chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Rash papular, Wrong technique in product usage process
Clinical narrative: red bumps on both arms; The lady who administered the vaccine did not go deeper in injecting the vaccine; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient's mother) reported for her (daughter, the patient). A 12-year-old female patient received first dose of bnt162b2 (Pfizer BioNTech covid-19 mRNA vaccine, Solution for injection), via an unspecified route on 01Sep2021, as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 02Sep2021 after the first dose of vaccine, reporter stated that the lady who administered the vaccine did not go deeper in injecting the vaccine and could have been an error on administration since today on 02Sep2021, patient started experiencing really red bumps on both of their arms (she and her daughter) where the injection site was. Reporter mentioned that her husband and two more daughters had the complete doses of the vaccine but did not have any adverse reactions and clarified that they were all fine. The clinical outcome of the events was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Diarrhoea, Disturbance in attention, Dysgeusia, Feeling abnormal
Clinical narrative: Flutter in heart; Metal taste in mouth; Nauseous; diarrhea; Fuzzy head; loss mental focus; Bump appeared on bottom lip; This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old female patient received the first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in Arm Right on 29Aug2021 13:00 (Lot Number: FD8448) as dose 1, single for COVID-19 immunisation. Medical history included known allergies to Morphine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. There were no concomitant medications. COVID test (Nasal Swab) on 07May2021 was negative. On 29Aug2021 after 30min of shot (at 13:30), patient experienced a metal taste in mouth; flutter in heart lasted a day; nauseous and diarrhea lasted 4 days; fuzzy head and loss mental focus that lasted 5 days; and a bump appeared on bottom lip. The adverse events result in Doctor or other healthcare professional office/clinic visit. The outcome of the event 'Flutter in heart' was recovered on 30Aug2021 13:30, for 'nauseous and diarrhea' was recovered on 02Sep2021 13:30, for 'Fuzzy head' and 'loss of mental focus' was recovered on 03Sep2021 13:30, for the other events was recovering.   No follow up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lip disorder, Nausea, SARS-CoV-2 test
Clinical narrative: Flutter in heart; Metal taste in mouth; Nauseous; diarrhea; Fuzzy head; loss mental focus; Bump appeared on bottom lip; This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old female patient received the first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in Arm Right on 29Aug2021 13:00 (Lot Number: FD8448) as dose 1, single for COVID-19 immunisation. Medical history included known allergies to Morphine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. There were no concomitant medications. COVID test (Nasal Swab) on 07May2021 was negative. On 29Aug2021 after 30min of shot (at 13:30), patient experienced a metal taste in mouth; flutter in heart lasted a day; nauseous and diarrhea lasted 4 days; fuzzy head and loss mental focus that lasted 5 days; and a bump appeared on bottom lip. The adverse events result in Doctor or other healthcare professional office/clinic visit. The outcome of the event 'Flutter in heart' was recovered on 30Aug2021 13:30, for 'nauseous and diarrhea' was recovered on 02Sep2021 13:30, for 'Fuzzy head' and 'loss of mental focus' was recovered on 03Sep2021 13:30, for the other events was recovering.   No follow up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Drug ineffective, Fatigue, Insomnia
Clinical narrative: tested positive on the PCR/Tested positive of the covid-19 virus after the both the doses; tested positive on the PCR/Tested positive of the covid-19 virus after the both the doses; sore arm; chills; couldn't sleep well/  couldn't sleep really well; felt feverish; fatigue; Injection site pain; Sleeplessness; This is a spontaneous report from a Contactable Consumer.   A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: FA6780), via an unspecified route of administration on 01Sep2021 age at vaccination was 61 years as DOSE 2, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine includes the patient received first dose of BNT162B2 Pfizer Covid 19 vaccine, Batch/Lot number: FA6780 on an unspecified date for COVID-19 immunization had side effect of sore arm. In Sep2021, the patient had sore arm, chills, couldn't sleep well/couldn't sleep really well, felt feverish, fatigue, injection site pain, and sleeplessness. On 03Sep2021, the patient tested positive on the PCR for the covid-19 virus after the both the doses. The reporter reported that, I have recently gotten vaccinated, my first dose a little over 3 weeks ago and my second dose Wednesday. On Wednesday night, I had a sore arm which is normal for me because I had it with the first one, but then I started with chills throughout the night. I couldn't sleep well, felt feverish. Around 5am, about 16 hours after injection, I took 1 Tylenol felt better almost immediately and said awesome I was just having side effects. To be safe, I went to go get tested around noon time the next feeling just fine back to myself, took another Tylenol as a precaution because I had the fatigue, the whole 9 yards. I felt fine yesterday for the rest of the day, I thought great my side effects are over, until I got a phone call this morning from the state of that said you tested positive on the PCR, you tested positive, but I'm feeling back to myself now, like okay. I went and got another PCR test that had someone else do it and that came back negative. I'm feeling just fine, oxygen at 99%, everything is normal about me, but I'm really concerned did I have covid. The lab data included oxygen saturation was 99% on an unspecified date in 2021, PCR test negative on an unspecified date in 2021, and PCR test positive on 03Sep2021. The treatment medication included TYLENOL for fever. Outcome of the events sore arm, chills, I couldn't sleep well/couldn't sleep really well, felt feverish, fatigue, injection site pain, and sleeplessness were recovered in 2021 and other events was unknown. Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Pain in extremity, Pyrexia, SARS-CoV-2 test, Sleep disorder
Clinical narrative: tested positive on the PCR/Tested positive of the covid-19 virus after the both the doses; tested positive on the PCR/Tested positive of the covid-19 virus after the both the doses; sore arm; chills; couldn't sleep well/  couldn't sleep really well; felt feverish; fatigue; Injection site pain; Sleeplessness; This is a spontaneous report from a Contactable Consumer.   A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: FA6780), via an unspecified route of administration on 01Sep2021 age at vaccination was 61 years as DOSE 2, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine includes the patient received first dose of BNT162B2 Pfizer Covid 19 vaccine, Batch/Lot number: FA6780 on an unspecified date for COVID-19 immunization had side effect of sore arm. In Sep2021, the patient had sore arm, chills, couldn't sleep well/couldn't sleep really well, felt feverish, fatigue, injection site pain, and sleeplessness. On 03Sep2021, the patient tested positive on the PCR for the covid-19 virus after the both the doses. The reporter reported that, I have recently gotten vaccinated, my first dose a little over 3 weeks ago and my second dose Wednesday. On Wednesday night, I had a sore arm which is normal for me because I had it with the first one, but then I started with chills throughout the night. I couldn't sleep well, felt feverish. Around 5am, about 16 hours after injection, I took 1 Tylenol felt better almost immediately and said awesome I was just having side effects. To be safe, I went to go get tested around noon time the next feeling just fine back to myself, took another Tylenol as a precaution because I had the fatigue, the whole 9 yards. I felt fine yesterday for the rest of the day, I thought great my side effects are over, until I got a phone call this morning from the state of that said you tested positive on the PCR, you tested positive, but I'm feeling back to myself now, like okay. I went and got another PCR test that had someone else do it and that came back negative. I'm feeling just fine, oxygen at 99%, everything is normal about me, but I'm really concerned did I have covid. The lab data included oxygen saturation was 99% on an unspecified date in 2021, PCR test negative on an unspecified date in 2021, and PCR test positive on 03Sep2021. The treatment medication included TYLENOL for fever. Outcome of the events sore arm, chills, I couldn't sleep well/couldn't sleep really well, felt feverish, fatigue, injection site pain, and sleeplessness were recovered in 2021 and other events was unknown. Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: tested positive on the PCR/Tested positive of the covid-19 virus after the both the doses; tested positive on the PCR/Tested positive of the covid-19 virus after the both the doses; sore arm; chills; couldn't sleep well/  couldn't sleep really well; felt feverish; fatigue; Injection site pain; Sleeplessness; This is a spontaneous report from a Contactable Consumer.   A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: FA6780), via an unspecified route of administration on 01Sep2021 age at vaccination was 61 years as DOSE 2, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine includes the patient received first dose of BNT162B2 Pfizer Covid 19 vaccine, Batch/Lot number: FA6780 on an unspecified date for COVID-19 immunization had side effect of sore arm. In Sep2021, the patient had sore arm, chills, couldn't sleep well/couldn't sleep really well, felt feverish, fatigue, injection site pain, and sleeplessness. On 03Sep2021, the patient tested positive on the PCR for the covid-19 virus after the both the doses. The reporter reported that, I have recently gotten vaccinated, my first dose a little over 3 weeks ago and my second dose Wednesday. On Wednesday night, I had a sore arm which is normal for me because I had it with the first one, but then I started with chills throughout the night. I couldn't sleep well, felt feverish. Around 5am, about 16 hours after injection, I took 1 Tylenol felt better almost immediately and said awesome I was just having side effects. To be safe, I went to go get tested around noon time the next feeling just fine back to myself, took another Tylenol as a precaution because I had the fatigue, the whole 9 yards. I felt fine yesterday for the rest of the day, I thought great my side effects are over, until I got a phone call this morning from the state of that said you tested positive on the PCR, you tested positive, but I'm feeling back to myself now, like okay. I went and got another PCR test that had someone else do it and that came back negative. I'm feeling just fine, oxygen at 99%, everything is normal about me, but I'm really concerned did I have covid. The lab data included oxygen saturation was 99% on an unspecified date in 2021, PCR test negative on an unspecified date in 2021, and PCR test positive on 03Sep2021. The treatment medication included TYLENOL for fever. Outcome of the events sore arm, chills, I couldn't sleep well/couldn't sleep really well, felt feverish, fatigue, injection site pain, and sleeplessness were recovered in 2021 and other events was unknown. Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest, Myocarditis, Pericarditis, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: Pulmonary Embolus; Sudden Cardiac Arrest; Myocarditis; Pericarditis; This is a spontaneous report from a contactable consumer (patient herself). A 45-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 27Apr2021 at 09:45 at the age of 45 years old (Batch/Lot Number: EN6206, Expiration date: unknown) as dose 2, single for COVID-19 immunization. The vaccination facility type was the physician/doctor's office/urgent care. The patient was not pregnant at the time of vaccination. Relevant medical history included anxiety and migraines, both from an unknown date and unknown if ongoing. The patient had no known allergies. The patient had no COVID-19 prior vaccination. The patient had no other vaccine in four weeks. Concomitant medications in two weeks included fluoxetine; minocycline; nortriptyline; and "Spironolac" (as reported); all taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in the right arm on 30Mar2021 at 09:00 AM at the age of 45 years old (Batch/Lot number: EN6202, Expiration date: unknown), as dose 1, single for COVID-19 immunization. On 31May2021 at 08:00, the patient experienced pulmonary embolus, sudden cardiac arrest, myocarditis, and pericarditis. The adverse events (AEs) resulted in both doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. This report was considered serious, as the events resulted in hospitalization and disability and were also considered life threatening. The patient was hospitalized for pulmonary embolus, sudden cardiac arrest, myocarditis, and pericarditis on an unspecified date for 6 days. The patient underwent lab test and procedure, which included COVID-19 test via nasal swab: negative on 26May2021. Therapeutic measures were taken as a result of pulmonary embolus, sudden cardiac arrest, myocarditis, and pericarditis, which included resuscitation, blood thinners, colchicine, and implantable cardioverter defibrillator (ICD). The patient had recovered with sequelae from all the events on an unspecified date in 2021.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Within several weeks my hair began to fall out in general, not patches.; This is a spontaneous report from a contactable consumer.  This 68-year-old male consumer (patient) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: ENG205), dose 1 via an unspecified route of administration, administered in Arm Right on 04Mar2021 (at the age of 68-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hiv infection from an unknown date and unknown if ongoing Other medical history: HIV, rubber sensitivity from an unknown date and unknown if ongoing Known allergies: Latex, drug hypersensitivity from an unknown date and unknown if ongoing Known allergies: Penicillan.      The patient experienced alopecia (within several weeks my hair began to fall out in general, not patches) on 30Mar2021 with outcome of recovered with sequelae.  Adverse events was classified as serious: Disability or permanent damage  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Gingival disorder, Oral disorder
Clinical narrative: I began getting lesions in my mouth and gums.; I began getting lesions in my mouth and gums.; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received the second dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration, administered in the left arm on 10Feb2021 (Batch/Lot Number: EL3249) single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have COVID prior to vaccination and had no known allergies. The patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine) on 21Jan2021 (Lot number: EK9231) in the left arm. The patient had no other vaccines within four weeks. The patient stated that one week after the second vaccine, on 17Feb2021, he began getting lesions in his mouth and gums. He has consulted an oral surgeon and ENT specialist but have received no answers and no relief from the lesions. Stated that he had never had as much as a cold sore or ulcer in his mouth prior to his injection. He believed that the vaccine had some part in causing the lesions. Treatment for the events included mouthwash and prednisone. The patient was not tested for COVID post vaccination. Outcome of the events was not recovered.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Lost some movements; Left arm still hurts; This is a spontaneous report from a contactable consumer (patient). A 55-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in the left arm on 05May2021 (as reported) (Batch/Lot Number: Ew0182) as dose 2, single (at the age of 55-years-old) for Covid-19 immunisation. There was no medical history. The patient has unspecified concomitant medications (other medications in two weeks). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the left arm on 05May2021 (as reported) at 12:00 AM (Batch/Lot Number: Ek10173) as dose 1, single for Covid-19 immunisation. The patient had no other vaccine in four weeks. The patient lost some movements and left arm still hurts on 01Jul2021. No treatment was administered for the events. The patient had no Covid prior vaccination. The patient was tested for Covid via nasal swab (PCR) on 11Aug2021 and resulted negative. The events had not resolved.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous report received from a contactable consumer (mother). This consumer re-ported behalf of female patient (daughter) in response to Non HCP telephonic follow up activity that included.   A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: not provided) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that she took Pfizer covid vaccine and got a rash. Outcome of event was unknown.  Follow-up attempts were completed. No further information is expected; information about lot/batch number could not be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101152710
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Lethargy, Pyrexia, Vaccination site pain
Clinical narrative: lethargic; trouble breathing; fever; Sore arm at injection site; tiredness; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (Pfizer COVID 19 ), dose 1 via an unspecified route of administration, administered in left arm on 12Apr2021 11:15 (Lot Number: EW0158) as dose 1, single at the age of 61-year-old for COVID-19 immunisation. The patient was not pregnant. Medical history included renal hypertension, osteoarthritis, born with one kidney, shellfish allergy, insulin allergy. Concomitant medications included pravastatin; candesartan cilexetil; chlorthalidone, all taken for an unspecified indication in two weeks. No other vaccine in four weeks. The patient experienced sore arm at injection site, tiredness on 15Apr2021. About a week later she was lethargic and had a fever, trouble breathing. Had to call ambulance to be transported to the hospital and was admitted. AE resulted in emergency room/department, hospitalization for 9 days, life threatening illness (immediate risk of death from the event). Treatment received for the events which included oxygen, medication. No COVID prior vaccination. It was unknown If COVID tested post vaccination. The outcome of events was recovering.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage, SARS-CoV-2 test
Clinical narrative: Post menopausal Vaginal bleeding x1 day beginning night of vaccination; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and expiration dates were not reported), dose 1 via unknown route administration at left arm on 01Sep2021 at 11:00 am (age at vaccination 65-year-old) as single dose for COVID-19 immunisation. The patient had allergy to sulfa from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient medical history included endometrial cancer with hysterectomy, asthma, hypothyroid, arthritis, retinal detachment and choledocholithiasis from an unknown date and unknown if ongoing. The patient took other medications in two weeks included amlodipine, levothyroxine, ursodiol, tramadol and vitamin B1 from an unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient had post-menopausal vaginal bleeding in 1 day beginning night of vaccination on 02Sep2021 at 12:00 am. The patient had not received any treatment for the event. The patient underwent lab tests and procedures which included Sars-cov-2 test (Nasal swab): Negative on 01Sep2021. The Facility where the most recent COVID-19 vaccine administered was Doctor's office/urgent care. The patient did not receive any treatment for the adverse event. The outcome of the event was recovered on an unknown date in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Illness
Clinical narrative: Then I got severe cardiac arrhythmias first time ever in my life. 20x PVC per minute. I still have it; after second dose really sick about 4 days.; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on Jan2021, as a single dose for COVID-19 immunization at hospital. The patient was not pregnant at the time of vaccination. The patient's medical history included hypothyroid. Concomitant medications were not reported. Past drug included morphine (known allergy: morphine). The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that after second dose she really sick about 4 days. Then she got severe cardiac arrhythmias first time ever in my life. 20x PVC per minute. She still had it on an unspecified date in Jan2021. The patient did not receive any treatment for the events. Outcome of the events was not recovered.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsey after receiving the vaccine; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer reported for a patient.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/lot number was not reported), via an unspecified route of administration, on an unspecified date at a dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient developed Bell's Palsey. The reporter stated a family member developed Bell's Palsey after receiving the vaccine. The reporter had first hand knowledge of the patient and was reporting on a specific patient. The reporter stated that she is not going to get the vaccine. The outcome of the event was unknown.  No follow up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Rheumatoid arthritis, SARS-CoV-2 test
Clinical narrative: Rheumatoid arthritis flare up; COVID-19; drug ineffective; This is a solicited report based on information received by Pfizer (Mfr. Control No.: 21K-163-4061179-00). A contactable consumer (patient) reported on herself. A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date: was not reported), dose 1 intramuscular on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation; upadacitinib (RINVOQ), oral from an unspecified date (Batch/Lot number and expiration date: was not reported) to an unspecified date, at unspecified dose for moderate to severe Rheumatoid Arthritis. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced rheumatoid arthritis flare up. On 15Jul2021, the patient experienced COVID-19. The patient underwent lab tests and procedures which included COVID-19: positive on 15Jul2021. The outcome for the events was unknown.  The reporter's causality for the events of Neck Procedure, COVID-19, and Rheumatoid Arthritis Flare with RINVOQ (UPADACITINIB) was not provided. Company's opinion is that there is no reasonable possibility that the events of Neck Procedure, COVID-19 and Rheumatoid Arthritis Flare are related to RINVOQ (UPADACITINIB).  The reporter's causality for the events of COVID-19, and Rheumatoid Arthritis Flare with PFIZER BIONTECH COVID-19 VACCINE was assessed as possible.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events, Covid 19, aggravated and suspect drug BNT162B2 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.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Headache
Clinical narrative: faint; I had sore arm; I had sore arm with numbness; I had sore arm with numbness and tingling; Sore throat; running nose; Chills; Headache; Weakness; body aches/my body is in a lot of pain; joints pain; dizziness; nausea; This is a spontaneous report from a contactable other hcp for herself. A 48-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FC31eZ, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on unspecified date of Aug2021 (age at vaccination was 48 years) as dose 1, single for COVID-19 immunization. The patient's medical history included psoriasis from an unknown date. The patient did not have any known allergies. The patient did not receive any concomitant medications or other medications in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 19Aug2021 at 15:00 immediate after vaccine patient had sore arm with numbness and tingling for 2 days, sore throat , running nose , chills , headache, weakness. After 24 hours patient start having body aches, joints pain with dizziness, faint, and nausea, weakness from that day to present. Patient did the vaccine 17 days ago and her body was in a lot of pain, joints pain, patient had days when she couldn't get out of bed. Patient had to call in to work multiple time because she couldn't function. Daily she had a lot joints pain all over her body. Treatment was referral to rheumatologist for treatment of psoria. Patient visit the clinic. Therapeutic measures were taken as a result of faint, i had sore arm, i had sore arm with numbness, i had sore arm with numbness and tingling, sore throat, running nose, chills, headache, weakness, body aches/my body is in a lot of pain , joints pain, dizziness and nausea. The outcome of the events i had sore arm and i had sore arm with numbness was recovered on 21Aug2021. Rest outcome of all event was not recovered.; Sender's Comments: Based on available information, there is reasonable possibility of causal association between the event syncope and the suspect drug BNT162B2
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nausea, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: faint; I had sore arm; I had sore arm with numbness; I had sore arm with numbness and tingling; Sore throat; running nose; Chills; Headache; Weakness; body aches/my body is in a lot of pain; joints pain; dizziness; nausea; This is a spontaneous report from a contactable other hcp for herself. A 48-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FC31eZ, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on unspecified date of Aug2021 (age at vaccination was 48 years) as dose 1, single for COVID-19 immunization. The patient's medical history included psoriasis from an unknown date. The patient did not have any known allergies. The patient did not receive any concomitant medications or other medications in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 19Aug2021 at 15:00 immediate after vaccine patient had sore arm with numbness and tingling for 2 days, sore throat , running nose , chills , headache, weakness. After 24 hours patient start having body aches, joints pain with dizziness, faint, and nausea, weakness from that day to present. Patient did the vaccine 17 days ago and her body was in a lot of pain, joints pain, patient had days when she couldn't get out of bed. Patient had to call in to work multiple time because she couldn't function. Daily she had a lot joints pain all over her body. Treatment was referral to rheumatologist for treatment of psoria. Patient visit the clinic. Therapeutic measures were taken as a result of faint, i had sore arm, i had sore arm with numbness, i had sore arm with numbness and tingling, sore throat, running nose, chills, headache, weakness, body aches/my body is in a lot of pain , joints pain, dizziness and nausea. The outcome of the events i had sore arm and i had sore arm with numbness was recovered on 21Aug2021. Rest outcome of all event was not recovered.; Sender's Comments: Based on available information, there is reasonable possibility of causal association between the event syncope and the suspect drug BNT162B2
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Rhinorrhoea, Syncope
Clinical narrative: faint; I had sore arm; I had sore arm with numbness; I had sore arm with numbness and tingling; Sore throat; running nose; Chills; Headache; Weakness; body aches/my body is in a lot of pain; joints pain; dizziness; nausea; This is a spontaneous report from a contactable other hcp for herself. A 48-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FC31eZ, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on unspecified date of Aug2021 (age at vaccination was 48 years) as dose 1, single for COVID-19 immunization. The patient's medical history included psoriasis from an unknown date. The patient did not have any known allergies. The patient did not receive any concomitant medications or other medications in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 19Aug2021 at 15:00 immediate after vaccine patient had sore arm with numbness and tingling for 2 days, sore throat , running nose , chills , headache, weakness. After 24 hours patient start having body aches, joints pain with dizziness, faint, and nausea, weakness from that day to present. Patient did the vaccine 17 days ago and her body was in a lot of pain, joints pain, patient had days when she couldn't get out of bed. Patient had to call in to work multiple time because she couldn't function. Daily she had a lot joints pain all over her body. Treatment was referral to rheumatologist for treatment of psoria. Patient visit the clinic. Therapeutic measures were taken as a result of faint, i had sore arm, i had sore arm with numbness, i had sore arm with numbness and tingling, sore throat, running nose, chills, headache, weakness, body aches/my body is in a lot of pain , joints pain, dizziness and nausea. The outcome of the events i had sore arm and i had sore arm with numbness was recovered on 21Aug2021. Rest outcome of all event was not recovered.; Sender's Comments: Based on available information, there is reasonable possibility of causal association between the event syncope and the suspect drug BNT162B2
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness, Pain in extremity, Vaccination site pain, Weight
Clinical narrative: mild headache; arm pain; Patient had pain at the injection site that was sore and a little stiff; Patient had pain at the injection site that was sore and a little stiff; This is a spontaneous report from a contactable consumer (patient). A 60-years-old male patient received bnt162b2 (PFIZER COVID 19 VACCINE, Solution for injection, Lot Number: EW0217; Expiration Date: 30Sep2021(further not clarified) via intramuscularly, administered in left arm on 29Jul2021 morning like between 9 and 10 O clock (at the age of 60-years-old) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were none. Vaccination Facility Type was Hospital. Investigation Assessment was no. Prior Vaccinations, no medication received within 4 weeks. On 29Jul2021 in the evening, patient experienced arm pain and mild headache which went away after 2 to 3 days. The patient had pain at the injection site that was sore and a little stiff in 2021. The patient was reading online, and they said most patients can still get headaches months after the shot. The caller wants to know if this was normal. After the first dose the caller had pain at the injection site that was sore and a little stiff. The headache and the arm pain started the evening after the first dose. The event did not require a visit to emergency room and physician office. During his first shot he experienced little arm pain and mild headache, which went away after 2-3 days. Consumer stated that had been taking Aspirin. Consumer stated that the day would both go (voice not clear) like Tylenol and Motrin like he did not know. It might be of 25 milligrams of each (further not clarified). The patient underwent lab tests and procedures which included weight 155 lbs on unspecified date. The outcome of the event mild headache was recovered on 31Jul2021, event arm pain was recovering, and other events was unknown.  Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; Joint pain; This is a non-interventional study report from the marketing program facilitated collect received from a contactable consumer or other non hcp received by Pfizer. (Manufacturer Control No: 2016-0191204). A 59-years-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN), solution for injection, Batch/Lot number was not reported), via intramuscular on an unspecified date as dose 1, single for covid-19 immunisation and adalimumab (HUMIRA, Solution for injection in pre-filled pen, Batch/Lot number was not reported), subcutaneous from an unspecified date to an unspecified date, at unspecified dose for psoriatic arthropathy. The patient medical history included psoriatic arthritis. The patient's concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On an unspecified date in Aug2021, the patient experienced covid-19, joint pain. The outcome of the events was unknown.  The reporter assessed the causality between humira and events as Reasonable possibility. The reporter assessed the causality between BNT162B2 and events as possible.; Sender's Comments: Based on the information in the case provided, the causal association between the events Suspected Covid 19 and Arthralgia and the suspect drug BNT162B2 cannot be excluded.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Heart rate increased
Clinical narrative: Periods of fluttering; rapid heart beat; This is a spontaneous report from a non-contactable consumer (patient).   A 35-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Left arm on 26Aug2021 09:00, at the age of 35-years-old, (Lot Number: FD8448) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included none. The patient's concomitant medications were not reported.  On 29Aug2021, the patient experienced periods of fluttering and rapid heart beat. The event involved physician office visit. The outcome of the event was unknown. It was unknown if treatment was received for the events.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Heart rate, Heart rate increased, Heart rate irregular
Clinical narrative: Partial loss of eyesight for short period; Irregular and rapid heartbeat a times; Irregular and rapid heartbeat a times; This is a spontaneous report from a non-contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history was not reported. The patient had no history of COVID prior vaccination. The patient was not COVID tested post vaccination. There were no concomitant medications. The patient experienced partial loss of eyesight for short period, and irregular and rapid heartbeat a times. The evens resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was unknown.  No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: had miscarriage after vaccination; This is a spontaneous report from a non-contactable consumer via a Pfizer Sponsored Program. This consumer reported for two female patients. This is the first of two reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as dose number unknown, single, for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient had miscarriage after vaccination on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101154145 different patient, same reporter/product/event
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: patient had miscarriage after vaccination; This is a spontaneous report from a non-contactable consumer via a Pfizer Sponsored Program. This consumer reported for two female patients. This is the second of two reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient had miscarriage after vaccination on an unspecified date. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101154129 different  patient, same reporter/product/event
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: SC3184, expiry date: unknown) via unspecified route of administration, on an unspecified date as dose 1, single for covid-19 immunisation. Patients medical history and concomitant medications were not reported. It seemed like patient got headache since got the (first dose) shot. Patient got it on Sunday and had headache in morning Monday and still had it today (unspecified date). Patient wanted to know what should be done to get rid of the headache. The outcome of event was unknown.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chest discomfort, Chest pain, Electrocardiogram
Clinical narrative: severe chest pain; severe chest pain / pressure on right side; severe chest pain / pressure on right side that woke me from sleep; This is a spontaneous report from a non-contactable consumer (patient). A 46-year-old female patient received first dose of bnt162b2 via unspecified route of administration in the arm left, on 03Aug2021 at 17:15 (lot number: fc3180), at the age of 46-years-old, at single dose for COVID-19 immunisation. Medical history included insomnia. Patient was not pregnant at the time of vaccination. Concomitant medication included diphenhydramine hydrochloride (BENADRYL) for unspecified indication, and unspecified vitamins. The patient experienced severe chest pain / pressure on right side that woke the patient from sleep, all on 19Aug2021 at 04:00 am. The events resulted in Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. Therapeutic measure was taken in response to the events which included unspecified IV med. Laboratory tests included EKG, Chest X-ray, blood work on unspecified date in Aug2021 with unknown results. Outcome of the event was recovered on unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: severe chest pain; severe chest pain / pressure on right side; severe chest pain / pressure on right side that woke me from sleep; This is a spontaneous report from a non-contactable consumer (patient). A 46-year-old female patient received first dose of bnt162b2 via unspecified route of administration in the arm left, on 03Aug2021 at 17:15 (lot number: fc3180), at the age of 46-years-old, at single dose for COVID-19 immunisation. Medical history included insomnia. Patient was not pregnant at the time of vaccination. Concomitant medication included diphenhydramine hydrochloride (BENADRYL) for unspecified indication, and unspecified vitamins. The patient experienced severe chest pain / pressure on right side that woke the patient from sleep, all on 19Aug2021 at 04:00 am. The events resulted in Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. Therapeutic measure was taken in response to the events which included unspecified IV med. Laboratory tests included EKG, Chest X-ray, blood work on unspecified date in Aug2021 with unknown results. Outcome of the event was recovered on unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Illness, Loss of consciousness, Vomiting
Clinical narrative: Threw up a couple of time and passed out; I just feel really sick; Extremely tired and weak yesterday and last night I started having numbness and extreme weakness on the right side of my body; Extremely tired and weak yesterday and last night I started having numbness and extreme weakness on the right side of my body; Threw up a couple of time and passed out; 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), dose 1 via an unspecified route of administration on 02Sep2021 (Batch/Lot Number: F3183) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced extremely tired and was weak the previous night and last night he/she started having numbness and extreme weakness on the right side of his/her body and then threw up a couple of time and passed out. The patient still had significant numbness and weakness on his/her right side so, he/she is trying to identify, if he/she need to go into an emergency room or anything or what to do. The patient just felt really sick. The outcome of all the events was unknown.