chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache; Chest pains; high fever; body aches; chills; first dose 16Dec2020/ second dose 04Jan2021; This is a spontaneous report from a contactable pharmacist (the patient). A 21-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL1284), intramuscularly in the right arm on 04Jan2021 at 12:30 PM (at the age of 21-years-old) as a single dose for COVID-19 immunization. The patient's medical history included COVID-19. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EK5730), intramuscularly in the right arm on 16Dec2020 at 11:30 AM (at the age of 21-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 05Jan2021 at 12 AM, the patient experienced chest pains, high fever, chills, body aches, and headache. No treatment was given for chest pains, high fever, chills, body aches, and headache. The clinical outcome of chest pains, high fever, chills, body aches, and headache, was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This is a spontaneous report from a contactable physician. A 49-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number EK9231), via an unspecified route of administration on 19Dec2020 08:00 at single dose at right arm for COVID-19 immunization. Medical history included asthma. Concomitant medications included budesonide (PULMICORT), mometasone furoate (NASONEX), ibuprofen, and paracetamol (TYLENOL). On 20Dec2020, the patient experienced arm soreness. The patient did not receive treatment for the event. The outcome of the event was recovered.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced itching without the presence of rash for 13 to 14 days on an unspecified date. The patient was asking if she should get the second dose of the vaccine if she had itching without the presence of rash for 13 to 14 days after receiving the vaccine. Clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: took first dose of BNT162B2 on 15Dec2020/second dose of BNT162B2 on 04Jan2021; Headache; Fever; Sweats; This is a spontaneous report from a contactable healthcare professional.  A 51-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 04Jan2021 07:45 at single dose for COVID-19 immunisation.  The patient had no medical history.  Concomitant medication was not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 15Dec2020.   The patient experienced fever, sweats, headache on 05Jan2021. The patient received no treatment. The outcome of the events was recovering.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Eye swelling, Musculoskeletal chest pain
Clinical narrative: Sharp stabbing pains in right rib then left.; Shortness of breathe; cough; eyes swelled shut; This is a spontaneous report from a contactable nurse. This 55-year-old female nurse reported for herself and received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL 3246; Expiration date was not reported) on 30Dec2020 08:45 (at the age of 55-years) as single dose, Intramuscular in left arm for COVID-19 immunisation. Medical history included allergy to hydroxychloroquine sulfate (PLAQUENIL), patient experienced sleep disorder, migraine, and lupus. The patient was not pregnant at the time of the vaccination. Prior to vaccination, the patient was diagnosed with COVID-19.  Concomitant medications include pregabalin (PREGABALIN), amitriptyline (AMITRIPTYLINE) for sleep, solifenacin succinate (SOLIFENACIN SUCCINATE), leflunomide (LEFLUNOMIDE), omeprazole (PROTONIX), ondansetron (ZOFRAN), mirabegron (MYRBETRIQ), azathioprine (AZATHIOPRINE), and sumatriptan succinate (SUMATRIPTAN SUCCINATE) for migraine. Since the vaccination, the patient has not tested for COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 31Dec2020 at 17:15, the patient experienced sharp stabbing pains in right rib then left. Shortness of breathe, cough, and eyes swelled shut.  The patient did received treatment as a result of the event with benadryl, aderol inhaler.  The outcome of event eyes swelled shut was recovering, Shortness of breathe was recovering, cough was recovering, and sharp stabbing pains in right rib then left was recovering.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on stomach and chest 48 hours after; This is a spontaneous report from a contactable other healthcare professional. A 55-year-old female patient received the first dose of bnt162b2 (lot no. and expiry date unknown), intramuscular in left arm on 02Jan2021 16:15 at single dose for Covid-19 immunization. Medical history included mastocytosis. The patient is not pregnant. The patient's concomitant medications were not reported. The most recent COVID-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 04Jan2021 at 16:00, the patient experienced hives on stomach and chest 48 hours after. No treatment was received for the event. The outcome of the event was recovering. The event was assessed as non-serious.  Information on the lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Rash papular, Vaccination site rash, Vaccination site warmth
Clinical narrative: small bulging rash on injection site that feels warm and is growing larger; small bulging rash on injection site that feels warm and is growing larger; small bulging rash on injection site that feels warm and is growing larger; BNT162B2 first dose was administered on 23Dec2020, second dose was administered on 04Jan2021; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 04Jan2021 09:00 at single dose for Covid-19 immunization. The first dose was administered on 23Dec2020 15:00 via an unspecified route of administration at single dose. The patient's medical history was not reported. No known allergies. Concomitant medication included fluoxetine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced a small bulging rash on injection site that feels warm and is growing larger on 04Jan2021 at 11:45 PM. It was unknown if a treatment has been received for the event. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.  Information about batch/lot number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Headache, Myalgia
Clinical narrative: chills; fever, up to 100.9; muscle aches; headache; nausea; diarrhea; This is a spontaneous report from a contactable other HCP (patient).  This 54-year-old female reported for herself and received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and Expiration date were not reported) on 03Jan2021 11:00 (at the age of 54-years) as single dose, Intramuscular left arm  for COVID-19 immunisation. Medical history included no allergies to medications, food, or other products and asthma. The patient was not pregnant at the time of the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications include DOXYCYCLINE (DOXYCYCLINE), METRONIDAZOLE (METRONIDAZOLE), minerals nos, vitamins nos  (ONE A DAY) and CALCIUM CARBONATE (CALTRATE).  Since the vaccination, the patient has not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 03Jan2021 at 03:30 AM the patient experienced fever, up to 100.9, muscle aches, headache, nausea, diarrhea, chills. Events lasted about 24 hours.  The patient did not received treatment as a result of the events.  Lab data included body temperature up to 100.9 on 03Jan2021. The outcome of event chills was recovered, fever, up to 100.9 was recovered, muscle aches was recovered, headache was recovered, nausea was recovered and diarrhea was recovered all on Jan2021.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: chills; fever, up to 100.9; muscle aches; headache; nausea; diarrhea; This is a spontaneous report from a contactable other HCP (patient).  This 54-year-old female reported for herself and received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and Expiration date were not reported) on 03Jan2021 11:00 (at the age of 54-years) as single dose, Intramuscular left arm  for COVID-19 immunisation. Medical history included no allergies to medications, food, or other products and asthma. The patient was not pregnant at the time of the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications include DOXYCYCLINE (DOXYCYCLINE), METRONIDAZOLE (METRONIDAZOLE), minerals nos, vitamins nos  (ONE A DAY) and CALCIUM CARBONATE (CALTRATE).  Since the vaccination, the patient has not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 03Jan2021 at 03:30 AM the patient experienced fever, up to 100.9, muscle aches, headache, nausea, diarrhea, chills. Events lasted about 24 hours.  The patient did not received treatment as a result of the events.  Lab data included body temperature up to 100.9 on 03Jan2021. The outcome of event chills was recovered, fever, up to 100.9 was recovered, muscle aches was recovered, headache was recovered, nausea was recovered and diarrhea was recovered all on Jan2021.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: He had very sore muscle aches the next morning; This is a spontaneous report from a contactable consumer. An adult male patient started to received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 2020 at a single dose, for covid-19 immunization. Medical history included covid-19.  The patient's concomitant medications were not reported.  The patient stated that he had very sore muscle aches the next morning (2020). The outcome of event was recovered.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chalazion, Swelling face, Vaccination site pruritus
Clinical narrative: itching at injection site; half of my face was swollen (right side); Chalazion on my right eye; This is a spontaneous report from a non-contactable consumer. A 71-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose at 10am: she felt okay, no issue. The next day, she had itching at injection site that was on and off not continuous, and that evening after dinner she walked past a mirror and noticed that half of her face was swollen (right side), not a lot swollen, but enough where she could tell it was swollen. The swelling was not going away and she called my internist, and the internist wanted the patient to see someone. The patient went down to the street to a neighbor who was a dermatologist and she looked at the patient and saw that the patient had a Chalazion on right eye and thought the swelling could be from applying heat to the chalazion. The patient called her Internist and told her to take Benadryl and put her on antibiotic; The dermatologist didn't know if it was from the chalazion or a reaction to the vaccine. The patient's lymph nodes were fine and glands were fine. No mass found by the dermatologist yesterday. The dermatologist recommended the patient to see another doctor, if it doesn't go away and to get  imaged. The outcome of the event itching was unknown while the outcome of the remaining events was not recovered.  No follow-up attempts are possible. Information on Lot/Batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: tingling and numbness to left arm/leg; tingling and numbness to left arm/leg; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), 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. On an unspecified date, the patient was still having tingling and numbness to left arm/leg. The outcome of the events was not recovered.   Information about lot/batch number requested
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Feeling cold, Headache
Clinical narrative: Began to feel really cold; Muscle pains; Joint pains; Throbbing headache; Fever of 101.7F; Shivering chills; Second dose of BNT162b2 was given 17 days after 1st dose; This is a spontaneous report from a contactable physician, the patient. A 27-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 04Jan2021 11:15 AM (at the age of 27-years) as a single dose (Lot Number EK9231) for COVID-19 immunization. Medical history included asthma and no allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 via an unspecified route of administration in the left arm on 18Dec2020 12:00 PM (at the age of 27-years) as a single dose (Lot Number EH9899) for COVID-19 immunization. The patient had not received any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 04Jan2021, approximately 10-12 hours after 2nd dose of vaccine the patient began to feel really cold, had some mild muscle pains, joint pains, and a headache. Overnight these symptoms worsened to severe muscle pains, joint pains, and a throbbing headache, shivering chills, took a temperature and had a fever of 101.7F. These symptoms did not subside until late the next morning. The headache had persisted. The patient reported taking paracetamol (TYLENOL) 1000 mg, which helped. The outcome of the events feels really cold, muscle pains, joint pains, throbbing headache, shivering chills, fever of 101.7F, were reported as recovering.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Myalgia, Pyrexia
Clinical narrative: Began to feel really cold; Muscle pains; Joint pains; Throbbing headache; Fever of 101.7F; Shivering chills; Second dose of BNT162b2 was given 17 days after 1st dose; This is a spontaneous report from a contactable physician, the patient. A 27-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 04Jan2021 11:15 AM (at the age of 27-years) as a single dose (Lot Number EK9231) for COVID-19 immunization. Medical history included asthma and no allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 via an unspecified route of administration in the left arm on 18Dec2020 12:00 PM (at the age of 27-years) as a single dose (Lot Number EH9899) for COVID-19 immunization. The patient had not received any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 04Jan2021, approximately 10-12 hours after 2nd dose of vaccine the patient began to feel really cold, had some mild muscle pains, joint pains, and a headache. Overnight these symptoms worsened to severe muscle pains, joint pains, and a throbbing headache, shivering chills, took a temperature and had a fever of 101.7F. These symptoms did not subside until late the next morning. The headache had persisted. The patient reported taking paracetamol (TYLENOL) 1000 mg, which helped. The outcome of the events feels really cold, muscle pains, joint pains, throbbing headache, shivering chills, fever of 101.7F, were reported as recovering.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Nausea
Clinical narrative: nausea; Headache; insomnia; This is a spontaneous report from a contactable healthcare professional. A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on the left arm on 30Dec2020 14:00 at a single dose for COVID-19 immunisation. Medical history was none. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. There were no allergies to medications, food, or other products. Concomitant medications included vitamin b complex (VITAMIN B), colecalciferol (VITAMIN D [COLECALCIFEROL]), and zinc. On 31Dec2020, the patient experienced nausea, headache and insomnia. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovering  Information about batch/lot number has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased, Nausea, SARS-CoV-2 antibody test
Clinical narrative: dizziness; Nausea; fast heart rate; This is a spontaneous report from a contactable other healthcare professional. A 20-year-old female patient received the first dose of bnt162b2 (lot number: EK9251), intramuscular in left arm on 04Jan2021 13:00 at single dose for covid-19 immunization.  Medical history included COVID-19. Concomitant medication included ethinylestradiol, norgestimate (MONO LINYAH). The patient previously took ciprofloxacin (CIPRO) and experienced drug allergy. The patient is not pregnant at the time of vaccination. The most recent COVID-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. The patient experienced dizziness, nausea, and fast heart rate on 05Jan2021. Since the vaccination, the patient has been tested for COVID-19 which included nasal swab test on 05Jan2021: negative. The outcome of the events was unknown. The events were reported as non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea
Clinical narrative: headache; chills; nausea; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 21Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache, chills, and nausea on an unspecified date. The patient asked if she is going to get the same reaction on the second dose. The outcome of events was unknown.  Information on the Lot/Batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin irritation, Urticaria
Clinical narrative: itching; irritation; hives/they are welty feeling and looking; This is a spontaneous report from a contactable nurse. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, from 02Jan2021 16:45 to 02Jan2021 16:45 at 0.3 mL, single for covid-19 immunization. Medical history reported as "none". There were no concomitant medications. The patient noticed hives on the back of her legs this morning 05Jan2021. She has taken oral Benadryl which took all the itching and irritation away but the hives are still there. Further described as "they are welty feeling and looking". She added that she was not scheduled for the second injection yet, they told her to wait for an email to arrive for her to set it up. She has informed her primary HCP of her hives. Outcome of events itching and irritation was recovered whereas the patient had not recovered from hives at the time of this report.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Feeling cold, Feeling hot, Hyperhidrosis
Clinical narrative: tested positive for COVID virus; tested positive for COVID virus; cold all day; tiny cough; chills; sweating/ woke up sweating wet; arm pain/Very sore arms; body aches; fever; some muscle aches; This is a spontaneous report from a contactable consumer(Patient's Wife).  A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 02Jan2021 13:30 at single dose for COVID-19 vaccination. There were no concomitant medications nor medical history. He did not receive any other vaccines that day or 4 weeks prior. No history of any other vaccines or events. He got his vaccine on Saturday(02Jan2021) at 1:30pm(13:30) and by 5:30pm(17:30) had very sore arms/arm pain, at 7:30pm(19:30) he had chills off and on and was sweating. He woke up soaking wet and did that on Sunday, but was feeling a little better today. He also experienced body aches and fever in Jan2021. Today is testing day at his work and he tested positive for COVID virus on 05Jan2021. Not sure if it's a coincidence. Again, he got the shot and then started having all these symptoms at 5:30 and 7:30. Now they are both on quarantine for the 10-14 days. He wanted to see if it's possible to test positive for the virus after getting the shot or is it just a coincidence. He also had some muscle aches in Jan2021. Last night (04Jan2021), he woke up again sweating, but not like on Saturday, but he got really warm and started to sweat a little, and on Sunday(03Jan2021) he was cold all day and had a tiny cough, but it wasn't significant. Ever so often she would hear him cough. All of a sudden patient would wake up sweating. Again, Saturday he soaked everything. There was no Emergency Room nor Physician Office. Outcome of Very sore arms, sweating was recovering, of pain and fever was unknown, of other events was not recovered.    Information on Lot/Batch has been requested.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Night sweats, Pain, Pain in extremity, Pyrexia
Clinical narrative: tested positive for COVID virus; tested positive for COVID virus; cold all day; tiny cough; chills; sweating/ woke up sweating wet; arm pain/Very sore arms; body aches; fever; some muscle aches; This is a spontaneous report from a contactable consumer(Patient's Wife).  A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 02Jan2021 13:30 at single dose for COVID-19 vaccination. There were no concomitant medications nor medical history. He did not receive any other vaccines that day or 4 weeks prior. No history of any other vaccines or events. He got his vaccine on Saturday(02Jan2021) at 1:30pm(13:30) and by 5:30pm(17:30) had very sore arms/arm pain, at 7:30pm(19:30) he had chills off and on and was sweating. He woke up soaking wet and did that on Sunday, but was feeling a little better today. He also experienced body aches and fever in Jan2021. Today is testing day at his work and he tested positive for COVID virus on 05Jan2021. Not sure if it's a coincidence. Again, he got the shot and then started having all these symptoms at 5:30 and 7:30. Now they are both on quarantine for the 10-14 days. He wanted to see if it's possible to test positive for the virus after getting the shot or is it just a coincidence. He also had some muscle aches in Jan2021. Last night (04Jan2021), he woke up again sweating, but not like on Saturday, but he got really warm and started to sweat a little, and on Sunday(03Jan2021) he was cold all day and had a tiny cough, but it wasn't significant. Ever so often she would hear him cough. All of a sudden patient would wake up sweating. Again, Saturday he soaked everything. There was no Emergency Room nor Physician Office. Outcome of Very sore arms, sweating was recovering, of pain and fever was unknown, of other events was not recovered.    Information on Lot/Batch has been requested.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID virus; tested positive for COVID virus; cold all day; tiny cough; chills; sweating/ woke up sweating wet; arm pain/Very sore arms; body aches; fever; some muscle aches; This is a spontaneous report from a contactable consumer(Patient's Wife).  A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 02Jan2021 13:30 at single dose for COVID-19 vaccination. There were no concomitant medications nor medical history. He did not receive any other vaccines that day or 4 weeks prior. No history of any other vaccines or events. He got his vaccine on Saturday(02Jan2021) at 1:30pm(13:30) and by 5:30pm(17:30) had very sore arms/arm pain, at 7:30pm(19:30) he had chills off and on and was sweating. He woke up soaking wet and did that on Sunday, but was feeling a little better today. He also experienced body aches and fever in Jan2021. Today is testing day at his work and he tested positive for COVID virus on 05Jan2021. Not sure if it's a coincidence. Again, he got the shot and then started having all these symptoms at 5:30 and 7:30. Now they are both on quarantine for the 10-14 days. He wanted to see if it's possible to test positive for the virus after getting the shot or is it just a coincidence. He also had some muscle aches in Jan2021. Last night (04Jan2021), he woke up again sweating, but not like on Saturday, but he got really warm and started to sweat a little, and on Sunday(03Jan2021) he was cold all day and had a tiny cough, but it wasn't significant. Ever so often she would hear him cough. All of a sudden patient would wake up sweating. Again, Saturday he soaked everything. There was no Emergency Room nor Physician Office. Outcome of Very sore arms, sweating was recovering, of pain and fever was unknown, of other events was not recovered.    Information on Lot/Batch has been requested.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Musculoskeletal chest pain, Myalgia, Vaccination site pain
Clinical narrative: site injection pain; muscle in arm pain; tiredness; foggy head; Chest muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 04Jan2021 15:15 (at the age of 38-years) 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. Concomitant medication included lisinopril and gabapentin. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took amoxicillin and experienced allergies. On 05Jan2021 04:15, the patient experienced injection site pain, muscle pain in arm, tiredness, foggy head, chest muscle pain. The patient did not receive any treatment for the events. Since vaccination, the patient had not been tested for COVID-19. The outcome of the events injection site pain, muscle pain in arm, tiredness, foggy head, chest muscle pain, was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching in hands and feet which progressed to back, neck and head/ later stated her head as well; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: 5K5730) via an unspecified route of administration in the upper right arm on 19Dec2020 11:00 at a single dose for covid-19 immunisation. Medical history included asthma in 1996, allergies to penicillin, high blood pressure, reflux, allergies, and broke her leg 17 years ago in 2003. The patient has no prior vaccinations within 4 weeks. Concomitant medications included unspecified medications for high blood pressure, reflux, and allergies. The patient previously had allergies with morphine (manifestation: holding hands over ears and felt everyone was screaming at her) and vancomycin. The patient got first dose on 19Dec2020 and is supposed to go back Saturday (09Jan2021) for follow up dose. She wanted to verify if she should get it. After the first injection, it was uneventful the day she got it, and then 4-5 days later, she got itching in hands and feet. It was not so alarming. She still has it and then it started progressing to her back and neck and later stated her head as well. It is not all the time just intermittent. She needed to take Benadryl to keep from scratching so much. Yesterday seemed to be worse. She did not have any hives. Around the end of last week is when it spread to other places besides hands and feet. She doesn't have itching today on back, but she does on her hands and feet. The outcome of the event was not recovered. No ER or physician's office required. She does take daily maintenance medications and she does not know if they are relevant. She also takes medication for high blood pressure, reflux and allergies. She was taking all of them before she took this.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Cough, Exposure to SARS-CoV-2, Feeling abnormal
Clinical narrative: a little bit of a cough.; headache; runny nose; Aside from her taste and smell still being gone; Aside from her taste and smell still being gone/loss of taste; fogginess; Patient had since tested positive; Patient had since tested positive; patient likely had exposure on 22Dec2020; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient likely had exposure on 22Dec2020. She showed the first covid symptoms on 31Dec2020. Patient experienced loss of taste, headache, fogginess, runny nose, and a little bit of a cough on unspecified date. Patient received her first covid dose on 21Dec2020. The first dose likely helped her, she has rapidly gotten better and was feeling much better today. Aside from her taste and smell still being gone. The patient was scheduled to receive her second dose on 11Jan2021. Patient had since tested positive. Caller clarified that the patient didn't get a test until 03Jan2021. Outcome of events taste and smell still being gone was not recovered, and outcome of other events was unknown.   Information on batch/lot number was requested.; Sender's Comments: No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the positive COVID likely represents the pre-existing infection prior to vaccine use.  Further information like confirmative COVID 19 Nucleic acid/ PCR test together with any associated symptoms are needed for full medical assessment.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: a little bit of a cough.; headache; runny nose; Aside from her taste and smell still being gone; Aside from her taste and smell still being gone/loss of taste; fogginess; Patient had since tested positive; Patient had since tested positive; patient likely had exposure on 22Dec2020; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient likely had exposure on 22Dec2020. She showed the first covid symptoms on 31Dec2020. Patient experienced loss of taste, headache, fogginess, runny nose, and a little bit of a cough on unspecified date. Patient received her first covid dose on 21Dec2020. The first dose likely helped her, she has rapidly gotten better and was feeling much better today. Aside from her taste and smell still being gone. The patient was scheduled to receive her second dose on 11Jan2021. Patient had since tested positive. Caller clarified that the patient didn't get a test until 03Jan2021. Outcome of events taste and smell still being gone was not recovered, and outcome of other events was unknown.   Information on batch/lot number was requested.; Sender's Comments: No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the positive COVID likely represents the pre-existing infection prior to vaccine use.  Further information like confirmative COVID 19 Nucleic acid/ PCR test together with any associated symptoms are needed for full medical assessment.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: tested positive; tested positive; runny nose; headache; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer reported that a 51-year-old female patient 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 tested positive, runny nose, headache after getting the vaccine on an unspecified date with outcome of unknown. This report is considered as non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic, Weight
Clinical narrative: a red looking rash that's itchy; a red looking rash that's itchy; This is a spontaneous report from a contactable consumer (patient).  A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL0140 and expiry date: Mar2021, via an unspecified route of administration in left arm from 23Dec2020 to 23Dec2020 as single dose (first dose) for COVID-19 immunisation.  Medical history was reported as none.  There were no concomitant medications. The patient stated she noticed the day after getting the COVID vaccine, 24Dec2020 that morning when she woke up between 9am to 10am that she had this red looking rash that it is itchy. The person who gave her the shot placed a band-aid on the site of injection. At first caller thought the person who gave her the injection missed the site where it was injected where placing the band-aid. However, this was a big red circle. The circle was bigger than a quarter. It is still itchy. This is located on her left arm. She stated she was hoping it would just go away on its own. No additional details provided. She is due to receive the second dose on 13Jan2021 or 14Jan2021 depending on when there is availability. The patient is about 130 pounds give or take. The outcome of the event was not recovered.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache is gradually getting worse; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male 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 04Jan2021, at a single dose, COVID-19 immunization. The patient had no medical history and concomitant medications. The patient works in a laboratory. The patient has had no issues with vaccines in the past. The patient got the vaccine yesterday (04Jan2021) and is wondering what to do with the headache side effects. The patient received his first dose yesterday and the headache was noticed today (05Jan2021) at 5 or 6 AM. The patient's headache is gradually getting worse. The patient wanted to confirm if this is a documented side effect. The patient was informed that Pfizer cannot provide any medical advice. The patient was provided a card when he got the vaccine. The patient has never taken any COVID or antibody tests prior to the vaccine. The patient had not recovered from the event.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache behind my eyesTiredness; Headache behind my eyesTiredness; This is a spontaneous report from a contactable healthcare professional.  A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 12:00 at single dose for covid-19 immunisation.  Medical history included gastrooesophageal reflux disease and known allergies: Penicillin.  Concomitant medication included omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]) and oxymetazoline hydrochloride (CLARITIN ALLERGIC).  The patient has known allergies: Codeine.  The patient stated, "headache behind my eyes tiredness", on 04Jan2021 12:15, The outcome of the events was recovering.   Information lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Inappropriate schedule of product administration, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: arm pain, concern is the injection site; a swollen injection site a size of a quarter with heat 13 hours later; she has swelling at the injection site and heat underneath it; BNT162B2 first dose was administered on 16Dec2020, second dose was administered on 04Jan2021; joint pain; This is a spontaneous report from a contactable healthcare professional (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), first dose on 16Dec2020 between 12:30 and 1:30 via an unspecified route of administration at single dose, then the second dose on 04Jan2021 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 got the first vaccine on the 16Dec2020 between 12:30 and 1:30 and had symptoms 12 to 13 hours post injection. She had joint pain which is normal. Two or three weeks later she had the second vaccine. It was given yesterday (04Jan2021) around the same time as the first one was given. About 13 hours later she had arm pain. She didn't feel anything until 2AM when she started feeling achiness. Her concern is the injection site. She doesn't know if it will get infected. The patient added that she had experienced arm pain, a swollen injection site a "size of a quarter" with heat 13 hours later. She also stated that she did not experience this with the first shot and is asking if this normal for the 2nd shot. She knows it is listed as part of the side effects, but she has swelling at the injection site and heat underneath it. The patient asked, "Is that normal to sustain for about 12 hours? It started around 2am". She took three Tylenol and that seemed to help. The outcome of events was unknown.  Information on the lot/ batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: Blood Pressure shot up to 170/100. took 3 hours to return to normal.; This is a spontaneous report from a contactable nurse. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK9231), via an unspecified route of administration in the left arm on 05Jan2021 07:00 at a single dose for covid-19 immunization. Medical history included arthritis, allergy to plants and arthropod sting. the patient was not pregnant at the time of the reporting. The patient's concomitant medications were not reported. On 05Jan2021 07:00, the patient's blood pressure shoot up to 170/100. It took 3 hours to return to normal. The outcome of event was recovered. No treatment was required/given due to the event.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Nausea, Vaccination site pain
Clinical narrative: non stop diarrhea; nausea; chills; joint pain; sore at the injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration on 02Jan2021 07:30 at single dose for covid-19 immunization. The patient's medical history was none, and there were no concomitant medications. The first dose patient received on 02Jan2021 morning, and she just had symptoms she expected, she was sore at the injection site and she had some joint pain on 03Jan2021, but those disappeared on 04Jan2021. On 05Jan2021, she woke up and had non stop diarrhea with a little bit of nausea. Patient had not had a fever, but did feel chilled. Patient didn't think she ate anything bad. She was suspecting this may be a side effect of the vaccine. Patient didn't have a prescribing doctor. She got it at the hospital she worked at. She received it the 02Jan2021 7:30 am. Patient started the diarrhea on 05Jan2021 morning at 8:30. The nausea was on and off, but started this morning as well. Patient didn't take any ongoing medication. Outcome of events sore at the injection site and joint pain was recovered on 04Jan2021, outcome of event diarrhea was not recovered, and outcome of events nausea, and chills was recovering.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia, Vaccination site pain
Clinical narrative: fever of 105F; chills; severe headache; arm pain; This is a spontaneous report from a Pfizer-sponsored program from a non-contactable healthcare professional (HCP).  A 70 year-old female patient (pregnancy information not reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, on 18Dec2020 (at the age of 70 years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Prior to receiving the vaccination it was not reported if the patient had been tested for COVID-10. It was also not known if she received any other vaccinations in 4 weeks or other medications in past 2 weeks. On 18Dec2020, the patient received the first dose of the COVID-19 vaccine and had arm pain that lasted for a few hours at that time. Seventeen days post first vaccination (approximately 04Jan2021), she developed a fever of 105F, chills and severe headache which have now resolved.  She wanted to know if she should get the second vaccine in series given her side effects. it was not reported if the patient was hospitalized or treated for the events.The clinical outcome of the events of arm pain, fever of 105F, chills and severe headache was recovered on an unspecified date. It was not reported if the patient was tested for COVID-19 after receiving the vaccination.  Information about batch/lot number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Oxygen saturation
Clinical narrative: shortness of breath; tightness in her chest; This is a spontaneous report from a contactable nurse (patient).  A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot Number: EL0140, expiry date: 19 Vaccine: Mar2021, via an unspecified route of administration in the left arm from 29Dec2020 16:00 to 29Dec2020 16:00 as SINGLE DOSE for COVID-19 immunisation.  Medical history included blood pressure abnormal (She has been on blood pressure med for 3 years).  Concomitant medication included labetalol oral 200 mg, 2x/day for Blood pressure. The patient reports since Sunday night, 03Jan2021, she noticed feeling a little tightness in her chest and shortness of breath but her O2 saturation is fine. Reports she tested it at 98% to 97%. Asking is this a side effect of the vaccine, has it been reported? Does it have anything to do with the expected effectiveness after a week of getting the first dose? She is scheduled for the second dose 18Jan2021. The outcome of the events was not recovered.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable nurse (patient) from a Pfizer-sponsored program Pfizer First Connect. A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration in the right arm on 18Dec2020 at single dose for covid 19 immunisation as healthcare professional and husband was high risk. Medical history included hypertension from 2019 and ongoing. Concomitant medication included amlodipine besilate (NORVASC, 5 mg) from 2019 and ongoing for high blood pressure. The patient experienced tested positive for covid-19 on 03Jan2021 with outcome of not recovered, congestion and headache in Jan2021 with outcome of unknown. The patient underwent lab tests and procedures which included COVID test on 03Jan2021 and the results came back positive on 04Jan2021. The patient was scheduled to receive her second injection on 08Jan2021. Since her first injection she had tested positive for COVID-19. The second dose had to be given a certain amount of days after the first. She would be outside that window. She would like to know if there is any guidance regarding the if/when she should get the second dose. The reporter would like to know if she waits longer than the recommended 21 days to receive her second dose of the COVID-19 vaccine would she need to restart the vaccination series. The reporter said this was not serious as she only had congestion and headache with treatment: using over the counter stuff. Event relatedness with COVID vaccine was unknown.; Sender's Comments: Based on available information, a possible contributory role of suspect BNT162B2 vaccine cannot be completely excluded for reported "tested positive for COVID-19".