chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram
Clinical narrative: weak in her knees; fluttering in chest; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Mar2021 as SINGLE DOSE for covid-19 immunisation.  Medical history included blood pressure high, diabetes, CKD 3, high cholesterol and aortic stenosis. The patient's concomitant medications were not reported. On 11Mar2021, the patient took the vaccine and she waited the 15 minutes and was fine but on her ride home, she and her husband both got the shots, she got a fluttering in chest, it is a 30 minute drive home. It went away. Monday the patient kind of felt it again, she got it so bad she got weak in her knees (occurred on an unspecified date) but it cleared up so she didn't got to the emergency room. They did an EKG on her at her primary care provider and it was normal. Saturday night the fluttering in the patient's chest happened again but was worse. At about 4:45pm the patient's husband carried her into the emergency room and they gave her an IV drip, put her on the machine and they didn't see anything. The patient is scheduled for her second dose on 01Apr2021. The patient underwent lab tests and procedures which included cholesterol: high, blood pressure: high, echo: aortic stenosis and EKG: normal on an unspecified date. Therapeutic measures were taken as a result of fluttering in chest included IVdrip. Outcome of the events was unknown.   Information about the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aortic stenosis, Cardiac function test, Chronic kidney disease, Heart valve incompetence
Clinical narrative: weak in her knees; fluttering in chest; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Mar2021 as SINGLE DOSE for covid-19 immunisation.  Medical history included blood pressure high, diabetes, CKD 3, high cholesterol and aortic stenosis. The patient's concomitant medications were not reported. On 11Mar2021, the patient took the vaccine and she waited the 15 minutes and was fine but on her ride home, she and her husband both got the shots, she got a fluttering in chest, it is a 30 minute drive home. It went away. Monday the patient kind of felt it again, she got it so bad she got weak in her knees (occurred on an unspecified date) but it cleared up so she didn't got to the emergency room. They did an EKG on her at her primary care provider and it was normal. Saturday night the fluttering in the patient's chest happened again but was worse. At about 4:45pm the patient's husband carried her into the emergency room and they gave her an IV drip, put her on the machine and they didn't see anything. The patient is scheduled for her second dose on 01Apr2021. The patient underwent lab tests and procedures which included cholesterol: high, blood pressure: high, echo: aortic stenosis and EKG: normal on an unspecified date. Therapeutic measures were taken as a result of fluttering in chest included IVdrip. Outcome of the events was unknown.   Information about the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Blood pressure measurement, Electrocardiogram, Hypoaesthesia
Clinical narrative: no strength in left arm; she had a Big red spot at the site; brain was not functioning; tingling in the tongue; numbness in the both hands; BP it was 164; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 67, no unit) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Mar2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that she was fine for 10 minutes after the first dose then she noticed her brain was not functioning, tingling in the tongue, numbness in the both hands, the nurse checked her BP it was 164, they took her to emergency, put her on oxygen, on monitor, had EKG done, and observed her for 1 hour. She was released after that. For 3 days she was out of it, had no strength in left arm and then she had a big red spot at the site. The patient stated a lot of the strength has came back came now. The outcome of no strength in left arm was recovering while unknown for the rest of the events.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Mental impairment, Paraesthesia oral, Vaccination site erythema
Clinical narrative: no strength in left arm; she had a Big red spot at the site; brain was not functioning; tingling in the tongue; numbness in the both hands; BP it was 164; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 67, no unit) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Mar2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that she was fine for 10 minutes after the first dose then she noticed her brain was not functioning, tingling in the tongue, numbness in the both hands, the nurse checked her BP it was 164, they took her to emergency, put her on oxygen, on monitor, had EKG done, and observed her for 1 hour. She was released after that. For 3 days she was out of it, had no strength in left arm and then she had a big red spot at the site. The patient stated a lot of the strength has came back came now. The outcome of no strength in left arm was recovering while unknown for the rest of the events.   Information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: Hearing loss in left ear for three days.; Ringing in both ears.; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 13Mar2021 18:00 (lot number: En6199) as single dose (at the age of 65-years-old) for COVID-19 immunisation. Medical history included atrial fibrillation (Afib) and shrimp allergy. Concomitant medication included diltiazem hydrochloride (DILTIAZEM [DILTIAZEM HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported; and multiple vitamins (unspecified). No other vaccine was given in fours weeks. The patient did not have COVID prior vaccination. On 17Mar2021 at 08:00, the patient experienced ringing in both ears, hearing loss in left ear for three days. The patient was concerned about taking second shot on 03Apr2021. No treatment was received for the events. The patient was not tested for COVID post vaccination. The patient has not recovered from the events.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Thrombophlebitis superficial
Clinical narrative: Right Femoral DVT; Superficial Great Saphenous Vein Symptoms; This is a spontaneous report from a contactable physician. A 71-year-old male patient received bnt162b2 (Pfizer COVID 19 vaccine), dose 2 intramuscular on 10Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history was not reported. The patient previously received sulfasalazine and experienced allergies. Received 1st dose of bnt162b2 (Pfizer COVID 19 vaccine) intramuscular on 12Feb2021 for COVID-19 immunisation. There were no concomitant medications. The patient experienced right femoral DVT (deep vein thrombosis) and superficial great saphenous vein symptoms on 14Mar2021, 4 days after #2 vaccination, with outcome of not recovered. Therapeutic measure taken as a result of events: Xarelto. Events resulted in doctor or other healthcare professional office/clinic visit. The patient was not diagnosed of COVID prior vaccination and has not been tested for COVID post vaccination.  Information on the lot/ batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on 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.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Influenza like illness, Polymyalgia rheumatica, Pyrexia, SARS-CoV-2 test
Clinical narrative: 2nd dose fever and flu like symptoms after midnight12 hours after shotsubsequently developed polymyalgia rheumatica; 2nd dose fever and flu like symptoms after midnight12 hours after shotsubsequently developed polymyalgia rheumatica; 2nd dose fever and flu like symptoms after midnight12 hours after shotsubsequently developed polymyalgia rheumatica; This is a spontaneous report from a contactable consumer (patient). A elderly male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: el8982), via an unspecified route of administration, administered in Arm Left on 21Jan2021 13:45 as single dose for COVID-19 immunization. Medical history included autoimmune illnesses, allergy to contrast, sulfa, and rose. The patient's concomitant medications were not reported.  The patient previously took azithromycin but experienced drug allergy, first dose of bnt162b2 for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered was Public Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After the 2nd dose, the patient experienced fever and flu like symptoms (03:00) after midnight 12 hours after shot subsequently developed polymyalgia rheumatica on 12Feb2021. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event was methylprednisolone. Since the vaccination, the patient has been tested for COVID-19 (unknown date, result). The patient underwent lab tests and procedures which included blood test: positive on 01Mar2021, COVID-19 test: unknown on an unspecified date. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter
Clinical narrative: heart fluttering; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients (herself and her husband). This is the 2nd of 2 reports (husband).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that after receiving the vaccines on 11Mar2021, on the drive home after the 15-minute waiting period the patient developed heart fluttering. The outcome of event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021314332 same reporter, product and event, different patient
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatic enzyme, Hepatic enzyme increased, Jaundice
Clinical narrative: Developed severe Jaundice with elevated liver enzymes and required hospital admission.; Developed severe Jaundice with elevated liver enzymes and required hospital admission.; This is a spontaneous report from a contactable Other HCP (patient). A 26-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6201), second dose via an unspecified route of administration, administered in Arm Left on 10Feb2021 12:00 (at the age of 25 -years-old), single dose for covid-19 immunisation. Medical history included Migraine headaches from an unknown date. The patient's concomitant medications were not reported.  The patient had the fist dose of BNT162B2 vaccine on 20Jan2021 (at the age of 25 -years-old) for COVID-19 immunisation. Lot number=EL9261,on right arm. On 10Mar2021, patient developed severe Jaundice with elevated liver enzymes and required hospital admission. Patient required three days of hospitalization. Ae treatment were IVF, Hepatic biopsy, CT imaging, MRCP, U/S. The events outcome was not recovered. No covid prior vaccination. Not covid tested post vaccination.; 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 Jaundice with elevated liver enzymes 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.
Sex: U
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: severe sudden onset hearing loss/ another person who is experiencing the same; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports.      A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient experienced severe sudden onset hearing loss/ another person who is experiencing the same. The event was assessed as serious (medically significant). The outcome of the event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021314158 same reporter/similar AE/drug and different patient.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Optic ischaemic neuropathy
Clinical narrative: non-arteritic anterior ischemic optic neuropathy; This is a spontaneous report from a contactable physician. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose intramuscular, administered in the left arm on 27Feb2021 11:00 (lot number was not reported) at a single dose for COVID-19 immunisation, vaccinated in a hospital. Medical history included sinus inverted papilloma, hypercholesterolemia, gastrooesophageal reflux disease (GERD), coronary artery disease (CAD), and benign prostatic hyperplasia (BPH). Concomitant medication included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); azelastine hydrochloride (ASTELIN [AZELASTINE HYDROCHLORIDE]); colecalciferol (VITAMIN D [COLECALCIFEROL]); fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]); metoprolol taken; naproxen; omeprazole (PROTONIX [OMEPRAZOLE]); ranitidine; rosuvastatin calcium (CRESTOR); solifenacin (SOLIFENACIN); all 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 06Feb2021 at 11:00 intramuscularly on the left arm (lot number not reported); and has known allergies with tamsulosin. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. On 01Mar2021, the patient experienced non-arteritic anterior ischemic optic neuropathy. The event resulted in a physician visit, emergency room/urgent care, hospitalization and disability or permanent damage. The patient was hospitalized for four days. The patient was not COVID tested post vaccination. The patient received a steroid as treatment. The patient was recovering from the event.   Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event 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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdomen scan, Angiogram, Back pain, Blood pressure measurement, Blood test
Clinical narrative: Couldn't breathe/shortness of breath; Back pain; blood pressure was high; was just sick; This is a spontaneous report from a contactable consumer. A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 08Mar2021 (at the age of 77-years-old) (Batch/Lot Number: EN6199; Expiration Date: 30Jun2021) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing blood pressure abnormal, cancer in her left lung, ongoing blood cholesterol abnormal, ongoing gastric disorder, ongoing diverticulitis Verbatim: Virticulitis. Concomitant medication included acetylsalicylic acid (ASPIRIN 81) taken for blood pressure abnormal; atorvastatin (ATORVASTATIN) taken for blood cholesterol; hydralazine taken for blood pressure abnormal; lisinopril (LISINOPRIL) taken for blood pressure abnormal from Feb2021 and ongoing; pantoprazole taken for gastric disorder from 2020 and ongoing. The patient had her first shot and after that, a week after she experienced some adverse events like back pain and sickness. After the patient started experiencing back pain, and got progressively worse, she was having problem breathing/Shortness of breath was reported. The patient was ambulanced and mentioned she was brought to the hospital/stayed with her doctors overnight due to the experiences she had. She had blood work done and based on the results, they suspected a blood clot on her lung and her CT scan did show that she did not have a clot in her lung. It was also reported that they did blood test and urine test and that all that EKG because the patient had her blood pressure gone considerably high and in the blood test. She was prescribed to take Tylenol every 8 hours and a to put a back patch on the left side of her back where she is experiencing pain. Caller did not provide if she was admitted to the hospital, or if she just stayed in the ER overnight for observation. Now, she wants to know if she will still proceed with her 2nd shot on 29Mar2021. The patient underwent lab tests and procedures which included abdomen scan: normal, no indication of blood clot   on 17Mar2021, angiogram: normal, no indication of blood clot on 17Mar2021, blood pressure measurement: high, blood test: a blood clot on her lung on Mar2021, computerised tomogram: normal, no indication of blood clot on 17Mar2021, covid-19: negative on 17Mar2021, x-ray of pelvis and hip: normal, no indication of blood clot on 17Mar2021. Therapeutic measures were taken as a result of back pain (back pain). The seriousness of the events back pain and Couldn't breathe/shortness of breath was hospitalization. The outcome of the events back pain was recovering. The outcome of the other events was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Computerised tomogram, Dyspnoea, Hypertension, Malaise
Clinical narrative: Couldn't breathe/shortness of breath; Back pain; blood pressure was high; was just sick; This is a spontaneous report from a contactable consumer. A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 08Mar2021 (at the age of 77-years-old) (Batch/Lot Number: EN6199; Expiration Date: 30Jun2021) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing blood pressure abnormal, cancer in her left lung, ongoing blood cholesterol abnormal, ongoing gastric disorder, ongoing diverticulitis Verbatim: Virticulitis. Concomitant medication included acetylsalicylic acid (ASPIRIN 81) taken for blood pressure abnormal; atorvastatin (ATORVASTATIN) taken for blood cholesterol; hydralazine taken for blood pressure abnormal; lisinopril (LISINOPRIL) taken for blood pressure abnormal from Feb2021 and ongoing; pantoprazole taken for gastric disorder from 2020 and ongoing. The patient had her first shot and after that, a week after she experienced some adverse events like back pain and sickness. After the patient started experiencing back pain, and got progressively worse, she was having problem breathing/Shortness of breath was reported. The patient was ambulanced and mentioned she was brought to the hospital/stayed with her doctors overnight due to the experiences she had. She had blood work done and based on the results, they suspected a blood clot on her lung and her CT scan did show that she did not have a clot in her lung. It was also reported that they did blood test and urine test and that all that EKG because the patient had her blood pressure gone considerably high and in the blood test. She was prescribed to take Tylenol every 8 hours and a to put a back patch on the left side of her back where she is experiencing pain. Caller did not provide if she was admitted to the hospital, or if she just stayed in the ER overnight for observation. Now, she wants to know if she will still proceed with her 2nd shot on 29Mar2021. The patient underwent lab tests and procedures which included abdomen scan: normal, no indication of blood clot   on 17Mar2021, angiogram: normal, no indication of blood clot on 17Mar2021, blood pressure measurement: high, blood test: a blood clot on her lung on Mar2021, computerised tomogram: normal, no indication of blood clot on 17Mar2021, covid-19: negative on 17Mar2021, x-ray of pelvis and hip: normal, no indication of blood clot on 17Mar2021. Therapeutic measures were taken as a result of back pain (back pain). The seriousness of the events back pain and Couldn't breathe/shortness of breath was hospitalization. The outcome of the events back pain was recovering. The outcome of the other events was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray of pelvis and hip
Clinical narrative: Couldn't breathe/shortness of breath; Back pain; blood pressure was high; was just sick; This is a spontaneous report from a contactable consumer. A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 08Mar2021 (at the age of 77-years-old) (Batch/Lot Number: EN6199; Expiration Date: 30Jun2021) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing blood pressure abnormal, cancer in her left lung, ongoing blood cholesterol abnormal, ongoing gastric disorder, ongoing diverticulitis Verbatim: Virticulitis. Concomitant medication included acetylsalicylic acid (ASPIRIN 81) taken for blood pressure abnormal; atorvastatin (ATORVASTATIN) taken for blood cholesterol; hydralazine taken for blood pressure abnormal; lisinopril (LISINOPRIL) taken for blood pressure abnormal from Feb2021 and ongoing; pantoprazole taken for gastric disorder from 2020 and ongoing. The patient had her first shot and after that, a week after she experienced some adverse events like back pain and sickness. After the patient started experiencing back pain, and got progressively worse, she was having problem breathing/Shortness of breath was reported. The patient was ambulanced and mentioned she was brought to the hospital/stayed with her doctors overnight due to the experiences she had. She had blood work done and based on the results, they suspected a blood clot on her lung and her CT scan did show that she did not have a clot in her lung. It was also reported that they did blood test and urine test and that all that EKG because the patient had her blood pressure gone considerably high and in the blood test. She was prescribed to take Tylenol every 8 hours and a to put a back patch on the left side of her back where she is experiencing pain. Caller did not provide if she was admitted to the hospital, or if she just stayed in the ER overnight for observation. Now, she wants to know if she will still proceed with her 2nd shot on 29Mar2021. The patient underwent lab tests and procedures which included abdomen scan: normal, no indication of blood clot   on 17Mar2021, angiogram: normal, no indication of blood clot on 17Mar2021, blood pressure measurement: high, blood test: a blood clot on her lung on Mar2021, computerised tomogram: normal, no indication of blood clot on 17Mar2021, covid-19: negative on 17Mar2021, x-ray of pelvis and hip: normal, no indication of blood clot on 17Mar2021. Therapeutic measures were taken as a result of back pain (back pain). The seriousness of the events back pain and Couldn't breathe/shortness of breath was hospitalization. The outcome of the events back pain was recovering. The outcome of the other events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Wrong technique in product usage process
Clinical narrative: With the patient ahead of her, she observed the pharmacist repeatedly thumping the syringe, and she is assuming that he did the same thing for her; With the patient ahead of her, she observed the pharmacist repeatedly thumping the syringe, and she is assuming that he did the same thing for her; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports.   A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 22Mar2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter got her first shot today. Another healthcare professional told the reporter that when drawing down the drug into the syringe, to be effective, one thing not to be done is thumping the syringe because it makes it less effective or ineffective. With the patient ahead of her (reporter), she observed the pharmacist repeatedly thumping the syringe (22Mar2021), and she is assuming that he did the same thing for her. So now, the reporter assumes that hers is not effective and she has to go back there and get her second dose and it probably won't be effective. Now that the reporter has had one of Pfizer's shots, she asked if she should get another shot of something else.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021315916 Same reporter, drug, and events; different patient
Sex: M
Vaccine: COVID19
Symptoms: Leukaemia recurrent, Pulmonary oedema
Clinical narrative: Leukemia diagnosed several years ago that was back since the vaccination; Lungs filled with liquid; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as a single dose, route of administration and therapy date unspecified, for COVID-19 immunization. Medical history included agent orange exposure, and leukemia that was diagnosed several years ago. The patient's concomitant medications were not reported. On an unspecified date, the patient's leukemia that was diagnosed several years ago had been back since the vaccination; and the patient's lungs were filled with liquid. The patient was in a care home. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got COVID within a few days of getting the immunization/five other patients of her own doctor who had that same experience in the same week; got COVID within a few days of getting the immunization/five other patients of her own doctor who had that same experience in the same week; This is a spontaneous report from a contactable consumer via the Pfizer sponsored program. This consumer reported similar events for five patients. This is the first of five reports. A patient of unspecified age and gender started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the reporter stated that the patients got covid within a few days of getting the immunization. Also, the reporter assumes that they got it at the testing site because she knows of five other patients of her own doctor who had that same experience in the same week. Outcome of the events was unknown.   Information about Lot/batch number is requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021317615 same drug/AE, different patient;US-PFIZER INC-2021317616 same drug/AE, different patient;US-PFIZER INC-2021317617 same drug/AE, different patient;US-PFIZER INC-2021317618 same drug/AE, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got COVID within a few days of getting the immunization/five other patients of her own doctor who had that same experience in the same week; got COVID within a few days of getting the immunization/five other patients of her own doctor who had that same experience in the same week; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 5 patients. This report is the second of 5 reports.     A patient of unspecified age and gender started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the reporter stated that the patients got covid within a few days of getting the immunization. Also, the reporter assumes that they got it at the testing site because she knows of five other patients of her own doctor who had that same experience in the same week. Outcome of the events was unknown.   Information about Lot/batch number is requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021317500 same reporter, product and event; different patient.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient got Covid within a few days of getting the immunization; patient got Covid within a few days of getting the immunization; This is a spontaneous report from a contactable consumer via the Pfizer-sponsored program. This consumer reported similar events for five patients. This is the 3rd of five reports.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the reporter stated that the patient got Covid within a few days of getting the immunization. Also, the reporter assumed that they got it at the testing site because she knows of five other patients of her own doctor who had that same experience in the same week. Outcome of the events was unknown.   Information about lot/batch number is requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021317500 same reporter, product and event; different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got COVID within a few days of getting the immunization/five other patients of her own doctor who had that same experience in the same week; got COVID within a few days of getting the immunization/five other patients of her own doctor who had that same experience in the same week; This is a spontaneous report from a contactable consumer via the Pfizer sponsored programt. This consumer reported similar events for five patients. This is the fourth of five reports. A patient of unspecified age and gender started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the reporter stated that the patients got covid within a few days of getting the immunization. Also, the reporter assumes that they got it at the testing site because she knows of five other patients of her own doctor who had that same experience in the same week. Outcome of the events was unknown.   Information about Lot/batch number is requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021317500 same drug/AE, different patient
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Feeling abnormal, Feeling cold, Feeling hot
Clinical narrative: still feels like shit today; cold like symptoms; chills; feels hot and cold; feels hot and cold; This is a spontaneous report received from a contactable consumer (patient). This 46-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 15Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported he still felt like "trash" today (as of 23Mar2021); further reporting cold like symptoms, chills, feeling hot and cold. He reported he was tested twice for COVID-19 and it was negative. He inquired if he would experience the same thing after the second dose. The clinical outcomes of feels like "trash" today, cold like symptoms, chills, feels hot and cold were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: still feels like shit today; cold like symptoms; chills; feels hot and cold; feels hot and cold; This is a spontaneous report received from a contactable consumer (patient). This 46-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 15Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported he still felt like "trash" today (as of 23Mar2021); further reporting cold like symptoms, chills, feeling hot and cold. He reported he was tested twice for COVID-19 and it was negative. He inquired if he would experience the same thing after the second dose. The clinical outcomes of feels like "trash" today, cold like symptoms, chills, feels hot and cold were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acne, Hypersensitivity, Lip pain, Nasal disorder, Stomatitis
Clinical narrative: bumps in his nostrils; In his mouth he has little sores; has little pimples on his chest, stomach, and head; he was thinking it was a hypersensitivity reaction because around his lips where his teeth meet it is very sensitive like you chewed on the side of the mouth; around his lips where his teeth met was very sensitive; This is a spontaneous report received from a contactable consumer (patient). This 48-year-old male patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 17Mar2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date "this weekend," the patient started getting little pimples. He had bumps in his nostrils, little bumps and only a couple. In his mouth he had little sores. He had little pimples on his chest, stomach, and head. They were tiny and nothing big. It was not that big of a deal. It was like a rash but not like a rash. He had bumps randomly, not a rash just bumps randomly here and there like pimples. He was thinking it was a hypersensitivity reaction because around his lips where his teeth met was very sensitive like you chewed on the side of the mouth. The events were reported as non-serious. The outcomes of little pimples on his chest, stomach, and head; bumps in his nostrils, in his mouth he had little sores, hypersensitivity reaction, and around his lips where his teeth met was very sensitive were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acne, Oral pain, Rash, Stomatitis
Clinical narrative: bumps in his nostrils; In his mouth he has little sores; has little pimples on his chest, stomach, and head; he was thinking it was a hypersensitivity reaction because around his lips where his teeth meet it is very sensitive like you chewed on the side of the mouth; around his lips where his teeth met was very sensitive; This is a spontaneous report received from a contactable consumer (patient). This 48-year-old male patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 17Mar2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date "this weekend," the patient started getting little pimples. He had bumps in his nostrils, little bumps and only a couple. In his mouth he had little sores. He had little pimples on his chest, stomach, and head. They were tiny and nothing big. It was not that big of a deal. It was like a rash but not like a rash. He had bumps randomly, not a rash just bumps randomly here and there like pimples. He was thinking it was a hypersensitivity reaction because around his lips where his teeth met was very sensitive like you chewed on the side of the mouth. The events were reported as non-serious. The outcomes of little pimples on his chest, stomach, and head; bumps in his nostrils, in his mouth he had little sores, hypersensitivity reaction, and around his lips where his teeth met was very sensitive were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Rhinorrhoea
Clinical narrative: cold; runny nose; This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 06Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported she received her first dose of BNT162B2 on 06Mar2021 and was scheduled to receive the second dose on 26Mar2021. She reported she worked with kids and developed a little bit of a cold and runny nose and had been taking dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol (NYQUIL) and dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL). She inquired if she could take the second dose of the vaccine on 26Mar2021 or if she should reschedule. The clinical outcomes of cold and runny nose were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Malaise
Clinical narrative: feeling a little not too well; blood sugar a little high; This is a spontaneous report received from a contactable consumer (reporter wife). A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection /Batch/lot number: unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's relevant medical history and concomitant medications was not reported. It was reported that the patients had taken COVID-vaccine that but he was feeling a little not too well in the morning since he had his blood sugar a little high (400 mg/dl) and she wanted to know if it was recommended to get or not to get the vaccine today the patient want to take second dose or not. Outcome of the events was unknown.  Follow-up information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Occupational exposure to product
Clinical narrative: administering a vaccine into a very muscular arm and the needle and syringe come apart and the majority of the vaccine come out and splashed in her eye; She does have some eye irritation; This is a spontaneous case received from a contactable physician. A female nurse (patient) of unspecified age was exposed to BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, the nurse (patient) was administering BNT162B2  into a very muscular arm and the needle and syringe came apart. The majority of the vaccine came out and splashed into her eye. She did have some eye irritation. The events were reported as non-serious. The outcomes of splashed into her eye and eye irritation were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Cystitis, Dizziness
Clinical narrative: Bladder infection; dizziness; This is a spontaneous report received from a contactable consumer. A 70-year-old female patient received the 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. Medical history and concomitant medications were not reported. The reporter stated that her sister, who was 70 years old, was scheduled to receive the second dose of BNT162B2 today (as of 23Mar2021). She reported the patient had a bladder infection that was current and had not resolved even after trying two different antibiotics. The patient also experienced severe dizziness and didn't even feel safe to drive her car. The reporter inquired if infections were a common adverse event after receiving the first dose of the vaccine and if her sister should delay receiving the second dose due to her symptoms. The clinical outcome of bladder infection was not recovered, and the outcome of dizziness was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Skin mass
Clinical narrative: lump on the top of her head the size of a 50 cent piece; This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 18Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number unknown) on an unspecified date for COVID-19 immunisation. The patient reported on Sunday (as of 23Mar2021) she noticed a lump on top of her head the size of a "50 cent piece," which she reported to her doctor, who referred her to Pfizer. The clinical outcome of lump on the top of her head the size of a 50-cent piece was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Haematoma
Clinical narrative: This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A male patient of an unspecified age received BNT162B2 (BNT162B2), dose 1 via an unspecified route of administration on 18Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Consumer said he received the 1st dose of the Pfizer-BioNTech COVID-19 Vaccine on Thursday (18Mar2021), last week. Afterwards, he developed a bruise, shaped like a quarter on his arm. He said that now, it has grown to the size of a 50 cent coin. He also noticed a ring-shaped bruise with a tiny bump on it on the bottom portion of his forearm. Consumer wanted to know if this is still associated with the vaccine. The consumer was told that there have been no reports yet of bruising associated with the Pfizer-BioNTech COVID-19 Vaccine. With this, the person referred the consumer to his HCP for more guidance. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pneumonia, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: pneumonia; fever; back pain; infected with Covid; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient received the first dose of the Pfizer COVID 19 vaccine on 04Mar2021, patient was scheduled for the second dose on 25Mar2021, but on 10Mar2021 she was infected with COVID. she had fever, back pain, and mild pneumonia but no pain or vomit. Outcome of the events was unknown.   Information on Lot/Batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot; This is a spontaneous report from a contactable consumer(patient). A female patient of an unspecified age received BNT162B,(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. prednisone (PREDNISONE), route of administration, start and stop date, batch/lot number and dose were not reported for allergies Medical history included weakened immune systems and ongoing allergies. It was reported that patient wants to know if there is any reported interactions between the use of prednisone and receiving the COVID-19 vaccine manufactured by Pfizer. She was informed that the vaccine might not work as well for patients taking prednisone. The patient has been on Prednisone for 10 years, caller heard that when the patient has been on Prednisone for that long the vaccine does not work. The patient is taking Prednisone to treat some allergies. Patient also has blood clots and wants to know if patients with a history of allergies should take the COVID-19 vaccine manufactured by Pfizer, and how could she know if she would have an allergic reaction towards the vaccine. The action taken in response to the event for Prednisone was unknown. The outcome of the event was unknown.  Information on the batch/lot number has been requested.