chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: About 2 day's later her daughter had symptoms of Covid in which she did test positive for; This is a spontaneous report from a contactable consumer. A female patient (reporter's daughter) of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration on 03Apr2021 as SINGLE DOSE for covid-19 immunization.The patient's medical history was not reported. The patient's concomitant medications were not reported. On 05Apr2021 about 2 days later, her daughter had symptoms of covid in which she did test positive for. Consumer's(mother) daughter would receive her second Pfizer Covid 19 Vaccine on 24Apr2021. Consumer wanted to know if her daughter would be okay to receive the second Pfizer Covid 19 Vaccine she will be okay. The patient underwent lab tests and procedures which included Covid:SARS-CoV-2 test: positive on 05Apr2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pain, Thrombosis, Wheezing
Clinical narrative: painful little clot in her front leg; pain/ache; shortness of breath like wheezing; shortness of breath like wheezing; This is a spontaneous report from a contactable consumer via a Pfizer sponsored program. A female patient (consumer) of an unspecified age received first dose of BNT162B2 (Pfizer COVID-19 Vaccine, Formulation: Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on 26Mar2021, at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had the first dose 26Mar2021 and scheduled for the second dose on 21Apr2021, which was more than 21 days. Caller read the news about the adverse events with (Other company vaccine). They experienced pain/ache and shortness of breath like wheezing on an unspecified date in 2021. They also had a painful little clot in her front leg on an unspecified date in 2021. They wants to know if she can take the second dose. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Haemorrhage
Clinical narrative: This is a spontaneous report from a contactable consumer. A 34-year-old female (patient) (pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8734), via an unspecified route of administration administered in left arm on 10Apr2021 as single dose for COVID-19 immunisation. The patient LMP Was on 24Feb2021 and 5 weeks of gestational period. Patient medical history included Known Allergies: Penicillin. Concomitant medications included Prenatal vitamins within 2 weeks of vaccination. There were no allergies to medications, food, or other products. Known allergies to Penicilin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12 Apr2021, 48 hours after the vaccine patient started bleeding that has progress from a brown color to a bright red and from a small amount to a moderate amount for 5 days. The adverse event resulted in emergency room. The outcome of the event hemorrhage was not recovered and other event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Groin pain
Clinical narrative: pain in his groin area; feeling pain in his mid-back and on his knee; feeling pain in his mid-back and on his knee; This is a spontaneous report from a contactable consumer(patient). A 53-years-old male patient received (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. Patient medical history and concomitant medications were not reported. On an unspecified date in the morning 25 minutes after receiving the shot patient experienced some pain in his groin area and feeling pain in his mid-back and on his knee. He wants to know if he should be seeking for medical attention. Outcome of the events was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Received the first dose of Pfizer's COVID vaccine on 29Mar2021. He tested positive for COVID and is now symptom free for 14 days.; Received the first dose of Pfizer's COVID vaccine on 29Mar2021. He tested positive for COVID and is now symptom free for 14 days.; This is a spontaneous report received from a contactable consumer (reporting on himself). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Formulation: solution for injection, Lot Number and Expiration Date was not reported), via an unspecified route of administration on 29Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient received the first dose of BNT162B2 vaccine on 29Mar2021. He tested positive for COVID and is now symptom free for 14 days. patient was wondering if it was ok for him to receive his second dose on Monday 19Apr2021. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: caller had red blotches to appear; This is a spontaneous report from a contactable consumer (patient). A-81-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number and expiry date was not reported) via an unspecified route of administration on 18Mar2021 (at the age of-81-year-old) as single dose for covid-19 immunization. Patient medical history and concomitant medications were not reported. Patient experienced about one week out from the vaccine. On an unspecified date, she had red blotches to appear. The blotches only appear for about 5 minutes at a time with each occurrence. The treatment given to event was unknown. The outcome of event was known.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: tiredness; headache; muscle pain; chills; joint pain; fever; not feeling well; injection site pain; This is a spontaneous report from a contactable consumer. A 58-Years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 31Mar2021 as single dose for Covid-19 immunization. Patients medical history and concomitant medications were not reported. It was reported that patient's sister went in for a chest x-ray and COVID-19 test & the x-ray was clear but she tested positive for COVID-19. Patient had a question, should I wait to go tested or should I just proceed with my second dose. Response received as Spoke from attached document, explained ACIP recommendation, and referred to HCP for further guidance. Patient experienced 8 of the possible side effects as tiredness, headache, muscle pain, chills, joint pain, fever, not feeling well, and injection site pain. Outcome of the event was unknown  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: tiredness; headache; muscle pain; chills; joint pain; fever; not feeling well; injection site pain; This is a spontaneous report from a contactable consumer. A 58-Years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 31Mar2021 as single dose for Covid-19 immunization. Patients medical history and concomitant medications were not reported. It was reported that patient's sister went in for a chest x-ray and COVID-19 test & the x-ray was clear but she tested positive for COVID-19. Patient had a question, should I wait to go tested or should I just proceed with my second dose. Response received as Spoke from attached document, explained ACIP recommendation, and referred to HCP for further guidance. Patient experienced 8 of the possible side effects as tiredness, headache, muscle pain, chills, joint pain, fever, not feeling well, and injection site pain. Outcome of the event was unknown  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack a two weeks after 1st dose of vaccine; This is a spontaneous report from a contactable consumer (patient). A 48-Year-Old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8727) via unspecified route of administration in the left arm on 21Mar2021 at 12:45 PM at single dose, for COVID-19 immunization. The relevant medical history included diabetic and high blood pressure from unspecified date. Concomitant medications included insulin, empagliflozin (JARDIANCE), atorvastatin, lisinopril. No other vaccine in four weeks. The patient experienced heart attack a two weeks after 1st dose of vaccine on 06Apr2021 at 08:00 AM. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization and life threatening illness (immediate risk of death from the event). The patient had hospitalization for 3 days. The patient received treatment including stent for the event. No covid prior vaccination and no covid tested post vaccination. The outcome of the event was recovered with sequel.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood Clot; This is a spontaneous report from a contactable nurse.  A 60-year-old female patient (no pregnant) received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6208), intramuscular at the age 60-year-old at arm right on 11Mar2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), intramuscular at the 60-year-old at right arm on 19Feb2021 for COVID-19 immunisation and experienced pneumonia. There was no other vaccine in four weeks. Facility type vaccine was reported as public health clinic/administration facility. The patient experienced blood clot on Mar2021 after 2nd. The patient was hospitalized for event for 5 days. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness. The patient received the treatment for event. The outcome of event was unknown.; Sender's Comments: Based on information available, a possible contribution role of the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of event clot blood cannot be completely excluded.  The case will be reassessed 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.,Linked Report(s) : US-PFIZER INC-2021422806 same patient/product, different dose and event
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pulmonary thrombosis
Clinical narrative: Blood Clot formed in lung; cough; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient received BNT162B2 (lot number: EL3246) second dose on 10Feb2021 (24-year-old) on left arm at single dose for COVID-19 immunisation. Medical history included Hypothyroidism. Patient had allergy to Hydrocodone, Oxycodone and Acyclovir. Patient is not pregnant. No covid prior vaccination. Concomitant medications included sertraline and levothyroxine. No other vaccine in four weeks. Historical vaccine included bnt162b2 (lot number: EL3246) on 16Jan2021 09:00 AM (vaccinate age 24 years old) first dose on left arm for covid-19 immunization. Facility type vaccine was Hospital. Patient had Blood Clot formed in lung on 17Feb2021 12:00 AM and cough a week in Feb2021 after second shot. Event resulted in Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event)]. Patient received Medication as treatment. The outcome of events was Recovered with lasting effects. No covid tested post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Urinary tract infection
Clinical narrative: she is experiencing headaches.; A urinary tract infection.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Expiry date: Unknown), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced she is experiencing headaches, a urinary tract infection. The outcome of the event was unknown on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-up#1(14Apr2021): New information was received from consumer included: No new information updated.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest, Seizure
Clinical narrative: Seizure activity; potential cardiac arrest; This is a spontaneous report from a non-contactable consumer (patient). An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown if she was pregnant. The patient experienced seizure activity / potential cardiac arrest (unknown etiology) on 15Apr2021. She was in ICU as of now. The adverse events resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Treatment and outcome for the events were unknown at the time of report.  No follow-up attempts are possible. Information on lot/batch cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pneumonia
Clinical narrative: got sick with Bronchopneumonia; This is a spontaneous report from a contactable consumer (patient) reported for herself from a Pfizer sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 02Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, patient was scheduled for a second dose due on 25Mar21, but because of the bad weather, she cancelled her schedule. She was rescheduled by her facility on 12Apr21, but she got sick with bronchopneumonia, bronchial trouble. She was at the risk as having the first shot. Patient treatment received for adverse events included: azithromycin, Prednisone, steroids and antibiotics. The outcome of the events was unknown.  QR Comment : Reason of delay: Daily spike of incoming calls due to COVID19 vaccine.  Follow up attempts are needed. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fluid retention, Headache, Pain
Clinical narrative: headache; Her left leg started to rush fluid; body ache; chills; This is a spontaneous report received from a contactable consumer (patient) via Pfizer sponsored program. A female patient of unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: UNKNOWN) via an unspecified route of administration on 25Mar2021 as a single dose for COVID-19 immunization. On, 25Mar2021, the patient left leg started to rush fluid like after 20 min later after getting the first dose and next, she experienced body ache, chills, and headache. Patient received Tylenol as a treatment. She was scheduled to take the second dose on 19Apr2021 and enquired whether she can take the second dose (Second dose is more than 21 days). The outcome for the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Pulmonary embolism, Thrombosis
Clinical narrative: NSTEMI; Pulmonary Embolism; left upper arm thrombosis; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 22Mar2021 (at the age of 48-years-old) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. No other vaccine received in four weeks. On 15Apr21, the patient presented to hospital with complaints of dyspnea, chest pain and arm swelling. The patient was found to have left upper arm thrombosis, pulmonary embolism, and NSTEMI. The adverse events started on 15Apr2021 and resulted in emergency room/department or urgent care visit, hospitalization on 15Apr2021 and life-threatening illness (immediate risk of death from the events). An unspecified treatment was received in response to the events. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Cystitis, Nausea, SARS-CoV-2 test, Weight decreased
Clinical narrative: Severe nausea; weight loss; stomach pain; bladder infection; This is a spontaneous report from a contactable Nurse (patient). An 82-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 25Mar2021 13:30 (Lot Number: EN6208) as single dose (at the age of 82-years-old) for covid-19 immunisation. Medical history included tachycardia, hypothyroidism and Covid prior vaccination (date unknown). Concomitant medications in two weeks prior to the vaccination included metoprolol succinate (TOPROL), levothyroxine sodium (LEVOXYL). The patient previously took sulfamethoxazole, trimethoprim (BACTRIUM DS) and experienced drug hypersensitivity.  Patient did not receive other vaccine in four weeks prior to the COVID vaccine. On 30Mar2021 patient experienced severe nausea, weight loss, stomach pain and bladder infection. Patient had three visits to primary care doctor (dr), one clinic visit for intravenous (iv) fluids, emergency room (ER) Visit and hospital admission. Patient was admitted for three days in response to the events (dates were not provided). Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient underwent laboratory tests and procedures which included sars-cov-2 test (Nasal Swab) negative on 14Apr2021 and sars-cov-2 test (Nasal Swab) negative on 16Apr2021. Patient had not recovered from the events, at the time of the report.; Sender's Comments: Based on the available information it is unlikely that BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) contributed to events occurrence. The reported events more likely represent intercurrent medical conditions unrelated to Covid-19 vaccination. 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: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Presyncope, SARS-CoV-2 test, Scan, Thrombosis
Clinical narrative: Felt something in my leg like a cramp / did a scan of my leg and found the clot; dizzy; nearly passed out; This is a spontaneous report from a contactable consumer (patient).  A 54-year-old male consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Mar2021 at 16:30 at single dose in right arm for COVID-19 immunisation at the age of 54-year-old. Lot number was ER8732. Medical history included Human papilloma virus (HPV) positive tonsil cancer, ankylosing spondylitis, tinnitus, neuropathy, decreased memory from chemo and radiation. The patient did not have Covid prior to vaccination. Concomitant medications were unknown. The patient felt something in leg like a cramp for a week since 06Apr2021 before ER visit. On 06Apr2021, the patient got dizzy at home nearly passed out, and he went to ER. On 14Apr2021, Doctor did a scan of leg and found the clot. The patient was hospitalized due to the events and they were considered life-threatening. The patient was treated with heparin and ELIQUIS. On 14Apr2021, Rapid Covid test was negative. The patient was recovering from the events.
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Syncopal episode; This is a spontaneous report from a Pfizer Sponsored program. A non-contactable male 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 SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported.  The patient had syncopal episode after receiving his shot on an unknown date. The patient was then transported to the emergency department (ED) as 911 was activated. Then, the patient was discharged from the ED with diagnosis of syncope. Outcome of the event was unknown.  No follow-up attempts are possible. Information on lot/batch cannot be obtained.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Seizure
Clinical narrative: Generalized seizures without ever having a seizure before; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not available), via an unspecified route of administration, Left arm on 08Apr2021 at 09:00 AM (at the age of 50-years-old) at a single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient had no known allergies. Concomitant medication included celecoxib (CELEXA). The patient was vaccinated at a hospital. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced generalized seizures without ever having a seizure before on 10Apr2021 at 15:00. The event caused hospitalization in Apr2021 and was also reported as life-threatening. The patient underwent lab tests and procedures which included nasal swab test: negative on 10Apr2021. Therapeutic measures taken as a result of the event included hospitalization and med flight, as reported. The outcome of the event was not recovered.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Death, Portal vein thrombosis, Thrombocytopenia
Clinical narrative: Patient died; portal vein thrombosis; thrombocytopenia; This is a spontaneous report from a contactable physician. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date 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 portal vein thrombosis and thrombocytopenia 2 weeks after first Pfizer vaccine. Patient died. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the events portal vein thrombosis and thrombocytopenia was unknown. The outcome of the event unknown cause of death was fatal.  Information on the lot/ batch number has been requested.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. Based on temporal association, a causal association between the reported events and BNT162B2 cannot be fully excluded. Case will be reassessed when additional information is available including medical history and concomitant drug information.  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. ; Reported Cause(s) of Death: Patient died
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died after taking the vaccine; This is a spontaneous report from a contactable consumer reporting on behalf of the mother. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient died after taking the vaccine, on an unspecified date. It was unknown if an autopsy was performed. Cause of death was unknown. The reporter believed that it was from the vaccine and ICU nurse said, doctor questioned about what the patient got sick and reporter just wanted to report it.  Information about lot/batch number has been requested.; Reported Cause(s) of Death: died after taking the vaccine
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pneumonia aspiration, Sepsis
Clinical narrative: SOB; Sepsis; aspiration pneumonia; This is a spontaneous report based on the information received by Pfizer. A contactable Other HCP reported that a 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration at the age of 59-year-old on 31Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included chronic UTI, and splenectomy for unknown reason, RMS (Rhabdomyosarcoma). Concomitant medication included ocrelizumab (OCREVUS). On 02Apr2021, it was reported that patient experienced: Went into hospital due to SOB (Shortness of breath) on 02Apr2021, died on 07Apr2021 related to aspiration pneumonia on an unspecified date. Patient developed Sepsis as well on an unspecified date. Patient became a DNR on 06Apr2021 then passed on 07Apr2021. The patient was hospitalized for SOB from 02Apr2021 to an unknown date. The patient died on 07Apr2021. It was not reported if an autopsy was performed. The outcome of event aspiration pneumonia was fatal. The outcome of events SOB and Sepsis was not recovered.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available and known drug safety profile, the reported events more likely represented intercurrent illnesses, but not related to Bnt162b2.  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. ; Reported Cause(s) of Death: aspiration pneumonia
Sex: U
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Peripheral swelling, Swelling
Clinical narrative: Lower part of my arm like close to my arm pit started swelling and I cannot really move my arm; Lower part of my arm like close to my arm pit started swelling and I cannot really move my arm; Had been so close to the body since like the arm pit was swelling; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number was unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. It was reported that the day after receiving the vaccine, the patient's lower part of arm like close to the arm pit started swelling and the patient could not really move the arm or it had been so close to the body since like the arm pit was swelling and it lasted for about four days and then it came down. The patient was recovering the events.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Chills, Dyspnoea, Fatigue, Oropharyngeal pain
Clinical narrative: asthma acting up; fatigued; sore throat; congestion with green/brown mucus; congestion with green/brown mucus; chills; strong fever; started wheezing having slight asthma; couldn't breathe; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 09Apr2021 09:15 (Batch/Lot Number: EW0158) as single dose for covid-19 immunisation.  Medical history included asthma and known allergies: peanuts. Concomitant medication included alprazolam, taken for an unspecified indication, start and stop date were not reported. On the First day of dose Friday 09Apr2021 9:00 am, patient felt fatigued only and it carried though until Monday night falling into Tuesday with a sore throat that kept getting worst so patient went for a COVID test and came back negative. Tuesday night patient self-medicated but was still feeling fatigued and woke up Wednesday fatigued as well as the extremely sore throat, congestion with green/brown mucus. Patient went to an urgent care got checked out and said this was a side effect. Later that night patient started getting the chills and came with a strong fever and started wheezing having slight asthma. Patient used rescue inhaler. Woke up Thursday morning, could not breathe due to asthma acting up and had not in 12 years. Patient used inhaler and it helped. Patient took a shower and had to cut it short because he could not breathe. He went and did a second COVID test and was negative. He also saw a doctor and took chest X-rays, said it was normal. Doctor said it was his asthma acting up most likely from the vaccine. Lab tests included Nasal Swab on 13Apr2021 and 15Apr2021 both were negative; X-rays on unknown date and was normal. It was reported that the events onset on 09Apr2021 at 12:00 pm. The events resulted in doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). Treatment was received for the events included asthma medication and steroid medication. Outcome of the events was resolving.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Sputum discoloured, Upper respiratory tract congestion, Wheezing
Clinical narrative: asthma acting up; fatigued; sore throat; congestion with green/brown mucus; congestion with green/brown mucus; chills; strong fever; started wheezing having slight asthma; couldn't breathe; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 09Apr2021 09:15 (Batch/Lot Number: EW0158) as single dose for covid-19 immunisation.  Medical history included asthma and known allergies: peanuts. Concomitant medication included alprazolam, taken for an unspecified indication, start and stop date were not reported. On the First day of dose Friday 09Apr2021 9:00 am, patient felt fatigued only and it carried though until Monday night falling into Tuesday with a sore throat that kept getting worst so patient went for a COVID test and came back negative. Tuesday night patient self-medicated but was still feeling fatigued and woke up Wednesday fatigued as well as the extremely sore throat, congestion with green/brown mucus. Patient went to an urgent care got checked out and said this was a side effect. Later that night patient started getting the chills and came with a strong fever and started wheezing having slight asthma. Patient used rescue inhaler. Woke up Thursday morning, could not breathe due to asthma acting up and had not in 12 years. Patient used inhaler and it helped. Patient took a shower and had to cut it short because he could not breathe. He went and did a second COVID test and was negative. He also saw a doctor and took chest X-rays, said it was normal. Doctor said it was his asthma acting up most likely from the vaccine. Lab tests included Nasal Swab on 13Apr2021 and 15Apr2021 both were negative; X-rays on unknown date and was normal. It was reported that the events onset on 09Apr2021 at 12:00 pm. The events resulted in doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). Treatment was received for the events included asthma medication and steroid medication. Outcome of the events was resolving.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: asthma acting up; fatigued; sore throat; congestion with green/brown mucus; congestion with green/brown mucus; chills; strong fever; started wheezing having slight asthma; couldn't breathe; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 09Apr2021 09:15 (Batch/Lot Number: EW0158) as single dose for covid-19 immunisation.  Medical history included asthma and known allergies: peanuts. Concomitant medication included alprazolam, taken for an unspecified indication, start and stop date were not reported. On the First day of dose Friday 09Apr2021 9:00 am, patient felt fatigued only and it carried though until Monday night falling into Tuesday with a sore throat that kept getting worst so patient went for a COVID test and came back negative. Tuesday night patient self-medicated but was still feeling fatigued and woke up Wednesday fatigued as well as the extremely sore throat, congestion with green/brown mucus. Patient went to an urgent care got checked out and said this was a side effect. Later that night patient started getting the chills and came with a strong fever and started wheezing having slight asthma. Patient used rescue inhaler. Woke up Thursday morning, could not breathe due to asthma acting up and had not in 12 years. Patient used inhaler and it helped. Patient took a shower and had to cut it short because he could not breathe. He went and did a second COVID test and was negative. He also saw a doctor and took chest X-rays, said it was normal. Doctor said it was his asthma acting up most likely from the vaccine. Lab tests included Nasal Swab on 13Apr2021 and 15Apr2021 both were negative; X-rays on unknown date and was normal. It was reported that the events onset on 09Apr2021 at 12:00 pm. The events resulted in doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). Treatment was received for the events included asthma medication and steroid medication. Outcome of the events was resolving.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction, Asthenia, Diarrhoea, Fatigue, Gastrointestinal disorder
Clinical narrative: Weak; Severe reaction; Fatigue; Severe diarrhea; GI issues; This is a spontaneous report received via Pfizer-sponsored program  from a contactable consumer (patient). A 67-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Batch/Lot number: unknown) via unspecified route of administration on 28Mar2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medication was not reported. The patient received first vaccine on 28Mar and had a severe reaction, fatigue and severe diarrhea and GI track problems. They were still occurring. The patient has a vaccine appointment next week. The patient does have a Colonoscopy appointment scheduled before his vaccine appointment. The patient wanted to know if he should reschedule his vaccine appointment or not. The patient does not think his problem is an adverse event. It may be just a coincidence. The patient would like to know if he can stall second shot. The patient was scheduled to get second dose on Sunday, and he was having GI issues that have left him very weak. The patient cannot get into the hospital for the GI test until 28 Apr 2021. The patient was hesitant to receive second shot until these circumstances have improved. The patient wants to know if he can get second shot 2-3 weeks after the 3-week normal time frame from first dose. The patient stated that the GI thing has been going on since last fall and he really did not think it was related to the vaccine. The outcome of the event asthenia was unknown. The outcome of the events severe reaction, fatigue, severe diarrhea and GI issues was not recovered/not resolved.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis
Clinical narrative: Appendicitis the following Sunday requiring surgery; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 01Apr2021 15:30 (Batch/Lot number was not reported) at the age of 28 years old, as single dose for COVID-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. The patient has no known allergies. The patient's concomitant medications were none. No other medicines received within two weeks of vaccination. No other vaccines within 4 weeks prior to vaccination. The patient experienced appendicitis the following Sunday (18Apr2021 00:00) requiring surgery. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Treatment was surgery. It was unknown if the patient has been tested for COVID post vaccination. The patient was recovering from the event.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Wife tested positive as well; Wife tested positive as well; This is a spontaneous report from a non contactable consumer.  A female patient of unspecified age received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported. The patient Concomitant medications was not reported. On 09Apr2021, the patient tested positive. The lab tests included PCR (Nasal swab), result: Positive on 09Apr2021. The outcome of the events was unknown.   Follow-Up (14Apr2021): Upon follow up, new information included that the patient was vaccinated (first and second dose of vaccine was unknown.)  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Cerebrovascular accident
Clinical narrative: My father had a massive stroke and brain hemorrhage that took his life.; My father had a massive stroke and brain hemorrhage that took his life.; This is a spontaneous report from a contactable consumer. A 65-year-old male patient (reporter's father) received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration at the age of 65-years-old on 15Mar2021 12:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history was not reported. No known allergies. Not diagnosed with COVID prior vaccination. There were no concomitant medications. No other vaccines in four weeks. No other medications in two weeks. 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 immunisation. The reporter stated that, "My father had a massive stroke and brain hemorrhage that took his life" on 15Apr2021 09:30 PM. No treatment received for the events. The events resulted in Emergency room/department or urgent care. The patient died on 18Apr2021. It was not reported if an autopsy was performed. Unknown if tested for COVID post vaccination.  Information about lot/batch number has been requested.; Reported Cause(s) of Death: My father had a massive stroke and brain hemorrhage that took his life.; My father had a massive stroke and brain hemorrhage that took his life.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Headache, Sinusitis
Clinical narrative: feel Funky; Headache; Low energy; sinus kicked in with runny nose; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A male patient of an unspecified age received second dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown) via an unspecified route of administration on unspecified date as single dose for covid-19 immunisation. On an unspecified date, the patient felt funky, had sinus issues on friday and on saturday had headache and low energy and sinus kicked in with runny nose, was fine by sunday. The patient informed that he had no problems with first dose and also asked whether it was true that the vaccine was good for 6 months, he was told this by a registered nurse (RN) at the vaccination site. The outcome of the events 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 the first dose of the Pfizer Covid 19 vaccine on a Monday and was diagnosed with Covid 19 the following Friday; This is a spontaneous report received from a contactable consumer (patient's girlfriend). A 54-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number and expiry was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient received the first dose of the Pfizer covid 19 vaccine on a Monday and was diagnosed with covid 19 the following Friday with the lab test of SARS-COV-2 test. He was due to get the second dose of the vaccine today (19Apr2021) and was wondering how long he has to wait to get the second dose. The outcome of the event was unknown.  No follow-up attempts are possible; Information related to batch/Lot number could not be requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report from a contactable nurse (patient) via a Pfizer-sponsored program. A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 31Mar2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. The patient tested positive for COVID-19 on 15Apr2021 and the patient was scheduled to receive the second dose of the vaccine on 23Apr2021. The patient had zero taste and smell at the time of report. The patient wanted to know if it was necessary to receive the second dose of the vaccine after contracting COVID-19 after the first dose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective / COVID-19 cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: This is a spontaneous report received from a non-contactable consumer. This female consumer (patient) reported that the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT number: unknown), via an unspecified route of administration on an 02Apr2021 at single dose for Covid-19 immunization. The patient's concomitant medication and medical history was not reported. On 06Apr2021 the patient tested positive for covid 19. The patient is all finished with quarantine and has no signs or symptoms. The patient also enquired that is it safe to receive her second dose due 4/23. Outcome of the event Unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paralysis
Clinical narrative: she could not feel her body from the neck down- She believes the vaccine paralyzed most of her body.; she could not feel her body from the neck down- She believes the vaccine paralyzed most of her body.; This is a spontaneous report from a contactable consumer. A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN) via an unspecified route of administration on unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced she could not feel her body from the neck down- she believes the vaccine paralyzed most of her body on an unspecified date. The patient underwent lab tests and procedures which included blood test: clear and/or negative, lumbar puncture: clear and/or negative, magnetic resonance imaging: clear and/or negative. The outcome of events was unknown.   Follow-up (19Apr2021): This follow-up contains no new safety information.  Follow-up attempts have been completed and no further information is expected.