chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Mar2021 (at the age of 37-years-old) at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. No COVID prior vaccination. The patient experienced heart attack in 2021. The adverse event resulted in emergency room/department or urgent care, hospitalization in 2021, life-threatening illness (immediate risk of death from the event), disability or permanent damage. No COVID tested post vaccination. The outcome of the event was unknown.   Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: I had a shock of pain, I was dying of pain.; This is a spontaneous report from a non-contactable consumer reporting for herself.  A 28-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on Apr2021 at 13:00 (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  had a shock of pain, was dying of pain. The reported event was considered serious because Important Medical Event.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: she received her first vaccine dose on 03Apr. On 14Apr she tested positive for covid; This is a spontaneous report received from a contactable consumer(patient) and from a Pfizer sponsored program. A 40-year-old female patient of received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown) on 03Apr2021 (at the age of 40-years-old) via an unknown route at single dose on the unspecified anatomical location for COVID-19 immunization. Relevant medical history and concomitant medication not provided.On 14Apr2021 she tested positive for COVID-19. The patient queried and recommended when to get the second dose of vaccine. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: received their First dose of the pfizer covid vaccine on 24Mar2021; a week and half later they were tested positive for covid.; This is a spontaneous report from a Pfizer sponsored program. A contactable pharmacist reported. A 41-year-old male patient received first dose of BNT162B2 (Solution for injection, Lot number: unknown) on an unspecified route of administration on 24Mar2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medication was no reported. Question: (caller was offered to be connected with safety department but caller refused, e-transmitted the AE) (Name) transferred the call. caller stated two patients (41 years old male and 40 years old female) received their first dose of the pfizer COVID vaccine on 24Mar2021; a week and half later they were tested positive for covid. caller needed information about the second dose. The outcome of the event was unknown.; Sender's Comments: Due to implausible temporal association, the events of COVID 19 is assessed as unrelated to vaccine. The patient has taken Vaccine 12 days prior to developing COVID 19, while it is known that it takes 14 days to develop antibodies and for the vaccine to work against SARS CoV-2 virus.,Linked Report(s) : US-PFIZER INC-2021434766 Same reporter/drug/AE, different patient
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Organ failure, Thrombosis
Clinical narrative: Hot a fever then full blown covid; Hot a fever then full blown covid; blood clot; organ failure; This is a spontaneous report from a Pfizer-sponsored program.  A contactable consumer reported that  a male patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 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. Previously on an unknown date, the patient received the first dose of BNT162B2 vaccine. On an unspecified date, the patient experienced hot a fever then full blown COVID, blood clot  and  organ failure  leading to patient death on an unknown date.   It was not reported if an autopsy was performed.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected; Reported Cause(s) of Death: Drug ineffective; Covid-19; Blood clot; Organ failure
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Chillblains, Haematology test normal, Laboratory test normal, Myocarditis
Clinical narrative: Myocarditis; Arrhythmia; Chillblains; This is a spontaneous report received from a contactable other Health Care Professional. A 70-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2, intramuscular, administered in left deltoid on 08Feb2021 (Lot Number: EL9265), at the age of 70 years, as a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications taken within two weeks of vaccination included vitamins nos, acetylsalicylic acid (ASPIRIN (E.C.), Vitamin D nos, metoprolol tartrate (LOPRESSOR), atorvastatin calcium (LIPITOR). Historical vaccine included BNT162b2, dose 1 on 14Jan2021, lot # EL3216, intramuscular in right deltoid. On an unspecified date, the patient experienced myocarditis, arrhythmia, and chilblains. The patient had lab tests which included haematology test: normal on 17Feb2021, clinical chemistry: normal on 17Feb2021, sars-cov-2 test negative: negative on 22Feb2021. The clinical outcome of the events myocarditis, arrhythmia, and chilblains was unknown.; Sender's Comments: Based on an implied vaccine-event chronological association, a causal relationship between reported events and PFIZER-BIONTECH COVID-19 mRNA VACCINE cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Myocarditis; Arrhythmia; Chillblains; This is a spontaneous report received from a contactable other Health Care Professional. A 70-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2, intramuscular, administered in left deltoid on 08Feb2021 (Lot Number: EL9265), at the age of 70 years, as a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications taken within two weeks of vaccination included vitamins nos, acetylsalicylic acid (ASPIRIN (E.C.), Vitamin D nos, metoprolol tartrate (LOPRESSOR), atorvastatin calcium (LIPITOR). Historical vaccine included BNT162b2, dose 1 on 14Jan2021, lot # EL3216, intramuscular in right deltoid. On an unspecified date, the patient experienced myocarditis, arrhythmia, and chilblains. The patient had lab tests which included haematology test: normal on 17Feb2021, clinical chemistry: normal on 17Feb2021, sars-cov-2 test negative: negative on 22Feb2021. The clinical outcome of the events myocarditis, arrhythmia, and chilblains was unknown.; Sender's Comments: Based on an implied vaccine-event chronological association, a causal relationship between reported events and PFIZER-BIONTECH COVID-19 mRNA VACCINE cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, SARS-CoV-2 test
Clinical narrative: Felt dizzy; was diagnosed with Covid on 05April2021; This is a spontaneous report reported by contactable consumer (self -reported) and received from Pfizer sponsored program. A 56-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiry date was not reported) via unknown route of administration on 26Mar2021 at single dose for COVID-19 immunization. Patient's medical were not reported. Concomitant medications included multivitamins. On 05Apr2021, the patient underwend covid-19 test and serult was positive. On 05Apr2021, the patient was diagnosed with COVID-19. On 06Apr2021, the patient felt dizzy. Caller was scheduled for his second Pfizer Covid 19 Vaccine on 16April2021. Caller asking what he should do about the second vaccine after his diagnosis with Covid and also wanted to confirm if how long he needs to wait before he can drink alcohol after the vaccine. The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Ligament rupture
Clinical narrative: She tore her ACL, Needing surgery; This is a spontaneous report from a contactable Pharmacist (Mother) via Pfizer-sponsored program COVAX US Support. A 17-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 03Apr2021 as a single dose for COVID-19 immunization and the patient scheduled to receive her second vaccine on 25Apr2021, but last Thursday the patient tore her ACL and will be needing surgery on 30Apr2021. Concerned about possible side effects. Husband received Pfizer doses. Trying to determine what the patient should do for the daughter to prevent blood clotting like what happened with (withheld) patients. Outcome of event was unknown.~  Additional information required. ; Sender's Comments: Based on the current limited available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be totally excluded/assessed. the case will be reassessed after additional information is received on the causal factor for the event such as incidents of trauma or accidents. 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: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase, Blood creatine phosphokinase increased, Hypoaesthesia, Paralysis
Clinical narrative: new numbness and pins & needles in left leg; It causes paralysis in muscles; CPK increased; This is a spontaneous report from a contactable consumer (patient).  This 60-year-old male consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Mar2021 at single dose in right arm for COVID-19 immunisation at the age of 60-year-old. Medical history and concomitant medications were unknown. Historical vaccine included fatigue with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Mar2021 for Covid-19 immunisation at the age of 60-year-old (1st dose, at 09:30, leftarm). The patient got up one day and legs where paralyzed on 08Apr2021. The patient kept trying to stand and walk thinking it was just legs fallen asleep, but the patient was falling every time she would try to walk it off. On 08Apr2021 at 07:30, new numbness and pins and needles in left leg. The patient was hospitalized due to the events and they were considered as disabiliting and life-threatening. The patient then had a bad moment when on his way to leave for pcp appt (as reported), a steel cabinet fell on him. The patient was taken by ems to trauma unit in Hospital. Creatine phosphokinase (CPK) levels were over 2,000 on unknown date. The outcome of Creatine phosphokinase increased was unknown, the patient was recovering from other events. Information on the Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Fatigue, Taste disorder
Clinical narrative: had DOE 3-4 days prior; fatigued; taste seems different; This is a spontaneous report from a non-contactable Other HCP. A 65-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 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. It was reported patient experienced DOE for the past 3-4 days and felt fatigued for the past week in 2021. His taste seemed different over the past couple of days in 2021. The outcome of events was unknown.   No follow-up attempts are possible. Information on lot number, batch number could not be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Gastrointestinal tract irritation
Clinical narrative: with only mild GI symptoms as a reaction; This is a spontaneous report from a contactable consumer (patient's mother). A 16-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Patient's mother reported that the patient had only mild GI symptoms as a reaction. Outcome of the event was unknown.  No follow-up attempts are needed. Information about lot and batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021433434 same reporter/drug/event, different patient.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Death, Dyspnoea, Illness, Myalgia, Nausea
Clinical narrative: Nausea; Vomiting; Shortness of breath; Muscle aches; Extremely ill; Body aches; expired; This is a report from a contactable consumer based on the information received by Pfizer. (Manufacturer Report Number: UNT-2021-006444).   A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunization; and treprostinil sodium (TYVASO, strength: 0.6, mg/ml), via resp inhalation (reported as via inhalation route) from 30Mar2021 (Batch/Lot Number: 2101912; Expiration Date: 31Jan2022) to an unspecified date, at 18-54 ug, four times a day (QID) for primary pulmonary arterial hypertension. Medical history included ongoing pulmonary arterial hypertension. Concomitant medications included riociguat (ADEMPAS), amlodipine besilate, rivaroxaban (XARELTO); all taken for an unspecified indication, start and stop date were not reported. It was reported that the patient began therapy with IH Tyvaso (treprostinil sodium, concentration of 0.6 mg/ml) delivered by Tyvaso Inhalation Device (TD-300/A), on 30Mar2021 for primary pulmonary arterial hypertension. The current dose was reported as 18-54 ug (3-9 breaths), four times a day (QID) via inhalation (IH) route. On an unspecified date, the patient experienced nausea, vomiting, shortness of breath, muscle aches, extremely ill, and body aches. The patient was hospitalized in response to the events on an unspecified date. The outcome of events was unknown. On an unspecified date in 2021, the patient expired, and cause of death was not reported. The action taken in response to the events for treprostinil sodium was unknown. The patient died on an unspecified date in 2021. It was unknown if an autopsy was performed.  The reporter's assessment of the causal relationship between the events with the suspect product 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.  Case Comment/Senders Comment: The company has assessed the serious adverse event of death as not related to IH treprostinil and TD-300/A device. The event was likely due to progressive complications and life limiting nature of underlying PAH in this elderly patient.  Information about lot/batch number has been requested.; Sender's Comments: The information currently available is limited and does not allow a meaningful causality assessment for reported event of death (unknown cause); however, based solely on implied vaccine-event chronological association a causal relationship between this event and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The other reported events; Reported Cause(s) of Death: expired
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pain, Vomiting
Clinical narrative: Nausea; Vomiting; Shortness of breath; Muscle aches; Extremely ill; Body aches; expired; This is a report from a contactable consumer based on the information received by Pfizer. (Manufacturer Report Number: UNT-2021-006444).   A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunization; and treprostinil sodium (TYVASO, strength: 0.6, mg/ml), via resp inhalation (reported as via inhalation route) from 30Mar2021 (Batch/Lot Number: 2101912; Expiration Date: 31Jan2022) to an unspecified date, at 18-54 ug, four times a day (QID) for primary pulmonary arterial hypertension. Medical history included ongoing pulmonary arterial hypertension. Concomitant medications included riociguat (ADEMPAS), amlodipine besilate, rivaroxaban (XARELTO); all taken for an unspecified indication, start and stop date were not reported. It was reported that the patient began therapy with IH Tyvaso (treprostinil sodium, concentration of 0.6 mg/ml) delivered by Tyvaso Inhalation Device (TD-300/A), on 30Mar2021 for primary pulmonary arterial hypertension. The current dose was reported as 18-54 ug (3-9 breaths), four times a day (QID) via inhalation (IH) route. On an unspecified date, the patient experienced nausea, vomiting, shortness of breath, muscle aches, extremely ill, and body aches. The patient was hospitalized in response to the events on an unspecified date. The outcome of events was unknown. On an unspecified date in 2021, the patient expired, and cause of death was not reported. The action taken in response to the events for treprostinil sodium was unknown. The patient died on an unspecified date in 2021. It was unknown if an autopsy was performed.  The reporter's assessment of the causal relationship between the events with the suspect product 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.  Case Comment/Senders Comment: The company has assessed the serious adverse event of death as not related to IH treprostinil and TD-300/A device. The event was likely due to progressive complications and life limiting nature of underlying PAH in this elderly patient.  Information about lot/batch number has been requested.; Sender's Comments: The information currently available is limited and does not allow a meaningful causality assessment for reported event of death (unknown cause); however, based solely on implied vaccine-event chronological association a causal relationship between this event and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The other reported events; Reported Cause(s) of Death: expired
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Lethargy
Clinical narrative: Tired and lethargic for 2 days post vaccine; Tired and lethargic for 2 days post vaccine; This is a spontaneous report from a non-contactable consumer from a Pfizer sponsored program Pfizer Colleagues' Immediate Family.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced tired and lethargic for 2 days post vaccine on 15Apr2021. Outcome of events was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site thrombosis
Clinical narrative: Blood clot in injection arm; This is a spontaneous report from a contactable Other-HCP.  A 39-years-old female patient received at hospital bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 27Jan2021 (Batch/Lot Number: El3249) as SINGLE DOSE for covid-19 immunisation  . No other vaccine in fours weeks. Other medications in two weeks: Multivitamin.The patient received the first dose on 06Jan2021 at 10:30 AM (lot number=El1284) on left arm via IM The patient medical history was not reported.     The patient experienced blood clot in injection arm (vaccination site thrombosis) (life threatening) on 02Apr2021 15:15 with outcome of not recovered.  The event was treated wth Xarelto. No Covid prior vaccination; No Covid tested post vaccination; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between event "blood clot in injection arm" and BNT162B2 vaccine 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: Anal incontinence, Headache, Vision blurred
Clinical narrative: has a headache; eyes are blurry; has been back and forth to the bathroom; This is a spontaneous report from a Pfizer sponsored program COVAX US support. A contactable female consumer (patient) of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 2 via an unspecified route of administration on 06Apr2021 (Lot number and Expiry date was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced headache, eyes are blurry and had been back and forth to the bathroom. Patient was very upset after vaccination as she thought it was the best one to take. Outcome of the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number and expiration were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date after vaccination administered. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Deceased; This is a spontaneous report from a Pfizer. A non-contactable consumer reported that a patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Consumer reported that, "Amongst my coworkers about 50% were put down for two to three days and one person became deceased a few hours after the second shot." The patient died on an unspecified date. It was not reported if an autopsy was performed.   No follow up attempts are possible; Information on the lot/batch number cannot be obtained.; Reported Cause(s) of Death: Deceased
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient tested positive for Covid; Patient tested positive for Covid; The patient died; This is a spontaneous report from a contactable consumer. An 86-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in right arm on Feb2021 (Batch/Lot Number: En6303) as single dose, and dose 2 via an unspecified route of administration on 16Mar2021 (Batch/Lot Number: Ep7534) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient tested positive for COVID on 08Apr2021 which resulted in Emergency room/department or urgent care, and hospitalization for 3 days. Treatment included high flow oxygen, doxycycline, inhalers, and Rocephin. The patient underwent lab tests and procedures which included Nasal Swab: positive on 08Apr2021. The patient died on an unspecified date. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: The patient died
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: died after the second one when they had covid; died after the second one when they had covid; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient died after the second one when they had Covid because there were too many antibodies on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: died after the second one when they had covid; died after the second one when they had covid
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Fatigue, Hypersomnia, Palpitations
Clinical narrative: Extreme fatigue; decreased energy; needed to sleep most of the day; difficulty maintaining balance; heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, lot number: EN6200), via an unspecified route of administration, administered in Arm Left on 09Mar2021 12:00 (received at the age of 73-years-old)  as single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to receiving bnt162b2. Medical history included asthenia and known allergies to Sulfa drugs, NSAIDS. The patient was not pregnant. She did not have covid prior vaccination. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication, start and stop date were not reported; lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported; and vitamins.  The patient experienced extreme fatigue (fatigue) (disability, life threatening), decreased energy (asthenia) (disability, life threatening), needed to sleep most of the day (hypersomnia) (disability, life threatening), difficulty maintaining balance (balance disorder) (disability, life threatening), heart palpitations (palpitations) (disability, life threatening), all on 11Mar2021 04:00. These conditions started 2-3 days after the first vaccine (as reported). The adverse events resulted in Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient did not receive any treatment for the adverse events. Outcome of the events was recovered on an unspecified date in 2021. The patient was not tested for covid post vaccination.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Viral load
Clinical narrative: unusually high number of covid infections in fully vaccinated employees; unusually high number of covid infections in fully vaccinated employees; This is a spontaneous report from a contactable physician. This physician reported similar events for 11 patients. This is the second of 11 reports. A patient of unspecified age and gender received the first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 17Dec2020 (lot number EH9899) and in Jan2021 (lot number unknown), respectively, both via an unspecified route of administration (age at vaccination unknown), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The physician stated they were seeing an unusually high number of COVID infections in fully vaccinated employees, with second dose plus two weeks, plus well over two weeks. All of whom received Pfizer and all of whom received their first dose from the same lot. The physician stated they may need some kind of investigation here, because they are seeing high viral loads in these individuals and symptoms. It is not right. All eleven individuals received their first dose from the same lot: EH9899. They did the standard dosage with the standard vanishing needle. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. The case will be reevaluated should additional information become available.,Linked Report(s) : US-PFIZER INC-2021446068 same reporter/ vaccine/ event, different patients;US-PFIZER INC-2021446063 same reporter/ vaccine/ event, different patients;US-PFIZER INC-2021446064 same reporter/ vaccine/ event, different patients;US-PFIZER INC-2021446065 same reporter/ vaccine/ event, different patients;US-PFIZER INC-2021446067 same reporter/ vaccine/ event, different patients;US-PFIZER INC-2021446066 same reporter/ vaccine/ event, different patients;US-PFIZER INC-2021446070 same reporter/ vaccine/ event, different patients;US-PFIZER INC-2021446069 same reporter/ vaccine/ event, different patients;US-PFIZER INC-2021446062 same reporter/ vaccine/ event, different patients;US-PFIZER INC-2021392224 same reporter/ vaccine/ event, different patients
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Viral load
Clinical narrative: unusually high number of covid infections in fully vaccinated employees; unusually high number of covid infections in fully vaccinated employees; This is a spontaneous report from a contactable Physician. This Physician reported similar events for 11 patients. This is 3rd of 11 reports.    A patient of unspecified age and gender received the first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on Dec2020 (reported as between 17Dec2020-30Dec2020 (lot number EH9899) and in Jan2021 (between range of 07Jan2021-20Jan2021) (lot number unknown), respectively, both via an unspecified route of administration (age at vaccination unknown), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The physician stated they were seeing an unusually high number of COVID infections in fully vaccinated employees, with second dose plus two weeks, plus well over two weeks.  All of whom received Pfizer and all of whom received their first dose from the same lot. The physician stated they may need an investigation, because they are seeing high viral loads in these individuals and symptoms. The physician reports it is not right. All eleven individuals received their first dose from the same lot: EH9899. They did the standard dosage with the standard vanishing needle. The outcome of the event was unknown.  The patent is not in a study or program.    Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.,Linked Report(s) : US-PFIZER INC-2021392224 same reporter/ vaccine/ event, different patients;US-PFIZER INC-2021445810 same reporter/ vaccine/ event, different patients
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: unusually high number of covid infections in fully vaccinated employees; unusually high number of covid infections in fully vaccinated employees; This is a spontaneous report from a contactable physician. This physician reported similar events for 11 patients. This is the 4th of 11 reports.  A patient of unspecified age and gender received the first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 18Dec2020 (lot number EH9899) and in Jan2021 (lot number unknown), respectively, both via an unspecified route of administration (age at vaccination unknown), as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The physician stated they were seeing an unusually high number of COVID infections in fully vaccinated employees, with second dose plus two weeks, plus well over two weeks. All of whom received Pfizer and all of whom received their first dose from the same lot. The physician stated they may need some kind of investigation here, because they are seeing high viral loads in these individuals and symptoms. It is not right. All eleven individuals received their first dose from the same lot: EH9899. They did the standard dosage with the standard vanishing needle. The report was not related to a study or programme. The outcome of the event was unknown.  Information on the lot/batch number has been requested; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. The case will be reevaluated should additional information become available.,Linked Report(s) : US-PFIZER INC-2021392224 same reporter/ vaccine/ event, different patients;US-PFIZER INC-2021445810 same reporter/ vaccine/ event, different patients
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Viral load
Clinical narrative: unusually high number of covid infections in fully vaccinated employees; unusually high number of covid infections in fully vaccinated employees; This is a spontaneous report from a contactable Physician. This Physician reported similar events for 11 patients. This is 5th of 11 reports.    A patient of unspecified age and gender received the first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on Dec2020 (reported as between 17Dec2020-30Dec2020 (lot number EH9899) and in Jan2021 (between range of 07Jan2021-20Jan2021) (lot number unknown), respectively, both via an unspecified route of administration (age at vaccination unknown), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The physician stated they were seeing an unusually high number of COVID infections in fully vaccinated employees, with second dose plus two weeks, plus well over two weeks.  All of whom received Pfizer and all of whom received their first dose from the same lot. The physician stated they may need an investigation, because they are seeing high viral loads in these individuals and symptoms. The physician reports it is not right. All eleven individuals received their first dose from the same lot: EH9899. They did the standard dosage with the standard vanishing needle. The outcome of the event was unknown.  The patent is not in a study or program.    Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), cannot be excluded. The case will be reevaluated should additional information become available. ,Linked Report(s) : US-PFIZER INC-2021392224 same reporter/ vaccine/ event, different patients;US-PFIZER INC-2021445810 same reporter/ vaccine/ event, different patients
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Viral load
Clinical narrative: unusually high number of covid infections in fully vaccinated employees; unusually high number of covid infections in fully vaccinated employees; This is a spontaneous report from a contactable physician. This physician reported similar events for 11 patients. This is the 6th of 11 reports.  A patient of unspecified age and gender received the first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on Dec2020 (reported as between 17Dec2020-30Dec2020 (lot number EH9899) and in Jan2021 (between range of 07Jan2021-20Jan2021) (lot number unknown), respectively, both via an unspecified route of administration (age at vaccination unknown), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The physician stated they were seeing an unusually high number of COVID infections in fully vaccinated employees, with second dose plus two weeks, plus well over two weeks.  All of whom received Pfizer and all of whom received their first dose from the same lot. The physician stated they may need an investigation, because they are seeing high viral loads in these individuals and symptoms. The physician reports it is not right. All eleven individuals received their first dose from the same lot: EH9899. They did the standard dosage with the standard vanishing needle. The outcome of the event was unknown. The patent is not in a study or program.    Information on the lot/batch number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the events drug ineffective and Covid 19 cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.,Linked Report(s) : US-PFIZER INC-2021392224 same reporter/ vaccine/ event, different patients;US-PFIZER INC-2021445810 same reporter/ vaccine/ event, different patients
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Viral load
Clinical narrative: unusually high number of covid infections in fully vaccinated employees; unusually high number of covid infections in fully vaccinated employees; This is a spontaneous report from contactable physician. This physician reported similar events for 11 patients. This report is for 7th of 11 patients.   A patient of unspecified age and gender received the first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on Dec2020 (reported as between 17Dec2020-30Dec2020 (lot number EH9899) and in Jan2021 (between range of 07Jan2021-20Jan2021) (lot number unknown), respectively, both via an unspecified route of administration (age at vaccination unknown), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The physician stated they were seeing an unusually high number of COVID infections in fully vaccinated employees, with second dose plus two weeks, plus well over two weeks.  All of whom received Pfizer and all of whom received their first dose from the same lot. The physician stated they may need an investigation, because they are seeing high viral loads in these individuals and symptoms. The physician reports it is not right. All eleven individuals received their first dose from the same lot: EH9899. They did the standard dosage with the standard vanishing needle. The outcome of the event was unknown.  The patent is not in a study or program.    Information on the lot/batch number has been requested.; Sender's Comments: Based on the known product safety profile and plausible temporal relationship, a possible contributory role of the suspect product BNT162B2 to the reported COVID-19 cannot be completely excluded. Case will be reassessed upon receipt of additional information.,Linked Report(s) : US-PFIZER INC-2021392224 same reporter/ vaccine/ event, different patients;US-PFIZER INC-2021445810 same reporter/ vaccine/ event, different patients
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: unusually high number of covid infections in fully vaccinated employees; unusually high number of covid infections in fully vaccinated employees; This is a spontaneous report from a contactable physician. This physician reported similar events for 11 patients. This is the eighth of 11 reports. A patient of unspecified age and gender received the first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 23Dec2020 (lot number EH9899) and in Jan2021 (lot number unknown), respectively, both via an unspecified route of administration (age at vaccination unknown), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The physician stated they were seeing an unusually high number of COVID infections in fully vaccinated employees, with second dose plus two weeks, plus well over two weeks. All of whom received Pfizer and all of whom received their first dose from the same lot. The physician stated they may need an investigation, because they were seeing high viral loads in these individuals and symptoms. It was not right. All eleven individuals received their first dose from the same lot: EH9899. They did the standard dosage with the standard vanishing needle. The reporter was unsure if they kept the empty vials. The outcome of the event unusually high number of COVID infections in fully vaccinated employees was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the events drug ineffective and Covid 19 infection cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.,Linked Report(s) : US-PFIZER INC-2021392224 same reporter/ vaccine/ event, different patients;US-PFIZER INC-2021445810 same reporter/ vaccine/ event, different patients
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure, Viral load
Clinical narrative: unusually high number of covid infections in fully vaccinated employees; unusually high number of covid infections in fully vaccinated employees; This is a spontaneous report from a contactable Physician. This Physician reported similar events for 11 patients. This is 9th of 11 reports.   A patient of unspecified age and gender received the first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on Dec2020 (reported as between 17Dec2020-30Dec2020 (lot number EH9899) and in Jan2021 (between range of 07Jan2021-20Jan2021) (lot number unknown), respectively, both via an unspecified route of administration (age at vaccination unknown), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The physician stated they were seeing an unusually high number of COVID infections in fully vaccinated employees, with second dose plus two weeks, plus well over two weeks.  All of whom received Pfizer and all of whom received their first dose from the same lot. The physician stated they may need an investigation, because they are seeing high viral loads in these individuals and symptoms. The physician reports it is not right. All eleven individuals received their first dose from the same lot: EH9899. They did the standard dosage with the standard vanishing needle. The outcome of the event was unknown.  The patent is not in a study or program.    Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected Vaccination failure.   It is reported that COVID infection developed in fully vaccinated employee, with second dose plus two weeks, plus well over two weeks. There is limited information provided in this report.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021392224 same reporter/ vaccine/ event, different patients;US-PFIZER INC-2021445810 same reporter/ vaccine/ event, different patients
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Viral load
Clinical narrative: unusually high number of covid infections in fully vaccinated employees; unusually high number of covid infections in fully vaccinated employees; This is a spontaneous report from a contactable Physician. This Physician reported similar events for 11 patients. This is 10th of 11 reports.   A patient of unspecified age and gender received the first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on Dec2020 (reported as between 17Dec2020-30Dec2020 (lot number EH9899) and in Jan2021 (between range of 07Jan2021-20Jan2021) (lot number unknown), respectively, both via an unspecified route of administration (age at vaccination unknown), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The physician stated they were seeing an unusually high number of COVID infections in fully vaccinated employees, with second dose plus two weeks, plus well over two weeks.  All of whom received Pfizer and all of whom received their first dose from the same lot. The physician stated they may need an investigation, because they are seeing high viral loads in these individuals and symptoms. The physician reports it is not right. All eleven individuals received their first dose from the same lot: EH9899. They did the standard dosage with the standard vanishing needle. The outcome of the event was unknown.  The patent is not in a study or program.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available,Linked Report(s) : PFIZER INC-2021392224 same reporter/ vaccine/ event, different patients;PFIZER INC-2021445810 same reporter/ vaccine/ event, different patients