chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: Her sister was diagnosed with covid today 27Jan2021/Positive with covid after the first dose; Positive with covid after the first dose; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable nurse (patient's sister). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on unknown date in Jan2021 at single dose on right arm for preventative.  Medical history and concomitant medications were not reported.  Reporter's sister had gotten COVID in between the two vaccine doses. She clarified that her sister only had the first dose of the vaccine. Her sister was diagnosed with COVID today 27Jan2021. Lab data included SARS-CoV-2 test positive on 27Jan2021. Her sister will be done with quarantine the day before she gets her second dose. She was calling to ask if her sister can get the second dose. She read all the information and she thought it should be ok for her sister to get the second dose. Outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Exposure during pregnancy, Off label use, Product use issue
Clinical narrative: Pregnant at the time of vaccination: Yes; She is pregnant at time of vaccination; She is pregnant at time of vaccination; first, covid 19; first, covid 19; This is a spontaneous report from a non-contactable consumer A 33-year-old pregnant female patient received bnt162b2 (BNT162B2; Solution for injection) via an unspecified route of administration on 31Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had last menstrual on 31Jan2021. She is pregnant at time of vaccination while taking bnt162b2. On an unknown date in 2021, patient had first, covid 19. The mother was due to deliver on 07Nov2021. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. There was no treatment for the event covid 19. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid positive; covid positive; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable female consumer (patient) of an unspecified age reported that she 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 was covid positive on 12Jan2021 with outcome of unknown. The patient underwent lab tests included covid-19 virus test: positive on 12Jan2021.  Information about lot/batch number has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: she had quite a rash, it was red, right where the injection was made; it was warm; her arm was hurting a bit; slight headache; This is a spontaneous report from a contactable consumer (patient) and contactable physician.  A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9263), via an unspecified route of administration at arm left on 22Jan2021 at single dose for COVID-19 immunization.  The patient medical history included COVID-19 (with symptoms: terrible headache, cough, shortness of breath for good 6 weeks and fatigue) from Nov2020 to an unknown date.  The patient experienced slight headache on 23Jan2021, her arm was hurting a bit on 25Jan2021. On 26Jan2021, her arm was still sore, it was warm, she had quite a rash, it was red, right where the injection was made, the rest was more pink.  The patient outcome of headache was recovered on 24Jan2021, the outcome of the other events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive for the COVID-19 Virus; positive for the COVID-19 Virus; This is a spontaneous report from a contactable consumer. This consumer reported for self that the female patient of unknown age received first dose of bnt162b2 (Covid-19 Vaccine), via an unspecified route of administration at single dose for covid-19 immunisation. Medical history included congestion. Concomitant medications were unknown. She said she didn't realize she was asymptomatic, and tested positive for the COVID-19 Virus. She said she had already received her first COVID-19 Vaccine dose before she was told she was positive for the COVID-19 Virus. Consumer asked if she should delay getting the second dose of the COVID-19 Vaccine, or does she need to start from scratch. She asked if Pfizer has any specific COVID-19 Vaccine protocol for someone who has tested positive for the COVID-19 Virus after already receiving a COVID-19 Vaccine dose. Reported she had been experiencing some congestion, so she decided on a Monday to get tested for the COVID-19 Virus. She said her COVID-19 Virus test was negative. She said on that Friday she was still congested. She said she had her first COVID-19 Vaccine dose earlier on that Friday. She said after she had received the COVID-19 Vaccine on that Friday, someone who she had been in close contact with tested positive for the COVID-19 Virus. She said since her congestion started, she had developed other symptoms, so she retested for the COVID-19 Virus later in the day that Friday. She said she received a positive COVID-19 Virus test result on Monday. She said she was guessing that the was positive for the COVID-19 Virus at the time she received her first COVID-19 Vaccine dose on that Friday. Reported she looked at Pfizer's Medical Information website to see if she needed to repeat her first COVID-19 Vaccine dose, and didn't find any information directly related to her situation. The outcome of the events was unknown.   No follow-up attempts are possible. Information about lot/batch number could not be requested.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid/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 2nd 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 has 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-2021076785 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid/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; tested positive for Covid/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 3rd 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-2021076785 same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: checked for antibodies and had none; This is a spontaneous report from a contactable physician via a sales representative. A female patient of an unspecified age received first and second doses 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 was not reported. The patient's concomitant medications were not reported. The patient stated that she completed her two dose series of the Pfizer vaccine, waited a week and checked for antibodies and had none. Outcome of event was not recovered.    information about lot and batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Chills, Drug ineffective
Clinical narrative: Tested positive for COVID; Tested positive for COVID; Lost taste and smell; Lost taste and smell; cold like symptoms; Fever; chills; nausea; vomiting; felt cold; runny nose; This is a spontaneous report from a contactable consumer (patient). This 69-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) via intramuscularly at left arm on 07Jan2021 at single dose for prevention. Medical history included allergic to Penicillin, quite a bit of discomfort with two shingles shots, exposed to COVID-19. Concomitant medications were none. The patient experienced cold like symptoms, Fever, chills, nausea, vomiting, felt cold, runny nose, all on 17Jan2021 10:00; lost taste and smell on 21Jan2021; tested positive for COVID on 22Jan2021 10:20. The patient received the first inoculation 07Jan2021, she had symptoms. The patient was tested for COVID on 22Jan2021 and both tested positive. The patient was scheduled to have their second dose on 28Jan2021, and she wanted to know if she should get it or not. She did not feel it was a result of the vaccination. She felt it was because she got exposed to COVID-19. Her symptoms were more severe on that one day. She felt like she was getting a cold that day. She was a compassionate care giver for her mother and wanted to get tested before they went to see her in a facility. She was surprised when she got a positive result. She still had a cough, runny nose and cold like symptoms. Her loss of taste and smell started about 4-5 days ago. Outcome of the event tested positive for COVID was unknown, of the event Lost taste and smell was not recovered, of other events was recovering.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Nasopharyngitis, Nausea, Pyrexia, Rhinorrhoea
Clinical narrative: Tested positive for COVID; Tested positive for COVID; Lost taste and smell; Lost taste and smell; cold like symptoms; Fever; chills; nausea; vomiting; felt cold; runny nose; This is a spontaneous report from a contactable consumer (patient). This 69-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) via intramuscularly at left arm on 07Jan2021 at single dose for prevention. Medical history included allergic to Penicillin, quite a bit of discomfort with two shingles shots, exposed to COVID-19. Concomitant medications were none. The patient experienced cold like symptoms, Fever, chills, nausea, vomiting, felt cold, runny nose, all on 17Jan2021 10:00; lost taste and smell on 21Jan2021; tested positive for COVID on 22Jan2021 10:20. The patient received the first inoculation 07Jan2021, she had symptoms. The patient was tested for COVID on 22Jan2021 and both tested positive. The patient was scheduled to have their second dose on 28Jan2021, and she wanted to know if she should get it or not. She did not feel it was a result of the vaccination. She felt it was because she got exposed to COVID-19. Her symptoms were more severe on that one day. She felt like she was getting a cold that day. She was a compassionate care giver for her mother and wanted to get tested before they went to see her in a facility. She was surprised when she got a positive result. She still had a cough, runny nose and cold like symptoms. Her loss of taste and smell started about 4-5 days ago. Outcome of the event tested positive for COVID was unknown, of the event Lost taste and smell was not recovered, of other events was recovering.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vomiting
Clinical narrative: Tested positive for COVID; Tested positive for COVID; Lost taste and smell; Lost taste and smell; cold like symptoms; Fever; chills; nausea; vomiting; felt cold; runny nose; This is a spontaneous report from a contactable consumer (patient). This 69-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) via intramuscularly at left arm on 07Jan2021 at single dose for prevention. Medical history included allergic to Penicillin, quite a bit of discomfort with two shingles shots, exposed to COVID-19. Concomitant medications were none. The patient experienced cold like symptoms, Fever, chills, nausea, vomiting, felt cold, runny nose, all on 17Jan2021 10:00; lost taste and smell on 21Jan2021; tested positive for COVID on 22Jan2021 10:20. The patient received the first inoculation 07Jan2021, she had symptoms. The patient was tested for COVID on 22Jan2021 and both tested positive. The patient was scheduled to have their second dose on 28Jan2021, and she wanted to know if she should get it or not. She did not feel it was a result of the vaccination. She felt it was because she got exposed to COVID-19. Her symptoms were more severe on that one day. She felt like she was getting a cold that day. She was a compassionate care giver for her mother and wanted to get tested before they went to see her in a facility. She was surprised when she got a positive result. She still had a cough, runny nose and cold like symptoms. Her loss of taste and smell started about 4-5 days ago. Outcome of the event tested positive for COVID was unknown, of the event Lost taste and smell was not recovered, of other events was recovering.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears; This is a spontaneous report from a contactable consumer (patient).   A 76-year-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL3246) at single dose, in the left arm, on 25Jan2021, at 04:45 PM, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history was unknown. No known allergies were reported. The patient had not experienced Covid-19 prior vaccination. Concomitant medications included metoprolol, gabapentin, triamcinolone acetonide (SYMCORT), chlorthalidone and doxepin. On 26Jan2021, the patient experienced ringing in ears. No treatment was received. Clinical outcome of the adverse event was unknown at time of this report. Post the vaccination, the patient has not been tested for COVID-19.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pyrexia
Clinical narrative: Lower extremity myalgia; Right hip pain; Fever; This is a spontaneous report from a non-contactable physician. A 26-year-old male patient received second dose of BNT162B2 (COVID 19, Pfizer, Solution for injection, lot number: EL324), intramuscular on 01Feb2021 07:00 at single dose for covid-19 immunisation. No other medical history, allergies to medications, food, or other products and concomitant medications were reported. Prior to vaccination the patient diagnosed with COVID-19 was unknown. The past medication included first dose of BNT162B2 (COVID 19, Pfizer, lot number: EK4176), intramuscular on 11Jan2021 07:00 at single dose for covid-19 immunisation. The patient experienced lower extremity myalgia, right hip pain and fever on 02Feb2021 07:00. The patient received acetaminophen as therapeutic measures of events. The outcome was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain
Clinical narrative: Ache in the lower left rib cage and left side; This is a spontaneous report received from a contactable other healthcare professional (patient herself). A 43-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL32Y6), via an unspecified route of administration on left arm on 16Jan2021 14:30 at single dose for COVID-19 immunization. Medical history included congenital heart defect and dairy sensitivity. The patient's concomitant medications were not reported. The patient experienced ache in the lower left rib cage and left side on 31Jan2021 12:00. The adverse event result in doctor or other healthcare professional office/ clinic visit. No treatment was received for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19. The event was assessed as non-serious by the reporter. The outcome of the event was reported as not recovered.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Decreased appetite, Fatigue, Headache
Clinical narrative: high blood pressure; headache; body aches; joint pain; fatigue; lack of appetite; This is a spontaneous report from a contactable consumer (patient).  A 70-year-old male patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: e79263), via an unspecified route of administration on 24Jan2021 at single dose for COVID-19 immunization. The patient medical history included high cholesterol and high blood pressure (controlled with medication), both from an unknown date and unknown if ongoing. The patient's concomitant medication included varicella zoster vaccine rge (cho) (SHINGRIX) on 30Dec2020 at single dose for immunization, paracetamol (TYLENOL), atorvastatin and olmesartan medoxomil (BENICAR). On 25Jan2021, the patient experienced high blood pressure, headache, body aches, joint pain, fatigue and lack of appetite. No therapeutic measures were taken in response to the events. The patient outcome of the events was not recovered.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Pain
Clinical narrative: high blood pressure; headache; body aches; joint pain; fatigue; lack of appetite; This is a spontaneous report from a contactable consumer (patient).  A 70-year-old male patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: e79263), via an unspecified route of administration on 24Jan2021 at single dose for COVID-19 immunization. The patient medical history included high cholesterol and high blood pressure (controlled with medication), both from an unknown date and unknown if ongoing. The patient's concomitant medication included varicella zoster vaccine rge (cho) (SHINGRIX) on 30Dec2020 at single dose for immunization, paracetamol (TYLENOL), atorvastatin and olmesartan medoxomil (BENICAR). On 25Jan2021, the patient experienced high blood pressure, headache, body aches, joint pain, fatigue and lack of appetite. No therapeutic measures were taken in response to the events. The patient outcome of the events was not recovered.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills
Clinical narrative: Severe chills; joint pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 60-year-old female patient received bnt162b2, via an unspecified route of administration on 30Jan2021 at 04:45, single dose in the Left arm for covid-19 immunization. Medical history included Hashimotos Thyroiditis. Concomitant medication included thyroid (ARMOUR THYROID). The patient previously took Levoquine and experienced allergies. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. In Feb2021, the patient experienced severe chills and joint pain still 4 days later. The patient did not receive treatment for the adverse events. The outcome of the events was recovering.   Information on the lot/batch number has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report from a contactable consumer (patient).  A 73-year-old male consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan2021at a single dose in left upper arm for Covid-19 immunisation at the age of 73-year-old. Lot number was EL9262. Medical history and concomitant medications were none. On 26Jan2021, the patient experienced Dizziness, it started in the morning, when he got out of bed, the first time he woke was at 5 AM and right at the time of report it was going on 11 AM and he was taking it easy, sitting back and relaxing, he fell asleep. The patient did not recover from the event.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Decreased appetite, Drug ineffective, Dry skin, Headache
Clinical narrative: On 25Jan2021 tested positive for COVID; On 25Jan2021 tested positive for COVID; Headache; Loss of appetite; Dry skin patches; This is a spontaneous report from a Contactable Consumer (patient) via a Pfizer-sponsored program. A 50-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 18:00 at single dose in left arm for COVID-19 immunization. Medical history and concomitant medications were none. The patient had no Prior Vaccinations within 4 weeks. The patient took the first dose of the COVID vaccine on 08Jan2021 and was due to get his second dose but on 25Jan2021 tested positive for COVID. The patient wanted to know if he was allowed to take the second dose. He had a PCR nasal swab that showed the positive COVID diagnosis. He took headache medication after, Tylenol. He had a headache starting on 21Jan2021 and it was lingering on and off but has resolved at this point. He noticed about 8-9 pm the night he got the shot, 08Jan2021, on both feet he had dry skin patches and this lasted about 2 hours; it resolved as this point. He also had a loss of appetite the next day though he ate anyway. That lasted about 8 hours. The outcome of Loss of appetite, Dry skin patches, Headache was resolved. The outcome of other events was unknown.  Information about Lot/ Batch has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: On 25Jan2021 tested positive for COVID; On 25Jan2021 tested positive for COVID; Headache; Loss of appetite; Dry skin patches; This is a spontaneous report from a Contactable Consumer (patient) via a Pfizer-sponsored program. A 50-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 18:00 at single dose in left arm for COVID-19 immunization. Medical history and concomitant medications were none. The patient had no Prior Vaccinations within 4 weeks. The patient took the first dose of the COVID vaccine on 08Jan2021 and was due to get his second dose but on 25Jan2021 tested positive for COVID. The patient wanted to know if he was allowed to take the second dose. He had a PCR nasal swab that showed the positive COVID diagnosis. He took headache medication after, Tylenol. He had a headache starting on 21Jan2021 and it was lingering on and off but has resolved at this point. He noticed about 8-9 pm the night he got the shot, 08Jan2021, on both feet he had dry skin patches and this lasted about 2 hours; it resolved as this point. He also had a loss of appetite the next day though he ate anyway. That lasted about 8 hours. The outcome of Loss of appetite, Dry skin patches, Headache was resolved. The outcome of other events was unknown.  Information about Lot/ Batch has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: On 25Jan2021 tested positive for COVID; On 25Jan2021 tested positive for COVID; Headache; Loss of appetite; Dry skin patches; This is a spontaneous report from a Contactable Consumer (patient) via a Pfizer-sponsored program. A 50-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 18:00 at single dose in left arm for COVID-19 immunization. Medical history and concomitant medications were none. The patient had no Prior Vaccinations within 4 weeks. The patient took the first dose of the COVID vaccine on 08Jan2021 and was due to get his second dose but on 25Jan2021 tested positive for COVID. The patient wanted to know if he was allowed to take the second dose. He had a PCR nasal swab that showed the positive COVID diagnosis. He took headache medication after, Tylenol. He had a headache starting on 21Jan2021 and it was lingering on and off but has resolved at this point. He noticed about 8-9 pm the night he got the shot, 08Jan2021, on both feet he had dry skin patches and this lasted about 2 hours; it resolved as this point. He also had a loss of appetite the next day though he ate anyway. That lasted about 8 hours. The outcome of Loss of appetite, Dry skin patches, Headache was resolved. The outcome of other events was unknown.  Information about Lot/ Batch has been requested.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid after receiving the vaccine; tested positive for Covid after receiving the vaccine; This is a spontaneous report from a contactable consumer (patient). This 48-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose (with a syringe) on the right arm for protection of COVID 19. The patient medical history and concomitant medications were not reported. Patient stated that he had got the vaccination on 08Jan2021 and ended up testing positive for COVID/tested positive for COVID after receiving the vaccine on 14Jan2021. He was supposed to get the second dose this week. Treatment was none. Outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive with Covid19; Tested positive with Covid19; Fever; Loss of smell; Muscular pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Jan2021 at single dose for covid-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced tested positive with covid19, fever, loss of smell, muscular pain in Jan2021.  The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding, Pyrexia
Clinical narrative: nursing my infant and he developed fever for 3 days without any other symptoms following my vaccination; nursing my infant and he developed fever for 3 days without any other symptoms following my vaccination; This is a spontaneous report from contactable other HCP. (mother) This other HCP reported information for both mother and baby. This is the baby report. An infant male patient started to received  the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot EK5730,   transmammary route of administration, on 22Dec2020 18:15 as a SINGLE DOSE for COVID-19 immunization. Medical history was not reported. Concomitant medication included levothyroxine (LEVOTHYROXINE), biotin (BIOTIN), ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]), ergocalciferol (VIT D) and lactobacillus acidophilus (PROBIO).   The patient experienced vaccine exposure via breastmilk on 22Dec2020.  The mother reported nursing my infant and he developed fever for 3 days without any other symptoms on unspecified date following my vaccination. Outcome of the nursing my infant and he developed fever for 3 days without any other symptoms following my vaccination was unknown.; Sender's Comments: Linked Report(s) :-PFIZER INC-2021098666 Infant case (dose 1)
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: This is a spontaneous report received from a contactable consumer (the patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the left arm on 29Jan2021 11:45 (at the age of 66-years-old) as a single dose for COVID-19 immunization. The patient's medical history included high cholesterol, and allergies to medications, food, or other products (unspecified). The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Jan2021 12:15, the first 8 hours, the patient experienced nausea, dizziness, and slight headache. The patient did not receive any treatment for the events. The clinical outcome of nausea, dizziness, and slight headache was recovered on 29Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Myocardial infarction
Clinical narrative: One week to the day after patient's first vaccine he died of a heart attack; This is a spontaneous report from a contactable consumer and from a contactable physician. A 71-year-old male patient (husband) received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at single dose on the right arm for COVID-19 immunization. The patient medical history included past heart conditions. No known allergies. Patient took other medications in two weeks. Facility type vaccine was doctor's office/urgent care. No other vaccine received in four weeks. One week to the day after patient's first vaccine he died of a heart attack on 19Jan2021 18:30. Cause of death was heart attack. No COVID prior vaccination. No COVID tested post vaccination. It was unknown if an autopsy was performed. The physician  reported that the patient arrived DOA. Physician signed the death certificate based on the patient's prior diagnosis. Physician would not provide additional cause of death medical background without consent. He was not aware of any adverse events experienced from the time of vaccination to the date of death.   Follow-up (05Feb2021): This is a follow up spontaneous report from a contactable physician. This physician reported in response to HCP telephonic follow up activity which the following: patient death and cause of death were confirmed.  Follow-up attempts are completed. No further information is expected. Information about Lot number is not available.; Sender's Comments: Based on the temporal relationship, the association between the event fatal heart attack with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: One week to the day after patient's first vaccine he died of a heart attack
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: received 2nd vaccine booster/ experience brief tingling but no other symptoms; This is a spontaneous report from a contactable consumer (patient).  A 44-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, Expiry Date: 31Mar2021), via an unspecified route of administration on 17Dec2020 10:00 at a single dose for COVID-19 immunization and experienced numbness to right hand, weakness in legs, right hand felt cold, "heaviness in my legs", Dry mouth, and "within less than 10 minutes I had a warm tingling feeling." The patient had since received 2nd vaccine booster and did experience brief tingling but no other symptoms on an unspecified date with outcome of unknown.  Information on lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test
Clinical narrative: headache; This is a spontaneous report from a contactable healthcare professional (hcp) (patient). A 39-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine) second dose (lot number: EK9231) on 09Jan2021 in left deltoid, intramuscularly at a single dose for prophylaxis. Medical history included Heart Disease (VSD asymptomatic). The patient previously took first dose of bnt162b2 (lot number: EH 9899) on 18Dec2020 for COVID-19 prophylaxis. The patient's concomitant medications were not reported. The patient had a test for SARS - CoV2: 27Dec2020: negative, none of symptoms; 28Dec2020: negative; 29Dec2020: positive: all PCRS. On 28Dec2020, the patient also had headache + cough. The patient was diagnosed positive COVID by PCR on 29Dec2020. The patient experienced 30 degree of severe symptoms headache on an unspecified date in Jan2021 continued daily as of 19Jan2021. The reported issue occurred after use of the product. No treatment received for headache. The outcome of event headache was not recovered.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, X-ray
Clinical narrative: She had no side effects after the first vaccine and was tender on the first day, which went away; This is a spontaneous report from a contactable nurse (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140 and expiration date not provided), via an unspecified route of administration (left arm) first dose on 19Dec2020 10:30 at single dose for Covid-19 immunization. The patient's medical history included hypertension. The patient had an X-ray back in Sep2020 (unknown result). The patient's concomitant medications were not reported. On 19Dec2020, the patient had the first dose and stated that she had no side effects after first vaccine and was tender on the first day which went away.  The outcome of the event was recovered on 20Dec2020. The event was treated with unspecified treatment. The reporter assesses the event as non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, SARS-CoV-2 antibody test
Clinical narrative: Headache; Fatigue; Feeling unwell; This is a spontaneous report from a contactable physician (patient). A 66-year-old male patient received his second dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 MRNA VACCINE; unknown lot number and expiration date), via an unspecified route of administration on 11Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 MRNA VACCINE number: EK5730), intramuscularly right deltoid on 21Dec2020 at a single dose for COVID-19 immunization but had tired, feeling unwell, lethargy, headache, and Covid 19 Ab on 05Jan2021 with + (positive) result, comments: (+) for antibody. The patient received the vaccine from a hospital that is not a facility. The patient reported that he was positive (+) for headache, fatigue and feeling unwell on the second dose with the "best & time" [pending clarification] of 5 days (16Jan2021). The outcome of the events was unknown. The reported considered the Pfizer product had a causal effect to the adverse events.  The following information on the batch/lot number has been requested.
Sex: U
Vaccine: FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis to influenza vaccination less than two months ago; Initial information received on 28-Jan-2021 regarding an unsolicited valid serious courtesy case from a physician.  This case involves a patient of an unknown age and gender who experienced anaphylaxis (anaphylactic reaction), after receiving INFLUENZA VACCINE.  Past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious anaphylaxis (anaphylactic reaction) (unknown latency, medically significant) after vaccination with influenza, less than two months ago.  Also reported: physician allergist stated, that the question was regarding the PEG (Polyethylene glycol) that's in the Pfizer Covid (coronavirus disease) (PFIZERBIONTECH COVID-19 VACCINE) vaccine, question was whether there is a polysorbate in the vaccine that he received, which was the fluzone quadrivalent and wondering if that is going to cross react with the PEG in the Pfizer vaccine. The chemical name that was given in the descriptions of the fluzone quadrivalent was ethyleneoxide, and need to know from someone who is closer to chemistry than physician is, if that was  polysorbate. Caller is in the vaccination clinic and has a potential vaccine recipient (who is scheduled to receive the vaccine today) in which had anaphylaxis to influenza vaccination less than two months ago  Adverse Event involving Influenza vaccination The patient did not experience any additional symptoms/events. Medication Details and reason for taking the medicine: Prophylactic Vaccination . It is unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the event anaphylactic reaction.  Information on the batch number to be requested for this case.; Sender's Comments: This case involves patient who had anaphylactic reaction, after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. Moreover, patient's medical condition at the time of vaccination and lab tests were not reported. Based upon the reported information, the role of  vaccine cannot be assessed.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: a patient received a dose of Fluzone which was stored at 0.7 Celsius for 25 hours and 24 minutes with no AE; Initial information received on 25-Jan-2021 regarding an unsolicited valid non-serious case received from the other health care professional (medical assistant) via agency (Reference number: 00444852).  This case involves a 4 years old female patient who received a 0.5 ml dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] that was stored at 0.7 Celsius for 25 hours and 24 minutes lot UJ477AA, Expiry date: 30-Jun-2021 via intramuscular route in unknown administration site on 15-Dec-2020 for prophylactic vaccination (Product storage error).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  It was an actual medication error due to incorrect product storage (latency: same day).  Reporter can be contacted by Sanofi: Yes, Potential Product technical complaint (PTC): No, Description: Call received from medical assistant (MA) reporting a temperature excursion of unknown cause. Caller reporting PENTACEL, IPOL, FLUZONE QUADRIVALENT Multi Dose Vials (MDVs) AND PREFILLED SYRINGES, MENACTRA, ADACEL, and DAPTACEL at 0.7C for 25 hours and 24 minutes. Caller reported opened IPOL MDVs and opened Fluzone Quadrivalent MDVs. Caller reporting excursion occurring in December 2020. Caller reporting 11 doses of Fluzone Quadrivalent MDVs were administered post excursion. Caller with question on viability of administered vaccines post excursion. Product used: Not Applicable.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: DTAP, DTAPIPVHIB, FLU3, IPV, MNQ, TDAP
Symptoms: Product temperature excursion issue
Clinical narrative: A temperature excursion of unknown cause at 0.7 Celsius for 25 hours and 24 minutes with no AE; Initial information received on 25-Jan-2021 regarding an unsolicited valid non-serious case received from an other health professional.   This case involves a 1 years old male patient for whom reported temperature excursion of unknown cause at 0.7 Celsius for 25 hours and 24 minutes (Product storage error), while he received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], ,MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], IPV (VERO) [IPOL], DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination and INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] [lot UJ477AA and expiry date: 30-Jun-2021] via an intramuscular route at an unknown administration site for prophylactic vaccination on 20-JAN-2021.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   It was a case of actual medication error due to product storage error temperature too low. [Latency: at the same time of vaccination].  Details of laboratory data not reported.  It was reported that, caller reported opened Ipol Multi dose vials and opened Fluzone quadrivalent MDVs. Caller reporting excursion occurring in Dece-2020. Caller reported 11 doses of Fluzone quadrivalent MDVs were administered post excursion. Caller with question on viability of administered vaccines.   It was not reported if the patient received a corrective treatment.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: No additional adverse event reported.; Nurse gave expired PROQUAD to patient, expired on 19-JAN-2021; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history, historical drug and concomitant therapies was not provided.  On 20-JAN-2021, the patient was vaccinated with one dose Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot number F022916 Expiration date 19-JAN-2021 (dosage regimen and route of administration were not provided) for prophylaxis.  Lot number F022916 is invalid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD). Lot number F022916 does not match any company product as confirmed by lot verification team.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event
Clinical narrative: No additional adverse event; Unknown 4 month old patient was administered first ROTATEQ dose; This spontaneous report was received from a medical assistant concerning a 4-month-old patient. Information regarding the patient's concurrent conditions, medical history, historical drug and concomitant therapies was not provided.  On 13-JAN-2021, the patient was vaccinated with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral route, lot #1688832 and expiration date 24-JUN-2021, for prophylaxis.  No additional adverse event was reported.