chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hypoaesthesia, Inflammation, SARS-CoV-2 test
Clinical narrative: Hand/arm numbness; Hand/arm numbness; burning; Body inflammatory response.; This is a spontaneous report from a contactable nurse (patient). A non-pregnant 39-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered at Workplace clinic via an unspecified route in right arm on 21Dec2020, at 39 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included hypertension and asthma, both from an unknown date. The patient didn't receive any other vaccine in the 4 weeks prior vaccination. Concomitant medication included lisinopril taken for an unspecified indication, since an unknown date. The patient was not diagnosed with COVID-19 prior vaccination. On 19Jan2021 the patient experienced hand/arm numbness and burning and body inflammatory response. The events resulted in Doctor or other healthcare professional office/clinic visit and Disability or permanent damage. It's unknown if the patient received any treatment. It was reported that on 10Sep2021 the patient underwent SARS-CoV-2 test via nasal swab, which turned to be negative. At the time of the report the events had not resolved yet.  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  events Hypoaesthesia, Burning sensation, Inflammation 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: M
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure decreased, Blood pressure measurement, Dizziness
Clinical narrative: weakness; blood pressure dropped significantly; light headedness; This is a spontaneous report from a contactable consumer (father). A 16-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on Jun2021 (Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced weakness, blood pressure dropped significantly and light headedness. The patient was hospitalized due to the reported events on an unspecified date in 2021. The father stated that his son had a severe reaction to the vaccine and went to the doctor twice and the hospital. He stated his son is feeling better now and wants to know if there is any evidence or data on the second dose and having another reaction. He stated when he first got the shot his blood pressure dropped significantly and they held him at the location for a while. His blood pressure returned to normal and he was good for about 2 weeks and then he started to experience light headedness and weakness that almost lasted two months. He states that his son is almost back to normal and is hesitant to get the second dose. The reported events resulted in physician office visit. Therapeutic measure was taken as a result of the events. The outcome of the events was recovering.    The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspepsia, Myocarditis, Pericarditis
Clinical narrative: Myocarditis/pericarditis; Myocarditis/pericarditis; Chest pain; Heart burn; This is a spontaneous report from a non-contactable consumer received from a Pfizer sponsored program.   An 18-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  On an unspecified date (1 or 2 days after receiving the first dose) the patient experienced chest pain and heart burn. The patient was not evaluated by a doctor at the time of the chest pains so was unclear if it was myocarditis/pericarditis. The patient outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal haemorrhage, Haemoglobin, Haemoglobin decreased, Myocardial infarction, SARS-CoV-2 test
Clinical narrative: Heart attack; Gastrointestinal Bleed; Gastrointestinal Bleed with a low hemoglobin of 5.8; This is a spontaneous report from a non-contactable consumer. An 80-year-old female patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown), at the age of 80 years old, via an unspecified route of administration on 22Jul2021 at single dose for COVID-19 immunisation. The patient was not pregnant at time of vaccination. The patient had no known allergies. Medical history included COVID-19 (prior vaccination). The patient did not receive any other vaccine within four weeks of vaccination. The patient's concomitant medications were not reported. The patient experienced heart attack 16 days after the first administration of vaccine and a gastrointestinal bleed with a low hemoglobin of 5.8 on 07Aug2021. Events resulted in hospitalization for 7 days. The patient had been tested for COVID-19 post vaccination. The patient underwent lab tests and procedures which included hemoglobin: 5.8 (low) on 07Aug2021, COVID-19 test: negative on 07Aug2021. Therapeutic measures were taken as a result of events and included treatment with clopidogrel bisulfate (PLAVIX) and aspirin, blood transfusion and iron. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Confusional state, Dizziness, Feeling abnormal
Clinical narrative: Confusions; Dizziness; Weakness in lower extremities; Back pain; Tingling legs and arms; Brain fog; This is a spontaneous report from a contactable Other HCP (patient herself).  A 32-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route administered in the arm, on 01Sep2021 (at the age of 32-year-old) at single dose for COVID-19 immunisation.  Historical vaccination includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route administered in the left arm, on unknown date at single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Relevant medical history included COVID-19 on unknown date (before vaccination). No known allergies. The patient did not have concomitant medications. On 09Sep2021 at 16:45, 8 days after the shot she suffering with confusions and dizziness. She was in the emergency room with weakness in lower extremities, back pain and tingling legs and arms. The events were reported as non-serious. It was reported that the events required also physician office visit. Therapeutic measures taken as result of events included intravenous (IV) fluids, dizziness medications, ketorolac tromethamine (TORADOL). Laboratory work was done but results were not provided. On 06Sep2021, a PCR Nasal swab was done and resulted negative. The patient was recovering from back pain while she had not recovered from the other events.  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  the causal role of BNT162B2 vaccine cannot be excluded for the reported events  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: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Paraesthesia, SARS-CoV-2 test
Clinical narrative: Confusions; Dizziness; Weakness in lower extremities; Back pain; Tingling legs and arms; Brain fog; This is a spontaneous report from a contactable Other HCP (patient herself).  A 32-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route administered in the arm, on 01Sep2021 (at the age of 32-year-old) at single dose for COVID-19 immunisation.  Historical vaccination includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route administered in the left arm, on unknown date at single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Relevant medical history included COVID-19 on unknown date (before vaccination). No known allergies. The patient did not have concomitant medications. On 09Sep2021 at 16:45, 8 days after the shot she suffering with confusions and dizziness. She was in the emergency room with weakness in lower extremities, back pain and tingling legs and arms. The events were reported as non-serious. It was reported that the events required also physician office visit. Therapeutic measures taken as result of events included intravenous (IV) fluids, dizziness medications, ketorolac tromethamine (TORADOL). Laboratory work was done but results were not provided. On 06Sep2021, a PCR Nasal swab was done and resulted negative. The patient was recovering from back pain while she had not recovered from the other events.  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  the causal role of BNT162B2 vaccine cannot be excluded for the reported events  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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Pt had covid; This is a spontaneous report from a contactable Nurse.   A 58-year-old-female consumer patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 14Aug2021 at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history included Rheumatoid arthritis. Concomitant medications included HYDROXYCHLOROQUINE SULFATE and tofacitinib citrate (XELJANZ XR) orally from Sep2017 at 5 mg twice daily for rheumatoid arthritis. It was informed that patient had Covid- 19 on 16Aug2021. It was also reported that he was aching and hurting and cough from Covid. At the time of the reporting the patient had not yet recovered from 'I'm aching and hurting' and cough, while outcome of other events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Facial asymmetry, Hypoaesthesia, Loss of consciousness
Clinical narrative: Passed out; Distorted face; Dizziness; Could not feel arms and legs; This is a spontaneous report from a Pfizer sponsored program with Regulatory Authority Support from a contactable registered nurse. A female (reporter's friend) patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient received the COVID-19 Vaccine. After the first dose, she had a distorted face, passed out, dizziness and could not feel arms and legs. The outcome of events was unknown.  The lot number for the vaccine BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Loss of consciousness and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 virus test positive; COVID-19 virus test positive; This is a solicited report based on the information received by Pfizer from AbbVie Inc. (MFR Control No. #21K-163-4074567-00). A contactable consumer (patient) reported for herself. Solicited report by a consumer of a 39 year old female with an event of non-serious COVID-19 Positive with Skyrizi (Risankizumab). There was no reported medical history. On 01Sep2021, the patient experienced COVID-19 Positive. Pfizer BioNTech COVID-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 08Aug2021 (at age of 39-year-old), she received 1st dose COVID-19 Vaccine manufactured Pfizer BioNTech via intramuscular at single dose for COVID-19 immunization. The action taken in response to the events for Risankizumab was unknown. The outcome of event was recovering.  The reporter's causality for the event(s) of COVID-19 POSITIVE with SKYRIZI(RISANKIZUMAB) was no reasonable possibility.   The reporter's assessment of the causal relationship of the events with the suspect product 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.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective and covid-19 and BNT162B2.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a solicited report based on the information received by Pfizer from AbbVie Inc. (MFR Control No. #21K-163-4072551-00). A contactable consumer(patient) reported a 48-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), intramuscular on an unspecified date (at unknown age) as single dose for COVID-19 immunization; adalimumab (HUMIRA), subcutaneous from 14Aug2021 to 30Aug2021, at unspecified dose for moderate to severe adult crohn's disease. Medical history included moderate to severe adult crohn's disease. The patient's concomitant medications were not reported. The patient was with an event of non-serious CAUGHT COVID with HUMIRA (ADALIMUMAB). In Aug2021, the patient experienced CAUGHT COVID. In 2021, the caught COVID resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. On an unknown date, patient received Covid-19 Vaccine manufactured by Pfizer. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of CAUGHT COVID with HUMIRA(ADALIMUMAB) was no reasonable possibility. Causality for COVID-19 as per reporter (Drug/Vaccine): Possible. The patient underwent lab tests and procedures which included Covid-19: positive on Aug2021. The action taken in response to the events for adalimumab was unknown. The outcome of the events was recovered in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Insomnia
Clinical narrative: Insomnia leading to sleep anxiety (dose 2); Insomnia leading to sleep anxiety (dose 2); This is a spontaneous report from a contactable consumer, the patient.  This is the second of two reports.  This case is for the second dose. A 38-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 22Apr2021 at 12:30 (Batch/Lot Number: EW0161) as dose 2, single (at the age of 38-years-old) for COVID-19 immunisation.  The patient medical history was not reported. The patient did not have COVID prior to vaccination.  Concomitant medications included ascorbic acid (VIT C) and multivitamin, both taken for an unspecified indication, start and stop date were not reported.  The patient previously took Omnipaque and experienced contrast media allergy and bnt162b2 via an unspecified route of administration, administered in the left arm on 01Apr2021 at 12:30 (Batch/Lot Number: ER8734) as dose 1, (at the age of 38-years-old) for COVID-19 immunisation and experienced hot warm shot running from right pelvis down to right leg.  The patient did not receive other vaccine in four weeks prior to bnt162b2. The patient experienced insomnia leading to sleep anxiety on an unknown date.  The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of insomnia leading to sleep and included anxiety pills and sleeping pills. The clinical outcome of the events insomnia leading to sleep anxiety was not recovered. It was also reported the patient was not tested for COVID post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101204737 same patient/drug, different vaccine dose/event
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Diagnosed with Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 24Apr2021 12:00 (at the age of 37 years) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient is not pregnant. The patient previously took DOSE 1 of BNT162B2 on 04Apr2021 01:00 (at the age of 37 years) for COVID-19 immunization. The patient was diagnosed with Bell's palsy on 06Jun2021. The event was assessed as serious (medically significant). The event resulted in a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event (prednisone). The outcome of the event was recovered on an unspecified date in 2021.  The information about the batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Intracranial aneurysm
Clinical narrative: Brain aneurysm; This is a spontaneous report from a contactable consumer.   A patient of unspecified age and gender received COVID-19 VACCINE-MANUFACTURER UNKNOWN (BNT162B2; Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation .  Medical history and concomitant medications were not reported.  The patient experienced a brain aneurysm on an unknown date after receiving "unknown Covid-19 Vaccine". The patient who received one of the Covid-19 Vaccines was recovering from a brain aneurysm and having to learn how to walk again. The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Loss of consciousness
Clinical narrative: Passed out; blood pressure bottomed out; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Fc3183), administered in the left arm on 11Sep2021 at 16:00 (at the age of 53-years-old) at dose 1, single for COVID-19 immunisation. Medical history included COVID prior vaccination. No COVID tested post vaccination. Concomitant medications were reported as none; no other vaccine in four weeks and no other medications in two weeks. The patient passed out and blood pressure bottomed out on 13Sep2021 at 05:00. Adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The outcome of the events was unknown.   Follow-Up (16Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Hypertension, Palpitations, Vaccination site swelling
Clinical narrative: palpitations; Hypertension; injection site (entire arm from elbow to armpit) swelling; anxiety; This is a spontaneous report from a Non-contactable Other HCP (patient herself). A 40-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: FC3183, expiry date: unknown) via unspecified route of administration, in left arm on 03Sep2021 16:30, (age at vaccination: 40-years) as dose 1, single for covid-19 immunisation. Patients medical history and concomitant medications were not reported. Facility type vaccine was Pharmacy or Drug Store. Patient did not take any other vaccines in four weeks, or medications in two weeks. On 05Sep2021, patient experienced hypertension, palpitations, anxiety, injection site (entire arm from elbow to armpit) swelling. Treatment was given due to the adverse events with HTN. AE resulted in doctor or other healthcare professional office/clinic visit .It was unknown whether patient had been diagnosed with COVID-19 prior to vaccination and was not tested since the vaccination. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Endocrine test, Postmenopausal haemorrhage, SARS-CoV-2 RNA
Clinical narrative: my menopause ended temporarily; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 61-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered at Pharmacy or Drug Store, via an unspecified route, in right arm on 08Apr2021, at 61 years of age, (Batch/Lot Number: EL8982) as single dose for COVID-19 immunization. Medical history included Chronic Lyme Disease from an unknown date and known allergies to penicillin, sulfa drugs, tramadol, ciprofloxacin (CIPRO), cephalosporin and atorvastatin (LIPITOR) from an unknown date. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered in right arm on 19Mar2021, at 61 years of age, (Batch/Lot Number: EL8982) as single dose for COVID-19 immunization. The patient didn't receive any other vaccine within the 4 weeks before vaccination. The patient was not diagnosed with COVID-19 prior vaccination. Concomitant medications included bupropion, levothyroxine, melatonin, colecalciferol (D3) and magnesium, all taken for an unspecified indication, since an unknown date. The patient reported that one month following her 2nd shot, on 14May2021, her menopause ended temporarily leading to two surgical procedures to rule out cancer and to stop or reduce menstrual flow. The event also resulted in Doctor or other healthcare professional office/clinic visit. Her postmenopausal phase was first identified at her women's health center in Apr2018 or Mar2018, but hormone testing on 14May2021 revealed that the patient was mid-cycle. This is highly irregular considering her age and considering how long she had been postmenopausal. The patient was treated with Dilatation and Curettage (D&C) as an outpatient on 15May2021 and with D&C and ablation on 20Jul2021. The patient underwent SARS-CoV2 test via nasal swab on 06Aug2021 which gave negative results. The reported events resolved on an unknown date.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I have broken out in a serious rash from head to toe; This is a spontaneous report from a contactable consumer (patient).  A 39-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the right arm on 01Sep2021 10:00 (at the age of 39-year-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Relevant medical history included asthma and penicillin allergy. There were no concomitant medications.  The patient had broken out in a serious rash from head to toe (medically significant) on 09Sep2021 12:00 with outcome of not recovered. Within 10 days of receiving then vaccine, the patient had broken out in a serious rash from head to toe, he has been seen in the Emergency Room, where a benadryl shot and a steroid shot was given to him; he has seen no relief from either. The patient never had a rash like this in his entire life. The event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. If covid prior vaccination: No. If covid tested post vaccination: No.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest pain, Chills, Diarrhoea, Drug ineffective
Clinical narrative: received both doses of the Pfizer covid vaccine/still came down with the virus; received both doses of the Pfizer covid vaccine/still came down with the virus/COVID -19; chills; fever; diarrhea; chest pain; This is a spontaneous report from a sponsored program. A contactable consumer (patient's husband) reported.  A 71-years-old female patient second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation for injection, Lot Number: unknown, Expiry date: Unknown) on unspecified date (age at vaccination 71-year-old) as dose 2, single and patient also received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation for injection, Lot Number: unknown, Expiry date: Unknown) on unspecified date (age at vaccination 71-year-old) as dose 1, single. The patient medical history was not reported. The concomitant medications were not reported. On unspecified date and month of 2021 patient experienced received both doses of the Pfizer Covid vaccine/still came down with the virus (medically significant), received both doses of the Pfizer Covid vaccine/still came down with the virus/Covid -19, chills, fever, diarrhea and chest pain. Events cause patient hospitalized from an unknown date to 14Sep2021. The patient underwent lab tests and procedures which included SARS-COV-2 test: Covid on 2021. The clinical outcome of the events were 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-202101206375 Same reporter/drug/event for different patients.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: received both doses of the Pfizer covid vaccine/still came down with the virus; received both doses of the Pfizer covid vaccine/still came down with the virus/COVID -19; chills; fever; diarrhea; chest pain; This is a spontaneous report from a sponsored program. A contactable consumer (patient's husband) reported.  A 71-years-old female patient second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation for injection, Lot Number: unknown, Expiry date: Unknown) on unspecified date (age at vaccination 71-year-old) as dose 2, single and patient also received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation for injection, Lot Number: unknown, Expiry date: Unknown) on unspecified date (age at vaccination 71-year-old) as dose 1, single. The patient medical history was not reported. The concomitant medications were not reported. On unspecified date and month of 2021 patient experienced received both doses of the Pfizer Covid vaccine/still came down with the virus (medically significant), received both doses of the Pfizer Covid vaccine/still came down with the virus/Covid -19, chills, fever, diarrhea and chest pain. Events cause patient hospitalized from an unknown date to 14Sep2021. The patient underwent lab tests and procedures which included SARS-COV-2 test: Covid on 2021. The clinical outcome of the events were 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-202101206375 Same reporter/drug/event for different patients.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive test; positive test; This is a spontaneous report from a contactable consumer. A 56-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiry date: unknown, at the age of 56 years), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation in hospital. The medical history and concomitant medications were not reported. It was not known if patient received 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 been tested for COVID-19. The patient reported, positive test and loss of taste and smell on an unspecified date. She was previously vaccinated. The patient underwent lab tests and procedures which included sars-cov-2 test positive on an unspecified date. It was not known if the patient received any treatment for the events. Adverse event result in doctor or other healthcare professional office/clinic visit. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Headache, Hyperhidrosis, Hypertension
Clinical narrative: very sick with chills; very sick with chills; a terrible and a terrible headache; a fever over 100 degrees; blood pressure of 172/128; heavy sweating with a terrible  headache; This is a Spontaneous report based on the information received by Pfizer from Corporation. A contactable consumer reported that: A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration on 31Aug2021 (Age at vaccination63 years old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient reported she received her first shot of the Pfizer Covid 19 vaccine on 10Aug2021 and reported chills. The patient reported she received her second vaccine on 31Aug2021 and got very sick with chills and a terrible and a terrible headache with a fever over 100 degrees. The patient reported on 01sep2021 she experienced heavy sweating with a terrible headache, so her husband took her to the emergency room she had a blood pressure of 172/128. The patient reported on 02Sep2021 her blood pressure and fever went down and by 03Sep2021 she was fine. The patient underwent lab tests and procedures which included blood pressure measurement: 172/128. Outcome of the events pyrexia, hypertension was recovered on 03Sep2021, and for other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pyrexia
Clinical narrative: very sick with chills; very sick with chills; a terrible and a terrible headache; a fever over 100 degrees; blood pressure of 172/128; heavy sweating with a terrible  headache; This is a Spontaneous report based on the information received by Pfizer from Corporation. A contactable consumer reported that: A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration on 31Aug2021 (Age at vaccination63 years old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient reported she received her first shot of the Pfizer Covid 19 vaccine on 10Aug2021 and reported chills. The patient reported she received her second vaccine on 31Aug2021 and got very sick with chills and a terrible and a terrible headache with a fever over 100 degrees. The patient reported on 01sep2021 she experienced heavy sweating with a terrible headache, so her husband took her to the emergency room she had a blood pressure of 172/128. The patient reported on 02Sep2021 her blood pressure and fever went down and by 03Sep2021 she was fine. The patient underwent lab tests and procedures which included blood pressure measurement: 172/128. Outcome of the events pyrexia, hypertension was recovered on 03Sep2021, and for other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pruritus, Rash, Rash papular
Clinical narrative: woke up I had a difficult time breathing; big rash I had on my back, my chest; had reaction; my back was itching; there were like at least a 100 small red bumps covering my entire back migrating towards my spinal area; This is a spontaneous report from a contactable consumer or other non hcp. A 28-years-old female patient received bnt162b2 (BNT162B2) formulation solution for injection, dose 1 (Lot Number: FD8448 expiry date was unknown) via an unspecified route of administration at deltoid muscle left on 14Aug2021 as a single for covid-19 immunisation. The patient medical history was not reported. Consumer stated no prior vaccinations. Medical Conditions or Concomitant medications: Consumer stated, "No. She means she do take an antidepressant (Further not clarified hence not captured) but She don't know if it even (incomplete sentence). Can she tell you the name?" (Further not clarified). Probed for side effects experienced: Consumer stated, "Well with her first shot, she had reaction so after 2 days she developed, she woke up she had a difficult time breathing and she back was itching so she reached back there and there were like at least 100 small red bumps covering her entire back migrating towards her spinal area and that lasted in for, that persisted for about 10 days. she went to the doctor to show her and everything and she told her to call you guys but she did not think that she would get any exemptions or anything, so she did not, she just went ahead and got the second vaccine, she went ahead and got the second vaccine and she did not have a rash the second time, for the second time was worse she ended up having this like pretty severe asthma attacks like her spO2 was at 73 percent. She had a very hard time breathing and it took like 15 days for her breathing to return to normal but she am still having to take albuterol and she know that was like from the vaccine itself other than that nothing, but she don't think that was necessarily safe for me to take it being she really had like such a severe reaction and with her breathing being so compromised but she did take like that was the second one so she already took her first and second she am just reporting her what happened and she don't see like she should be taking that again. No laboratory tests. Treatment: Consumer stated, "she took Albuterol. It was her inhaler, a rescue inhaler it was not one that she was like it was her nephew's, so she had to end up getting her own to help with her breathing. Outcome of the events was unknown.    Follow-Up (20Sep2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis allergic, Herpes zoster, Pruritus, Rash
Clinical narrative: Itchy spots; Allergic rash; Rash on all of her joints was reported as worsened; Has to live with this rash and it's driving her nuts; Shingles; Another rash/rash on all of her joints; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received second dose of bnt162b2 (BNT162B2, solution for injection) via an unspecified route of administration on 30Aug2021 (Batch/Lot Number: FC3182) as SINGLE for covid-19 immunization. Historical vaccine included received first dose of bnt162b2 (BNT162B2, solution for injection) at the age of 79-years-old via an unspecified route of administration on 09Aug2021 (Batch/Lot number: EW0198) as SINGLE for covid-19 immunization. Patient medical history included, allergic to sulfa from an unknown date and unknown if ongoing. There were no concomitant medications reported. On an unspecified date in Sep2021, somewhere around 4 to 5 days after the vaccination, the patient developed shingles and another rash that was not diagnosed as shingles and she went to her HCP last saturday and stated that "the rash on the left side of her neck definitely feels like shingles and it was heading towards her eye. On an unspecified date, she also developed a rash on all of her joints which was started a little bit after the shingles, maybe a day or two after and it is still spreading every day and was worsened. Patient reported that shingles stayed the same but as far as the other rash that one keeps getting new spots every day. On an unspecified date, it was reported that patient had to live with this rash and it's driving her nuts, found some itchy spots which she didn't paid attention, allergic rash which is like hives. Patient was asking if sulfa drugs are in the Pfizer COVID-19 vaccine because she is allergic to it and wanted to know if this had been reported as side effects with the Pfizer COVID-19 vaccine. The outcome of event for shingles and rash was not recovered whereas for remaining events it was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 40-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 05Jul2021 as dose 2, single for covid-19 immunization. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on unspecified date for covid-19 immunization with reaction head rush after the first dose but was extremely poorly with covid and was on a virtual ward and needed an inhaler. The patient concomitant medications were not reported. On 16Aug2021 the patient was tested positive for covid.  The patient underwent lab tests and procedures which included sars-cov-2 test was positive on 16Aug2021. The outcome of event covid-19 was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow-up.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Inappropriate schedule of product administration, Suspected COVID-19
Clinical narrative: The patient has covid symptoms on 09Sep2021; The patient has covid symptoms on 09Sep2021; 1st dose date: 25Apr2021, 2nd dose date: 16Jun2021; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 26-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date: unknown), via intramuscular administered in Arm Left on 16Jun2021 (at the age of 26-year-old) as single dose for COVID-19 immunisation. Medical history included birth control pills from May2020 and ongoing. Concomitant diseases and concomitant drugs were reported as none. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date: unknown) via intramuscular route of administration in left arm on 25Apr2021 (at the age of 26-year-old) as single dose for COVID-19 immunisation. Previous vaccination within 4 weeks and any additional vaccines were reported as none. The patient has covid symptoms on 09Sep2021 as running nose, cough, pain in whole body, dizziness. The patient stated that she has been lost her taste and smell. The outcome of event was reported as not resolved.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Diarrhoea; Vomiting; Nausea; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for a female patient (Wife). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 01Sep2021 at dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date in Sep2021 the patient experienced diarrhoea, vomiting, nausea. Additional Context: Concern: Reporter stated, Me and my wife had the first shot of the Pfizer vaccine on September the first and she just started having diarrhoea and vomiting. So, nausea, could that be coming from the vaccine. Concern Paraphrased: Reporter stated, Right, we had it September the first. We both went for our first shot September the first. Reporter stated, no, right now I got to check on her. She been living around awful. So I am trying to find out if it be coming from the Pfizer. Outcome of the events was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for the Covid19 virus; tested positive for the Covid19 virus; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), 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 and concomitant medications were not reported. It was stated that on an unspecified date, patient reported they had been vaccinated but tested positive for the Covid19 virus. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. Event took place after use of product. The outcome of Covid-19 was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Had both doses and 6 months later tested positive for covid virus; Had both doses and 6 months later tested positive for covid virus; This is a spontaneous report from a contactable female consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGL: on an unspecified date DOSE 1, SINGLE for COVID-19 immunisation. Medical history and concomitant medication were not reported. It was reported that INT withheld swap from withheld had both doses and 6 months she tested positive for COVID virus and she thought she had delta variant. She wanted to get the booster but wanted to be ensured that would be better that the other 2 she got. The patient also reported that the governor in withheld got the covid virus and he got the infusion and why did not she get the infusion. She had to suffer with her illness no one told her about the infusion. Asking if we are working on a better booster. The patient was told she would have to wait 90 days to get the booster because she tested positive. The patient underwent lab tests which included Covid virus test: positive. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Therapeutic response unexpected
Clinical narrative: had Covid 19 disease; had Covid 19 disease; he has had no symptoms of diabetes since having Covid-19; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (Reporter's cousin). A 62-years-old male patient received bnt162b2 (COMIRNATY, formulation: solution for injection, Batch/Lot number: unknown) via an unspecified route of administration on an unspecified date, as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history included diabetes. The patient's concomitant medications were not reported. It was reported that on an unspecified date, the patient had Covid 19 disease, had diabetes and on insulin, he has had no symptoms of diabetes since having Covid-19. At the time of this report the outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and would be requested during follow up.; Sender's Comments: Linked Report(s): US-PFIZER INC-202101211823 same reporter/vaccine, similar AE, different patient
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nausea; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, the patient developed nausea after receiving the first dose of the vaccine which lasted for a day. The next day he was asymptomatic. The outcome of the event was recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.