines and booster. She declined consent to contact but agreed to provide lot numbers at a later date.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.