chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination failure
Clinical narrative: feeling weak; fever; cough; congestion; sick; he is now Covid positive; he is now Covid positive; This is a spontaneous report from a contactable pharmacist (parent). A 17-years-old male patient (son) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EW0181, Expire Date: Unknown), via an unspecified route of administration, administered in left arm on 28Jun2021 (mid-morning) (age at vaccination: 17 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included asthma, seasonal allergy, environmental allergies. SARS-CoV2 antibodies at diagnosis was reported as unknown. Prior Vaccinations (within 4 weeks) included had allergy shots. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EW0182) via an unspecified route of administration, administered in left arm on 22May2021 (at the age of 17 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient was administered vaccine in a mass vaccination site, mall. On 11Oct2021, the patient experienced was now covid positive. Patient was sick a week and a half prior to testing positive. They did a home test and it was negative. He went to the doctor's office 01Oct2021 to confirm if self home test was negative. He had a molecular test done and it was negative. All of his symptoms at that time had gone away except the cough. Then symptoms came back. He had a fever on 10Oct2021 and another covid test done on 11Oct2021 and it came back as positive. On an unknown date, the patient was feeling weak, fever, cough and congestion. She stated his is mild to moderate. He has asthma and that is why his symptoms were lingering.The patient underwent lab tests and procedures which included on an unknown date, sars-cov-2 test was negative and on 11Oct2021, sars-cov-2 test was positive. The patient did not require an emergency room visit. No additional vaccines administered on same date of the Pfizer suspect. The patient was treated for symptoms. The patient displayed clinical signs at rest indicative of severe systemic illness included fever. When patient gets sick it goes to his chest. His asthma exacerbates when he was sick. He used a steroid inhaler (Dulera) 2 puffs 2 times a day, rescue inhaler (Ventolin) 4 times in a day, allergy medicine (Zyrtec, Flonase Nasal Spray, Asteline Nasal Spray) and Tylenol for temperature and vitamins to keep immune system healthy. He only takes the inhalers when sick, it's not constant. Only when sick to keep out of his chest. On a regular basis he takes the allergy medicines. There was no product quality complaint (PQC) present.The event did not require the initiation of new medication or other treatment or procedure. patient hospitalized was reported as no. The outcome of the events was unknown.; Sender's Comments: Based on the available information in the case, the causal association between the event vaccination failure, COVID-19 and the suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Myalgia
Clinical narrative: tiredness; muscle pain; chills; feeling unwell; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received BNT162B2 (COMIRNATY, solution for injection; lot number and expiry date were not reported) via an unspecified route of administration, on 11Oct2021, as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medication were not reported. Historical vaccine included BNT162B2 (COMIRNATY, solution for injection; lot numbers and expiry dates were not reported)  dose 1, single and dose 2, single both given via an unspecified route of administration, on unknown date, for covid-19 immunisation. On Oct2021, the patient experienced tiredness, muscle pain, chills and Feeling unwell three or four times in a day. The outcome of the event was not recovered at the time of report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 1.83
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk, Serum sickness
Clinical narrative: developed a severe rash diagnosed as serum sickness; My 22 month old daughter, whom I am breastfeeding; This is a spontaneous report from a contactable healthcare professional (patient's mother). This healthcare professional reported information for both mother and baby. This is the baby report. Only this case is serious.   A 22-month-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0186), transmammary on 01Oct2021 at 11:00 (at the age of 22-months-old) at dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications were reported as none. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0186), transmammary on 10Sep2021 at 11:00 at dose 1, single for COVID-19 immunisation. She was breastfed at that time. Facility where the most recent COVID-19 vaccine was administered was reported as school or student health clinic. The patient, who was breastfed, developed a severe rash on 12Oct2021 at 07:00 (also reported as 10 days after the second vaccine dose) diagnosed as serum sickness which was reported to be life-threatening. Serum sickness is an allergic reaction to a serum protein. She had not been sick or received any vaccines or medications during this time period. The event required emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit. She was treated with antihistamines, analgesics, and anti-inflammatory. The outcome of the event was recovering.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Serum sickness and BNT162B2.  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. ,Linked Report(s) : US-PFIZER INC-202101383919 maternal case
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest pain, Extrasystoles, Hypertension, Myocarditis
Clinical narrative: mycardatis; Chest pains; high blood pressure; skipping heartbeat; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose via an unspecified route of administration, administered in left arm on 07Sep2021 at 02:30 (Batch/Lot Number: FC3183) as single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient experienced mycardatis on 08Oct2021, chest pains on 08Oct2021, high blood pressure on 08Oct2021, skipping heartbeat on 08Oct2021. The patient was hospitalized for the events for 6 days. Treatment received for the events included blood pressure and heart medicines (as reported). The events were reported as serious due to hospitalization and life-threatening. The patient underwent lab tests and procedures which included blood pressure: high on 08Oct2021. Therapeutic measures were taken as a result of mycardatis, chest pains, high blood pressure, skipping heartbeat. The outcome of the events was recovered with sequel on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Breakthrough Covid case (positive result and symptoms); Breakthrough Covid case (positive result and symptoms); This is a spontaneous report from a contactable consumer (patient herself). A 38-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EW0151), via intramuscular route, administered in right arm on 14Apr2021 (age at vaccination: 38-year-old) as dose 2, single for covid-19 immunization and dose 1 via intramuscular route, administered in right arm on 08Mar2021 (age at vaccination: 38-year-old) (Lot Number: EL3247) as dose 1, single for covid-19 immunization. The patient's medical history included allergy. The patient's concomitant medications were not reported. The vaccine was administered in a pharmacy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine or other medications the patient received within 2 weeks of vaccination. On 13Oct2021, the patient experienced breakthrough covid case. On 14Oct2021, the patient sars-cov-2 test (saliva PCR) was positive. The patient was not hospitalized nor received any treatment for the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. The outcome of the event COVID-19 was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Circulatory collapse
Clinical narrative: died in her sleep anaphylactic reaction; complete failure of the cardiovascular system; This is a spontaneous report from a contactable consumer (patient's friend). A female patient of unspecified age received the dose of BNT162B2 (COMIRNATY solution for injection; batch/lot number not reported), via an unspecified route of administration on an unspecified date (at an unspecified age) at dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, 7 hours after the vaccination (also reported as 10 hours after the vaccination), the patient died in her sleep due to anaphylactic reaction. It was determined as a complete failure of the cardiovascular system. The patient's husband tried to wake her up. The patient was put on life support but did not make it. The patient died on that night, on an unspecified date, on that bed. The patient's husband went to pick her up, but the patient was cold. It was unknown if autopsy was done. Outcome of the events was fatal.   No follow-up attempts are possible; Information about the batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: complete failure of the cardiovascular system; died in her sleep anaphylactic reaction
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, SARS-CoV-2 test, Weight decreased
Clinical narrative: weight loss; loss of taste; loss of taste and smell; This is a spontaneous report from a contactable consumer reporting on behalf of the patients. This consumer reported same events under the same suspect product for two patients. This is one of 2 reports.   A female patient of unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. It was reported that the patient experienced weight loss and loss of taste and smell on unspecified dates, but the COVID-19 test result was negative on unspecified date. All of the symptoms were escalating and getting worse. The patient has not yet recovered from the events. The events were assessed as serious (life-threatening condition).   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101383020 same reporter, product, event; different patient
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Fall
Clinical narrative: had a fall; after the 2nd dose, they have been diagnosed with COVID19.; after the 2nd dose, they have been diagnosed with COVID19.; This is a spontaneous report from a contactable consumer (nursing assistant) via medical information team. An 85-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318), via an unspecified route of administration, administered in left arm on an unspecified date as DOSE 1, SINGLE and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318) via an unspecified route of administration, administered in upper left arm on an unspecified date as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were none. On an unknown date, the patient after the 2nd dose, they have been diagnosed with covid-19. On 25Jul2021, the patient had a fall. The patient was hospitalized for fall from 25Jul2021 to 01Aug2021. She was in the hospital they were doing tests due to fall and when she contracted covid she was at the hospital and was admitted the day of the fall which was 25Jul2021. On an unknown date, the patient underwent lab tests and procedures which include: covid-19 test which was positive. She quarantined for three weeks in July2021. The reporter was wondering about the booster vaccine because after having their Pfizer COVID Vaccines, she came down with covid and wanted to know having had covid is it safe to take the booster vaccine. The outcome of all events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101381139 same reporter/drug/event, different pt
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Multiple sclerosis relapse
Clinical narrative: a flare up of multiple sclerosis (MS); autoimmune conditions were "going crazy"/ "several autoimmune things that were going bizarre"; This is a spontaneous report from a contactable consumer (patient) reported for self. A 77-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. On an unspecified date, 2 weeks following the injection, she is still experiencing a flare up of her multiple sclerosis (MS). She explained after getting the second dose, she was "down for a week then everything went away".  She specified this booster caused her a lot of problem with her MS, and all her autoimmune conditions are "going crazy". She also described it to the DSU agent as "several autoimmune things that are going bizarre". She explained prednisone is the only thing that currently alleviates her symptoms. She mentioned she continues to take her allergy shot every two weeks and her MS treatment, Betaferon, every other day. Caller suggested that we find ways to minimize adverse reaction from the booster shot, such as her multiple sclerosis flaring up. She reinforced her suggestion explaining that this may be a vaccine that will be administered yearly or more frequently, thus we must come up with something. Seriousness criteria was assessed as medically significant for both the events.Therapeutic measures were taken as result of events included Betaferon for multiple sclerosis and prednisone for several autoimmune things The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: blood clot in the lungs; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received bnt162b2 (BNT162B2), first single dose via an unspecified route of administration, administered in arm right on 10Sep2021 (Batch/Lot Number: FC3182) for covid-19 immunisation at age of 50-year-old. The patient was not pregnant at vaccination. Medical history included covid-19. No other vaccine received in four weeks. There were no concomitant medications. There was no covid tested post vaccination. The patient experienced blood clot in the lungs (death, life threatening) on 21Sep2021. No treatment received for the event.  The patient died on 21Sep2021. It was unknown if an autopsy was performed.   Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: blood clot in the lungs
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: He had the 1st 2 shots and caught a "mild case" of COVID19 afterwards; He had the 1st 2 shots and caught a "mild case" of COVID19 afterwards; This is a spontaneous report from a Pfizer sponsored Program. A contactable male consumer reported for himself that he had received the first dose of BNT162B2 (Lot number unknown) and the second dose of BNT162B2 (Lot number unknown), both at single dose for COVID-19 immunisation on unknown date. Relevant history and concomitant drugs were unknown.  The patient stated he had the 1st 2 shots and caught a "mild case" of COVID19 afterwards.  Outcome of the event was unknown.  Relevant test included SARS-CoV-2 test on unkwown date with positive result.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: got their booster they died; This is a spontaneous report from a non-contactable consumer. This consumer reported similar event for two patients. This is the second of two reports.   A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took dose 1 and dose 2 of Comirnaty; both on unspecified date for COVID-19 immunization. The reporter informed that she knew of two people who got their booster they died. The patient died on an unspecified date. It was unknown if an autopsy was performed.  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-202101396129 same reporter/product/events, different patients; Reported Cause(s) of Death: got their booster they died
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Pain in extremity
Clinical narrative: I developed neuropathy in 3 of the fingers on my left hand.; Specifically the finger pads of my thumb, pointer, and middle fingers were particularly sore and the pain got worse when touching objects or warm/cold temperatures.; This is a spontaneous report from a contactable consumer (patient). A 33-year-old non-pregnant female patient received booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FH8020, Expiration date not reported), via an unspecified route of administration, administered in left arm on 17Oct2021 14:15 (at the age of 33 years) as dose 3 (booster), single for COVID-19 immunization; and influenza vaccine (FLU) (yearly flu shot, lot number and expiration date not reported), via an unspecified route of administration on 17Oct2021, at unspecified dose for an unspecified indication. Medical history included allergy to environmental allergens, penicillin, amoxicillin, ceclor, biaxin, and codeine, all from an unknown date and unknown if ongoing. Concomitant medications received within 2 weeks of vaccination included fexofenadine hydrochloride (ALLEGRA); diphenhydramine hydrochloride (BENADRYL); and fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), all taken for allergy, start and stop date were not reported. The patient previously took first dose of bnt162b2 (Lot Number: EN5318, Expiration date not reported) on 27Jan2021 10:00 as dose 1, singe, and second dose of bnt162b2 (Lot Number: EN5318, Expiration date not reported) on 17Feb2021 10:00, both via an unspecified route of administration for COVID-19 immunization. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Oct2021 08:00, patient developed neuropathy in 3 of the fingers on left hand for 6 hours. Specifically, the finger pads of her thumb, pointer, and middle fingers were particularly sore and the pain got worse when touching objects or warm/cold temperatures. By late afternoon, the neuropathy seemed to resolve itself. It only occurred in the fingers on my left arm (same arm in which I got in the injection). Patient did not receive any treatment for events. The event neuropathy in 3 of the fingers on my left hand was recovered on 18Oct2021 and outcome of event finger pads of my thumb, pointer, and middle fingers were particularly sore and the pain got worse when touching objects or warm/cold temperatures was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Premenstrual syndrome, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 vaccine), dose 1 via an unspecified route of administration, administered in Arm Left on 06Apr2021 (Batch/Lot number was not reported) at the age of 29-years-old as dose 1, single for covid-19 immunisation. Medical history included ADHD (attention deficit hyperactivity disorder), clinical depression and allergy with almonds from an unknown date and unknown if ongoing. The patient is not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has the patient has not been tested for COVID-19. Concomitant medication included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in 2021, the patient experienced caused heavy, elongated cycle in addition to 2 weeks of heightened PMS symptoms. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 15Oct2021. The event required physician office visit and patient received talk therapy and medicinal adjustment as treatment for the events. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died as a result of the COVID-19 vaccine shot; This is a spontaneous report from a contactable consumer reporting same event under the same suspect product for twenty patients. This is one of twenty reports.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The reporter personally knows of 20 people who have died as a result of the COVID-19 vaccine shot. The patient died on an unspecified date. It was not reported if an autopsy was performed.  The lot number for BNT162B2, was not provided and will be requested during follow up.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101416258 same reporter, different patient;US-PFIZER INC-202101416725 same reporter, different patient;US-PFIZER INC-202101416710 same reporter, different patient;US-PFIZER INC-202101416719 same reporter, different patient;US-PFIZER INC-202101416714 same reporter, different patient;US-PFIZER INC-202101416720 same reporter, different patient;US-PFIZER INC-202101416720 same reporter, different patient;US-PFIZER INC-202101416712 same reporter, different patient;US-PFIZER INC-202101416717 same reporter, different patient;US-PFIZER INC-202101416716 same reporter, different patient;US-PFIZER INC-202101416724 same reporter, different patient;US-PFIZER INC-202101416715 same reporter, different patient;US-PFIZER INC-202101416718 same reporter, different patient;US-PFIZER INC-202101416713 same reporter, different patient;US-PFIZER INC-202101416723 same reporter, different patient;US-PFIZER INC-202101416722 same reporter, different patient;US-PFIZER INC-202101416711 saem reporter, different patient;US-PFIZER INC-202101416708 same reporter, different patient;US-PFIZER INC-202101416721 same reporter, different patient; Reported Cause(s) of Death: died as a result of the COVID-19 vaccine shot
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: He took the first Pfizer Covid-19 Shot and he developed blood clots from those shots; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: Unknown, Expiration date: Unknown), via an unspecified route of administration in Mar2021 as dose 1, single for COVID-19 immunization. It was not known that how many doses of BNT162B2 was administered to the patient. The patient's medical history and concomitant medications were not reported. The patient took the first pfizer COVID-19 shot and developed blood clots from those shots in 2021. The outcome of the event was unknown at the time of report.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Plasma cell myeloma, Ventricular extrasystoles
Clinical narrative: Smoldering Myeloma his level bumped up 3 months after taking the 2nd dose of Covid vaccine; after receiving the 2nd dose of the vaccine he was sick for 6 weeks; had PVC's for 6-8 week; This is a spontaneous report from a contactable consumer (Patient). A male patient of an unspecified age received BNT162B2 (BNT162B2 Formulation: Solution for Injection, Batch/Lot number: Unknown Expiration Date: Unknown) via an unspecified route of administration on an unspecified date as dose 2, single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient states that he has Smoldering Myeloma, a type of blood cancer. States that he has his levels checked every 3 months and his level bumped up 3 months after taking the 2nd dose of Covid vaccine. Wondering if we have any information on Smoldering Myeloma and the Covid vaccine as he is paranoid about getting the booster. Wondering if his levels are going to go back down. Patient also stated that after receiving the 2nd dose of the vaccine he was sick for 6 weeks, had premature ventricular contractions (PVC) for 6-8 weeks. States that he treated with Magnesium and started feeling better. States that he is not calling to report an AE, just looking for answers. The outcome of event was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Intermenstrual bleeding, Menstrual disorder, SARS-CoV-2 test, Suicidal ideation
Clinical narrative: disturbance to menstrual cycle/cycle began on 01Oct2021 to 04Oct2021, and the menstrual bleeding begins again on 16Oct2021; disturbance to menstrual cycle/cycle began on 01Oct2021 to 04Oct2021, and the menstrual bleeding begins again on 16Oct2021; severe suicidal ideation; first dose: 06Apr2021, second dose: 14Sep2021; This is a spontaneous report from a contactable consumer (patient). A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown as unable to locate or read the details), via an unspecified route of administration, administered in arm left on 14Sep2021 as dose 2, single for covid-19 immunization. Medical history included ADHD, clinical depression, and allergies: almonds. The patient was previously vaccinated with the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE, lot number unknown as unable to locate or read the details) administered in the arm left on 06Apr2021 for covid-19 immunization at 29-years old and experienced heavy, elongated cycle in addition to 2 weeks of heightened PMS symptoms. Concomitant medication included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported. The second dose was administered in a pharmacy or drug store. No other vaccines were received within 4 weeks prior to the covid-19 vaccine. Prior to vaccination, the patient was not patient diagnosed with covid-19. The second dose caused severe disturbance to menstrual cycle. Cycle began on 01Oct2021 to 04Oct2021, and the menstrual bleeding begins again on 16Oct2021. Severe suicidal ideation for 2 weeks after completion of first menstrual cycle post-administration - suicidal ideation daily on 04Oct2021 (reported as between 04Oct2021 and 14Oct2021). Both events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the aforementioned adverse events included talk therapy and medicinal adjustment. The patient had a negative covid-19 nasal swab on 15Oct2021. The outcome of the events was reported as unknown. The events suicidal ideation and disturbance to menstrual cycle was reported as serious due to life-threatening.  The lot number for BNT162b2 was not provided and will be requested during follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: two people who got their booster they died; This is a spontaneous report from a non-contactable consumer. This consumer reported similar event for two patients. This is the first of two reports.  A patient of unspecified age and gender received bnt162b2 (COMIRNATY) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter knows of two people who got their booster they died on an unspecified date. It was unknown if autopsy was done.    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-202101392251 Same reporter/drug/AE and different patients.; Reported Cause(s) of Death: two people who got their booster they died
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Hypothyroidism, Immunisation, Off label use
Clinical narrative: Booster dose; Booster dose; Decreased thyroid function; Decreased thyroid function; This is a spontaneous report from contactable consumer (patient). A 74-year-old female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: FF2588) on 30Aug2021 (at the age of 74-years-old) as a single dose for COVID-19 immunization. Medical history included celiac from 05Feb2017 and ongoing (also reported as diagnosed 2014), hypothyroidism from 1985 and ongoing, mild depression from 1972 and ongoing, high blood pressure from 1992 and ongoing and old age from an unspecified date and ongoing. Concomitant medications included levothyroxine orally taken for hypothyroid from an unspecified date and ongoing at 0.075mg, citalopram orally taken for depression from an unspecified date and ongoing at 10mg and estradiol orally taken for old age from an unspecified date and ongoing at 0.5mg. Prior vaccinations were reported as none. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EN6202) on 24Feb2021 (at the age of 74-years-old) as a single dose in the left upper arm for COVID-19 immunization and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EP6955) on 24Mar2021 (at the age of 74-years-old) as a single dose in the right upper arm for COVID-19 immunization and experienced decreased thyroid function, increased atrial fibrillation, hair loss, bruising, slight confusion, memory loss, exhaustion, significantly increased depression and sensitivity to cold. On an unspecified date in 2021 (summer 2021), the patient experienced decreased thyroid function. The event was reported as serious for medically significant and required a physician office visit. It was reported that the patient's thyroid supplement stopped working. The first step was to switch from generic levothyroxine to name brand Synthroid. New bloodwork was scheduled for 03Nov2021. The next stop would be to increase dosage of Synthroid if the 03Nov2021 bloodwork, showed no improvement for return of hypothyroidism. Symptoms were reported as "many". The patient underwent lab tests that included: TSH (0.300 to 4.500) on 31Dec2019 which was 5.340 uiU/mL; on 17Aug2020 which was 4.933 uiU/mL; on 08Mar2021 which was 4.838 uiU/mL and on 14Sep2021 which was 8.141 uiU/mL. Treatment was received for the event decreased thyroid function. The clinical outcome of the event decreased thyroid function was not recovered/not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Pulmonary embolism; specified as a Saddle pulmonary embolism,  after second vaccine; This is a spontaneous report from a contactable Nurse via Pfizer-sponsored program (patient reported for self). A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0182, Expiry date: unknown), dose 2 via an unspecified route of administration, administered in left arm on 13May2021 (at the age of 63-years-old), as dose 2, single for COVID-19 immunisation. Medical history was reported as none. The concomitant medications were not reported. Patient had earlier received first dose of BNT162B2(Lot: ER, Reporter states it looks like 8731, handwritten on card), via unspecified route administered on left arm on 22Apr2021 (at the age of 63-years-old) as dose 1, single for COVID-19 immunization. The patient experienced pulmonary embolism, specified as a saddle pulmonary embolism in both lungs, after second vaccine on 09Oct2021. States she got the vaccine because it was work related. Reports that the doctors do seem to think that it was from the vaccine. She got out of the hospital on 13Oct2021, and is now on the medication Eliquis, for therapy. Seriousness was reported as hospitalization and life threatening. Outcome of events were resolved on 13Oct2021.; Sender's Comments: Based on temporal association and known safety profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), to the event saddle pulmonary embolism cannot be completely excluded.The case will be reassessed if additional information becomes available. 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: Immunisation, Off label use, Rash
Clinical narrative: booster COVID vaccine; booster COVID vaccine; bad rash all over his body; This is a spontaneous report from a non-contactable consumer (patient wife). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: not reported) via an unspecified route of administration on an unspecified date as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single, and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation and the patient was in the hospital with septicemia before the booster. It was reported that three weeks after getting the third dose, he had developed a body rash all over his body. Reporter said that she did not think it was from the vaccine. This may or may not be related to the Pfizer COVID booster shot. It was reported that he had been to infectious disease, dermatology, etc and no one seems to know what was causing the rashes. He had just been doctor to doctor, and no one knows. The reporter just wanted to know if other people developed unusual rashes weeks after the vaccine. He had no rash after the shot. It may not be related to it. It could be the antibiotic he was one. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on known disease pathophysiology, the event of Rash is assessed as not related to BNT162B2  and more likely due to underlying medical condition of septicemia and antibiotic he was on.,Linked Report(s) : US-PFIZER INC-202101400636 Same patient and drug, different event separated in time
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Off label use
Clinical narrative: received the booster dose and his  annual flu shot in the other arm; received the booster dose and his  annual flu shot in the other arm; her husband tested positive after receiving the booster dose; her husband tested positive after receiving the booster dose; This is a spontaneous report from a contactable consumer or other non-HCP (consumer reported on behalf of her husband). A 63-year-old male patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in the arm on 09Oct2021 as DOSE 3 (BOOSTER), SINGLE (Age of vaccination: 63-year-old) for COVID-19 immunization. The patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, on an unspecified date as DOSE 1, SINGLE and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, on an unspecified date as DOSE 2, SINGLE (Age of vaccination: Unknown) for covid-19 immunization. The patient medical history was not reported. Concomitant medication included influenza vaccine (FLU) dose number unknown, single on an unspecified date. On 09Oct2021 patient received the booster dose and his annual flu shot in the other arm. That evening, he started with a cough and was quick tested 2 days after booster which came back positive, on the same day did drive-thru PCR test and Wednesday received positive results. He started with symptoms the same day as booster and his doctor said he was already infected prior to getting the booster on Saturday maybe 3-5 days prior to 09Oct2021 . Then he monoclonal antibody infusion on Thursday 5 days after booster. Is that going to negate the booster shot the reporter queried. The patient underwent lab tests and procedures which included PCR test (sars-cov-2 test): positive (drive-thru PCR test and Wednesday received positive results) on 11Oct2021. The outcome of all events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Patient tested positive for COVID following completion of the 2 dose series; Patient tested positive for COVID following completion of the 2 dose series; This is a spontaneous report from a non-contactable consumer or other non-health care professional. A 59-year-old male patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FC3180) via an unspecified route of administration, on 05Aug2021 (at the age at vaccination of 59-year-old) as dose 1, single; second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FC3180) via an unspecified route of administration, on 26Aug2021 (at the age at vaccination of 59-year-old) as dose 2, single both doses for covid-19 immunization at unknown vaccine facility. The patient's medical history and concomitant medications were not reported. On 18Oct2021, patient tested positive for COVID following completion of the 2 dose series. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 18Oct2021. Outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report from a non-contactable other hcp. A 47-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318, Expiration date: not reported) via an unspecified route of administration at workplace clinic on 17Feb2021(at the age of 47-years-old) as dose 2, single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318, Expiration date: not reported) via an unspecified route of administration on 26Jan2021 as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 08Oct2021, patient experienced vaccination failure and covid-19 which were medically significant. On 08Oct2021, patient underwent lab tests and procedures which included SARS-CoV-2 test: positive. Prior to the vaccination, unknown if the patient was diagnosed with COVID-19. Post the vaccination, the patient had been tested for COVID-19. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, SARS-CoV-2 test
Clinical narrative: Light headed; Chest pain; trouble breathing; This is a spontaneous report from a contactable consumer reported for herself. This 16-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 12Jun2021 10:30 (Lot Number: 59267-1000-01) as DOSE 1, SINGLE for COVID-19 immunisation at the age of 16 years old. The patient was not pregnant. Medical history included depression, anxiety, migraines. Known allergies slight elm, almond, cockroach. Did not have COVID prior vaccination. Concomitant medication(s) included fexofenadine (FEXOFENADINE); fluoxetine (FLUOXETINE); quetiapine (QUETIAPINE); topiramate (TOPIRAMATE).  The patient experienced Light headed, Chest pain and trouble breathing on 12Jun2021 11:00 with outcome of recovered with sequelae. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event).  Treatment received for events included Epi pen.  The patient underwent lab tests and procedures which included COVID-19 test (Nasal Swab): negative on 11Jul2021 and 07Sep2021.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report from a contactable consumer (parent). A 23-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as dose 1, single (lot number and expiry date not reported); then via an unspecified route of administration on an unspecified date (Lot Number: EW0187; Expiration Date: 31Aug2021) as dose 2, single; for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced covid-19 on 01Oct2021.  The outcome of the event was unknown.  Conclusion of Completed Investigation (FCI/SI/OffCI) from Pfizer product quality group was reported as: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EW0187 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EW0187, fill lot EP8737, and the bulk formulated drug product lot EP8618. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Sex: F
Vaccine: COVID19
Symptoms: Choking sensation, Dizziness, Dysphagia, Fall, Neuropathy peripheral
Clinical narrative: neuropathy; had a bad fall twice; tingling sensations; had really cold toes and fingers; had problems with swallowing; felt dizzy; feels like she would choke.; On her left foot, she said it felt like she stepped on shards of glass and cut her toes.; This is a spontaneous report from a non-contactable consumer (patient). A 70-year-old female patient received bnt162b2 (COMIRNATY; lot/batch number and expiration date not reported) via an unspecified route of administration on Mar2021 as dose 1, single and via an unspecified route of administration on Mar2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient said she received her 1st and 2nd doses last Mar2021. Months after the 1st dose, she said she felt dizzy. She also mentioned that she is currently dizzy, and feels "dizzy to the left." However, she isn't sure whether if it was because of the vaccine or if it was because she's recently had a bad fall twice. A month, 2, or 3 months after her 1st dose (2021), she said she had neuropathy. She had tingling sensations, and had really cold toes and fingers. On her left foot, she said it felt like she stepped on shards of glass and cut her toes. She also said she had problems with swallowing, and feels like she would choke. She wants to know if these were symptoms of the vaccine. Outcome of the event dizzy was not recovered while unknown for the other events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.