chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Deep vein thrombosis, Pulmonary embolism, Pyrexia
Clinical narrative: Large burden of DVT/PEs; Large burden of DVT/PEs; Associated acute kidney injury and fevers; Associated acute kidney injury and fevers; This is a spontaneous report from a contactable physician. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on May2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medication included drospirenone, ethinylestradiol (YASMIN) taken as birth control pills, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization. The patient diagnosed with COVID-19 prior to vaccination. The patient experienced large burden of DVT/PEs noticed approximately 1 month after vaccination in Jun2021 and associated acute kidney injury and fevers. Events resulted in visit to Doctor or other healthcare professional office/clinic and Emergency room/department or urgent care. Patient was hospitalized for the events. Treatment received included anticoagulation + IVC Filter. Outcome of the events was recovering. The patient had not been tested for COVID-19 since the vaccination.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the reported events cannot be excluded.  The impacts of this report on the benefit/risk profile of the product and on the conduct of the study are evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concerns identified as part of this review, as well as any appropriate actions in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Chest pain, Haemoptysis
Clinical narrative: having some mild heart pain that fades away; had a mild heart pain and moderate pain in the chest; wife also had blood in he mouth. She was coughing up blood; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22May2021 (lot number and expiry date: unknown) as dose 1, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of the Pfizer COVID-19 vaccine. On 23May2021 (second day), she had a mild heart pain and moderate pain in the chest for 1-2 days. The adverse events already decreased and faded away. On unspecified date in May2021, the patient also had blood in the mouth. She was coughing up blood. It was a one-time event. The husband reported that his wife (patient) wanted to know if she would have these adverse events with the second dose of the vaccine. Outcome of the events was recovered on unspecified date in May2021.  Information on lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Bowel movement irregularity, Burning sensation, Dizziness, Fatigue
Clinical narrative: blackouts; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; pressure in bowel movements,; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 59-years-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 59-years-old via an unspecified route of administration, administered in Arm Right on 28May2021 16:00 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation.  Medical history included chronic obstructive pulmonary disease. No known allergies.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  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's concomitant medications were not reported.  The patient experienced bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movements, having blackouts on 28May2021 16:00. The adverse event resulted in: Doctor or other healthcare professional office/clinic visit. Treatment was received including Horticozone Shot.  The outcome was recovering. Seriousness was reported as yes.  Information on the Lot / Batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Loss of consciousness, Pruritus, Rash
Clinical narrative: blackouts; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; pressure in bowel movements,; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 59-years-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 59-years-old via an unspecified route of administration, administered in Arm Right on 28May2021 16:00 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation.  Medical history included chronic obstructive pulmonary disease. No known allergies.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  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's concomitant medications were not reported.  The patient experienced bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movements, having blackouts on 28May2021 16:00. The adverse event resulted in: Doctor or other healthcare professional office/clinic visit. Treatment was received including Horticozone Shot.  The outcome was recovering. Seriousness was reported as yes.  Information on the Lot / Batch number has been requested.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Febrile convulsion, Seizure
Clinical narrative: Extremely high fever that led to a seizure; Extremely high fever that led to a seizure; This is a spontaneous report from a contactable consumer (patient's parent) received via COVID-19 Vaccine Adverse Event Self-Reporting Solution (COVAES) portal. A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 08Jun2021 at the age of 12 years old (Batch/Lot number and Expiration date were unknown) as dose 2, single for COVID-19 immunization. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at the age of 12 years old, dose 1 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Jun2021 at 20:00, the patient experienced extremely high fever that led to a seizure. The adverse event did result in an emergency room/department or urgent care. Therapeutic measures were taken as a result of extremely high fever that led to a seizure, which included emergency medical services (EMS) support, paracetamol (TYLENOL), and ice bath. The patient recovered from the events on an unspecified date.  Information on the batch/lot number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Investigation, Urticaria
Clinical narrative: hives that have progressivly become worse and worse over the last several months/bruising and welts that seemingly are not manageable with drugs; bruising and welts that seemingly are not manageable with drugs; This is a spontaneous report from a contactable Other Health Professional (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 41 years of age), intramuscular on 04Feb2021 12:00 (Batch/Lot Number: EL0142) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Medical history was none. There were no concomitant medications. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. She has not been tested for COVID-19 since the vaccination. The patient experienced hives that have progressively become worse and worse over the last several months. She was now on high dose steroids and have bruising and welts that seemingly are not manageable with drugs. The events started on 12Feb2021 with outcome of not recovered. The patient underwent lab tests and procedures which included pooled test was negative (Other) on an unspecified date. Therapeutic measures were taken as a result of the events. The events resulted to doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care.; Sender's Comments: Considering a plausible drug-event temporal relationship, a causal association between the reported 'hives/welts and 'bruising', and the administration of the vaccine BNT162B2 in this patient cannot be completely excluded. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Myocarditis, Troponin, Troponin increased
Clinical narrative: Chest pain with elevated troponin; Chest pain with elevated troponin; Suspect myocarditis; This is a spontaneous report from a contactable physician. A 15-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0178) via an unspecified route of administration, on 06Jun2021 (at the age of 15 years old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since the vaccination. The facility where the most recent COVID-19 vaccine was administered was at the Pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Any other medications that the patient received within 2 weeks of vaccination was not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0176) on 16May2021. On 08Jun2021, it was reported that the patient experienced chest pain with elevated troponin which was treated with IVIG and ketorolac. Suspect myocarditis was also reported. The outcome of the event was unknown.  Follow-up attempts are possible. Further information is expected.; Sender's Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the events chest pain with elevated troponin, Suspect myocarditis  onset.  More information such as complete medical history and concomitant medications are needed for fully medical assessment. 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: Blood test, Contusion, Eye haemorrhage, Haemorrhage, Platelet count
Clinical narrative: bleeding problem/issues with bleeding; bleeding in her eyeball; bruising on her legs; Prothrombin Time (PTT) was elevated; This is a spontaneous report from a contactable consumer (patient's daughter) via Medical information team and via Pfizer- Sponsored Program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced some issues with bleeding and bruising, that there was "bruising in the leg, and bleeding in her eyeball". The patient's prothrombin time (PTT) was elevated. The patient's daughter wanted to ask if it is possible that the spike protein would damage her mother's vascular system and made her mother's veins leak? But upon transfer, the patient's daughter pushed on "what doctor" does her mother need to see?. The patient's daughter mentioned that their Doctor and Hematologist both mentioned that this is not related to the vaccine, but the patient's daughter asked for more information since this happened after the vaccination. The patient has developed a bleeding problem after getting the COVID 19 vaccine. The patient has gone to the regular doctor. Her regular doctor said it is nothing to do with the vaccine. The patient had an elevated PTT. The patient has bruising on her legs, and her keeps bruising for no reason. The patient went to the doctor because of the bruising. The bruising started after the vaccine. The patient never had an issue with bruising before. The doctor sent her to the hematologist. That doctor keeps taking blood work. He says the patient's blood work is getting more normal, but this is going on three months since the second shot. They also sent her mother to the eye doctor. They found that the patient was bleeding in her eyeball. They gave her an injection in her eyeball to stop the bleeding. The caller is worried that her mother is going to bleed in her brain and have a stroke. Just like the regular doctor said, the eye doctor says the bleeding has nothing to do with the vaccine. The patient has seen a hematologist, and her blood levels are more normal. The PTT is only slightly elevated it is not 60-70 and platelets are normal. The doctors cannot explain why this could be happening. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Prothrombin time, Prothrombin time prolonged
Clinical narrative: bleeding problem/issues with bleeding; bleeding in her eyeball; bruising on her legs; Prothrombin Time (PTT) was elevated; This is a spontaneous report from a contactable consumer (patient's daughter) via Medical information team and via Pfizer- Sponsored Program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced some issues with bleeding and bruising, that there was "bruising in the leg, and bleeding in her eyeball". The patient's prothrombin time (PTT) was elevated. The patient's daughter wanted to ask if it is possible that the spike protein would damage her mother's vascular system and made her mother's veins leak? But upon transfer, the patient's daughter pushed on "what doctor" does her mother need to see?. The patient's daughter mentioned that their Doctor and Hematologist both mentioned that this is not related to the vaccine, but the patient's daughter asked for more information since this happened after the vaccination. The patient has developed a bleeding problem after getting the COVID 19 vaccine. The patient has gone to the regular doctor. Her regular doctor said it is nothing to do with the vaccine. The patient had an elevated PTT. The patient has bruising on her legs, and her keeps bruising for no reason. The patient went to the doctor because of the bruising. The bruising started after the vaccine. The patient never had an issue with bruising before. The doctor sent her to the hematologist. That doctor keeps taking blood work. He says the patient's blood work is getting more normal, but this is going on three months since the second shot. They also sent her mother to the eye doctor. They found that the patient was bleeding in her eyeball. They gave her an injection in her eyeball to stop the bleeding. The caller is worried that her mother is going to bleed in her brain and have a stroke. Just like the regular doctor said, the eye doctor says the bleeding has nothing to do with the vaccine. The patient has seen a hematologist, and her blood levels are more normal. The PTT is only slightly elevated it is not 60-70 and platelets are normal. The doctors cannot explain why this could be happening. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 100.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Asymptomatic COVID-19, Drug ineffective, Polymerase chain reaction positive
Clinical narrative: contracted COVID-19, was diagnosed with COVID-19 and was asymptomatic; contracted COVID-19, was diagnosed with COVID-19 and was asymptomatic; This is a spontaneous report from a Pfizer sponsored program COVAX US Support received from a contactable consumer. A 100-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (reported as late December or early January) (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration in Jan2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunization; paracetamol (TYLENOL), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included atrial fibrillation. The patient's concomitant medications were not reported. The patient previously took amiodarone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. In Apr2021, it was reported that the patient contracted COVID-19, was diagnosed with COVID-19 and was asymptomatic. The patient got COVID even though she received the vaccine. Patient is in a nursing home. Every week the nursing home test her, every single week for everybody. In Apr2021, they did the PCR, she is asymptomatic and it says that she is positive. The action taken in response to the events for paracetamol was unknown. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: 5 days after receiving the Pfizer vaccination I ended up in the ER due to me having a miscarriage that had started approximately 4 days after the vaccination was given.; This is a spontaneous report received from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 05May2021 13:00 (Batch/Lot Number: EW0171) (at age of 36 years) as DOSE 1, SINGLE for COVID-19 immunisation. Patient was pregnant at time of vaccination. Last menstrual date was on 09Apr2021. Medical history included known allergies (unspecified) and other unspecified medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were other unspecified medications the patient received within 2 weeks of vaccination. 5 days after receiving the Pfizer vaccination, patient ended up in the ER due to having a miscarriage that had started approximately 4 days after the vaccination was given, on 08May2021 08:00 (as reported). The mother was 4 weeks pregnant at the onset of the event (also reported as 5 with unspecified unit). The mother was due to deliver on 14Jan2022. The mother delivered the pregnancy (as reported, pending clarification). The pregnancy resulted in spontaneous abortion. Adverse event resulted in Emergency room/department or urgent care. Treatment for event was unknown. The outcome of event was recovered on May2021.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Chills, Computerised tomogram, Cough, Pneumonia
Clinical narrative: High Fever; chills; cough; vomiting; Pneumonia; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 23May2021 18:00 (at the age of 59 years old), dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the has not patient been tested for COVID-19. On 26May2021 15:00, the patient experienced high fever and chills, cough and vomiting. He reported to his doctor. Chest x-ray on 09Jun2021 showed Pneumonia. Pneumonia was reported to have lasted more than 30 days and not getting better. A CT scan was done on 09Jun2021 and waiting for report (unknown results). The adverse events resulted in doctor or healthcare professional office/clinic visit. The adverse events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the events. The outcome of the events was not recovered.   Information on the batch/lot number has been requested.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: High Fever; chills; cough; vomiting; Pneumonia; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 23May2021 18:00 (at the age of 59 years old), dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the has not patient been tested for COVID-19. On 26May2021 15:00, the patient experienced high fever and chills, cough and vomiting. He reported to his doctor. Chest x-ray on 09Jun2021 showed Pneumonia. Pneumonia was reported to have lasted more than 30 days and not getting better. A CT scan was done on 09Jun2021 and waiting for report (unknown results). The adverse events resulted in doctor or healthcare professional office/clinic visit. The adverse events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the events. The outcome of the events was not recovered.   Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: pass away recently due to blood clots; This is a spontaneous report from a contactable nurse (parent) and consumer. The nurse reported similar events for three patients. This is the first of three reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient pass away recently due to blood clots on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. It was reported that even though the event was outside of reporting timelines & deemed by the PI to be unrelated to study drug.  Information on batch and lot number is requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of thrombosis with fatal outcome due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this patient. There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including vascular imaging studies, coagulation panel and autopsy results, counteractive treatment measures and concomitant medications. 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) : PFIZER INC-2021688670 same reporter, event and suspect drug; different patient; PFIZER INC-2021688671 same reporter, event and suspect drug; different patient; Reported Cause(s) of Death: blood clots
Sex: F
Vaccine: PPV
Symptoms: Bell's palsy
Clinical narrative: The customer had Bell's Palsy the day after the pneumonia vaccine; This is a spontaneous report from a Pfizer-sponsored program, from a contactable pharmacist. A 64-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration on an unspecified date (Lot number was not reported) as unknown dose number, single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient had a reaction with the pneumonia vaccine which was not specified. The patient had Bell's Palsy the day after the pneumonia vaccine on an unspecified date. The outcome of the event was unknown.  Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) (pneumonia vaccine) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) (pneumonia vaccine) has submitted the same report to the regulatory authorities.  Information about lot/batch number has been requested.; Sender's Comments: Based on the close temporal relationship, the association between the event Bell's Palsy with pneumococcal 13-valent conjugate vaccine can not 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: Decreased appetite, Loss of consciousness, Nausea
Clinical narrative: loss of consciousness x 2; nausea; loss of appetite; This is a spontaneous report from a non-contactable consumer (patients father) regarding product Pfizer BioNTech vaccine. This report was received from a Pfizer Colleague.  A 16 years old female patient received 2nd dose of BNT162B2 (Pfizer BioNTech vaccine) at single dose for COVID-19 immunisation. Medical history and concomitant drug were not reported. Patient experienced nausea and loss of appetite. Patient only had one meal at the end of that day and continued to have loss of appetite the next day following the dose. Patient experienced loss of consciousness x 2 in the afternoon the day after the vaccine. Parents took patient to ER for evaluation. Patient was given fluids & sent home feeling better. Event took place after use of product. Outcome of the event was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Patient died due to Blood clots; This is a spontaneous report from a contactable nurse.  This nurse reported similar events for 3 patients. This is the 2nd of 3 reports.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown dose, single for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient pass away recently due to blood clots.  The agency also stated that all 3 of these nurses had received the Pfizer vaccine. Document submitted for patient even though the event was outside of reporting timelines and deemed by the PI to be unrelated to study drug. It is not reported if autopsy was performed.   information about lot/batch number has been requested.; Sender's Comments: Based from current drug profile, the event thrombosis is assessed as unrelated to suspected drug  BNT162B2 . It is difficult to provide possible cause of the event due to limited patient medical  information or background.,Linked Report(s) : PFIZER INC-2021683252 same reporter, same drug, same event, different patient;PFIZER INC-2021688671 same reporter, same drug, same event, different patient; Reported Cause(s) of Death: Blood clots
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cardiac disorder, Electrocardiogram, Heart rate increased, Magnetic resonance imaging
Clinical narrative: heart was a little weird but then it went away; heart beating really fast; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 34-years-old male patient received bnt162b2 (BNT162B2, solution for injection) via an unspecified route of administration, administered in Arm Right on 17Mar2021 (at the age of 34-year-old)  (Lot Number: EN6208) as 1ST DOSE, SINGLE DOSE for covid-19 immunization. Medical history included heart problems (a month ago). He was eating really bad junk food/eating a lot of junk food. He was also smoking a lot of marijuana prior, but he stopped that like a month ago because he started getting a lot of heart problems a month ago which was almost like a month after the vaccine or a few weeks after. The patient concomitant medications were not reported. Regarding family Medical History Relevant to AE, consumer stated, No, but he was eating really bad junk food for like two years so that could also not make it any better. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that, the first shot which was on 17Mar2021 and his heart was a little weird but then it went away and also reported that, it was not the too serious it was just heart beating really fast and then yeah on 17Mar2021. Also reported that, there was a possibility or reports of people having issues with their heart after receiving the vaccine or not. Reporter would like to know if the vaccine could cause heart issues. The patient underwent lab tests and procedures which included blood test, electrocardiogram, and magnetic resonance imaging results unknown on unknown dates (but they were saying they were waiting for the MRI he got a do MRI). The clinical outcome of the event heart was a little weird but then it went away was recovered on an unspecified date and heart beating really fast was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chest pain, Chills, Fatigue
Clinical narrative: chills; sweating; tired; high fever with reading 105F; severe chest pain; intense pressure starting in back and radiating in front...This pain was worst than fever; This is a spontaneous report from a contactable consumer(patient). A 38-years-old female patient received bnt162b2(Pfizer vaccine, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 29May2021 17:45 (Batch/Lot Number: EW0182) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included historical vaccine BNT162B2 as 1st dose single dose, administered in left arm on 08May2021 5:45pm (Lot no. EW0182) for covid 19 immunisation. Prior to the vaccination, the patient was not diagnosed with covid 19. Since the vaccination, had not been tested for covid 19. Allergies was not reported. Concomitant medications were not reported.The patient reported after 6 hours of her second dose, on 29May2021 02:00, she got a high fever with reading 105F along with severe chest pain. Chest pain started first, it seemed like intense pressure starting in back and radiating in front. This pain was worst than fever, she thought it was likely caused by gas, so took GasX  pill and did not help. This lasted for an hr, after that she got chills and then the fever. she tool Tylenol and then after sweating, fever was gone. After exact 4 Hrs, same thing started again with chest pain, chills, fever and sweating. This went on for 2 days. Even with Tylenol fever never came down below 100F and at the end of 4th hour it was always high in a range of 104F-105F. On 3rd day, she switched to ibuprufen and then fever didn't come after that. she felt very tired all 3rd day, but returned to normal activities on 4th day. The patient received Birth Control Pills within 2 weeks of vaccination as medications. Outcome of the events the patient experienced high fever with reading 105f, severe chest pain, intense pressure starting in back and radiating in front this pain was worst than fever recovered on unspecified date in 2021. Outcome of the other events was recovered on unspecified date.  Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pyrexia
Clinical narrative: chills; sweating; tired; high fever with reading 105F; severe chest pain; intense pressure starting in back and radiating in front...This pain was worst than fever; This is a spontaneous report from a contactable consumer(patient). A 38-years-old female patient received bnt162b2(Pfizer vaccine, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 29May2021 17:45 (Batch/Lot Number: EW0182) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included historical vaccine BNT162B2 as 1st dose single dose, administered in left arm on 08May2021 5:45pm (Lot no. EW0182) for covid 19 immunisation. Prior to the vaccination, the patient was not diagnosed with covid 19. Since the vaccination, had not been tested for covid 19. Allergies was not reported. Concomitant medications were not reported.The patient reported after 6 hours of her second dose, on 29May2021 02:00, she got a high fever with reading 105F along with severe chest pain. Chest pain started first, it seemed like intense pressure starting in back and radiating in front. This pain was worst than fever, she thought it was likely caused by gas, so took GasX  pill and did not help. This lasted for an hr, after that she got chills and then the fever. she tool Tylenol and then after sweating, fever was gone. After exact 4 Hrs, same thing started again with chest pain, chills, fever and sweating. This went on for 2 days. Even with Tylenol fever never came down below 100F and at the end of 4th hour it was always high in a range of 104F-105F. On 3rd day, she switched to ibuprufen and then fever didn't come after that. she felt very tired all 3rd day, but returned to normal activities on 4th day. The patient received Birth Control Pills within 2 weeks of vaccination as medications. Outcome of the events the patient experienced high fever with reading 105f, severe chest pain, intense pressure starting in back and radiating in front this pain was worst than fever recovered on unspecified date in 2021. Outcome of the other events was recovered on unspecified date.  Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Had arm pain for three days; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program COVAX US support. A 38-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0175, expiry date: 31Aug2021) via unspecified route of administration, administered in right side upper arm on 20May2021 (08:05 AM may be, he clearly didn't remember) as single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient had no family medical history. Patient did not receive prior vaccination (4 weeks prior). In May2021, after the first dose patient had arm pain for about three days. Patient did not received treatment. The outcome of event was resolved in May2021.  Information on lot/batch number was available. Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Rheumatological examination
Clinical narrative: joint pain/joint ache; his patient may have some arthritis in his joint; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date as unknown single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Physician was calling for his patient who had the Pfizer COVID-19 vaccine. Prior to vaccination, he was fine but after he got the vaccine, on an unspecified date he had joint pain. Caller already ordered all rheumatologic tests and they were all negative. He said that his patient might have some arthritis in his joint but no other major issues. Caller wanted to know if there had been studies for causal relation and long term effects of the vaccine to the joints. It was reported that, joint pain has been reported as an adverse event with the Pfizer COVID-19 vaccine. The physician stated, "So, recently I had a patient who received the Covid vaccine few months ago and after a week or so developed a lots of joint aches, joint pains". Among the Pfizer-BioNTech COVID-19 Vaccine recipients, mild-to-moderate pain at the injection site within 7 days after an injection was the most commonly reported local reaction, with less than 1 percent of participants across all age groups reporting severe pain. In general, local side effects; the ones you get on the arm where you got the shot (such as injection site redness and injection site swelling) were mostly mild-to moderate in severity." and resolved within 1 to 2 days. Side effects that you may experience throughout the rest of your body; (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. The patient underwent lab tests and procedures which included rheumatological examination which was negative on an unspecified date. The outcome of all events was unknown.  Information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Chills, Decreased appetite, Delusion
Clinical narrative: Fever of 103.1; Cold Chills; Body Ache; Pain At Injection Site; Very Tired, Extremely exhausted; Delusional off/On; Mild/Sever Diarrhea; Headache On/Off; Upset stomach; Loss of appetite; Lazy Feeling(Extremely exhausted); Left arm swelling arm & Injection Site; Left arm swelling arm & Injection Site; left arm pain, very red tender to touch; Very red tender to touch; This is a spontaneous report from a contactable consumer (patient). A 27-years-old female patient received bnt162b2 via an unspecified route of administration, administered in left arm on 10Jun2021 11:00 (Lot Number: Ew0180) as 2nd dose, single dose at the age of 27-year-old for covid-19 immunization. The patient was not pregnant. Historic vaccine was bnt162b2 via an unspecified route of administration, administered in left arm on 17May2021 13:45 (Lot Number: Ewv172) as 1st dose, single dose at the age of 27-year-old for covid-19 immunization. Medical history included Lung disease- Histoplasmosis, Stress Seurizes, chronic back pain, and Known allergies: Adhesive tape from an unknown date. Past drug event included ibuprofen and doxycycline and experienced allergies. Concomitant medication included cetirizine hydrochloride (CETIRIZINE HCL); oxycodone hydrochloride, paracetamol (PERCOCET, 5 mg); women vitamins (OLLY), all taken for an unspecified indication within 2 weeks of vaccination. The patient experienced left arm swelling arm & injection site, very red tender to touch/left arm pain, cold chills, body ache, pain at injection site, very tired, delusional off/on, mild/sever diarrhea, headache on/off, upset stomach, loss of appetite, lazy feeling (Extremely exhausted) on 10Jun2021. The patient also experienced fever of 103.1 on 10Jun2021 11:00 am. The patient underwent lab tests and procedures which included body temperature: 103.1 on 10Jun2021 11:00 am. Therapeutic measures were not taken as a result of events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination,  the patient had not been tested for COVID-19. The outcome of events was not recovered.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Erythema, Fatigue, Headache, Laziness
Clinical narrative: Fever of 103.1; Cold Chills; Body Ache; Pain At Injection Site; Very Tired, Extremely exhausted; Delusional off/On; Mild/Sever Diarrhea; Headache On/Off; Upset stomach; Loss of appetite; Lazy Feeling(Extremely exhausted); Left arm swelling arm & Injection Site; Left arm swelling arm & Injection Site; left arm pain, very red tender to touch; Very red tender to touch; This is a spontaneous report from a contactable consumer (patient). A 27-years-old female patient received bnt162b2 via an unspecified route of administration, administered in left arm on 10Jun2021 11:00 (Lot Number: Ew0180) as 2nd dose, single dose at the age of 27-year-old for covid-19 immunization. The patient was not pregnant. Historic vaccine was bnt162b2 via an unspecified route of administration, administered in left arm on 17May2021 13:45 (Lot Number: Ewv172) as 1st dose, single dose at the age of 27-year-old for covid-19 immunization. Medical history included Lung disease- Histoplasmosis, Stress Seurizes, chronic back pain, and Known allergies: Adhesive tape from an unknown date. Past drug event included ibuprofen and doxycycline and experienced allergies. Concomitant medication included cetirizine hydrochloride (CETIRIZINE HCL); oxycodone hydrochloride, paracetamol (PERCOCET, 5 mg); women vitamins (OLLY), all taken for an unspecified indication within 2 weeks of vaccination. The patient experienced left arm swelling arm & injection site, very red tender to touch/left arm pain, cold chills, body ache, pain at injection site, very tired, delusional off/on, mild/sever diarrhea, headache on/off, upset stomach, loss of appetite, lazy feeling (Extremely exhausted) on 10Jun2021. The patient also experienced fever of 103.1 on 10Jun2021 11:00 am. The patient underwent lab tests and procedures which included body temperature: 103.1 on 10Jun2021 11:00 am. Therapeutic measures were not taken as a result of events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination,  the patient had not been tested for COVID-19. The outcome of events was not recovered.