chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle discomfort, Pain in extremity
Clinical narrative: Upper arm pain, mild; muscular discomfort, mild; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL3247) solution for injection intramuscular in the left arm on 20Jan2021 at 13:45 (at the age of 47-years-old) as a single dose for COVID-19 vaccination. There was no medical history. There were no concomitant medications. There were no allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 21Jan2021 at 13:45, the patient experienced upper arm pain, mild with associated muscular discomfort, mild. No treatment was provided for the events upper arm pain and muscular discomfort. The outcome of the events upper arm pain and muscular discomfort was recovering. Since the vaccination, the patient has not been tested for COVID-19.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Covid-19 (confirmed by positive COVID-19 test); Covid-19 (confirmed by positive COVID-19 test); This is a spontaneous report from a contactable consumer, the patient.  A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, on 22Dec2020 (at the age of 54-year-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that she received the first vaccine 22Dec2020. On 10Jan2021, she got COVID-19 and was due to get second shot 2 days later on 12Jan2021. The patient underwent lab tests which included sars-cov-2 test: positive on 10Jan2021. The patient inquired about how long to wait before the second dose after being diagnosed with COVID after receiving the first dose. The clinical outcome of the event COVID-19 was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive 6 days after receiving vaccine; tested positive 6 days after receiving vaccine; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program Pfizer First Connect. A patient of unspecified age and gender received 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 tested positive 6 days after receiving vaccine on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of the events was unknown.  Information about the batch/lot number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm
Clinical narrative: Eye twitching; This is a spontaneous report from a contactable Other HCP (patient). This 29-year-old female patient (no pregnant) received 1st dose of BNT162B2 Intramuscular on 07Jan2021 02:00 PM at single dose on Right arm for covid-19 immunization. Medical history was COVID prior vaccination. No other vaccine in four weeks. Concomitant drug was not reported. Patient experienced Eye twitching on 07Jan2021 04:00 PM. No treatment. Outcome of the event was Not Recovered. No COVID tested post vaccination.  No follow-up attempts are possible; information about batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: small red itchy bumpy rash on chest and arms; small red itchy bumpy rash on chest and arms; small red itchy bumpy rash on chest and arms; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL1284) via an unspecified route of administration in the right arm on 02Jan2021 at a single dose as Covid vaccine. Medical history included hypothyroid. The patient had no known allergies. Concomitant medication included thyroid (ARMOUR THYROID) (other medications in two weeks). The patient had no other vaccine in four weeks. It was reported that the next day after receiving the vaccine, the patient developed a small red itchy bumpy rash on chest and arms on 03Jan2021. Treatment was not received for the events. She had no Covid prior to vaccination. She did not have Covid tested post vaccination. The outcome of the events was recovered with sequelae (reported as recovered with lasting effects) on Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got ill for 2 days after the second  dose of the vaccine; This is a spontaneous report from a Pfizer Sponsored Program, received by a contactable consumer (patient's sister).  A 70-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunization. No relevant medical history and concomitant medications were provided. The patient was not sure if it was Pfizer or Moderna. The patient had received the 2 doses of the COVID-19 Vaccine 3 weeks apart. The patient was ill for 2 days after receiving the 2nd dose of the COVID-19 Vaccine, and then was fine. The patient had recovered from the  event on unknown date.  No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: fatigue; sore arm; This is a spontaneous report from a contactable nurse. A patient of unspecified age (reported as 59 unknown unit) and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration from an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fatigue and sore arm. Clinical outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Malaise, Nausea, Pain
Clinical narrative: Light headed; lack of appetite; achy; nauseous; sick feeling; This is a spontaneous report from a contactable consumer (Patient). A 73-Year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EH9899), via an unspecified route of administration at Arm Right on 07Jan2021 10:30 at the 73 years old at single dose for COVID-19 immunization.  The medical history was none. The concomitant medications were vitamin C (ascorbic acid), atorvastatin (strength 5 mg), valsartan (strength 80 mg). There was no other vaccine in four weeks. On15Jan2021 08:00 the patient experienced Light headed, lack of appetite, achy, nauseous, sick feeling. The events were continuing though lighter for at least another 3 days. There was no treatment received for all the adverse events.  The patient had no Covid prior vaccination. There was covid tested post vaccination. The patient underwent lab tests and procedures, which included Nasal Swab negative on 18Jan2021.  The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Light headed; lack of appetite; achy; nauseous; sick feeling; This is a spontaneous report from a contactable consumer (Patient). A 73-Year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EH9899), via an unspecified route of administration at Arm Right on 07Jan2021 10:30 at the 73 years old at single dose for COVID-19 immunization.  The medical history was none. The concomitant medications were vitamin C (ascorbic acid), atorvastatin (strength 5 mg), valsartan (strength 80 mg). There was no other vaccine in four weeks. On15Jan2021 08:00 the patient experienced Light headed, lack of appetite, achy, nauseous, sick feeling. The events were continuing though lighter for at least another 3 days. There was no treatment received for all the adverse events.  The patient had no Covid prior vaccination. There was covid tested post vaccination. The patient underwent lab tests and procedures, which included Nasal Swab negative on 18Jan2021.  The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Drug ineffective, Fatigue, Pyrexia, SARS-CoV-2 test
Clinical narrative: I tested positive for covid on 09Jan2021; I tested positive for covid on 09Jan2021; Fatigue, sore arm up to 48 hours post injection. Started feeling feverish with chills on 03Jan2021. I tested positive for covid on 09Jan2021; Fatigue, sore arm up to 48 hours post injection. Started feeling feverish with chills on 03Jan2021. I tested positive for covid on 09Jan2021; Fatigue, sore arm up to 48 hours post injection. Started feeling feverish with chills on 03Jan2021. I tested positive for covid on 09Jan2021; Fatigue, sore arm up to 48 hours post injection. Started feeling feverish with chills on 03Jan2021. I tested positive for covid on 09Jan2021; This is a spontaneous report from a contactable nurse.  A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EK5730), intramuscular in Left arm on 30Dec2020 17:00 at single dose for covid-19 immunisation.  Medical history included asthma (as a child).  Concomitant medication included loratadine (CLARITIN [LORATADINE]), cyanocobalamin (B12 [CYANOCOBALAMIN]), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]). The patient previously took morphine and experienced Known allergies. The patient experienced fatigue, sore arm up to 48 hours post injection. Started feeling feverish with chills on 03Jan2021. I tested positive for covid on 09Jan2021. The patient received just fluids, vit c,zinc, and vitd as treatment. No covid prior vaccination. Covid tested post vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 09Jan2021, sars-cov-2 test: positive on 07Jan2021. The outcome of the event Feverish and Chills was resolved on Jan2021, Vaccination site pain and Fatigue was resolved on an unspecified date, while the outcome of the other events was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Vaccination site pain
Clinical narrative: I tested positive for covid on 09Jan2021; I tested positive for covid on 09Jan2021; Fatigue, sore arm up to 48 hours post injection. Started feeling feverish with chills on 03Jan2021. I tested positive for covid on 09Jan2021; Fatigue, sore arm up to 48 hours post injection. Started feeling feverish with chills on 03Jan2021. I tested positive for covid on 09Jan2021; Fatigue, sore arm up to 48 hours post injection. Started feeling feverish with chills on 03Jan2021. I tested positive for covid on 09Jan2021; Fatigue, sore arm up to 48 hours post injection. Started feeling feverish with chills on 03Jan2021. I tested positive for covid on 09Jan2021; This is a spontaneous report from a contactable nurse.  A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EK5730), intramuscular in Left arm on 30Dec2020 17:00 at single dose for covid-19 immunisation.  Medical history included asthma (as a child).  Concomitant medication included loratadine (CLARITIN [LORATADINE]), cyanocobalamin (B12 [CYANOCOBALAMIN]), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]). The patient previously took morphine and experienced Known allergies. The patient experienced fatigue, sore arm up to 48 hours post injection. Started feeling feverish with chills on 03Jan2021. I tested positive for covid on 09Jan2021. The patient received just fluids, vit c,zinc, and vitd as treatment. No covid prior vaccination. Covid tested post vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 09Jan2021, sars-cov-2 test: positive on 07Jan2021. The outcome of the event Feverish and Chills was resolved on Jan2021, Vaccination site pain and Fatigue was resolved on an unspecified date, while the outcome of the other events was unknown.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Heart rate, Heart rate increased, Photopsia
Clinical narrative: About 5-7 minutes after vaccination I felt very weak and dizzy; About 5-7 minutes after vaccination I felt very weak and dizzy; Saw stars, and very high heart rate; Saw stars, and very high heart rate; This is a spontaneous report from a contactable other hcp (patient).  A 21-year-old male patient received first dose of bnt162b2 (BNT162B2) , via an unspecified route of administration on 15Jan2021 10:00 at single dose on left arm for covid-19 immunisation.  Medical history included ongoing penicillin allergy.  There were no concomitant medications.  The patient stated that, "About 5-7 minutes after vaccination I felt very weak and dizzy. Saw stars, and very high heart rate" on 15Jan2021 10:00. No other vaccine in four weeks, no other medications in two weeks. No COVID prior vaccination, no COVID tested post vaccination. No treatment was received for the events. The outcome of the events was resolved in Jan2021.  Information about batch/lot number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pain, Pyrexia
Clinical narrative: Fever; chills; body aches; muscle aches; headaches; This is a spontaneous report from a contactable Health Professional, the patient. A 34-year-old non-pregnant female received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via intramuscular route in the right arm on 09Jan2021 at 11:45 as a single dose for COVID-19 immunization. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not have any allergies to medications, food, or other products. Historical Vaccine data included the first dose of BNT162B2 on an unknown date for COVID-19 immunization. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 09Jan2021 at 20:00, the patient experienced fever, chills, body aches, muscle aches, and headaches. The patient did not receive treatment for the events. Since the vaccination, the patient had tested for COVID-19 via Nasal Swab on 11Jan2021 with a Negative result. The clinical outcome of the events, fever, chills, body aches, muscle aches, and headaches was recovered in Jan2021.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Fever; chills; body aches; muscle aches; headaches; This is a spontaneous report from a contactable Health Professional, the patient. A 34-year-old non-pregnant female received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via intramuscular route in the right arm on 09Jan2021 at 11:45 as a single dose for COVID-19 immunization. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not have any allergies to medications, food, or other products. Historical Vaccine data included the first dose of BNT162B2 on an unknown date for COVID-19 immunization. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 09Jan2021 at 20:00, the patient experienced fever, chills, body aches, muscle aches, and headaches. The patient did not receive treatment for the events. Since the vaccination, the patient had tested for COVID-19 via Nasal Swab on 11Jan2021 with a Negative result. The clinical outcome of the events, fever, chills, body aches, muscle aches, and headaches was recovered in Jan2021.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Tunnel vision, Visual impairment
Clinical narrative: lost partial vision in my left eye for 10 minutes; tunnel vision; This is a spontaneous report from a contactable consumer reported for himself. A 65-year-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration on 14Jan2021 16:00 at single dose, left arm for covid-19 immunization. Medical history reported as none. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Allergies to medications, food, or other products reported as No. The patient experienced "lost partial vision in my left eye for 10 minutes" and tunnel vision on 19Jan2021 18:00 with outcome of recovered. On January 19th at 6 pm, the patient had lost partial vision in his left eye for 10 minutes. He had tunnel vision. The patient went to his eye doctor yesterday and his vision was fine with not noticeable issues. No treatment received for the adverse event. Events reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Nausea, Pyrexia
Clinical narrative: fever (high 100.9 fahrenheit); chills; nausea; This is a spontaneous report from a non-contactable consumer via a sales representative. A 51-year-old male patient 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 18Jan2021 at single dose for Covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications was none. The patient's historical vaccine included first dose of BNT162B2 on 28Dec2020 for Covid-19 immunization. The patient experienced fever (high 100.9 fahrenheit), chills, and nausea following second dose approximately 12 hours after dose (Jan2021) and falling to normal at approximately 36 hours (Jan2021). The patient received Tylenol 500 mg twice taken for fever every eight hours. The outcome of the event fever (high 100.9 fahrenheit), chills, and nausea was recovered on Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: extreme fatigue; chills; This is a spontaneous report from a non-contactable other HCP communicated to a Pfizer colleague.   A patient (demographics unknown), received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on an unspecified date at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On an unspecified date after the 1st dose of vaccine, patient experienced extreme fatigue and chills. She was knocked out for like 4 hours (as reported). At the time of the reporting event outcome was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe headache; This is a spontaneous report from a non-contactable consumer. A 47-year-old female patient (pregnant no) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 for second dose at single dose at right arm for COVID-19 immunization. The first dose was on 30Dec2020 on left arm for COVID-19 immunization, at age of 47-year-old.  Medical history included cancer (former cancer patient). Allergies to medications, food, or other products was unknown. The patient was not pregnant at the time of vaccination. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included levothyroxine sodium (SYNTHROID), estradiol (ESTROGEN). The patient experienced severe headache lasting all day and currently since this morning when she woke up on 21Jan2021 06:00.  Seriousness criteria was not results in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating, congenital anomaly/birth defect. Prior to vaccination and since the vaccination, the patient was not diagnosed with COVID-19. There was no treatment received for the adverse event. The outcome of the event was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Pain
Clinical narrative: Body ache; Coughing; This is a spontaneous report from a Pfizer-sponsored Program. A contactable other healthcare professional reported that a male patient (reporter's husband) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown), via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunization. The patient's medical history included diabetes mellitus from an unknown date and unknown if ongoing. The patient tested positive in COVID-19 prior to getting the first dose. Concomitant medications were not reported. After taking the vaccine, the patient was having side effects like body ache and coughing on Jan2021. The outcome of the events was unknown.    Information on the lot/batch number has been requested.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain
Clinical narrative: chills, muscle pain at site of injection and generally, fatigue, headache, woke from sleep at 2 AM, continued through that day
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer reported for himself. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration on unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache on unspecified date. The patient took a Tylenol for his headache a few hours before the shot. The outcome of the event was unknown.  Follow-up activities are possible, information on the batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: My nose started bleeding this afternoon about an hour ago/start walking it starts bleeding again; This is a spontaneous report from a contactable consumer reported for himself. This male consumer of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 14:00 at single dose for COVID-19 immunisation. The medical history and concomitant medications were not reported. The consumer reported nose started bleeding in the afternoon about an hour before on 21Jan2021. When the consumer start walking it started bleeding again. The consumer was on clopidogrel bisulfate (PLAVIX). The outcome of the event was unknown. The event was non-serious.  Information on the Lot/Batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Orthostatic heart rate response increased, Palpitations, Postural orthostatic tachycardia syndrome, SARS-CoV-2 test
Clinical narrative: Developed palpitations with orthostatic Increase in heart rate upon standing; Developed palpitations with orthostatic Increase in heart rate upon standing; Concern for postural orthostatic tachycardia/POTs; This is a spontaneous report from a contactable Physician (patient). A 53-year-old female patient (not pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EL0140, intramuscularly on 21Dec2020 07:30 at single dose in Left arm for COVID-19 immunization in hospital. Medical history was none, no known allergies. Patient didn't have covid prior vaccination. There were no concomitant medications. There were no other vaccines in four weeks and no other medications in two weeks. The patient developed palpitations with orthostatic increase in heart rate upon standing. Concern for postural orthostatic tachycardia/POTs. Adverse events started from 23Dec2020, 07:00 AM and resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The patient had not recovered from the events. Covid test with nasal swab type post vaccination was performed on 01Jan2021 with negative result.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Neck pain, Pain, Pain in extremity, Restlessness
Clinical narrative: Pain at the injection site that radiated down the arm and up the neck. Body aches inside and out. Restlessness. All for about 24 hours
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: diagnosed with pneumonia; This is a spontaneous report from a contactable consumer via Pfizer Sponsored Program.  A 73-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Jan2021 at single dose for COVID-19 immunisation at the age of 73-year-old. Lot number was EL1284. There was no medical history nor concomitant medications. The patient experienced pneumonia on 18Jan2021. Pneumonia was diagnosed at check up on 25Jan2021. They were not thinking patient got the pneumonia after the vaccine, they did not know if he had the pneumonia already or not at the time of vaccination. The outcome of the event was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Rash was reported as worsened.; she has developed a rash all over her face, arm, chest, and belly; The rash is just red, raised, and itchy; The rash is just red, raised, and itchy; This is a spontaneous report from a contactable Nurse (patient). The 61-years-old female patient received first dose of bnt162b2 (BNT162B2, lot number: EL3248, Expiry Date: 01Apr2021), unknown in right deltoid on 13Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included Patient History: No. No allergies. There were no concomitant medications. The Caller, an LPN, reporting on the COVID 19 Vaccine and who explains she had it on 13Jan2021. Starting Friday into the weekend and through today she has developed a rash all over her face, arm, chest, and belly on 18Jan2021. The only thing that she can figure is the injection. She was told to call and report this.  There has been no treatment, due to the holiday everything is closed. The rash is just red, raised, and itchy and driving her crazy. It is not anything too terrible, just uncomfortable. Rash was reported as worsened. No visit to emergency room or physician office. The outcome of the event condition aggravated was unknown and was not recovered or the rest events.  No follow-up attempts possible. No further information expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Immediate rapid swelling at injection site (golfball-sized within a minute), fever 101, headache, injection site pain, myalgias
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable Health Professional, the patient. A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache. The clinical outcome of the event headache was not recovered.   No follow-up attempts are possible; information about lot number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dementia, Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: dementia; contracted the covid virus; contracted the covid virus; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's wife) reported that a male patient of an unspecified age received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), with first dose in Dec2020 and with second dose on 19Jan2021, both via an unspecified route of administration at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received BNT162B2 3 weeks ago and got second dose on 19Jan2021, patient had dementia and contracted the COVID virus on 20Jan2021, patient had exposed to COVID 24-48 hours by a healthcare professional in the facility. The outcome of events was unknown.  Information on the Lot/Batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Eight days after injection, I got a hard, red, swollen, itchy bump at injection site. It was a 4 inch square that was warm to the touch.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Hyperhidrosis, Insomnia, Pyrexia, Vision blurred
Clinical narrative: Starred to get blurred vision like a migraine; Fever/temperature was 99.8 then later that day it was 103; Sweat some during sleep, which was pretty normal; No sleep; This is a spontaneous report from a contactable Consumer (patient). An 81-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1284; Expiry Date: 30Apr2021) on 14Jan2021 at SINGLE DOSE in the right arm for covid-19 immunisation, so she did not get the virus.  Medical history included Inflammatory bowel disease. There were no concomitant medications. she was allergic to Sulfa. She had no sleep the first night on 14Jan2021. The next day on 15Jan2021 she had a fever. Her temperature was 99.8 then later that day it was 103. She took an Aspirin. Friday night on 15Jan2021, she slept alright but sweat some, which was pretty normal. Saturday morning on 16Jan2021, her temperature was fine but she starred to get blurred vision like a migraine. She took another Aspirin and it went away. Later that day her temperature was normal at 97.2. She was a pretty active person. After she had the shot around 8 AM-10 AM in the morning, at 12 or 1230 she went out and took down her Christmas lights and she thought she felt good so she was going to trim her plants and she wondered if that had anything to do with her adverse events. Her arm did not hurt or anything. She is wondering if her activity had anything to do with disrupting the medicine? She was using that arm a lot, she probably should not have done it. She will not do it again. The outcome of Starred to get blurred vision like a migraine was recovered on 16Jan2021, of other events were recovered on 15Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore on in the injection site; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient).  A 49-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the right arm on 26Dec2020 08:30 AM at a single dose as COVID vaccine. Medical history included seasonal allergy and high blood pressure. Concomitant medications were not reported. The patient had no other vaccine in four weeks. The patient previously had known allergies to amlodipine. The patient experienced sore on in the injection site on an unspecified date. Treatment was not received for the event. She has no COVID prior to vaccination. She did not have COVID tested post vaccination. The outcome of the event was recovering.   Information about lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Immediate post-injection reaction, Injection site erythema, Injection site pain, Lymph node pain
Clinical narrative: Sore arm 2 days immediately following the shot.  New onset erythema Lupper arm at 8days post vaccine.  Redness has spread down over 1/3 of lateral portion of L upper arm, with slight tenderness, tender lymph node behind L ear.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: fever; body aches; This is a spontaneous report from a non-contactable consumer (patient). A female patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 19:00 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 on 23Dec2020 and experienced arm sore. After the second dose, patient experienced fever and body aches. Outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Bad headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 first dose on 18Jan2021 15:30 on left arm at single dose for COVID-19 immunization at Parking lot of a big stadium. Medical history included stressed and headache, both from 18Jan2021 before vaccine and medication to help sleep. Concomitant medication included ongoing clonazepam (KLONOPIN) tablet at 2mg pill at night to help sleep. Vaccine not Administered at Military Facility. No History of all previous immunizations with the Pfizer Vaccine considered as suspect. No Additional Vaccines Administered on Same Date. No Prior Vaccinations within 4 weeks. She is calling because she got the vaccine today and she has a bad headache. She mentioned she knows headache is a possible side effect. However, she is calling to see what she can take or what she cannot take for the headache. She stated before getting the vaccine she was stressed and had a headache that had started today, 18Jan2021, before she got the vaccine. She mentioned she was waiting 3.5 to 4 hours before getting the shot and that is when the headache started. However, after getting the vaccine it has gotten worse and it is to the point where she wants to place an icepack on her face. Stated it could be situational. She knows she was in the car for at least 5 hours. She also mentioned the paperwork we provide with a list of symptoms should also have listed what medications she can or cannot take. She finds it troubling that we do not have the listed on the paperwork. We have headache could be a possible symptom, but no information on what can be taken for symptoms. She also mentioned she needed her reading glasses to attempt to read the patient card provided that list the lot number and details regarding date for next dose. She then stated after looking at the card it is impossible to read. She cannot read the person's handwriting. The lot number is so messy. She believes it is: L2 7 or 8, 922 or 422, something like that, she cannot really tell the handwriting is so messy. The event not require a visit to Emergency Room or Physician's Office. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever that lasted for a day then it resolved; This is a spontaneous report from a Pfizer sponsored program IBCC (Inbound Call Center for HCPs). A non-contactable consumer reported for a male patient (her husband). A male 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 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fever that lasted for a day then it resolved on an unspecified date with outcome of recovered on an unspecified date. Caller wanted to know any data available for covid vaccine use in GBS (Guillain-Barre syndrome) and autoimmune disorder. caller sated her husband had reaction to the vaccine, fever that lasted for a day then it resolved. caller stated she has autoimmune disease also so wanted to know does the vaccine worsen the symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: dull headache; body aches; This is a spontaneous report from a contactable consumer, the patient received from Pfizer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 vaccination.  Medical history and concomitant medication were not reported. On an unspecified date, the patient experienced dull headache and body aches. The clinical outcome of dull headache and body aches was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported same events for two patients. This is the second of two reports.   A male patient (husband) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284 and expiry date unknown) via unspecified route of administration on 17Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's wife reported that she got the shot on Sunday (17Jan2021) along with her husband (patient). The patient's wife informed that all of the sudden she was getting dizzy, otherwise they had no problem. She even made a second appointment. The reporter informed that her husband (patient) was getting it also. The reporter informed that the dizziness for both of them started today on 19Jan2021. The outcome of the event dizziness was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021061733 same reporter/drug/event and different patients
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Had a stroke; This is a spontaneous report from a contactable consumer via Pfizer-sponsored programs. A male patient (reporter's husband) of an unspecified age received first single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first dose of Covid vaccine on an unspecified date (Friday) at 12:35 PM, and had a stroke on Saturday morning at 10:30AM and was confined at the hospital (date/s unspecified) at the time of reporting. Reporter asked if there was any correlation or any fact sheets available with the vaccine and the stroke that happened to the patient. The outcome of the event was unknown.   Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Underdose, Vaccination site haemorrhage
Clinical narrative: patient bled, and a proportion of vaccine in the syringe was not administered; patient bled, and a proportion of vaccine in the syringe was not administered; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunization. The pharmacist had a question regarding incomplete administration of 2nd dose of bnt162b2. While one patient was given a vaccine, patient bled, and a proportion of vaccine in the syringe was not administered on an unspecified date. The pharmacist asking was there any information about giving a third dose to those who received invalid second dose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event haemorrhage cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: Body aches; Chills; Headache; Arm was really, really sore - the whole arm; This is a spontaneous report from a contactable consumer (patient who is a mental health therapist). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 15Jan2021 at 16:00 (4 PM), at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. No other vaccines were given the same day or 4 weeks prior. No problem with vaccines in past that she can recall from childhood. The patient received the vaccine last Friday (15Jan2021) and side effects started early evening Saturday (16Jan2021) or late afternoon. The patient had body aches, a few chills, headache, and her arm was really, really sore - the whole arm. At the time of reporting, all are way better. The patient was recovering from the events.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Throat irritation
Clinical narrative: very itchy throat; can't sleep; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 15Jan2021 as a single dose for COVID-19 immunization. Medical history included "underlying conditions." Concomitant medications were not reported. The patient reported after she received the vaccine her throat was very itchy and no pain on an unspecified date. It bothered her so much that she couldn't even sleep. She wanted to know if this was a normal side effect to be very itchy in the throat. She had called out of work since Monday (18Jan2021) and did not want to go to the emergency room where people had COVID. She did not want to be around people. The outcomes of the events were unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: anxious; This is spontaneous report from a contactable consumer (patient's niece). A 92-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via an unspecified route of administration, on 18Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient's niece reported that her uncle had the Pfizer vaccine yesterday and now was acting really anxious. She was wondering if this is normal. Outcome of the event was unknown.  Information on lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: left paraclavicular lymphadenopathy; This is a spontaneous report from a contactable nurse (patient) reported that a 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscular on the left arm on 14Jan2021 14:30 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was not pregnant. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscularly on the left arm on 23Dec2020 10:45 for Covid-19 immunization. It was reported that approximately 72 hours (17Jan2021) after second dose, the patient developed left paraclavicular lymphadenopathy. No treatment received was reported for the reported event. The outcome of the event was not recovered.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test negative, SARS-CoV-2 antibody test negative
Clinical narrative: tested for antibodies, and does not have any; States her second dose was on 05Jan2021, that was day number 18 after the first one.; States her second dose was on 05Jan2021, that was day number 18 after the first one.; This is a spontaneous report from a Pfizer-sponsored program from a contactable pharmacist (patient).  A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 05Jan2021 at single dose (reported as 0.3, unit not provided) for COVID-19 immunisation, by injection to left arm.  Medical history was none. Concomitant medications included levothyroxine sodium (SYNTHROID). Historical vaccine included first dose of BNT162B2 on an unknown date for COVID-19 immunisation. The patient states her second dose was on 05Jan2021, that was day number 18 after the first one.  On 18Jan2021 the patient was tested for antibodies, and does not have any. She was expecting to have antibodies. She is not sick, she did not get sick, but because she didn't have antibodies it is upsetting, but there is nothing going on with body because she doesn't have the antibodies. Calling to find out what she should do now, if she needs to be revaccinated. The event was reported serous as medically significant. Outcome was not recovered. Method of assessment: Global Introspection was related, there is no reason why she wouldn't develop antibodies normally.; Sender's Comments: The 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unknown date, and then received second dose on 05Jan2021, that was day number 18 after the first one.  On 18Jan2021 the patient was tested for antibodies, and does not have any.  There is possibility of false negative COVID-19 antibody test. The exact reason was unknown.  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.