chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Irritability
Clinical narrative: Dizzy; cranky and irritable; This is a spontaneous report from a contactable consumer (parent). A 38-year-old male patient received first dose of bnt162b2 (Batch/Lot number was not reported) via an unspecified route of administration, administered in arm right on an unspecified date as single dose for COVID-19 immunisation. Medical history included diabetes, depression (mental illness), smoker, alcohol, from an unknown date, unknown if alcohol is ongoing. Concomitant medication(s) included metformin taken for diabetes mellitus, start and stop date were not reported. The patient is going to be 39 in two week and he is not normal boy at all and the fact that he wanted the reporter to take him to go get the shot last time and shot this time just blew the reporter away because usually he is like leave me alone. I will do it myself type stuff. He has mild limited health issues but last time they went they didn't stay after the shot. He got dizzy real dizzy, dizzy in the sense the reporter almost took him to the hospital and they had probably been a block or 2 of it, and he said now I am really fine. The another problem to know about that ,he was cranky and irritable after the first shot . He also a smoker, alcohol, the reporter was comfortable with his drinking the reporter doesn't know if he is doing that anymore. But he is smoker and he is a diabetic. He is on Metformin. About the lab test, reporter stated, "Not that I am aware of. May be a couple of weeks ago he had some blood work done for HIV but I am not sure." The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: a small bruise; This is a spontaneous report received from a contactable consumer (patient). A 79-year-old female patient received bnt162b2  (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  Medical history included a little bit asthma, pine allergy, oak allergy, food allergy, 'blood pressure', stroke. Concomitant medications included losartan taken for blood pressure; hydrochlorothiazide taken for blood pressure; omeprazole; fluticasone taken for allergy; acetylsalicylic acid (BABY ASPIRIN); vitamins.  The first shot she had, she ended up with a small bruise about the size of a quarter but she did not have any bruise with the second shot.  The outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: about 3 inches below site she had a rash/rash was about 3 inches below the injection site; below site she had a rash, It was still red; below site she had a rash, swollen, little bit of swelling; below site she had a rash, it was still little sore to touch; below site she had a rash, itchy; Second day I was still tired; had no appetite; Extreme tiredness; chilling; Small fever of 100.5; dull headache; Slept for about 12 hours; This is a spontaneous report received from a contactable consumer (patient). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Left on 28Mar2021 at age of 79-year-old (Lot Number: EN6208) at single dose for COVID-19 immunization. Medical history included a little bit asthma, pine allergy, oak allergy, food allergy, 'blood pressure', stroke. Concomitant medications included losartan taken for blood pressure; hydrochlorothiazide taken for blood pressure; omeprazole; fluticasone taken for allergy; acetylsalicylic acid (BABY ASPIRIN); vitamins. The first shot she had, she ended up with a small bruise about the size of a quarter but she did not have any bruise with the second shot. The patient just wanted to report the side effects from the second Pfizer COVID-19 vaccination. She received the second one in the afternoon on 28Mar2021. And on 29Mar2021, just a little less than 24 hours later, it was at about 13:30, she got hit with extreme tiredness and she got in the recliner and got a little blanket and then she started chilling. She did not have the shakes but she couldn't get warm. She ran a small fever of 100.5 and this was for about 4 hours. And she had a dull headache. She slept for about 12 hours out of 16 that day on 29Mar2021. And then, the second day on 30Mar2021 she was still tired and had no appetite and the third day on 31Mar2021 about 3 inches below site she had a rash, swollen and itchy and 01Apr2021 was the fourth day, but it was still sore. The swelling was way down but the rash was still there and it is still itchy. She did take paracetamol (TYLENOL) that first day for the headache and chills. The paracetamol she took was two of them and they were 8 hour arthritic dosage. When paraphrased the concern, the patient stated the rash was about 3 inches below the injection site. It was still red, little sore to the touch, most of swelling down and there was little bit of swelling and red and it had gone down on 01Apr2021. Treatment for events included paracetamol and she had laid down and slept. The outcome of rash, swollen, sore below the injection site were resolving, the red and itchy below injection site was not resolved, the outcome of other events were unknown.   No follow-up attempts are needed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: about 3 inches below site she had a rash/rash was about 3 inches below the injection site; below site she had a rash, It was still red; below site she had a rash, swollen, little bit of swelling; below site she had a rash, it was still little sore to touch; below site she had a rash, itchy; Second day I was still tired; had no appetite; Extreme tiredness; chilling; Small fever of 100.5; dull headache; Slept for about 12 hours; This is a spontaneous report received from a contactable consumer (patient). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Left on 28Mar2021 at age of 79-year-old (Lot Number: EN6208) at single dose for COVID-19 immunization. Medical history included a little bit asthma, pine allergy, oak allergy, food allergy, 'blood pressure', stroke. Concomitant medications included losartan taken for blood pressure; hydrochlorothiazide taken for blood pressure; omeprazole; fluticasone taken for allergy; acetylsalicylic acid (BABY ASPIRIN); vitamins. The first shot she had, she ended up with a small bruise about the size of a quarter but she did not have any bruise with the second shot. The patient just wanted to report the side effects from the second Pfizer COVID-19 vaccination. She received the second one in the afternoon on 28Mar2021. And on 29Mar2021, just a little less than 24 hours later, it was at about 13:30, she got hit with extreme tiredness and she got in the recliner and got a little blanket and then she started chilling. She did not have the shakes but she couldn't get warm. She ran a small fever of 100.5 and this was for about 4 hours. And she had a dull headache. She slept for about 12 hours out of 16 that day on 29Mar2021. And then, the second day on 30Mar2021 she was still tired and had no appetite and the third day on 31Mar2021 about 3 inches below site she had a rash, swollen and itchy and 01Apr2021 was the fourth day, but it was still sore. The swelling was way down but the rash was still there and it is still itchy. She did take paracetamol (TYLENOL) that first day for the headache and chills. The paracetamol she took was two of them and they were 8 hour arthritic dosage. When paraphrased the concern, the patient stated the rash was about 3 inches below the injection site. It was still red, little sore to the touch, most of swelling down and there was little bit of swelling and red and it had gone down on 01Apr2021. Treatment for events included paracetamol and she had laid down and slept. The outcome of rash, swollen, sore below the injection site were resolving, the red and itchy below injection site was not resolved, the outcome of other events were unknown.   No follow-up attempts are needed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling
Clinical narrative: about 3 inches below site she had a rash/rash was about 3 inches below the injection site; below site she had a rash, It was still red; below site she had a rash, swollen, little bit of swelling; below site she had a rash, it was still little sore to touch; below site she had a rash, itchy; Second day I was still tired; had no appetite; Extreme tiredness; chilling; Small fever of 100.5; dull headache; Slept for about 12 hours; This is a spontaneous report received from a contactable consumer (patient). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Left on 28Mar2021 at age of 79-year-old (Lot Number: EN6208) at single dose for COVID-19 immunization. Medical history included a little bit asthma, pine allergy, oak allergy, food allergy, 'blood pressure', stroke. Concomitant medications included losartan taken for blood pressure; hydrochlorothiazide taken for blood pressure; omeprazole; fluticasone taken for allergy; acetylsalicylic acid (BABY ASPIRIN); vitamins. The first shot she had, she ended up with a small bruise about the size of a quarter but she did not have any bruise with the second shot. The patient just wanted to report the side effects from the second Pfizer COVID-19 vaccination. She received the second one in the afternoon on 28Mar2021. And on 29Mar2021, just a little less than 24 hours later, it was at about 13:30, she got hit with extreme tiredness and she got in the recliner and got a little blanket and then she started chilling. She did not have the shakes but she couldn't get warm. She ran a small fever of 100.5 and this was for about 4 hours. And she had a dull headache. She slept for about 12 hours out of 16 that day on 29Mar2021. And then, the second day on 30Mar2021 she was still tired and had no appetite and the third day on 31Mar2021 about 3 inches below site she had a rash, swollen and itchy and 01Apr2021 was the fourth day, but it was still sore. The swelling was way down but the rash was still there and it is still itchy. She did take paracetamol (TYLENOL) that first day for the headache and chills. The paracetamol she took was two of them and they were 8 hour arthritic dosage. When paraphrased the concern, the patient stated the rash was about 3 inches below the injection site. It was still red, little sore to the touch, most of swelling down and there was little bit of swelling and red and it had gone down on 01Apr2021. Treatment for events included paracetamol and she had laid down and slept. The outcome of rash, swollen, sore below the injection site were resolving, the red and itchy below injection site was not resolved, the outcome of other events were unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: She (Patient) got Covid in the mean time; She (Patient) got Covid in the mean time; This is a spontaneous report from a contactable consumer (Husband). A female patient (Wife) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 14Mar2021 (Batch/Lot Number: EN6199) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient received the first shot of Pfizer BioNTech Covid-19 vaccine on 14Mar2021 and she scheduled for the 2nd dose on 14Apr2021. But she got Covid in the mean time. The outcome was recovering.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: 1st dose last 17th of March and was tested positive on the 26th of March; This is a spontaneous report received from Pfizer-sponsored program. A contactable consumer reported that an unspecified aged male patient (reporter's husband) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 17Mar2021 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Reporter stated that patient (her husband) was scheduled on the 07Apr2021 for the 2nd dose. He had his 1st dose last 17Mar2021 and patient was tested positive on the 26Mar2021. Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral artery occlusion, SARS-CoV-2 test
Clinical narrative: Pt suffered right Posterior cerebral artery occlusion; This is a spontaneous report from a contactable physician (reporting for a patient). A 56-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 30Mar2021 12:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, at 56 years old. Medical history included hyperlipidaemia and hypertension from an unknown date and ongoing, both well controlled. Concomitant medications included atorvastatin and hydrochlorothiazide taken for an unspecified indication, start and stop date were not reported. The patient previously took the first dose of bnt162b2 for covid-19 immunisation on 09Mar2021 1200 (intramuscular left arm) and terfenadine and experienced allergies. The patient suffered right posterior cerebral artery occlusion (hospitalization, life threatening) on 01Apr2021 treated with mechanical thrombectomy with stent placement. Event required emergency room visit.  The patient was hospitalized for suffered right posterior cerebral artery occlusion for 4 days on Apr2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 07Apr2021. Outcome of the event was recovered on Apr2021 with sequelae (Recovered with lasting effects).  Information about Lot/batch number is requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Posterior cerebral artery occlusion cannot be excluded.  However, the medical history of hyperlipidaemia and hypertension may provide plausible alternative explanations for the events.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable consumer reporting for self. This patient with unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Mar2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient already got the first dose of Pfizer vaccine but afterwards tested positive for COVID on unspecified date. Patient had second dose scheduled in about one and a half week on 11Apr2021, and wanted to know if still should get second dose. The outcome of event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: Had 1st dose of covid vaccine March 23. Later had tested positive for covid virus; Had 1st dose of covid vaccine March 23. Later had tested positive for covid virus; This is a spontaneous report via Pfizer-sponsored program  from contactable consumer (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 23Mar2021 at single dose for Covid-19 immunization. Medical history and Concomitant medications were not reported. It was reported as patient had 1st dose of covid vaccine March 23. Later had tested positive for covid virus in 2021. supposed to get 2nd dose of vaccine on April 23. wanted to know if she was able to get 2nd dose in April. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Asthenia, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Rapid COVID test was positive/Next day long test came back negative and was quickly moved out of the COVID-19 unit; Hemoglobin Anemia; difficulty breathing; fast heartbeat; dizziness; weakness; tiredness; over all feeling of unwell.; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 19Mar2021 10:00 (Lot Number: EN6198) as SINGLE DOSE for COVID-19 immunization. Medical history included lower left lung lobectomy in Mar2019 and cancer in May-Jul2019 treated with chemotherapy 4x. The patient previously had first dose of BNT162B2 in the left arm on 26Feb2021 10:00, lot number: EN5318 for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 20Mar2021 06:00, 1 day later had side effects of tiredness and over all feeling of unwell. On 22Mar2021, 3 days later, the patient had additional side effects of difficulty breathing, fast heartbeat,dizziness and weakness. On the 6th day, the patient went to ER 26Mar2021, the patient was admitted to the hospital. Rapid COVID-19 test was positive and sent to COVID-19 unit. Next day long test came back negative and was quickly moved out of the COVID-19 unit. The patient was diagnosed with hemoglobin anemia. Over all, hemoglobin dropped from normal base line of 14 to 6.1. The patient was given 2 units of blood, was given a shot of prednisone and then put on 60 mg of prednisone daily. Release from hospital after 6 days with hemoglobin of 9.9. Still being followed by doctor and follow up blood work. Continuing 60mg of prednisone daily until hemoglobin reaches normal range. If prednisone does not work, next step is an infusion of Rituxan. The patient underwent lab tests and procedures which included haemoglobin: 9.9 on unspecified date, haemoglobin: dropped from normal base line of 14 to 6.1 on 27Mar2021, long test: negative   on 27Mar2021 and Nasal swab/Rapid test: positive on 26Mar2021. All events were reported as life threatening. The outcome of the events was recovered with lasting effect
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoglobin, Heart rate increased, Malaise, SARS-CoV-2 test, SARS-CoV-2 test false positive
Clinical narrative: Rapid COVID test was positive/Next day long test came back negative and was quickly moved out of the COVID-19 unit; Hemoglobin Anemia; difficulty breathing; fast heartbeat; dizziness; weakness; tiredness; over all feeling of unwell.; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 19Mar2021 10:00 (Lot Number: EN6198) as SINGLE DOSE for COVID-19 immunization. Medical history included lower left lung lobectomy in Mar2019 and cancer in May-Jul2019 treated with chemotherapy 4x. The patient previously had first dose of BNT162B2 in the left arm on 26Feb2021 10:00, lot number: EN5318 for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 20Mar2021 06:00, 1 day later had side effects of tiredness and over all feeling of unwell. On 22Mar2021, 3 days later, the patient had additional side effects of difficulty breathing, fast heartbeat,dizziness and weakness. On the 6th day, the patient went to ER 26Mar2021, the patient was admitted to the hospital. Rapid COVID-19 test was positive and sent to COVID-19 unit. Next day long test came back negative and was quickly moved out of the COVID-19 unit. The patient was diagnosed with hemoglobin anemia. Over all, hemoglobin dropped from normal base line of 14 to 6.1. The patient was given 2 units of blood, was given a shot of prednisone and then put on 60 mg of prednisone daily. Release from hospital after 6 days with hemoglobin of 9.9. Still being followed by doctor and follow up blood work. Continuing 60mg of prednisone daily until hemoglobin reaches normal range. If prednisone does not work, next step is an infusion of Rituxan. The patient underwent lab tests and procedures which included haemoglobin: 9.9 on unspecified date, haemoglobin: dropped from normal base line of 14 to 6.1 on 27Mar2021, long test: negative   on 27Mar2021 and Nasal swab/Rapid test: positive on 26Mar2021. All events were reported as life threatening. The outcome of the events was recovered with lasting effect
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: My husband tested positive; My husband tested positive; This is a spontaneous report received from a Pfizer sponsored program. This consumer reported for her husband (patient) that:  A male patient of unknown age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 06Mar2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 for Covid-19 Immunisation. Reporters husband tested positive on 01Apr2021 at Hospital after testing negative the day before at another Hospital. He had his second vaccine shot on 06Mar2021. On 01Apr2021, the patient was tested positive at Hospital, after testing negative the day before (31Mar2021) at Hospital. Outcome of the events was unknown.  Information about batch no/lot no has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she had a PCR test before taking the 2nd dose vaccine and she got a result this morning after she took the 2nd dose vaccine and she is positive in covid 19; she is positive in covid-19; This is a Spontaneous report from a contactable consumer (Patient herself) via Pfizer program. A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: Not reported, Expiry date: Not reported) via an unspecified route of administration 04Apr2021 at SINGLE DOSE for COVID-19 Immunization. The patients medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: Not reported, Expiry date: Not reported) via an unspecified route of administration 10Mar2021 at SINGLE DOSE for COVID-19 Immunization. The patient got the 1st dose 10Mar2021 and got the 2nd dose on 04Apr2021. She had a PCR test before taking the 2nd dose vaccine and she got a result this morning after she took the 2nd dose vaccine and she is positive in covid 19. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: after 2 weeks got COVID; got positive after the first dose; after 2 weeks got COVID; got positive after the first dose; This is a spontaneous report from a contactable consumer or other non-health care professional via Pfizer Sponsored Program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number/ Batch number: not reported) via an unspecified route of administration on 03Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 16Mar2021, after 2 weeks, the patient got COVID; got positive after the first dose and was hospitalized. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 16Mar2021. Patient had to do the second shot of Pfizer vaccine on 09Apr2021. Patient wanted to know if it was safe to go on have a shot. Outcome of the events was unknown.  Information about batch/lot no has been requested.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: Right ear Hearing loss; more tinitas in ear; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 58-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Mar2021 at 12:15 PM (Lot number: er8734) on the left arm as single dose for COVID-19 immunization. Medical history was not provided. There were no allergies to medications, food, or other products. Patient had unspecified concomitant medication(s). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 03:00 AM, the patient experienced right ear hearing loss, and more tinitas in ear, happened 4 days after injection; events also resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events including took Sudafed for 5 days. The outcome of events was not recovered.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 26Mar2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose on 26Mar2021 then she was tested positive for COVID-19 last Tuesday (30Mar2021). The patient wanted to know if she can get the second dose of vaccine on 16Apr2021. The outcome of the event was unknown.  Follow-up attempts are completed; information about batch number cannot be obtained. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Loss of consciousness, Pulse pressure decreased, Shock, Unresponsive to stimuli
Clinical narrative: Shock; Reduced Central pulse volume; Loss of consciousness; potential anaphylactic reaction; found unresponsive in a swimming pool; This is a spontaneous report received from a contactable Physician. An 81-year old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included cardiac arrest, congestive heart failure, difficult breathing and arrhythmia. Concomitant medications included metoprolol; omeprazole; propranolol; duloxetine; fosinopril; pravastatin; hydrochlorothiazide, triamterene (TRIAMTERENE HCTZ); levothyroxine sodium (SYNTHROID); insulin glargine (BASAGLAR); asa and ranitidine hydrochloride (ZANTAC). The patient previously minocycline for swelling and the patient had a historical vaccine of shingrix on 11May2020. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Jan2021 for covid-19 immunisation. The reporter stated that the patient was found unresponsive in a swimming pool on 18Feb2021. The patient also experienced shock, reduced central pulse volume and loss of consciousness and potential anaphylactic reaction on an unspecified date. The patient did not received any recent vaccines for SARS-CoV2 other than Pfizer_BioNtech COVID-19 Vaccine prior to the event being reported. The patient died on 22Feb2021. It was not reported if an autopsy was performed. Outcome of the events was fatal.  Information on Lot/Batch number has been requested.; Sender's Comments: Based on temporal association, a contributory role of BNT162B2 to the reported events 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.; Reported Cause(s) of Death: found unresponsive in a swimming pool; Shock; Reduced Central pulse volume; Loss of consciousness; potential anaphylactic reaction
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got positive after the first dose/COVID positive; got positive after the first dose/COVID positive; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer. The consumer reported similar events for two patients, this is the second (consumer's wife) of two reports.   A female patient (consumer's wife) with unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Mar2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient (consumer's wife) got tested and got positive after the first dose on unspecified date, and they were asking if before getting the second dose of the vaccine do they need to or test negative until they do reschedule it. Lab data included COVID positive on unspecified date. The outcome of event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021386457 Same reporter/drug/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Caller was tested Covid19 Positive; This is a spontaneous report from Pfizer Sponsored Patient Support Program COVAX US Support report from a contactable consumer (Patient). A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported),  via an unspecified route of administration on 25Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  on 05Apr2021, The patient experienced caller was tested covid19 positive (covid-19). The patient underwent lab tests and procedures which included sars-cov-2 test: positive on. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive after 1st dose; positive after 1st dose; This is a spontaneous report from Pfizer-sponsored program by a contactable Consumer (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for Covid-19 immunisation. The patient medical history and concomitant medication were not reported. It was reported that patient tested positive after 1st dose of covid vaccine. The patient wanted to know about getting second dose. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report from a Pfizer sponsored programme, from a non-contactable consumer (patient, self-reported). A female patient of an unspecified age, received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not reported), via an unspecified route of administration, on an unspecified date, as single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, as single dose for COVID-19 immunization. It was reported that patient had both doses and tested positive for COVID in SARS-CoV-2 test. Patient asked that would like to know if she can get the vaccine again. Outcome of the event was unknown.  Additional information has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the vaccine BNT162B2 cannot be completely excluded. However, information provided is limited and does not allow for a complete medical assessment. Case will be  reassessed if additional information is received
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: patient is experiencing a shingles rash; This is a spontaneous report from a contactable pharmacist. A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration on an unspecified as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that patient had gotten the Moderna vaccine. On an unspecified date, patient experienced shingles rash. Reporter wanted to know if the patient can get the second dose on 08April. Outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour
Clinical narrative: displaying odd behavior; had a due second dose last March 19, he didn't want to take it and so he missed the dose; This is a spontaneous report received from a . A contactable consumer (patient's mother) reported for a 48-year-old male patient received first dose of BNT162B2 (Pfizer COVID-19 Vaccine, Formulation: solution for injection, Batch/Lot number: unknown), via unspecified route of administration on 17Feb2021 as single dose for COVID-19 immunization. Patient's medical history included head injury, road accident (had a head injury because of a car accident years ago). The patient concomitant medications were not reported. Reporter stated patient had a due second dose last 19Mar2021 and he did not want to take it and so he missed the dose. After a week of receiving the vaccine, he is displaying odd behavior and he was admitted in a psychiatric hospital on 27Mar2021. Reporter asked is there a 42 day window after receiving the first shot to get the second shot. The outcome of event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Patient has reported having COVID-19; Patient has reported having COVID-19; This is a spontaneous report from a non-contactable physician via Pfizer sales representative. A 3-decade-old female patient (in her 20s) received second dose bnt162b2 (BNT162B2, Solution for injection, Lot number and expiration date was not provided), via an unspecified route of administration on 05Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included received first dose of BNT162B2 via unspecified route of administration on an unspecified date for Covid-19 Immunisation. Patient received 2 doses of Pfizer COVID vaccine with final dose occurring on 5Feb2021. Patient has reported having COVID-19 as of 4/5. Event took place after use of product on 05Apr2021. The patient underwent lab tests and procedures which included covid-19: positive on 05Apr2021. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and Covid-19 cannot be totally excluded.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Pulmonary embolism numerous in both lung happened  with 48 of second dose; second dose was administered on 15Mar2021; first dose was administered on 01Mar2021; second dose was administered on 15Mar2021; first dose was administered on 01Mar2021; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided) via an unspecified route of administration on 15Mar2021 as a single dose for COVID-19 immunisation. Medical history included Lupus, glaucoma, hypertension, irritable bowel syndrome (IBS), fibro and allergies to Gluten. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient has not had any vaccine in four weeks but took other medications in two weeks (unspecified). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Mar2021 13:15 for COVID-19 immunization. On 17Mar2021 20:00, the patient experienced Pulmonary embolism numerous in both lung happened with 48 of second dose. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (Prolongation of existing hospitalization) as the vaccine was received during existing hospitalization, Life threatening illness (immediate risk of death from the event). Treatment was given in response to the event which included bed rest and pain medications. The patient underwent COVID test post vaccination via nasal swab on 24Mar2021 and was negative. The outcome of the event pulmonary embolism was recovering.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I broke out in a rash; it's very sore; This is spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162b2 (PFIZER-COVID-19 VACCINE), via an unspecified route of administration on 23Mar2021 (Lot Number: ER2613) as single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had Covid Pfizer shot on 23rd of March and about the 27Mar2021 the patient broke out in a rash and patient just wanted to know what can be done to relieve it. Patient thought maybe it was patient's medications (unspecified medication) so called pharmacist and she said no sometime people have rash associated with it because before patient had the Pfizer patient's medicine was fine, Ionly take 2. Patient didn't had no problems when had it. First of all would like to know if people who got this that happened to them and then wanted to know what can be done to relieve it because it's very sore. Event outcome was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Antinuclear antibody, Bursitis, Peripheral swelling, Rheumatoid arthritis
Clinical narrative: thumb swelled; This is spontaneous report received from contactable consumer  A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9262) via an unspecified route of administration on left arm on 22Jan2021 at single dose for Prevention of COVID-19 pandemic. The patient medical history included kidney problems. The patient concomitant medications were not reported. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9266), via an unspecified route of administration on left arm on 12Feb2021 at single dose for Prevention of COVID-19 pandemic. On an unspecified date, thumbs swelled after he received his first COVID-19 Vaccine. The next week, patient had swelling in both of his hands. The following week, patient hand swelling got worse, and had pain with the hand swelling. The third week, the patient went to a doctor at a place where he could get an appointment the same day and then went to his primary care doctor. The patient continued to have hand swelling, and then he was taken to the Emergency Room. The events resulted in Emergency Room visit. The patient had to go to a Rheumatoid Arthritis specialist and then this morning patient woke up, and half of his face was swollen. The patient hands swelled after his second COVID-19 Vaccine, it progressed from a little bit of swelling to lot of swelling. The Pain of the hands on the scale of 1 to 10 is reported as 3 or 4. The relevant lab test included doctor did tests on patient for Rheumatoid Arthritis and Bursitis, and both tests were negative. The Emergency Room doctor did an ANA test that was inconclusive, and an ESR test that was negative. The patient's primary care doctor gave him more lab tests, and did another Rheumatoid Arthritis test, which was negative. The treatment included Prednisone and his hand swelling went down for 3-4 days. when patient stopped the Prednisone, the swelling in his hands came back. The patient primary care doctor provided the patient with Rheumatoid Arthritis medicine to take, but patient stopped taking the medicine after 2 days. The patient received the Colchicine twice because he was been told not to take it anymore. So, they repeated that (Colchicine) if it was arthritis then it would help and it would go down but it did not and they told him to stop taking it. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.  Follow up (02Apr2021):Upon follow up, new information included anatomical location details, lot details,treatment details like colchicine.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: contracted covid; This is a spontaneous report from a contactable consumer (patient's husband) via Pfizer-sponsored program . A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unspecified route on 18Mar2021 at single dose for covid-19 immunisation. Reporter and patient both received first dose of the Pfizer covid vaccine on 18Mar2021 and both contracted covid, reporter tested positive on 25Mar2021 and patient on 26Mar2021 (2 days later). Both were due for her second vaccine tomorrow and reporter wanted to know if they can take it. The case was reported as non-serious. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on Bilateral hands and feet; This is a spontaneous report from a contactable physician (reporter) reported for a 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Not available) via an unspecified route of administration on an unspecified date at single dose for COVID-19 Immunization. Patient medical history was none, and concomitant medication were Unknown. On 10Jan2021, patient experienced rash. On 24Jan2021, patient visited the emergency room for Rash on Bilateral hands and feet and received treatment as Podiatry meds. The reporter assessed the event as serious (important medical event), and outcome for the event was recovering at the time of report.  No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event rash on bilateral hands and feet and the usage of the vaccine BNT162B2 cannot be completely excluded. The case will be reassessed once new information is available.  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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest, Hypoxia
Clinical narrative: Hypoxia; cardiac arrest; This is a spontaneous report from a contactable physician. A 67-year-old female patient received the second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207), via intramuscular route of administration on 03Apr2021 at 15:15 (at the age of 67 years) at a single dose in the left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Mar2021 (at the age of 67 years) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. On 05Apr2021, the patient experienced hypoxia and subsequent cardiac arrest. The events resulted in Emergency room/department or urgent care and hospitalization. The events were considered life threatening. Therapeutic measures were taken as a result of the events which included CPR and intubation.  It was unknown if patient has been tested for COVID-19. The outcome of the events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events hypoxia and cardiac arrest cannot be excluded.  The case will be reassessed if additional information becomes available.  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.