chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysphemia, Electrocardiogram, Gastrointestinal pain, Headache, Magnetic resonance imaging head
Clinical narrative: terrible aches all over; headache; there is something wrong with her smell/she can smell but things do not smell right; She has chills really bad; felt really awful; nausea; She had a fever; dry cough; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982 and expiry date:31May2021), via an unspecified route of administration on the left arm, on 22Jan2021 10:45 at a single dose for COVID-19 immunization. Medical history included atrial fibrillation from Nov2019, heart attack 2016, stent placed from 2016, and cardiac ablation from Aug2020. There were no concomitant medications. Patient had her first dose on 22Jan2021 and she felt all the side effects like nausea, fever, chills, headache on 24Jan2021 and wanted to know if that is normal. She also experienced dry cough on Jan2021. Patient reported she was fine and did not even feel it. She was fine that day and the next day. By the third day she started getting every symptom in the world. The one that really bothered her, and she cannot find any information on it was the dry cough. She was asking if dry cough is a reported side effect. She further clarified that the dry cough started either the same day she received the vaccine or the next day and all her other symptoms started on Sunday afternoon (24Jan2021). She had a fever and still has fever at the time of report, and had improved slightly since she takes Tylenol every 6 hours which was keeping the fever at bay. But her temperature was still over 100. She had terrible aches all over which has slightly improved and a headache (she does not think she has one now), and stated it had improved. The nausea was off and on and there was something wrong with her smell. She can smell but things do not smell right. She smelled something like gasoline earlier but she knew it was not gasoline. She thought about food and she wanted to gag, and her taste seems ok. She has chills really bad and clarified all symptoms aside from the dry cough started Sunday around 4 in the afternoon. She felt really awful and took her temperature and it was 101 on Jan2021. The chills are off and on and when her fever goes up, then her chills go up. Outcome of the events of nausea, chills and felt awful was unknown, for events dry cough and something wrong with smell was not recovered, and for the remaining events was recovering. Patient was asking if she somehow contracted covid in between getting her vaccine and now. She had a negative covid test a long time ago when she was going to have procedures done. She confirmed she has not had a covid test recently and stated it was just seems weird since she felt fine right after getting the covid shot.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging neck, Nausea, Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: terrible aches all over; headache; there is something wrong with her smell/she can smell but things do not smell right; She has chills really bad; felt really awful; nausea; She had a fever; dry cough; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982 and expiry date:31May2021), via an unspecified route of administration on the left arm, on 22Jan2021 10:45 at a single dose for COVID-19 immunization. Medical history included atrial fibrillation from Nov2019, heart attack 2016, stent placed from 2016, and cardiac ablation from Aug2020. There were no concomitant medications. Patient had her first dose on 22Jan2021 and she felt all the side effects like nausea, fever, chills, headache on 24Jan2021 and wanted to know if that is normal. She also experienced dry cough on Jan2021. Patient reported she was fine and did not even feel it. She was fine that day and the next day. By the third day she started getting every symptom in the world. The one that really bothered her, and she cannot find any information on it was the dry cough. She was asking if dry cough is a reported side effect. She further clarified that the dry cough started either the same day she received the vaccine or the next day and all her other symptoms started on Sunday afternoon (24Jan2021). She had a fever and still has fever at the time of report, and had improved slightly since she takes Tylenol every 6 hours which was keeping the fever at bay. But her temperature was still over 100. She had terrible aches all over which has slightly improved and a headache (she does not think she has one now), and stated it had improved. The nausea was off and on and there was something wrong with her smell. She can smell but things do not smell right. She smelled something like gasoline earlier but she knew it was not gasoline. She thought about food and she wanted to gag, and her taste seems ok. She has chills really bad and clarified all symptoms aside from the dry cough started Sunday around 4 in the afternoon. She felt really awful and took her temperature and it was 101 on Jan2021. The chills are off and on and when her fever goes up, then her chills go up. Outcome of the events of nausea, chills and felt awful was unknown, for events dry cough and something wrong with smell was not recovered, and for the remaining events was recovering. Patient was asking if she somehow contracted covid in between getting her vaccine and now. She had a negative covid test a long time ago when she was going to have procedures done. She confirmed she has not had a covid test recently and stated it was just seems weird since she felt fine right after getting the covid shot.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tremor
Clinical narrative: terrible aches all over; headache; there is something wrong with her smell/she can smell but things do not smell right; She has chills really bad; felt really awful; nausea; She had a fever; dry cough; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982 and expiry date:31May2021), via an unspecified route of administration on the left arm, on 22Jan2021 10:45 at a single dose for COVID-19 immunization. Medical history included atrial fibrillation from Nov2019, heart attack 2016, stent placed from 2016, and cardiac ablation from Aug2020. There were no concomitant medications. Patient had her first dose on 22Jan2021 and she felt all the side effects like nausea, fever, chills, headache on 24Jan2021 and wanted to know if that is normal. She also experienced dry cough on Jan2021. Patient reported she was fine and did not even feel it. She was fine that day and the next day. By the third day she started getting every symptom in the world. The one that really bothered her, and she cannot find any information on it was the dry cough. She was asking if dry cough is a reported side effect. She further clarified that the dry cough started either the same day she received the vaccine or the next day and all her other symptoms started on Sunday afternoon (24Jan2021). She had a fever and still has fever at the time of report, and had improved slightly since she takes Tylenol every 6 hours which was keeping the fever at bay. But her temperature was still over 100. She had terrible aches all over which has slightly improved and a headache (she does not think she has one now), and stated it had improved. The nausea was off and on and there was something wrong with her smell. She can smell but things do not smell right. She smelled something like gasoline earlier but she knew it was not gasoline. She thought about food and she wanted to gag, and her taste seems ok. She has chills really bad and clarified all symptoms aside from the dry cough started Sunday around 4 in the afternoon. She felt really awful and took her temperature and it was 101 on Jan2021. The chills are off and on and when her fever goes up, then her chills go up. Outcome of the events of nausea, chills and felt awful was unknown, for events dry cough and something wrong with smell was not recovered, and for the remaining events was recovering. Patient was asking if she somehow contracted covid in between getting her vaccine and now. She had a negative covid test a long time ago when she was going to have procedures done. She confirmed she has not had a covid test recently and stated it was just seems weird since she felt fine right after getting the covid shot.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-1 test
Clinical narrative: received Pfizer vaccine on 07Jan2021 tested positive on 26Jan2021 for covid; received Pfizer vaccine on 07Jan2021 tested positive on 26Jan2021 for covid; This is a spontaneous report from a contactable other health care professional (reported as nurse and NP).  A female patient of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on 07Jan2021 for Covid-19 immunization. Medical history and concomitant drug were not provided. The reporter reported that patient received Pfizer vaccine on 07Jan2021 tested positive on 26Jan2021 for COVID.  The reporter inquired the recommendations to get their second shot. Outcome of the event was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in this patient cannot be completely excluded.  However, no complete effect of the suspect vaccine could be reasonably achieved from the first dose to protect from the targeted infection.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: 4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test after receiving the whole series; 4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test after receiving the whole series; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar events for 4 patients, calling on behalf of another office. This report is for 1st of 4 patient.   A patient of unspecified age and gender received the 1st and 2nd doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient was tested positive for covid after receiving the 2nd dose over 15 days before this report/4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test 15 days after receiving the whole series on an unspecified date. The patient had no Covid symptoms, feeling fine after both doses. The patient underwent lab tests and procedures which included Sars-cov-2 test (rapid antigen test kit): positive. The outcome of events was unknown. Reporter was wondering if it was a false positive.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021101864 same reporter/drug/event, different patient;US-PFIZER INC-2021101866 same reporter/drug/event, different patient;US-PFIZER INC-2021101865 same reporter/drug/event, different patient
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Asthenia, Dehydration, Discoloured vomit, Dysentery
Clinical narrative: felt weak; Dysentery; violently sick; throwing up; dehydrated; dry heaving; This is a spontaneous report from a contactable consumer. An 84-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: E18982, expiration date was not reported), intramuscular on the left arm (also reported as left shoulder) on 15Jan2021 at single dose for COVID-19 immunization.  The patient medical history was not reported. It was reported that the patient was taking an unspecified blood thinner and other unspecified products. It was reported that patient got the first dose on 15Jan2021 and everything was fine. The following Friday, exactly a week later, on 22Jan2021 at 930am he got violently sick as far as throwing up and dysentery. He was asking if it could be from the shot. He got sick and was heaving for 7 hours, then he was dry heaving after throwing up so much, it was green bile. He knew he was getting dehydrated and drank a bottle of Pedialyte at 7pm that night. He had to stay a half hour after getting the vaccine since they wanted to monitor him a little longer since he takes blood thinners an other crap. He did not specify the other medications that he takes. On Saturday he felt fine but he felt weak. The patient recovered from dysentery and throwing up on 23Jan2021, while outcome of the remaining events was unknown.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Retching, Vomiting
Clinical narrative: felt weak; Dysentery; violently sick; throwing up; dehydrated; dry heaving; This is a spontaneous report from a contactable consumer. An 84-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: E18982, expiration date was not reported), intramuscular on the left arm (also reported as left shoulder) on 15Jan2021 at single dose for COVID-19 immunization.  The patient medical history was not reported. It was reported that the patient was taking an unspecified blood thinner and other unspecified products. It was reported that patient got the first dose on 15Jan2021 and everything was fine. The following Friday, exactly a week later, on 22Jan2021 at 930am he got violently sick as far as throwing up and dysentery. He was asking if it could be from the shot. He got sick and was heaving for 7 hours, then he was dry heaving after throwing up so much, it was green bile. He knew he was getting dehydrated and drank a bottle of Pedialyte at 7pm that night. He had to stay a half hour after getting the vaccine since they wanted to monitor him a little longer since he takes blood thinners an other crap. He did not specify the other medications that he takes. On Saturday he felt fine but he felt weak. The patient recovered from dysentery and throwing up on 23Jan2021, while outcome of the remaining events was unknown.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Fatigue, Nasal congestion, Oropharyngeal pain
Clinical narrative: got positive with Covid Virus; he tested positive for the COVID; sore throat; stuffiness; fatigue; This is a spontaneous report received from a Pfizer-sponsored program from a contactable consumer reported for himself.     A 51-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1283), via an unspecified route of administration in the left arm on 16Jan2021 16:00 at SINGLE DOSE for covid-19 immunization. Medical history included ongoing Ulcerative colitis, ongoing Allergy and "had close contact with someone who was positive". Concomitant medication included ongoing mesalazine (taking for over 20 years) for Ulcerative colitis and ongoing allergy medicine (taking for two years, thinks it is Claritin grocery brand) for Allergy.  Caller received first Pfizer vaccine on 16Jan2021. He was performed the nasal test at 11: 40 AM yesterday (25Jan2021) and received positive results for Covid 19 today (26Jan2021). Adds he had no symptoms after the vaccine. But he has sore throat, stuffiness, fatigue that started the 23Jan2021 with the COVID 19. All of these are getting better as of today (26Jan2021). The event did not require a visit to physician or ER. The patient stated "I had close contact with someone who was positive." He was supposed to receive his second vaccine dose on 06Feb2021. The patient stated "they told me to quarantine for 10 days from the time I was exposed and that would be until 02Feb2021. Is there any reason I shouldn't get my 2nd dose?" The outcome of the event COVID 19 was unknown, of other events was recovering.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: got positive with Covid Virus; he tested positive for the COVID; sore throat; stuffiness; fatigue; This is a spontaneous report received from a Pfizer-sponsored program from a contactable consumer reported for himself.     A 51-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1283), via an unspecified route of administration in the left arm on 16Jan2021 16:00 at SINGLE DOSE for covid-19 immunization. Medical history included ongoing Ulcerative colitis, ongoing Allergy and "had close contact with someone who was positive". Concomitant medication included ongoing mesalazine (taking for over 20 years) for Ulcerative colitis and ongoing allergy medicine (taking for two years, thinks it is Claritin grocery brand) for Allergy.  Caller received first Pfizer vaccine on 16Jan2021. He was performed the nasal test at 11: 40 AM yesterday (25Jan2021) and received positive results for Covid 19 today (26Jan2021). Adds he had no symptoms after the vaccine. But he has sore throat, stuffiness, fatigue that started the 23Jan2021 with the COVID 19. All of these are getting better as of today (26Jan2021). The event did not require a visit to physician or ER. The patient stated "I had close contact with someone who was positive." He was supposed to receive his second vaccine dose on 06Feb2021. The patient stated "they told me to quarantine for 10 days from the time I was exposed and that would be until 02Feb2021. Is there any reason I shouldn't get my 2nd dose?" The outcome of the event COVID 19 was unknown, of other events was recovering.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Borrelia test negative, Facial paralysis, Injection site pain
Clinical narrative: Bell's palsy on left side; soreness at the injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number EV1685, expiry date unknown) via an unspecified route of administration on the left deltoid, left arm, on 05Jan2021 08:15 AM at a single dose for COVID-19 immunization. The patient's medical history included allergies to Penicillin and Sulfa from an unknown date and unknown if ongoing. The patient had no current Illness and no family medical history. The patient is not pregnant. Concomitant medications included metoprolol tartrate, Vitamin C [ascorbic acid], Vitamin D3, and Multivitamins; patient received these medications within two weeks prior to the COVID vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. Patient had a routine Physical Examination on Nov2020 and underwent lab tests and procedures on 24Jan2021 which included unknown BW and negative Lyme Disease Test. On 23Jan2021 18:30, the patient developed bell's palsy on left side which was reported as getting a little worse every day. The event required Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care; the event resulted in Disability or permanent damage. Since 24Jan2021, patient received Prednisone 60 mg, daily for 7days and Valtrex 1g, 3x/day (TID) for 7days as treatment for the event. The patient did not recover from the event Bell's palsy on left side.' It was further reported that patient experienced soreness at the injection site on an unspecified date with outcome of unknown.; Sender's Comments: Based on temporal association and safety profile of the product, the contributory role of the suspect product BNT162B2 to reported event Facial paralysis cannot totally 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: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Nasal congestion, Nasopharyngitis
Clinical narrative: tested positive for covid-19; tested positive for covid-19; he had a cold; Coughing; runny nose; congestion; This is a spontaneous report from a contactable consumer (Patient's wife). A 68-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3246), intramuscular in Right arm on 07Jan2021 at 08:30-08:35 at single dose for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient had symptoms and was tested positive for covid-19 on 22Jan2021 10:20. On 12Jan2021 04:00, the patient had coughing, runny nose, congestion and thought he had a cold. The patient was scheduled to have his second dose on 28Jan2021, and the reporter wanted to know if the patient should get it or not. The outcome of the event COVID-19 was unknown, of other events was recovering.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: tested positive for covid-19; tested positive for covid-19; he had a cold; Coughing; runny nose; congestion; This is a spontaneous report from a contactable consumer (Patient's wife). A 68-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3246), intramuscular in Right arm on 07Jan2021 at 08:30-08:35 at single dose for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient had symptoms and was tested positive for covid-19 on 22Jan2021 10:20. On 12Jan2021 04:00, the patient had coughing, runny nose, congestion and thought he had a cold. The patient was scheduled to have his second dose on 28Jan2021, and the reporter wanted to know if the patient should get it or not. The outcome of the event COVID-19 was unknown, of other events was recovering.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Got sick after the first dose; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect via a non-contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown), via an unspecified route of administration on an unspecified date at SINGLE DOSE (first dose) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced got sick after the first dose on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Feeling hot, Hypertension
Clinical narrative: warm feelings; his blood pressure was high; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. It was reported that patient received his first dose of the Pfizer-BioNTech COVID-19 Vaccine and stated "right after I got the shot, hot flashes on chest and stomach which went to both of my arms, then went down to the legs and feet, and back to the arms". Patient mentioned that this lasted for 45 minutes and he was brought by an ambulance to a hospital. Patient was then observed but wasn't administered any medicine. Patient stated that he had a high blood pressure but was not sure if it was because he was afraid or because of the experience with the vaccine. Patient confirmed that he was not given any medication and eventually discharged after a few hours. Patient clarified regarding 'hot flashes' and mentioned that these were not rashes but warm feelings, "similar to when they prep you for a CAT scan". It was also reported that patient asked for any available reports on this. Patient also asked what to do about the second shot if he got the shot on the outside of the parking lot. Patient was also seeking guidance on local vaccination site and mentioned that he would want to be inside a facility when taking his 2nd shot (scheduled in 21 days). Outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report from a contactable nurse who reported for herself. A 25-year-old female patient received her first single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) on 22Jan2021 for Covid-19 immunization. The patient's concomitant medications were not reported. The patient got her first dose on 22Jan2021 and was tested positive for Covid that night due to close contact with a friend that had had a positive test. Her next vaccination date was after the 14 days quarantine but she was wondering if someone kept testing positive after that 14 day period, she knew some people test positive for months. She would like to know was it still safe to get the second dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. While the vaccine may not provide protection yet, further clinical information is needed for meaningful medical assessment.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: had the "usual side effects", aches and pains; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (parent) reported that a female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via an unspecified route of administration, on an unspecified date, at a single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter stated that her daughter (patient) who is a nurse experienced the "usual side effects", aches and pains on an unspecified date after her second dose. The patient took ibuprofen as treatment. The reporter's healthcare professional (HCP) told her not to take any ibuprofen because it reduces effectiveness of the vaccine. The reporter wanted to know if it was true. Outcome of the event pain was unknown.  Information on the lot/batch number has been requested.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: legs were not working after the Covid-19 vaccine shot; This is a spontaneous report from a contactable consumer. A 91-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261, expiration date 31May2021), intramuscular on her left arm on 23Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient's legs were not working after the Covid-19 vaccine shot on 24Jan2021. She got the shot on Saturday afternoon. The patient seems to be ok today. The outcome of the event was recovered in 25Jan2021.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Heart rate irregular, Inappropriate schedule of product administration, Palpitations
Clinical narrative: felt near syncopal; very short of breath; heart was pounding hard; felt tachycardic; BP was 160/100; irregular HR with PVCs; HR 40; This is a spontaneous report from a contactable healthcare professional (patient).  A 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL1283) on 25Jan2021 08:15 given intramuscular (left arm) single dose for COVID-19 immunization.  Medical history included was reported as none.  The patient was not pregnant at the time of vaccination. Concomitant medication included estradiol, testosterone, lorazepam (ATIVAN).  The patient previously received ultram/ Zofran ad experienced drug allergies, and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL1284) on 04Jan2021 08:15 intramuscular single dose for COVID-19 immunization. The patient was not diagnosed with covid prior vaccination and the patient was not tested for covid post vaccination. On 25Jan2021 at 08:45 AM, 30 minutes after injection,-the patient felt horrible described as her heart was pounding hard and felt tachycardic. BP was 160/100 and HR 110 and felt near syncopal. Then PVCs started/ very short of breath, and HR went from 112, 69, 40, then 80. The patient went to ER. The patient was monitored and given was IVFs and O2, and labs checked. The patient was discharged 7 hours later and continued having irregular HR with PVCs. Outcome of the events was recovering at the time of the report.; Sender's Comments: Based on the available information, a possible contribution of the drug to the event syncope 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Tachycardia, Ventricular extrasystoles
Clinical narrative: felt near syncopal; very short of breath; heart was pounding hard; felt tachycardic; BP was 160/100; irregular HR with PVCs; HR 40; This is a spontaneous report from a contactable healthcare professional (patient).  A 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL1283) on 25Jan2021 08:15 given intramuscular (left arm) single dose for COVID-19 immunization.  Medical history included was reported as none.  The patient was not pregnant at the time of vaccination. Concomitant medication included estradiol, testosterone, lorazepam (ATIVAN).  The patient previously received ultram/ Zofran ad experienced drug allergies, and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL1284) on 04Jan2021 08:15 intramuscular single dose for COVID-19 immunization. The patient was not diagnosed with covid prior vaccination and the patient was not tested for covid post vaccination. On 25Jan2021 at 08:45 AM, 30 minutes after injection,-the patient felt horrible described as her heart was pounding hard and felt tachycardic. BP was 160/100 and HR 110 and felt near syncopal. Then PVCs started/ very short of breath, and HR went from 112, 69, 40, then 80. The patient went to ER. The patient was monitored and given was IVFs and O2, and labs checked. The patient was discharged 7 hours later and continued having irregular HR with PVCs. Outcome of the events was recovering at the time of the report.; Sender's Comments: Based on the available information, a possible contribution of the drug to the event syncope 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: F
Vaccine: COVID19
Symptoms: Nerve injury, Nightmare
Clinical narrative: Nightmares; Jumping nerves; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL9262), via an unspecified route of administration on 18Jan2021 at single dose on Left arm for COVID-19 immunization. No Other vaccine in four weeks. No Covid prior vaccination. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced nightmares and jumping nerves on an unspecified date. Treatment AE: No. No covid tested post vaccination. Outcome of events was recovering.    No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Chest discomfort, Dyspepsia, Echocardiogram normal, Pericarditis
Clinical narrative: Pericarditis after admit and negative ECHO, and CTA; Chest discomfort; initially thought it was heart burn lasted over 15 overs decided to visit ER.; Had elevated troponins was diagnosed with Pericarditis after admit and negative ECHO, and CTA; This is a spontaneous report from a contactable nurse (patient) reported that a 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on the left arm on 14Jan2021 15:30 at a single dose for COVID-19 immunization. Medical history included high cholesterol from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received influenza vaccine (FLU) on 10Dec2020 for immunization; and received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) on 24Dec2020 15:30 for Covid-19 immunization. On 16Jan2021 15:30, the patient experienced chest discomfort, initially thought it was heart burn lasted over 15 "overs" decided to visit ER. The patient had elevated troponins, and was diagnosed with Pericarditis after admit and negative ECHO, and CTA. As treatment, patient received IV Toradol. The reported events resulted hospitalization for 1 day. The patient underwent lab tests and procedures which included angiogram (CTA): negative, echocardiogram (ECHO): negative, troponin: elevated; all on 16Jan2021. The outcome of the events was recovering.; Sender's Comments: Based on the vaccine's safety profile, the event pericarditis and the associated symptoms are more likely intercurrent condition, unrelated to suspect vaccine BNT162B2 administration.  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: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin increased
Clinical narrative: Pericarditis after admit and negative ECHO, and CTA; Chest discomfort; initially thought it was heart burn lasted over 15 overs decided to visit ER.; Had elevated troponins was diagnosed with Pericarditis after admit and negative ECHO, and CTA; This is a spontaneous report from a contactable nurse (patient) reported that a 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on the left arm on 14Jan2021 15:30 at a single dose for COVID-19 immunization. Medical history included high cholesterol from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received influenza vaccine (FLU) on 10Dec2020 for immunization; and received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) on 24Dec2020 15:30 for Covid-19 immunization. On 16Jan2021 15:30, the patient experienced chest discomfort, initially thought it was heart burn lasted over 15 "overs" decided to visit ER. The patient had elevated troponins, and was diagnosed with Pericarditis after admit and negative ECHO, and CTA. As treatment, patient received IV Toradol. The reported events resulted hospitalization for 1 day. The patient underwent lab tests and procedures which included angiogram (CTA): negative, echocardiogram (ECHO): negative, troponin: elevated; all on 16Jan2021. The outcome of the events was recovering.; Sender's Comments: Based on the vaccine's safety profile, the event pericarditis and the associated symptoms are more likely intercurrent condition, unrelated to suspect vaccine BNT162B2 administration.  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: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: sore; tired; getting this stabbing shock pain on the left side of my head; This is a spontaneous report from a contactable Other HCP (patient). A 24-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3249) via an unspecified route of administration on 22Jan2021 07:45 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at workplace clinic. No other vaccine was given within 4 weeks prior to the COVID vaccine. Patient age at vaccination was 24 years. The patient has no known allergies. Medical history was none. The patient's concomitant medications were not reported. The patient reported first days she was just sore, tired then by the 3rd day began getting this stabbing shock pain on the left side of her head that last about 3-5 seconds each time through out the whole day. It is not like a regular headache pain it is a sudden stabbing shocking pain only on the left side of the head. Over the counter migrane medicine does not take that pain away when it does come. Onset date of the events was reported as 25Jan2021 01:00 PM. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The events had not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her arm was sore; This is a spontaneous report received by Pfizer from a contactable other healthcare professional (HCP) (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. It was stated that an NP at the clinic also reported her arm was sore following the vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: A person gets the first dose of the COVID-19 vaccine and within 5-7 days gets COVID-19; A person gets the first dose of the COVID-19 vaccine and within 5-7 days gets COVID-19; This is a spontaneous report from a contactable physician. This physician reported for a patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient got the first dose of the covid-19 vaccine and within 5-7 days got covid-19 on an unspecified date with outcome of unknown.    Information about batch/lot number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), and within 5-7 days got COVID-19.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the COVID 19 likely represents a pre-existing infection prior to vaccine use.  Further information is needed for full medical assessment.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She tested positive for Covid19; She tested positive for Covid19; This is a spontaneous report from a contactable consumer. A 32-year-old female patient (reporter's daughter) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient tested positive for covid19 on 21Jan2021. The patient wanted to know can the patient get a 2nd vaccine if they are positive or will she have to start with dose 1 again. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Loss of consciousness, Muscle spasms, Pallor
Clinical narrative: collapse and passed out; Woke up at midnight with severe leg cramps; I turned white as a ghost and sweats; I turned white as a ghost and sweats; Got the chills after sweating; This is a spontaneous report from a contactable 62-year-old female consumer reported for herself that she received 1st dose of bnt162b2 (BNT162B2; lot number EL9261) on 26Jan2021 04:30 PM at left arm for COVID-19 immunization in Public Health Clinic. Medical history and concomitant drugs was none. The patient woke up at midnight with severe leg cramps, tried walking it out, collapse and passed out (according to husband). He stated that the patient turned white as a ghost and sweats.  After coming too, drank electrolytes and water. The patient got the chills after sweating.  It took a while for her to warm up and go back to sleep. Event start time was reported as 27Jan2021. The outcome of the event was resolved.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Syncope
Clinical narrative: collapse and passed out; Woke up at midnight with severe leg cramps; I turned white as a ghost and sweats; I turned white as a ghost and sweats; Got the chills after sweating; This is a spontaneous report from a contactable 62-year-old female consumer reported for herself that she received 1st dose of bnt162b2 (BNT162B2; lot number EL9261) on 26Jan2021 04:30 PM at left arm for COVID-19 immunization in Public Health Clinic. Medical history and concomitant drugs was none. The patient woke up at midnight with severe leg cramps, tried walking it out, collapse and passed out (according to husband). He stated that the patient turned white as a ghost and sweats.  After coming too, drank electrolytes and water. The patient got the chills after sweating.  It took a while for her to warm up and go back to sleep. Event start time was reported as 27Jan2021. The outcome of the event was resolved.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Myalgia, Vaccination site pain
Clinical narrative: Muscle soreness at injection site; Muscle soreness at injection site; left bicep muscle twitching for about 1-2 minutes at around midnight; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EN5318, on 26Jan2021 07:00 at single dose in left arm for Covid-19 immunization. Medical history included high blood pressure, allergies to penicillin and amoxicillin. Concomitant medications included amlodipine besilate (NORVASC), atorvastatin (LIPITOR), pseudoephedrine hydrochloride (SUDAFED), VITAMIN D NOS, and cetirizine hydrochloride (WAL ZYR). The patient was not Pregnant at the time of vaccination. The patient had no any other vaccines within 4 weeks prior to the COVID vaccine. The patient had Muscle soreness at injection site that was still occurring but lessened 24h later and left bicep muscle twitching for about 1-2 minutes at around midnight. No treatment was received for all events. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. The outcome of all events was resolving.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: diagnosed with COVID-19; diagnosed with COVID-19; This is a spontaneous report from a contactable consumer. This consumer reported for self that the male patient of unknown age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. On 10Jan2021 the patient developed symptoms and was diagnosed with COVID-19 (unrelated to vaccine obviously). He was fully recovered as of 26Jan2021. He was scheduled for the second doze of vaccine for 28Jan2021. The outcome of the events was recovered.   Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 infection/Covid-19 positive; COVID-19 infection/Covid-19 positive; This is a spontaneous report from a contactable physician (patient).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Jan2021 at single dose for COVID-19 immunisation.  The patient medical history and the concomitant medications were not reported.  The patient received her first dose on 12Jan2021. She developed COVID-19 infection two weeks after receiving the vaccine in Jan2021. The lab data included Covid-19 positive in Jan2021. The outcome was unknown.  Information about batch/lot number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.