chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, COVID-19, Drug ineffective, SARS-CoV-2 test, Weight
Clinical narrative: tested positive with few symptoms; tested positive with few symptoms/I had a mouth taste away; This is a spontaneous report from the Pfizer-sponsored program, via a contactable consumer (who reported for herself). A female patient of unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number ER8730) on 27Mar2021, via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. Medical history and concomitant medications were not reported. The On 11Apr2021, the patient experienced she got the 1st dose of the vaccine, but she stated that after 2 weeks she got tested positive with few symptoms, I had a mouth taste away. Right now she wants to ask when she will be getting the 2nd dose of the vaccine, upon probing she mentioned that on the 01May she will be getting it. The clinical outcome of the events was unknown.   Information on lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; This is a spontaneous report from a contactable consumer, the patient, via a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Apr2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was unknown if the patient was pregnant. On an unspecified date in Apr2021, the patient tested positive for COVID-19. Her second dose was scheduled for 11May2021 and the patient queried if she needed to reschedule her second dose. The clinical outcome of "tested positive for COVID" was unknown.  Information on lot number has been requested.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Dizziness, Encephalopathy, Fatigue
Clinical narrative: This is a spontaneous report received from a contactable physician (patient). A 36-year-old male patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, lot number EW0169), via unspecified route of administration in left arm on 29Apr2021 05:00 PM (at the age of 36-year-old) as 2nd dose, single for COVID-19 immunisation. The patient had no medical history. Prior to vaccination the patient was not diagnosed with COVID-19. No concomitant medications were reported. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, lot number EW0150), via unspecified route of administration in left arm on 05Apr2021 04:00 PM (at the age of 36-year-old) as 1st dose, single for COVID-19 immunisation. On 30Apr2021 09:00 the patient experienced encephalopathy, vertigo, dizziness, fever, chills, nausea, myalgia, fatigue, cold sweats, headache, neck pain, injection site pain. The reporter stated that he was a doctor, he treated himself symptomatically. Patient had not been tested for COVID-19 since the vaccination. The outcome of the events was resolved with sequel.; Sender's Comments: The etiology for the reported event could be multifactorial however.Based on a temporal association  a causal relationship between the reported event and suspect drug is assessed as possible. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Neck pain, Pyrexia
Clinical narrative: This is a spontaneous report received from a contactable physician (patient). A 36-year-old male patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, lot number EW0169), via unspecified route of administration in left arm on 29Apr2021 05:00 PM (at the age of 36-year-old) as 2nd dose, single for COVID-19 immunisation. The patient had no medical history. Prior to vaccination the patient was not diagnosed with COVID-19. No concomitant medications were reported. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, lot number EW0150), via unspecified route of administration in left arm on 05Apr2021 04:00 PM (at the age of 36-year-old) as 1st dose, single for COVID-19 immunisation. On 30Apr2021 09:00 the patient experienced encephalopathy, vertigo, dizziness, fever, chills, nausea, myalgia, fatigue, cold sweats, headache, neck pain, injection site pain. The reporter stated that he was a doctor, he treated himself symptomatically. Patient had not been tested for COVID-19 since the vaccination. The outcome of the events was resolved with sequel.; Sender's Comments: The etiology for the reported event could be multifactorial however.Based on a temporal association  a causal relationship between the reported event and suspect drug is assessed as possible. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vertigo
Clinical narrative: This is a spontaneous report received from a contactable physician (patient). A 36-year-old male patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, lot number EW0169), via unspecified route of administration in left arm on 29Apr2021 05:00 PM (at the age of 36-year-old) as 2nd dose, single for COVID-19 immunisation. The patient had no medical history. Prior to vaccination the patient was not diagnosed with COVID-19. No concomitant medications were reported. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, lot number EW0150), via unspecified route of administration in left arm on 05Apr2021 04:00 PM (at the age of 36-year-old) as 1st dose, single for COVID-19 immunisation. On 30Apr2021 09:00 the patient experienced encephalopathy, vertigo, dizziness, fever, chills, nausea, myalgia, fatigue, cold sweats, headache, neck pain, injection site pain. The reporter stated that he was a doctor, he treated himself symptomatically. Patient had not been tested for COVID-19 since the vaccination. The outcome of the events was resolved with sequel.; Sender's Comments: The etiology for the reported event could be multifactorial however.Based on a temporal association  a causal relationship between the reported event and suspect drug is assessed as possible. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Feeling cold
Clinical narrative: Light headedness; Feeling of wanting to pass out; Fatigue; Muscle and joint soreness; Muscle and joint soreness; Extreme warm feeling; Hot and cold flashes; Hot and cold flashes; Chills; Some twitching in my left hand; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: ER8732) via an unspecified route of administration on 26Mar2021 at 13:30 (at the age of 64-years-old) as a single dose in the left arm for COVID-19 immunisation. Medical history included high blood pressure from an unspecified date and unspecified if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (received within wo weeks of the vaccination) included lisinopril, rosuvastatin and doxycycline, all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EN6205) via an unspecified route of administration on 05Mar2021 at 13:30 (at the age of 64-years-old) as a single dose in the left arm for COVID-19 immunisation. On 26Mar2021 at 18:00 the patient experienced lightheadedness, feeling of wanting to pass out, fatigue, muscle and joint soreness, extreme warm feeling, hot and cold flashes, chills, and some twitching in my left hand. The clinical course was reported as follows: "The patient reported that all symptoms occurred between 3 to 5 hours after the second injection. Fatigue, light headedness, muscle and joint soreness, extreme warm feeling over his entire body, hot and cold flashes that lasted several minutes at a time, chills; however, no fever. All the symptoms subsided after three days from the second injection. Several side effects continued for over a month now. Fatigue, muscle and joint soreness as well as the light headedness with the feeling of wanting to pass out.  Some twitching in the left hand intermittently throughout the day skipping days at a time." The adverse events resulted in a doctor or other healthcare professional office/clinic visit. The clinical outcomes of the events lightheadedness, feeling of wanting to pass out, fatigue, muscle and joint soreness, extreme warm feeling, hot and cold flashes, chills, and some twitching in my left hand were recovered/resolved with sequel (recovered with lasting effects). Since the vaccination, the patient had not been tested for COVID-19.   Follow up needed, further information has been requested.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Hot flush, Muscle twitching, Myalgia, Presyncope
Clinical narrative: Light headedness; Feeling of wanting to pass out; Fatigue; Muscle and joint soreness; Muscle and joint soreness; Extreme warm feeling; Hot and cold flashes; Hot and cold flashes; Chills; Some twitching in my left hand; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: ER8732) via an unspecified route of administration on 26Mar2021 at 13:30 (at the age of 64-years-old) as a single dose in the left arm for COVID-19 immunisation. Medical history included high blood pressure from an unspecified date and unspecified if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (received within wo weeks of the vaccination) included lisinopril, rosuvastatin and doxycycline, all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EN6205) via an unspecified route of administration on 05Mar2021 at 13:30 (at the age of 64-years-old) as a single dose in the left arm for COVID-19 immunisation. On 26Mar2021 at 18:00 the patient experienced lightheadedness, feeling of wanting to pass out, fatigue, muscle and joint soreness, extreme warm feeling, hot and cold flashes, chills, and some twitching in my left hand. The clinical course was reported as follows: "The patient reported that all symptoms occurred between 3 to 5 hours after the second injection. Fatigue, light headedness, muscle and joint soreness, extreme warm feeling over his entire body, hot and cold flashes that lasted several minutes at a time, chills; however, no fever. All the symptoms subsided after three days from the second injection. Several side effects continued for over a month now. Fatigue, muscle and joint soreness as well as the light headedness with the feeling of wanting to pass out.  Some twitching in the left hand intermittently throughout the day skipping days at a time." The adverse events resulted in a doctor or other healthcare professional office/clinic visit. The clinical outcomes of the events lightheadedness, feeling of wanting to pass out, fatigue, muscle and joint soreness, extreme warm feeling, hot and cold flashes, chills, and some twitching in my left hand were recovered/resolved with sequel (recovered with lasting effects). Since the vaccination, the patient had not been tested for COVID-19.   Follow up needed, further information has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: DVT to right popliteal vein; This is a spontaneous report from a contactable physician (patient). A 68-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), intramuscularly, administered in left arm, on 29Dec2020 (at the age of 68-years-old) at 1st dose, single for COVID-19 immunisation. Medical history included type II diabetes and hypertension. The patient was not pregnant. No COVID prior vaccination and no COVID tested post vaccination. The patient had no known allergies. Other medications in two weeks included metoprolol, ramipril and metformin. No other vaccines were received in four weeks. The patient experienced deep vein thrombosis (DVT) to right popliteal vein on 15Mar2021. The event resulted in doctor or other healthcare professional office/clinic visit. Treatments were administered as a result of the event and included ELIQUIS, bed rest, legs elevated. The patient was recovering from the event.; Sender's Comments: Based on the temporal relationship, the association between the event deep vein thrombosis with BNT162b2 can not be fully 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: Cardiac arrest, Cerebrovascular accident, Lead dislodgement
Clinical narrative: massive stroke; coded six times at the hospital; a pacemaker lead possibly dislodged during vigorous CPR; This is a spontaneous report from a contactable nurse (patient's son) communicated to a Pfizer sales representative. An 81-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration on 18Feb2021 as single dose for COVID-19 immunization. Medical history included diffuse atherosclerotic disease including single vessel coronary artery disease, two prior carotid endarterectomy surgeries, an abdominal aortic aneurysm and iliac disease, and cardiac pacemaker insertion. The patient's concomitant medications were not reported. On 20Feb2021, the patient experienced massive stroke less than 48 hours after receiving his second dose of vaccine. On 20Feb2021, the patient coded six times at the hospital and one his pacemaker leads appeared to not be working properly, possibly dislodged during vigorous CPR (Cardiopulmonary resuscitation). The patient's son, a RN (registered nurse) in a cardiology practice for more than 20 years was the reporter. The clinical course was as follows: The stroke happened on 20Feb2021. The patient was taken to Hospital. The patient coded six times at the hospital. One his pacemaker leads appeared to not be working properly, possibly dislodged during vigorous CPR. The clinical outcomes of the events massive stroke, coded six times at the hospital, and a pacemaker lead possibly dislodged during vigorous CPR were not reported.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the preexisting complicated cardiovascular conditions including diffuse atherosclerotic disease, two carotid endarterectomy surgeries, abdominal aortic aneurysm and cardiac pacemaker user, the events massive stoke, coded six times (cardiac arrest transient) and pacemaker dislocation in this 81 years old elderly patient are considered most likely intercurrent medical conditions and not related to 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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient reported that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: EWO151) via an unspecified route in the left arm on 14Apr2021 at 11:30 (at the age of 51-years-old) as a single dose for COVID-19 immunization. Medical history included diabetes mellitus. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications the patient received within 2 weeks of vaccination included insulin and metformin. On 15Apr2021 at 06:00 (reported as18 hours later), the patient had a "gran map seizure" and had to be taken to the hospital via ambulance. The event resulted in visit to emergency room/department or urgent care. The patient was not treated for "gran map seizure". The clinical outcome of "gran map seizure" was unknown. Since the vaccination, the patient has not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Polymerase chain reaction
Clinical narrative: currently asymptomatic but he tested positive on his polymerase chain reaction (PCR) shortly after received the BNT162b2; currently asymptomatic but he tested positive on his polymerase chain reaction (PCR) shortly after received the BNT162b2; This is a spontaneous report from a contactable pharmacist reporting on her son. A 22-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was currently asymptomatic but he tested positive on his polymerase chain reaction (PCR) shortly after received the BNT162b2 on an unspecified date in Apr2021. The patient underwent lab tests and procedures which included PCR test: positive in Apr2021. The outcome of event was unknown.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: The contribution of the suspect drug to the onset of event drug ineffective cannot be ruled out since drug efficacy varies from one patient to another and affected by different factors.
Age: 51.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction on April 13th, 2021 after 2nd Pfizer shot. Took 2 Naproxen and had reaction 6 hours later. Allergic reaction again 4-29-2021 after taking Naproxen again. Never had allergic reactions; This is a spontaneous report received from a contactable consumer, the patient. A 51-year-old adult male received the second dose of BNT162B2 (solution for injection, batch/lot and expiry information not provided) as a single dose via an unspecified route in the left arm on 13Apr2021 at 14:30 (2:30pm; at 51-years-old) for COVID-19 immunization. The patient also started to receive naproxen (unspecified formulation) unspecified dose at an unspecified frequency via an unspecified route from an unspecified date for an unspecified indication. There was no medical history or concomitant medications reported. The patient previously received COVID-19 immunization with the first dose of BNT162B2 (solution for injection; lot unknown) in the left arm on an unspecified date in Mar2021 at 14:30 (2:30pm; at 51-years-old). The patient denied being diagnosed with COVID prior to the vaccine. The patient denied receiving any other vaccinations within four weeks of this vaccine. The patient also denied receiving any other medications within two weeks of the vaccination. The patient reported that on 13Apr2021 at 20:30 (8:30pm) six hours after getting the second Pfizer shot, she had an allergic reaction. The patient reported that she took two naproxen and had a reaction six hours later. The patient reported that she had an allergic reaction again on 29Apr2021, after taking naproxen again. The patient reported that she has never had allergic reactions to naproxen prior to the vaccination shots. The patient reported that the events did not result in any visit to an Emergency room or doctor's office. The patient denied being tested for COVID-19 since receiving the vaccine. Treatment for the event included diphenhydramine HCL (BENADRYL). The outcome of the event allergic reaction was recovered on an unspecified date in Apr2021.   Information on the batch/lot number has been requested.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient). A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number ER8731, on 16Apr2021 13:30 at single dose in left arm for COVID-19 immunization. Medical history included high blood pressure. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. Concomitant medication was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient developed Bell's Palsy confirmed in ER on 18Apr2021 14:30. The event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the event included steroids & antivirals. The outcome of the event was resolving.
Sex: M
Vaccine: COVID19
Symptoms: Haematochezia, Headache
Clinical narrative: blood in stool; headache; This is a spontaneous report from a contactable consumer (patient's wife) from Pfizer sponsored program Pfizer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Apr2021 (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation. The patient medical history and patient's concomitant medications were not reported. Patient received vaccine yesterday (unspecified) and now had blood in stool and headache. The event outcome for events was unknown.  Information about Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: she was diagnosed with Covid; This is a spontaneous report from a contactable consumer (patient's daughter). A 93-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient was diagnosed with COVID on 24Feb2021. She had an antibody infusion and her doctor said that she should wait 90 days to get the second dose. The event was considered serious as medically significant. The outcome of the event was unknown.  The information on the batch number has been requested.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Confusional state, Dizziness, Pain
Clinical narrative: convulsions; Fever (up to 103 F degrees); chills; confusion; dizziness for first 48 hours; body aches for 96 hours.; This is a spontaneous report from a non-contactable consumer who reported for himself.   A 54-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0172), via an unspecified route of administration, in Arm Left on 20Apr2021 at 13:30  (at 54 years) at single dose for covid-19 immunisation . Medical history included known allergies penicillin. Previously, on 29Mar2021, patient took the first dose of the vaccine (lot Number: EQ0150) administered in Arm Left for covid-19 immunisation. The patient's concomitant medications were not reported.  Patient had no COVID prior vaccination and was not covid tested post vaccination. On an unspecified date in 2021 patient experienced fever (up to 103 F degrees), chills, convulsions, confusion, dizziness for first 48 hours, body aches for 96 hours. No treatment given. Patient recovered from all the events on an unknown date in 2021. No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Seizure
Clinical narrative: convulsions; Fever (up to 103 F degrees); chills; confusion; dizziness for first 48 hours; body aches for 96 hours.; This is a spontaneous report from a non-contactable consumer who reported for himself.   A 54-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0172), via an unspecified route of administration, in Arm Left on 20Apr2021 at 13:30  (at 54 years) at single dose for covid-19 immunisation . Medical history included known allergies penicillin. Previously, on 29Mar2021, patient took the first dose of the vaccine (lot Number: EQ0150) administered in Arm Left for covid-19 immunisation. The patient's concomitant medications were not reported.  Patient had no COVID prior vaccination and was not covid tested post vaccination. On an unspecified date in 2021 patient experienced fever (up to 103 F degrees), chills, convulsions, confusion, dizziness for first 48 hours, body aches for 96 hours. No treatment given. Patient recovered from all the events on an unknown date in 2021. No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Bell's palsy, Nasopharyngitis, Paraesthesia, Paraesthesia oral
Clinical narrative: left eye tingling and not able to close with Left side mouth not able to close; left eye tingling and not able to close with Left side mouth not able to close; loss of taste of left side of tongue; Bell's palsy symptoms; Cold with light sneezing; Cold with light sneezing; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8737), dose 2 via an unspecified route of administration, administered in left arm on 06Apr2021 15:00  as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955) administered in left arm on 16Mar2021 18:30 for COVID-19 Immunization. Cold with light sneezing developed on 27Apr2021 and Bell's palsy symptoms developed from 28Apr2021 around night before bed (22:45). On 29Apr2021, left eye tingling and not able to close with Left side mouth not able to close and loss of taste of left side of tongue. Doctor diagnosed on 30Apr2021 that it is early stages of Bell's palsy could be due to vaccine or shingles. No symptoms of shingles. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in doctor or other healthcare professional office/clinic visit. The patient received treatment (Bell's Palsy along with Shingles) for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There is no COVID prior vaccination, no COVID tested post vaccination,  no known allergies. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: left eye tingling and not able to close with Left side mouth not able to close; left eye tingling and not able to close with Left side mouth not able to close; loss of taste of left side of tongue; Bell's palsy symptoms; Cold with light sneezing; Cold with light sneezing; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8737), dose 2 via an unspecified route of administration, administered in left arm on 06Apr2021 15:00  as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955) administered in left arm on 16Mar2021 18:30 for COVID-19 Immunization. Cold with light sneezing developed on 27Apr2021 and Bell's palsy symptoms developed from 28Apr2021 around night before bed (22:45). On 29Apr2021, left eye tingling and not able to close with Left side mouth not able to close and loss of taste of left side of tongue. Doctor diagnosed on 30Apr2021 that it is early stages of Bell's palsy could be due to vaccine or shingles. No symptoms of shingles. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in doctor or other healthcare professional office/clinic visit. The patient received treatment (Bell's Palsy along with Shingles) for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There is no COVID prior vaccination, no COVID tested post vaccination,  no known allergies. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Petechiae, Platelet count, Thrombocytopenia
Clinical narrative: Scattered petechial spots in both legs with thrombocytopenia with platelets count of 91000.; Scattered petechial spots in both legs with thrombocytopenia with platelets count of 91000.; This is a spontaneous report from a contactable consumer. A 60-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number ER8737, on 02Apr2021 13:00 at single dose in left arm for COVID-19 immunization. Medical history included myocardial infarction, hyperthyroidism, allergy to Contrast agent. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)), clopidogrel bisulfate (PLAVIX), atorvastatin, pantoprazole sodium sesquihydrate (CONORAN), sertraline. The patient experienced Scattered petechial spots in both legs with thrombocytopenia with platelets count of 91000 on 13Apr2021. The outcome of the events was unknown.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Diarrhoea haemorrhagic, Malaise, Neck pain
Clinical narrative: diarrhea; Vomiting; sore throat; sore shoulder; sore neck; blood in her diarrhea; feeling icky; This is a spontaneous report from a contactable consumer (patient's mother). A 20-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8735), administered in left arm, on 28Apr2021 at 13:00 (at the age of 20-years-old) at 1st dose, single for COVID-19 immunisation. Medical history included bipolar disorder, bipolar depression, anxiety and depression. Family medical history relevant to the adverse events was reported as none. Concomitant medications included ongoing citalopram (provided as CELEXA, clarified that she took the generic citalopram) taken from an unspecified date (has been taking for about 4 years, as reported) at 40mg orally daily for anxiety and depression, ongoing lamotrigine (provided as LAMICTAL, clarified that she took the generic lamotrigine) taken orally from an unspecified date (had been taking for 2-3 years, as reported) at 150mg twice daily for bipolar disorder, ongoing lithium taken orally at 300mg twice daily for bipolar depression. No prior vaccinations (within 4 weeks) were received, no history of all previous immunization with the Pfizer vaccine was considered as suspect, no additional vaccines administered on same date of the Pfizer suspect. The patient experienced blood in diarrhea and sore neck on 30Apr2021, diarrhea, vomiting, sore throat, sore shoulder on 30Apr2021 at 01:00, feeling icky on 29Apr2021 at 18:00. The events did not require emergency room and/or physician office visit. The reporter stated that the patient was fine until 29Apr2021 around 6 pm when she started feeling icky. She woke up at 1 am with diarrhea and vomiting, sore throat and sore shoulder. The patient was having blood in her diarrhea. The last time she threw up was around 7:30. Her daughter developed a sore throat and sore shoulder late last night of the reporting day or early the morning of the reporting day. Reporter added that her daughter also had a sore neck that started late last night of the reporting day or early the morning of the reporting day. No relevant tests were performed. The patient had not recovered from diarrhea, sore throat, sore shoulder and sore neck, had recovered from vomiting on 30Apr2021 at 07:30, the outcome of the other events was unknown.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Vomiting
Clinical narrative: diarrhea; Vomiting; sore throat; sore shoulder; sore neck; blood in her diarrhea; feeling icky; This is a spontaneous report from a contactable consumer (patient's mother). A 20-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8735), administered in left arm, on 28Apr2021 at 13:00 (at the age of 20-years-old) at 1st dose, single for COVID-19 immunisation. Medical history included bipolar disorder, bipolar depression, anxiety and depression. Family medical history relevant to the adverse events was reported as none. Concomitant medications included ongoing citalopram (provided as CELEXA, clarified that she took the generic citalopram) taken from an unspecified date (has been taking for about 4 years, as reported) at 40mg orally daily for anxiety and depression, ongoing lamotrigine (provided as LAMICTAL, clarified that she took the generic lamotrigine) taken orally from an unspecified date (had been taking for 2-3 years, as reported) at 150mg twice daily for bipolar disorder, ongoing lithium taken orally at 300mg twice daily for bipolar depression. No prior vaccinations (within 4 weeks) were received, no history of all previous immunization with the Pfizer vaccine was considered as suspect, no additional vaccines administered on same date of the Pfizer suspect. The patient experienced blood in diarrhea and sore neck on 30Apr2021, diarrhea, vomiting, sore throat, sore shoulder on 30Apr2021 at 01:00, feeling icky on 29Apr2021 at 18:00. The events did not require emergency room and/or physician office visit. The reporter stated that the patient was fine until 29Apr2021 around 6 pm when she started feeling icky. She woke up at 1 am with diarrhea and vomiting, sore throat and sore shoulder. The patient was having blood in her diarrhea. The last time she threw up was around 7:30. Her daughter developed a sore throat and sore shoulder late last night of the reporting day or early the morning of the reporting day. Reporter added that her daughter also had a sore neck that started late last night of the reporting day or early the morning of the reporting day. No relevant tests were performed. The patient had not recovered from diarrhea, sore throat, sore shoulder and sore neck, had recovered from vomiting on 30Apr2021 at 07:30, the outcome of the other events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: dropped dead; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a patient of unspecified gender in 20s 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 a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter reported that someone in town in their 20s that had the Pfizer vaccine in the morning and dropped dead in the afternoon for no reason. Between all 3, there have been quite a bit of deaths in the last few months. The patient died on an unspecified date.  It was not reported if an autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: dropped dead
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Pain in extremity
Clinical narrative: a potential false blood pressure readings/The readings were over 200/140/took it on his wrist and measured at 215/147; the pain at the location of the lower arm got near tremble; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 28Apr2021 16:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included blood pressure abnormal, blood cholesterol abnormal, deafness. The patient's concomitant medications included unspecified products received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 on 06Apr2021 01:15 PM at arm left for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, he has not been tested for COVID-19. The patient reported a potential false blood pressure readings on 29Apr2021, a day after administered 2nd dose. The readings were over 200/140 and he took it at home using a blood pressure reading device. He took it on his wrist and measured at 215/147. In his recent doctors visit prior to administer the 2nd dose, the accurate readings was 183/136 (estimated). With the false blood pressure readings, the pain at the location of the lower arm got near tremble due to the fact of the false readings has been taken. The events outcome was unknown.  Information on the Lot/Batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash morbilliform
Clinical narrative: Measle-like rash; itchy; This is a spontaneous report received from a contactable consumer (patient).    A 49-years-old female patient received first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 17Apr2021 12:30 (Lot Number: EW0162) at single dose for COVID-19 immunization.  Medical history included the patient had elevated liver enzymes until late 2020, but those have been reduced; just on the cusp of overweight/obese; intolerant of opiods/opiates (itching); allergy to Pollen; allergy to Z-pack antibiotic. The patient was not pregnant. On 27Apr2021, the patient experienced measle-like rash (fine, small, red distinct spots) on tops of hands and feet. More prevalent on feet, from just above ankles to toes. Not on soles (or palms). Rash was not up the legs or up the arms. Itchy, rough. No swelling or fever in the affected areas. The adverse events result in visit to emergency room/department or urgent care. The patient was hospitalized for the events. Treatment received for the adverse event included steroid cream prescribed and the patient was told to take Benadryl. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was Hospital. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: This is a spontaneous report from a contactable other hcp (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Er8731), dose 2 via an unspecified route of administration, administered in arm right on an unspecified date as 2nd dose, single for covid-19 immunisation. Concomitant medications included metformin; insulin glargine (TOUJEO); lisinopril; atorvastatin calcium; piroxicam (FARXICAN). Medical history included ongoing diabetes mellitus. The patient previously took Ibuprofen and experienced allergy to Ibuprofen. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ep7534,) administered in right arm on 24Mar2021 10:30 for COVID-19 Immunization. The patient had a mini stroke on 25Apr2021 20:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered.; Sender's Comments: Based on the limited available information, the reported event I had a mini stroke is assessed as unlikely related to the suspect product BNT 162b2 (PFIZER-BIONTECH COVID-19 VACCINE). 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: F
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 other HCP. A 5-decade-old female patient (in her 40's) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 06Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated they have a female patient in her 40s who received the first dose of the Pfizer covid vaccine on 06Feb2021 and tested positive for Covid, she was in the hospital for it. The reporter wanted to know about the second dose, can she still get Pfizer covid vaccine; if not, can she get J&J vaccine. The patient underwent lab tests and procedures which included COVID-19 test: positive on an unknown date. The outcome of the event was unknown.  The information on the lot/batch number has been requested.; 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  COVID-19 cannot be ruled out in terms of drug ineffective.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Ear discomfort, Insomnia, Paraesthesia, Tinnitus
Clinical narrative: states she cant sleep; cant concentrate; tinnitus, ringing of ears; Ear fullness; Tingling in right side of face, around eye and cheeks and everything; This is a spontaneous report from /Medical Information received from a contactable nurse  reporting for herself  A 46 year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6206) on 21Mar2021 at single dose via an unspecified route of administration  on right deltoid for COVID-19 immunization. Relevant medical history included ongoing autoimmune disease from 2016 (diagnosed about 5 years ago). Concomitant medications were not reported. On 21Mar2021 the patient experienced Tingling in right side of face, around eye and cheeks and everything, started little bit the day of vaccination  and then just kept going and got gradually a little bit worse. The events was considered as medically significant. On 23Mar2021 the patient started complaining ear fullness, started to get full like feeling in ear, like plugged under water kind of thing described as ongoing as improved slightly but  it comes and goes (as such). The event was considered medically significant. On 27Mar2021 the patient also started experiencing tinnitus, clogged/plugged  ears and ringing in the ears. The event was considered medically significant. This was not going away, she also mentioned can' t sleep and  can' t concentrate. Patient also informed that she is part of a huge online Support group (1500-2000) for people who have developed tinnitus after covid vaccination with either of Pfizer, Moderna or Jansen and Jansen Covid vaccine. Patient declined to provide information on the persons other people who were experiencing the same symptoms, hopefully, those persons call Pfizer on their own. She also informed that was not be getting her second dose (as such). The patient recovered from 'Tingling in right side of face, around eye and cheeks and everything' on an unspecified date in Mar2021, was recovering from ear fullness, while have not yet recovered from tinnitus, ringing of ears. At the time of the reporting outcome of other events was unknown.; Sender's Comments: Based on the close temporal relationship, the association between the event "tingling in right side of face" with BNT162b2 can not be fully excluded. The association between the events "ear fullness" and "tinnitus" with BNT162b2 can not be fully excluded based on the temporal relationship.  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: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Diagnosed with Bells Palsy; This is a spontaneous report from a contactable consumer (patient).   A 45-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 13Apr2021 15:00 (Lot Number: ER8737) as single dose for covid-19 immunisation.  Medical history included ongoing high blood pressure. There were no known allergies. Concomitant medications included omeprazole; tizanidine; meloxicam and metoprolol all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient was diagnosed with bells palsy on 26Apr2021 08:00 with outcome of recovering. The event resulted in Doctor or other healthcare professional office/clinic visit.