chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Dyspnoea, Feeling hot, Flushing
Clinical narrative: Difficulty swallowing; Swollen throat; difficulty breathing; light headed/dizzy; felt hot; flushed; This is a spontaneous report from a contactable consumer (patient, reported for self).  A 31-years-old (Non- pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH-mRNA COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6205, Expiration date: UNKNOWN), via an unspecified route of administration, administered in Arm Left on 11Mar2021 10:00 (At the age of 31-years-old) as single for COVID-19 immunisation. No Medical history reported. The patient concomitant medication included metronidazole taken for an unspecified indication at an unspecified dose. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Mar2021 10:30 (30 minutes after) the patient experienced Difficulty swallowing, Swollen throat, difficulty breathing, lightheaded, dizzy, felt hot and flushed. Patient visited Emergency room [department or urgent care] for the adverse events. Patient received treatment of Epipen and steroid shot for the adverse events. Sinc e the vaccination, the patient had not been tested for COVID-19.  The out-come of event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: Difficulty swallowing; Swollen throat; difficulty breathing; light headed/dizzy; felt hot; flushed; This is a spontaneous report from a contactable consumer (patient, reported for self).  A 31-years-old (Non- pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH-mRNA COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6205, Expiration date: UNKNOWN), via an unspecified route of administration, administered in Arm Left on 11Mar2021 10:00 (At the age of 31-years-old) as single for COVID-19 immunisation. No Medical history reported. The patient concomitant medication included metronidazole taken for an unspecified indication at an unspecified dose. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Mar2021 10:30 (30 minutes after) the patient experienced Difficulty swallowing, Swollen throat, difficulty breathing, lightheaded, dizzy, felt hot and flushed. Patient visited Emergency room [department or urgent care] for the adverse events. Patient received treatment of Epipen and steroid shot for the adverse events. Sinc e the vaccination, the patient had not been tested for COVID-19.  The out-come of event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: His BP was very elevated-197/146/His BP remained high; This is a spontaneous report from a contactable consumer (patients parent). A 32-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm right on 15Mar2021 11:00 as 1st dose, single for covid-19 immunisation. Medical history included diabetes type 2, asthma and hypertension. Patient had known allergies to metformin, ritalin, adderal, eggplant and peanuts. Patient had covid prior vaccination. On 15Mar2021 11:15 AM, 10 minutes after the injection patient experienced a severe headache and dizziness. His BP was very elevated - 197/146. He was observed for almost an hour. His BP remained high and his headache continued. He was referred to the ER where he received antihypertensives and pain medication. Patient took medication for the treatment of events. He had not tested for covid post vaccination. No other vaccine received in four weeks and received antihypertensive and diabetic medication in two weeks. The outcome of the event was recovering.   No follow-up attempts are possible. Information about lot/ batch no cannot be requested. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear infection, Ear pain, Headache, Pain
Clinical narrative: earache/ear infection; earache/ear infection; fever; chills; headache; bodyaches; This is a spontaneous report from a contactable consumer or other non hcp. A 50-year-old non-pregnant female patient received second dose of BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EN6205), via an unspecified route of administration, administered in Arm Left on 05Mar2021 12:00 (at the age of 50-year-old) as single dose for covid-19 immunisation. Medical history included renal transplant (Kidney Transplant) from 2018 to an unknown date. Concomitant medication(s) included prednisone (PREDNISONE); tacrolimus (TACROLIMUS); mycophenolate mofetil (MYCOPHENOLATE); omeprazole (OMEPRAZOLE). The patient had no known allergies. The patient did not take any other vaccines within four weeks, prior to covid-19 vaccination. Patient was not tested positive for covid-19 prior to vaccination. Patient done covid test post vaccination. The patient previously took BNT162B2 (BNT162B2, solution for injection), via an unspecified route of administration, on an unknown date as 1st dose, single for covid-19 immunisation. On 14Mar2021, the patient experienced earache/ear infection, fever, chills, headache, bodyaches. The patient adverse events includes Side effects (fever, chills, headache, earache/ear infection, and bodyaches) didn't occur until 14Mar2021. Patient was informed by her physician to report this as paperwork she received indicated possible side effects up to 72 hours. Adverse events resulted in Emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): pending on 15Mar2021. Therapeutic measures were taken as a result of earache/ear infection included antibiotics. The outcome of the events were not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: earache/ear infection; earache/ear infection; fever; chills; headache; bodyaches; This is a spontaneous report from a contactable consumer or other non hcp. A 50-year-old non-pregnant female patient received second dose of BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EN6205), via an unspecified route of administration, administered in Arm Left on 05Mar2021 12:00 (at the age of 50-year-old) as single dose for covid-19 immunisation. Medical history included renal transplant (Kidney Transplant) from 2018 to an unknown date. Concomitant medication(s) included prednisone (PREDNISONE); tacrolimus (TACROLIMUS); mycophenolate mofetil (MYCOPHENOLATE); omeprazole (OMEPRAZOLE). The patient had no known allergies. The patient did not take any other vaccines within four weeks, prior to covid-19 vaccination. Patient was not tested positive for covid-19 prior to vaccination. Patient done covid test post vaccination. The patient previously took BNT162B2 (BNT162B2, solution for injection), via an unspecified route of administration, on an unknown date as 1st dose, single for covid-19 immunisation. On 14Mar2021, the patient experienced earache/ear infection, fever, chills, headache, bodyaches. The patient adverse events includes Side effects (fever, chills, headache, earache/ear infection, and bodyaches) didn't occur until 14Mar2021. Patient was informed by her physician to report this as paperwork she received indicated possible side effects up to 72 hours. Adverse events resulted in Emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): pending on 15Mar2021. Therapeutic measures were taken as a result of earache/ear infection included antibiotics. The outcome of the events were not recovered.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pyrexia
Clinical narrative: she has a little bit of a fever, '101 point something'; little bit of a cold; This is a spontaneous report from a contactable consumer or other non-Health Care Professional (herself). A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for Covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date (next day after vaccination), the patient experienced she has a little bit of a fever, 101 point something and a little bit of a cold. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Blood pressure measurement, Body temperature, Disturbance in attention, Feeling cold
Clinical narrative: Blood sugar won't control ;  using 4x insulin and can't get Blood sugar below 250; Pulse rate over 110 in morni gs; Delayed inj site pain After 2 days --- Hot / Cold sensation --- Vision narrowed --- difficult mental focus focus --- Blood sugar won't control ;  using 4x insulin and can't get Blood sugar below 250 -; Delayed inj site pain After 2 days --- Hot / Cold sensation --- Vision narrowed --- difficult mental focus focus --- Blood sugar won't control ;  using 4x insulin and can't get Blood sugar below 250 -; Delayed inj site pain After 2 days --- Hot / Cold sensation --- Vision narrowed --- difficult mental focus focus --- Blood sugar won't control ;  using 4x insulin and can't get Blood sugar below 250 -; Difficult mental focus; Unusual headach; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 76-year-old male patient received first dose of bnt162b2 via an unspecified route of administration, administered in right arm on 13Feb2021 09:00 AM (Batch/Lot Number: EN 6201), the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 13Mar2021 15:00 (Age at vaccination was 75 years) (Batch/Lot Number: EN 6208) as 2nd dose, single for covid-19 immunization. The patient's medical history included atrial fibrillation, cardiac disorder (bypasses stints), Right lower leg amputation, insulin dependent Diabetes (type 1 diabetes mellitus), Right eye Prosthetic. The patient was allergic to erythromycin keflex all benzo's all codeins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient's concomitant medication included clopidogrel (CLOPIDOGREL), digoxin (DIGOXIN), gabapentin (GABAPENTIN), warfarin (WARFARIN), insulin human (NOVOLIN). On 17Mar2021, 2 days after the vaccination the patient experienced delayed Injection site pain, Hot / Cold sensation, Vision narrowed, Difficult mental focus, Blood sugar would not control, using 4x insulin and could not get Blood sugar below 250, Pulse rate over 110 in mornings and unusual headache. The patient used Metoprolaaol as a treatment to pulse rate over 110. The patient's BP 110 / 55 Temp 97.3 Fahrenheit was well controlled until vaccination +2 days. The patient underwent lab tests and procedures which included blood pressure measurement: 110/55 and body temperature: 97.3 Fahrenheit on an unspecified date. The events Blood sugar would not control, using 4x insulin and could not get Blood sugar below 250, Pulse rate over 110 in mornings was considered as medically significant, the other events were reported as non-serious. The outcome of the events was not recovered.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Vaccination site pain, Visual impairment
Clinical narrative: Blood sugar won't control ;  using 4x insulin and can't get Blood sugar below 250; Pulse rate over 110 in morni gs; Delayed inj site pain After 2 days --- Hot / Cold sensation --- Vision narrowed --- difficult mental focus focus --- Blood sugar won't control ;  using 4x insulin and can't get Blood sugar below 250 -; Delayed inj site pain After 2 days --- Hot / Cold sensation --- Vision narrowed --- difficult mental focus focus --- Blood sugar won't control ;  using 4x insulin and can't get Blood sugar below 250 -; Delayed inj site pain After 2 days --- Hot / Cold sensation --- Vision narrowed --- difficult mental focus focus --- Blood sugar won't control ;  using 4x insulin and can't get Blood sugar below 250 -; Difficult mental focus; Unusual headach; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 76-year-old male patient received first dose of bnt162b2 via an unspecified route of administration, administered in right arm on 13Feb2021 09:00 AM (Batch/Lot Number: EN 6201), the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 13Mar2021 15:00 (Age at vaccination was 75 years) (Batch/Lot Number: EN 6208) as 2nd dose, single for covid-19 immunization. The patient's medical history included atrial fibrillation, cardiac disorder (bypasses stints), Right lower leg amputation, insulin dependent Diabetes (type 1 diabetes mellitus), Right eye Prosthetic. The patient was allergic to erythromycin keflex all benzo's all codeins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient's concomitant medication included clopidogrel (CLOPIDOGREL), digoxin (DIGOXIN), gabapentin (GABAPENTIN), warfarin (WARFARIN), insulin human (NOVOLIN). On 17Mar2021, 2 days after the vaccination the patient experienced delayed Injection site pain, Hot / Cold sensation, Vision narrowed, Difficult mental focus, Blood sugar would not control, using 4x insulin and could not get Blood sugar below 250, Pulse rate over 110 in mornings and unusual headache. The patient used Metoprolaaol as a treatment to pulse rate over 110. The patient's BP 110 / 55 Temp 97.3 Fahrenheit was well controlled until vaccination +2 days. The patient underwent lab tests and procedures which included blood pressure measurement: 110/55 and body temperature: 97.3 Fahrenheit on an unspecified date. The events Blood sugar would not control, using 4x insulin and could not get Blood sugar below 250, Pulse rate over 110 in mornings was considered as medically significant, the other events were reported as non-serious. The outcome of the events was not recovered.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Lymphadenopathy, Oropharyngeal pain, Pruritus, Swelling face
Clinical narrative: Face swollen; Hives and itching, mostly upper body. Chest and arms/Hives all over the body; Swollen gland under the left arm; Arm irritation on the sight of the shot; Itchy scalp, slightly swollen top lip; Itchy scalp, slightly swollen top lip; 3/5 Slight sore throat; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 49-years-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EN6199, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 05Mar2021 19:00 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient was not diagnosed with COVID-19 prior to the vaccination. Medical history included asthma from an unknown date. The patient has allergy to penicillin and omeprazole magnesium. The patient's concomitant medications were not reported. Since the vaccination the patient had not been diagnosed with COVID-19. On 05Mar2021 19:30, post vaccination the patient experienced slight sore throat. On 11Mar2021 19:30, the patient had itchy scalp, slightly swollen top lip. On 12Mar2021, the patient felt arm irritation on the sight of the shot. On 13Mar2021, the patient had swollen gland under the left arm. On 15Mar2021, it was reported that the patient developed hives and itching, mostly upper body, chest and arms/hives all over the body. On 17Mar2021, the patient had her face swollen. On 17Mar2021, the patient had to go to the emergency room due to the events. The patient was treated with Zyrtec, Pepcid IV, Deltasone and Benadryl. The outcome of the events was reported as not recovered at the time of report.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site irritation
Clinical narrative: Face swollen; Hives and itching, mostly upper body. Chest and arms/Hives all over the body; Swollen gland under the left arm; Arm irritation on the sight of the shot; Itchy scalp, slightly swollen top lip; Itchy scalp, slightly swollen top lip; 3/5 Slight sore throat; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 49-years-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EN6199, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 05Mar2021 19:00 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient was not diagnosed with COVID-19 prior to the vaccination. Medical history included asthma from an unknown date. The patient has allergy to penicillin and omeprazole magnesium. The patient's concomitant medications were not reported. Since the vaccination the patient had not been diagnosed with COVID-19. On 05Mar2021 19:30, post vaccination the patient experienced slight sore throat. On 11Mar2021 19:30, the patient had itchy scalp, slightly swollen top lip. On 12Mar2021, the patient felt arm irritation on the sight of the shot. On 13Mar2021, the patient had swollen gland under the left arm. On 15Mar2021, it was reported that the patient developed hives and itching, mostly upper body, chest and arms/hives all over the body. On 17Mar2021, the patient had her face swollen. On 17Mar2021, the patient had to go to the emergency room due to the events. The patient was treated with Zyrtec, Pepcid IV, Deltasone and Benadryl. The outcome of the events was reported as not recovered at the time of report.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Pain, Pruritus, SARS-CoV-2 test
Clinical narrative: My breast implants swelled up at top of my chest and an intense itchiness occurred that was painful.; My breast implants swelled up at top of my chest and an intense itchiness occurred that was painful.; My breast implants swelled up at top of my chest and an intense itchiness occurred that was painful.; This is a spontaneous report from a contactable consumer (patient). A 54-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6206), via an unspecified route of administration, administered in left arm on 12Mar2021 08:00 (age at vaccination: 54 years) as 1st dose, single for covid-19 immunisation. The patient was administered vaccine in Clinic facility. The patient medical history included covid-19. Prior to vaccination, the patient diagnosed with COVID-19. The patient did not receive other medications within 2 weeks of vaccination. The patient was allergic to ampicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Mar2021 21:00, the patient breast implants swelled up at top of chest and an intense itchiness occurred that was painful. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient received anti-inflammatory medicine as treatment for the adverse events. On an unknown date, the patient underwent sars-cov-2 test which was positive. Since the vaccination the patient was not tested for covid-19. The outcome of the events was not recovered.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Feeding disorder, Lymphadenopathy, Oral herpes, Pain
Clinical narrative: This is a spontaneous report from a contactable other nurse (patient). A 29-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6206), via an unspecified route of administration in Arm Left on 11Mar2021 at 14:45 (29-years-old at the time of vaccination) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unspecified date in Mar2021, the patient experienced swollen lymph nodes hours after COVID-19 vaccine, then fever and next day developed aphthous ulcers in mouth and tongue. She also developed a strep throat infection and cold sores on lower lip, it's been a week and she still have the cold sores on her lip that became infected. She hasn't been able to eat well due to the pain she was currently experiencing. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, it was unknown if patient tested for COVID-19. The outcome of events was not resolved.  Follow-up attempts are needed. Information Lot/Batch number was available. Additional information has been requested. ; Sender's Comments: As there is limited information in the case provided, the causal association between the event bacterial pharyngitis, Lymphadenopathy, Asthenia and Pain with the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngitis bacterial, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable other nurse (patient). A 29-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6206), via an unspecified route of administration in Arm Left on 11Mar2021 at 14:45 (29-years-old at the time of vaccination) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unspecified date in Mar2021, the patient experienced swollen lymph nodes hours after COVID-19 vaccine, then fever and next day developed aphthous ulcers in mouth and tongue. She also developed a strep throat infection and cold sores on lower lip, it's been a week and she still have the cold sores on her lip that became infected. She hasn't been able to eat well due to the pain she was currently experiencing. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, it was unknown if patient tested for COVID-19. The outcome of events was not resolved.  Follow-up attempts are needed. Information Lot/Batch number was available. Additional information has been requested. ; Sender's Comments: As there is limited information in the case provided, the causal association between the event bacterial pharyngitis, Lymphadenopathy, Asthenia and Pain with the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Dyspnoea, Urticaria
Clinical narrative: Hives; cough; chest pain; shortness of breath; This is a spontaneous report from a contactable physician. A 45-years-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via intramuscular route of administration, administered in left arm on 05Mar2021 at 13:30 hours as 1st dose, single (at the age of 45-years-old) for covid-19 immunisation. Medical history included achalasia, asthma, allergy to latex and allergy to penicillin, all from an unknown date and unknown if ongoing. Concomitant medications included patient received within 2 weeks of vaccination included celecoxib (CELEXA); esomeprazole magnesium (NEXIUM) and pramipexole dihydrochloride (MIRAPEX), all taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromycin and gabapentin and experienced allergy to erythromycin and allergy to gabapentin. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. On 05Mar2021, at 13:30 hours, patient experienced hives, cough, chest pain and shortness of breath. Patient had emergency room/department or urgent care for the events, Patient received epinephrine, Benadryl, steroids and pepcid, as treatment for all the events. The reporter considered the events as non-serious. Patient was not tested for COVID-19 since the vaccination. Events resulted in emergency room/department or urgent care. The outcome of all the events was recovered in Mar2021.  Information on the lot/batch number has been requested. ; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events of urticaria, cough, chest pain, dyspneoa and suspect drug BNT162B2 cannot be excluded  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Cold sweat, Fatigue, Headache
Clinical narrative: BP shot up to 197/130; Throbbing headache; Nausea; Tingling in both arms and fingers; Itchy tongue; Iitching all over body; Clamminess; Fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 52-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EP6955), via an unspecified route of administration, administered in left arm on 18Mar2021, 15:30 (age at vaccination was 52-year-old) as single dose for covid-19 immunization at hospital. Medical history included hypertension. The patient concomitant medication included Hydrochlorothiazide. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient did not diagnose with COVID-19. The patient had not been tested for COVID-19 since the vaccination. The patient had no known allergies to medications, food, or other products. On 18Mar2021 at 15:45 Within 60 seconds of vaccine, I got an immediate throbbing headache, nausea, tingling in both arms and fingers, itchy tongue, itching all over body, BP shot up to 197/130, clamminess, and fatigue. Patient received a treatment with Antihistamine given during episode for the events. The patient underwent lab test and procedures which included blood pressure measurement: 197/130 on unspecified date in Mar2021. The outcome of the events was not recovered.  Additional information is excepted. Follow up is requested.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia, Pruritus, Tongue pruritus
Clinical narrative: BP shot up to 197/130; Throbbing headache; Nausea; Tingling in both arms and fingers; Itchy tongue; Iitching all over body; Clamminess; Fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 52-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EP6955), via an unspecified route of administration, administered in left arm on 18Mar2021, 15:30 (age at vaccination was 52-year-old) as single dose for covid-19 immunization at hospital. Medical history included hypertension. The patient concomitant medication included Hydrochlorothiazide. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient did not diagnose with COVID-19. The patient had not been tested for COVID-19 since the vaccination. The patient had no known allergies to medications, food, or other products. On 18Mar2021 at 15:45 Within 60 seconds of vaccine, I got an immediate throbbing headache, nausea, tingling in both arms and fingers, itchy tongue, itching all over body, BP shot up to 197/130, clamminess, and fatigue. Patient received a treatment with Antihistamine given during episode for the events. The patient underwent lab test and procedures which included blood pressure measurement: 197/130 on unspecified date in Mar2021. The outcome of the events was not recovered.  Additional information is excepted. Follow up is requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood pressure increased, Blood pressure measurement, Chills, Dizziness
Clinical narrative: dizzy; cramping in stomach; hard to swallow solid food; body shook; chills/teeth chattered; BP rose to 170/89; felt jittery; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported that a 78-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EN6200), dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 14:00 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing high BP Onset date: 5+ years Stop date: Ongoing Pertinent details: Controlled; ongoing acid reflux disease Onset date: 10+ years Stop date: Ongoing Pertinent details: Controlled. There were no concomitant medications. On 20Feb2021, the patient experienced BP rose to 170/89; felt jittery; chills/teeth chattered; body shook; On 21Feb2021, dizzy; cramping in stomach; hard to swallow solid food. The patient underwent lab tests and procedures which included blood pressure measurement: 217/105 mmhg on 28Jan2021, blood pressure measurement: 170/89 mmhg on 20Feb2021, pyrexia: 103 on 28Jan2021. It was reported that patient took 2nd shot on Wednesday 17Feb. On Saturday 20Feb BP rose to 170/89 felt jittery. On Sunday 21Feb become jittery, dizzy, BP high and had cramping in stomach. Hard to swallow solid food. Went on until doctor ordered Dicyclomine. It helps. On Saturday 20Feb had chills for 2and half hours. Teeth chattered and body shook. Stomach was still cramping after 2and half weeks and solid food is hard to swallow. I have an appointment with a gastrologist. The clinical outcome of all events were unknown.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Nervousness, Pyrexia, Tremor
Clinical narrative: dizzy; cramping in stomach; hard to swallow solid food; body shook; chills/teeth chattered; BP rose to 170/89; felt jittery; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported that a 78-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EN6200), dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 14:00 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing high BP Onset date: 5+ years Stop date: Ongoing Pertinent details: Controlled; ongoing acid reflux disease Onset date: 10+ years Stop date: Ongoing Pertinent details: Controlled. There were no concomitant medications. On 20Feb2021, the patient experienced BP rose to 170/89; felt jittery; chills/teeth chattered; body shook; On 21Feb2021, dizzy; cramping in stomach; hard to swallow solid food. The patient underwent lab tests and procedures which included blood pressure measurement: 217/105 mmhg on 28Jan2021, blood pressure measurement: 170/89 mmhg on 20Feb2021, pyrexia: 103 on 28Jan2021. It was reported that patient took 2nd shot on Wednesday 17Feb. On Saturday 20Feb BP rose to 170/89 felt jittery. On Sunday 21Feb become jittery, dizzy, BP high and had cramping in stomach. Hard to swallow solid food. Went on until doctor ordered Dicyclomine. It helps. On Saturday 20Feb had chills for 2and half hours. Teeth chattered and body shook. Stomach was still cramping after 2and half weeks and solid food is hard to swallow. I have an appointment with a gastrologist. The clinical outcome of all events were unknown.  No follow-up attempts are possible. No further information is expected.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Tongue disorder
Clinical narrative: lips swollen; Tongue got cut; This is a spontaneous report received from a contactable consumer (patient). A 92-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in right arm on 05Mar2021 at 10:00 AM as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included blood pressure, cholesterol, panic attack, macular degeneration from an unknown date and unknown if ongoing. The patient has allergies to Cipro XR; Macrobid; Keflex; Levaquin. No family medical history was provided and no relevant tests were performed. Concomitant medications included azilsartan kamedoxomil (EDARBI) 40 mg for blood pressure; azilsartan medoxomil, chlortalidone (EDARBYCLOR) for blood pressure; nebivolol hydrochloride (BYSTOLIC, take once daily by mouth) 5 mg for blood pressure; rosuvastatin calcium (CRESTOR) 20 mg for blood cholesterol; aspirin [acetylsalicylic acid] 81 mg for anticoagulant therapy; pregabalin (LYRICA) 25 mg; midodrine hydrochloride 2.5 mg; olanzapine (ZYPREXA) 2.5 mg; omeprazole (OMEPRAZOLE) 40 mg; alprazolam (ALPRAZOLAM) 0.5 mg for panic attack; ciclosporin (RESTASIS) 0.05 mg for macular degeneration; captopril (CAPTOPRIL) 50 mg, (take only as needed) for blood pressure; linaclotide (LINZESS) 72 ug; triazolam (TRIAZOLAM) 0.25 mg; doxepin (DOXEPIN) 10 mg; diclofenac (DICLOFENAC), 1 % gel apply as needed for arthritis. Concomitant products from a list written by patient's caregiver. He doesn't know the dosage or how long his mother has been taking many of the mediations. Patient had no previous history of immunization with the Pfizer vaccine considered as suspect. The patient did not receive additional vaccines on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. His mother got the first dose of the Pfizer COVID 19 vaccine two weeks ago 05Mar2021 at 10:00AM in the right arm. In about four hours after the vaccine, on 05Mar2021 her lips were swollen; they read that it is one of the known side effects. Then next day they went to the family doctor who prescribed Benadryl. She took it for about a week but her lips are still swollen. His mother told him she noticed her tongue has had a few cuts in it but he is unsure of the exact date. His mother is not in bad condition and but she did have a severe reaction. She is scheduled for the second shot next week 26Mar2021. They stopped the Benadryl a few days ago because they are planning to see a specialist in allergies and heard they might want to do some testing so he wanted his mother to be clear of the Benadryl. Not have any product or information to provide NDC, UPC, lot or expiration for the Benadryl his mother took. The events resulted in a visit to physician or ER: Monday they saw the family doctor who prescribed Benadryl for lips swollen. The outcome of lips swollen was recovering, while with other events was not recovered.  Information about batch/ lot number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Labyrinthitis, Vestibular neuronitis
Clinical narrative: Vestibular Neuronitis/Labyrnthitis; Vestibular Neuronitis/Labyrnthitis; This is a spontaneous report from a contactable physician (Patient herself). A 42-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL3246; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 22Jan2021 09:00 as unknown single dose for COVID-19 immunization. Medical history included drug hypersensitivity, allergies to medications, food, or other products: Sulfur from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. 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. On 16Mar2021 the patient experienced vestibular neuronitis/labyrnthitis. The adverse event resulted in Emergency room/department or urgent care visit. Therapeutic measures were taken as a result of vestibular neuronitis/labyrnthitis as patient had received Valium, IV hydration. Since the vaccination, the patient was not tested for COVID-19. The outcome of events was unknown.  Additional information has been requested.; Sender's Comments: Based on the information currently available,The casual association between the reported event "Labyrinthitis,Vestibular neuronitis   "and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: Her blood pressure spiked to 220/180 and she ended up in the Emergency Room.; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6207; Expiration Date: 31Jul2021), via an unspecified route of administration in right arm (at the age of 65-years-old) on 17Mar2021 at 14:59 as single dose for COVID-19 immunization. Medical history included ongoing high blood pressure. Patient's family history reported as none. Concomitant medication(s) included losartan (LOSARTAN) 25mg, one tablet daily for hypertension from Feb2021 and ongoing and hydrochlorothiazide (HYDROCHLOROTHIAZIDE) 12.5mg once daily for hypertension from Feb2021 and ongoing, patient did not provide lot number for Losartan and Hydrochlorothiazide. Patient did not receive any other vaccine prior four weeks of vaccination. On 17Mar2021, patient had an incident of high blood pressure right after the vaccine. Her blood pressure spiked to 220/180 on 17Mar2021 and she ended up in the Emergency Room. She had a band aid on right arm. When the patient was in the ER test and blood work were conducted, but she was not sure what that was. Her blood pressure came down that same evening. Patient wanted to know if she should still get the second vaccine. The patient underwent lab tests and procedures which included blood pressure measurement: 220/180 mmhg on 17Mar2021 High. The outcome of the event was recovered on 17Mar2021.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Eye contusion, Eye injury, Fall, X-ray
Clinical narrative: lacerations on right eye; bad fall; right shoulder very sore; significant black eye; This is a spontaneous report from a contactable consumer or other non health care professional. A 74-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot Number: EN6198; Expiration Date: 30Jun2021), via an unspecified route of administration, in left arm on 24Feb2021 at 11:00 AM (at the age of 74-years-old) as 1st dose, single for Covid-19 immunisation. The patient medical history included hysterectomy from 1996 to an unknown date 1996 hysterectomy, she used to take a higher dose and has gone down, pain from an unknown date and unknown if ongoing. The patient concomitant medication included estrogens esterified, methyltestosterone (ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE) taken for hysterectomy from 1996 to an unspecified stop date. The patient received second dose of bnt162b2 (BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EN6208, Expiration date: Unknown) via unspecified route of administration, in left arm on 17Mar2021 at 10:45 AM (at the age of 74-years-old) as 2 nd dose, single for Covid-19 immunisation. The patient had a bad fall on 09Mar2021 and further stated that after the first dose she was in her house and tripped and fell. She had her glasses on, they are metal frames, the frames bent and caused the two lacerations. The patient right shoulder had also been very sore from the fall and she had a significant black eye. She went to the emergency room. They did x rays and told her she had no broken bones, they glued shut the lacerations because they said that would not leave as bad a scar. On 09Mar2021, the patient had experienced bad fall, right shoulder very sore, significant black eye, lacerations on right eye, She was advised to take Advil (Ibuprofen) with meals so it would not bother her stomach, and Tylenol (acetaminophen) for pain. She was not admitted to the hospital and is recovering from the fall. Mentions it was hard to tell if the two lacerations just above her eye are better since they was glued shut. Mentions her husband died two months ago and now she does not have anyone to do the heavy lifting and it is really hard with her one arm sore from the vaccine and her shoulder painful from the fall. The patient underwent lab tests and procedures which included X Ray : no broken bones on an unspecified date. The outcome of event bad fall was recovered with Sequel. Outcome for other events right shoulder very sore, significant black eye, lacerations on right eye was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Illness, Pain, Pulmonary oedema, Rash
Clinical narrative: was so sick with fluids in her lungs, and she was gurgling and trying to cough it up; Terrible side effects she is very sick and got bad stuffs; she is bedridden; got helped to her do everything; Terrible side effects she is very sick and got bad stuffs; she is bedridden; got helped to her do everything; his wife was up all night; his wife has thrown up a few times; having body aches; Rash; This is a spontaneous report from a contactable consumer (patient husband). A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number and Expiration date: Unknown), via an unspecified route of administration in left arm on 18Mar2021 (at the age of 61-year-old) as a single dose for COVID-19 immunization at hospital. Medical history included patient got crushed up in a car wreck and lost 53% of her pancreas and had a bad heart valve. Concomitant medications were reported as none. Patient did not receive any other vaccines on the same day as the COVID shot. On 18Mar2021, after her first dose of Covid shot, she was up all night last night because she was so sick with fluids in her lungs, and she was gurgling and trying to cough it up and she stated that she was going to get better, but she was still in bed today. Reporter stated that his wife had fluid in her lungs and stuff, that maybe her heart couldn't push it out and did not get out of bed yesterday to sit on the couch and see the grandkids, but she wanted to be in bed. She was ok but had terrible side effects she was very sick and got bad stuffs, she was bedridden and got helped to her do everything. She had thrown up a few times and was just really sick and also experienced rash on an unspecified date in 2021. He stated that he hopes his wife does not have any permanent damage from this, as she just had a lot of things already, his wife was sick and disabled, having body aches, and is not planning on getting the second dose and he stated his wife does think that she will get well again. Patient did not receive any treatment for the events. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Vomiting
Clinical narrative: was so sick with fluids in her lungs, and she was gurgling and trying to cough it up; Terrible side effects she is very sick and got bad stuffs; she is bedridden; got helped to her do everything; Terrible side effects she is very sick and got bad stuffs; she is bedridden; got helped to her do everything; his wife was up all night; his wife has thrown up a few times; having body aches; Rash; This is a spontaneous report from a contactable consumer (patient husband). A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number and Expiration date: Unknown), via an unspecified route of administration in left arm on 18Mar2021 (at the age of 61-year-old) as a single dose for COVID-19 immunization at hospital. Medical history included patient got crushed up in a car wreck and lost 53% of her pancreas and had a bad heart valve. Concomitant medications were reported as none. Patient did not receive any other vaccines on the same day as the COVID shot. On 18Mar2021, after her first dose of Covid shot, she was up all night last night because she was so sick with fluids in her lungs, and she was gurgling and trying to cough it up and she stated that she was going to get better, but she was still in bed today. Reporter stated that his wife had fluid in her lungs and stuff, that maybe her heart couldn't push it out and did not get out of bed yesterday to sit on the couch and see the grandkids, but she wanted to be in bed. She was ok but had terrible side effects she was very sick and got bad stuffs, she was bedridden and got helped to her do everything. She had thrown up a few times and was just really sick and also experienced rash on an unspecified date in 2021. He stated that he hopes his wife does not have any permanent damage from this, as she just had a lot of things already, his wife was sick and disabled, having body aches, and is not planning on getting the second dose and he stated his wife does think that she will get well again. Patient did not receive any treatment for the events. The outcome of the events was unknown.  Information on the lot/batch number has been requested.