chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased, Hypersensitivity, Hypoaesthesia oral
Clinical narrative: I had an allergic reaction; I experienced a tingling feeling in my lips, which then spread to my mouth, throat and tongue.; I experienced a tingling feeling in my lips, which then spread to my mouth, throat and tongue.; lightheaded; elevated heart rate; tongue was swollen; my tongue felt like it was numb/burnt by drinking a hot liquid; my tongue felt like it was numb/burnt by drinking a hot liquid; woke up in the middle of the night; trouble sleeping; This is a spontaneous report from contactable consumers (one is the patient). A 28-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EN6203), via an unspecified route of administration in the left arm on 25Feb2021 15:30 at a single dose for COVID-19 immunisation. Medical history included postural orthostatic tachycardia syndrome, migraines, asthma, hay fever, acid reflux, hives when exercising outdoors in the cold, and allergies: latex, cats, dustmites, gluten and dairy intolerance; all from unknown dates. Concomitant medications included sumatriptan, bupropion, pepsin, calcium carbonate and unspecified herbs. The patient did not received other vaccine in four weeks. The patient previously took fluconazole (DIFLUCAN) and experienced allergies. A few minutes after taking the vaccine, the patient experienced a tingling feeling in lips, which then spread to mouth, throat and tongue. The patient told a nurse and she said that she looked fine. The patient asked if lips were swollen but they weren't. Then a few minutes later she felt very lightheaded and had an elevated heart rate. Then around this time, she saw her tongue was swollen to about double the size. The nurse said she looked fine, and monitored her for 30 minutes then let her go. This swollen tongue lasted for about 2.5 - 3 hours. After the swelling subsided, tongue felt like it was numb/burnt by drinking a hot liquid. 12 hours later, she woke up in the middle of the night with an elevated heart rate and had trouble sleeping. The patient spoke to her doctor and it sounds like she had an allergic reaction, even though she have no history of allergies for any of the vaccine ingredients. Onset date of all events were reported as 25Feb2021 15:30. Outcome of all events reported as recovered on an unspecified date. No treatment was given for all events. The patient was not diagnosed of covid prior vaccination and has not tested for covid post vaccination.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Middle insomnia, Paraesthesia oral, Pharyngeal paraesthesia, Swollen tongue
Clinical narrative: I had an allergic reaction; I experienced a tingling feeling in my lips, which then spread to my mouth, throat and tongue.; I experienced a tingling feeling in my lips, which then spread to my mouth, throat and tongue.; lightheaded; elevated heart rate; tongue was swollen; my tongue felt like it was numb/burnt by drinking a hot liquid; my tongue felt like it was numb/burnt by drinking a hot liquid; woke up in the middle of the night; trouble sleeping; This is a spontaneous report from contactable consumers (one is the patient). A 28-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EN6203), via an unspecified route of administration in the left arm on 25Feb2021 15:30 at a single dose for COVID-19 immunisation. Medical history included postural orthostatic tachycardia syndrome, migraines, asthma, hay fever, acid reflux, hives when exercising outdoors in the cold, and allergies: latex, cats, dustmites, gluten and dairy intolerance; all from unknown dates. Concomitant medications included sumatriptan, bupropion, pepsin, calcium carbonate and unspecified herbs. The patient did not received other vaccine in four weeks. The patient previously took fluconazole (DIFLUCAN) and experienced allergies. A few minutes after taking the vaccine, the patient experienced a tingling feeling in lips, which then spread to mouth, throat and tongue. The patient told a nurse and she said that she looked fine. The patient asked if lips were swollen but they weren't. Then a few minutes later she felt very lightheaded and had an elevated heart rate. Then around this time, she saw her tongue was swollen to about double the size. The nurse said she looked fine, and monitored her for 30 minutes then let her go. This swollen tongue lasted for about 2.5 - 3 hours. After the swelling subsided, tongue felt like it was numb/burnt by drinking a hot liquid. 12 hours later, she woke up in the middle of the night with an elevated heart rate and had trouble sleeping. The patient spoke to her doctor and it sounds like she had an allergic reaction, even though she have no history of allergies for any of the vaccine ingredients. Onset date of all events were reported as 25Feb2021 15:30. Outcome of all events reported as recovered on an unspecified date. No treatment was given for all events. The patient was not diagnosed of covid prior vaccination and has not tested for covid post vaccination.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tongue discomfort
Clinical narrative: I had an allergic reaction; I experienced a tingling feeling in my lips, which then spread to my mouth, throat and tongue.; I experienced a tingling feeling in my lips, which then spread to my mouth, throat and tongue.; lightheaded; elevated heart rate; tongue was swollen; my tongue felt like it was numb/burnt by drinking a hot liquid; my tongue felt like it was numb/burnt by drinking a hot liquid; woke up in the middle of the night; trouble sleeping; This is a spontaneous report from contactable consumers (one is the patient). A 28-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EN6203), via an unspecified route of administration in the left arm on 25Feb2021 15:30 at a single dose for COVID-19 immunisation. Medical history included postural orthostatic tachycardia syndrome, migraines, asthma, hay fever, acid reflux, hives when exercising outdoors in the cold, and allergies: latex, cats, dustmites, gluten and dairy intolerance; all from unknown dates. Concomitant medications included sumatriptan, bupropion, pepsin, calcium carbonate and unspecified herbs. The patient did not received other vaccine in four weeks. The patient previously took fluconazole (DIFLUCAN) and experienced allergies. A few minutes after taking the vaccine, the patient experienced a tingling feeling in lips, which then spread to mouth, throat and tongue. The patient told a nurse and she said that she looked fine. The patient asked if lips were swollen but they weren't. Then a few minutes later she felt very lightheaded and had an elevated heart rate. Then around this time, she saw her tongue was swollen to about double the size. The nurse said she looked fine, and monitored her for 30 minutes then let her go. This swollen tongue lasted for about 2.5 - 3 hours. After the swelling subsided, tongue felt like it was numb/burnt by drinking a hot liquid. 12 hours later, she woke up in the middle of the night with an elevated heart rate and had trouble sleeping. The patient spoke to her doctor and it sounds like she had an allergic reaction, even though she have no history of allergies for any of the vaccine ingredients. Onset date of all events were reported as 25Feb2021 15:30. Outcome of all events reported as recovered on an unspecified date. No treatment was given for all events. The patient was not diagnosed of covid prior vaccination and has not tested for covid post vaccination.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactoid reaction, Erythema, Flushing, Irregular breathing, Nausea
Clinical narrative: anaphylactic reaction, then pharmacist gave epi and called 911, taken to the hospital and admitted for 4 days. Sent home, after my steroids ran out after 5 days, the reaction came back. Ambulance called and taken to the hospital and put in the ICU. discharged home,  then again after the steroids ran out 5 days later all symptoms came back again. Went to the ER then discharged home with steroids and seeing allergist thursday . In between hospital stays i was unable to get out of bed.  I did go to two separate hospitals. The first one was farther from home due to getting the vaccine farther from home
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: anaphylactic reaction, then pharmacist gave epi and called 911, taken to the hospital and admitted for 4 days. Sent home, after my steroids ran out after 5 days, the reaction came back. Ambulance called and taken to the hospital and put in the ICU. discharged home,  then again after the steroids ran out 5 days later all symptoms came back again. Went to the ER then discharged home with steroids and seeing allergist thursday . In between hospital stays i was unable to get out of bed.  I did go to two separate hospitals. The first one was farther from home due to getting the vaccine farther from home
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Blood test, Electrocardiogram, Intensive care, Mobility decreased
Clinical narrative: anaphylactic reaction, then pharmacist gave epi and called 911, taken to the hospital and admitted for 4 days. Sent home, after my steroids ran out after 5 days, the reaction came back. Ambulance called and taken to the hospital and put in the ICU. discharged home,  then again after the steroids ran out 5 days later all symptoms came back again. Went to the ER then discharged home with steroids and seeing allergist thursday . In between hospital stays i was unable to get out of bed.  I did go to two separate hospitals. The first one was farther from home due to getting the vaccine farther from home
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Dyspnoea, Electrocardiogram, Feeling abnormal, Headache
Clinical narrative: cardiac arrhythmia's; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender receive second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), at single dose, on an unspecified date via unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. 2 weeks post second dose of vaccine, the patient experienced cardiac arrhythmia intermittent. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Laboratory test, Malaise, Palpitations, Tremor
Clinical narrative: cardiac arrhythmia's; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender receive second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), at single dose, on an unspecified date via unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. 2 weeks post second dose of vaccine, the patient experienced cardiac arrhythmia intermittent. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia
Clinical narrative: cardiac arrhythmia's; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender receive second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), at single dose, on an unspecified date via unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. 2 weeks post second dose of vaccine, the patient experienced cardiac arrhythmia intermittent. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Balance disorder, Cardiac stress test normal, Chest X-ray normal, Chest pain
Clinical narrative: unable to stand; L shoulder/arm chest pain; arm pain; chest pain; significant dizzy spells; chills; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6203, expiry date not reported), via an unspecified route of administration on 26Feb2021 16:15 at single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease and coronary artery disease from an unknown date and unknown if ongoing.  Concomitant medication included tamsulosin, metoprolol tartrate, atorvastatin calcium, rivaroxaban, cyanocobalamin (B12). The patient previously took levaquin and experienced allergies. The patient was 78-years-old when he received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EM9809, expiry date not reported) on 05Feb2021 16:15 on the right arm for covid-19 immunisation. The patient experienced unable to stand, L shoulder/arm, chest pain, arm pain, significant dizzy spells and chills on 27Feb2021 03:00 with outcome of recovered. The events resulted in emergency room/department or urgent care and hospitalization. The patient was hospitalized for the events for 2 days. The patient underwent lab tests and procedures which included chest x-ray: unknown results, electrocardiogram: unknown results, nitrate compound therapy: unknown results, sars-cov-2 test: negative on 27Feb2021. Therapeutic measures were taken as a result of the events. The patient recovered from the events on an unspecified date.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Myocardial necrosis marker normal, Pain in extremity
Clinical narrative: unable to stand; L shoulder/arm chest pain; arm pain; chest pain; significant dizzy spells; chills; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6203, expiry date not reported), via an unspecified route of administration on 26Feb2021 16:15 at single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease and coronary artery disease from an unknown date and unknown if ongoing.  Concomitant medication included tamsulosin, metoprolol tartrate, atorvastatin calcium, rivaroxaban, cyanocobalamin (B12). The patient previously took levaquin and experienced allergies. The patient was 78-years-old when he received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EM9809, expiry date not reported) on 05Feb2021 16:15 on the right arm for covid-19 immunisation. The patient experienced unable to stand, L shoulder/arm, chest pain, arm pain, significant dizzy spells and chills on 27Feb2021 03:00 with outcome of recovered. The events resulted in emergency room/department or urgent care and hospitalization. The patient was hospitalized for the events for 2 days. The patient underwent lab tests and procedures which included chest x-ray: unknown results, electrocardiogram: unknown results, nitrate compound therapy: unknown results, sars-cov-2 test: negative on 27Feb2021. Therapeutic measures were taken as a result of the events. The patient recovered from the events on an unspecified date.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chest X-ray, Chest pain, Chills, Dizziness
Clinical narrative: unable to stand; L shoulder/arm chest pain; arm pain; chest pain; significant dizzy spells; chills; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6203, expiry date not reported), via an unspecified route of administration on 26Feb2021 16:15 at single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease and coronary artery disease from an unknown date and unknown if ongoing.  Concomitant medication included tamsulosin, metoprolol tartrate, atorvastatin calcium, rivaroxaban, cyanocobalamin (B12). The patient previously took levaquin and experienced allergies. The patient was 78-years-old when he received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EM9809, expiry date not reported) on 05Feb2021 16:15 on the right arm for covid-19 immunisation. The patient experienced unable to stand, L shoulder/arm, chest pain, arm pain, significant dizzy spells and chills on 27Feb2021 03:00 with outcome of recovered. The events resulted in emergency room/department or urgent care and hospitalization. The patient was hospitalized for the events for 2 days. The patient underwent lab tests and procedures which included chest x-ray: unknown results, electrocardiogram: unknown results, nitrate compound therapy: unknown results, sars-cov-2 test: negative on 27Feb2021. Therapeutic measures were taken as a result of the events. The patient recovered from the events on an unspecified date.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dysstasia, Electrocardiogram, Nitrate compound therapy, Pain in extremity, SARS-CoV-2 test
Clinical narrative: unable to stand; L shoulder/arm chest pain; arm pain; chest pain; significant dizzy spells; chills; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6203, expiry date not reported), via an unspecified route of administration on 26Feb2021 16:15 at single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease and coronary artery disease from an unknown date and unknown if ongoing.  Concomitant medication included tamsulosin, metoprolol tartrate, atorvastatin calcium, rivaroxaban, cyanocobalamin (B12). The patient previously took levaquin and experienced allergies. The patient was 78-years-old when he received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EM9809, expiry date not reported) on 05Feb2021 16:15 on the right arm for covid-19 immunisation. The patient experienced unable to stand, L shoulder/arm, chest pain, arm pain, significant dizzy spells and chills on 27Feb2021 03:00 with outcome of recovered. The events resulted in emergency room/department or urgent care and hospitalization. The patient was hospitalized for the events for 2 days. The patient underwent lab tests and procedures which included chest x-ray: unknown results, electrocardiogram: unknown results, nitrate compound therapy: unknown results, sars-cov-2 test: negative on 27Feb2021. Therapeutic measures were taken as a result of the events. The patient recovered from the events on an unspecified date.
Age: 94.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: Cardiac Arrest; became ill the next day after the first dose; This is a spontaneous report from a contactable consumer.  A 94-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in left arm, on 29Jan2021 at 12:00 (at the age of 94-years-old), at single dose for covid-19 immunisation. Prior to vaccination, patient was not diagnosed with COVID-19. There were no other vaccines received in four weeks. Medical history included pulmonary embolism and leukemia. Concomitant medications included unspecified medicine for leukemia. The patient became ill the next day after the first dose. The patient died 14Feb2021 due to cardiac arrest.  An autopsy was not performed.   Information on batch/lot number was requested.; Reported Cause(s) of Death: Cardiac Arrest
Age: 94.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, General physical health deterioration, Malaise
Clinical narrative: Cardiac Arrest; became ill the next day after the first dose; This is a spontaneous report from a contactable consumer.  A 94-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in left arm, on 29Jan2021 at 12:00 (at the age of 94-years-old), at single dose for covid-19 immunisation. Prior to vaccination, patient was not diagnosed with COVID-19. There were no other vaccines received in four weeks. Medical history included pulmonary embolism and leukemia. Concomitant medications included unspecified medicine for leukemia. The patient became ill the next day after the first dose. The patient died 14Feb2021 due to cardiac arrest.  An autopsy was not performed.   Information on batch/lot number was requested.; Reported Cause(s) of Death: Cardiac Arrest
Age: 94.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, Illness
Clinical narrative: Cardiac Arrest; became ill the next day after the first dose; This is a spontaneous report from a contactable consumer.  A 94-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in left arm, on 29Jan2021 at 12:00 (at the age of 94-years-old), at single dose for covid-19 immunisation. Prior to vaccination, patient was not diagnosed with COVID-19. There were no other vaccines received in four weeks. Medical history included pulmonary embolism and leukemia. Concomitant medications included unspecified medicine for leukemia. The patient became ill the next day after the first dose. The patient died 14Feb2021 due to cardiac arrest.  An autopsy was not performed.   Information on batch/lot number was requested.; Reported Cause(s) of Death: Cardiac Arrest
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Syncope
Clinical narrative: faint with passing out after 10minutes of receiving vaccination; faint with passing out after 10minutes of receiving vaccination; dizzy/lightheadedness; HR 120/Palp; This is a spontaneous report from a contactable pharmacist. A 42-year-old female patient (pregnant unknown at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN5318), via an unspecified route of administration on 22Jan2021 10:00 AM at single dose for COVID-19 immunization.  Medical history included allergies to sulfa drugs.  The patient's concomitant medications were not reported.  The patient previously took azithromycin and experienced allergy to azithromycin.  Patient with history of allergy to azithromycin and sulfa drugs.  The patient experienced lightheadedness, dizzy, and faint with passing out after 10minutes of receiving vaccination on 22Jan2021 10:10 AM.  Nurse lead and observer present. Patient had VSS: HR 80 120/Palp, SaO2 97% on RA CBG: 105. Assess by EMS on duty.  Symptoms improving after placed on gurney and water provided.  Patient reported not having had eaten before being vaccinated. Water given and patient continued to be observed for a total of 45 minutes.  Patient discharged home with her ride with VSS: b/p 120/90, HR 84, Skin: PWD, SaO2 96% on RA. There was no treatment received for the adverse events. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown the list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, it was unknown if the patient been tested for COVID-19. The outcome of the event was recovered on an unspecified date in 2021. Seriousness criteria: results in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating, congenital anomaly/birth defect were no.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported events faint and passed out. 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: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose, Blood pressure measurement, Dizziness, Heart rate, Heart rate increased
Clinical narrative: faint with passing out after 10minutes of receiving vaccination; faint with passing out after 10minutes of receiving vaccination; dizzy/lightheadedness; HR 120/Palp; This is a spontaneous report from a contactable pharmacist. A 42-year-old female patient (pregnant unknown at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN5318), via an unspecified route of administration on 22Jan2021 10:00 AM at single dose for COVID-19 immunization.  Medical history included allergies to sulfa drugs.  The patient's concomitant medications were not reported.  The patient previously took azithromycin and experienced allergy to azithromycin.  Patient with history of allergy to azithromycin and sulfa drugs.  The patient experienced lightheadedness, dizzy, and faint with passing out after 10minutes of receiving vaccination on 22Jan2021 10:10 AM.  Nurse lead and observer present. Patient had VSS: HR 80 120/Palp, SaO2 97% on RA CBG: 105. Assess by EMS on duty.  Symptoms improving after placed on gurney and water provided.  Patient reported not having had eaten before being vaccinated. Water given and patient continued to be observed for a total of 45 minutes.  Patient discharged home with her ride with VSS: b/p 120/90, HR 84, Skin: PWD, SaO2 96% on RA. There was no treatment received for the adverse events. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown the list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, it was unknown if the patient been tested for COVID-19. The outcome of the event was recovered on an unspecified date in 2021. Seriousness criteria: results in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating, congenital anomaly/birth defect were no.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported events faint and passed out. 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: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Oxygen saturation, Syncope
Clinical narrative: faint with passing out after 10minutes of receiving vaccination; faint with passing out after 10minutes of receiving vaccination; dizzy/lightheadedness; HR 120/Palp; This is a spontaneous report from a contactable pharmacist. A 42-year-old female patient (pregnant unknown at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN5318), via an unspecified route of administration on 22Jan2021 10:00 AM at single dose for COVID-19 immunization.  Medical history included allergies to sulfa drugs.  The patient's concomitant medications were not reported.  The patient previously took azithromycin and experienced allergy to azithromycin.  Patient with history of allergy to azithromycin and sulfa drugs.  The patient experienced lightheadedness, dizzy, and faint with passing out after 10minutes of receiving vaccination on 22Jan2021 10:10 AM.  Nurse lead and observer present. Patient had VSS: HR 80 120/Palp, SaO2 97% on RA CBG: 105. Assess by EMS on duty.  Symptoms improving after placed on gurney and water provided.  Patient reported not having had eaten before being vaccinated. Water given and patient continued to be observed for a total of 45 minutes.  Patient discharged home with her ride with VSS: b/p 120/90, HR 84, Skin: PWD, SaO2 96% on RA. There was no treatment received for the adverse events. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown the list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, it was unknown if the patient been tested for COVID-19. The outcome of the event was recovered on an unspecified date in 2021. Seriousness criteria: results in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating, congenital anomaly/birth defect were no.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported events faint and passed out. 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: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia oral, Illusion, Swollen tongue
Clinical narrative: Felt a wave of heat come over; Felt her tongue started to swell; Her lips became numb; Her throat became scratchy; Hard to swallow; This is a spontaneous report from a contactable consumer reporting for herself. A 52-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EN 6205), via an unspecified route of administration in the left arm, on 02Mar2021 at 16:15, at single dose, for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, contrast media allergy (CAT scan die). No other vaccine in four weeks. Patient did not have COVID-19 prior to vaccination. Concomitant medications included quetiapine fumarate (SEROQUEL), zolpidem tartrate (AMBIEN), rosuvastatin calcium (CRESTOR), metoprolol succinate (TOPROL), prazosin (unknown manufacturer), alprazolam (XANAX). The patient previously took  metoclopramide hydrochloride (REGLAN) and experienced drug hypersensitivity, prochlorperazine maleate (COMPAZINE) and experienced drug hypersensitivity, promethazine (PHENERGAN) and experienced drug hypersensitivity. On 02Mar2021 at 16:15, about 30 seconds after vaccination was administered, the patient felt a wave of heat come over, felt her tongue started to swell, her lips became numb, her throat became scratchy, hard to swallow. The events caused patient's hospitalization in Mar2021, required physician office visit and emergency room visit. Therapeutic measures were taken as a result of the events and included treatment with EpiPen, Benadryl, steroids and 2 others medications. The events recovered in Mar2021. Patient was not tested for COVID-19 post vaccination. The events were considered life-threatening.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysphagia, Feeling hot, Hypoaesthesia oral, Swollen tongue, Throat tightness
Clinical narrative: Felt a wave of heat come over; Felt her tongue started to swell; Her lips became numb; Her throat became scratchy; Hard to swallow; This is a spontaneous report from a contactable consumer reporting for herself. A 52-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EN 6205), via an unspecified route of administration in the left arm, on 02Mar2021 at 16:15, at single dose, for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, contrast media allergy (CAT scan die). No other vaccine in four weeks. Patient did not have COVID-19 prior to vaccination. Concomitant medications included quetiapine fumarate (SEROQUEL), zolpidem tartrate (AMBIEN), rosuvastatin calcium (CRESTOR), metoprolol succinate (TOPROL), prazosin (unknown manufacturer), alprazolam (XANAX). The patient previously took  metoclopramide hydrochloride (REGLAN) and experienced drug hypersensitivity, prochlorperazine maleate (COMPAZINE) and experienced drug hypersensitivity, promethazine (PHENERGAN) and experienced drug hypersensitivity. On 02Mar2021 at 16:15, about 30 seconds after vaccination was administered, the patient felt a wave of heat come over, felt her tongue started to swell, her lips became numb, her throat became scratchy, hard to swallow. The events caused patient's hospitalization in Mar2021, required physician office visit and emergency room visit. Therapeutic measures were taken as a result of the events and included treatment with EpiPen, Benadryl, steroids and 2 others medications. The events recovered in Mar2021. Patient was not tested for COVID-19 post vaccination. The events were considered life-threatening.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysphagia, Electrocardiogram, Feeling hot, Hypoaesthesia oral, Immediate post-injection reaction
Clinical narrative: Felt a wave of heat come over; Felt her tongue started to swell; Her lips became numb; Her throat became scratchy; Hard to swallow; This is a spontaneous report from a contactable consumer reporting for herself. A 52-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EN 6205), via an unspecified route of administration in the left arm, on 02Mar2021 at 16:15, at single dose, for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, contrast media allergy (CAT scan die). No other vaccine in four weeks. Patient did not have COVID-19 prior to vaccination. Concomitant medications included quetiapine fumarate (SEROQUEL), zolpidem tartrate (AMBIEN), rosuvastatin calcium (CRESTOR), metoprolol succinate (TOPROL), prazosin (unknown manufacturer), alprazolam (XANAX). The patient previously took  metoclopramide hydrochloride (REGLAN) and experienced drug hypersensitivity, prochlorperazine maleate (COMPAZINE) and experienced drug hypersensitivity, promethazine (PHENERGAN) and experienced drug hypersensitivity. On 02Mar2021 at 16:15, about 30 seconds after vaccination was administered, the patient felt a wave of heat come over, felt her tongue started to swell, her lips became numb, her throat became scratchy, hard to swallow. The events caused patient's hospitalization in Mar2021, required physician office visit and emergency room visit. Therapeutic measures were taken as a result of the events and included treatment with EpiPen, Benadryl, steroids and 2 others medications. The events recovered in Mar2021. Patient was not tested for COVID-19 post vaccination. The events were considered life-threatening.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swollen tongue, Throat irritation
Clinical narrative: Felt a wave of heat come over; Felt her tongue started to swell; Her lips became numb; Her throat became scratchy; Hard to swallow; This is a spontaneous report from a contactable consumer reporting for herself. A 52-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EN 6205), via an unspecified route of administration in the left arm, on 02Mar2021 at 16:15, at single dose, for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, contrast media allergy (CAT scan die). No other vaccine in four weeks. Patient did not have COVID-19 prior to vaccination. Concomitant medications included quetiapine fumarate (SEROQUEL), zolpidem tartrate (AMBIEN), rosuvastatin calcium (CRESTOR), metoprolol succinate (TOPROL), prazosin (unknown manufacturer), alprazolam (XANAX). The patient previously took  metoclopramide hydrochloride (REGLAN) and experienced drug hypersensitivity, prochlorperazine maleate (COMPAZINE) and experienced drug hypersensitivity, promethazine (PHENERGAN) and experienced drug hypersensitivity. On 02Mar2021 at 16:15, about 30 seconds after vaccination was administered, the patient felt a wave of heat come over, felt her tongue started to swell, her lips became numb, her throat became scratchy, hard to swallow. The events caused patient's hospitalization in Mar2021, required physician office visit and emergency room visit. Therapeutic measures were taken as a result of the events and included treatment with EpiPen, Benadryl, steroids and 2 others medications. The events recovered in Mar2021. Patient was not tested for COVID-19 post vaccination. The events were considered life-threatening.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Deafness unilateral, Sudden hearing loss
Clinical narrative: received first vaccine and a few days later lost hearing in left ear; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 92-year-old male patient received the first dose of BNT162B2 (lot no. and expiry date was not reported), via an unspecified route of administration on 04Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. A few days later after receiving his first dose of the COVID-19 vaccine the patient experienced lost of hearing in left ear (on unspecified date in 2021), currently recieving cortisone injections and has partial recovery. Worried he will lose all hearing when he recieves second dose. The outcome of the event was recovering.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deafness
Clinical narrative: received first vaccine and a few days later lost hearing in left ear; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 92-year-old male patient received the first dose of BNT162B2 (lot no. and expiry date was not reported), via an unspecified route of administration on 04Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. A few days later after receiving his first dose of the COVID-19 vaccine the patient experienced lost of hearing in left ear (on unspecified date in 2021), currently recieving cortisone injections and has partial recovery. Worried he will lose all hearing when he recieves second dose. The outcome of the event was recovering.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heart rate increased, Palpitations
Clinical narrative: I exp with in 20 mins exp nausea, dizziness heart rate 163 beats and BP182/14.Since then Im still exp symptoms now on blood pressure medications and have follow up on 3/16 with a cardiologist.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Brain natriuretic peptide, Chest X-ray, Computerised tomogram, Dizziness, Full blood count
Clinical narrative: I exp with in 20 mins exp nausea, dizziness heart rate 163 beats and BP182/14.Since then Im still exp symptoms now on blood pressure medications and have follow up on 3/16 with a cardiologist.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Scan with contrast, Troponin I
Clinical narrative: I exp with in 20 mins exp nausea, dizziness heart rate 163 beats and BP182/14.Since then Im still exp symptoms now on blood pressure medications and have follow up on 3/16 with a cardiologist.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure measurement, Blood test, Cardiac stress test, Colitis ulcerative, Computerised tomogram
Clinical narrative: I exp with in 20 mins exp nausea, dizziness heart rate 163 beats and BP182/14.Since then Im still exp symptoms now on blood pressure medications and have follow up on 3/16 with a cardiologist.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Decreased appetite, Dizziness, Dyspnoea, Echocardiogram, Fibrin D dimer
Clinical narrative: I exp with in 20 mins exp nausea, dizziness heart rate 163 beats and BP182/14.Since then Im still exp symptoms now on blood pressure medications and have follow up on 3/16 with a cardiologist.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heart rate, Heart rate increased, Hypertension, Insomnia, Laboratory test
Clinical narrative: I exp with in 20 mins exp nausea, dizziness heart rate 163 beats and BP182/14.Since then Im still exp symptoms now on blood pressure medications and have follow up on 3/16 with a cardiologist.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging, Paraesthesia, Red blood cell sedimentation rate, Tilt table test, Ultrasound kidney
Clinical narrative: I exp with in 20 mins exp nausea, dizziness heart rate 163 beats and BP182/14.Since then Im still exp symptoms now on blood pressure medications and have follow up on 3/16 with a cardiologist.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immune thrombocytopenia, Petechiae, Platelet count decreased, Purpura
Clinical narrative: 2/25/21 @ 8:00 pm had fever, chills, vomited.  Over those symptoms by 9:00 am next day.  Did notice red spots on my face. On 2/27 noticed red spots on legs from knee down.  3/4/21 had appointment with my dermatologist and she sent me to have blood work.  Blood work showed my platelets were down to 33.  Went to hematologist same day and was put on dexamethasone 4mg . 10 pills a day for 4 days.  Had blood work done  3/8/21,  platelets 186.  Stopped dexamethasone.  Had blood work done 3/11/21, platelets now 300.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Platelet count decreased, Pyrexia, Rash macular, Vomiting
Clinical narrative: 2/25/21 @ 8:00 pm had fever, chills, vomited.  Over those symptoms by 9:00 am next day.  Did notice red spots on my face. On 2/27 noticed red spots on legs from knee down.  3/4/21 had appointment with my dermatologist and she sent me to have blood work.  Blood work showed my platelets were down to 33.  Went to hematologist same day and was put on dexamethasone 4mg . 10 pills a day for 4 days.  Had blood work done  3/8/21,  platelets 186.  Stopped dexamethasone.  Had blood work done 3/11/21, platelets now 300.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Immune thrombocytopenia, Platelet count decreased
Clinical narrative: 2/25/21 @ 8:00 pm had fever, chills, vomited.  Over those symptoms by 9:00 am next day.  Did notice red spots on my face. On 2/27 noticed red spots on legs from knee down.  3/4/21 had appointment with my dermatologist and she sent me to have blood work.  Blood work showed my platelets were down to 33.  Went to hematologist same day and was put on dexamethasone 4mg . 10 pills a day for 4 days.  Had blood work done  3/8/21,  platelets 186.  Stopped dexamethasone.  Had blood work done 3/11/21, platelets now 300.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Seizure
Clinical narrative: Epileptic seizure and fever for a day
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Epilepsy, Pyrexia
Clinical narrative: Epileptic seizure and fever for a day
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax, Dyspnoea
Clinical narrative: Pulmonary embolism
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax, Pulmonary embolism
Clinical narrative: Pulmonary embolism
Age: 97.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Decreased appetite, General physical health deterioration, Lethargy, Nausea
Clinical narrative: My father was old and frail but was not sick prior to the vaccine. The day after receiving the shot he developed a fever. This spiked during the day and he stated he didn't feel good. He became nauseous after dinner. He began vomiting during the early evening and passed away at approximately 10:00pm that night.
Age: 97.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: My father was old and frail but was not sick prior to the vaccine. The day after receiving the shot he developed a fever. This spiked during the day and he stated he didn't feel good. He became nauseous after dinner. He began vomiting during the early evening and passed away at approximately 10:00pm that night.
Age: 97.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Feeling abnormal, Nausea, Pyrexia, Vomiting
Clinical narrative: My father was old and frail but was not sick prior to the vaccine. The day after receiving the shot he developed a fever. This spiked during the day and he stated he didn't feel good. He became nauseous after dinner. He began vomiting during the early evening and passed away at approximately 10:00pm that night.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: Tingling on lips, tip of tongue, and roof of the mouth which then turned to numbness- started 03/09/2021 @ 11:15 - only numbness at the tip of the tongue is still occurring, all other symptoms have subsided   66 year old female (DOB: 07/15/1954) received the Moderna COVID-19 Vaccine Lot# 030A21A  on 03/09/2021 @ 10:30. On 03/09/2021 @ 11:15 pt reported tingling on lips, tip of tongue, and roof of the mouth which then turned to numbness. Pt took Benedryl on 03/09/2021 @ 11:30, pt reports the symptoms subsided 30 minutes after taking Benedryl but returned again 6 hours later and @ 19:00 on 03/09/2021 pt took another dose of Benedryl. Symptoms resolved momentarily until 03/11/2021 @ 09:00, pt then took Benedryl and the symptoms subsided 30 minutes later, except for numbness on the tip of the tongue. The pt is currently experiencing numbness on the tip of the tongue. Through talking to the pt, the pt's speech does not seem effected by symptoms, pt's speech is coherent and without slurr, stutter, or impediments. Pt takes Armor Thyroid 60 mg, Valsartan 160 mg, Amlodipine 10 mg, and Zyrtec. Pt was diagnosed with hypothyroidism and hypertension. Pt is allergic to shellfish (hives reaction), wheat/gluten (sinus congestion, cough, headache, constipation reaction), and chocolate (headache reaction). Pt was advised to continue Benedryl regiment. Pt asked if the second dose should be administered. Pt was advised since the 2nd dose was weeks away, the symptoms should resolve by then, if they do, the 2nd dose can be administered, alert the staff of this reaction, stay at the facility longer for observation, and if the symptoms are not resolved in a couple of days to seek medical care. SPI was consulted and Dr was notified.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: Patient presented for left eye watering, inability to blink, inability to raise his left elbow, and abnormal sensation in his mouth with difficulty chewing.  He has loss of forehead wrinkles on the left side with elevating his eyebrows.  He did receive his Pfizer COVID-19 vaccine 2 weeks ago.  Started noticing the abnormal sensation to his left eye on Sunday and then yesterday when he was eating he noticed the sensation to the left side of his tongue.  No difficulty swallowing, no speech impairment, no extremity weakness, no ataxia or dysarthria.  He is a diabetic and received the Pfizer vaccine.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abnormal sensation in eye, Corneal reflex decreased, Lacrimation increased, Mastication disorder, Mobility decreased
Clinical narrative: Patient presented for left eye watering, inability to blink, inability to raise his left elbow, and abnormal sensation in his mouth with difficulty chewing.  He has loss of forehead wrinkles on the left side with elevating his eyebrows.  He did receive his Pfizer COVID-19 vaccine 2 weeks ago.  Started noticing the abnormal sensation to his left eye on Sunday and then yesterday when he was eating he noticed the sensation to the left side of his tongue.  No difficulty swallowing, no speech impairment, no extremity weakness, no ataxia or dysarthria.  He is a diabetic and received the Pfizer vaccine.