chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Erythema, Fatigue, Feeling abnormal
Clinical narrative: Fever and chills (8:30pm-2:00am next day)  Nausea / vomiting (3-4am next day) Extreme back pain (mostly lower back) (2am-7am next day) Red, hot, itchy rash on left side of back / abdomen (I just noticed at 11pm day after, not sure when it began) Extreme fatigue and mental fogginess (8pm day of - still continuing 11pm day after)
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Nausea, Pyrexia, Rash pruritic, Vomiting
Clinical narrative: Fever and chills (8:30pm-2:00am next day)  Nausea / vomiting (3-4am next day) Extreme back pain (mostly lower back) (2am-7am next day) Red, hot, itchy rash on left side of back / abdomen (I just noticed at 11pm day after, not sure when it began) Extreme fatigue and mental fogginess (8pm day of - still continuing 11pm day after)
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Fatigue, Injection site pain
Clinical narrative: Ongoing migraine present for over 48 hours. Nausea, vomiting, back pain, joint pain, neck pain, pain at injection site, fever, chills, fatigue, all lasting for 36 hours.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Neck pain, Pyrexia, Vomiting
Clinical narrative: Ongoing migraine present for over 48 hours. Nausea, vomiting, back pain, joint pain, neck pain, pain at injection site, fever, chills, fatigue, all lasting for 36 hours.
Age: 57.0
Sex: M
Vaccine: UNK
Symptoms: Acoustic stimulation tests, Deafness neurosensory, Diplacusis, Tinnitus
Clinical narrative: Sudden Sensorineural Hearing Loss in the left ear, including tinnitus and diplacusis.  Treated 24 hours after onset with 500mg IV methylprednisolone from Dr. Repeated 45 hours after onset with 500mg IV methylprednisolone.  Prescription of 500mg Trental q.d.  The hearing normalized after several weeks.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Nausea, Pain
Clinical narrative: Swollen painful lymph nodes under left arm, headache, nausea, chills, body aches
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Headache, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Headache, fever, bone and bodyaches. Inflamed red area at site of injectionwith itching, painful and hot to the touch started within 24 hours after injection. Still red inflamed hot and itchy as of day of report. Fever has resolved, bone and body ache diminished. No betterment as of yet at injection site
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Pain, Pyrexia, Skin warm
Clinical narrative: Headache, fever, bone and bodyaches. Inflamed red area at site of injectionwith itching, painful and hot to the touch started within 24 hours after injection. Still red inflamed hot and itchy as of day of report. Fever has resolved, bone and body ache diminished. No betterment as of yet at injection site
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Sudden onset of tinnitus in my left ear. Still ongoing as of 10 days later. Very prominent hissing.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deafness unilateral, SARS-CoV-2 test, Tinnitus
Clinical narrative: Sudden onset of tinnitus in my left ear. Still ongoing as of 10 days later. Very prominent hissing.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, Tremor
Clinical narrative: Went downhill rapidly... Aprox 6 hours after shot was administered I was shaking uncontrollably (freezing sensation) fever 102.6 and commiting. Woke up this morning and felt better but still very much aches and pains and headache
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Note: These symptoms are from the second injection of the vaccine; first was March 11...no problematic symptoms from that one. Symptoms started at midnight on April 2 (10 hours after injection) with chills, not sure if accompanied by fever.  By 8:00am, chills subsided, but had body aches and headache the rest of the day and though the night.  Ended by 8:00am on April 3.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Fever of 100.2 starting morning after vaccination.  Body aches, chills, fatigue.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Chills, Headache, Nausea, Pain
Clinical narrative: body aches; nausea; headache; fever; chills; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EK9231), via an unspecified route of administration on 08Jan2021 as single dose for COVID-19 immunization. The patient's medical history reported as blood pressure high. The patient previously took the first dose of bnt162b2 (Lot number: EK5730) on 18Dec2020 for COVID-19 immunization. Concomitant medication included nifedipine extended release 60 mg, one time a day for blood pressure high from 20 years and continuing. On 08Jan2021, the patient experienced body aches, nausea, headache, fever and chills. The patient was neither admitted to hospital nor received treatment for the events. The patient was fine. On 09Jan2021, the outcome of the events was recovered.  Follow-up (03Feb2021): The initial case was missing the following minimum criteria: No adverse event. Upon receipt of follow-up information on (03Feb2021), this case now contains all required information to be considered valid. This is a follow-up spontaneous report received from a contactable consumer in response to Non-HCP letter sent that included: events, suspect product details and relevant medical history.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Weight
Clinical narrative: body aches; nausea; headache; fever; chills; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EK9231), via an unspecified route of administration on 08Jan2021 as single dose for COVID-19 immunization. The patient's medical history reported as blood pressure high. The patient previously took the first dose of bnt162b2 (Lot number: EK5730) on 18Dec2020 for COVID-19 immunization. Concomitant medication included nifedipine extended release 60 mg, one time a day for blood pressure high from 20 years and continuing. On 08Jan2021, the patient experienced body aches, nausea, headache, fever and chills. The patient was neither admitted to hospital nor received treatment for the events. The patient was fine. On 09Jan2021, the outcome of the events was recovered.  Follow-up (03Feb2021): The initial case was missing the following minimum criteria: No adverse event. Upon receipt of follow-up information on (03Feb2021), this case now contains all required information to be considered valid. This is a follow-up spontaneous report received from a contactable consumer in response to Non-HCP letter sent that included: events, suspect product details and relevant medical history.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cognitive disorder, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: fogginess; tiredness; dizzy feeling. lasted 24 hours.; chills at night; cloudy minded. started approximately 2 hours after shot; sore arm for 24 hours as well; numbness in top of hand and thumb and pointer finger; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old female patient (not pregnant) received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, on Arm Left on 22Jan2021 at 12:15 as a single dose for COVID-19 immunization. Medical history included coronary artery disease, cough, back issues, arthritis and multiple allergies (from an unknown date and unknown if ongoing). Patient had allergies to medications, food, or other products. Concomitant medications included levothyroxine (Levothyroxine), clopidogrel bisulfate (Plavix), dexlansoprazole (Dexilant), metoclopramide hydrochloride (Metoperon) and pravastatin (Pravastatin). All medications were received within 2 weeks of vaccination. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 22Jan2021, immediately after vaccine, warmth radiating down left arm followed by numbness in top of hand and thumb and pointer finger. Lasted several hours. Approximately 2 hours after shot), the patient experienced chills at night and cloudy minded. At 14:00 patient had fogginess, tiredness and dizzy feeling. Lasted 24 hours. Patient had sore arm for 24 hours as well. No treatment was provided for events. Outcome of the events was reported as recovering.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: fogginess; tiredness; dizzy feeling. lasted 24 hours.; chills at night; cloudy minded. started approximately 2 hours after shot; sore arm for 24 hours as well; numbness in top of hand and thumb and pointer finger; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old female patient (not pregnant) received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, on Arm Left on 22Jan2021 at 12:15 as a single dose for COVID-19 immunization. Medical history included coronary artery disease, cough, back issues, arthritis and multiple allergies (from an unknown date and unknown if ongoing). Patient had allergies to medications, food, or other products. Concomitant medications included levothyroxine (Levothyroxine), clopidogrel bisulfate (Plavix), dexlansoprazole (Dexilant), metoclopramide hydrochloride (Metoperon) and pravastatin (Pravastatin). All medications were received within 2 weeks of vaccination. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 22Jan2021, immediately after vaccine, warmth radiating down left arm followed by numbness in top of hand and thumb and pointer finger. Lasted several hours. Approximately 2 hours after shot), the patient experienced chills at night and cloudy minded. At 14:00 patient had fogginess, tiredness and dizzy feeling. Lasted 24 hours. Patient had sore arm for 24 hours as well. No treatment was provided for events. Outcome of the events was reported as recovering.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: he is experiencing soreness in the arm.; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer reported for an 87-years-old male patient (husband) received first dose of BNT162B2 (solution for injection; Lot Number: EL8982) via intramuscular at left arm on 27Jan2021 12:30 PM as single dose for covid-19 immunisation. The patient medical history reported None and concomitant medications were not reported. The reporter stated that her husband received the vaccine as well he is experiencing soreness in the arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Therapeutic measures were taken for this event. The event considered non serious. The outcome of the event was unknown.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid-19; This is a spontaneous report from a contactable consumer (patient's wife). A 78-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL8982), via an unspecified route of administration in right arm on 22Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The consumer confirmed that the patient did not received other vaccines on the same day as the COVID vaccine. The consumer reported that she and the patient were scheduled for the second dose on 12Feb2021, 3 weeks later. On 27Jan2021, the patient underwent COVID-19 PCR test, which was positive on 28Jan2021. The consumer was also tested, and her test result was negative, but they were unsure if the patient got it from her because she had a minor exposure 14 days ago. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Investigation
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A 75-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot #: EL9262), dose 1 via an unspecified route of administration, administered in Arm Left on 28Jan2021 as SINGLE DOSE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing Verbatim: Asthma, hypertension from an unknown date and unknown if ongoing Verbatim: High blood pressure, blood cholesterol increased from an unknown date and unknown if ongoing Verbatim: High cholesterol, drug hypersensitivity from an unknown date and unknown if ongoing, headache from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took halothane and experienced drug hypersensitivity, nitrous oxide and experienced drug hypersensitivity. The patient experienced constant headache on 28Jan2021. The patient underwent lab tests and procedures which included investigation: normal. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was not recovered.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, SARS-CoV-2 test
Clinical narrative: arm soreness at injection site (both vaccines); This is a spontaneous report from a contactable Other HCP (patient). A 61-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number EL0140), via an Intramuscular route of administration on left arm on 28Dec2020 12:00 at single dose for Covid-19 immunization administered at Hospital. The patient medical history included hypothyroidism and hyperlipidemia. Concomitant medication in two weeks of vaccination were not reported. No Allergies to medications, food, or other products was reported. The patient reported, arm soreness at injection site on an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any treatment for the event. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has been tested for COVID-19. On 25Jan2021, the patient underwent lab test SARS-CoV-2 test Nasal Swab result-negative. The outcome of event was recovered.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue
Clinical narrative: More tired feeling than usual; cough since two days after vaccine; This is a spontaneous report received from a contactable other healthcare professional. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: unknown), intramuscular in the right arm, on 15Jan2021 12:00, as single dose, for covid-19 immunisation, at a hospital. Medical history included HIV infection and fatigue. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. Concomitant medication included bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY). The patient previously took codeine and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced more tired feeling than usual and had a cough two days after the vaccine, on 17Jan2021. No treatment was received for the events. The patient was recovering from the events. The reporter assessed the events as non-serious.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: fatigue; nausea; This is a spontaneous report from a contactable nurse(patient herself). A 29-year-old female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE solution for injection; batch/lot number and expiry date were unknown) via an unspecified route of administration in the right arm on 20Jan2021 11:00 (at the age of 29-years-old) at a single dose for covid-19 immunization in a pharmacy or drug store. Medical history included Hashimoto's disease, anxiety and depression; all of which started from an unknown date and unknown if ongoing. Concomitant medications included piroxicam (PAXIL) and bupropion hydrochloride (WELLBUTRIN), both taken for an unspecified indication and start and stop dates were not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient has no allergies to medications, food, or other products. On 24Jan2021 23:00, the patient experienced fatigue and nausea and reported that she has been experiencing the events since her shot. Events resulted in physician office visit. The events were reported as non-serious. It was unknown if a treatment was received for the events. The outcome of these events was not recovered.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: sore and swollen arm; sore and swollen arm; This is a spontaneous report from a non-contactable consumer (patient). A 41-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number EL9261; expiration date not reported), via an unspecified route (administered on right arm) at the age of 41-years-old on 22Jan2021 06:15 AM as single dose for COVID-19 immunization. Medical history included seasonal allergy and penicillin allergy both from unknown date and unknown if ongoing. Concomitant medication included cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19 and didn't receive any other vaccines. The patient is not pregnant at the time of vaccination. The patient experienced sore and swollen arm on 23Jan2021. The events were reported as non-serious.  Since the vaccination the patient has not been tested positive for COVID-19. No treatment was received for the events. The outcome of the events was not recovered/resolved.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity
Clinical narrative: arm was sore; This is a spontaneous report from a non-contactable consumer or other non hcp (patient herself).   A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's arm was sore on an unspecified date (reporter was uncertain for the event duration reported as "maybe an hour or 2").  The patient underwent lab tests and procedures which included body temperature: 97.4 degrees Fahrenheit and 97.6 degrees Fahrenheit on an unspecified date. The outcome of the event was recovered on unspecified date.    No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Dizziness, Fatigue, Inner ear disorder
Clinical narrative: inner ear disorder; debilitating; extreme dizziness; nausea; vomiting; stomach discomfort; slight weakness; This is a spontaneous report from a contactable consumer. A 69-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN5318), via an unspecified route of administration, administered in Arm Left on 25Jan2021 13:30 (at the age of 49-years-old) at a single dose for COVID-19 immunization. Medical history included blood pressure, cholesterol and seasonal allergies. Blood pressure and cholesterol controlled by meds. Other medical history included drug hypersensitivity. The patient was known allergies to Codeine, Erythromycin, Septra, Sulfa drugs, Vicodin, Medrol. The patient's concomitant medications were not reported.. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced inner ear disorder, very debilitating, extreme dizziness, nausea, vomiting on 27Jan2021 at 08:30 AM. The patient had inner ear problems before, 5 or 6 in my lifetime. She was still experiencing some stomach discomfort and a slight weakness. She had no idea if her inner ear problems this week are related to the vaccine or not. The outcome of events were recovering.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: inner ear disorder; debilitating; extreme dizziness; nausea; vomiting; stomach discomfort; slight weakness; This is a spontaneous report from a contactable consumer. A 69-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN5318), via an unspecified route of administration, administered in Arm Left on 25Jan2021 13:30 (at the age of 49-years-old) at a single dose for COVID-19 immunization. Medical history included blood pressure, cholesterol and seasonal allergies. Blood pressure and cholesterol controlled by meds. Other medical history included drug hypersensitivity. The patient was known allergies to Codeine, Erythromycin, Septra, Sulfa drugs, Vicodin, Medrol. The patient's concomitant medications were not reported.. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced inner ear disorder, very debilitating, extreme dizziness, nausea, vomiting on 27Jan2021 at 08:30 AM. The patient had inner ear problems before, 5 or 6 in my lifetime. She was still experiencing some stomach discomfort and a slight weakness. She had no idea if her inner ear problems this week are related to the vaccine or not. The outcome of events were recovering.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Muscle aches localized to right upper extremity, shoulder and neck muscles; Significant tenderness to right deltoid (injection site); This is a spontaneous report from a non-contactable health care professional (other HCP; patient herself). A 26-year-old female patient received the second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE solution for injection; Batch/Lot Number: EL3248; Expiration date: Unknown) via an unspecified route of administration in the right arm on 28Jan2021 14:15 (at the age of 26-years-old) at a single dose for covid-19 immunization in a hospital. The patient's medical history and concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (Batch/Lot Number: EL1284; Expiration date: Unknown) via an unspecified route of administration in the right arm on 08Jan2021 10:00 (at the age of 25-years-old) at a single dose for covid-19 immunization. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has not been tested for COVID-19. The patient has no allergies to medications, food, or other products. On 30Jan2021 09:00, the patient experienced muscle aches localized to right upper extremity, shoulder and neck muscles and significant tenderness to right deltoid (injection site). Injection site was also reported as right arm. The events were reported as non-serious. No treatment was given for the events. The outcome of these events was recovering.  No follow up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Fatigue, Headache
Clinical narrative: Canker Sores; Intermittent Headache; Intermittent fatigue; This is a spontaneous report from a contactable consumer (patient).  A 61-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number EL3248; expiration date not reported), via an unspecified route (administered on left arm) at the age of 61-years-old on 27Jan2021 02:00 PM as single dose for COVID-19 immunization. Medical history included hypertension and sulfonamide allergy (Allergies: Sulfur-based) both from an unknown date and unknown if ongoing. The patient reported unspecified concomitant medications. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. The patient is not pregnant at the time of vaccination. The patient experienced canker sores, intermittent headache and intermittent fatigue on 27Jan2021 16:00. The events were reported as non-serious. Since the vaccination the patient has not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovering/resolving.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Pruritus, Swollen tongue
Clinical narrative: allergic reaction; her face was itchy; swollen tongue; This is a spontaneous report from a contactable consumer (sister-in-law) via Medical Information Team. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 29Jan2021 as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Jan2021, the patient experienced allergic reaction and described it as "her face was itchy and has a swollen tongue." The reporter assessed the events as non-serious. Therapeutic measures were taken as a result of all events which includes Benadryl. The patient was recovering from all events.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face, Swollen tongue
Clinical narrative: allergic reaction; her face was itchy; swollen tongue; This is a spontaneous report from a contactable consumer (sister-in-law) via Medical Information Team. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 29Jan2021 as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Jan2021, the patient experienced allergic reaction and described it as "her face was itchy and has a swollen tongue." The reporter assessed the events as non-serious. Therapeutic measures were taken as a result of all events which includes Benadryl. The patient was recovering from all events.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Eye allergy, Eye pruritus, Eye swelling, Lacrimation increased, Ocular hyperaemia
Clinical narrative: rash, very mild just itching a little bit on right arm just inside the elbow/rash on both arms; took some Benadryl, it helped him sleep; Swelling in eyes; Eyes watering a lot; eyes red, itchy, and swollen/he deduced that he was having an allergic reaction; eyes red, itchy, and swollen/he deduced that he was having an allergic reaction; eyes red, itchy, and swollen/he deduced that he was having an allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 21Jan2021 (Batch/Lot Number: EL9262) as a single dose for COVID-19 immunization. Medical history included cannot see well out of right eye. There were no concomitant medications. Patient had a rash that appeared a couple days after, very mild just itching a little bit on his right arm just inside the elbow. Patient received the vaccine in the opposite arm in the left arm. Patient is going back on 11Feb2021 for the second dose. It was reported that it is better than being on a ventilator. Patient ruled out everything else the rash could have come from, he didn't change his laundry soap, or anything else. He haven't changed anything since he took the vaccine. He didn't speak to his MD about the rash, because he didn't think about it. He is going to be talking to his Doctor on Monday (unspecified date). He is going to get some calamine lotion but he took some Benadryl, it helped him sleep. It was also reported that the patient had a rash on both arms and swelling in his eyes and he went to the eye doctor who has prescribed him some medication and cream from family doctor. He noticed the rash a couple days after the vaccine and the issues with his eyes too, they were also watering a lot, can hardly see out of the right eye, he had this problem prior to vaccination. The cornea specialist prescribed him some drops, that his eyes were red, itchy, and swollen, he deduced that he was having an allergic reaction. Outcome of the event "took some Benadryl, it helped him sleep" was recovering and of the other events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic, Sleep disorder
Clinical narrative: rash, very mild just itching a little bit on right arm just inside the elbow/rash on both arms; took some Benadryl, it helped him sleep; Swelling in eyes; Eyes watering a lot; eyes red, itchy, and swollen/he deduced that he was having an allergic reaction; eyes red, itchy, and swollen/he deduced that he was having an allergic reaction; eyes red, itchy, and swollen/he deduced that he was having an allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 21Jan2021 (Batch/Lot Number: EL9262) as a single dose for COVID-19 immunization. Medical history included cannot see well out of right eye. There were no concomitant medications. Patient had a rash that appeared a couple days after, very mild just itching a little bit on his right arm just inside the elbow. Patient received the vaccine in the opposite arm in the left arm. Patient is going back on 11Feb2021 for the second dose. It was reported that it is better than being on a ventilator. Patient ruled out everything else the rash could have come from, he didn't change his laundry soap, or anything else. He haven't changed anything since he took the vaccine. He didn't speak to his MD about the rash, because he didn't think about it. He is going to be talking to his Doctor on Monday (unspecified date). He is going to get some calamine lotion but he took some Benadryl, it helped him sleep. It was also reported that the patient had a rash on both arms and swelling in his eyes and he went to the eye doctor who has prescribed him some medication and cream from family doctor. He noticed the rash a couple days after the vaccine and the issues with his eyes too, they were also watering a lot, can hardly see out of the right eye, he had this problem prior to vaccination. The cornea specialist prescribed him some drops, that his eyes were red, itchy, and swollen, he deduced that he was having an allergic reaction. Outcome of the event "took some Benadryl, it helped him sleep" was recovering and of the other events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Arm pain for 48 hours; Some tingling down to fingertips; This is a spontaneous report from a non-contactable consumer. A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number EL8982; expiration date not reported), via an unspecified route (administered on right arm) at the age of 46-years-old on 21Jan2021 01:45 PM as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included rosuvastatin calcium (CRESTOR) and levothyroxine sodium (SYNTHROID) both taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. The patient is not pregnant at the time of vaccination. The patient has no allergies to medications, food, or other products. The patient experienced arm pain for 48 hours and some tingling down to fingertips on 21Jan2021 05:00 PM. Therapeutic measures were taken as a result of the events included ibuprofen and Tylenol. The events were reported as non-serious. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovered/resolved.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Myoclonus
Clinical narrative: episodes of Myoclonus (jerking) that seem to have accelerated of late; episodes of Myoclonus (jerking) that seem to have accelerated of late; This is a spontaneous report from a contactable consumer or other non hcp (patient himself).   A 67-year-old male patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249, batch and expiration date not reported), via an unspecified route of administration, administered on the right arm on 19Jan2021 15:00 (at the age of 67-years-old) at a single dose for COVID-19 immunisation. Medical history included degenerative disc disease, allergies to penicillin, and ongoing myoclonus. Prior to vaccination, the patient was not diagnosed with COVID-19.The patient's concomitant medications were not reported. Since the vaccination, has not been tested for COVID-19. The patient experienced episodes of myoclonus that seem to have accelerated of late on an unspecified date. Events were assessed as non-serious. Treatment was not received for the events. The outcome of the events reported was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate irregular
Clinical narrative: Had heartbeat irregularity; This is a spontaneous report from a Pfizer-sponsored program . An unspecified age of female patient received first dose of bnt162b2 (BNT162B2; Solution for injection) via unspecified route of administration on 25Jan2021 at single dose for covid-19 immunization. Relevant medical history and concomitant medications were not provided. It was reported that on 25Jan had her first dose of the vaccine then had heartbeat irregularity yesterday and today, also taking amlodipine regularly. The outcome of the event was "Unknown".  Information on the lot/batch number has been requested.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Pain
Clinical narrative: Felt spaced out/feels spacy; Tired; Achy; This is a spontaneous report from a contactable consumer. An 86-year-old female patient received first dose of bnt162b2 (BNT162B2; Solution for injection) via unspecified route of administration on Left arm on 28Jan2021 13.00 at single dose for covid-19 immunization. Relevant medical history and concomitant medications were not provided. It was reported that caller received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 28Jan2021, this morning she felt spaced out, tired and achy. Caller would like to know if this normal 4 days after receiving the vaccine. From 01Feb2021 patient experienced Ongoing feeling spacy, tired and achy. Caller states she has a quick question, states she had second Pfizer vaccination last Thursday 28Jan2021, states she felt real well until today, states she feels spacy, tired, and achy. Wants to know if this is normal for four days later. States she got the vaccine in her left arm on 28Jan2021 at 1PM. Declined to provide HCP information. Does not have NDC, Lot, or Expiration Date to provide at this time. The caller was provided with a phone number of (phone ), option 3, and business hours prior to warm transfer to (name withheld), INT-#. The outcome of the event was "Not recovered".  Information on the Lot/batch number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Dizziness, Dysgeusia, Vaccination site hypoaesthesia, Vaccination site pruritus
Clinical narrative: numbness at the injection site and swelling; swelling reappeared, and this time it was itchy; numbness at the injection site and swelling; swelling reappeared, and this time it was itchy; Dizzy; little taste in mouth; numbness at the injection site and swelling; swelling reappeared, and this time it was itchy; This is a spontaneous report from a contactable consumer (patient).  A 77-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3246) via an unspecified route of administration on 21Jan2021 (at the age of 77-years-old) as single dose for protection. There were no medical history and concomitant medications reported. The patient experienced Dizzy, little taste in mouth, numbness at injection area, swelling came back 1 week later, 4 inches and round in shape on 21Jan2021 and itchy in Jan2021. It was reported that the patient got her vaccination on 21Jan2021. When she got it, she felt a little dizzy, and a little taste in her mouth that disappeared. She did experience numbness at the injection area and swelling that disappeared after two days. Then, after one week, the swelling came back. She still has it. It is 4 inches, and round in shape on 28Jan2021. She wants to know if this is life threatening. Her next vaccine is on 12Feb2021. Her height has went down. She got it at the Hospital. She doesn't have a prescribing doctor. She experienced the dizziness and taste in her mouth occurred while in the recovery room, it lasted a couple of hours. The arm numbness and swelling started a few hours later and lasted two days. Right now it is itchy, but she tries not to scratch her arm. The initial injection wasn't itchy when she had the numbness and swelling. It was just numb and swollen the first time. This time, it is itchy and swollen. She got the vaccine because she wants to be safe, for protection. The patient underwent lab tests and procedures which included body height: her height has went down in Jan2021. The outcome of events, dizzy, little taste in mouth on 21Jan2021 and numbness at injection area on 23Jan2021. The outcome of swelling came back 1 week later, 4 inches and round in shape was resolving and was not recovered for event itchy.   No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: numbness at the injection site and swelling; swelling reappeared, and this time it was itchy; numbness at the injection site and swelling; swelling reappeared, and this time it was itchy; Dizzy; little taste in mouth; numbness at the injection site and swelling; swelling reappeared, and this time it was itchy; This is a spontaneous report from a contactable consumer (patient).  A 77-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3246) via an unspecified route of administration on 21Jan2021 (at the age of 77-years-old) as single dose for protection. There were no medical history and concomitant medications reported. The patient experienced Dizzy, little taste in mouth, numbness at injection area, swelling came back 1 week later, 4 inches and round in shape on 21Jan2021 and itchy in Jan2021. It was reported that the patient got her vaccination on 21Jan2021. When she got it, she felt a little dizzy, and a little taste in her mouth that disappeared. She did experience numbness at the injection area and swelling that disappeared after two days. Then, after one week, the swelling came back. She still has it. It is 4 inches, and round in shape on 28Jan2021. She wants to know if this is life threatening. Her next vaccine is on 12Feb2021. Her height has went down. She got it at the Hospital. She doesn't have a prescribing doctor. She experienced the dizziness and taste in her mouth occurred while in the recovery room, it lasted a couple of hours. The arm numbness and swelling started a few hours later and lasted two days. Right now it is itchy, but she tries not to scratch her arm. The initial injection wasn't itchy when she had the numbness and swelling. It was just numb and swollen the first time. This time, it is itchy and swollen. She got the vaccine because she wants to be safe, for protection. The patient underwent lab tests and procedures which included body height: her height has went down in Jan2021. The outcome of events, dizzy, little taste in mouth on 21Jan2021 and numbness at injection area on 23Jan2021. The outcome of swelling came back 1 week later, 4 inches and round in shape was resolving and was not recovered for event itchy.   No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal
Clinical narrative: still felt bad along with shortness of breath; received his first vaccine dose yesterday and began feeling unwell; This is a spontaneous report from a contactable consumer. A 68-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration Date were not reported) via intramuscular route of administration as a single dose in Arm Right on 31Jan2021 13:00 for covid-19 immunization. Medical history included Allergies to medications: Ace inhibitors, HHT(Hereditary hemorrhagic telangiectasia )/High Blood Pressure, Eye conditions, Parkinson's Disease. No other vaccines received within 4 weeks prior to the COVID. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Other medications the patient received within 2 weeks of vaccination: Men's Multivitamins, Amlodipine, Tamsulosin, ferosul Iron, Ropinirole, Stool Softener. On 31-JAN-2021 21:00 the patient began feeling unwell. On 01-FEB-2021 08:00 still felt bad along with shortness of breath. No treatment received for the adverse event. Outcome of events at the time of last observation was not recovered/not resolved.  Information on the Lot/Batch number has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: severe rash and hives over entire body; severe rash and hives over entire body; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9262), via an unspecified route of administration in the left arm on 22Jan2021 at 09:30 AM as single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were reported as eliquis 5mg, venlafaxine 150mg, atorvastatin 10mg. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that on 22Jan2021 at 11:00 PM patient experienced severe rash and hives over entire body.Patient received the treatment with zyrtec, prednisone, benadryl, hydrocortisone. Outcome of all the events were recovering.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Pain
Clinical narrative: Headache; body and joint aches; body and joint aches; chills; extrem tiredness; This is a spontaneous report from a contactable consumer or other non hcp. A 71-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot #;FL9265), dose 1 via an unspecified route of administration, administered in Arm Left on 30Jan2021 10:00 as SINGLE DOSE for covid-19 immunisation. Medical history included cardiac disorder from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing, covid-19 from an unknown date and unknown if ongoing. Concomitant medication included pramipexole dihydrochloride (PRAMIPEXOLE DIHYDROCHLORIDE) taken for an unspecified indication, start and stop date were not reported; ezetimibe (EZETIBE) taken for an unspecified indication, start and stop date were not reported; clopidogrel (CLOPIDOGREL) taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient experienced headache, body and joint aches, chills, extrem tiredness. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was recovering.