chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Nephrolithiasis, Pruritus, Skin disorder, Urticaria
Clinical narrative: kidney stone, last time he had one was in Jul or Aug2021; Hives/raised bumps on his arms and front chest; being itches/itching shortly after each dose; These bumps are turning into hard skin cells; This is a spontaneous report from a contactable consumer (patient). This 65-year-old male patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on Jun2021 (around noon to 1300) at age of 65 years old as single dose for COVID-19 immunization. Medical history and concomitant medications were none. The patient got the Pfizer shot twice, first shot was in mid Jun and the second shot was around Sep2021. He ended up with some type of hives or raised bumps on his arms and front chest after both doses. These bumps were turning into hard skin cells, didn't know how to explain them. He went to the dermatologist and they took biopsies of the ones on his arms. He did not know if it was covid vaccine related but both times it happened within a couple of days of getting the shots. It first started as being itches/itching shortly after each dose and now his skin cells were all hardening up on his arm. He went to urgent care to ask for something to stop the itches and he was given a prescription for Triamcinolone Cream. He stopped at a dermatologist and they were dumbfounded as to what it was and were concerned about the lumps. He asked if there was any connection with the bumps and the covid shot and dermatologist stated she had not seen that before. However, he talked to the pharmacist when he went to pick up the ointment and they told him that they had heard of this happening. He was now on a tapered dose of prednisone and he will try different ointments, he thought one was called clobetasol. He just took his last prednisone. He was left handed. He may have gone to ER after the first dose since he was opening up his bill and it said he was in the ER in June. Confirmed he was not admitted. He only went to ER for kidney stone or something else and he was not having a kidney stone in June. Events resulted in visit to Physician Office: dermatologist and urgent care. The patient had kidney stone, last time he had one was in Jul or Aug2021. When asked did he have to worry about these hard skin lesions, the patient stated he was probably not using the correct term by calling them lesions but his skin was scaly and hard and growing up and down his arm and were now up to his shoulder. Outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Mass, Pain
Clinical narrative: Chills; slight fever; woozy; aches everywhere; weary; lump under left arm; This is a spontaneous report from a contactable consumer(patient) reported for herself. A 62-year-old non-pregnant female patient received third dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FF2590) via an unspecified route of administration, administered in left arm on 13Oct2021 at 16:00 pm (At the age of 62-year-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient medical history was not reported. Concomitant medications in 4 weeks included influenza vaccine (FLU) (Batch/Lot Number was unknown) via an unspecified route of administration, administered in right arm on 06Oct2021 taken for an unspecified indication. The patient previously received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in left arm on 26Mar2021 04:00pm (At the age of 61-year-old) as dose 2, and first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6205), via an unspecified route of administration in left arm on 03Mar2021 at 05:15 pm (At the age of 61-year-old ) as dose 1 single for COVID-19 immunization.The patient had not diagnosed with COVID-19 Prior to vaccination and since the vaccination. On 14Oct2021 at 06:00 am, the patient experienced chills, slight fever, woozy, aches everywhere, weary, lump under left arm. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills; slight fever; woozy; aches everywhere; weary; lump under left arm; This is a spontaneous report from a contactable consumer(patient) reported for herself. A 62-year-old non-pregnant female patient received third dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FF2590) via an unspecified route of administration, administered in left arm on 13Oct2021 at 16:00 pm (At the age of 62-year-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient medical history was not reported. Concomitant medications in 4 weeks included influenza vaccine (FLU) (Batch/Lot Number was unknown) via an unspecified route of administration, administered in right arm on 06Oct2021 taken for an unspecified indication. The patient previously received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in left arm on 26Mar2021 04:00pm (At the age of 61-year-old) as dose 2, and first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6205), via an unspecified route of administration in left arm on 03Mar2021 at 05:15 pm (At the age of 61-year-old ) as dose 1 single for COVID-19 immunization.The patient had not diagnosed with COVID-19 Prior to vaccination and since the vaccination. On 14Oct2021 at 06:00 am, the patient experienced chills, slight fever, woozy, aches everywhere, weary, lump under left arm. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Biopsy, Oral mucosal blistering, Pemphigoid, SARS-CoV-2 test
Clinical narrative: Oral blisters; Autoimmune condition; mucous membrane pemphigoid; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 26May2021 13:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history was reported as none. Patient was not pregnant, and has 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. Concomitant medication included cephalexin (CEFALEXIN) received within 2 weeks of vaccination. The patient experienced oral blisters, autoimmune condition and mucous membrane pemphigoid, all on 09Jun2021 12:00. It was however reported that patient was diagnosed with mucous membrane pemphigoid by biopsy in Aug2021. The events were reported as serious, disability. Events resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has been tested for COVID-19 with unknown results. The patient underwent lab tests and procedures which included biopsy: diagnosed with mucous membrane pemphigoid in Aug2021, and sars-cov-2 test (nasal swab): unknown results in 2021. Treatment for the events included steroids. Patient received the second dose of BNT162b2 on an unspecified date in 2021. The outcome of the events was not recovered.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiomyopathy, Fatigue, Heart rate increased, Investigation
Clinical narrative: I now have myocardial issues; fatigued; while exercising started having rapid heartbeat; This is a spontaneous report from a non-contactable consumer (patient). A 19-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 16Sep2021 (Batch/Lot Number: FC3181) (at the age of 19-year-old) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. 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. The patient had no medical history and no past drug history. Concomitant medication included methylphenidate taken for an unspecified indication, start and stop date were not reported (received within 2 weeks of vaccination). The patient reported that a few days after her first shot she was fatigued, then while exercising started having rapid heartbeat. She went to the cardiologist where they did tests (on an unspecified date in 2021) that showed she now has myocardial issues. The onset of events was on 19Sep2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Computerised tomogram, Pulmonary thrombosis
Clinical narrative: she had blood clots in her lungs; severe back pain; This is a spontaneous report from a contactable consumer. An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 06Oct2021 (Batch/Lot number was not reported) (at the age of 80 years old) as dose 3 (booster), single for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication included influenza vaccine (FLU VACCINE VII) taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 for COVID-19 immunisation, the first dose was on 03Feb2021 at 10:30 and the second dose was on 24Feb2021. On 14Oct2021, the patient experienced she had blood clots in her lungs and severe back pain. She was experiencing severe back pain and went to her doctor. A CT scan was performed, showing that she had blood clots in her lungs. Event resulted in Doctor or other healthcare professional office/clinic visit. The treatment included medication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. The outcome of the events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: my husband was tested and was positive for covid; my husband was tested and was positive for covid; This is a spontaneous report from a contactable consumer (patient's wife).  A 64-years-old male patient BNT162B2 (BNT162B2), dose 2 via an unspecified route of administration in May2021 (Batch/Lot number was not reported) age at vaccination of 63-years-old, as single dose, dose 1 via an unspecified route of administration in Apr2021 (Batch/Lot number was not reported) age at vaccination of 63-years-old, as single dose for covid-19 immunisation. Medical history included ongoing diabetes mellitus. The patient received concomitant medication (he was treatment for diabetes, he takes some medication). The patient received two doses of the Pfizer vaccine and he had no side effects from the vaccine but he was tested positive on 15Oct2021 for Covid-19. No treatments were given. Outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pneumonia, Pyrexia
Clinical narrative: pneumonia; chills; fever; head ache; body ache; This is a spontaneous report from a contactable consumer (patient). This 71-year-old female patient received the 3rd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 06Oct2021 at 12:00 PM at age of 71 years old as single dose for COVID-19 immunization; influenza vaccine (FLU) via an unspecified route of administration in the right arm on 06Oct2021 for immunization. Medical history included High blood pressure, high cholesterol. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included diltiazem, atorvastatin, citalopram, pantoprozole, received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm on 04Feb2021 at 12:00 PM at age of 71 years old, the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, both for COVID-19 immunization. The patient had covid test post vaccination with blood test on 12Oct2021 and the covid test result was negative. The patient developed chills, fever, head ache, body ache and pneumonia on 07Oct2021 at 12:00 AM. AE resulted in Doctor or other healthcare professional office/clinic visit. Treatment with antibiotics was received for the events. Outcome of the events was recovering. This report was reported as non-serious.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: pneumonia; chills; fever; head ache; body ache; This is a spontaneous report from a contactable consumer (patient). This 71-year-old female patient received the 3rd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 06Oct2021 at 12:00 PM at age of 71 years old as single dose for COVID-19 immunization; influenza vaccine (FLU) via an unspecified route of administration in the right arm on 06Oct2021 for immunization. Medical history included High blood pressure, high cholesterol. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included diltiazem, atorvastatin, citalopram, pantoprozole, received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm on 04Feb2021 at 12:00 PM at age of 71 years old, the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, both for COVID-19 immunization. The patient had covid test post vaccination with blood test on 12Oct2021 and the covid test result was negative. The patient developed chills, fever, head ache, body ache and pneumonia on 07Oct2021 at 12:00 AM. AE resulted in Doctor or other healthcare professional office/clinic visit. Treatment with antibiotics was received for the events. Outcome of the events was recovering. This report was reported as non-serious.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swollen tongue
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the 3rd booster of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, in left arm, on Oct 12, 2021, at 09:30, single dose, for COVID-19 immunization. The patient previously received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), at the age of 65, on Mar 22, 2021, at 11:45; and the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), at the age of 65, on Apr 12, 2021 11:30, both in the right arm, for COVID-19 immunization. Medical history included known allergies: sulfa drugs and sulfite. She was not pregnant at vaccination. She was not diagnosed with COVID-19 prior to vaccination. No concomitant medications. She did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No other medications received within 2 weeks of vaccination. On Oct 12, 2021, 19:00, after receiving the booster at 9:30, she had a reaction: tongue and lips swelling. She is  allergic to sulfite preservative. She was wondering if it was in the booster. She took Benadryl and it subsided after about 10 min. Since the vaccination, she has not tested for COVID-19. The patient recovered from the event on Oct 12, 2021. Information about the lot number will be requested during follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Influenza, Pain, Pyrexia
Clinical narrative: Started developing flu symptoms; Temperature like up to a hundred and one almost/I got like a hundred and one fever; I am aching all over/Achiness; I feel miserable; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: 30125BA), dose 3 via an unspecified route of administration on 11Oct2021 as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took two doses of bnt162b2 (COMIRNATY, formulation: Solution for injection, lot number: not reported), via an unspecified route of administration on an unspecified dates as dose 1, single and dose 2, single for covid-19 immunisation and had no symptoms after first two doses. On 15Oct2021, the patient experienced started developing flu symptoms, temperature like up to a hundred and one almost/i got like a hundred and one fever. On an unspecified date in Oct2021, the patient experienced am aching all over/achiness and i feel miserable. Patient went to went to 'immediate' care center, had covid test and the doctor there felt like or may be just could be related to the vaccine. The patient underwent lab tests and procedures which included body temperature: 101 on 15Oct2021, sars-cov-2 test: negative on 16Oct2021. The events result in physician office visit. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Started developing flu symptoms; Temperature like up to a hundred and one almost/I got like a hundred and one fever; I am aching all over/Achiness; I feel miserable; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: 30125BA), dose 3 via an unspecified route of administration on 11Oct2021 as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took two doses of bnt162b2 (COMIRNATY, formulation: Solution for injection, lot number: not reported), via an unspecified route of administration on an unspecified dates as dose 1, single and dose 2, single for covid-19 immunisation and had no symptoms after first two doses. On 15Oct2021, the patient experienced started developing flu symptoms, temperature like up to a hundred and one almost/i got like a hundred and one fever. On an unspecified date in Oct2021, the patient experienced am aching all over/achiness and i feel miserable. Patient went to went to 'immediate' care center, had covid test and the doctor there felt like or may be just could be related to the vaccine. The patient underwent lab tests and procedures which included body temperature: 101 on 15Oct2021, sars-cov-2 test: negative on 16Oct2021. The events result in physician office visit. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: passed out; dizzy; This is a spontaneous report from a contactable nurse (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 14Oct2021 at 16:30 (Lot Number: F00809) as dose 3 (booster), single for COVID-19 immunisation. Medical history included COVID-19, hypothyroidism, arthritis, migraines, rash, GI upset and known allergies to Nexium, amoxicillin, Duricef, and Monica. The patient was not pregnant at the time of the events. Concomitant medications included levothyroxine sodium (SYNTHROID), pearls probiotics, magnesium, and amitriptyline hydrochloride (AMITRIPTYLENE). The patient previously took the first dose of BNT162B2 (Lot Number: EJ1686) administered in right arm on 30Dec2020 for COVID-19 immunisation. The patient also previously took the second dose of BNT162B2 (Lot Number: EL9261) administered in right arm on 21Jan2021 at 13:15 for COVID-19 immunisation and experienced dizzy and passed out. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Synthroid, Pearls probiotic, magnesium, and amitrpytil. On 16Oct2021 at 07:45, the patient became dizzy and passed out. The patient received treatment (Paramedics came to house) for the events. The patient had COVID-19 prior to vaccination and had not been tested for COVID-19 post-vaccination. The outcome of the events was recovered on 16Oct2021.; Sender's Comments: As there is limited information in the case provided, the causal association between the event  loss of consciousness and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new 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.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling, Rheumatoid arthritis
Clinical narrative: Tremendous flare ups/a rheumatoid reaction; Knees swelled up/ ankles swelled up; Feet swelled up; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: ER8727) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: ER8730) as DOSE 2, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient had tremendous flare ups from both of those doses. She was in bed for like 3 days with both of those doses. It was definitely a rheumatoid reaction. Her knees swelled up, her feet swelled up and her ankles swelled up. The outcomes of events were unknown.   Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood thyroid stimulating hormone, Cerebrovascular accident, Full blood count, Lipids
Clinical narrative: Stroke; This is a spontaneous report from a contactable nurse (patient wife). A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in right bicep on 11Oct2021 (at the age of 65-years-old) as dose 3 (booster), single for COVID-19 immunisation. Previously the patient received first and second dose of bnt162b2 on an unsoecified date for COVID-19 immunisation. Medical history included hypothyroidism and. Concomitant medications included losartan and levothyroxine, both taken for an unspecified indication, start and stop date were not reported.  The patient experienced on 11Oct2021, 10 hours after vaccination. The patient had lab work done right before he got the shot and he has had done multiple lab works since he  had the stroke. He had a physical, he had his blood work for his physical Monday morning before the stroke. So, he had a CBC, he had a chemistry, he had lipids and cholesterol, he had TSH and T3, T4 and since then he has had every test known. The event was treated with TPA (Alteplase), the dose of TPA was 90 mg, the maximum dose allowed, the complete name is TPA and it is also known as Alteplase (as reported). The outcome of event was unknown.   The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of stroke. The case will be reassessed once new 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
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Thyroxine, Tri-iodothyronine
Clinical narrative: Stroke; This is a spontaneous report from a contactable nurse (patient wife). A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in right bicep on 11Oct2021 (at the age of 65-years-old) as dose 3 (booster), single for COVID-19 immunisation. Previously the patient received first and second dose of bnt162b2 on an unsoecified date for COVID-19 immunisation. Medical history included hypothyroidism and. Concomitant medications included losartan and levothyroxine, both taken for an unspecified indication, start and stop date were not reported.  The patient experienced on 11Oct2021, 10 hours after vaccination. The patient had lab work done right before he got the shot and he has had done multiple lab works since he  had the stroke. He had a physical, he had his blood work for his physical Monday morning before the stroke. So, he had a CBC, he had a chemistry, he had lipids and cholesterol, he had TSH and T3, T4 and since then he has had every test known. The event was treated with TPA (Alteplase), the dose of TPA was 90 mg, the maximum dose allowed, the complete name is TPA and it is also known as Alteplase (as reported). The outcome of event was unknown.   The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of stroke. The case will be reassessed once new 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
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Chills, Computerised tomogram, Dyspnoea
Clinical narrative: PAC; Shortness of breath; Sore arm; Chills; Nausea; Vomiting; Fever / fever went to 103.6; Sweating; Extreme Headache; fatigue; complete body ache; illness; Third dose was administered; Third dose was administered; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 08Oct2021 13:00 (Batch/Lot Number: FF2590) (at the age of 62 years old) as dose 3 (booster), single dose for Covid-19 immunisation. Medical history included hypothyroidism and fibromyalgia. The patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient did not have Covid-19 prior to vaccination. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 09Mar2021 at 09:15am (Batch/Lot No: Pfizer EN6199) (at the age of 61 years old) in left arm, second dose on 25Mar2021 at 10:15am (Batch/Lot No: Pfizer ER8732) (at the age of 61 years old) in left arm, both for Covid-19 immunisation. Concomitant medication included unspecified prescription medication. Third dose was administered on 08Oct2021 at 13:00. The following day, 09Oct2021 at 10:00, the patient experienced shortness of breath, sore arm, chills, nausea, vomiting, fever/fever went to 103.6, sweating, PAC's (premature atrial contraction), extreme headache, fatigue, complete body ache, and illness. They lasted for 6 days (as reported), fever going lower and lower. Patient had two ER visits and visit with her own personal internist doctor. Treatment received: Tylenol and potassium. The events resulted in emergency room visit and physician office visit. The patient underwent lab tests and procedures which included body temperature: 103.6 on 09Oct2021 at 10:00; Cat Scan, Blood Work, and X-ray in Oct2021 with unknown results; Covid-19 PCR/Nasal swab: negative on 10Oct2021. Outcome of the events was recovering.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Fatigue, Headache, Hyperhidrosis, Illness
Clinical narrative: PAC; Shortness of breath; Sore arm; Chills; Nausea; Vomiting; Fever / fever went to 103.6; Sweating; Extreme Headache; fatigue; complete body ache; illness; Third dose was administered; Third dose was administered; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 08Oct2021 13:00 (Batch/Lot Number: FF2590) (at the age of 62 years old) as dose 3 (booster), single dose for Covid-19 immunisation. Medical history included hypothyroidism and fibromyalgia. The patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient did not have Covid-19 prior to vaccination. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 09Mar2021 at 09:15am (Batch/Lot No: Pfizer EN6199) (at the age of 61 years old) in left arm, second dose on 25Mar2021 at 10:15am (Batch/Lot No: Pfizer ER8732) (at the age of 61 years old) in left arm, both for Covid-19 immunisation. Concomitant medication included unspecified prescription medication. Third dose was administered on 08Oct2021 at 13:00. The following day, 09Oct2021 at 10:00, the patient experienced shortness of breath, sore arm, chills, nausea, vomiting, fever/fever went to 103.6, sweating, PAC's (premature atrial contraction), extreme headache, fatigue, complete body ache, and illness. They lasted for 6 days (as reported), fever going lower and lower. Patient had two ER visits and visit with her own personal internist doctor. Treatment received: Tylenol and potassium. The events resulted in emergency room visit and physician office visit. The patient underwent lab tests and procedures which included body temperature: 103.6 on 09Oct2021 at 10:00; Cat Scan, Blood Work, and X-ray in Oct2021 with unknown results; Covid-19 PCR/Nasal swab: negative on 10Oct2021. Outcome of the events was recovering.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Off label use, Pain, Pain in extremity, Pyrexia
Clinical narrative: PAC; Shortness of breath; Sore arm; Chills; Nausea; Vomiting; Fever / fever went to 103.6; Sweating; Extreme Headache; fatigue; complete body ache; illness; Third dose was administered; Third dose was administered; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 08Oct2021 13:00 (Batch/Lot Number: FF2590) (at the age of 62 years old) as dose 3 (booster), single dose for Covid-19 immunisation. Medical history included hypothyroidism and fibromyalgia. The patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient did not have Covid-19 prior to vaccination. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 09Mar2021 at 09:15am (Batch/Lot No: Pfizer EN6199) (at the age of 61 years old) in left arm, second dose on 25Mar2021 at 10:15am (Batch/Lot No: Pfizer ER8732) (at the age of 61 years old) in left arm, both for Covid-19 immunisation. Concomitant medication included unspecified prescription medication. Third dose was administered on 08Oct2021 at 13:00. The following day, 09Oct2021 at 10:00, the patient experienced shortness of breath, sore arm, chills, nausea, vomiting, fever/fever went to 103.6, sweating, PAC's (premature atrial contraction), extreme headache, fatigue, complete body ache, and illness. They lasted for 6 days (as reported), fever going lower and lower. Patient had two ER visits and visit with her own personal internist doctor. Treatment received: Tylenol and potassium. The events resulted in emergency room visit and physician office visit. The patient underwent lab tests and procedures which included body temperature: 103.6 on 09Oct2021 at 10:00; Cat Scan, Blood Work, and X-ray in Oct2021 with unknown results; Covid-19 PCR/Nasal swab: negative on 10Oct2021. Outcome of the events was recovering.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Supraventricular extrasystoles, Vomiting, X-ray
Clinical narrative: PAC; Shortness of breath; Sore arm; Chills; Nausea; Vomiting; Fever / fever went to 103.6; Sweating; Extreme Headache; fatigue; complete body ache; illness; Third dose was administered; Third dose was administered; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 08Oct2021 13:00 (Batch/Lot Number: FF2590) (at the age of 62 years old) as dose 3 (booster), single dose for Covid-19 immunisation. Medical history included hypothyroidism and fibromyalgia. The patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient did not have Covid-19 prior to vaccination. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 09Mar2021 at 09:15am (Batch/Lot No: Pfizer EN6199) (at the age of 61 years old) in left arm, second dose on 25Mar2021 at 10:15am (Batch/Lot No: Pfizer ER8732) (at the age of 61 years old) in left arm, both for Covid-19 immunisation. Concomitant medication included unspecified prescription medication. Third dose was administered on 08Oct2021 at 13:00. The following day, 09Oct2021 at 10:00, the patient experienced shortness of breath, sore arm, chills, nausea, vomiting, fever/fever went to 103.6, sweating, PAC's (premature atrial contraction), extreme headache, fatigue, complete body ache, and illness. They lasted for 6 days (as reported), fever going lower and lower. Patient had two ER visits and visit with her own personal internist doctor. Treatment received: Tylenol and potassium. The events resulted in emergency room visit and physician office visit. The patient underwent lab tests and procedures which included body temperature: 103.6 on 09Oct2021 at 10:00; Cat Scan, Blood Work, and X-ray in Oct2021 with unknown results; Covid-19 PCR/Nasal swab: negative on 10Oct2021. Outcome of the events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective
Clinical narrative: experienced inefficacy from Pfizer COVID vaccine; This is a spontaneous report from a non-contactable other health professional (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient reported to experience inefficacy from Pfizer COVID vaccine. The patient further reported that it may be the timing. Sometimes, he was getting the blood after the first shot and it was still going up so it's possible this was still going up but it seems kind of low a month later (as reported). The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; 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 cannot be ruled out
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: We had a patient who reported a massive heart attack four days after the vaccination; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. Medical history and concomitant medications were not reported. The patient experienced we had a patient who reported a massive heart attack four days after the vaccination. It was reported that. We had a patient who reported a massive heart attack four days after the vaccination, but it wasn't looked by the doctor at because it wasn't within the 48-hour time frame. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Myocardial infarction and 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: patient caught COVID after vaccine/symptomatic; patient caught COVID after vaccine/symptomatic; This is a spontaneous report from a non-contactable other healthcare professional. This other healthcare professional reported similar events for four patients. This is the one of four reports. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in Jan2021, as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated that the patient caught COVID after vaccine. The patent was vaccinated in Jan2021 and already had COVID. The reporter stated that they do not think they have, they were associating to it at the hospital, but patient was symptomatic. The outcome of the events was unknown. The causality of the events was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of COVID-and Drug Ineffective.,Linked Report(s) : PFIZER INC-202101392304 Same reporter/product/events, different patient; PFIZER INC-202101392306 Same reporter/product/events, different patient; PFIZER INC-202101392297 Same reporter/product/events, different patient
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: PCR Nasal Swab positive; PCR Nasal Swab positive; fever; body aches; dry cough; This is a spontaneous report from a contactable consumer or other non hcp. A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), vaccinated at age of 39 years old, dose 2 via an unspecified route of administration on 16Mar2021 (Batch/Lot Number: EL6208) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on 23Feb2021 (Batch/Lot Number: EL6201) as DOSE 1, SINGLE for covid-19 immunisation. No other vaccine in four weeks. The patient medical history and concomitant medications were not reported. The patient had PCR Nasal Swab positive on 16Oct2021, breakthrough symptoms of fever, body aches, dry cough on 12Oct2021. The patient underwent lab tests and procedures which included PCR Nasal Swab: negative on 13Oct2021, positive on 16Oct2021. There is no treatment for all events. The outcomes of events were recovering. No covid prior vaccination.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: PCR Nasal Swab positive; PCR Nasal Swab positive; fever; body aches; dry cough; This is a spontaneous report from a contactable consumer or other non hcp. A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), vaccinated at age of 39 years old, dose 2 via an unspecified route of administration on 16Mar2021 (Batch/Lot Number: EL6208) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on 23Feb2021 (Batch/Lot Number: EL6201) as DOSE 1, SINGLE for covid-19 immunisation. No other vaccine in four weeks. The patient medical history and concomitant medications were not reported. The patient had PCR Nasal Swab positive on 16Oct2021, breakthrough symptoms of fever, body aches, dry cough on 12Oct2021. The patient underwent lab tests and procedures which included PCR Nasal Swab: negative on 13Oct2021, positive on 16Oct2021. There is no treatment for all events. The outcomes of events were recovering. No covid prior vaccination.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Post procedural complication, Pulmonary thrombosis
Clinical narrative: Blood clot in lung from the operation; Blood clot in lung from the operation; This is a solicited report from a marketing program, FACILITATED COLLECT received from a contactable consumer (patient herself) based on information received by Pfizer from Facilitating Company, manufacturer control number: 21K-163-4117921-00. A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),  intramuscular on 18Mar2021 (Batch/Lot number was not reported) (at the age of 62-years-old) as DOSE 1, SINGLE, and the second dose of BNT162B2 intramuscular on 19Apr2021 (Batch/Lot number was not reported) (at the age of 63-years-old) as DOSE 2, SINGLE for COVID-19 immunisation; and upadacitinib (RINVOQ), oral on unspecified date (Batch/Lot number was not reported), at unspecified dose and frequency  for moderate to severe rheumatoid arthritis.  The patient's medical history and concomitant medications were not reported. On unspecified date, the patient had left knee replaced and experienced blood clot in lung from the operation and non-serious Blood clot in lung from the operation with upadacitinib (RINVOQ).  PFIZER-BIONTECH COVID-19 VACCINE was also considered suspect.  The events were considered serious due to hospitalization prolonged and medically significant. The patient had her left knee replaced and was recovering. She got a blood clot in her lung form the operation. She was in hospital for five days. She was on blood thinner and was recovering. It was unknown if patient was enrolled in a COVID-19.  The action taken in response to the events for upadacitinib was unknown.  Therapeutic measures were taken as a result of blood clot in lung from the operation (pulmonary thrombosis). The outcome of blood clot in her lung from the operation (Pulmonary thrombosis) was recovering while Blood clot in lung from the operation (postoperative complication) was not recovered.  Causality for RINVOQ(UPADACITINIB): The reporter's causality for the events of Left knee replaced and Blood clot in lung from the operation unknown onset and Blood clot in lung from the operation unknown onset was not provided. Facilitating Company opinion is that there is no reasonable possibility that the events of IN lung from the operation unknown onset and Blood clot in lung from the operation unknown onset are related to RINVOQ(UPADACITINIB).  The reporter's assessment of the causal relationship of the events left knee replaced and Blood clot in lung from the operation and BNT162B2 was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the Limited information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be established.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Drug ineffective, Incorrect route of product administration, SARS-CoV-2 test
Clinical narrative: This is a solicited report from a Non-Interventional Study (FACILITATED COLLECT) based on information received by Pfizer from the (manufacturer control number: 21K-163-4116265-00).  A contactable 44-year-old female patient received bnt162b2 (BNT162B2), subcutaneous on 01Feb2021, at the age of 44-years-old, (Batch/Lot number was not reported) as DOSE 1, SINGLE, subcutaneous on 01Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to Dec2020 at unspecified dose; and subcutaneous from Jan2021 (Batch/Lot number was not reported) and ongoing, at unspecified dose for an unspecified indication.  The patient's medical history and concomitant medications were not reported.   On unknown dates, the patient experienced covid-19 and entire family caught covid-19. In 2021, the covid-19 and entire family caught covid-19 resolved.  PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 01Feb2021, she received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 01Mar2021, she received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. Primary reporter contact for lot number information was not available. The patient underwent lab tests and procedures which included blood test: blood count came back up on Jan2021, sars-cov-2 test: positive on 2021.  The action taken in response to the event for adalimumab was permanently withdrawn on an unspecified date.  The reporter's causality for the event ENTIRE FAMILY CAUGHT COVID-19 with HUMIRA(ADALIMUMAB) was no reasonable possibility.   The reporter's causality for the event ENTIRE FAMILY CAUGHT COVID-19 with BNT162B2 was possible.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, The casual association between the reported events with suspected vaccine BNT162B2 cannot be completely excluded.