chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: I think the person had covid at the time; 6 months after the 2nd dose he then got a booster/3rd shot; 6 months after the 2nd dose he then got a booster/3rd shot; 102F fever; developed lumps on their neck; very tender and sore; left side back neck. Uncomfortable; hard time moving their head right and left; extremely tired; weak; developed lumps lymph node lumps same side as injection; tender and sore; This is a spontaneous report from a contactable consumer. A 42-year-old male patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on an unspecified date (age at the time of vaccination 42-years-old), as a single dose for COVID-19 immunization. The patient medical history included toxoplasmosis, and mononucleosis. The patient concomitant medications were not reported. Patient previously received first dose of BNT162B2 vaccine, via an unspecified route of administration on an unspecified date (age at the time of vaccination 42-years-old), as a single dose for COVID-19 immunization; and second dose of BNT162B2 vaccine, via an unspecified route of administration on an unspecified date (age at the time of vaccination 42-years-old), as a single dose for COVID-19 immunization and experienced fever, achy, extremely tired. On an unspecified date, the patient experienced I think the person had covid at the time, 6 months after the 2nd dose he then got a booster/3rd shot, 102F fever, developed lumps on their neck; very tender and sore, left side back neck Uncomfortable, hard time moving their head right and left, extremely tired, weak, and developed lumps lymph node lumps same side as injection; tender and sore. On an unspecified date, the patient underwent lab tests and procedures which included Body temperature: 102 Fahrenheit, fever went down to 99.7 in about 3 days. Patient was put on an Amoxil treatment and then fever went down to 99.7 in 3 days. Patient saw a doctor who had no clue and put him on antibiotics. The outcome of the event 102F fever was recovering; and for all the events was unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow-up
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a solicited report based on the information received by Pfizer from AbbVie Inc. (MFR Control No. # 21K-163-4079635-00) from a contactable consumer (patient). A 23-year-old female patient received first dose of bnt162b2 intramuscular on 01Jan2021, at the age of 22-years-old, at single dose for COVID-19 immunization. The patient also received risankizumab (SKYRIZI) subcutaneous on unspecified date at unknown dose for moderate to severe chronic plaque psoriasis. Patient medical history included moderate to severe chronic plaque psoriasis. It was unknown if patient was enrolled in a COVID-19 vaccine trial. On unknown date in 2021, the patient experienced tested positive for covid-19 and symptoms to felt like a cold. The patient reported that she tested positive for COVID about one week after her last Skyrizi injection. Her symptoms to feel like a cold. Outcome of the events was unknown. Causality for SKYRIZI(RISANKIZUMAB): The reporter's causality for the events of tested positive for covid and symptoms to felt like a cold was not provided.   The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on available information and a possible contributory role of suspect product BNT162B2 to the development of events drug ineffective and covid19 cannot be totally excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Diabetes mellitus, Diabetic coma
Clinical narrative: diabetic coma; my sugar skyrocketed/my blood sugar went up to over 600; This is a spontaneous report from a contactable consumer.  A 58-year-old female patient of received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 25Mar2021 (Batch/Lot Number: ER2613) as dose 1, single (at the age of 58 years old), dose 2 via an unspecified route of administration, administered in right arm on 22Apr2021 (Batch/Lot Number: EW0158) as dose 2, single for COVID-19 immunisation.  Medical history included diabetes. Concomitant medications included metformin taken for diabetes mellitus, start and stop date were not reported.  The patient experienced that when she received her vaccine her sugar skyrocketed and asked why there is no warning for people, and that people are "leaving in ambulances" (from the vaccination site). Her blood sugar went to 600 for 3 weeks and that she was in a diabetic coma and know it was the vaccine, no doubt in her mind. Her blood sugar was never over 400 and she didn't do anything different and that this was scary. Treatment was they finally up her metformin (from 1000 a day to 3000 a day) after 3 weeks and gave her Glipizide 10 milligrams on the ER. The outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pyrexia, Rheumatoid arthritis, Urticaria
Clinical narrative: Rheumatoid arthritis; Joint pain; Fever; Hives; This is a solicited report from the Regulatory Authority by a non-contactable consumer (patient) based on information by Pfizer from the RA, Manufacturer control number: 21K-163-4080010-00.   A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 30Mar2021 (Batch/Lot number was not reported) at the age of 54-year-old as single dose for covid-19 vaccination; adalimumab (HUMIRA, Solution for injection in pre-filled pen), via subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for moderate to severe ulcerative colitis. Medical history included sulfa allergy. It was unknown if patient was enrolled in a covid-19 vaccine trial. There were no concomitant medications. The patient previously took amoxicillin;clavulanate potassium (AUGMENTAN) and lisinopril and experienced allergy. On 30Mar2021, the patient experienced possible rheumatoid arthritis and joint pain, fever within 24 hours of covid shot and hives within 24 hours of covid shot. The action taken in response to the events for adalimumab was unknown. Outcome of rheumatoid arthritis was unknown, of joint pain was not recovered, of other events was recovered in 2021.   The reporter's assessment of the causal relationship of the rheumatoid arthritis and joint pain with the bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The reporter's causality for the event of possible rheumatoid arthritis was not provided. The reporter's causality for the events of joint pain, fever within 24 hours of covid shot and hives within 24 hours of covid shot with adalimumab was no reasonable possibility.  The reporter's causality for fever within 24 hours of covid shot and hives within 24 hours of covid shot with bnt162b2 was a reasonable possibility.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the reasonable temporal association, the Company cannot completely exclude the possible causality between the reported events, possible rheumatoid arthritis and joint pain, fever within 24 hours of covid shot and hives, and the administration of the COVID 19 vaccine, 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 RA, as appropriate.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Diabetes mellitus, Dyspnoea, Neck pain
Clinical narrative: Diabetic; Neck pain; Back pain; Difficulty breathing; This is a solicited report from contactable consumer (patient) via non Pfizer sponsored program FACILITATED COLLECT based on information received by Pfizer from AbbVie, manufacturer control number: 21K-163-4079276-00.   Solicited report by a consumer of a 78 year old male with events of non-serious neck pain, diabetic, back pain and difficulty breathing with adalimumab (HUMIRA). There was no reported medical history. On an unknown date, the patient experienced diabetic. In 2021, the patient experienced neck pain, back pain and difficulty breathing. Pfizer Biontech covid-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 12Mar2021 (at 78 year old), patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported) intramuscular as single dose for covid-19 immunisation. Suspect Drugs (include generic name): adalimumab (HUMIRA; Solution for injection in pre-filled pen), subcutaneous for moderate to severe chronic plaque psoriasis and psoriatic arthritis and 1st dose Pfizer Biontech Covid-19  Vaccine(Tozinamera, Injection) intramuscular as covid-19 vaccination given on 12Mar2021.Causality for adalimumab (HUMIRA) :The reporter's causality for the events of neck pain, diabetic, back pain and difficulty breathing with adalimumab (HUMIRA) was no reasonable possibility. Concomitant drugs and dates of administration: Concomitant Drug Not reported. Other Relevant history: Not reported. Outcome of Diabetic was not recovered; outcome of the other events was recovering. Action taken for HUMIRA was unknown. Causality for adalimumab (HUMIRA; Solution for injection in pre-filled pen) and Neck pain, Diabetic, Back pain and Back pain was reported as No reasonable possibility. Causality for Pfizer Biontech Covid-19 Vaccine(Tozinameran, Injection) and Neck pain, Back pain and Back pain was possible and was not reported for Diabetic. The reporter's assessment of the causal relationship of the event Diabetic with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, the causal relationship between the events Diabetic, Neck pain, Back pain, Difficulty breathing and suspect drug BNT162B2 cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Amnesia, Atrial fibrillation, Confusional state, Contusion
Clinical narrative: decreased thyroid function; increased atrial fibrillation; Hair loss; bruising; slight confusion; memory loss; exhaustion; significantly increased depression; sensitivity to cold; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the second dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration, administered in the right arm on 24Mar2021 (Batch/Lot Number: EP6955) at the age of 74-years-old, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant, did not have any other vaccines within four weeks, did not have COVID prior to vaccination, and was not COVID tested post vaccination. The patient previously received the first dose of BNT162B2 on 24Feb2021 (Lot number: EN6202) in the left arm for COVID-19 immunization; and levothyroxine. The patient stated that she had taken the same level of levothyroxine for many years, and suddenly she started having breakthrough symptoms (after the Pfizer vaccinations) in Mar2021: hair loss, bruising, increased atrial fibrillation, slight confusion and memory loss, exhaustion, significantly increased depression, and sensitivity to cold. According to laboratory results on 14Sep2021, the patient had significantly decreased thyroid function. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Fatigue, Hypothyroidism, Temperature intolerance, Thyroid function test
Clinical narrative: decreased thyroid function; increased atrial fibrillation; Hair loss; bruising; slight confusion; memory loss; exhaustion; significantly increased depression; sensitivity to cold; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the second dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration, administered in the right arm on 24Mar2021 (Batch/Lot Number: EP6955) at the age of 74-years-old, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant, did not have any other vaccines within four weeks, did not have COVID prior to vaccination, and was not COVID tested post vaccination. The patient previously received the first dose of BNT162B2 on 24Feb2021 (Lot number: EN6202) in the left arm for COVID-19 immunization; and levothyroxine. The patient stated that she had taken the same level of levothyroxine for many years, and suddenly she started having breakthrough symptoms (after the Pfizer vaccinations) in Mar2021: hair loss, bruising, increased atrial fibrillation, slight confusion and memory loss, exhaustion, significantly increased depression, and sensitivity to cold. According to laboratory results on 14Sep2021, the patient had significantly decreased thyroid function. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Respiratory tract infection, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Bad respiratory infection; This is a solicited report received from marketing program, database, based on the information received by Pfizer. (manufacturer control number 21K-163-3943566-00). A 71-year-old contactable female consumer (patient) reported for herself that she received bnt162b2 (BNT162B2), intramuscular on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation; and adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) and ongoing at citrate free 40 mg (40 mg,1 in 2 week) for moderate to severe chronic plaque psoriasis. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced covid-19 and bad respiratory infection. It was further reported that this is a solicited report from the consumer of an elderly female with events of non-serious bad respiratory infection and COVID-19 with HUMIRA (ADALIMUMAB). PFIZER BIONTECH COVID-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. She received COVID-19 Vaccine manufactured by Pfizer. The patient underwent lab tests and procedures which included Covid-19 test showed covid-19 on an unspecified date. The action taken in response to the events for adalimumab was dose not changed. The outcome of the events was unknown. The reporter's causality for the event(s) of bad respiratory infection and COVID-19 with HUMIRA (ADALIMUMAB) was no reasonable possibility. The company causality with regards to the drug Humira and the event respiratory infection was not related while for the event Covid-19 was no reasonable possibility. In regard to the causality for the drug PFIZER BIONTECH COVID-19 vaccine (tozinameran) and the reported events respiratory infection and COVID-19 were not reported.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events (Covid-19, Drug ineffective, Respiratory  tract Infection) and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot in her finger; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on May2021 (Batch/Lot number and expiration date were not reported) as dose 1, single for COVID-19 immunisation. The patient has no medical history and there were no concomitant medications. Family history included brain aneurysm. Her mom died at the age of 50 due to a brain aneurysm and both her grandmothers died of a brain aneurysm. The patient reported that in May2021, she had the first dose of the COVID vaccine. About a week later, on an unspecified date, she suddenly, randomly developed a blood clot in her finger. She stated that her mom died at the age of 50 due to a brain aneurysm and both her grandmothers died of a brain aneurysm. Due to this, she was afraid and missed her second dose. She stated that she also got scared thinking about it because she knows that COVID can increase the risk of blood clots. She was wondering if she should get the second dose, but did not know since it's been such a long time since her first dose. She stated that she called her pharmacy and the first lady she spoke to told her it had been too long and that she needed to start over again with her first one and second one. She then asked the person since she had a blood clot, would it be safe to have three doses in a relatively short amount of time. She confirmed that she has never had blood clots before. She verified that she had a blood clot in her finger about a week after receiving her first dose. She did not have her vaccine record card, she believes she lost it. She has not seen it in a long time. She can confirm that she got the first dose sometime in May2021 but does not know the exact date since she no longer had the card. The outcome of the event was unknown.   The lot number for BNT162B2 was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Colitis, Colonoscopy, Drug level, Drug level decreased, Fatigue
Clinical narrative: Low drug level; Flu; Feeling cold; Fatigue; Blood in stool; Colon inflammation; FACILITATED COLLECT  This is a Solicited report (Manufacturer Control No: 21K-163-3987994-00) from a contactable female consumer reporting for herself.  A 26-year-old female subject received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation; adalimumab (HUMIRA, 40 mg), subcutaneous from Sep2014 and ongoing (Batch/Lot number was not reported), at 40 mg for rheumatoid arthritis and colitis ulcerative.  Medical history included moderate to severe rheumatoid arthritis and moderate to severe ulcerative colitis, both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  The patient experienced blood in stool on an unspecified date with outcome of recovered, colon inflammation in Jun2021 with outcome of recovered, low drug level on an unspecified date with outcome of unknown, flu on an unspecified date with outcome of recovered, feeling cold on an unspecified date with outcome of recovered, fatigue on an unspecified date with outcome of recovered.  The patient underwent lab tests and procedures which included colonoscopy: inflammation in May2021, drug level (Humira levels): low on an unspecified date.  The action taken in response to the events for adalimumab was dose increased. Causality for HUMIRA: causality for the event of Inflammation in colonoscopy was a reasonable possibility; for the events levels were low and blood in stools was not provided and for the events of Felt cold/Flu symptoms and a lot of Fatigue taking COVID Vaccine was no reasonable possibility. Causality for COVID Vaccine: causality for the event felt cold/flu symptoms and fatigue was possible; not reported for the other events.  The reporter's assessment of the causal relationship of the event with BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Haematochezia, Colitis (non-serious), Drug level decreased (non-serious), Influenza (non-serious), Feeling cold (non-serious), and Fatigue (non-serious) 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, COVID19
Symptoms: Feeling cold, Haematochezia, Influenza
Clinical narrative: Low drug level; Flu; Feeling cold; Fatigue; Blood in stool; Colon inflammation; FACILITATED COLLECT  This is a Solicited report (Manufacturer Control No: 21K-163-3987994-00) from a contactable female consumer reporting for herself.  A 26-year-old female subject received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation; adalimumab (HUMIRA, 40 mg), subcutaneous from Sep2014 and ongoing (Batch/Lot number was not reported), at 40 mg for rheumatoid arthritis and colitis ulcerative.  Medical history included moderate to severe rheumatoid arthritis and moderate to severe ulcerative colitis, both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  The patient experienced blood in stool on an unspecified date with outcome of recovered, colon inflammation in Jun2021 with outcome of recovered, low drug level on an unspecified date with outcome of unknown, flu on an unspecified date with outcome of recovered, feeling cold on an unspecified date with outcome of recovered, fatigue on an unspecified date with outcome of recovered.  The patient underwent lab tests and procedures which included colonoscopy: inflammation in May2021, drug level (Humira levels): low on an unspecified date.  The action taken in response to the events for adalimumab was dose increased. Causality for HUMIRA: causality for the event of Inflammation in colonoscopy was a reasonable possibility; for the events levels were low and blood in stools was not provided and for the events of Felt cold/Flu symptoms and a lot of Fatigue taking COVID Vaccine was no reasonable possibility. Causality for COVID Vaccine: causality for the event felt cold/flu symptoms and fatigue was possible; not reported for the other events.  The reporter's assessment of the causal relationship of the event with BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Haematochezia, Colitis (non-serious), Drug level decreased (non-serious), Influenza (non-serious), Feeling cold (non-serious), and Fatigue (non-serious) 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.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Pain, Vomiting
Clinical narrative: throwing up every week for 3 weeks; now walks with gain; experiencing severe pain; This is a spontaneous report from a contactable consumer (patient). An 85-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EN6207), via an unspecified route of administration, administered in arm right on 11Mar2021 09:15 as dose 1, single for covid-19 immunization. Medical history included high blood pressure, and cholesterol. There were no known allergies. Concomitant medications included hydrochlorothiazide, lisinopril and; meloxicam (MOBIC) - both taken for unspecified indications, start and stop dates were not reported. There were no other vaccines in four weeks. The patient had no covid-19 prior vaccination. On Mar2021 the patient experienced throwing up every week for 3 weeks, now walks with gain and, have been experiencing severe pain - all with no treatment received. These adverse events were reported as serious - resulted in disability or permanent damage. The patient recovered from the adverse events on an unspecified date in 2021 with sequel (with lasting effects). The patient was not tested for covid-19 post-vaccination.  Follow-up (30Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Coccydynia
Clinical narrative: extreme lower back/ tailbone pain; extreme lower back/ tailbone pain; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiry date unknown), via an unspecified route of administration, administered in arm left on 03Sep2021 08:15 as dose 1, single for covid-19 immunization. Medical history included allergies: penicillin. There were no concomitant medications. There were no other vaccines in four weeks. It was unknown if the patient had covid-19 prior to vaccination. The patient was not tested for covid-19 post-vaccination. The patient experienced extreme lower back/tailbone pain on 11Sep2021. No treatment was received for the events. The patient had not recovered from the events at the time of the report.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Fall, Malaise, Movement disorder
Clinical narrative: Pneumonia; Falls; wasn't moving around; weak; sick; tested positive for COVID-19 on 27AUG2021, after receiving both doses of BNT162B2; tested positive for COVID-19 on 27AUG2021, after receiving both doses of BNT162B2; This is a spontaneous report from a contactable consumer via a Pfizer Sponsored Program and Medical information team. A 91 years old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE at the age of 90 years old and via an unspecified route of administration on 05Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE at the age of 90 years old for COVID-19 immunization in a retirement facility. Medical history included ongoing Parkinson's disease and ongoing dementia. The patient's concomitant medications were not reported. The patient was just getting over COVID-19 and pneumonia and he is on antibiotics and a blood thinner. The patient is very weak because he wasn't moving around a lot when he was sick so he is doing physical therapy. Reported treatment for events was antibiotics and blood thinners, Mucinex, Inhalers and physical therapy. The patient has been to the ER for falls and he fell again last week. Caller states they didn't keep him overnight, they just checked him in the ER. The patient was under the care now in the community retirement facility they live in. The patient tested positive for COVID-19 and developed pneumonia by late Aug2021. The patient tested positive for COVID-19 on 27Aug2021, after receiving both doses of BNT162B2. The fall resulted in emergency room and all the events resulted in physician office visit. The outcome of COVID-19 was recovered on 11Sep2021, pneumonia and fall recovered on unspecified date. The outcome of the rest of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: Pneumonia; Falls; wasn't moving around; weak; sick; tested positive for COVID-19 on 27AUG2021, after receiving both doses of BNT162B2; tested positive for COVID-19 on 27AUG2021, after receiving both doses of BNT162B2; This is a spontaneous report from a contactable consumer via a Pfizer Sponsored Program and Medical information team. A 91 years old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE at the age of 90 years old and via an unspecified route of administration on 05Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE at the age of 90 years old for COVID-19 immunization in a retirement facility. Medical history included ongoing Parkinson's disease and ongoing dementia. The patient's concomitant medications were not reported. The patient was just getting over COVID-19 and pneumonia and he is on antibiotics and a blood thinner. The patient is very weak because he wasn't moving around a lot when he was sick so he is doing physical therapy. Reported treatment for events was antibiotics and blood thinners, Mucinex, Inhalers and physical therapy. The patient has been to the ER for falls and he fell again last week. Caller states they didn't keep him overnight, they just checked him in the ER. The patient was under the care now in the community retirement facility they live in. The patient tested positive for COVID-19 and developed pneumonia by late Aug2021. The patient tested positive for COVID-19 on 27Aug2021, after receiving both doses of BNT162B2. The fall resulted in emergency room and all the events resulted in physician office visit. The outcome of COVID-19 was recovered on 11Sep2021, pneumonia and fall recovered on unspecified date. The outcome of the rest of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Immunodeficiency
Clinical narrative: immunocompromised; This is a spontaneous report from a contactable consumer (patient's parent) via the Pfizer-sponsored program. A 38-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 22Feb2021 (Lot number was not reported) as single dose (at the age 38-years-old) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 28Jan2021 (Lot number was not reported) as single dose (at the age 38-years-old) for COVID-19 immunization. The patient experienced "immunocompromised" on Jun2021. The reporter was calling on behalf of her son who is 38 years old. The patient received his first dose 28Jan2021 and second dose 22Feb2021 and in June of this year he was started on a biologic agent Entyvio which is an infusion because he is immunocompromised. When he got the first and second dose he wasn't on the biologic, he started on it in June. Therapeutic measures were taken as a result of "immunocompromised" which included Entyvio. The outcome of the event was unknown. The event was considered as serious (medically significant).  The lot number for the vaccine, BNT162B2 was not provided and will be requested during follow-up.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: severe migraines; This is a spontaneous report from a non-contactable consumer (patient).  A 31-years-old female patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown), at the age of 31 years old, via an unspecified route of administration in left arm on 29Apr2021 at 12:00 at single dose for COVID-19 immunisation. The patient was not pregnant at time of vaccination. The patient had no known allergies. Other medical history was none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine in four weeks or any other medications in two weeks of vaccination. The patient previously received the first dose of BNT162B2 (lot number: unknown), at the age of 31 years old, via an unspecified route of administration in left arm on 08Apr2021 at 12:00 at single dose for COVID-19 immunisation. The patient started getting severe migraines after second dose on 29Apr2021 at 16:00. Migraines continue even after 5 months since last shot. Event resulted in none of the above. Since the vaccination, the patient had not been tested for COVID-19. No treatment received. The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Gastrointestinal disorder, Hypersensitivity, Pain, Pyrexia
Clinical narrative: The patient reported that he had surgery to remove part of damage colon.; Allergy; ache; Fever; This is a solicited report based on the information received by Pfizer (Mfr. Control No.: 21K-163-4082894-00). A contactable consumer reported himself. A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 intramuscular in Apr2021 (Batch/Lot number was not reported) at age of 65-year-old as single dose for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at UNK (CF) for Moderate to severe adult Crohn's disease. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received 1st dose Intramuscular bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in Mar2021 at age of 65-year-old. It was unknown if he was enrolled in a COVID-19 Vaccine Trial. The patient experienced the patient reported that he had surgery to remove part of damage colon on an unspecified date, fever on Apr2021, allergy on an unspecified date, ache on Apr2021. The event colopathy was reported as serious as medically significant, other events reported as non-serious. Clinical course: The patient reported that he had surgery to remove part of damage colon. In Apr2021, he received 2nd dose COVID-19 Vaccine manufactured by Pfizer BioNTech. He had fever for one day and achy after second covid vaccine. He also had allergies. The action taken in response to the events for bnt162b2 was not applicable, for adalimumab was unknown. The outcome of the events was recovering.   Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the events of DAMAGED COLON, FEVER, ALLERGIES and ACHY with HUMIRA (ADALIMUMAB) was no reasonable possibility. Causality for FIZER BIONTECH COVID-19 VACCINE: The reporter's causality for the events of Fever and Ache was Probable, for other events was not reported.  The reporter's assessment of the causal relationship of the events colopathy and allergy with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported fever, allergies, achy and the administration of the COVID19 vaccine, BNT162B2, based on the reasonable temporal association.  Conversely, the reported "surgery to remove part of damage colon" is unrelated to BNT162B2.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Loss of consciousness, Pain in extremity, SARS-CoV-2 test
Clinical narrative: I''ve passed out several times; Headaches; leg pain; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 17Sep2021 14:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included known allergies: Sulfur. Patient did not have COVID prior vaccination. There were no concomitant medications. Patient passed out several times and patient had not been sick nor taken any medicine. Patient also experienced headaches and leg pain. Adverse events start date was 20Sep2021. Treatment for the events was unknown. Nasal Swab on 17Sep2021 was negative. Outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Deafness, Electrocardiogram, Heart rate, Heart rate increased
Clinical narrative: started to lose hearing and sight, and they thought she was on the verge of passing out; started to lose hearing and sight, and they thought she was on the verge of passing out; started to lose hearing and sight, and they thought she was on the verge of passing out; Rapid Heart Beat; Dilated Eyes and Pupils; This is a spontaneous report from a contactable consumer or other non hcp (Father).   A 15-year-old female patient (daughter) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 17May2021 (Lot Number: EW0168) at age of 15-year-old as single dose for covid-19 immunisation.  Medical history included covid-19 (the patient was diagnosed with Covid 19 about 6 months before she received her first dose of the Covid Vaccine).  There were no concomitant medications.  There were no vaccines administered on same date of the Pfizer Suspect. No Prior Vaccinations (within 4 weeks). Caller (father) stated that back in May, his then 15 years old daughter became eligible for the vaccine. Caller stated they are big fans of being vaccinated and very glad that Pfizer came out with a strong vaccine. Caller stated his daughter was the last one in the family to get vaccinated, they all got the Pfizer vaccine. Caller stated his daughter had a negative reaction right after the vaccine that cause rapid heart beat and dilated eyes and pupils. Caller stated the attending nurse monitoring her said they had to call it in as it was an emergency, so the ambulance showed up, and they said either they were taking her to the ER or the parent are. Caller stated his wife was aware that if the ambulance transported her there, it would be costly and they were close and they didn't want huge charges, so she drove her to the emergency room. Caller stated they were all under the impression that there weren't going to be charges to them so she went to the hospital and they gave her a lot of treatments. Caller stated the patient also started to lose hearing and sight, and they thought she was on the verge of passing out. Event onset date was 17May2021. Treatment included: ER, IV, Pharmacy-IV Solutions, IV-Injection Therapy, Laboratory-Chemistry, Hematology, ER General Classification, EKG, ECG, Electrocardiogram. Caller stated the bottom line was she was under observation for 3 hours, then they released her and she got the second shot with no adverse reactions. Caller stated they did say she could get the second shot. Patient also later received her second dose of the Pfizer Covid Vaccine 07Jun2021 Lot: EW0187. The outcome of events was recovered on 17May2021.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Mydriasis, Presyncope
Clinical narrative: started to lose hearing and sight, and they thought she was on the verge of passing out; started to lose hearing and sight, and they thought she was on the verge of passing out; started to lose hearing and sight, and they thought she was on the verge of passing out; Rapid Heart Beat; Dilated Eyes and Pupils; This is a spontaneous report from a contactable consumer or other non hcp (Father).   A 15-year-old female patient (daughter) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 17May2021 (Lot Number: EW0168) at age of 15-year-old as single dose for covid-19 immunisation.  Medical history included covid-19 (the patient was diagnosed with Covid 19 about 6 months before she received her first dose of the Covid Vaccine).  There were no concomitant medications.  There were no vaccines administered on same date of the Pfizer Suspect. No Prior Vaccinations (within 4 weeks). Caller (father) stated that back in May, his then 15 years old daughter became eligible for the vaccine. Caller stated they are big fans of being vaccinated and very glad that Pfizer came out with a strong vaccine. Caller stated his daughter was the last one in the family to get vaccinated, they all got the Pfizer vaccine. Caller stated his daughter had a negative reaction right after the vaccine that cause rapid heart beat and dilated eyes and pupils. Caller stated the attending nurse monitoring her said they had to call it in as it was an emergency, so the ambulance showed up, and they said either they were taking her to the ER or the parent are. Caller stated his wife was aware that if the ambulance transported her there, it would be costly and they were close and they didn't want huge charges, so she drove her to the emergency room. Caller stated they were all under the impression that there weren't going to be charges to them so she went to the hospital and they gave her a lot of treatments. Caller stated the patient also started to lose hearing and sight, and they thought she was on the verge of passing out. Event onset date was 17May2021. Treatment included: ER, IV, Pharmacy-IV Solutions, IV-Injection Therapy, Laboratory-Chemistry, Hematology, ER General Classification, EKG, ECG, Electrocardiogram. Caller stated the bottom line was she was under observation for 3 hours, then they released her and she got the second shot with no adverse reactions. Caller stated they did say she could get the second shot. Patient also later received her second dose of the Pfizer Covid Vaccine 07Jun2021 Lot: EW0187. The outcome of events was recovered on 17May2021.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; This is a spontaneous report from Pfizer sponsored program. A contactable consumer (patient) reported that a 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on 02Sep2021 as single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose of Pfizer COVID 19 Vaccine on 02Sep2021. The patient tested positive for COVID on Monday, 13Sep2021. She did receive the antibody infusion. Her second vaccine was scheduled on 23Sep2021, on her tenth day of isolation. Patient was asking if there are any recommendation on proceeding with the second vaccine after being diagnosed with COVID. She stated that she tested positive for COVID on 13Sep2021. Patient stated since she's had COVID, it will be her 10 days quarantine on 23Sep2021. Therapeutic measures were taken as a result of the event. The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Glomerular filtration rate, Glomerular filtration rate decreased, Nephropathy, Renal disorder
Clinical narrative: Bloodly urine; gfr to 42 (from >60); kidney damage; Now stage 3b kidney dosease; This is a spontaneous report from a contactable Other HCP(patient). A 33-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 28Jan2021 14:00 (Batch/Lot Number: EL3302) at the age of 33-year-old, as single dose for covid-19 immunisation. Medical history included hypothyroidism. The patient previously received first dose of bnt162b2 on 06Jan2021 02:00 PM(lot number: El1284) at the age of 33-year-old at right arm for Covid-19 immunization. There was no other vaccine in four weeks. The patient had no covid prior vaccination. The patient had no known allergies. Concomitant medication included levothyroxine taken for an unspecified indication, start and stop date were not reported. The patient experienced bloodly urine on 29Jan2021 16:00 with outcome of not recovered, gfr to 42 (from >60) on 29Jan2021 16:00 with outcome of not recovered, kidney damage on 29Jan2021 16:00 with outcome of not recovered, now stage 3b kidney disease on 29Jan2021 16:00 with outcome of not recovered. Events resulted in [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage]. Treatment received for the event on 30Jan2021. Covid test type post vaccination was Nasal Swab with unknown results.; Sender's Comments: The reported bloodly urine, GFR decreased, kidney damage, now stage 3b kidney disease are unlikely related to the COVID19 vaccine, BNT162B2, administration. More information regarding the patient's underlying medical condition is required for the Company to make a more meaningful causality assessment.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.