chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Fatigue, Feeling hot, Interchange of vaccine products
Clinical narrative: I have developed diarrhea and I am pretty sure it''s because of the booster shot; Fatigue; Low grade fever; I originally got the J&J shot which was done in March; two days ago, I got the Pfizer booster; I combined the two, if that was a bad thing to do; I originally got the J&J shot which was done in March; two days ago, I got the Pfizer booster; I combined the two, if that was a bad thing to do; The day after the booster, my arm was extremely sore; hot; slightly swollen; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EW0196) via an unspecified route of administration, administered in Arm Left on 01Nov2021 13:00 as dose 2, single for covid-19 immunization (at the age of 65 years). Medical history included chronic obstructive pulmonary disease, emphysema, asthma, blood cholesterol increased, thrombosis, gastrooesophageal reflux disease, arthropod sting and penicillin.  Concomitant medication included montelukast sodium (SINGULAIR), omeprazole, aspirin [acetylsalicylic acid] (ASPIRIN), atorvastatin, calcium, colecalciferol (CALCIUM PLUS VITAMIN D), and fluticasone propionate (FLONASE), and Albutamol (albuterol). The patient was not tested covid positive post vaccination. The patient did not experienced covid prior vaccination.The patient previously took janssen covid-19 vaccine (lot number unknown) via an unspecified route on an unspecified date for covid-19 immunization, and experienced hypersensitivity, and demerol and experienced hypersensitivity. The patient originally got the J&J shot (Later clarified as first COVID-19 vaccine J&J) which was done in March On 01Nov2021 day of shot, in the evening, patient was extremely sore, hot, slightly swollen.On 02Nov2021 she was fatigued, listless, had a low-grade fever of 100.9. That all lasted until evening. 03Nov2021 after lunch, about noon, she developed diarrhea.The patient underwent lab tests and procedures which included body temperature: 100.9 on an unspecified date. The outcome of all events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain in extremity, Pyrexia, Swelling
Clinical narrative: I have developed diarrhea and I am pretty sure it''s because of the booster shot; Fatigue; Low grade fever; I originally got the J&J shot which was done in March; two days ago, I got the Pfizer booster; I combined the two, if that was a bad thing to do; I originally got the J&J shot which was done in March; two days ago, I got the Pfizer booster; I combined the two, if that was a bad thing to do; The day after the booster, my arm was extremely sore; hot; slightly swollen; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EW0196) via an unspecified route of administration, administered in Arm Left on 01Nov2021 13:00 as dose 2, single for covid-19 immunization (at the age of 65 years). Medical history included chronic obstructive pulmonary disease, emphysema, asthma, blood cholesterol increased, thrombosis, gastrooesophageal reflux disease, arthropod sting and penicillin.  Concomitant medication included montelukast sodium (SINGULAIR), omeprazole, aspirin [acetylsalicylic acid] (ASPIRIN), atorvastatin, calcium, colecalciferol (CALCIUM PLUS VITAMIN D), and fluticasone propionate (FLONASE), and Albutamol (albuterol). The patient was not tested covid positive post vaccination. The patient did not experienced covid prior vaccination.The patient previously took janssen covid-19 vaccine (lot number unknown) via an unspecified route on an unspecified date for covid-19 immunization, and experienced hypersensitivity, and demerol and experienced hypersensitivity. The patient originally got the J&J shot (Later clarified as first COVID-19 vaccine J&J) which was done in March On 01Nov2021 day of shot, in the evening, patient was extremely sore, hot, slightly swollen.On 02Nov2021 she was fatigued, listless, had a low-grade fever of 100.9. That all lasted until evening. 03Nov2021 after lunch, about noon, she developed diarrhea.The patient underwent lab tests and procedures which included body temperature: 100.9 on an unspecified date. The outcome of all events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Colitis ulcerative
Clinical narrative: Ulcerative Colitis about 90 days after second injection; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received bnt162b2 (BNT162B2, Lot Number: EN6205), dose 2 via an unspecified route of administration, administered in left arm on 26Mar2021 (at the age of 41-year-old) as dose 2, single for COVID-19 immunization. No Covid prior vaccination. The patient medical history was none. Concomitant medication included escitalopram oxalate (LEXAPRO). The patient previously received the first dose of bnt162b2 (lot number: ER8732) administered in left arm on 05Mar2021 (at the age of 41-year-old) as dose 1, single for COVID-19 immunization. The patient experienced ulcerative colitis about 90 days after second injection in Jun2021. The event resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included oral and suppository treatment. The outcome of the event was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Pain, Peripheral swelling, Pyrexia
Clinical narrative: arms are currently swelling; Fever/ and 102 (reporter stated 102.4) temperature; ''aches like aching'' almost like a flu; ''aches like aching'' almost like a flu; This is a spontaneous report from contactable consumer (patient) via regulatory authority. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient mentioned that his arms were currently swelling right now and he had fever right now. The patient stated not always like, not swelling but it was like 'aches like aching' almost like a flu throughout the body and 102 (reporter stated 102.4) temperature. Patient wanted to know if he can take Tylenol or not because he was getting aggravated here because, he went through this over half an hour and now (voice overlap). Outcome of the events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Myalgia, Rheumatoid arthritis
Clinical narrative: it's been depressing; Severe muscle aches; I have rheumatoid arthritis and it's making this flare up; This is a spontaneous report from a contactable consumer (patient). This 43-year-old female none pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 on 03Oct2021 11:00 AM at age of 43-year-old Left arm (Batch/Lot number: FE3592) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included Rheumatoid arthritis, known allergies: Bactrim and Penicillin, Covid prior vaccination. Concomitant vaccine was not reported. No other medications in four weeks and in two weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 12Sep2021 11:00 AM Left arm at age of 42-year-old (Batch/Lot number: FF8839) for COVID-19 immunisation. Severe muscle aches since the 2nd shot on 03Oct2021. Also bones and joints feel inflamed and are aching. She had rheumatoid arthritis and it's making this flare up and has been non-stop since 03Oct2021. It's making life very uncomfortable and she had been on a heated pad/blanket this symptom has not stopped and hoped it stops soon but it's been a month feeling miserable. She can't stand up for longer than 1 hour the pain is so bad can't stand long. She felt like was in 90s it's been depressing and can't function and be a Mom properly. All Adverse events start date was 04Oct2021 9:00 AM. No Covid tested post vaccination. No treatments were received. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis; This is a spontaneous report from a non-contactable consumer (lawyer).  A 13-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization.   Medical history and concomitant medications were not reported.  It was reported that the patient was hospitalized on unknown date with myocarditis after receiving the Pfizer BioNTech Covid-19 vaccine.  He was now out of sports for at least 6 months.  Outcome of the event was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: tight chest; shortness of breath; This is a spontaneous report from a contactable consumer. A 41 year old female patient (not pregnant, also at time of vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular, administered in Arm Right on 14Oct2021 at 41 years old (Batch/Lot Number: 30155BA) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced tight chest and shortness of breath 30 mins after shot on 14Oct2021. Lasted 2 hours, no treatment given. The outcome of the events was recovering. Facility type vaccine: Workplace clinic. No covid prior vaccination. Not covid tested post vaccination.  Follow-Up (08Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Chest discomfort, Feeling cold, Hypoaesthesia
Clinical narrative: Tight chest; Slept terrible the night after shot; Both arms kept falling asleep even though person was not laying on them funny; 2nd shot burned going in.; Hand and arm tingly; Body joints hurt/ache; Person feels ice cold; Terribly nauseous; Low grade fever (99.1 F).; This is a spontaneous report from a contactable consumer. A 41-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Right on 03Nov2021 (Batch/Lot Number: E100176) at age of 41-years-old as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 14Oct2021 (Batch/Lot Number: 30155BA) at age of 41-years-old for COVID-19 immunization and experienced tight chest and shortness of breath 30 mins after shot. Lasted 2 hours. Patient was not pregnant. Facility type vaccine was workplace clinic. The patient experienced tight chest on 03Nov2021, 2nd shot burned going in on Nov2021, hand and arm tingly on Nov2021, body joints hurt/ache on Nov2021, person feels ice cold on Nov2021, terribly nauseous on Nov2021, low grade fever (99.1 f) on Nov2021, slept terrible the night after shot on 03Nov2021 and both arms kept falling asleep even though person was not laying on them funny on Nov2021. Clinical course reported as follow: Dose 2 Symptoms: tight chest about 20mins after shot. Tightness not as bad as dose 1. 2nd shot burned going in. Hand and arm tingly. Day after dose 2: Body joints hurt/ache. Person feels ice cold. Chest tight again. Terribly nauseous. Low grade fever (99.1 F). Slept terrible the night after shot. Both arms kept falling asleep even though person was not laying on them funny. No matter what sleep position, arms would fall asleep. No COVID prior vaccination. No COVID tested post vaccination. No treatment received for the events. Outcome of the events was recovering.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia, Pyrexia, Sleep disorder
Clinical narrative: Tight chest; Slept terrible the night after shot; Both arms kept falling asleep even though person was not laying on them funny; 2nd shot burned going in.; Hand and arm tingly; Body joints hurt/ache; Person feels ice cold; Terribly nauseous; Low grade fever (99.1 F).; This is a spontaneous report from a contactable consumer. A 41-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Right on 03Nov2021 (Batch/Lot Number: E100176) at age of 41-years-old as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 14Oct2021 (Batch/Lot Number: 30155BA) at age of 41-years-old for COVID-19 immunization and experienced tight chest and shortness of breath 30 mins after shot. Lasted 2 hours. Patient was not pregnant. Facility type vaccine was workplace clinic. The patient experienced tight chest on 03Nov2021, 2nd shot burned going in on Nov2021, hand and arm tingly on Nov2021, body joints hurt/ache on Nov2021, person feels ice cold on Nov2021, terribly nauseous on Nov2021, low grade fever (99.1 f) on Nov2021, slept terrible the night after shot on 03Nov2021 and both arms kept falling asleep even though person was not laying on them funny on Nov2021. Clinical course reported as follow: Dose 2 Symptoms: tight chest about 20mins after shot. Tightness not as bad as dose 1. 2nd shot burned going in. Hand and arm tingly. Day after dose 2: Body joints hurt/ache. Person feels ice cold. Chest tight again. Terribly nauseous. Low grade fever (99.1 F). Slept terrible the night after shot. Both arms kept falling asleep even though person was not laying on them funny. No matter what sleep position, arms would fall asleep. No COVID prior vaccination. No COVID tested post vaccination. No treatment received for the events. Outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Immunisation, Interchange of vaccine products, Off label use
Clinical narrative: Off label use; had 2 shots of the Moderna; She is just concerned that she made a terrible mistake getting a Pfizer booster when she got her first two shots with Moderna. /Afterwards she had some dizziness and when she lays down she's dizzy.; Booster; This is a spontaneous report from a contactable consumer or other non-healthcare professional. An 85-years-old female patient received bnt162b2(COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included that the patient received covid-19 vaccine (MODERNA COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1 and dose 2, single for COVID-19 immunisation and she got flu shot on an unspecified date. The patient experienced off label use and booster on an unspecified date and had 2 shots of the Moderna on an unspecified date she was just concerned that she made a terrible mistake getting a Pfizer booster when she got her first two shots with Moderna or afterwards she had some dizziness and when she lays down she was dizzy on an unspecified date. The patient stated that she has been relayed dizzy when she lays down at night the bed was moving and right now she was a little dizzy. The outcome all the events was unknown.   No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient herself) via COVID-19 Vaccine Adverse Event Self-Reporting Solution portal. A 14-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the right arm on 17Sep2021 at the age of 14 years old (Batch/Lot Number: FC3182, Expiration date: unknown) as dose 1, single for COVID-19 immunization. The vaccination facility type was reported as the urgent care center. The patient was not pregnant at the time of vaccination. The patient's medical history was not reported. The patient had no known allergies. There were no concomitant medications; the patient had no other medications in two weeks. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination and was not tested for covid post vaccination. On 24Sep2021, 1 week after first dose, grand mal seizure and hospitalization occurred. The adverse event also resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of grand mal seizure. The patient had recovered from grand mal seizure on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Immunisation, Pain in extremity
Clinical narrative: chills; arm pain; I received my third booster dose on 03Nov; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported, Expiration date: not reported) via an unspecified route of administration, administered at unspecified anatomical location on 03Nov2021 09:00 as dose 3(BOOSTER), single for COVID-19 immunization. Medical history included, type 2 diabetes mellitus non-insulin from an unknown date. The patient's concomitant medications were not reported. Patient previously received 2 doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported, Expiration date: not reported) via an unspecified route of administration, administered on an unspecified date as dose 1, single and dose 2, single for COVID-19 immunization. On 03Nov2021, patient experienced arm pain and chills. Clinical course:  Patient received his third booster dose on 03Nov2021 at approximately 9am at the Pfizer facility. At approximately 1pm patient started experiencing mild arm pain. By the time patient got home at 6am he had to go straight to bed. The arm pain severely worsened and he started to get chills around 10pm. Patient was better on next day morning with minor arm discomfort. The outcome of the events arm pain and chills was recovering.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Fear of death, Fibrin D dimer, Fibrin D dimer increased, Thrombosis
Clinical narrative: she had very high blood clots; get the vaccine is like "death"; chest pain; D-dimer, and it came back really high, 0.91; This is a spontaneous report from Pfizer- sponsored program, received from a non-contactable consumer (patient) via medical information team. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that patient consulted her doctor after she had Covid-19 vaccine. She said she had very high blood clots, and chest pain. She got tested for D-dimer, and it came back really high, 0.91. She said her doctor told her not to worry about it, and was not given blood clot medications. She said having her get the vaccine is like death. The 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.
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Thrombosis
Clinical narrative: she was having severe bleeding; blood clots; This is a spontaneous report from a contactable pharmacist. A 25-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced she was having severe bleeding and blood clots and was hospitalized 2 or 3 times all of which happened just right after the vaccine on an unspecified date. Of note, her MD didn't advise her to receive the second dose and the caller does not feel comfortable administering it, given her response after the first dose. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The information available in this report is limited and the reported events haemorrhage and thrombosis cannot be totally excluded/assessed. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 antibody test positive
Clinical narrative: He received his first dose on 27 Oct 2021. He tested tested positive for covid on 28 Oct 2021 but was asymptomatic.; This is a spontaneous report from contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (COMIRNATY, Batch/Lot Number: ER8735; Expiration Date: Oct2021), via an unspecified route of administration on 27Oct2021 as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included stage 3 cirrhosis and wanted information. The patient's concomitant medications were not reported. The patient received his first dose on 27Oct2021, he tested positive for covid on 28Oct2021 but was asymptomatic. Stated this was a lot number that was expired but was given an extended expiration date of 90 days and the expiration date was provided as Oct2021. He is asking what studies have been done on the lot number with the extended expiration dates prior to administration. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: developed Covid; developed Covid; This is a spontaneous report from a contactable pharmacist. A 55-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on Oct2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Pharmacist is calling about a patient, male, aged 55, who received his first dose of the Pfizer BioNTech Covid 19 vaccine 21 days ago (not specified) and then developed Covid on an unspecified date. He is due to receive his second dose of the vaccine today. The outcome of the events was unknown. The events were considered as serious (medically significant).  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events  Drug ineffective, COVID-19  cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Dizziness, Feeling hot, Heart rate
Clinical narrative: Blood pressure 155/95/  her blood pressure was going up; tachycardic; hot; dizzy; weak/ weakness; nauseated; This is a spontaneous report from a contactable nurse practitioner. A 38-year-old female patient (Weight: 68.04, Height: 165) received bnt162b2 (COMIRNATY Batch/Lot Number: FE3590; Expiration Date: 30Nov2021, NDC number: 59267100002) via an unspecified route of administration, administered in Arm on 04Nov2021 (at 38-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Allergy, had allergies to soy and wheat. Concomitant medication included diphenhydramine. The patient previously took folic acid, Calamine, and calamine;zinc oxide (CALADRY) and experienced allergies. Caller clarifies that she is reporting on a patient, and she was the vaccinator of the patient, but is not a primary care provider for the patient. The patient was sent to the hospital in an ambulance, though it is not known if she was admitted to the hospital. The patient's reaction was that she was tachycardia, her blood pressure was going up, she was hot, dizzy, and weak. The patient was nauseated after two mins after she gave the injection, which was when she started having symptoms. At 4 minutes after injection she gave the patient 50mg of Benadryl PO, and maintained her vitals every few minutes until the ambulance arrived. The patient's blood pressure did come down some, but as far as the patient's dizziness and weakness, that was still the same before she left. Other Medical Conditions: Caller says the only difference for the two medications that patient is allergic to is that one is clear and one is not. On patient's questionnaire she did not report anything abnormal. The nurse considered the events as serious with Seriousness criteria-Other medically important condition. Results of tests and procedures for investigation of the patient included: the highest Blood pressure: 155/95 and Pulse rate: got up to 125 beats per minute, both on 04Nov2021 at 1444. Outcome of reaction/event at the time of last observation: Unknown.; Sender's Comments: As there is limited information in the case provided, the causal association between the events 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 and on the conduct of the study 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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Nausea, Tachycardia
Clinical narrative: Blood pressure 155/95/  her blood pressure was going up; tachycardic; hot; dizzy; weak/ weakness; nauseated; This is a spontaneous report from a contactable nurse practitioner. A 38-year-old female patient (Weight: 68.04, Height: 165) received bnt162b2 (COMIRNATY Batch/Lot Number: FE3590; Expiration Date: 30Nov2021, NDC number: 59267100002) via an unspecified route of administration, administered in Arm on 04Nov2021 (at 38-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Allergy, had allergies to soy and wheat. Concomitant medication included diphenhydramine. The patient previously took folic acid, Calamine, and calamine;zinc oxide (CALADRY) and experienced allergies. Caller clarifies that she is reporting on a patient, and she was the vaccinator of the patient, but is not a primary care provider for the patient. The patient was sent to the hospital in an ambulance, though it is not known if she was admitted to the hospital. The patient's reaction was that she was tachycardia, her blood pressure was going up, she was hot, dizzy, and weak. The patient was nauseated after two mins after she gave the injection, which was when she started having symptoms. At 4 minutes after injection she gave the patient 50mg of Benadryl PO, and maintained her vitals every few minutes until the ambulance arrived. The patient's blood pressure did come down some, but as far as the patient's dizziness and weakness, that was still the same before she left. Other Medical Conditions: Caller says the only difference for the two medications that patient is allergic to is that one is clear and one is not. On patient's questionnaire she did not report anything abnormal. The nurse considered the events as serious with Seriousness criteria-Other medically important condition. Results of tests and procedures for investigation of the patient included: the highest Blood pressure: 155/95 and Pulse rate: got up to 125 beats per minute, both on 04Nov2021 at 1444. Outcome of reaction/event at the time of last observation: Unknown.; Sender's Comments: As there is limited information in the case provided, the causal association between the events 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 and on the conduct of the study 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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Coordination abnormal, Dizziness, Hypoaesthesia
Clinical narrative: My waist down numb; Mouth swollen; Fever; Dizzy; Nauseous; Many panic attacks; Have no strength on my legs or coordination; Have no strength on my legs or coordination; This is a spontaneous report from a contactable consumer (patient). This 47-year-old non-pregnant female patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration in Arm left on 02Oct2021 at 11:30 AM (at the age of 47-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included penicillin allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive within 2 weeks of vaccination. There were no concomitant medications. The patient previously took amoxicillin and experienced allergy. On 03Oct2021 12:00 AM, the patient reported that her waist down numb, mouth swollen, had fever, dizzy, nauseous and many panic attacks; all of this 2nd day after shot. The patient still had no strength on my legs or coordination. Events resulted in emergency room/department or urgent care visit, and with 3 days hospitalization. Treatment received for events including MRI CAT scan and blood work, both with unknown results on unspecified date. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient did not test for COVID-19. Outcome of events was not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Mouth swelling, Muscular weakness, Nausea, Panic attack
Clinical narrative: My waist down numb; Mouth swollen; Fever; Dizzy; Nauseous; Many panic attacks; Have no strength on my legs or coordination; Have no strength on my legs or coordination; This is a spontaneous report from a contactable consumer (patient). This 47-year-old non-pregnant female patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration in Arm left on 02Oct2021 at 11:30 AM (at the age of 47-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included penicillin allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive within 2 weeks of vaccination. There were no concomitant medications. The patient previously took amoxicillin and experienced allergy. On 03Oct2021 12:00 AM, the patient reported that her waist down numb, mouth swollen, had fever, dizzy, nauseous and many panic attacks; all of this 2nd day after shot. The patient still had no strength on my legs or coordination. Events resulted in emergency room/department or urgent care visit, and with 3 days hospitalization. Treatment received for events including MRI CAT scan and blood work, both with unknown results on unspecified date. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient did not test for COVID-19. Outcome of events was not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: My waist down numb; Mouth swollen; Fever; Dizzy; Nauseous; Many panic attacks; Have no strength on my legs or coordination; Have no strength on my legs or coordination; This is a spontaneous report from a contactable consumer (patient). This 47-year-old non-pregnant female patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration in Arm left on 02Oct2021 at 11:30 AM (at the age of 47-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included penicillin allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive within 2 weeks of vaccination. There were no concomitant medications. The patient previously took amoxicillin and experienced allergy. On 03Oct2021 12:00 AM, the patient reported that her waist down numb, mouth swollen, had fever, dizzy, nauseous and many panic attacks; all of this 2nd day after shot. The patient still had no strength on my legs or coordination. Events resulted in emergency room/department or urgent care visit, and with 3 days hospitalization. Treatment received for events including MRI CAT scan and blood work, both with unknown results on unspecified date. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient did not test for COVID-19. Outcome of events was not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis, Pneumonitis, Thrombosis
Clinical narrative: Inflammation of heart; Significant amount of blood clots in both lobes of lungs; Inflammation of lungs; This is a spontaneous report from a contactable consumer (Daughter). An 85-years-old male patient received bnt162b2 (BNT162B2), dose 2 on Apr2021 (Batch/Lot number was not reported) at 85-year-old as DOSE 2, SINGLE for covid-19 immunisation. Medical history was none. There were no concomitant medications.  The patient previously received first dose of bnt162b2 (MANUFACTURER UNKNOWN), dose 1 on unknown date in Apr2021 (Batch/Lot Number: Unknown) at age of 85-year-old for covid-19 immunisation. Events occurred within a few days after the second dose in Apr2021. Started off with inflammation of the heart, inflammation of the lungs.  There was a significant amount of blood clots in both lobes of patient's lungs. Patient was put on blood thinners after the discovery of the blood clots. Patient has been started on Eliquis. Needs blood thinners for rest of life. The outcome was recovering.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Bone swelling, Diarrhoea, Fatigue, Loss of consciousness, Pain
Clinical narrative: Vomiting; Diarrhea; She passed out; Woke up all achy; Tired; sore at the injection site; Felt like they hit a bone/ swollen; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in Deltoid Right (reported as right shoulder/right arm) on 08Oct2021 between 10am to noon (Batch/Lot Number: EW0186; Expiration Date: Nov2021) at age of 67-years-old as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history was none. Concomitant medication included influenza vaccine (FLU SHOT) taken for immunization within 4 weeks. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on 19Dec2020 (Batch/Lot Number: EJ1685; Expiration Date: 31Mar2021) and dose 2 on 09Jan2021 (Batch/Lot Number: EL0142; Expiration Date: 31Mar2021) for COVID-19 immunisation. Vaccination facility type was hospital. No additional vaccines administered on same date of the Pfizer suspect. No AE following prior vaccinations. No family medical history relevant to AE. The patient experienced passed out on 09Oct2021 with outcome of unknown, woke up all achy on 09Oct2021 with outcome of recovered in Oct2021, tired on 09Oct2021 with outcome of recovered in Oct2021, vomiting on 09Oct2021 17:00 with outcome of recovered in Oct2021, diarrhea on 09Oct2021 17:00 with outcome of recovered in Oct2021, felt like they hit a bone/swollen on 2021 with outcome of unknown. AE require a visit to emergency room and not admitted to the hospital. Clinical course reported as follow: Patient had the Pfizer COVID booster shot on 08Oct2021 and the following morning she woke up all achy and tired, sore at the injection site. Then it went to vomiting and diarrhea and she went to the ER. First two shots went very smoothly. Felt like they hit a bone when she was given the booster injection, it was hurting, it was swollen and sore for a week. She passed out on 09Oct2021 and her husband called an ambulance and she went to ER and was kept till the morning. Confirmed she was not admitted, they kept her in the ER. 1700 was when vomiting and diarrhea started on 09Oct2021, it only lasted for a day or two. Put patient on iv something for the vomiting. No relevant tests.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: Vomiting; Diarrhea; She passed out; Woke up all achy; Tired; sore at the injection site; Felt like they hit a bone/ swollen; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in Deltoid Right (reported as right shoulder/right arm) on 08Oct2021 between 10am to noon (Batch/Lot Number: EW0186; Expiration Date: Nov2021) at age of 67-years-old as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history was none. Concomitant medication included influenza vaccine (FLU SHOT) taken for immunization within 4 weeks. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on 19Dec2020 (Batch/Lot Number: EJ1685; Expiration Date: 31Mar2021) and dose 2 on 09Jan2021 (Batch/Lot Number: EL0142; Expiration Date: 31Mar2021) for COVID-19 immunisation. Vaccination facility type was hospital. No additional vaccines administered on same date of the Pfizer suspect. No AE following prior vaccinations. No family medical history relevant to AE. The patient experienced passed out on 09Oct2021 with outcome of unknown, woke up all achy on 09Oct2021 with outcome of recovered in Oct2021, tired on 09Oct2021 with outcome of recovered in Oct2021, vomiting on 09Oct2021 17:00 with outcome of recovered in Oct2021, diarrhea on 09Oct2021 17:00 with outcome of recovered in Oct2021, felt like they hit a bone/swollen on 2021 with outcome of unknown. AE require a visit to emergency room and not admitted to the hospital. Clinical course reported as follow: Patient had the Pfizer COVID booster shot on 08Oct2021 and the following morning she woke up all achy and tired, sore at the injection site. Then it went to vomiting and diarrhea and she went to the ER. First two shots went very smoothly. Felt like they hit a bone when she was given the booster injection, it was hurting, it was swollen and sore for a week. She passed out on 09Oct2021 and her husband called an ambulance and she went to ER and was kept till the morning. Confirmed she was not admitted, they kept her in the ER. 1700 was when vomiting and diarrhea started on 09Oct2021, it only lasted for a day or two. Put patient on iv something for the vomiting. No relevant tests.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: UNK
Symptoms: Condition aggravated, Fatigue, Rheumatoid arthritis, Therapeutic product effect decreased
Clinical narrative: some of the side effects of the vaccine were very similar to the Rheumatoid Arthritis; Remicade lowers the effectiveness of the vaccine; Remicade lowers the effectiveness of the vaccine; She was tired; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [04Nov2021], this case now contains serious adverse reaction(s). Information processed together.   This is a spontaneous report from a Pfizer sponsored program COVAX US Support from a contactable female consumer. A elderly female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 05Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation; infliximab (REMICADE), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to Sep2021, at UNK (every 6 weeks) for rheumatoid arthritis.  Medical history included ongoing rheumatoid arthritis which  I have Rheumatoid arthritis for 30 years now and I just this Remicade is really really worked well and I do not think it has worked this well since I took the vaccine back in February.The patient's concomitant medications were not reported. patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for  covid-19 immunization.The patient experienced some of the side effects of the vaccine were very similar to the rheumatoid arthritis, remicade lowers the effectiveness of the vaccine, she was tired on an unspecified date. Outcome of events was unknown. The clinical course was reported as follow: Caller received two doses of Pfizer BioNtech COVID-19 vaccine. She received the second dose on 05Feb2021. Caller is on Remicade infusion. She heard the use of Remicade can lower the immune response by 40 to 50 or 60%. Caller is interested to know if the effectiveness of Remicade can be diminished by taking the vaccine. Realized after the caller disconnected the line. Caller is a female who's almost 80 years old. She states she is concerned she felt Remicade did not work. She was tired and some of the side effects of the vaccine were very similar to the Rheumatoid Arthritis. Her last infusion was six weeks ago, and she felt the best. She never felt this way in months. She just feels like the booster dose is not ideal. She wishes she had done some studies because these drugs are very powerful and based on the ongoing studies she doesn't know if taking the booster dose can lower the effectiveness of her medication Remicade. She states Remicade can affect the liver and kidneys. The vaccine is presented like a flu shot and I heard of a possible 4th booster dose that's going to be out.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Loss of personal independence in daily activities, Memory impairment, Reading disorder
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program. This contactable consumer (patient) reported for herself that the female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as dose 1, single, dose 2 via an unspecified route of administration on 04Jun2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included hypertension (For 3.5 years, was training to be a dietary aide, but her blood pressure was too high). The patient's concomitant medications were not reported.  The patient experienced stroke (hospitalization, medically significant) on May2021 with outcome of unknown, having a hard time with memory on 2021 with outcome of unknown, having a hard time processing information/is so messed up right now, doesn't know what's going on 2021 with outcome of unknown, states she can't read her own handwriting on 2021 with outcome of unknown. Therapeutic measures were taken as a result of stroke. The clinical course was reported as follows: Got her first and second dose of Pfizer COVID-19 Vaccine. Caller mentioned she had a stroke. Caller states she can't remember. Had stroke back in May2021, can't remember anything. Had second dose 04Jun2021. Having a hard time processing information. Still treating for the stroke now. Will have to ask the hospital when she had the stroke. Knows the date of her second dose as 04Jun2021, because the funeral for her nephew was that day. Doesn't know if she had her stroke before or after the COVID-19 Vaccines. Has a hard time remembering. Declines report stating she doesn't have any pertinent information and what she would provide wouldn't be correct. She will follow up with her hospital and get back up with Pfizer to provide it. For 3.5 years, was training to be a dietary aide, but her blood pressure was too high. Called withheld for information about the Pfizer BioNTech COVID-19 Vaccine, because she wants to know has enough time passed for her to get the booster dose. States she will ask her doctor. Having a hard time with memory. Has missed appointments and everything. She is so messed up right now, doesn't know what's going on. States she can't read her own handwriting.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: fully vaccinated, tested positive for Covid with symptoms; fully vaccinated, tested positive for Covid with symptoms; This is a spontaneous report from a contactable physician (patient's husband). A female patient of an unspecified age received BNT162B2 (COMIRNATY), as dose 2, single (Batch/Lot number was not reported), and as dose 1, single (Batch/Lot number was not reported), via an unspecified route of administration on unspecified dates for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was fully vaccinated and tested positive for COVID with symptoms lasting for more than a week on an unspecified date. Outcome of the events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective / COVID-19 cannot be ruled out.