chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction, SARS-CoV-2 test, Transient ischaemic attack
Clinical narrative: 2 TIA; Heart attack; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 08Mar2021 at 08:00 AM (Batch/Lot Number: EN6203) (at the age of 52-year-old) as dose 1, single, and via an unspecified route of administration, administered in the left arm on 2021 (Batch/Lot Number: ER8730) ((at the age of 52-year-old) as dose 2, single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no COVID prior to vaccination. Medical history included high blood pressure (BP), high cholesterol, and allergy to bee stings. Concomitant medications included blood pressure medication and cholesterol medication. On an unspecified date in 2021, the patient experienced 2 TIA (transient ischemic attack) heart attack, which resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization. The patient was hospitalized for 2 days. The patient was tested for COVID post vaccination which was a nasal swab with negative result in 2021. Therapeutic measures were taken as a result of the events which included stents, follow up appointments with multiple doctors. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Dizziness, Extra dose administered, Fatigue
Clinical narrative: Fever of 103.4; headache; body aches; nausea; fatigue; weakness; dizziness; Received my 3rd "booster" shot and had very strong side effects.; Received my 3rd "booster" shot and had very strong side effects.; This is a spontaneous report from a contactable consumer or other non hcp. A 50-years-old male patient received bnt162b2 (BNT162B2) formulation solution for injection, dose 3 Lot Number: FF2587) via an unspecified route of administration arm right on 16Sep2021 14:45 as a single dose for covid-19 immunisation. Medical history included hairy cell leukaemia from an unknown date and unknown if ongoing recovered hairy cell leukaemia patient (4 years into remission), drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included influenza vaccine (FLU) taken for an unspecified indication from 09Sep2021 to 09Sep2021; fluoxetine, buspirone, finasteride taken for an unspecified indication, start and stop date were not reported. The patient previously took augmentine [amoxicillin sodium; clavulanate potassium] and experienced drug hypersensitivity, vancomycin, and experienced drug hypersensitivity, bnt162b2 for covid-19 immunisation, bnt162b2 for covid-19 immunisation. Historical vaccine dose 1, (Lot number: EN6206 expiry date was unknown) via unspecified route of administration at right arm on 16Sep2021 as a single dose for COVID-19 immunisation, dose 2 (Lot number EP7533 expiry date was unknown) via unspecified route of administration at left arm on 16Sep2021 02:45 PM.  Location of injection for vaccine received same date: Pfizer BioNTech - Right, Pfizer BioNTech  Right. Location of injection for vaccine received within 4 weeks PRIOR: Flu shot - Left arm List of any other medications the patient received within 2 weeks of vaccination: Fluoxetine, Buspirone, Finasteride. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: 103.4 on 17Sep2021. Received his 3rd "booster" shot and had very strong side effects. Fever of 103.4, headache, body aches, nausea, fatigue, weakness, dizziness. His on second day now and still dealing with side effects however fever was under control so far without Tylen finally. His recovered hairy cell leukemia patent (4 years into remission) and wanted extra protection before his travel overseas in Oct.. Outcome of the event was recovering    Follow-Up (21 Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Off label use, Pain, Pyrexia
Clinical narrative: Fever of 103.4; headache; body aches; nausea; fatigue; weakness; dizziness; Received my 3rd "booster" shot and had very strong side effects.; Received my 3rd "booster" shot and had very strong side effects.; This is a spontaneous report from a contactable consumer or other non hcp. A 50-years-old male patient received bnt162b2 (BNT162B2) formulation solution for injection, dose 3 Lot Number: FF2587) via an unspecified route of administration arm right on 16Sep2021 14:45 as a single dose for covid-19 immunisation. Medical history included hairy cell leukaemia from an unknown date and unknown if ongoing recovered hairy cell leukaemia patient (4 years into remission), drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included influenza vaccine (FLU) taken for an unspecified indication from 09Sep2021 to 09Sep2021; fluoxetine, buspirone, finasteride taken for an unspecified indication, start and stop date were not reported. The patient previously took augmentine [amoxicillin sodium; clavulanate potassium] and experienced drug hypersensitivity, vancomycin, and experienced drug hypersensitivity, bnt162b2 for covid-19 immunisation, bnt162b2 for covid-19 immunisation. Historical vaccine dose 1, (Lot number: EN6206 expiry date was unknown) via unspecified route of administration at right arm on 16Sep2021 as a single dose for COVID-19 immunisation, dose 2 (Lot number EP7533 expiry date was unknown) via unspecified route of administration at left arm on 16Sep2021 02:45 PM.  Location of injection for vaccine received same date: Pfizer BioNTech - Right, Pfizer BioNTech  Right. Location of injection for vaccine received within 4 weeks PRIOR: Flu shot - Left arm List of any other medications the patient received within 2 weeks of vaccination: Fluoxetine, Buspirone, Finasteride. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: 103.4 on 17Sep2021. Received his 3rd "booster" shot and had very strong side effects. Fever of 103.4, headache, body aches, nausea, fatigue, weakness, dizziness. His on second day now and still dealing with side effects however fever was under control so far without Tylen finally. His recovered hairy cell leukemia patent (4 years into remission) and wanted extra protection before his travel overseas in Oct.. Outcome of the event was recovering    Follow-Up (21 Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Headache, Syncope
Clinical narrative: syncope; Dizziness; headache; diarrhea; This is a spontaneous report from a non-contactable physician (patient) reported for herself. A 41-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date: unknown), via an unspecified route of administration on 17Sep202116:00 as dose number unknown, single (at the age of 41 years) for COVID-19 immunisation. Medical history included immunodeficiency common variable, interstitial lung disease, colitis and allergy unspecified. The concomitant medications were not reported. 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 has not been tested for COVID-19. The patient experienced Dizziness, headache, syncope, diarrhoea on 17Sep2021. The patient did not undergo prolonged hospitalization. The patient did not receive any treatment for the events. The outcome of events was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the event syncope 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.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Appendix disorder, Incorrect dose administered, Overdose
Clinical narrative: Appendectomy out of nowhere!; administration date: 16Apr2021 lot number: EW0151/administration date: 16Apr2021 lot number: EW0170; administration date: 16Apr2021 lot number: EW0151/administration date: 16Apr2021 lot number: EW0170; This is a spontaneous report from a contactable consumer (patient)   A 45-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 16Apr2021 17:00 (Batch/Lot Number: EW0151) as single dose, and the second dose via an unspecified route of administration, administered in Arm Left on 16Apr2021 (Batch/Lot Number: EW0170) as single dose (at the age of 45) for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Medical history included sulfa allergy. Concomitant medications included sertraline hydrochloride (ZOLOFT), spironolactone, silicon dioxide (VIVISCAL). The patient previously took wellbutrin, phenergan [promethazine], nubain and with all she experienced drug hypersensitivity. The patient experienced appendectomy out of nowhere! on 26Jul2021 23:00. The patient was hospitalized for appendectomy out of nowhere! for 1 day. The outcome was recovered. Patient had an incorrect dose administration with outcome of unknown.    No follow-up attempts are needed. No further information is expected
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Seizure
Clinical narrative: I experienced my soy reaction (a seizure) to the PEG in the shot; I experienced my soy reaction (a seizure) to the PEG in the shot; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional.   A 59-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date (at the age of 59-years-old) as dose 2, single for covid-19 immunization. Medical history included refractory epilepsy, asthma, Sleep apnea, back injury, joint injury, Neuropathy in left thigh all from an unknown date and unknown if ongoing. Patient had known allergy to soy, Polyeythylene glycol, Penicillin, Sulfa and Latex from an unknown date and unknown if ongoing. Concomitant medications included eslicarbazepine acetate (APTIOM), clobazam (ONFI), gabapentin, buspirone hydrochloride (BUSPAR), vitamin c [ascorbic acid], ergocalciferol (VITAMIN D [ERGOCALCIFEROL]), zinc all taken for an unspecified indication, start and stop date were not reported. The patient received these medications within 2 weeks. Patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had been not tested for COVID-19 since the vaccination. On an unspecified date in 2021 the patient experienced her soy reaction (a seizure) to the PEG in the shot. Event reported as medically significant. No treatment was received for the events. Outcome of the events were resolving.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Pharyngeal swelling, Pruritus, SARS-CoV-2 test, Throat irritation
Clinical narrative: itchiness and mild swelling in throat; itchiness and mild swelling in my throat; itchiness of face and neck with flushing; itchiness of face and neck with flushing; This is a spontaneous report from a non-contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FD8448), via an unspecified route of administration in left arm on 27Aug2021 11:30 (at the age of 36-years-old) as dose 2, single for COVID-19 immunization. Medical history included asthma, Penicillin allergy, and latex allergy. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FC3181), via an unspecified route of administration in left arm on 06Aug2021 11:45 (at the age of 36-years-old) as dose 1, single for COVID-19 immunization and experienced itchiness and mild swelling in throat. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks and was not pregnant. The patient experienced itchiness and mild swelling in throat and itchiness of face and neck with flushing on 27Aug2021 12:15. The patient was advised to take Benadryl. The patient underwent lab tests and procedures which included Covid-19 RT-PCR (Nasal Swab): negative on 15Sep2021. Outcome of events was resolved on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Redness that is spreading, itchiness, swelling lump at injection site; itchiness, swelling lump at injection site; swelling lump at injection site; swelling lump at injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot Number: EW0168), dose 1 via an unspecified route of administration, administered in arm left on 17Sep2021 12:00 (at the age of 40-year-old) as dose 1, single for COVID-19 immunization. Medical history included Sulfa allergies. The patient's concomitant medications were not reported. The patient previously took doxycycline and experienced allergies and dichloralphenazone;isometheptene;paracetamol (MIDRIN) and experienced allergies. 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 has not been tested for COVID-19. On 18Sep2021 at 15:00, the patient experienced redness that is spreading, itchiness, swelling lump at injection site. Therapeutic measures were taken as a result of the reported events which included Benadryl. The outcome of the events was not recovered.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal faeces, Axillary pain, Diarrhoea, Groin pain, Monoplegia
Clinical narrative: Temporary paralysis in right hand (happened two different times); Daily diarrhea with a very odd foul smell; Daily diarrhea with a very odd foul smell; Sharp severe pains in left and right groin; Sharp severe pains in right armpit; Severe sore throat; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 09Sep2021 18:00 (at the age of 35-year-old) (Lot Number: FC5184) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. There were no concomitant medications. 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 and since the vaccination, the patient has not been tested for COVID-19. On 11Sep2021, the patient had daily diarrhea with a very odd foul smell, temporary paralysis in right hand (happened two different times), sharp severe pains in left and right groin, sharp severe pains in right armpit and severe sore throat lasting for days. The events resulted in doctor/HCP/clinic office visit. The patient did not receive treatment for the events. The outcome of the events was not recovered. The events were assessed as non-serious by the reporter.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Temporary paralysis in right hand (happened two different times); Daily diarrhea with a very odd foul smell; Daily diarrhea with a very odd foul smell; Sharp severe pains in left and right groin; Sharp severe pains in right armpit; Severe sore throat; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 09Sep2021 18:00 (at the age of 35-year-old) (Lot Number: FC5184) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. There were no concomitant medications. 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 and since the vaccination, the patient has not been tested for COVID-19. On 11Sep2021, the patient had daily diarrhea with a very odd foul smell, temporary paralysis in right hand (happened two different times), sharp severe pains in left and right groin, sharp severe pains in right armpit and severe sore throat lasting for days. The events resulted in doctor/HCP/clinic office visit. The patient did not receive treatment for the events. The outcome of the events was not recovered. The events were assessed as non-serious by the reporter.  Follow-up attempts are completed. No further information is expected.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Immunisation, Off label use
Clinical narrative: then I got the pfizer booster; then I got the pfizer booster; I am so miserable; This is a spontaneous report from a contactable consumer (patient). A 92-years-old non-pregnant female patient received third dose (Booster dose) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported, patient was 92-year-old at the time of vaccination), via an unspecified route of administration on an unspecified date in 2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included atrial fibrillation. Concomitant medication(s) included warfarin sodium (COUMADIN); losartan (LOSARTAN); bisoprolol fumarate, hydrochlorothiazide (BISOPROLOL /HCTZ) all were taken for an unspecified indication received within 2 weeks of vaccination, start and stop date were not reported. Reported that patient started itching all over, no rash. It has kept me up at night (it's the worse at night) but I itch all day. After a couple of weeks, I got a rash; thinking it was where I would scratch. I went to several dermatologist and nothing. I got off the bisoprl; thinking that was it. I got the second shot and then I got the Pfizer booster, and my daughter gave me a printout saying itching and rash were side effects of the shots. If I had known that; I wouldn't have taken it. I am so miserable. Creams from dermatologist doesn't work. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL3248, patient was 92-year-old at the time of vaccination), via an unspecified route of administration, administered on left arm on 13Jan2021 at 15:15 as DOSE 1, SINGLE for covid-19 immunisation and experienced Itching all over and Rash on 20Jan2021 at 08:00 PM which resulted in to visit doctor or other healthcare professional office/clinic visit having treatment with unspecified creams with outcome not recovered; and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, on an unspecified date in 2021 as DOSE 2, SINGLE for covid-19 immunisation. 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 was not tested for COVID-19. On an unspecified date in 2021, the patient experienced then i got the Pfizer booster, i am so miserable. The outcomes of events were unknown.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Uveitis
Clinical narrative: WORSENED UVEITIS; UVEITIS; FACILITATED COLLECT  This is a Solicited report based on the information received by Pfizer from AbbVie Pharmacovigilance (Manufacturer Control No: 21K-163-4075510-00) from a contactable female consumer reported for herself.  A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular on an unspecified date in Jan2021 and the second dose on 13Feb2021, at the age of 32-years-old, (Batch/Lot number was not reported), via intramuscular route as single dose for covid-19 immunisation and ADALIMUMAB (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, for Non-Infectious intermediate, Posterior and Panuveitis.  The patient medical history included uveitis. The patient's concomitant medications were not reported. On unknown date in Jan2021, the patient had worsened uveitis. The outcome of the event was recovering.   The reporter's causality for the event with HUMIRA(adalimumab) was not provided.   The reporter's assessment of the causal relationship of the event with bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and considering drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the reported events of worsened Uveitis cannot be completely excluded. Case will be reassessed upon receipt of additional information.  The impact of this report on the benefit/risk profile of the Pfizer drug 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: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; FACILITATED COLLECT  This is a solicited report based on the information received by Pfizer from Pharmacovigilance (Manufacturer Control No: 21K-163-4077839-00) from a contactable male consumer reported for himself.  A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 intramuscular on 25Mar2021, at the age of 66-years-old (Batch/Lot number was not reported) as single dose for covid-19 immunisation and adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, for psoriatic arthritis. The patient had received the first dose of bnt162b2 on 02Mar2021 at the age of 66-year-old. The patient medical history and the patient's concomitant medications were not reported. On 09Sep2021, the patient had a SARS-CoV-2 test positive. The outcome of the event was recovering.   The reporter's causality for the event of COVID with HUMIRA (ADALIMUMAB) was a reasonable possibility.  The reporter's assessment of the causal relationship of the event with bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
Sex: M
Vaccine: COVID19
Symptoms: Chills, Extra dose administered, Fatigue, Feeling abnormal, Feeling cold
Clinical narrative: we talk to the radiologist about getting the Pfizer booster and he said, yes you should definitely get it and get it asap so, we got it Thursday afternoon; we talk to the radiologist about getting the Pfizer booster and he said, yes you should definitely get it and get it asap so, we got it Thursday afternoon; He is shaking like tremoring; Little fatigue; Fever; temperature and its only 99.3; Freezing; Shivering; I just don't feel alright; This is a spontaneous report from a contactable consumer. A male patient (reporter's husband) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 3 via an unspecified route of administration on an unspecified date as dose 3, single for covid-19 immunisation.  Medical history included Immunocompromised, Cancer, Metastases to brain. The patient also underwent radiation treatment on Wednesday afternoon and (voice not clear) he has metastases to his brain (medical condition) and they have talked to the radiologist about getting the Pfizer booster and he recommended to definitely get it. The patient's concomitant medications were not reported.  Historical vaccine included BNT162B2  as dose 1 and dose 2 on unspecified date for COVID-19 immunization . On an unspecified date, the patient experienced "we talk to the radiologist about getting the pfizer booster and he said, yes you should definitely get it and get it asap so, we got it thursday afternoon", he is shaking like tremoring, little fatigue, fever; temperature and its only 99.3, freezing, shivering, i just don't feel alright.  The patient underwent lab tests and procedures which included pyrexia: 99.3 fahrenheit on  Fever; temperature and its only 99.3. It was reported that the patient got the vaccine Thursday afternoon and he was little fatigue obviously from the radiation and now not sure if its also from the booster and the biggest symptoms were he was shaking like tremoring like he had the high fever and freezing and his temperature was  99.3.The reporter asked if it was a normal reaction. Reporter asked since it was Saturday, would there be somebody there to address them. Reporter was informed that the Pfizer Medical Information Department closed on Saturday and Sunday and was advised to contact health care provider at that time.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (27Sep2021) This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.   Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Pyrexia, Tremor
Clinical narrative: we talk to the radiologist about getting the Pfizer booster and he said, yes you should definitely get it and get it asap so, we got it Thursday afternoon; we talk to the radiologist about getting the Pfizer booster and he said, yes you should definitely get it and get it asap so, we got it Thursday afternoon; He is shaking like tremoring; Little fatigue; Fever; temperature and its only 99.3; Freezing; Shivering; I just don't feel alright; This is a spontaneous report from a contactable consumer. A male patient (reporter's husband) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 3 via an unspecified route of administration on an unspecified date as dose 3, single for covid-19 immunisation.  Medical history included Immunocompromised, Cancer, Metastases to brain. The patient also underwent radiation treatment on Wednesday afternoon and (voice not clear) he has metastases to his brain (medical condition) and they have talked to the radiologist about getting the Pfizer booster and he recommended to definitely get it. The patient's concomitant medications were not reported.  Historical vaccine included BNT162B2  as dose 1 and dose 2 on unspecified date for COVID-19 immunization . On an unspecified date, the patient experienced "we talk to the radiologist about getting the pfizer booster and he said, yes you should definitely get it and get it asap so, we got it thursday afternoon", he is shaking like tremoring, little fatigue, fever; temperature and its only 99.3, freezing, shivering, i just don't feel alright.  The patient underwent lab tests and procedures which included pyrexia: 99.3 fahrenheit on  Fever; temperature and its only 99.3. It was reported that the patient got the vaccine Thursday afternoon and he was little fatigue obviously from the radiation and now not sure if its also from the booster and the biggest symptoms were he was shaking like tremoring like he had the high fever and freezing and his temperature was  99.3.The reporter asked if it was a normal reaction. Reporter asked since it was Saturday, would there be somebody there to address them. Reporter was informed that the Pfizer Medical Information Department closed on Saturday and Sunday and was advised to contact health care provider at that time.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (27Sep2021) This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.   Follow-up attempts completed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Haematochezia, Influenza like illness, Laboratory test, Malaise
Clinical narrative: Sick; Fluish; Blood in his stool; This is a spontaneous report from a contactable consumer. A 45-year-old male patient (husband) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: FF2587 ) via an unspecified route of administration on 17Sep2021 (at the age of 45-year-old) as Dose 1,Single for COVID-19 immunization.  The patient's medical history and concomitant medications was not reported. The patient denied for any medical condition before covid and also denied for other medication. On an unspecified date in Sep2021, the patient experienced blood in his stool and on 17Sep2021 at 19:00 , patient was sick and felt fluish. On 17Sep2021, the patient underwent lab tests and procedures to see if he is okay to get the vaccine so the patient underwent laboratory and glucose test and found that all result were normal. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: red, itching, burning rash; red, itching, burning rash; rash that looked like mosquito bites between her legs and arms/ She says in a matter of hours it spread all over; they kind of clumped together to make one bigger mosquito bite, like welts; This is a spontaneous report from a contactable consumer (patient's mother) Pfizer-sponsored program  A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), an unspecified route of administration, administered in left arm on 15Sep2021 (Batch/Lot Number: FC3183) (at the age of 16 years old) as dose 1, single for COVID-19 immunisation. Medical history included seasonal allergies. There were no concomitant medication. The patient previously took Allegra, patient had seasonal allergies and occasionally takes over the counter Allegra for that but not every day and only on occasion. Patient had a reaction to her first dose of the Pfizer COVID-19 vaccine she got on 15Sep2021. Patient had a red, itching, burning rash that started two days after the vaccine on 17Sep2021. It started for hours between her legs and then was all over her body kind of like mosquito bites that were more concentrated on lower body mostly. The patient's mother said that she gave her daughter Benadryl (25mg Ultra-tabs; LOT: SHF054 EXP: Feb2022) and that it didn't do anything. She developed a rash that looked like mosquito bites between her legs, a lot of them, and she said it was itchy and burning. She says in a matter of hours it spread all over, a lot on her bottom half, and some on her back, arms, and chest. She says that they kind of clumped together to make one bigger mosquito bite, like welts, they kind of make one bigger one. She says they spread a lot, the little bumps, into big huge one. She says that this was on her thighs and all around, but she didn't see any on her feet, they were on her ankle but not on her feet. Patient suffered with the rash over the weekend, but she didn't get to look at her legs before she went to school today, which she let the school nurse know she was having an adverse reaction to the shot. She says Friday was the worst when it was developing, then on Saturday it was still itching and burning with redness. She says the red was clumped together to make big ones. She says Sunday the rash was still there, this morning it is unknown if still there. The outcome of the events was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Extra dose administered
Clinical narrative: 3rd dose, expired 9/17/2021; 3rd dose, expired 9/17/2021; This is a spontaneous report from a contactable Pharmacist (patient) via Medical Information Team. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection Lot number: FD0809; Expiration Date: 17Sep2021), via an unspecified route of administration in left deltoid on 20Sep2021 at 10:30 (at the age of 61 years old) as DOSE 3, 0.3 ML SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first and second dose of BNT162B2 for covid-19 immunisation. Pharmacist stated that this was regarding a Beyond use date - was mixed on 17Sep2021 and in syringe at 10:04AM - and remained at room temperature until administered 20Sep2021 at 10:30am. She stated they gave a third dose to the patient, and it was expired. They did not realize at the time it was expired. Third dose was given because patient was immunocompromised. The outcome of events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This patient has had a break through case of COVID.; This patient has had a break through case of COVID.; This is a spontaneous report from a contactable Pfizer colleague (consumer) reported for an adult male patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) 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. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not positive for COVID-19 prior to vaccination, since the vaccination the patient been tested for COVID-19. On 14Sep2021 it was reported that the patient has had a breakthrough case of COVID. On 16Sep2021 patient underwent lab tests and procedures which included Covid Test: positive. It was unknown if patient received treatment for the events. The outcome of the event was recovering.  The lot number for BNT162b2 was not provided and will be requested during follow up. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101242580 same reporter/product/event, different patients
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 virus test positive; COVID-19; This is a solicited report based on the information received by Pfizer  (Mfr. Control No.: 21K-163-3821345-00) from a contactable consumer (patient). A 49-year-old male patient received BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number and expiration date: Not reported), via intramuscular route of administration on 03Ju12021 as dose 2, single, BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number and Expiration date: Not reported), via intramuscular route of administration on 10Jun2021 as dose 1, single for COVID-19 immunisation; adalimumab (HUMIRA Solution for injection in pre-filled pen), subcutaneous from an unspecified date for Moderate to Severe Chronic Plaque Psoriasis. The medical history and concomitant medications of the patient were not reported. The patient experienced covid-19 on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date and sars-cov-2 test: unknown results on an unspecified date. The action taken in response to the event for Humira was unknown. The outcome of the event was reported as unknown. Causality for Humira (Adalimumab): The reporter's causality for the event of Positive FOR COVID-19, COVID-19 virus test positive was a reasonable possibility. Causality for BNT162B2: the reporter causality for the event of COVID-19 virus test positive was Possible.  The lot number for BNT162B2 was not provided and will be request during follow-up. ; Sender's Comments: As there is limited information in the case provided, the causal association between the event Covid-19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Breakthrough COVID 19 infection after fully vaccinated; Breakthrough COVID 19 infection after fully vaccinated; This is a spontaneous report from a non-contactable consumer (patient) reported for self. A patient of an unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced breakthrough COVID 19 infection after fully vaccinated (drug ineffective). The event took place after use of product. The 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.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Body temperature, Body temperature decreased, Bone pain
Clinical narrative: my right arm is starting to hurt; arthritis pain; muscle hurts/muscle pain; injection pain; joint pain; pain is in her shoulder to the hip bone on the left side; pain is in her shoulder to the hip bone on the left side; Chills; three days after not feeling well/ didn't feel well; tired; lousy; last night I didn't sleep; whole left side from her shoulder to bottom of her back bone hurts; she couldn't get her temperature. It was reading like 93.0 when her normal was 97. something; This is a spontaneous report from a contactable consumer reported that. A 87-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 17Sep2021 (Batch/Lot Number: FE3592; Expiration Date: 28Feb2022) as DOSE 1, SINGLE for covid-19 immunizations (Age at vaccination 87 years). The patient past Medical history included ongoing arthritis, ongoing atrial fibrillation. Concomitant medication was none.  Caller states "I just feel tired and lousy and like I was telling her, I take my vital signs every morning and everything is usually pretty low, my temperature is normally 97. something and last night I didn't sleep at all because of the pain in my left side and now my right arm is starting to hurt I guess because I'm using it more on an unspecified date in 2021. The patient reported she had chills and didn't feel well on 17Sep2021. She reports she was tired and so she just rested. The next day she didn't have chills but still rested that day. It is explained that the night before, the pain in her left arm, where the shot was given, and that whole left side from her shoulder to bottom of her backbone hurts and this is not going way. She has been using the right arm, and now that muscle hurts too. The caller explains she feels unwell and wants to know how long this and the muscle pain will last. The caller clarified that the pain is in her shoulder to the hip bone on the left side. This started on 18Sep2021 but last night it was the worst. Today it is a little better. Treatment- The caller notes that she checked her vitals, her temperature and blood pressure, like she does every morning. On 20Sep2021, she couldn't get her temperature. It was reading like 93.0 when her normal was 97. Something. She had to use the heating pad and it took a while to get her temperature back up. She doesn't take vaccines because she is so sensitive to things, she doesn't even the flu shot. She might have gotten it 5 years ago. Caller states "they said in 3 or 4 weeks I'm supposed to get my second dose, but that seems awfully close. The event outcome Unknown for fatigue, lousy, Insomnia, Pain in arm, Joint pain, Pain in spine, Muscle pain, Body temperature decrease, Vaccination site pain and Arthritis flare up, Not recovered Feeling unwell, recovered for Chills, recovering for Shoulder pain and Pain bone
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Insomnia, Malaise
Clinical narrative: my right arm is starting to hurt; arthritis pain; muscle hurts/muscle pain; injection pain; joint pain; pain is in her shoulder to the hip bone on the left side; pain is in her shoulder to the hip bone on the left side; Chills; three days after not feeling well/ didn't feel well; tired; lousy; last night I didn't sleep; whole left side from her shoulder to bottom of her back bone hurts; she couldn't get her temperature. It was reading like 93.0 when her normal was 97. something; This is a spontaneous report from a contactable consumer reported that. A 87-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 17Sep2021 (Batch/Lot Number: FE3592; Expiration Date: 28Feb2022) as DOSE 1, SINGLE for covid-19 immunizations (Age at vaccination 87 years). The patient past Medical history included ongoing arthritis, ongoing atrial fibrillation. Concomitant medication was none.  Caller states "I just feel tired and lousy and like I was telling her, I take my vital signs every morning and everything is usually pretty low, my temperature is normally 97. something and last night I didn't sleep at all because of the pain in my left side and now my right arm is starting to hurt I guess because I'm using it more on an unspecified date in 2021. The patient reported she had chills and didn't feel well on 17Sep2021. She reports she was tired and so she just rested. The next day she didn't have chills but still rested that day. It is explained that the night before, the pain in her left arm, where the shot was given, and that whole left side from her shoulder to bottom of her backbone hurts and this is not going way. She has been using the right arm, and now that muscle hurts too. The caller explains she feels unwell and wants to know how long this and the muscle pain will last. The caller clarified that the pain is in her shoulder to the hip bone on the left side. This started on 18Sep2021 but last night it was the worst. Today it is a little better. Treatment- The caller notes that she checked her vitals, her temperature and blood pressure, like she does every morning. On 20Sep2021, she couldn't get her temperature. It was reading like 93.0 when her normal was 97. Something. She had to use the heating pad and it took a while to get her temperature back up. She doesn't take vaccines because she is so sensitive to things, she doesn't even the flu shot. She might have gotten it 5 years ago. Caller states "they said in 3 or 4 weeks I'm supposed to get my second dose, but that seems awfully close. The event outcome Unknown for fatigue, lousy, Insomnia, Pain in arm, Joint pain, Pain in spine, Muscle pain, Body temperature decrease, Vaccination site pain and Arthritis flare up, Not recovered Feeling unwell, recovered for Chills, recovering for Shoulder pain and Pain bone