chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Headache, Myalgia, Arthralgia, chills, fatigue Narrative:  Arthralgia, myalgia, headache, chills, fatigue; took in fluids; recovering but not complete
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Headache, Myalgia, tired Narrative:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash & UrticariaPruritus  Narrative:
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Headache, Myalgia, tired Narrative:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Myalgia
Clinical narrative: Headache, Myalgia, injection site pain Narrative:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever chills, fever, body aches, fever 101 Narrative:
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia, Pyrexia
Clinical narrative: Myalgia, Arthralgia, Fever, chills  Narrative:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Headache & Myalgia Narrative:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Pyrexia
Clinical narrative: Headache, Fever, Diarrhea, chills Narrative:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nasal congestion, Pyrexia
Clinical narrative: Headache, Myalgia, Fever, Nasal congestion Narrative:
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Malaise
Clinical narrative: Dizziness, Headache, Malaise Narrative:
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Nausea, Tremor
Clinical narrative: Headache, NauseaVomiting, chills, shaking, "felt like I had the flu" Narrative:
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Headache, NauseaVomiting, chills, shaking, "felt like I had the flu" Narrative:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Headache, Malaise, Myalgia
Clinical narrative: Headache, Myalgia, Malaise, chills tightness in chest Narrative:
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Erythema multiforme, Fatigue, Headache, Injection site erythema
Clinical narrative: Headache, Myalgia, Arthralgia, ErythemaMultiform, fatigue, arm soreness Narrative: Redness and pain at injection site, myalgia, arthralgia, headache, fatigue;
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Pain in extremity
Clinical narrative: Headache, Myalgia, Arthralgia, ErythemaMultiform, fatigue, arm soreness Narrative: Redness and pain at injection site, myalgia, arthralgia, headache, fatigue;
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Headache, Myalgia, Arthralgia, Fever & NauseaVomiting Narrative:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Headache, Myalgia, Arthralgia, Fever & NauseaVomiting Narrative:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, Myalgia, Fever, c/o fatigue. told to see primary care physician if no improvement Narrative:
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypoaesthesia, Injected limb mobility decreased, Injection site pain
Clinical narrative: Headache pain @ inj site + (swelling size of an orange) unable to raise arm 4 hrs post vaccination fatigue lasting 2 weeks, migraines w/ aura lingering malaise facial numbness left sided neck pain Narrative:
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site swelling, Malaise, Migraine with aura, Neck pain
Clinical narrative: Headache pain @ inj site + (swelling size of an orange) unable to raise arm 4 hrs post vaccination fatigue lasting 2 weeks, migraines w/ aura lingering malaise facial numbness left sided neck pain Narrative:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Vomiting
Clinical narrative: Headache, Myalgia, NauseVomiting, Chills Narrative:
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Myalgia fatigue Narrative:  fatigue, myalgia
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Pyrexia
Clinical narrative: Dizziness, Headache, Fever, Chills Narrative:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pyrexia
Clinical narrative: Headache, Arthralgia, Fever, fatigue Narrative:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever chills Narrative:  Fever 100.1, chills
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Headache, Myalgia, Fever, NauseaVomiting, chills, Narrative:
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Headache, Myalgia, Fever, NauseaVomiting, chills, Narrative:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Headache & NauseaVomiting Narrative:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Insomnia, Myalgia
Clinical narrative: Headache, Myalgia, CHILLS, SLEEPLESS, Narrative:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Erythema, Nausea, Pain in extremity
Clinical narrative: Dizziness, Arthralgia, Fever, ErythemaMultiform, NauseaVomiting, arm soreness Narrative:  Fever 100.6, arthralgia, nausea, dizzy, arm sore, reddened, swollen. Took Tylenol, better but still nausea and dizzy.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling
Clinical narrative: Dizziness, Arthralgia, Fever, ErythemaMultiform, NauseaVomiting, arm soreness Narrative:  Fever 100.6, arthralgia, nausea, dizzy, arm sore, reddened, swollen. Took Tylenol, better but still nausea and dizzy.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, Myalgia, Fever, CHILLS Narrative:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lethargy
Clinical narrative: Arthralgia lethargy for 48 hours Narrative:
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Fatigue, Headache, Myalgia, Pain
Clinical narrative: Headache, Myalgia, HEADACHE, BODY ACHES, WEAKNESS, FATIGUE, VERY SORE LEFT ARM Narrative:
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Headache, Myalgia, HEADACHE, BODY ACHES, WEAKNESS, FATIGUE, VERY SORE LEFT ARM Narrative:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19 pneumonia, Chills, Cough, Fatigue
Clinical narrative: Headache, Myalgia, Arthralgia, Fever, CoughWheeze, Extreme Fatigue, Chills, Body Aches, Fever 101.1; decreased 02 sats during worst of the chills last night- had to put O2 back on. Injection site soreness. Everything started about 0200. Was critically ill with COVID pneumonia in Nov/Dec. Have been muc Narrative:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Myalgia, Oxygen saturation decreased, Pain
Clinical narrative: Headache, Myalgia, Arthralgia, Fever, CoughWheeze, Extreme Fatigue, Chills, Body Aches, Fever 101.1; decreased 02 sats during worst of the chills last night- had to put O2 back on. Injection site soreness. Everything started about 0200. Was critically ill with COVID pneumonia in Nov/Dec. Have been muc Narrative:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Wheezing
Clinical narrative: Headache, Myalgia, Arthralgia, Fever, CoughWheeze, Extreme Fatigue, Chills, Body Aches, Fever 101.1; decreased 02 sats during worst of the chills last night- had to put O2 back on. Injection site soreness. Everything started about 0200. Was critically ill with COVID pneumonia in Nov/Dec. Have been muc Narrative:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: ITCHING LEFT PALM Narrative:
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Narrative: pain at the injection; resolved within 48 hours  Other Relevant Hx: Symptoms:  & arm pain Treatment:
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Bladder disorder, Condition aggravated, Injection site pain
Clinical narrative: Narrative: Patient states he had pain in injection site for one day. He also reports that his bladder control has worsened after receiving the vaccine, but this has been an ongoing problem. He has an appt with private provider regarding this issue within the next week.  Other Relevant Hx: Symptoms: & injection site reaction, bladder control Treatment:
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Injection site reaction, SARS-CoV-2 test
Clinical narrative: Narrative: Patient reports injection site reaction for one day. He also states he had dry cough and took a test for COVID- 19 by outside provider. Pending results.  Other Relevant Hx: Symptoms:  & injection site reaction, dry cough Treatment:
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Narrative: chills x1 day; resolved with the fever 99 degree fever on 1/12  Other Relevant Hx: Symptoms: Fever & Chills Treatment:
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Narrative: Patient reports slight arm pain at injection pain.  Other Relevant Hx: Symptoms:  & slight arm pain at injection site Treatment:
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: Narrative: SORENESS AND FATIGUE LASTED 24 HR  Other Relevant Hx: Symptoms:  & FATIGUE AND SORENESS AT INJECTION SITE Treatment:
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: Narrative: Patient reports injection site pain for one day after vaccination.  Other Relevant Hx: Symptoms: & injection site reaction Treatment:
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Fatigue 1x day on 1/13 Headache 1x day on 1/13
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Narrative:   Other Relevant Hx:  Symptoms:  Headache Treatment:  ACETAMINOPHEN 325 MG ONCE
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Fatigue
Clinical narrative: Patient states fatigue and lower back pain after vaccination
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Narrative: Patient states arm pain at injection site, resolved within 48 hours  Other Relevant Hx: Symptoms: & arm pain Treatment:
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Patient reports arm pain at injection site. Resolved within 24 hours
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Narrative: Patient reports arm pain at injection site, resolved within 2 days Other relevant Hx: Symptoms: & arm pain Treatment:
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Muscle spasms
Clinical narrative: Headache & cramps, fatigue, headache
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Narrative:  Patient has arm soreness in injection site. Resolved within 48 hours.   Other Relevant Hx:  Symptoms:  & arm pain Treatment:
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Pyrexia
Clinical narrative: Patient reported fatigue, fever 99.8 F, and diarrhea. Symptoms developed around 01/17/2021 or 01/18/2021. Patient felt better around 01/20/2021 but not entirely resolved.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Narrative: Patient reports arm pain 02/10, resolved within 48 hours Other Relevant Hx: Symptoms: & arm pain Treatment:
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Myalgia & Fever
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia
Clinical narrative: Narrative:  SLEPT ALL DAY  Other Relevant Hx: Symptoms:  & FATIGUE Treatment:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: & SORENESS AT INJECTION SITE
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Narrative:  Other Relevant Hx: Symptoms:  Headache Treatment: ACETAMINOPHEN 325 MG ONCE
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dialysis, Mental status changes, Pruritus, Urticaria
Clinical narrative: Narrative:  Patient received 2nd dose Pfizer COVID-19 vaccination during dialysis session. 20 minutes after the vaccination, he reported feeling confused and was found to have altered mental status. This reportedly has happened to him after dialysis sessions in the past, and was felt to be unrelated to his vaccination. However, he then reported having itching in both his hands. Because of this, he was given diphenhydramine and methylprednisolone. He was then sent to the nearest Emergency Room for further evaluation, and ultimately discharged home.  Other Relevant Hx: Symptoms:  Confusion & UrticariaPruritus Treatment:  DIPHENHYDRAMINE 25 MG ONCE
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Narrative:  Other Relevant Hx: Symptoms:  & Tested positive for COVID Treatment:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Pyrexia
Clinical narrative: Headache, Myalgia, Fever, Malaise
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: NauseaVomiting Narrative:  Other Relevant History:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Myalgia, Night sweats
Clinical narrative: Dizziness, Myalgia, Arthralgia, fatigue, night sweats Narrative:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Vomiting
Clinical narrative: Headache, Myalgia & NauseaVomiting
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, Myalgia, Arthralgia, Fever, fatigue Narrative:  Other Relevant History:
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Headache, Migraine, Myalgia
Clinical narrative: Headache, Myalgia, Arthralgia, NauseaVomiting, "severe back and body aches with nausea and migraine Narrative: OTC Tylenol and Motrin: Zofran
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: Headache, Myalgia, Arthralgia, NauseaVomiting, "severe back and body aches with nausea and migraine Narrative: OTC Tylenol and Motrin: Zofran
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: headache, arm soreness, achey, fatigue Narrative:  Other Relevant History:
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: PATIENT ACQUIRED COVID-19 ON 12/29/2020 AND SYMPTOMS WERE EXHAUSTION, SEVERE HEADACHE, BODY ACHES, COUGH, SOB, CHILLS, SWEATS, FEVER OF 103 DEGREES, RHINORRHEA, CHEST PAIN, FATIGUE, TIREDNESS, WEAKNESS, SUDDEN LOSS OF SENSE OF TASTE,, SUDDEN LOSS OF SENSE OF SMELL.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, Asthenia, COVID-19, Chest pain
Clinical narrative: PATIENT ACQUIRED COVID-19 ON 12/29/2020 AND SYMPTOMS WERE EXHAUSTION, SEVERE HEADACHE, BODY ACHES, COUGH, SOB, CHILLS, SWEATS, FEVER OF 103 DEGREES, RHINORRHEA, CHEST PAIN, FATIGUE, TIREDNESS, WEAKNESS, SUDDEN LOSS OF SENSE OF TASTE,, SUDDEN LOSS OF SENSE OF SMELL.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Cough, Dyspnoea, Fatigue, Headache
Clinical narrative: PATIENT ACQUIRED COVID-19 ON 12/29/2020 AND SYMPTOMS WERE EXHAUSTION, SEVERE HEADACHE, BODY ACHES, COUGH, SOB, CHILLS, SWEATS, FEVER OF 103 DEGREES, RHINORRHEA, CHEST PAIN, FATIGUE, TIREDNESS, WEAKNESS, SUDDEN LOSS OF SENSE OF TASTE,, SUDDEN LOSS OF SENSE OF SMELL.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Pain, Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: PATIENT ACQUIRED COVID-19 ON 12/29/2020 AND SYMPTOMS WERE EXHAUSTION, SEVERE HEADACHE, BODY ACHES, COUGH, SOB, CHILLS, SWEATS, FEVER OF 103 DEGREES, RHINORRHEA, CHEST PAIN, FATIGUE, TIREDNESS, WEAKNESS, SUDDEN LOSS OF SENSE OF TASTE,, SUDDEN LOSS OF SENSE OF SMELL.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction, Pain in extremity
Clinical narrative: Sore arm-vaccine site, chills, fever, headache, muscle and bone aches, stiffness, nausea, no appetite, fatigue
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bone pain, Decreased appetite, Fatigue, Feeling cold, Headache
Clinical narrative: Sore arm-vaccine site, chills, fever, headache, muscle and bone aches, stiffness, nausea, no appetite, fatigue
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Musculoskeletal stiffness, Myalgia, Nausea, Pyrexia
Clinical narrative: Sore arm-vaccine site, chills, fever, headache, muscle and bone aches, stiffness, nausea, no appetite, fatigue
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Tired; dizzy; nauseated; shivery; could not even stay awake; This is a spontaneous report from a contactable nurse. This 84-year-old female nurse (Patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunication on 14Jan2021. Relevant history included Atrial fibrillation, Rheumatic heart disease several years ago and needed a pacemaker, getting shingles and ongoing, Congestive heart failure, she got really bad 2.5 years ago after she got the flu and it affected her flu. Relevant concomitant drugs were unknown. The patient stated she got the vaccine on 14Jan2021 (a week ago). She got really tired, stated she slept 9 hours, she was dizzy, nauseated and shivery which started yesterday or the night before, she was really tired for about 3 days after the vaccine, could not even stay awake. Exact dates were not provided. The symptoms were somewhat improved. She took some meclizine and it helped some. She wanted to know if these were side effects of the vaccine. Outcome of events was resolving.  Information on the lot/batch number has been requested.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Fatigue, Nausea, Somnolence
Clinical narrative: Tired; dizzy; nauseated; shivery; could not even stay awake; This is a spontaneous report from a contactable nurse. This 84-year-old female nurse (Patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunication on 14Jan2021. Relevant history included Atrial fibrillation, Rheumatic heart disease several years ago and needed a pacemaker, getting shingles and ongoing, Congestive heart failure, she got really bad 2.5 years ago after she got the flu and it affected her flu. Relevant concomitant drugs were unknown. The patient stated she got the vaccine on 14Jan2021 (a week ago). She got really tired, stated she slept 9 hours, she was dizzy, nauseated and shivery which started yesterday or the night before, she was really tired for about 3 days after the vaccine, could not even stay awake. Exact dates were not provided. The symptoms were somewhat improved. She took some meclizine and it helped some. She wanted to know if these were side effects of the vaccine. Outcome of events was resolving.  Information on the lot/batch number has been requested.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This is a spontaneous report from a contactable physician reported for self. This 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Jan2021 10:50 on Arm left at single dose (Lot # EK5730) for covid-19 immunisation. None additional vaccines administered on same date of the Pfizer suspect. Medical history included ongoing Cardiac disorder from Jun1990, Type 1 diabetes mellitus from 2000, Heart Attack from Jun1990. Concomitant drugs were none. He said he has a question. He stated he got his first dose of the COVID-19 Vaccine on 04Jan2021 and woke up 9 days later on 13Jan2021 with Bell's Palsy, which was medically significant. He said he was not sure if he should get his second COVID-19 Vaccine shot that was scheduled for Monday, 25Jan2021. He asked if Bell's Palsy has been a reported side effect of the COVID-19 Vaccine. He said he refuses to take steroids for the Bell's Palsy. He said he had an incident in 2019 where he was prescribed steroids for an arthritic condition, and he ended up septic. No treatments were received. Outcome of the event was resolving. Drug result by physician was related.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported Bell's Palsy 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: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis
Clinical narrative: Bell's palsy; This is a spontaneous report from a contactable physician reported for self. This 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Jan2021 10:50 on Arm left at single dose (Lot # EK5730) for covid-19 immunisation. None additional vaccines administered on same date of the Pfizer suspect. Medical history included ongoing Cardiac disorder from Jun1990, Type 1 diabetes mellitus from 2000, Heart Attack from Jun1990. Concomitant drugs were none. He said he has a question. He stated he got his first dose of the COVID-19 Vaccine on 04Jan2021 and woke up 9 days later on 13Jan2021 with Bell's Palsy, which was medically significant. He said he was not sure if he should get his second COVID-19 Vaccine shot that was scheduled for Monday, 25Jan2021. He asked if Bell's Palsy has been a reported side effect of the COVID-19 Vaccine. He said he refuses to take steroids for the Bell's Palsy. He said he had an incident in 2019 where he was prescribed steroids for an arthritic condition, and he ended up septic. No treatments were received. Outcome of the event was resolving. Drug result by physician was related.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported Bell's Palsy 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: 33.0
Sex: F
Vaccine: COVID19, COVID19, HEP, HPV4, MMR, VARCEL
Symptoms: Maternal exposure during pregnancy, Off label use, Pain in extremity, Product use issue, Serology test
Clinical narrative: arm soreness; Pregnancy; This spontaneous report was received from a 33 years old female patient via Pfizer, referring to herself. The patient's concomitant medication included probiotics (unspecified), iron (unspecified) (+) minerals (unspecified) (+) vitamins (unspecified), fluticasone propionate (FLONASE), cetirizine hydrochloride (ZYRTEC). Concomitant vaccine included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. Medical history included seasonal allergies and 2 previous pregnancies. The patient had no perinatal mental health (PMH), no history of genetic abnormalities materal or patemal. The patient's family medical history included seasonal allergies of father. On 29-SEP-2020, the patient was pregnant. The last menstrual period (LMP) was on 10-SEP-2020 and estimated date of delivery was 17-JUN-2021. The pregnancy outcome was pending and fetus outcome was on an unknown date in 2021. Ultrasound at 8 and 14 weeks was normal.  On unknown dates, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and varicella virus vaccine live (oka/merck) (manufacturer unknown) (strength, dose, route, lot# and expiration date were not provided) for prophylaxis (exposure during pregnancy). On 19-DEC-2020, the patient was vaccinated with the first dose of SARS-CoV-2 vaccine (unspecified) (reported as BNT16282) 0.3mcg via intramuscular route as COVID-19 vaccine. At 09:10 on 09-JAN-2021, the patient was vaccinated with the second dose of SARS-CoV-2 vaccine (unspecified) (reported as BNT16282) (0.3mcg, lot# EJ1685, expiration date March 2021) via intramuscular route in left deltoid as COVID-19 vaccine at workplace clinic. On the same day, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) and hepatitis b vaccine (recombinant) (manufacturer unknown) (strength, dose, route, lot# and expiration date were unknown) for prophylaxis.  On an unknown date, the patient experienced arm soreness. No emergency room or physician office was required. The outcome of the event was unknown. Action taken with suspect vaccines was not applicable.  The relationship between the event and all suspect vaccines was not reported.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, HEP, HPV4, MMR, VARCEL
Symptoms: Ultrasound scan, Underdose
Clinical narrative: arm soreness; Pregnancy; This spontaneous report was received from a 33 years old female patient via Pfizer, referring to herself. The patient's concomitant medication included probiotics (unspecified), iron (unspecified) (+) minerals (unspecified) (+) vitamins (unspecified), fluticasone propionate (FLONASE), cetirizine hydrochloride (ZYRTEC). Concomitant vaccine included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. Medical history included seasonal allergies and 2 previous pregnancies. The patient had no perinatal mental health (PMH), no history of genetic abnormalities materal or patemal. The patient's family medical history included seasonal allergies of father. On 29-SEP-2020, the patient was pregnant. The last menstrual period (LMP) was on 10-SEP-2020 and estimated date of delivery was 17-JUN-2021. The pregnancy outcome was pending and fetus outcome was on an unknown date in 2021. Ultrasound at 8 and 14 weeks was normal.  On unknown dates, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and varicella virus vaccine live (oka/merck) (manufacturer unknown) (strength, dose, route, lot# and expiration date were not provided) for prophylaxis (exposure during pregnancy). On 19-DEC-2020, the patient was vaccinated with the first dose of SARS-CoV-2 vaccine (unspecified) (reported as BNT16282) 0.3mcg via intramuscular route as COVID-19 vaccine. At 09:10 on 09-JAN-2021, the patient was vaccinated with the second dose of SARS-CoV-2 vaccine (unspecified) (reported as BNT16282) (0.3mcg, lot# EJ1685, expiration date March 2021) via intramuscular route in left deltoid as COVID-19 vaccine at workplace clinic. On the same day, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) and hepatitis b vaccine (recombinant) (manufacturer unknown) (strength, dose, route, lot# and expiration date were unknown) for prophylaxis.  On an unknown date, the patient experienced arm soreness. No emergency room or physician office was required. The outcome of the event was unknown. Action taken with suspect vaccines was not applicable.  The relationship between the event and all suspect vaccines was not reported.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, HEP, HPV4, MMR, VARCEL
Symptoms: Exposure during pregnancy, Pain in extremity
Clinical narrative: arm soreness; Pregnancy; This spontaneous report was received from a 33 years old female patient via Pfizer, referring to herself. The patient's concomitant medication included probiotics (unspecified), iron (unspecified) (+) minerals (unspecified) (+) vitamins (unspecified), fluticasone propionate (FLONASE), cetirizine hydrochloride (ZYRTEC). Concomitant vaccine included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. Medical history included seasonal allergies and 2 previous pregnancies. The patient had no perinatal mental health (PMH), no history of genetic abnormalities materal or patemal. The patient's family medical history included seasonal allergies of father. On 29-SEP-2020, the patient was pregnant. The last menstrual period (LMP) was on 10-SEP-2020 and estimated date of delivery was 17-JUN-2021. The pregnancy outcome was pending and fetus outcome was on an unknown date in 2021. Ultrasound at 8 and 14 weeks was normal.  On unknown dates, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and varicella virus vaccine live (oka/merck) (manufacturer unknown) (strength, dose, route, lot# and expiration date were not provided) for prophylaxis (exposure during pregnancy). On 19-DEC-2020, the patient was vaccinated with the first dose of SARS-CoV-2 vaccine (unspecified) (reported as BNT16282) 0.3mcg via intramuscular route as COVID-19 vaccine. At 09:10 on 09-JAN-2021, the patient was vaccinated with the second dose of SARS-CoV-2 vaccine (unspecified) (reported as BNT16282) (0.3mcg, lot# EJ1685, expiration date March 2021) via intramuscular route in left deltoid as COVID-19 vaccine at workplace clinic. On the same day, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) and hepatitis b vaccine (recombinant) (manufacturer unknown) (strength, dose, route, lot# and expiration date were unknown) for prophylaxis.  On an unknown date, the patient experienced arm soreness. No emergency room or physician office was required. The outcome of the event was unknown. Action taken with suspect vaccines was not applicable.  The relationship between the event and all suspect vaccines was not reported.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, C-reactive protein, Liver injury, Pyrexia
Clinical narrative: acute hepatitis/The transaminase was elevated to four times the upper limit; Fever/temperature yesterday was 103 degrees/ Today it is 98 degrees; Fatigue; Myalgia; Malaise; This is a spontaneous report from a contactable pharmacist and a contactable consumer. A 61-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Not at Military Facility. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient developed an acute hepatitis after receiving the second dose of the Covid-19 vaccine on 20Jan2021. The transaminase was elevated to four times the upper limit. The aspartate aminotransferase (AST) was 183 and alanine aminotransferase (ALT) was 270. The patient reported fever on 18Jan2021, fatigue on 16Jan2021, malaise on an unknown date in Jan2021 and myalgia on 16Jan2021. Events of acute hepatitis, Fever and Fatigue were assessed as serious due to medically significant and Myalgia was non-serious, the events of Fever, Fatigue and Myalgia were Related to Covid-19 vaccine, and unable to provide causality of acute hepatitis. Pharmacist was unable to confirm if the patient was still experiencing myalgia. The patient reported that he felt better today. His temperature yesterday (21Jan2021) was 103 degrees. Today (22Jan2021) it is 98 degrees. Adverse event required a visit to Physician Office. The patient underwent lab tests and procedures which included ALT: 270 on 20Jan2021, AST: 183 on 20Jan2021, alkaline phosphatase: 241 on 20Jan2021, body temperature: 103 degrees on 21Jan2021, body temperature: 98 degrees on 22Jan2021, serology test: negative on 20Jan2021. The outcome of the event acute hepatitis was not recovered, event Fever was recovered on 22Jan2021, event Fatigue was recovering and the events of Myalgia and Malaise was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events hepatitis acute, fever and fatigue. 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: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Respiratory viral panel, SARS-CoV-2 test negative
Clinical narrative: acute hepatitis/The transaminase was elevated to four times the upper limit; Fever/temperature yesterday was 103 degrees/ Today it is 98 degrees; Fatigue; Myalgia; Malaise; This is a spontaneous report from a contactable pharmacist and a contactable consumer. A 61-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Not at Military Facility. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient developed an acute hepatitis after receiving the second dose of the Covid-19 vaccine on 20Jan2021. The transaminase was elevated to four times the upper limit. The aspartate aminotransferase (AST) was 183 and alanine aminotransferase (ALT) was 270. The patient reported fever on 18Jan2021, fatigue on 16Jan2021, malaise on an unknown date in Jan2021 and myalgia on 16Jan2021. Events of acute hepatitis, Fever and Fatigue were assessed as serious due to medically significant and Myalgia was non-serious, the events of Fever, Fatigue and Myalgia were Related to Covid-19 vaccine, and unable to provide causality of acute hepatitis. Pharmacist was unable to confirm if the patient was still experiencing myalgia. The patient reported that he felt better today. His temperature yesterday (21Jan2021) was 103 degrees. Today (22Jan2021) it is 98 degrees. Adverse event required a visit to Physician Office. The patient underwent lab tests and procedures which included ALT: 270 on 20Jan2021, AST: 183 on 20Jan2021, alkaline phosphatase: 241 on 20Jan2021, body temperature: 103 degrees on 21Jan2021, body temperature: 98 degrees on 22Jan2021, serology test: negative on 20Jan2021. The outcome of the event acute hepatitis was not recovered, event Fever was recovered on 22Jan2021, event Fatigue was recovering and the events of Myalgia and Malaise was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events hepatitis acute, fever and fatigue. 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: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: AST/ALT ratio abnormal, Blood alkaline phosphatase increased, C-reactive protein increased, Liver function test abnormal
Clinical narrative: acute hepatitis/The transaminase was elevated to four times the upper limit; Fever/temperature yesterday was 103 degrees/ Today it is 98 degrees; Fatigue; Myalgia; Malaise; This is a spontaneous report from a contactable pharmacist and a contactable consumer. A 61-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Not at Military Facility. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient developed an acute hepatitis after receiving the second dose of the Covid-19 vaccine on 20Jan2021. The transaminase was elevated to four times the upper limit. The aspartate aminotransferase (AST) was 183 and alanine aminotransferase (ALT) was 270. The patient reported fever on 18Jan2021, fatigue on 16Jan2021, malaise on an unknown date in Jan2021 and myalgia on 16Jan2021. Events of acute hepatitis, Fever and Fatigue were assessed as serious due to medically significant and Myalgia was non-serious, the events of Fever, Fatigue and Myalgia were Related to Covid-19 vaccine, and unable to provide causality of acute hepatitis. Pharmacist was unable to confirm if the patient was still experiencing myalgia. The patient reported that he felt better today. His temperature yesterday (21Jan2021) was 103 degrees. Today (22Jan2021) it is 98 degrees. Adverse event required a visit to Physician Office. The patient underwent lab tests and procedures which included ALT: 270 on 20Jan2021, AST: 183 on 20Jan2021, alkaline phosphatase: 241 on 20Jan2021, body temperature: 103 degrees on 21Jan2021, body temperature: 98 degrees on 22Jan2021, serology test: negative on 20Jan2021. The outcome of the event acute hepatitis was not recovered, event Fever was recovered on 22Jan2021, event Fatigue was recovering and the events of Myalgia and Malaise was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events hepatitis acute, fever and fatigue. 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: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Body temperature increased, Fatigue
Clinical narrative: acute hepatitis/The transaminase was elevated to four times the upper limit; Fever/temperature yesterday was 103 degrees/ Today it is 98 degrees; Fatigue; Myalgia; Malaise; This is a spontaneous report from a contactable pharmacist and a contactable consumer. A 61-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Not at Military Facility. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient developed an acute hepatitis after receiving the second dose of the Covid-19 vaccine on 20Jan2021. The transaminase was elevated to four times the upper limit. The aspartate aminotransferase (AST) was 183 and alanine aminotransferase (ALT) was 270. The patient reported fever on 18Jan2021, fatigue on 16Jan2021, malaise on an unknown date in Jan2021 and myalgia on 16Jan2021. Events of acute hepatitis, Fever and Fatigue were assessed as serious due to medically significant and Myalgia was non-serious, the events of Fever, Fatigue and Myalgia were Related to Covid-19 vaccine, and unable to provide causality of acute hepatitis. Pharmacist was unable to confirm if the patient was still experiencing myalgia. The patient reported that he felt better today. His temperature yesterday (21Jan2021) was 103 degrees. Today (22Jan2021) it is 98 degrees. Adverse event required a visit to Physician Office. The patient underwent lab tests and procedures which included ALT: 270 on 20Jan2021, AST: 183 on 20Jan2021, alkaline phosphatase: 241 on 20Jan2021, body temperature: 103 degrees on 21Jan2021, body temperature: 98 degrees on 22Jan2021, serology test: negative on 20Jan2021. The outcome of the event acute hepatitis was not recovered, event Fever was recovered on 22Jan2021, event Fatigue was recovering and the events of Myalgia and Malaise was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events hepatitis acute, fever and fatigue. 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: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hepatitis acute, Hepatitis viral test negative, Malaise, Myalgia, Pyrexia
Clinical narrative: acute hepatitis/The transaminase was elevated to four times the upper limit; Fever/temperature yesterday was 103 degrees/ Today it is 98 degrees; Fatigue; Myalgia; Malaise; This is a spontaneous report from a contactable pharmacist and a contactable consumer. A 61-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Not at Military Facility. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient developed an acute hepatitis after receiving the second dose of the Covid-19 vaccine on 20Jan2021. The transaminase was elevated to four times the upper limit. The aspartate aminotransferase (AST) was 183 and alanine aminotransferase (ALT) was 270. The patient reported fever on 18Jan2021, fatigue on 16Jan2021, malaise on an unknown date in Jan2021 and myalgia on 16Jan2021. Events of acute hepatitis, Fever and Fatigue were assessed as serious due to medically significant and Myalgia was non-serious, the events of Fever, Fatigue and Myalgia were Related to Covid-19 vaccine, and unable to provide causality of acute hepatitis. Pharmacist was unable to confirm if the patient was still experiencing myalgia. The patient reported that he felt better today. His temperature yesterday (21Jan2021) was 103 degrees. Today (22Jan2021) it is 98 degrees. Adverse event required a visit to Physician Office. The patient underwent lab tests and procedures which included ALT: 270 on 20Jan2021, AST: 183 on 20Jan2021, alkaline phosphatase: 241 on 20Jan2021, body temperature: 103 degrees on 21Jan2021, body temperature: 98 degrees on 22Jan2021, serology test: negative on 20Jan2021. The outcome of the event acute hepatitis was not recovered, event Fever was recovered on 22Jan2021, event Fatigue was recovering and the events of Myalgia and Malaise was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events hepatitis acute, fever and fatigue. 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: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Transaminases increased, Viral test negative
Clinical narrative: acute hepatitis/The transaminase was elevated to four times the upper limit; Fever/temperature yesterday was 103 degrees/ Today it is 98 degrees; Fatigue; Myalgia; Malaise; This is a spontaneous report from a contactable pharmacist and a contactable consumer. A 61-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Not at Military Facility. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient developed an acute hepatitis after receiving the second dose of the Covid-19 vaccine on 20Jan2021. The transaminase was elevated to four times the upper limit. The aspartate aminotransferase (AST) was 183 and alanine aminotransferase (ALT) was 270. The patient reported fever on 18Jan2021, fatigue on 16Jan2021, malaise on an unknown date in Jan2021 and myalgia on 16Jan2021. Events of acute hepatitis, Fever and Fatigue were assessed as serious due to medically significant and Myalgia was non-serious, the events of Fever, Fatigue and Myalgia were Related to Covid-19 vaccine, and unable to provide causality of acute hepatitis. Pharmacist was unable to confirm if the patient was still experiencing myalgia. The patient reported that he felt better today. His temperature yesterday (21Jan2021) was 103 degrees. Today (22Jan2021) it is 98 degrees. Adverse event required a visit to Physician Office. The patient underwent lab tests and procedures which included ALT: 270 on 20Jan2021, AST: 183 on 20Jan2021, alkaline phosphatase: 241 on 20Jan2021, body temperature: 103 degrees on 21Jan2021, body temperature: 98 degrees on 22Jan2021, serology test: negative on 20Jan2021. The outcome of the event acute hepatitis was not recovered, event Fever was recovered on 22Jan2021, event Fatigue was recovering and the events of Myalgia and Malaise was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events hepatitis acute, fever and fatigue. 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.