chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Stress, Urine analysis, Weight decreased
Clinical narrative: rash got better and about 12 days ago it got worse; weight has gone down substantially; This is difficult for him to talk about or hear about therefore very stressful; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient's wife). A 72-year-old male patient received BNT162B2 (Lot ZN6200, second dose) solution for injection intramuscular in left arm on 20Mar2021 (at the age of 72-years-old) as a single dose for COVID-19 immunization. There was no medical history. Concomitant medications were not reported. Historical vaccine included BNT162B2 (first dose, lot EL3248) for COVID-19 vaccination on 20Feb2021 and experienced bullous pemphigoid, severe rash blisters from his neck all the way down to his legs, arms, back and chest, anxiety, loss of weight, mental distress, itching a little bit, dry skin, stinging, and knee and foot got swollen. In Mar2021, the patient had a rash which got better and about 12 days ago it got worse which resulted in emergency room visit and physician office visit. In 2021, the patient weight has gone down substantially and this was difficult for him to talk about or hear about therefore very stressful. Treatment for the event rash included doxycycline. Lab tests in 2021 included cholesterol and triglycerides: low, it came back that he was healthy; blood tests: unknown; lot of tests: all came back negative; urine tests: unknown. The outcome of the event rash was not recovered. The outcome of the other events was unknown.  Follow-up (09Nov2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101515942 same reporter/drug, different patient, similar AE
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Illness, Loss of consciousness, SARS-CoV-2 test, Seizure
Clinical narrative: to the point a pass out; its effect my seizures condition; its effect my seizures condition; I have been sick for months sick with the COVID symptoms; This is a spontaneous report from a contactable consumer (patient). A 26-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 13May2021 (Batch/Lot number was not reported) (at the age of 26-year-old) as dose 2, single for COVID-19 immunisation. Medical history included seizures. She had been taking mass medications but then not now because it doesn't help her. She was not currently on medication for her seizures. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on unknown date for Covid-19 immunization. The patient got the Pfizer COVID-19 Vaccine, her second dose was on 13May2021 and she had been having the adverse side effects to this vaccine. Since 14May2021, she had been sick with COVID symptoms since she got her second shot and they have not gone away, she had been sick for months to the point a pass out or its effect her seizures condition (medical history). She went to ER, they don't do anything for her. As treatment, she used Nyquil 30ml, she used day time codeine fluid (Further clarification unknown), she had used Benadryl 25mg. She just went up today (04Nov2021) and got the COVID test straight on her that the influenster the all the test and they all come back negative and also the strep test is also coded. Lab data results was confirmed as negative, reported as it's been negative for months. Events outcome was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Streptococcus test
Clinical narrative: to the point a pass out; its effect my seizures condition; its effect my seizures condition; I have been sick for months sick with the COVID symptoms; This is a spontaneous report from a contactable consumer (patient). A 26-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 13May2021 (Batch/Lot number was not reported) (at the age of 26-year-old) as dose 2, single for COVID-19 immunisation. Medical history included seizures. She had been taking mass medications but then not now because it doesn't help her. She was not currently on medication for her seizures. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on unknown date for Covid-19 immunization. The patient got the Pfizer COVID-19 Vaccine, her second dose was on 13May2021 and she had been having the adverse side effects to this vaccine. Since 14May2021, she had been sick with COVID symptoms since she got her second shot and they have not gone away, she had been sick for months to the point a pass out or its effect her seizures condition (medical history). She went to ER, they don't do anything for her. As treatment, she used Nyquil 30ml, she used day time codeine fluid (Further clarification unknown), she had used Benadryl 25mg. She just went up today (04Nov2021) and got the COVID test straight on her that the influenster the all the test and they all come back negative and also the strep test is also coded. Lab data results was confirmed as negative, reported as it's been negative for months. Events outcome was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood test
Clinical narrative: atrial fibrillation/it is not improving at all, it's bad, it's worse; This is a spontaneous report from a contactable consumer. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as dose number unknown, single (at the age of 45 years old) for COVID-19 immunization. Medical history included diabetic from an unknown date, ongoing atrial fibrillation (years and years he had it, been probably 6 to 7 years). Concomitant medications included apixaban (ELIQUIS) and metformin, both were taken for an unspecified indication, start and stop date were not reported. Patient's weight was 140.61 kg and height was 165 cm. No family history with the same adverse event. The patient experienced atrial fibrillation on an unspecified date. It was reported that the patient has been hospitalized many times and the reporter heard that it could had been the vaccine that causing it and he keep having atrial fibrillation. Patient has been hospitalized even over night from it. No prior vacciantion (within four weeks). The patient was still experiencing the adverse event, reporter stated that he has goes in and out atrial fibrillation like every single day and sometimes it doesn't get back to normal so patient has to be taken to the hospital and put him on 'IV'. It was not improving at all, stated that it's bad, it's worse, it's has been overnight sleepily. The patient was hospitalized for atrial fibrillation from 16Oct2021 to 17Oct2021 then on 30Oct2021. The patient underwent lab tests and procedures which included blood work: unknown results on Oct2021 (all kind of blood work, He just went again last week). Therapeutic measures were taken as a result of atrial fibrillation. The outcome of the event was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: arm pain; chills; fever; body aches; headache; fatigue; This is a spontaneous report from a contactable other hcp (patient).   A 24-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL961), via an unspecified route of administration, administered in Arm Left on 22Jan2021 at 15:00 (at the age of 24 years old) as dose 2, single for covid-19 immunisation. Patient Medical history included none. Concomitant medications were not reported. Patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3246), via an unspecified route of administration, administered in Arm Left on 02Jan2021 at 15:00 (at the age of 24 years old) as dose 1, single for covid-19 immunisation and experienced sore arm on 03Jan2021 which recovered to days post injection. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. No relevant tests done. Specific Relevant Test for thromboembolic events with thrombocytopenia was reported as none. On 23Jan2021, the patient experienced arm pain. On 23Jan2021, the patient experienced covid-19 like symptoms, starting about 14 hours post injection. These symptoms resided after about 15 hours of rest. They included chills, fever, body aches, headache and fatigue. The events required the imitation of new medication or other treatment or procedure. Patient received treatment with Advil and heat packs for adverse events. Patient also received the third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: FE3590) via an unspecified route of administration at left arm on 09Oct2021 as dose 3 (booster), single for covid-19 immunisation and experienced sores and swollen armpit 10Oct2021 and recovered on 24Oct2021. The outcome of the events chills, fever, body aches, headache and fatigue were recovered an unspecified date in Jan2021 and pain in arm on unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101352909 same drug, reporter, patient; different doses, event (second dose)
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: arm pain; chills; fever; body aches; headache; fatigue; This is a spontaneous report from a contactable other hcp (patient).   A 24-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL961), via an unspecified route of administration, administered in Arm Left on 22Jan2021 at 15:00 (at the age of 24 years old) as dose 2, single for covid-19 immunisation. Patient Medical history included none. Concomitant medications were not reported. Patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3246), via an unspecified route of administration, administered in Arm Left on 02Jan2021 at 15:00 (at the age of 24 years old) as dose 1, single for covid-19 immunisation and experienced sore arm on 03Jan2021 which recovered to days post injection. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. No relevant tests done. Specific Relevant Test for thromboembolic events with thrombocytopenia was reported as none. On 23Jan2021, the patient experienced arm pain. On 23Jan2021, the patient experienced covid-19 like symptoms, starting about 14 hours post injection. These symptoms resided after about 15 hours of rest. They included chills, fever, body aches, headache and fatigue. The events required the imitation of new medication or other treatment or procedure. Patient received treatment with Advil and heat packs for adverse events. Patient also received the third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: FE3590) via an unspecified route of administration at left arm on 09Oct2021 as dose 3 (booster), single for covid-19 immunisation and experienced sores and swollen armpit 10Oct2021 and recovered on 24Oct2021. The outcome of the events chills, fever, body aches, headache and fatigue were recovered an unspecified date in Jan2021 and pain in arm on unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101352909 same drug, reporter, patient; different doses, event (second dose)
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain
Clinical narrative: pain; held xeljanz in the setting of getting her covid booster and recently resumed; This is a spontaneous report from a contactable Physician. This Physician reported for 47-year-old female patient in response to HCP follow-up letter sent to nurse in cross referenced case that included: This is a spontaneous report from a contactable physician.   A 47-years-old female patient received bnt162b2 (BNT162B2), dose 3 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. Medical history  and concomitant medications were not reported.  The patient experienced pain (pain) (medically significant) on an unspecified date with outcome of recovering , held xeljanz in the setting of getting her covid booster and recently resumed (immunisation) (non-serious) on an unspecified date with outcome of unknown.     The lot number for vaccine [BNT162B2] was not provided and will be requested during follow-up.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer. A 07-year-old female non Pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via Intramuscular Left arm on 04Nov2021 03:00 PM at age of 07-year-old (Batch/Lot Number: FK5127) as DOSE 1, SINGLE (Lot number: FK5127) for covid-19 immunisation and influenza vaccine (FLU VACCINE VII) on 13Oct2021 Left arm as DOSE 1, SINGLE for immunisation. No covid prior vaccination. No Known allergies. She experienced very sore arm at injection site on 05Nov2021 with outcome recovering. No covid tested post vaccination. No treatments received for Very sore arm at injection site.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Fatigue, Palpitations, Ventricular extrasystoles
Clinical narrative: fluttering; heart started racing; diagnosed with MVPC, multiple ventricular premature complexes; fatigue; same heart issue.; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 29Oct2021 16:45 (Lot Number: FH8027) at age of 53-year-old as single dose for covid-19 immunisation.  Medical history included asthma, allergy to sulfur drugs, latex, guillain-barre syndrome, fibromyalgia.  The patient was not pregnant at time of vaccination. No covid prior vaccination. The other medications in two weeks included normal prescriptions. The patient previously took bnt162b2 (lot number=FF2587) dose 1 on 08Oct2021 04:45 PM at Left arm at age of 53-year-old for covid-19 immunisation, azithromycin (Z-PAK). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Within 30 minutes (29Oct2021 17:15), heart started racing, fluttering, palpitations. Patient went to the ER Saturday morning, diagnosed with MVPC, multiple ventricular premature complexes- V complexes w/ short R-R. A week later she was still feeling the same, now with fatigue, still have same heart issue.  She cannot get into a cardiologist as ER doctor recommended until 24Nov2021. All event onset date was 29Oct2021 17:15. The adverse event result in Emergency room/department or urgent care. No treatment received for the events. The covid was not tested post vaccination. The outcome of events was not recovered. Since the vaccination, the patient had not been tested for COVID-19.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Dermatitis contact, Disease recurrence, Herpes zoster, Rash
Clinical narrative: I developed a bad rash mainly on my torso, back, and neck.; At first I thought poison ivy; Then thought shingles; disease recurrence; Currently have itchy rash along my back neck and right torso; This is a spontaneous report from a contactable consumer. This 64-year-old female consumer (patient) reported for herself that: A 64-year-old nonpregnant female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 16Apr2021 (Lot Number: ewO1333) (at the age of 64-year-old) as DOSE 2, SINGLE for covid-19 immunization. The patient was not pregnant at time of vaccination and event onset. Medical history included PVC pre ventricular contraction- no meds, no constraints, Shingles (Got the shingles vax 4 years ago), Allergy: maybe horse serum anti-venom. The patient previously took BNT162B2 (first dose, lot number: er8730) (at the age of 63-year-old) administrated in Arm Left on 26Mar2021 for COVID-19 Immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medication included multi vitamin within 2 weeks of vaccination. The patient developed a bad rash mainly on her torso, back, and neck on 19Apr2021 with outcome of not recovered; At first she thought poison ivy. Then thought shingles (she got the shingles vax 4 years ago, but doctor said it did not resemble shingles thought it was mostly on one side but not limited to my right side. It was quite bad at one point. Patient still has never gone away though subsided. Currently had itchy rash along my back neck and right torso. Went to GP, dermatologist, and had an allergist appt next week. Two biopsies were taken. No revelation. Patient said some looked like one thing, another part of the rash looked like something else. She was not certain what's wrong. Patient did read on a website where she was registering someone for a booster- they asked if you allergic to polyethylene glycol, formaldehyde, gentamicin, thimerosal, bovine protein gelatin, etc.  Patient had not registered for the booster. Patient underwent lab tests and procedures included SARS-CoV-2 test: negative  on 25Aug2021 Nasal Swab. Outcome of events was not recovered and all events required a physician office visit. Therapeutic medications 3 topical meds -steroid topicals, antibiotic cream were taken for all events.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, SARS-CoV-2 test
Clinical narrative: I developed a bad rash mainly on my torso, back, and neck.; At first I thought poison ivy; Then thought shingles; disease recurrence; Currently have itchy rash along my back neck and right torso; This is a spontaneous report from a contactable consumer. This 64-year-old female consumer (patient) reported for herself that: A 64-year-old nonpregnant female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 16Apr2021 (Lot Number: ewO1333) (at the age of 64-year-old) as DOSE 2, SINGLE for covid-19 immunization. The patient was not pregnant at time of vaccination and event onset. Medical history included PVC pre ventricular contraction- no meds, no constraints, Shingles (Got the shingles vax 4 years ago), Allergy: maybe horse serum anti-venom. The patient previously took BNT162B2 (first dose, lot number: er8730) (at the age of 63-year-old) administrated in Arm Left on 26Mar2021 for COVID-19 Immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medication included multi vitamin within 2 weeks of vaccination. The patient developed a bad rash mainly on her torso, back, and neck on 19Apr2021 with outcome of not recovered; At first she thought poison ivy. Then thought shingles (she got the shingles vax 4 years ago, but doctor said it did not resemble shingles thought it was mostly on one side but not limited to my right side. It was quite bad at one point. Patient still has never gone away though subsided. Currently had itchy rash along my back neck and right torso. Went to GP, dermatologist, and had an allergist appt next week. Two biopsies were taken. No revelation. Patient said some looked like one thing, another part of the rash looked like something else. She was not certain what's wrong. Patient did read on a website where she was registering someone for a booster- they asked if you allergic to polyethylene glycol, formaldehyde, gentamicin, thimerosal, bovine protein gelatin, etc.  Patient had not registered for the booster. Patient underwent lab tests and procedures included SARS-CoV-2 test: negative  on 25Aug2021 Nasal Swab. Outcome of events was not recovered and all events required a physician office visit. Therapeutic medications 3 topical meds -steroid topicals, antibiotic cream were taken for all events.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Gynaecological examination, Postmenopausal haemorrhage, Ultrasound scan, Urine analysis
Clinical narrative: Mild spotting post menopause; This is a spontaneous report from a contactable other hcp (patient).   A 58-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: FE3590) via an unspecified route of administration, administered in left arm on 29Oct2021 (at the age of 58-year-old) at 15:30 as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation at doctor office/urgent care. Medical history included stress urinary incontinence and allergies to sulfa drugs from an unknown date and unknown if ongoing. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), colecalciferol (VIT D [COLECALCIFEROL]), fish oil, paracetamol (TYLENOL), ibuprofen (ADVIL [IBUPROFEN]) and melatonin all medication taken for an unspecified indication with start and stop dates were unknown (in two weeks). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN5318) on 30Jan2021 as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6198) as dose 2, single on 23Feb2021 both at the age of 57-year-old via unspecified route, administered in left arm for COVID-19 Immunization. On 31Oct2021 at 18:00 patient had mild spotting post menopause. It was reported that patient had received booster on Friday afternoon, and on Sunday afternoon she had one incident of mild menstrual spotting despite being in menopause. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the events. On an unspecified date, patient underwent lab tests and procedures which included gynaecological examination (pelvic exam), ultrasound scan and urine analysis, all the results were unknown. The patient had not received any other vaccine within four weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of event was recovered.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, there is reasonable possibility of causal association between the event postmenopausal haemorrhage  and the suspect drug 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.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Dizziness, Immunisation, SARS-CoV-2 test, Visual impairment
Clinical narrative: loss of depth of perception; Double vision; dizziness; dose number=3; This is a spontaneous report from a contactable consumer. This contactable consumer reported for a 78-year-old male consumer (patient).   A 78-years-old male patient received bnt162b2 (PHIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in Arm Left on 03Nov2021 09:30 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation at the age of 78 years old.  Medical history included Hypertension, survivor of pancreatic cancer. The patient did not have any known allergies. The patient received first and second dose of bnt162b2 (PHIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on unspecified date at single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medication within 2 weeks of vaccination. The patient experienced loss of depth of perception, double vision, dizziness, above on 03Nov2021 21:00 with outcome of not recovered. All events resulted in hospitalization with emergency room visit. The patient underwent lab tests and procedures which included nasal swab : negative   on 04Nov2021.  Prior to vaccination, the patient was not diagnosed with COVID-19.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: diagnosed with Covid-19; diagnosed with Covid-19; This is a spontaneous report from a non-contactable consumer (patient). A female patient of unspecified age received the first dose of BNT162B2 (COMIRNATY, batch/lot number and expiration date not provided), via an unspecified route of administration, on 23Aug2021, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient stated that she received the first dose of the Pfizer Covid-19 vaccine on 23Aug2021 but did not received the second dose yet. Patient was diagnosed with Covid-19 back in Oct2021 and stated that she finishes up with quarantine today 05Nov2021. Patient was asking what she should do about getting a second dose of the Pfizer Covid-19 vaccine since she has just been diagnosed with Covid-19 after the first dose. The outcome of the events was recovered in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Pulmonary embolism; This is a spontaneous report from a contactable nurse.   A 69-year-old male patient received the second dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient was otherwise healthy. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. On an unspecified date, a few weeks after the second dose, the patient experienced pulmonary embolism (PE) and he was on anticoagulants. The reporter asked about reports of polychondritis, as a different patient reported this "many months after their dose". The outcome of event was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Immunisation
Clinical narrative: All minor joints (knees, ankles, wrists, hands and feet) were in searing pain for a week; legs were still very unstable; booster; This is a spontaneous report from a contactable consumer (patient) received via Regulatory Authority. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm, on 27Sep2021 at 01:15 PM (Batch/Lot number was unknown) (at the age of 46 years old) as dose 3 (booster), single for COVID-19 immunisation. Medical history included breast cancer IV and known allergy to sulfa. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included capecitabine; tucatinib (TUKYSA); dabigatran etexilate mesilate (PRADAXA); venlafaxine hydrochloride (EFFEXOR); montelukast sodium (SINGULAIR), all taken for an unspecified indication, start and stop date were not reported. The patient was previously administered the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm, on 05Mar2021 at 11:30 AM (Batch/Lot number was unknown) (at the age of 45 years old) as dose 1, single; second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm, on 27Mar2021 at 11:30 AM (Batch/Lot number was unknown) (at the age of 45 years old) as dose 2, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Sep2021 at 01:15 PM, the patient was administered the third (booster) dose of BNT162B2. On 29Sep2021, the patient's all minor joints (knees, ankles, wrists, hands and feet) were in searing pain for a week. The patient was prescribed 3 days on a fentanyl patch and dexamethasone (DECADRON). During that time, the patient was basically bedridden. The patient was 46 years old and was now on a cane because her legs were still very unstable. Though more manageable, the patient continue to have joint pain in the areas mentioned above. The events were reported as serious (disability). The events resulted to emergency room and physician office visit. The outcome of events all minor joints (knees, ankles, wrists, hands and feet) were in searing pain for a week and legs were still very unstable was not recovered.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Menstrual disorder, Thrombosis
Clinical narrative: bleeding; Clot blood; Menstrual cycle abnormal; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, administered in arm left on 22Oct2021 10:15 at 42-year-old (Lot Number: FD8448) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. Patient was not pregnant and was not pregnant at time of vaccination. Patient did not have COVID-19 prior to vaccination. Patient did not have known allergies. The patient's concomitant medications were not reported. Patient did not receive other vaccine in four weeks. The patient experienced bleeding (medically significant) on 02Nov2021 10:00 with outcome of recovering, clot blood (medically significant) on 02Nov2021 10:00 with outcome of recovering, menstrual cycle abnormal (medically significant) on 02Nov2021 10:00 with outcome of recovering. No therapeutic measures were taken as a result of the events. Patient did not tested for COVID-19 post vaccination. It was reported that the patient experienced very profuse bleeding with presence of large amount of blood clots for two days in the subsequent menstrual period after vaccination. This was completely abnormal to her regular menstrual periods.  No follow-up attempts are possible. No further information is expected.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: This is a spontaneous report received from a contactable physician. A 9-year-old male patient received BNT162B2 (COMIRNATY, solution for injection; Batch/lot number and expiration date were not reported), intramuscularly administered in the left arm on 05Nov2021 12:00 PM (at the age of 9-years-old) as dose 1, single for COVID-19 immunisation. Medical history included penicillin allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced itch, swelling (both arms and both legs), redness including on face on 05Nov2021 12:00. Treatment with Benadryl was received for the events. The outcome of the events was recovered on an unspecified date in 2021.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Immunisation, Myalgia
Clinical narrative: Sepsis like syndrome tmax 102.9, he 110 to 120; Sepsis like syndrome tmax 102.9, he 110 to 120; myalgia; severe fatigue; nausea; shaking chills; The patient received booster dose of BNT162B2 on 04Nov2021 at 16:30; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: Fh8028, Expiration Date: not reported) via an unspecified route of administration, administered in left arm on 04Nov2021 16:30 (at the age of 53 years old) as dose 3 (booster), single for COVID-19 immunisation. Medical history included HTN (hypertension) from an unknown date. The patient has no known allergies and prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medication included amlodipine taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (lot number: El9274), via an unspecified route of administration, administered in left arm on 02Feb2021 at 12:00 (at the age of 53 years old) as dose 1, single and second dose of BNT162B2 (lot number: En6200), via an unspecified route of administrationm administered in left arm on 25Feb2021 at 12:00 (at the age of 53 years old) , both for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received booster dose of BNT162B2 on 04Nov2021 at 16:30. On 05Nov2021 at 10:00, the patient experienced sepsis like syndrome "tmax 102.9, he 110 to 120" (as reported), myalgia, severe fatigue, nausea and shaking chills. No treatment was received for the adverse events. Since vaccination, the patient has not been tested for COVID-19. Outcome of all events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Sepsis
Clinical narrative: Sepsis like syndrome tmax 102.9, he 110 to 120; Sepsis like syndrome tmax 102.9, he 110 to 120; myalgia; severe fatigue; nausea; shaking chills; The patient received booster dose of BNT162B2 on 04Nov2021 at 16:30; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: Fh8028, Expiration Date: not reported) via an unspecified route of administration, administered in left arm on 04Nov2021 16:30 (at the age of 53 years old) as dose 3 (booster), single for COVID-19 immunisation. Medical history included HTN (hypertension) from an unknown date. The patient has no known allergies and prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medication included amlodipine taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (lot number: El9274), via an unspecified route of administration, administered in left arm on 02Feb2021 at 12:00 (at the age of 53 years old) as dose 1, single and second dose of BNT162B2 (lot number: En6200), via an unspecified route of administrationm administered in left arm on 25Feb2021 at 12:00 (at the age of 53 years old) , both for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received booster dose of BNT162B2 on 04Nov2021 at 16:30. On 05Nov2021 at 10:00, the patient experienced sepsis like syndrome "tmax 102.9, he 110 to 120" (as reported), myalgia, severe fatigue, nausea and shaking chills. No treatment was received for the adverse events. Since vaccination, the patient has not been tested for COVID-19. Outcome of all events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID - minor symptoms; Tested positive for COVID - minor symptoms; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 30Mar2021 (at the age of 41 years old) (Batch/Lot number was not reported) as dose 2, single; and via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not have COVID-19 prior to vaccination. On 05Nov2021, the patient tested positive for COVID - minor symptoms. The patient received no treatment for the event COVID-19. The events resulted in physician office visit. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 05Nov2021. The patient had been tested for COVID-19 post-vaccination. The outcome of the event vaccination failure was unknown and event COVID-19 was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure timing unspecified, Tourette's disorder
Clinical narrative: someone that was 23 years old and pregnant that received Pfizer Covid vaccine; Tourette-like symptoms; This is a spontaneous report from a non-contactable consumer.  A 23-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient was pregnant that received Pfizer Covid vaccine and shortly after the patient began to have horrible side effects and Tourette-like symptoms. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Polychondritis
Clinical narrative: polychondritis; This is a spontaneous report from a contactable Nurse. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced polychondritis on an unspecified date with outcome of unknown. A patient reported symptoms "many months after their dose".  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on limited information in the case  a possible causal association between the reported  event Polychondritis  and the suspect drug BNT162B2 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: Ophthalmic herpes zoster
Clinical narrative: Ophthalmic herpes zoster; This is a spontaneous report from a contactable consumer. 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 DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced ophthalmic herpes zoster on an unspecified date with outcome of unknown.    The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101529294 same reporter/drug/event, different patient;US-PFIZER INC-202101529173 same reporter/drug/event, different patient
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Confusional state, Dizziness, Fall, Fatigue
Clinical narrative: a little temperature / fever probably; chills; Confused; Caller states she took the Johnson and Johnson originally; Caller states she took the Johnson and Johnson originally; Booster; seizure; got lightheaded/ dizzy; sleepy / Fell asleep; tired; got sick; lethargic; When I got sick fell into fall; Sluggish; This is a spontaneous report from a contactable consumer.  A 52-year-old female consumer reported that she received third dose (booster) of bnt162b2 (COMIRNATY; Batch/Lot Number: FD0818) into left arm on 04Nov2021 at at 2:15  PM (at the age of 52-year-old) as single dose  for covid-19 immunisation. Medical history included  epilepsy diagnosed over 15 years. Concomitant drugs were none. The patient had received Johnson and Johnson vaccine on 15Mar2021 for covid-19 immunisation before the booster dose. The consumer reported that about 20 minutes after the booster vaccine on 04Nov2021, she went down the street to the chiropractor to work on her shoulder that was out of place from a fall previously, so she got vaccine in opposite arm, clarifies in the left arm, when she got there she walked in the door and she got really really lightheaded and so the nurse came and got her and took her to the room and fell against the wall, asked for an ice pack and laid down.  At this time she was very sleepy really quickly and tired, stated she laid down and went straight to sleep. The patient stated that this often happened when she had epileptic episodes, stated she was still aware and very confused at the time. She has been seizure free for 2 years, stated her mom took her home after the appointment on 04Nov2021, stated she was trying to figure out it if this was a breakthrough seizure or if it has anything to do with the shot. Haven't had a seizure in two years. Epilepsy for fifteen years, Focal seizure, she did not have gran mal, Simple complex. She had nocturnal seizures and got regularly monitored. Focal monitoring device. Slide the magnet over the device brewing or anything. Confused, sluggish and lethargic. When she got sick fell into fall. Put some ice and heat on other arm. Nurse just set her there for twenty minutes. Something was going on. Fell asleep.  Called her neurologist and they told her there have not been side effects of seizures with the vaccine.  On 05Nov2021 she felt fine, had a little bit of a temperature and chills, stated she has improved.   The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow-up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Immunisation, Interchange of vaccine products, Lethargy, Off label use
Clinical narrative: a little temperature / fever probably; chills; Confused; Caller states she took the Johnson and Johnson originally; Caller states she took the Johnson and Johnson originally; Booster; seizure; got lightheaded/ dizzy; sleepy / Fell asleep; tired; got sick; lethargic; When I got sick fell into fall; Sluggish; This is a spontaneous report from a contactable consumer.  A 52-year-old female consumer reported that she received third dose (booster) of bnt162b2 (COMIRNATY; Batch/Lot Number: FD0818) into left arm on 04Nov2021 at at 2:15  PM (at the age of 52-year-old) as single dose  for covid-19 immunisation. Medical history included  epilepsy diagnosed over 15 years. Concomitant drugs were none. The patient had received Johnson and Johnson vaccine on 15Mar2021 for covid-19 immunisation before the booster dose. The consumer reported that about 20 minutes after the booster vaccine on 04Nov2021, she went down the street to the chiropractor to work on her shoulder that was out of place from a fall previously, so she got vaccine in opposite arm, clarifies in the left arm, when she got there she walked in the door and she got really really lightheaded and so the nurse came and got her and took her to the room and fell against the wall, asked for an ice pack and laid down.  At this time she was very sleepy really quickly and tired, stated she laid down and went straight to sleep. The patient stated that this often happened when she had epileptic episodes, stated she was still aware and very confused at the time. She has been seizure free for 2 years, stated her mom took her home after the appointment on 04Nov2021, stated she was trying to figure out it if this was a breakthrough seizure or if it has anything to do with the shot. Haven't had a seizure in two years. Epilepsy for fifteen years, Focal seizure, she did not have gran mal, Simple complex. She had nocturnal seizures and got regularly monitored. Focal monitoring device. Slide the magnet over the device brewing or anything. Confused, sluggish and lethargic. When she got sick fell into fall. Put some ice and heat on other arm. Nurse just set her there for twenty minutes. Something was going on. Fell asleep.  Called her neurologist and they told her there have not been side effects of seizures with the vaccine.  On 05Nov2021 she felt fine, had a little bit of a temperature and chills, stated she has improved.   The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow-up.