chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Inappropriate schedule of product administration, Migraine, Pyrexia
Clinical narrative: Dose1 start time 28Dec2020, dose 2 start time 11Jan2021; Red, inflamed, hot to touch injection site; Red, inflamed, hot to touch injection site; Red, inflamed, hot to touch injection site; Chills; fever- 99.8; severe headache (migraine); This is a spontaneous report from a contactable nurse (patient) reported for herself. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand=Pfizer, lot number=Ek9231) intramuscularly at left arm on 11Jan2021 at 01:30 PM at a single dose (dose number:2) for COVID-19 immunization. Medical history included type 2 diabetes mellitus (DM) and known allergies to latex. 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 metformin, atorvastatin, lisinopril, exenatide (BYDUREON) and bimatoprost (LUMIGAN). Historical vaccination included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand=Pfizer, lot number= Ek5730) intramuscularly at left arm on 28Dec2020 at 02:30 PM at a single dose (dose number:1) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced adverse events included "red, inflamed, hot to touch injection site", chills, fever- 99.8, and severe headache (migraine); all with start dates on 11Jan2021 at 08:00 PM. The events were reported as non-serious. No treatment received for events. The outcome of events was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site inflammation, Vaccination site warmth
Clinical narrative: Dose1 start time 28Dec2020, dose 2 start time 11Jan2021; Red, inflamed, hot to touch injection site; Red, inflamed, hot to touch injection site; Red, inflamed, hot to touch injection site; Chills; fever- 99.8; severe headache (migraine); This is a spontaneous report from a contactable nurse (patient) reported for herself. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand=Pfizer, lot number=Ek9231) intramuscularly at left arm on 11Jan2021 at 01:30 PM at a single dose (dose number:2) for COVID-19 immunization. Medical history included type 2 diabetes mellitus (DM) and known allergies to latex. 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 metformin, atorvastatin, lisinopril, exenatide (BYDUREON) and bimatoprost (LUMIGAN). Historical vaccination included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand=Pfizer, lot number= Ek5730) intramuscularly at left arm on 28Dec2020 at 02:30 PM at a single dose (dose number:1) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced adverse events included "red, inflamed, hot to touch injection site", chills, fever- 99.8, and severe headache (migraine); all with start dates on 11Jan2021 at 08:00 PM. The events were reported as non-serious. No treatment received for events. The outcome of events was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site nodule, Injection site pain, Nausea
Clinical narrative: Fatigue, sore arm with red swollen nodule at site. Nausea, vomiting, body-aches, and headache lasting almost 3  days.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Fatigue, sore arm with red swollen nodule at site. Nausea, vomiting, body-aches, and headache lasting almost 3  days.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Eye swelling, Pruritus, Rash
Clinical narrative: mild redness; mild swelling; itchy; burning; swelling to the eye; mild rash around her left eye; This is a spontaneous report from a contactable nurse reported for herself. This 42-year-old female patient (No pregnant) received the second dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 08Jan2021, 10:45 AM on Right arm at single dose for covid-19 immunisation. Medical history included juvaderm under her eye approximately 1 year and half to two years ago. Prior to vaccination, the patient did not diagnose with COVID-19. No Allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at age of 42-year-old on an 18Dec2020, 11:15 AM on Right arm at single dose for covid-19 immunisation. Day after the 2nd dose, the patient had a mild rash around her left eye only on 09Jan2021. 3rd day (11Jan2021) swelling to the eye. The day of this report is 4 days post vaccine (12Jan2021), the patient mild redness mild swelling but remain itchy and burning. The patient did not report to her dr as the symptoms seem to be resolving on its own. No covid tested post vaccination. No treatments were received. Outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: mild redness; mild swelling; itchy; burning; swelling to the eye; mild rash around her left eye; This is a spontaneous report from a contactable nurse reported for herself. This 42-year-old female patient (No pregnant) received the second dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 08Jan2021, 10:45 AM on Right arm at single dose for covid-19 immunisation. Medical history included juvaderm under her eye approximately 1 year and half to two years ago. Prior to vaccination, the patient did not diagnose with COVID-19. No Allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at age of 42-year-old on an 18Dec2020, 11:15 AM on Right arm at single dose for covid-19 immunisation. Day after the 2nd dose, the patient had a mild rash around her left eye only on 09Jan2021. 3rd day (11Jan2021) swelling to the eye. The day of this report is 4 days post vaccine (12Jan2021), the patient mild redness mild swelling but remain itchy and burning. The patient did not report to her dr as the symptoms seem to be resolving on its own. No covid tested post vaccination. No treatments were received. Outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dysstasia, Fatigue, Headache
Clinical narrative: Did not start developing symptoms until the night of with body aches and hot flashes. Then the next day body aches from the waist down, was unable to stand for more than 2 mins. Sitting down had mild relief. Then fatigue, fever, cough, headache, chills/hot flashes. Symptoms started to fade down towards the end of the day. Just still feverish, headache, and cough. Treatment tried are two 500 MG of tylenol, sleep, and Vicks rub. The next day, only had a headache and cough which had resolved overnight.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Pain, Pyrexia
Clinical narrative: Did not start developing symptoms until the night of with body aches and hot flashes. Then the next day body aches from the waist down, was unable to stand for more than 2 mins. Sitting down had mild relief. Then fatigue, fever, cough, headache, chills/hot flashes. Symptoms started to fade down towards the end of the day. Just still feverish, headache, and cough. Treatment tried are two 500 MG of tylenol, sleep, and Vicks rub. The next day, only had a headache and cough which had resolved overnight.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Neck pain
Clinical narrative: severe chills; severe nausea (no vomiting); headache; neck aches; This is a spontaneous report from a contactable physician (reported for herself). A 41-year-old female patient (Pregnant at the time of vaccination) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: el3248), via an unspecified route of administration on 10Jan2021 08:30 at single dose for COVID-19 immunization. The patient's medical history included Allergies to amoxicillin. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (lot number: ek9231) on 22Dec2020 21:45 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe chills, severe nausea (no vomiting), neck aches, headache on 10Jan2021 20:30. Treatment received for the adverse events included tylenol 1g x3 doses. 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 recovered in Jan2021.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: left subscapular lymphnode swelling with tenderness; left subscapular lymphnode swelling with tenderness; This is a spontaneous report from a contactable nurse. A 45-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), via an unspecified route of administration from 16Dec2020 11:15 to 16Dec2020 11:15 at a single dose for covid-19 immunization. Medical history included seasonal allergy and Sulfa drugs Allergies. Concomitant medication included minerals nos, vitamins nos (CENTRUM A to Z) and naproxen sodium (ALEVE). The patient had left subscapular lymph node swelling with tenderness on 01Jan2021. The outcome of the events was recovering.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: After the first dose at noon 1/16/2021 mountain time, I began to have a fever in the evening, starting from 101 F,  then it went up to 104 F at midnight, feel chill and body aches, bad headache. I never had such high temperature in my lifetime.  I took ibuprofen and it seems the fever went away in the next early morning 1/17. However, my temperature went up again 101.3 F at noon 1/17 and it went up to 103 F at night 1/17. I consulted the doctor and took Tylenol. 1/18 the fever was way but still headache, body aches and feel very weak.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Bedridden, Dizziness, Vertigo
Clinical narrative: I am very off balance; Dizziness; It's gotten worst to the point I can hardly get out of bed in the morning; I am having vertigo. It was mild at first but now it's gotten worst to the point I can hardly get out of bed in the morning; This is a spontaneous report from a contactable nurse (patient)  A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced vertigo on 31Dec2020. The patient reported that it was mild at first but now it's gotten worst to the point she can hardly get out of bed in the morning on unknown date. After sleep of about 2 hours it was better but she had been up for over all 2 hour that morning and it was still, the patient was very off balance on unknown date. The patient experience also dizziness on an unspecified date. The outcome of vertigo was not recovered, for the other events was unknown.  No treatment as performed for the event vertigo.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Feeling hot, Myalgia
Clinical narrative: Pain at injection site; swelling,(size of my palm,); warm to touch, all over body; muscle aches, especially shoulder blades; tired/sleepy; tired/sleepy; chills; This is a spontaneous report from a contactable other HCP (patient). This 64-year-old female other HCP reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL128H), via unspecified route at right arm on 08Jan2021 07:45 AM at single dose for COVID-19 immunization. Facility type vaccine was hospital. Medical history included elevated blood pressure and atrial septal defect repair 2008. Concomitant medications included olmesartan medoxomil and hydrochlorothiazide. Historical vaccine included the first dose of BNT162B2 (lot# EH9899) on 18Dec2020 at age of 64 years old for COVID-19 immunization and having arm pain. No Covid prior vaccination. No Covid tested post vaccination. No known allergies. On 08Jan2021 07:00 PM, patient experienced pain at injection site, swelling (size of her palm), warm to touch all over body and muscle aches, especially shoulder blades, very tired/sleepy with chills. No treatment was received. It was reported normal temperature for patient was 97.2 (+) or (-) 98.6. Outcome of events was recovering.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Swelling, Vaccination site pain
Clinical narrative: Pain at injection site; swelling,(size of my palm,); warm to touch, all over body; muscle aches, especially shoulder blades; tired/sleepy; tired/sleepy; chills; This is a spontaneous report from a contactable other HCP (patient). This 64-year-old female other HCP reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL128H), via unspecified route at right arm on 08Jan2021 07:45 AM at single dose for COVID-19 immunization. Facility type vaccine was hospital. Medical history included elevated blood pressure and atrial septal defect repair 2008. Concomitant medications included olmesartan medoxomil and hydrochlorothiazide. Historical vaccine included the first dose of BNT162B2 (lot# EH9899) on 18Dec2020 at age of 64 years old for COVID-19 immunization and having arm pain. No Covid prior vaccination. No Covid tested post vaccination. No known allergies. On 08Jan2021 07:00 PM, patient experienced pain at injection site, swelling (size of her palm), warm to touch all over body and muscle aches, especially shoulder blades, very tired/sleepy with chills. No treatment was received. It was reported normal temperature for patient was 97.2 (+) or (-) 98.6. Outcome of events was recovering.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA Diarrhea Tiredness Slight Chills
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Vaccination site pain
Clinical narrative: pain at injection site; body aches; headache; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 06Jan2021, the patient experienced pain at injection site, body aches and headache. Clinical outcome of the events was unknown.  Information about lot and batch number was requested.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: COVID-19 virus test positive; COVID-19 virus test positive; This is a spontaneous report from a Pfizer-sponsored program "Pfizer First Connect" from a contactable consumer reporting for himself. A male patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2), via an unspecified route of administration, on 22Dec2020, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced COVID-19 virus test positive on an unspecified date with outcome of unknown. It was reported that the patient was scheduled to get his second dose on 12Jan2021, however between 22Dec2020 and 12Jan2021 the patient experienced the adverse event.  The information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: some pain at the injection site; This is a spontaneous report from a contactable other healthcare professional via Pfizer sales representative. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced some pain at the injection site after use of product. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Myalgia, Nausea, Pain
Clinical narrative: Nauseous,  extremely sore and aching muscles and body, migraine
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise
Clinical narrative: 24 hoursMalaise; flu like symptoms; This is a spontaneous report from a non-contactable Physician reporting for herself. The case was also reported via Pfizer employee. A 32-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 08Jan2021 at single dose in the right arm for COVID-19 immunisation. The patient was vaccinated at hospital. No other vaccine was given within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 administered on an unspecified date. The patient's medical history was not reported. The patient had no allergies to medications, food, or other products. The patient did not receive concomitant medications. On 08Jan2021 the patient experienced 24 hours malaise and in Jan2021 flu like symptoms. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, she has not been tested for COVID-19. The patient received treatment with paracetamol (TYLENOL) for the event malaise. Malaise resolved on 09Jan2021, while outcome of flu like symptoms was unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Got the first dose and was contracted with COVID; Got the first dose and was contracted with COVID; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was contracted with covid on an unspecified date in Dec2020 (27Dec2020 or 28Dec2020) with outcome of unknown.    Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Headache, Injection site pain, Pain
Clinical narrative: throat swelling; headache; Pain; little bit of chills; GI upset; This is a spontaneous report from a contactable nurse. A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EK9231, expiry: 30Apr2021), via an unspecified route of administration on an unspecified date at 0.3 mL, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose of bnt162b2 on an unknown date for covid-19 immunization and experienced pain at the injection site. On an unspecified date, the patient experienced head ache, throat swelling, gastrointestinal (GI) upset, pain, and little bit of chills (don't believe to have had fever). It was clarified that the event took place after use of product. The outcome of the events was unknown.; Sender's Comments: The information in this report is limited, and does not allow a full medically meaningful assessment of the case.   Considering temporal relationship, a causal relationship between the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) and the reported events including throat swelling cannot be excluded.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: throat swelling; headache; Pain; little bit of chills; GI upset; This is a spontaneous report from a contactable nurse. A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EK9231, expiry: 30Apr2021), via an unspecified route of administration on an unspecified date at 0.3 mL, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose of bnt162b2 on an unknown date for covid-19 immunization and experienced pain at the injection site. On an unspecified date, the patient experienced head ache, throat swelling, gastrointestinal (GI) upset, pain, and little bit of chills (don't believe to have had fever). It was clarified that the event took place after use of product. The outcome of the events was unknown.; Sender's Comments: The information in this report is limited, and does not allow a full medically meaningful assessment of the case.   Considering temporal relationship, a causal relationship between the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) and the reported events including throat swelling cannot be excluded.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Eye irritation, Eye pruritus
Clinical narrative: Burning and itchy eyes; Burning and itchy eyes; This is a spontaneous report from a non-contactable consumer (the patient).  A patient of unspecified age and gender received bnt162b2 (BNT162B2) vaccine,  via an unspecified route of administration on 07Jan2021 10:45 at single dose for covid-19 immunisation.  The patient medical history  and concomitant medications were not reported.  The patient  stated that starting 07Jan2021 at 17:00 it started burning and itchy eyes. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Injection site swelling and redness; Injection site swelling and redness; Low grade fever; Nausea; This is a spontaneous report from a contactable nurse reporting for herself. A 54-year-old female patient received bnt162b2 (BNT162B2) (Lot# EJ1686, Exp date 31Mar2021), via an unspecified route of administration, on 05Jan2021, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. The patient experienced injection site swelling and redness, low grade fever and nausea all on 06Jan2021 with outcome of unknown. Therapeutic measures were taken as result of the events and included treatment with a 1000 mg Tylenol. The events were considered related (source of assessment: primary source reporter, method of assessment: global introspection).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Chills, Condition aggravated, Diarrhoea
Clinical narrative: This morning it started all these different side effects and it's progressively getting worse, so I left work; Body aches; Headache; Stomach issues; pain; Diarrhea; Chills; Fever I just checked it's 102.4; Little sore arm at night; This is a spontaneous report from a contactable consumer (patient).  A 56-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Batch/lot # EK9231) at single dose on 06Jan2021 around 2 O'clock for Covid-19 immunisation, administered ad hospital.  Medical history included high cholesterol, hypertension, irregular heart beats, arrhythmia, acid reflux. Concomitant medication included amlodipine (AMLODIPINE) 10 mg once a day for hypertension, acetylsalicylic acid (BABY ASPIRIN) at 81 mg, once a day, carvedilol (CARVEDILOL) at 12.5 mg, two times a day hypertension, flecainide (FLECAINIDE) at 50 mg, twice a day for irregular heart beats, arrhythmia, olmesartan (OLMESARTAN) at 40 mg once a day for hypertension, omeprazole (OMEPRAZOLE) at 40 mg when needed for acid reflux, rosuvastatin (ROSUVASTATIN) at 20 mg, once a day for high cholesterol.  The patient experienced little sore arm at night on 06Jan2021. Then, on  07Jan2021 morning he went in to work and it started all these different side effects and it's progressively getting worse, so he left work at abut 10 O' clock AM. He was getting body aches, headache, stomach issues, pain, diarrhea, chills, and fever I just checked it's 102.4 on 07Jan2021. The patient underwent lab tests physical examination with unknown results in Dec2020 3 weeks before this report (he had complete physical lab work with his doctor).  Treatment included taking Tylenol and Advil. The outcome of all events was not recovered. Due date of second shot will be 23Jan2021.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity, Physical examination, Pyrexia
Clinical narrative: This morning it started all these different side effects and it's progressively getting worse, so I left work; Body aches; Headache; Stomach issues; pain; Diarrhea; Chills; Fever I just checked it's 102.4; Little sore arm at night; This is a spontaneous report from a contactable consumer (patient).  A 56-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Batch/lot # EK9231) at single dose on 06Jan2021 around 2 O'clock for Covid-19 immunisation, administered ad hospital.  Medical history included high cholesterol, hypertension, irregular heart beats, arrhythmia, acid reflux. Concomitant medication included amlodipine (AMLODIPINE) 10 mg once a day for hypertension, acetylsalicylic acid (BABY ASPIRIN) at 81 mg, once a day, carvedilol (CARVEDILOL) at 12.5 mg, two times a day hypertension, flecainide (FLECAINIDE) at 50 mg, twice a day for irregular heart beats, arrhythmia, olmesartan (OLMESARTAN) at 40 mg once a day for hypertension, omeprazole (OMEPRAZOLE) at 40 mg when needed for acid reflux, rosuvastatin (ROSUVASTATIN) at 20 mg, once a day for high cholesterol.  The patient experienced little sore arm at night on 06Jan2021. Then, on  07Jan2021 morning he went in to work and it started all these different side effects and it's progressively getting worse, so he left work at abut 10 O' clock AM. He was getting body aches, headache, stomach issues, pain, diarrhea, chills, and fever I just checked it's 102.4 on 07Jan2021. The patient underwent lab tests physical examination with unknown results in Dec2020 3 weeks before this report (he had complete physical lab work with his doctor).  Treatment included taking Tylenol and Advil. The outcome of all events was not recovered. Due date of second shot will be 23Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Neck pain, Pain in extremity
Clinical narrative: Muscle ache; Joint pain; Arm still hurt/arm was really sore and my neck was sore/ forearms blades; Arm still hurt/arm was really sore and my neck was sore; Her shoulder, knee blades; Her shoulder, knee blades; This is a spontaneous report from a contactable nurse reporting for herself. A 60-year-old female patient received bnt162b2 (BNT162B2) (lot# EL1284), via an unspecified route of administration, in Jan2021, at single dose, for COVID-19 immunisation.  Medical history and concomitant medications were none. The patient experienced muscle ache, joint pain, arm still hurt/arm was really sore and my neck was sore/ forearms blades; her shoulder, knee blades all in Jan2021 with outcome of unknown. Therapeutic measures were taken as a result of the events and included treatment with ibuprofen and Tylenol.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Myalgia
Clinical narrative: malaise; myalgias; This is a spontaneous report from a contactable physician (patient's parent). A 27-year-old male patient received second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patiently previously received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) at a single dose for COVID-19 immunization. The patient experienced malaise and myalgias which took place after the administration of second dose. He took Tylenol 6 hours ago, and the symptoms are decreasing. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Large red circle around injection site, hot, itchy, painful that continues to expand even at day 4
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: headache; fatigue; pain at the injection site; This is a spontaneous report from a non-contactable consumer. A male patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization on an unspecified date. The reporter mentioned that the patient received the COVID-19 vaccine series. The patient experienced headache and fatigue after the second injection (same day) and pain at the injection site, all on unspecified date. The outcome of the events was unknown. No follow-up attempts are possible; information on the lot/batch number could not be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: arm pain; chills; This is a spontaneous report received from a non-contactable consumer (patient's sister). A female patient of an unspecified age received the second dose of BNT162B2 (BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine and after the second dose experienced arm pain and chills that same day (unspecified date). The outcome of the events was unknown.  No follow up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: feeling weak; tired; This is a spontaneous report received from a contactable physician (also reported as consumer). A male patient of an unspecified age (reported as "over the age of 60") received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced feeling weak and tired a few hours after receiving his second vaccination (unspecified date). The outcome of the events was unknown.  No follow-up attempts are possible. Information about batch/lot number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash macular
Clinical narrative: Numbness in L hand  developing 3 hours after the second dose, which occurred while I was asleep and then woke up and then went away  within  5 minutes. Today,  1/18/2020, I developed dark red blotches on my L hand, especially visible near the knuckles (the metacarpophalangeal joints). It then went away  within 3 minutes but then appeared on other parts of my hand, including on my  R hand. The blotches all went away within 2-3 minutes but occurred consecutively in different parts of my hand (i.e., some area developed the blotchiness prior to others, and then other parts developed it)
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vomiting
Clinical narrative: vomiting; Headache; This is a spontaneous report from a contactable consumer from a Pfizer sponsored program Pfizer First Connect. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced headaches and vomiting on an unspecified date. Outcome of event was unknown.    Information on the Lot/Batch number has been requested
Sex: U
Vaccine: COVID19
Symptoms: Cough, Malaise
Clinical narrative: malaise; cough; This is a spontaneous report received from a contactable other healthcare professional. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Four days after the patient's COVID-19 vaccine (unspecified date), the patient started experiencing malaise and cough. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Injection site erythema, Injection site papule, Injection site rash, Lymph node pain
Clinical narrative: 1) 36 hours post vaccination rash developed below injection site approximately 1 inch in diameter, rash was red, but not itchy until 72 hours. Rash subsided in color, but was slightly itchy when arm was moved. Rash completely gone at 5-7 days post vaccination. 2) 8 days post vaccination, rash re-appeared and become red, itchy, raised  (1.5 - 2 inches diameter), same location: below injection site. Pain/tenderness in armpit of right arm, especially when pressure is applied deep into armpit. Feels bruised or soreness.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: 1) 36 hours post vaccination rash developed below injection site approximately 1 inch in diameter, rash was red, but not itchy until 72 hours. Rash subsided in color, but was slightly itchy when arm was moved. Rash completely gone at 5-7 days post vaccination. 2) 8 days post vaccination, rash re-appeared and become red, itchy, raised  (1.5 - 2 inches diameter), same location: below injection site. Pain/tenderness in armpit of right arm, especially when pressure is applied deep into armpit. Feels bruised or soreness.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: soreness; pain at the injection site; This is a spontaneous report from a Pfizer-sponsored program. A non- contactable male consumer (patient) received 1st dose of BNT162B2 (COVID-19 vaccine) on 08Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant drug were not reported. He received the 1st dose of the Covid-19 vaccine yesterday, the HCP told the caller to avoid taking Aspirin and Tylenol for 3 days. Caller wanted to have a quick review on that. Experienced a little soreness and pain at the injection site. Getting better now. Outcome of the event was recovering.  No follow-up attempts are possible. Information about Lot/Batch could not be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever/elevated temperature; This is a spontaneous report from a contactable physician (on behalf of a nurse) and a nurse. A female patient of an unspecified age (reported as 18 unit unknown) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration on 06Jan2021 at single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient got her first Pfizer Covid 19 vaccine and a couple of days later she developed symptoms of Covid and tested positive. The patient recovered and had no symptoms. The physician informed that the patient received the second shot and experienced fever. The physician wanted to know if it was okey to give the second shot. The patient got her second injection yesterday (06Jan2020) and had an elevated temperature which was an immune response (Jan2021). The outcome of the event fever/elevated temperature was unknown.  Follow-up activities are possible, information on the batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Peripheral swelling, Wrong technique in product usage process
Clinical narrative: Patient is over 220 lb and a 5/8 inch needle was used so vaccine was given subcutaneously. Se thinks that it was administered subcutaneously instead of IM; Wrong sized needle was used to give vaccine; experienced swollen arms after getting the 2nd dose; This is a spontaneous report from a contactable nurse (patient). This 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), subcutaneous at single dose in the left arm on 10Jan2021 07:15 for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Dec2020 (first dose) for Covid-19 immunisation.   It was reported that wrong sized needle was used to give vaccine in 10Jan2021 10:00. The patient is over 220 lb and a 5/8 inch needle was used so vaccine was given subcutaneously. She received the 2nd dose with 1 inch 5/8 size needle which she believes that is inappropriate to use since her weight is 240lbs. She experienced swollen arms after getting the 2nd dose and she thinks that it was administered subcutaneously instead of IM. Asking for recommendations on what to do next if she needs to have another dose or not. The outcome of the events was unknown.    Information on the lot/batch number has been requested.  Follow-up (11Jan2021): New information received from a contactable nurse (patient) includes: Events details, and new event (swollen arms)
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Ear congestion, Ear discomfort, Injection site hypoaesthesia, Injection site pain, Joint stiffness
Clinical narrative: Received Thursday 1/7. Sore arm and numbness at injection site day of vaccine. Numbness resolved on Friday 1/8, arm still sore. Saturday 1/9 increased salivation bilaterally left greater than right. Left sided  jaw and eye facial stiffness, left tongue and cheek swollen. Excess saliva coming from corners of mouth, left jaw and eye stiffness, harder to open and close left side of face, jaw and eye. Able to move face but harder to do, takes several tries to get a smile or close eye fully. No drooping noted.  Facial symmetry preserved. Completed video visit Saturday evening, prescribed prednisone 80 mg x 7 days and acyclovir 400 mg 5x's/day for 7 days. Took first dose on Saturday night 1/9. Sunday morning swelling of tongue resolved and cheek swelling improved. Since Sunday 1/10, symptoms remain similar. Stiffness left side of face in jaw and eye. Mild excess salvia produced bilaterally left greater than right and mild excess tear production left sided only. Ear pressure started around 1/10 and continues, feel pressure and clogged ears, left greater than right. Started using left arm at work more on Wednesday 1/13 and Thursday 1/14, and after this could no longer use left arm due to pain at 8-9/10. Could not hold laptop or dragon mic. Called out of work on Friday 1/15 due to arm pain and facial issues. Job involves patient care, talking with patients in office. Thursday 1/13, pain of left arm also felt into the left shoulder. Pain also remained in area of injection site. Second Video Visit Friday 1/17 as follow up.  Today 1/18, arm pain 4-5/10 with rest, 6-7/10 with use. Jaw, eye stiffness are similar.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Musculoskeletal stiffness, Salivary hypersecretion, Swelling face, Swollen tongue
Clinical narrative: Received Thursday 1/7. Sore arm and numbness at injection site day of vaccine. Numbness resolved on Friday 1/8, arm still sore. Saturday 1/9 increased salivation bilaterally left greater than right. Left sided  jaw and eye facial stiffness, left tongue and cheek swollen. Excess saliva coming from corners of mouth, left jaw and eye stiffness, harder to open and close left side of face, jaw and eye. Able to move face but harder to do, takes several tries to get a smile or close eye fully. No drooping noted.  Facial symmetry preserved. Completed video visit Saturday evening, prescribed prednisone 80 mg x 7 days and acyclovir 400 mg 5x's/day for 7 days. Took first dose on Saturday night 1/9. Sunday morning swelling of tongue resolved and cheek swelling improved. Since Sunday 1/10, symptoms remain similar. Stiffness left side of face in jaw and eye. Mild excess salvia produced bilaterally left greater than right and mild excess tear production left sided only. Ear pressure started around 1/10 and continues, feel pressure and clogged ears, left greater than right. Started using left arm at work more on Wednesday 1/13 and Thursday 1/14, and after this could no longer use left arm due to pain at 8-9/10. Could not hold laptop or dragon mic. Called out of work on Friday 1/15 due to arm pain and facial issues. Job involves patient care, talking with patients in office. Thursday 1/13, pain of left arm also felt into the left shoulder. Pain also remained in area of injection site. Second Video Visit Friday 1/17 as follow up.  Today 1/18, arm pain 4-5/10 with rest, 6-7/10 with use. Jaw, eye stiffness are similar.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID; five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID; This is a spontaneous report from a contactable nurse. This nurse reported similar events for five patients. This is the first of five reports.   A patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration, on an unspecified date, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. It was reported that five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID on an unspecified date. They would like to know if they still get the second dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Covid-19 virus test positive and  suspected LOE  due to temporal relationship.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is 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.,Linked Report(s) : US-PFIZER INC-2021021909 Same reporter/ drug/ event for different patients.;US-PFIZER INC-2021021910 Same reporter/ drug/ event for different patients.;US-PFIZER INC-2021021911 Same reporter/ drug/ event for different patients.;US-PFIZER INC-2021021912 Same reporter/ drug/ event for different patients.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID; five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID; This is a spontaneous report from contactable nurse. This nurse reported similar events for 5 patients. This is the second of five reports. A patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration, on an unspecified date, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. It was reported that five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID on an unspecified date. They would like to know if they still get the second dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.,Linked Report(s) : US-PFIZER INC-2021021881 Same reporter/ drug/ event for different patients
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Body height, Chills, Condition aggravated, Pain, Pain in extremity
Clinical narrative: Very sore arm (7/10 scale) starting about 6 hours after the vaccine, and lasting up for 72 hours since the vaccine dose. Next day after vaccine had moderate chills and body aches that was present for one day. Tingling sensation on ulnar/pinky side of arm after waking up from first morning after vaccine. Worsened my cough from my cold.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Very sore arm (7/10 scale) starting about 6 hours after the vaccine, and lasting up for 72 hours since the vaccine dose. Next day after vaccine had moderate chills and body aches that was present for one day. Tingling sensation on ulnar/pinky side of arm after waking up from first morning after vaccine. Worsened my cough from my cold.