chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Incomplete course of vaccination, SARS-CoV-2 test
Clinical narrative: got the first Pfizer vaccine dose, then got Covid and became severely sick, missed her second dose and when she tried to get her second dose 8 months later was told that it was too late; got the first Pfizer vaccine dose, then got Covid and became severely sick, missed her second dose and when she tried to get her second dose 8 months later was told that it was too late; got the first Pfizer vaccine dose, then got Covid and became severely sick, missed her second dose and when she tried to get her second dose 8 months later was told that it was too late; This is a spontaneous report from a contactable consumer or other non hcp (patients cousin). A 6-decade-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller reported that she received her first vaccine dose on 25Jun2021 but is not able to get the second dose until the end of Aug or early Sep. Caller was asking if that is ok reporting that she has spoken to her HCP for advice as well and she was told to wait a little bit. During this call the caller also reported that her cousin, who also lives in (name withheld), who is in her 50's, got the first Pfizer vaccine dose, then got Covid and became severely sick on an unspecified date in 2021, missed her second dose and when she tried to get her second dose 8 months later was told that it was too late and she would have to repeat the series so instead she switched over to (name). Offered to transfer the caller to safety to report this occurrence, caller declined. The patient underwent lab tests and procedures which included covid test: got covid on an unspecified date in 2021. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness neurosensory, SARS-CoV-2 test
Clinical narrative: Acute sensory neural hearing loss, 2 week after initial injection, occurred in an ear that already had some symptoms; This is a spontaneous report from a contactable physician (patient). A 63-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EH9899), via an unspecified route of administration, administered in Arm Left on 17Dec2020 at 13:00 (age at time of vaccination was 63-year-old) as single dose for COVID-19 immunisation. The patient's medical history included Known allergies of Penicillin. The patient's concomitant medications were not reported. No other vaccine in four weeks were taken by patient. No other medications in two weeks. No covid prior vaccination. On 29Dec2021, the patient experienced acute sensory neural hearing loss, 2 week after initial injection, occurred in an ear that already had some symptoms. AE resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures post vaccination which included Nasal Swab unknown results. The patient received unspecified steroids as corrective treatment for the event. The outcome of event was not recovered.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug 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: Dizziness, Muscular weakness, Seizure, Walking disability
Clinical narrative: seizures; weakness in my legs; dizziness; in a wheelchair now, and cant walk; This is a spontaneous report from a non-contactable consumer or other non hcp (patient herself). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date in Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the Pfizer vaccine on an unspecified date in Apr2021, and since been hospitalized with weakness in my legs, seizures, dizziness. She is in a wheelchair now and cannot walk. She has been seen by neurologist, and other specialists and no one is giving any answers and wanted to know if Pfizer has received any calls regarding the side effects that she reported and the risks of the COVID-19 vaccine. The re-porter asked if Is Pfizer is doing research for people who have the type of side effects that she is re-porting. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Fatigue, Irritability, Malaise
Clinical narrative: irritability/craby/bitchy; nose congestion; coughing; sneezing; couldn't sleep well; running/her nose is runny/blowing her nose; lack of appetite/not really hungry; pain at injection site in left arm/injection site painful swollen and warm; pain at injection site in left arm/injection site painful swollen and warm; pain at injection site in left arm/injection site painful swollen and warm; Nausea/feeling a little nauseous; fatigue/She is just so tired and crabby; she does not feel good; This is a spontaneous report from a contactable consumer (patient). This consumer reported different event for 2 patients. This is the first report. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number EY0584 and expiry date not reported), via an unspecified route of administration, administered in Arm Left on 18Jul2021 (at the age of 62-year-old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing GERD (gastrooesophageal reflux disease) and has had for about 30 years. There were no concomitant medications. On 18Jul2021, about 3 hours after receiving the first dose of the Pfizer Covid-19 vaccine the patient started having complaints of nausea/feeling a little nauseous, sneezing, running/her nose is runny/blowing her nose, coughing, couldn't sleep well and pain at injection site in left arm that was also swollen and warm. On the same day, the patient also experienced nose congestion, fatigue, irritability and lack of appetite. The patient wanted to know if these were normal reactions to the vaccine. On an unspecified date in Jul2021, the patient took off work because she does not feel good. She was tired and bitchy and crabby. It was reported that she does not want to be left alone also reported that wants to be left alone (discrepant information, pending clarification). The patient was not really hungry, and her nose was runny. The outcome for coughing, sneezing, nausea/feeling a little nauseous, and pain at injection site in left arm that was also swollen and warm was not recovered while the outcome for irritability/crabby/bitchy, nose congestion, couldn't sleep well, running/her nose is runny/blowing her nose, lack of appetite/not really hungry, fatigue/she is just so tired and crabby, she does not feel good was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100917618 same reporter/drug, different patient/AE
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nausea, Poor quality sleep, Rhinorrhoea, Sneezing
Clinical narrative: irritability/craby/bitchy; nose congestion; coughing; sneezing; couldn't sleep well; running/her nose is runny/blowing her nose; lack of appetite/not really hungry; pain at injection site in left arm/injection site painful swollen and warm; pain at injection site in left arm/injection site painful swollen and warm; pain at injection site in left arm/injection site painful swollen and warm; Nausea/feeling a little nauseous; fatigue/She is just so tired and crabby; she does not feel good; This is a spontaneous report from a contactable consumer (patient). This consumer reported different event for 2 patients. This is the first report. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number EY0584 and expiry date not reported), via an unspecified route of administration, administered in Arm Left on 18Jul2021 (at the age of 62-year-old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing GERD (gastrooesophageal reflux disease) and has had for about 30 years. There were no concomitant medications. On 18Jul2021, about 3 hours after receiving the first dose of the Pfizer Covid-19 vaccine the patient started having complaints of nausea/feeling a little nauseous, sneezing, running/her nose is runny/blowing her nose, coughing, couldn't sleep well and pain at injection site in left arm that was also swollen and warm. On the same day, the patient also experienced nose congestion, fatigue, irritability and lack of appetite. The patient wanted to know if these were normal reactions to the vaccine. On an unspecified date in Jul2021, the patient took off work because she does not feel good. She was tired and bitchy and crabby. It was reported that she does not want to be left alone also reported that wants to be left alone (discrepant information, pending clarification). The patient was not really hungry, and her nose was runny. The outcome for coughing, sneezing, nausea/feeling a little nauseous, and pain at injection site in left arm that was also swollen and warm was not recovered while the outcome for irritability/crabby/bitchy, nose congestion, couldn't sleep well, running/her nose is runny/blowing her nose, lack of appetite/not really hungry, fatigue/she is just so tired and crabby, she does not feel good was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100917618 same reporter/drug, different patient/AE
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: irritability/craby/bitchy; nose congestion; coughing; sneezing; couldn't sleep well; running/her nose is runny/blowing her nose; lack of appetite/not really hungry; pain at injection site in left arm/injection site painful swollen and warm; pain at injection site in left arm/injection site painful swollen and warm; pain at injection site in left arm/injection site painful swollen and warm; Nausea/feeling a little nauseous; fatigue/She is just so tired and crabby; she does not feel good; This is a spontaneous report from a contactable consumer (patient). This consumer reported different event for 2 patients. This is the first report. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number EY0584 and expiry date not reported), via an unspecified route of administration, administered in Arm Left on 18Jul2021 (at the age of 62-year-old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing GERD (gastrooesophageal reflux disease) and has had for about 30 years. There were no concomitant medications. On 18Jul2021, about 3 hours after receiving the first dose of the Pfizer Covid-19 vaccine the patient started having complaints of nausea/feeling a little nauseous, sneezing, running/her nose is runny/blowing her nose, coughing, couldn't sleep well and pain at injection site in left arm that was also swollen and warm. On the same day, the patient also experienced nose congestion, fatigue, irritability and lack of appetite. The patient wanted to know if these were normal reactions to the vaccine. On an unspecified date in Jul2021, the patient took off work because she does not feel good. She was tired and bitchy and crabby. It was reported that she does not want to be left alone also reported that wants to be left alone (discrepant information, pending clarification). The patient was not really hungry, and her nose was runny. The outcome for coughing, sneezing, nausea/feeling a little nauseous, and pain at injection site in left arm that was also swollen and warm was not recovered while the outcome for irritability/crabby/bitchy, nose congestion, couldn't sleep well, running/her nose is runny/blowing her nose, lack of appetite/not really hungry, fatigue/she is just so tired and crabby, she does not feel good was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100917618 same reporter/drug, different patient/AE
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She had the virus (was hospitalized and released after the treatment and receiving the antibodies); She had the virus (was hospitalized and released after the treatment and receiving the antibodies); This is a spontaneous report from a non-contactable consumer. A 95-years-old (95 and a half years) female patient (Mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had the virus (was hospitalized and released after the treatment and receiving the antibodies) (Hospitalized, Medically Significant). She was told she needs the covid vaccine. Reporter stated his mother received the first dose of the Pfizer Covid vaccine after some time from getting the antibodies. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Inappropriate schedule of product administration, Menstrual disorder, Overdose
Clinical narrative: Passing extremely large clumps/clots of blood multiple times per day.; Excessive menstrual bleeding for nearly 30 days post second vaccination shot/ Bleeding is ongoing; first dose 24May2021 and second dose 24May2021; first dose 24May2021 and second dose 24May2021; This is a spontaneous report from a contactable consumer (patient). A 14-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0173), via an unspecified route of administration, administered in arm left on 24May2021 14:15 (at the age of 14-year-old) as dose 2, single; dose 1 via an unspecified route of administration, administered in arm left on 24May2021 14:15 (Batch/Lot Number: EW0173) as dose 1, single, both doses for COVID-19 immunization. Medical history included allergy to peanuts, hazelnuts, soy, almonds, coconut. No concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications the patient received within 2 weeks 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. The patient experienced passing extremely large clumps/clots of blood multiple times per day, excessive menstrual bleeding for nearly 30 days post second vaccination shot/ bleeding was ongoing on 23Jun2021. Clinical course: Excessive menstrual bleeding for nearly 30 days post second vaccination shot, currently passing extremely large clumps/clots of blood multiple times per day. Bleeding was ongoing since 23Jun2021. The patient received hormones to stop bleeding as a treatment medication for the events. The reporter assessed the events as non-serious. Outcome of the events was not recovered and outcome of other events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Condition aggravated, Pyrexia
Clinical narrative: it caused an autoimmune disorder to flare up; it caused an autoimmune disorder to flare up; she had a fever; This is a spontaneous report from a contactable consumer. A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 28Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date caller states that she had a fever when she wanted to get second dose, so put it off. Her rheumatologist didn't think it was a good idea to get the second dose, and caller thinks it might put her in the hospital. She is also worried, however, about getting COVID and particularly the Delta variant. Caller said she got 1st dose of the Pfizer BIONTECH Covid-19 vaccine on 28Feb2021, and it caused an autoimmune disorder to flare up. She wants to know if she should get the 2nd dose after that happened. Caller took the first dose of the Pfizer COVID 19 Vaccine and was having auto immune flare ups. Caller wants to know if she can and should get the second dose. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Breakthrough Covid-19 diagnosis.; Breakthrough Covid-19 diagnosis.; This is a spontaneous report from a contactable consumer or other non hcp. A 40-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Batch/Lot number was not reported) via an unspecified route of administration on Mar2021 (at the age of 40-years) as dose number unknown, single for covid-19 immunisation. She was no pregnant. The patient medical history was not reported. The patient's concomitant medications were not reported. No covid prior vaccination, no covid tested post vaccination. On 17Jul2021, the patient experienced breakthrough covid-19 diagnosis. She had taken doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included Covid test: positive on 18Jul2021. Treatment for event was Unknown. The outcome of the event breakthrough covid-19 diagnosis was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inflammation, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; slight inflammation; Fatigue; This is a solicited report based on the information received by Pfizer. (Manufacturer control number: 21K-163-3986159-00).  A contactable consumer (patient) reported that a 55-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via intramuscular on an unspecified date (Batch/Lot number was not reported), as single dose for Covid-19 vaccination; upadacitinib (RINVOQ), orally from an unspecified date (Batch/Lot number was not reported) and ongoing, at unspecified dose for Moderate to severe Rheumatoid arthritis. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via intramuscular on an unspecified date as single dose for Covid-19 vaccination. Medical history included ongoing Moderate to severe Rheumatoid arthritis. The patient's concomitant medications were not reported. Solicited report by a consumer of an adult female with events of non-serious fatigue and rheumatoid arthritis flare up with RINVOQ (UPADACITINIB). On unknown date, patient received 1st dose Covid-19 vaccine manufactured by Pfizer. On unknown date, patient received 2nd dose Covid-19 vaccine manufactured by Pfizer. On unknown dates, the patient experienced Fatigue and Rheumatoid arthritis flare up. PFIZER BIONTECH COVID-19 VACCINE was also considered suspect. The patient had slight inflammation. She had Covid-19 vaccine Pfizer brand. She had a reaction on second dose of fatigue. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken in response to the events for upadacitinib was dose not changed. The outcome of the event fatigue and slight inflammation was unknown, of the event Rheumatoid arthritis flare up was Not recovered.  The reporter's causality for the events of fatigue with Rinvoq (Upadacitinib) was no reasonable possibility. The reporter's causality for the events of Rheumatoid arthritis flare up with Rinvoq (Upadacitinib) was no reasonable possibility. The reporter's assessment of the causal relationship of the events with the suspect product BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the event Rheumatoid arthritis (Rheumatoid arthritis flare up) and the suspect drug BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dysarthria, Fatigue, Headache, Hypoaesthesia
Clinical narrative: Doctors suspect aTTP; platelets were very low so they gave her a transfusion.; Fatigue; Headaches; Numbness; Weakness; Speech began to get slurred; This is a spontaneous report from a contactable consumer or other non hcp.     A 24-years-old female patient received bnt162b2 (BNT162B2) dose number unknown , via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as  single dose  for covid-19 immunisation.  The patient medical history  and concomitant medications were not reported.  The patient experienced doctors suspect a TTP (thrombotic thrombocytopenic purpura) (medically significant) on an unspecified date with outcome of unknown , platelets were very low so they gave her a transfusion.  (medically significant) on an unspecified date with outcome of unknown , fatigue  (non-serious) on an unspecified date with outcome of unknown , headaches  (non-serious) on an unspecified date with outcome of unknown , numbness  (non-serious) on an unspecified date with outcome of unknown , weakness  (non-serious) on an unspecified date with outcome of unknown , speech began to get slurred  (non-serious) on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included platelet count decreased: very low .  Therapeutic measures were taken as a result of platelets were very low  and included a transfusion.   Doctors suspect a TTP and she had the Pfizer vaccine so they suspect the two could be linked.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Platelet count decreased, Thrombotic thrombocytopenic purpura
Clinical narrative: Doctors suspect aTTP; platelets were very low so they gave her a transfusion.; Fatigue; Headaches; Numbness; Weakness; Speech began to get slurred; This is a spontaneous report from a contactable consumer or other non hcp.     A 24-years-old female patient received bnt162b2 (BNT162B2) dose number unknown , via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as  single dose  for covid-19 immunisation.  The patient medical history  and concomitant medications were not reported.  The patient experienced doctors suspect a TTP (thrombotic thrombocytopenic purpura) (medically significant) on an unspecified date with outcome of unknown , platelets were very low so they gave her a transfusion.  (medically significant) on an unspecified date with outcome of unknown , fatigue  (non-serious) on an unspecified date with outcome of unknown , headaches  (non-serious) on an unspecified date with outcome of unknown , numbness  (non-serious) on an unspecified date with outcome of unknown , weakness  (non-serious) on an unspecified date with outcome of unknown , speech began to get slurred  (non-serious) on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included platelet count decreased: very low .  Therapeutic measures were taken as a result of platelets were very low  and included a transfusion.   Doctors suspect a TTP and she had the Pfizer vaccine so they suspect the two could be linked.  Information about lot/batch number has been requested.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmogenic right ventricular dysplasia, Cardiac flutter, Cardiac sarcoidosis, Syncope
Clinical narrative: Three ICD/Defibrilator surgeries later and shifting diagnosis from AVRC to Cardiac Sarcoiditis.; Three ICD/Defibrilator surgeries later and shifting diagnosis from AVRC to Cardiac Sarcoiditis.; March 8th or 9th had episode of heart fluttering that lasted about 1 minute; faint; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 03Mar2021 at 15:00 (at the age of 39-year-old), as dose 1, single in left arm for COVID-19 immunisation at Pharmacy or Drug Store. The patient's medical history included hypertension. Concomitant medications in 2 weeks included lisinopril, hydrochlorothiazide and simvastatin; all taken for unspecified indications, start and stop dates were not reported. Patient had no known allergies. The patient was not diagnosed with COVID, prior to the vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks after COVID vaccine. On 08Mar2021 or 09Mar2021, the patient experienced episode of heart fluttering that lasted about 1 minute. Was fainted, sat down, and went back to normal. On 15Mar2021 at 11:30, he went into sustained VTAC of 223 and was in VTAC for an hour. ER revived rhythm. Patient had three ICD/Defibrillator surgeries later and shifting diagnosis from AVRC to cardiac sarcoiditis. Any uncertainty on sarcoiditis leads to a vaccine driven event or awakening of a past virus or harm. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was hospitalized for 4 days due to the events. The events were considered as life threatening illness (immediate risk of death from the event), with disability or permanent damage. Therapeutic measures were taken for events which included ICD Implantation and then a cardiac CRT implant. The clinical outcome of the event heart fluttering was resolved on an unspecified date in Mar2021 and the clinical outcome of all other events was not resolved.  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 for COVID; tested positive for COVID; This is a spontaneous report from a contactable physician received via Pfizer-sponsored program. A 45-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on an unspecified date in May2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines on the same day of vaccine vaccination. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On an unspecified date in 2021, the patient tested positive for COVID. The event tested positive for covid assessed as serious (medically significant). Caller stated, the patient was basically saying he was having COVID symptoms, so like nasal congestion, runny nose, not severe, not shortness of breath or chest pain, just mainly URI symptoms, fatigue, just feeling the initial COVID symptoms, not really severe, but having COVID symptoms. Caller states she knows the symptoms were still going on, the exact day she was unsure. Caller confirms all symptoms began sometime in July2021 in the last week and was persisting. Caller states it was not serious from a medical standpoint. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date in 2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship,  a possible causal relationship between the events of  DI ,Covid 19 and suspect drug BNT162B2 cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Fatigue, Nasal congestion, Rhinorrhoea
Clinical narrative: tested positive for Covid; feeling the initial COVID symptoms; nasal congestion; runny nose; fatigue; This is a spontaneous report from regulatory authority. A contactable Physician reported for a 45-Year-old female patient that: A 45-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on May2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Caller stated that the husband and wife got the vaccine, the second vaccine dose back in May2021, but got COVID this week, over the last week. Caller stated that the patient was basically says she was having Covid symptoms, so like nasal congestion, runny nose, not severe, not shortness of breath or chest pain, just mainly URI symptoms, fatigue, just feeling the initial COVID symptoms, not really severe, but having COVID symptoms. Caller stated that she knows the symptoms are still going on, the exact day she was unsure. Caller confirms all symptoms began sometime in July 2021 and is persisting. Caller stated that it was not serious from a medical standpoint. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: tested positive for Covid; feeling the initial COVID symptoms; nasal congestion; runny nose; fatigue; This is a spontaneous report from regulatory authority. A contactable Physician reported for a 45-Year-old female patient that: A 45-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on May2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Caller stated that the husband and wife got the vaccine, the second vaccine dose back in May2021, but got COVID this week, over the last week. Caller stated that the patient was basically says she was having Covid symptoms, so like nasal congestion, runny nose, not severe, not shortness of breath or chest pain, just mainly URI symptoms, fatigue, just feeling the initial COVID symptoms, not really severe, but having COVID symptoms. Caller stated that she knows the symptoms are still going on, the exact day she was unsure. Caller confirms all symptoms began sometime in July 2021 and is persisting. Caller stated that it was not serious from a medical standpoint. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Paraesthesia, Rhinorrhoea
Clinical narrative: also cannot breathe well; snotty nose; tingling all over her body/whole body tingles; This is a spontaneous report from a contactable consumer or other non health care professional. A 15-years-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, formulation: solution for injection, Batch/Lot Number: EW0181), via an unspecified route of administration, administered in Arm Right on 15Jul2021 (at the age of 15-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included anxiety: Chronic anxiety (Diagnosed 3-4 months ago). Concomitant medications included fluoxetine indication for chronic anxiety from 15Jul2021. On 16Jul2021, the patient experienced tingling all over her body/whole body tingles. On 17Jul2021, the patient could not breathe well and snotty nose. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Lip swelling, Speech disorder, Swelling face
Clinical narrative: her eyes and everything else that swelled up; having a problem talking because her lips are so swollen now; having a problem talking because her lips are so swollen now; Face swelling; This is a spontaneous report from a contactable Nurse (patient). A 75-years-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 10Mar2021 (at the age of 75-years) as a single dose in the left arm for COVID-19 immunization. The patient medical history included blood pressure high, type II diabetes, high cholesterol was ongoing. The patient concomitant medications included Amlodipine 10mg once a day for Blood pressure high, Lisinopril 10mg once a day for unspecified indication, sitagliptin phosphate (JANUVIA) for unspecified indication from an unknown date and unknown if ongoing. On unspecified date of 2021, the patient experienced face swelling. After she got the shot, her face swelled up. She got the shot in Mar and her face swelled up about a week after that. However, her tongue did not swell up. It was her eyes and everything else that swelled up. Then when she went to get the second shot they did not give it to her. Due to face swelling she was placed on Prednisone therapy. After completing the Prednisone Therapy they would not give the second dose. Since that date each month since getting the first dose her face swells up. Like this morning it started to swell up again. She wonders if she can still get the COVID vaccine, but a different one instead, or does it have to be Pfizer, or can she not take any COVID vaccine. The swelling continues, but she can wear masks and it covers it up. Like cannot see her lip under the masks, but it is swollen. She was having a problem talking because her lips are so swollen now. Each month when the facial swelling begins it last for 2-3 days. The event face swelling was assessed as serious medically significant. The clinical outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event face swelling and the suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Dyskinesia, Fall, Movement disorder, Sleep disorder
Clinical narrative: I went to sleep mode; I could not move my body; collapsed; I have lost movement in my legs at that point and I have to be in the wheel chair and I have shaken in my body; Burning sensation in my chest; my head feels fuel like it is inflamed and I was wondering; Blood clots; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in APR2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date in April2021, after 4 hours of vaccination the patient went to sleep mode, could not move body, collapsed, have lost movement in legs at that point, have to be in the wheelchair and have shaken in the body, burning sensation in chest; head feels fuel like it is inflamed, was wondering and blood clots. The patient was hospitalized on an unknown date in April2021 for all the events. The patient was admitted in the hospital different weeks at a time for the past two and half months now. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot not be requested.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: I went to sleep mode; I could not move my body; collapsed; I have lost movement in my legs at that point and I have to be in the wheel chair and I have shaken in my body; Burning sensation in my chest; my head feels fuel like it is inflamed and I was wondering; Blood clots; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in APR2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date in April2021, after 4 hours of vaccination the patient went to sleep mode, could not move body, collapsed, have lost movement in legs at that point, have to be in the wheelchair and have shaken in the body, burning sensation in chest; head feels fuel like it is inflamed, was wondering and blood clots. The patient was hospitalized on an unknown date in April2021 for all the events. The patient was admitted in the hospital different weeks at a time for the past two and half months now. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot not be requested.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Colitis ulcerative, Polymerase chain reaction
Clinical narrative: I started to have a flare up of my ulcerative colitis; This is a spontaneous report from a contactable pharmacist (Patient). A 38-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 31Jan2021 13:00 as dose 1, single for COVID-19 immunization.  Medical history included colitis ulcerative from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. It was reported that on 02Feb2021 06:00, two days after the first dose he started to have a flare up of his ulcerative colitis which he had not had a flare up for over 4 years. This flare lasted almost 3 weeks. It went away by the time he had to do the second dose. Patient had to take mesalamine, high two prednisone, dicyclomine and patient had a very bad time. Patient had to visit emergency room and physician office due to event. Since the vaccination, patient tested for COVID-19. The patient underwent lab tests and procedures which included polymerase chain reaction: negative   on 01Mar2021 Nasal Swab. The outcome of the event was recovered with sequelae.     No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on close temporal relationship the causal association of the events ulcerative colitis flare up and blood in my feces with the usage of the vaccine BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Cognitive disorder, Language disorder, Neuropathy peripheral
Clinical narrative: experienced lasting effect permanent cognitive/neurological decline after 2nd dose.; experienced lasting effect permanent cognitive/neurological decline after 2nd dose.; short term memory loss.; unable to articulate the language arts side of the brain, even though high professional performer; This is a spontaneous report from a contactable other hcp (patient). A 41-years-old non-pregnant female patient received bnt162b2 (Pfizer, covid 19, formulation: solution for injection, Batch/Lot Number: el9262), via an unspecified route of administration, administered in Arm Left on 19Feb2021 13:45 (at the age of 41-years-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications ware not reported. The patient had no allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medication in two weeks. The patient previously took bnt162b2 (Pfizer, covid 19, formulation: solution for injection, Batch/Lot Number: el3249), via an unspecified route of administration, administered in Arm Left on 21Jan2021 01:15 (at the age of 41-years-old) as dose 1, single for covid-19 immunisation. On 22Feb2021, the patient experienced lasting effect permanent cognitive/neurological decline after 2nd dose, short term memory loss, unable to articulate the language arts side of the brain, even though high professional performer. Therapeutic measures were taken as a result of experienced lasting effect permanent cognitive/neurological decline after 2nd dose. (neuropathy peripheral), experienced lasting effect permanent cognitive/neurological decline after 2nd dose. (cognitive disorder), short term memory loss. (amnesia), unable to articulate the language arts side of the brain, even though high professional performer (language disorder). The clinical outcome of the events was not recovered.  Case comment: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between Neuropathy peripheral, cognitive deterioration, amnesia, language disorder and suspect product bnt162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product was 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: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: tested positive for Covid after getting the vaccine; tested positive for Covid after getting the vaccine; This is a spontaneous report from a contactable consumer (friend) reported for a female patient. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date (Lot number and expiry date was not reported) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 13Jul2021, the patient tested positive for COVID after getting the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on 13Jul2021. The event outcome was unknown.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Suicide threat
Clinical narrative: patient stated she would slit her wrist if we weren't able to assist her.; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medication were not reported. The patient stated she would slit her wrist if we were not able to assist her. Patient stated she had COVID-19 shots. The outcome of the event was unknown.   Information about lot and batch number was requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Exposure during pregnancy, SARS-CoV-2 test
Clinical narrative: patient is pregnant; tested positive for Covid after getting vaccine; tested positive for Covid after getting vaccine; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (friend). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for Covid-19 immunisation. The patient medical history and patient's concomitant medications were not reported. The patient was tested positive for Covid on unknown date in Jul2021 after receiving the Pfizer Covid 19 vaccine. Patient was pregnant. The patient underwent lab tests and procedures which included sars-cov-2 test results positive on Jul2021. Query was sent to the reporter to ask whether the patient was pregnant before Pfizer COVID Vaccine to which a response was received to clarify that the patient was pregnant, but it was not clarified whether or not the patient received the vaccine while she was pregnant or prior to her pregnancy. Investigation Assessment reported as Yes. There was a Product Complaint. Description of complaint: Caller reporting an adverse event and mentions her friend who tested positive for Covid after receiving the Pfizer Covid 19 vaccine. LOT; NDC; Expiry Date: Not provided. Caller declines to complete report. The outcome for the events was unknown.   Information about lot and batch number was requested.