chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Eye swelling, Inappropriate schedule of product administration, Off label use, Rash erythematous
Clinical narrative: Red flat itchy rash on torso, face, arms, legs; Red flat itchy rash on torso, face, arms, legs; facial swelling; eyes swollen; itchy throat; cotton mouth; Received first dose on 25Jan2021 and second dose on 11Feb2021; Received first dose on 25Jan2021 and second dose on 11Feb2021; This is a spontaneous report from a contactable Other Health Professional. A 43-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9266), intramuscularly in Left arm on 11Feb2021 17:15 at single dose for covid-19 immunisation. Medical history included allergy to dairy products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262) at the age of 43 years old and Intramuscularly in Left arm on 25Jan2021 17:00 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Red flat itchy rash on torso, face, arms, legs; facial swelling; eyes swollen; itchy throat; cotton mouth on 12Feb2021 12:00. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Since the vaccination, the patient has been tested for COVID-19 via Nasal Swab on 02Feb2021 with result Negative. Therapeutic measures (reported as 'IV Epinephrine, Solumedrol, 'Pepcid', 'Benadryl', prednisone) were taken as a result of red flat itchy rash on torso, face, arms, legs, facial swelling, eyes swollen, itchy throat, cotton mouth. The outcome of the events was not recovered. This case reported as non-serious.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation and known safety profile of suspect drug. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, SARS-CoV-2 test, Swelling face, Throat irritation
Clinical narrative: Red flat itchy rash on torso, face, arms, legs; Red flat itchy rash on torso, face, arms, legs; facial swelling; eyes swollen; itchy throat; cotton mouth; Received first dose on 25Jan2021 and second dose on 11Feb2021; Received first dose on 25Jan2021 and second dose on 11Feb2021; This is a spontaneous report from a contactable Other Health Professional. A 43-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9266), intramuscularly in Left arm on 11Feb2021 17:15 at single dose for covid-19 immunisation. Medical history included allergy to dairy products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262) at the age of 43 years old and Intramuscularly in Left arm on 25Jan2021 17:00 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Red flat itchy rash on torso, face, arms, legs; facial swelling; eyes swollen; itchy throat; cotton mouth on 12Feb2021 12:00. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Since the vaccination, the patient has been tested for COVID-19 via Nasal Swab on 02Feb2021 with result Negative. Therapeutic measures (reported as 'IV Epinephrine, Solumedrol, 'Pepcid', 'Benadryl', prednisone) were taken as a result of red flat itchy rash on torso, face, arms, legs, facial swelling, eyes swollen, itchy throat, cotton mouth. The outcome of the events was not recovered. This case reported as non-serious.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation and known safety profile of suspect drug. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Flushing
Clinical narrative: In mid afternoon day of vaccination I was feeling flushed; My neck and face and scalp turned red; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration in left arm on 15Feb2021 10:00 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Public Health Clinic/Veterans Administration facility. Medical history included asthma, drug allergy (Allergies to combo glucomate). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously took [amoxicillin sodium;clavulanate potassium] (AUGMENTIN) and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  In mid afternoon day of vaccination on 15Feb2021 15:00 patient as feeling flushed. Patient's neck and face and scalp turned red on 15Feb2021 15:00. This went away later that evening in Feb2021. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. Case was non-serious. The outcome of the events was recovered in Feb2021.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Palpitations, Pollakiuria
Clinical narrative: heart racing and erratic; urinated 9 times in the next hour +; This is a spontaneous report from a contactable consumer reported for him/herself. A 76 Years old patient received 1st dose of BNT162B2 (lot number=EL1283) on 16Jan2021 at single dose on Left arm for covid-19 immunization. Medical history was Addison's Disease, 6 heart bypasses. Concomitant drugs were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Past drug was Allergies to Sulphur. 11 days later (27Jan2021), patient woke up at 02:30 am with heart racing and erratic. Patient also urinated 9 times in the next hour +. No treatment. Outcome of the event was recovered. Patient also received 2nd dose of BNT162B2 (Lot number=EL9261) on 06Feb2021 01:30 AM at single dose on Left arm for covid-19 immunization.  No follow-up attempts possible. No further information expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: headache; muscle pain; chills; joint pain; low grade fever; feeling unwell; tiredness; This is a spontaneous report from a non-contactable consumer (patient). A 69-year-old male patient received the first dose of BNT162B2 (lot: fb9810), via an unspecified route of administration in arm left on 13Feb2021 14:15 at single dose for COVID-19 immunisation. Medical history included diabetes, pacemaker, and high cholesterol. Prior to vaccination, patient was not diagnosed with COVID-19. Allergies to medications, food, or other products was none. Concomitant medications included metformin, insulin glargine (LANTUS), insulin lispro (HUMALOG), and atorvastatin. The patient experienced headache, muscle pain, chills, joint pain, low grade fever, feeling unwell, and tiredness on 14Feb2021 08:00. Treatment was not received for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not resolved. This case was reported as non-serious.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: headache; muscle pain; chills; joint pain; low grade fever; feeling unwell; tiredness; This is a spontaneous report from a non-contactable consumer (patient). A 69-year-old male patient received the first dose of BNT162B2 (lot: fb9810), via an unspecified route of administration in arm left on 13Feb2021 14:15 at single dose for COVID-19 immunisation. Medical history included diabetes, pacemaker, and high cholesterol. Prior to vaccination, patient was not diagnosed with COVID-19. Allergies to medications, food, or other products was none. Concomitant medications included metformin, insulin glargine (LANTUS), insulin lispro (HUMALOG), and atorvastatin. The patient experienced headache, muscle pain, chills, joint pain, low grade fever, feeling unwell, and tiredness on 14Feb2021 08:00. Treatment was not received for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not resolved. This case was reported as non-serious.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Pyrexia, Wheezing
Clinical narrative: Fell feverish on and off; a lot of coughing; a lot of wheezing; This is a spontaneous report from a contactable consumer (patient) for herself. A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: pfizerbiontech) via an unspecified route of administration at left arm on 06Feb2021 at 04:00 AM at a single dose for COVID-19 immunisation. Age at vaccination was reported as 75-year-old. Medical history included fibromyalgia and arthritis. Allergies to medications, food, or other products reported as no. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included lisinopril, omeprazole and pregabalin. Facility where the most recent COVID-19 vaccine was administered at a drug store. The patient experienced adverse events included fell feverish on and off, a lot of coughing, a lot of wheezing; with adverse event start date on 11Feb2021 at 09:00 AM. The events were reported as non-serious. The outcome of events was unknown. Treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Cough, Wheezing
Clinical narrative: Fell feverish on and off; a lot of coughing; a lot of wheezing; This is a spontaneous report from a contactable consumer (patient) for herself. A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: pfizerbiontech) via an unspecified route of administration at left arm on 06Feb2021 at 04:00 AM at a single dose for COVID-19 immunisation. Age at vaccination was reported as 75-year-old. Medical history included fibromyalgia and arthritis. Allergies to medications, food, or other products reported as no. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included lisinopril, omeprazole and pregabalin. Facility where the most recent COVID-19 vaccine was administered at a drug store. The patient experienced adverse events included fell feverish on and off, a lot of coughing, a lot of wheezing; with adverse event start date on 11Feb2021 at 09:00 AM. The events were reported as non-serious. The outcome of events was unknown. Treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal
Clinical narrative: had chills about 18 hours after; felt cloudy in the head; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received second dose of bnt162b2 (BNT162B2, lot number: EL3247) , via an unspecified route of administration at arm left on 09Feb2021 15:00 at SINGLE DOSE for COVID-19 immunisation. Medical history included inflammatory bowel disease (IBS) from an unknown date. Not Pregnant at the time of vaccination. No allergies to medications, food, or other products.Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included plecanatide (TRULANCE) received within 2 weeks of vaccination. The patient historical vaccine included first dose of bnt162b2 (lot number=EL3247) on 19Jan2021 03:00 PM, at left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No symptoms after the first dose. After the second dose, had chills about 18 hours after and felt cloudy in the head, but was able to go to work and function. Adverse event start date was 10Feb2021 06:30 AM. No treatment received for the adverse event. Event was reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Within 1 hr pain in right leg above knee; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Feb2021 07:45 at single dose for at left arm covid-19 immunisation. Medical history included type 2 diabetes, heart surgery in 2017, spinal stenosis, high blood pressure. Concomitant medications within 2 weeks of vaccination included metformin, metoprolol, gabapentin, glipizide, warfarin, acetylsalicylic acid (ASPIR). The patient experienced within 1 hr pain in right leg above knee on 12Feb2021 08:30 with outcome of not recovered. Patient didn't receive treatment for the event. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. The report was considered as non-serious.  Information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chest pain, Dizziness, Headache, Myalgia
Clinical narrative: chest pain; dizziness; joint pain; muscle pain; bad headache; Extreme facial swelling began in areas of dermal filler, which was administered 10/2019 and progressed throughout face; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6200, expiry date unknown) via an unspecified route of administration on 13Feb2021 13:15 in left arm at single dose for COVID-19 immunization. Medical history included migraine, joint pain and dermal filler in Oct2019; allergies to penicillin, mango, tree nuts, bees, shrimp. 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. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication received within 2 weeks of vaccination included estrogens conjugated (PREMARIN), celecoxib (CELEBREX), levothyroxine, colecalciferol (D3), cyanocobalamin (B12), ascorbic acid (C) and Mul. The patient previously received first dose of BNT162B2 (lot number EL9262), on 23Jan2021 09:30 AM at Left arm. At 4:30 am 14Feb2021, the patient woke with chest pain, dizziness, joint and muscle pain; and bad headache. Extreme facial swelling began in areas of dermal filler, which was administered Oct2019 and progressed throughout face. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included Benadryl and Tylenol (today 1 Celebrex). The outcome of the events was recovering. The events were reported as non-serious, did not result in death, life threatening, caused or prolonged hospitalization, disabling or incapacitating, congenital anomaly or birth defect
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face
Clinical narrative: chest pain; dizziness; joint pain; muscle pain; bad headache; Extreme facial swelling began in areas of dermal filler, which was administered 10/2019 and progressed throughout face; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6200, expiry date unknown) via an unspecified route of administration on 13Feb2021 13:15 in left arm at single dose for COVID-19 immunization. Medical history included migraine, joint pain and dermal filler in Oct2019; allergies to penicillin, mango, tree nuts, bees, shrimp. 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. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication received within 2 weeks of vaccination included estrogens conjugated (PREMARIN), celecoxib (CELEBREX), levothyroxine, colecalciferol (D3), cyanocobalamin (B12), ascorbic acid (C) and Mul. The patient previously received first dose of BNT162B2 (lot number EL9262), on 23Jan2021 09:30 AM at Left arm. At 4:30 am 14Feb2021, the patient woke with chest pain, dizziness, joint and muscle pain; and bad headache. Extreme facial swelling began in areas of dermal filler, which was administered Oct2019 and progressed throughout face. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included Benadryl and Tylenol (today 1 Celebrex). The outcome of the events was recovering. The events were reported as non-serious, did not result in death, life threatening, caused or prolonged hospitalization, disabling or incapacitating, congenital anomaly or birth defect
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face, Tinnitus
Clinical narrative: chest pain; dizziness; joint pain; muscle pain; bad headache; Extreme facial swelling began in areas of dermal filler, which was administered 10/2019 and progressed throughout face; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6200, expiry date unknown) via an unspecified route of administration on 13Feb2021 13:15 in left arm at single dose for COVID-19 immunization. Medical history included migraine, joint pain and dermal filler in Oct2019; allergies to penicillin, mango, tree nuts, bees, shrimp. 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. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication received within 2 weeks of vaccination included estrogens conjugated (PREMARIN), celecoxib (CELEBREX), levothyroxine, colecalciferol (D3), cyanocobalamin (B12), ascorbic acid (C) and Mul. The patient previously received first dose of BNT162B2 (lot number EL9262), on 23Jan2021 09:30 AM at Left arm. At 4:30 am 14Feb2021, the patient woke with chest pain, dizziness, joint and muscle pain; and bad headache. Extreme facial swelling began in areas of dermal filler, which was administered Oct2019 and progressed throughout face. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included Benadryl and Tylenol (today 1 Celebrex). The outcome of the events was recovering. The events were reported as non-serious, did not result in death, life threatening, caused or prolonged hospitalization, disabling or incapacitating, congenital anomaly or birth defect
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dehydration, Dizziness, Headache, Hypertension
Clinical narrative: Dizziness; high blood pressure; dehydration; severe headache; This is a spontaneous report from a non-contactable 42-year-old male consumer reported for himself. A 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN 6201), via an unspecified route of administration in Arm Left on 13Feb2021 12:30 at single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no allergies to medications, food, or other products. Medical history included high bp, fatty liver.  Concomitant medication included lisinopril (LISINOPRIL), hctz (HCTZ).  The patient experienced dizziness, high blood pressure, dehydration, severe headache all on 14Feb2021 with outcome of recovering. The events were reported as non-serious.  No treatment was received.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Fever; chill; headache; body aches; sweats; This is a spontaneous report from a contactable consumer reported for himself. A 46-year-old male patient received his 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247) at single dose via an unknown route in left arm on 15Feb2021 08:15 AM for Covid-19 immunization. Medical history included vitiligo. No allergies to medications, food, or other products. Concomitant drug that patient received within 2 weeks of vaccination included Vitamin D 50,000 IU once a week. Historical vaccine included 1st dose of PFIZER-BIONTECH COVID-19 VACCINE (lot number: EL3247 on 27Jan2021 10:00AM in left arm for Covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 12 hours after injection (on 15Feb202108:30 PM), patient experienced adverse events of Fever, chill, headache, body aches, sweats.  No treatment received for the adverse event. Outcome of the events was resolving.  Since the vaccination, the patient had not been tested for COVID-19.   The report was considered non-serious.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Pyrexia
Clinical narrative: chills; fever initially 100.6F/Fever returned at 101.1F by about 5pm; aches (injection site); aches (spine); aches (occiput); aches ( hips, knees); This is a spontaneous report from a contactable other healthcare professional (patient). A 29-year-old male patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration in left arm on 13Feb2021 14:30 at single dose for COVID-19 immunisation .  The patient medical history was not reported. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 in left arm on 23Jan2021 at 12:30 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Beginning approx 11 hours post (14Feb2021 01:00) was chills, aches (spine, occiput, hips, knees, injection site), and fever initially 100.6F. Fever reduced acetaminophen over time. Aches continued. Fever returned at 101.1F by about 5pm day after shot. The patient underwent lab tests and procedures which included body temperature: 100.6 fahrenheit (fever initially) on 14Feb2021, body temperature: 101.1 fahrenheit by about 5pm day after shot on 14Feb2021. Treatment received for the adverse event included acetaminophen, water, rest The outcome of events aches (spine, occiput, hips, knees, injection site) was not recovered, the outcome of other events was recovered on an unspecified date of Feb2021. This case was reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Spinal pain, Vaccination site pain
Clinical narrative: chills; fever initially 100.6F/Fever returned at 101.1F by about 5pm; aches (injection site); aches (spine); aches (occiput); aches ( hips, knees); This is a spontaneous report from a contactable other healthcare professional (patient). A 29-year-old male patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration in left arm on 13Feb2021 14:30 at single dose for COVID-19 immunisation .  The patient medical history was not reported. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 in left arm on 23Jan2021 at 12:30 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Beginning approx 11 hours post (14Feb2021 01:00) was chills, aches (spine, occiput, hips, knees, injection site), and fever initially 100.6F. Fever reduced acetaminophen over time. Aches continued. Fever returned at 101.1F by about 5pm day after shot. The patient underwent lab tests and procedures which included body temperature: 100.6 fahrenheit (fever initially) on 14Feb2021, body temperature: 101.1 fahrenheit by about 5pm day after shot on 14Feb2021. Treatment received for the adverse event included acetaminophen, water, rest The outcome of events aches (spine, occiput, hips, knees, injection site) was not recovered, the outcome of other events was recovered on an unspecified date of Feb2021. This case was reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: The site is still red, painful and hot to the touch; The site is still red, painful and hot to the touch; The site is still red, painful and hot to the touch; This is a spontaneous report from a contactable consumer (reported for herself). A 49-year-old female patient (not pregnant at the time of vaccination) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 13Feb2021 08:15 at single dose in left arm for COVID-19 immunisation. Medical history included diabetes type 2; no Allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included sertraline; acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE). The patient previously took the first dose of bnt162b2 on 19Jan2021 07:15 (at the age of 39 years old) in left arm for Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It has been over 72 hours since the vaccination. The site was still red, painful and hot to the touch which started from 13Feb2021 08:15. Not sure if this was normal for this to continue so long. No treatment received for the adverse events. The events were non-serious per the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Heart rate, Heart rate increased
Clinical narrative: Rapid pulse 121-133; fever 101.3; chills; dizzy; body aches; This is a spontaneous report from a contactable consumer (parent).  A 17-years-old male patient received bnt162b2 (BNT162B2, lot number=EM9709) second dose, vaccination location of left arm, via an unspecified route of administration on 14Feb2021 17:15 at SINGLE DOSE for covid-19 immunisation.  Medical history was none. No Allergies to medications, food, or other products. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on 24Jan2021 16:00 (lot number=EL9261; vaccine location=Left arm). The patient experienced rapid pulse 121-133, fever 101.3, chills, dizzy and body aches, all on 15Feb2021 14:30 with outcome of recovering. No treatment received for events. The patient underwent lab tests which included body temperature: 101.3 on 15Feb2021, heart rate: 121-133 on 15Feb2021. The events reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Rapid pulse 121-133; fever 101.3; chills; dizzy; body aches; This is a spontaneous report from a contactable consumer (parent).  A 17-years-old male patient received bnt162b2 (BNT162B2, lot number=EM9709) second dose, vaccination location of left arm, via an unspecified route of administration on 14Feb2021 17:15 at SINGLE DOSE for covid-19 immunisation.  Medical history was none. No Allergies to medications, food, or other products. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on 24Jan2021 16:00 (lot number=EL9261; vaccine location=Left arm). The patient experienced rapid pulse 121-133, fever 101.3, chills, dizzy and body aches, all on 15Feb2021 14:30 with outcome of recovering. No treatment received for events. The patient underwent lab tests which included body temperature: 101.3 on 15Feb2021, heart rate: 121-133 on 15Feb2021. The events reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy; This is a spontaneous report from Pfizer-sponsored program. A contactable healthcare professional reported that a patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration, first dose on 27Jan2021 at single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient received first COVID vaccine 27Jan2021 and was diagnosed with Bells Palsy on 10Feb2021. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Bell's palsy cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Angioedema, Chest discomfort, Dry eye, Dyspnoea
Clinical narrative: Angioedema; swelling; Difficulty breathing; Tight chest; Facial flushing; Dry eyes and unsettled stomach; Dry eyes and unsettled stomach; This is a spontaneous report from a contactable nurse.  A 27-years-old non-pregnant female patient started treceive bnt162b2 (BNT162B2), Lot number: EL9266,  intramuscular in left arm on 15Feb2021 at 0900 (at the age of 27 years-old) for COVID-19 immunzation. The vaccination was administered at a workplace clinic.  Medical history included Allergy/Sports-Induced Asthma, Lactose Intolerant and food allergies of Kiwi, Lactose Intolerant, Cherry.  The patient had a positive COVID-19 test prior to vaccination on 14Nov2020. There was no other vaccinations given within 4 week and concomitant medications within 2 weeks included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE), cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC-D), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), fish oil (FISH OIL).  On 15Feb2021 at 10:00, the patient experienced Angioedema/swelling, Difficulty breathing/tight chest, facial flushing, dry eyes and unsettled stomach. Experienced symptoms of flushing 1hour post-vaccination. The clinical course was as follows: She reported that she experienced symptoms of flushing 1hour post-vaccination. About 4 hours later swelling persisted and took Zyrtec to alleviate symptoms, which provided minimal relief. 24 hours post vaccination resulted in ER admission advised per Occupational Medicine at (name). IV SoluMedrol, Bendaryl and Pepcid administered. Overall stay in ER 3 hours. On 17Feb2021, 24 hours post admission rebound symptoms occurring with facial flushing and swelling. Will repeat allergy medication to relieve symptoms PRN.  The clinical outcome of the events was recovered with sequalae (as reported by patient: recovered with lasting effects).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Swelling
Clinical narrative: Angioedema; swelling; Difficulty breathing; Tight chest; Facial flushing; Dry eyes and unsettled stomach; Dry eyes and unsettled stomach; This is a spontaneous report from a contactable nurse.  A 27-years-old non-pregnant female patient started treceive bnt162b2 (BNT162B2), Lot number: EL9266,  intramuscular in left arm on 15Feb2021 at 0900 (at the age of 27 years-old) for COVID-19 immunzation. The vaccination was administered at a workplace clinic.  Medical history included Allergy/Sports-Induced Asthma, Lactose Intolerant and food allergies of Kiwi, Lactose Intolerant, Cherry.  The patient had a positive COVID-19 test prior to vaccination on 14Nov2020. There was no other vaccinations given within 4 week and concomitant medications within 2 weeks included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE), cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC-D), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), fish oil (FISH OIL).  On 15Feb2021 at 10:00, the patient experienced Angioedema/swelling, Difficulty breathing/tight chest, facial flushing, dry eyes and unsettled stomach. Experienced symptoms of flushing 1hour post-vaccination. The clinical course was as follows: She reported that she experienced symptoms of flushing 1hour post-vaccination. About 4 hours later swelling persisted and took Zyrtec to alleviate symptoms, which provided minimal relief. 24 hours post vaccination resulted in ER admission advised per Occupational Medicine at (name). IV SoluMedrol, Bendaryl and Pepcid administered. Overall stay in ER 3 hours. On 17Feb2021, 24 hours post admission rebound symptoms occurring with facial flushing and swelling. Will repeat allergy medication to relieve symptoms PRN.  The clinical outcome of the events was recovered with sequalae (as reported by patient: recovered with lasting effects).
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Body temperature, Feeling cold, Head discomfort
Clinical narrative: felt a little colder than usual; trouble falling asleep; general feeling of malaise; pressure building in my head and abdomen; pressure building in my head and abdomen; left shoulder became increasing sore over 24 hours; This is a spontaneous report from a contactable consumer reported for himself that: 43-years-old male patient started to receive the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 16Feb2021 15:45 at single dose at left arm  for covid-19 immunisation.  The patient previously took the first dose bnt162b2 on 26Jan2021 at 43 years old for covid-19 immunization. The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced left shoulder became increasing sore over 24 hours on 16Feb2021 15:45, trouble falling asleep on 17Feb2021 04:00, general feeling of malaise, pressure building in my head and abdomen on 17Feb2021, felt a little colder than usual on 17Feb2021 08:30. No treatment was received for the adverse events. Under the tongue temperature reading was 97.9 (The patient was usually 97.5 with this thermometer) on 17Feb2021. The outcome of events was not recovered. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination  Information on the lot/batch number has been requested.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Initial insomnia, Malaise
Clinical narrative: felt a little colder than usual; trouble falling asleep; general feeling of malaise; pressure building in my head and abdomen; pressure building in my head and abdomen; left shoulder became increasing sore over 24 hours; This is a spontaneous report from a contactable consumer reported for himself that: 43-years-old male patient started to receive the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 16Feb2021 15:45 at single dose at left arm  for covid-19 immunisation.  The patient previously took the first dose bnt162b2 on 26Jan2021 at 43 years old for covid-19 immunization. The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced left shoulder became increasing sore over 24 hours on 16Feb2021 15:45, trouble falling asleep on 17Feb2021 04:00, general feeling of malaise, pressure building in my head and abdomen on 17Feb2021, felt a little colder than usual on 17Feb2021 08:30. No treatment was received for the adverse events. Under the tongue temperature reading was 97.9 (The patient was usually 97.5 with this thermometer) on 17Feb2021. The outcome of events was not recovered. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination  Information on the lot/batch number has been requested.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: Body aches; injection site pain; low grade fever; This is a spontaneous report from a contactable consumer(patient). A 30-year-old male patient received second dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration at left arm on 16Feb2021 10:00 at the 30 years old at single dose for COVID-19 immunization.  The medical history was not reported. The concomitant medications were Lisinopril and sertraline hydrochloride (ZOLOFT). The Historical Vaccine was first dose BNT162B2 on 26Jan2021 12:00 AM at 30 years old at Left arm for COVID-19 immunization. The patient experienced Body aches, injection site pain, and low-grade fever on 16Feb2021 22:00. There was no treatment received for all the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling cold, Hot flush, Pain
Clinical narrative: low grade fever 101 highest; hot/cold flashes; hot/cold flashes; exhausted; overall body achy; sore arm at/around injection site; This is a spontaneous report from a contactable consumer. A 51-years-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EN 5318), via an unspecified route of administration at Left arm on 16Feb2021 08:45 at single dose for covid-19 immunisation. The patient medical history was not reported. Allergies to medications, food, or other products: none. Prior to vaccination, was the patient was not diagnosed with COVID-19. Concomitant medication included naproxen sodium (ALEVE) and multi vitamins. The patient previously received first dose of bnt162b2 on 26Jan2021 for covid-19 immunisation. The patient experienced low grade fever 101 highest, hot/cold flashes, exhausted, overall body achy, sore arm at/around injection site on 16Feb2021 12:30. No treatment received for the events. Outcome of events was recovering.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: low grade fever 101 highest; hot/cold flashes; hot/cold flashes; exhausted; overall body achy; sore arm at/around injection site; This is a spontaneous report from a contactable consumer. A 51-years-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EN 5318), via an unspecified route of administration at Left arm on 16Feb2021 08:45 at single dose for covid-19 immunisation. The patient medical history was not reported. Allergies to medications, food, or other products: none. Prior to vaccination, was the patient was not diagnosed with COVID-19. Concomitant medication included naproxen sodium (ALEVE) and multi vitamins. The patient previously received first dose of bnt162b2 on 26Jan2021 for covid-19 immunisation. The patient experienced low grade fever 101 highest, hot/cold flashes, exhausted, overall body achy, sore arm at/around injection site on 16Feb2021 12:30. No treatment received for the events. Outcome of events was recovering.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain
Clinical narrative: nausea - 6hrs post shot; headache -10hrs; body aches-14hrs; chills - 14hrs; This is a spontaneous report from a non-contactable consumer (patient). A 35-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on left arm on 16Feb2021 11:30 AM at single dose for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included hypothyroid, Allergies to amoxicillin and sulfa drugs. Concomitant medication (received within 2 weeks of vaccination) included levothyroxine sodium (SYNTHROID), buspirone hydrochloride (BUSPAR) and vitamin D. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation on 26Jan2021 at age of 35 years old. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Feb2021, the patient experienced nausea - 6hrs post shot, headache - 10hrs, body aches and chills - 14hrs. The outcome of events was not recovered. No treatment received for the adverse events. All events reported as non-serious.   No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Rash erythematous
Clinical narrative: Red rash on chest, back, neck, and arms (does not appear to be hives and does not itch); Two sudden, swollen nodules under my chin. Located in the center, almost directly under the center of my tongue. Very tender locally, externally; This is a spontaneous report from a contactable consumer, the patient.  A 45-years-old non-pregnant female patient  received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number:EN5318), via an unspecified route of administration in the left arm on 15Feb2021 at 09:00 (at the age of 45-years-old) as a single dose,  for COVID-19 vaccination. Facility where the most recent COVID-19 vaccine was administered was a workplace clinic.  Medical history included known  Drug Allergy to: Sulfa and Cipro antibiotics..  Concomitant medication included buspirone (BUSPIRONE), bupropion (BUPROPION), vitamin c [ascorbic acid] (VITAMIN C), vitamin d vitamin d [nos] (VITAMIN D), vitamin b complex (VITAMIN B). Historical Vaccine BNT162B2 received on 25Jan2021 at 09:00 Dose 1,  Lot Number EN5318 in Left arm.  No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 17Feb2021 at 07:00 The patient experienced red rash on chest, back, neck, and arms (does not appear to be hives,  two sudden, swollen nodules under my chin, located in the center, almost directly under the center of my tongue, very tender locally, externally. The events were considered non serious.  No treatment was  given for the event. The clinical outcome of the event Red Rash and Lymph nodes cervical swollen was not recovered.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Pain in extremity
Clinical narrative: abdominal cramping; diarrhea; sore arm day of injection (dose 2); This is a spontaneous report from a non-contactable consumer (patient). A 72-years-old female patient (not pregnant) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19), via an unspecified route of administration at arm left on 16Feb2021 at single dose for COVID-19 immunisation. Medical history included cirrhosis unknown origin, autoimmune disease/unknown origin and no known allergies. Concomitant medication included sertraline hydrochloride (ZOLOFT), omeprazole. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The historical vaccine included 1st of BNT162B2 on 26Jan2021. The patient experienced sore arm day of injection (dose 2) on 16Feb2021, abdominal cramping/diarrhea post dose day 2 (17Feb2021) vax 2. No treatment was received for the adverse events. The events outcome was recovering. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious.  Information on the lot/batch number has been requested.