chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Decreased appetite, Headache
Clinical narrative: pressure in chest; no appetite (no hungry); huge headache; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 14May2021 at 17:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included none. Patient had no known allergies. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15May2021 at 08:00, the patient experienced huge headache. Therapeutic measures were taken as a result of the event and included treatment with TYLENOL. On 16May2021, the patient experienced pressure in chest, have no appetite (no hungry). The patient did not receive any treatment for the events. The clinical outcome of events huge headache, pressure in chest, have no appetite (no hungry) was unknown. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Inappropriate schedule of product administration, Nasal congestion, Throat irritation, Vaccination site bruising
Clinical narrative: Soreness, bruising at injection site; Soreness, bruising at injection site; dry+ scratchy throat with nasal congestion; dry+ scratchy throat with nasal congestion; dry+ scratchy throat with nasal congestion; Dose 1: 20210501 and Dose2: 20210515; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15May2021 at 12:30, (at the age of 16-year-old) as a single dose for COVID-19 immunisation. Medical history included anemia, oral allergy syndrome and allergy to penicillin. Concomitant medications included cetirizine hydrochloride (ZYRTEC), for unknown indication from an unknown date. The patient previously received the first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01May2021 at 14:30, (at the age of 16-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16May2021, the patient experienced Soreness, bruising at injection site, and dry + scratchy throat with nasal The patient did not receive any treatment for the reported event. The clinical outcome of the event vaccination site pain, vaccination site bruising, dry throat, itchy throat and nasal congestion was recovered on 16May2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness, bruising at injection site; Soreness, bruising at injection site; dry+ scratchy throat with nasal congestion; dry+ scratchy throat with nasal congestion; dry+ scratchy throat with nasal congestion; Dose 1: 20210501 and Dose2: 20210515; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15May2021 at 12:30, (at the age of 16-year-old) as a single dose for COVID-19 immunisation. Medical history included anemia, oral allergy syndrome and allergy to penicillin. Concomitant medications included cetirizine hydrochloride (ZYRTEC), for unknown indication from an unknown date. The patient previously received the first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01May2021 at 14:30, (at the age of 16-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16May2021, the patient experienced Soreness, bruising at injection site, and dry + scratchy throat with nasal The patient did not receive any treatment for the reported event. The clinical outcome of the event vaccination site pain, vaccination site bruising, dry throat, itchy throat and nasal congestion was recovered on 16May2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Itching; Red around upper chest; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0183) via an unspecified route of administration in the arm left on 12May2021 at 14:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. Concomitant medications included lisinopril dihydrate (LISINOPRIL) for unknown indication. The patient reported that he was taking medication for high blood pressure which was unspecified. The patient previously took compazine (MANUFACTURER UNKNOWN) on an unknown date and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16May2021 at 10:00, the patient experienced itching and red around upper chest. Therapeutic measures were not taken as a result of these events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event itching and red around upper chest was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Concussion, Epistaxis, Headache
Clinical narrative: Bloody nose with long clothes removed loud of nose; Headache; Feeling of a concussion; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 14May2021 at 09:30 (at the age of 25-years-old), as a single dose for COVID-19 immunisation. Medical history included ADHD. The patient did not have any allergies to medications, food or other products. Concomitant medication included methylphenidate hydrochloride (CONCERTA) from an unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 23Apr2021 at 13:15 (at the age of 25-years-old), as a single dose for COVID-19immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16May2021 at 14:45, the patient experienced bloody nose with long clothes removed loud of nose, headache, feeling of a concussion. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events bloody nose with long clothes removed loud of nose, headache and feeling of a concussion were resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Right arm aches where the shot was given, some days worse than others.; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the right arm on 20Apr2021 at 10:45 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. The patients' medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included colecalciferol (VIT.D3), ascorbic acid (VITAMIN C) and vitamin b complex (B-COMPLEX); all from unknown dates for unspecified indications. The patient previously received TAMIFLU and experienced a drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 30Mar2021 at 10:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines with in four weeks of the COVID-19 vaccination. On 20Apr2021 at 13:00, the patient experienced "right arm aches where the shot was given, some days worse than others." The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event "right arm aches where the shot was given, some days worse than others."  was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Fatigue, Feeling of body temperature change, Headache
Clinical narrative: Dizziness; disorientation; body aches; switching between feeling too hot and too cold; headache; nausea; arm pain; extreme tiredness; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 15May2021 at 16:30 hours (at the age of 25-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications included escitalopram oxalate (LEXAPRO) 20 mg, daily and testosterone phenylpropionate (TESTOSTERONE) 25 mg, weekly, both from unknown date for unspecified indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 24Apr2021 at 16:30 hours (at the age of 25-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15May2021 at 21:00 hours the patient experienced dizziness, disorientation, body aches, switching between feeling too hot and too cold, headache, nausea and extreme tiredness. No therapeutic measures were taken a s a result of the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event dizziness, disorientation, body aches, switching between feeling too hot and too cold, headache, nausea, pain and extreme tiredness was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: Dizziness; disorientation; body aches; switching between feeling too hot and too cold; headache; nausea; arm pain; extreme tiredness; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 15May2021 at 16:30 hours (at the age of 25-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications included escitalopram oxalate (LEXAPRO) 20 mg, daily and testosterone phenylpropionate (TESTOSTERONE) 25 mg, weekly, both from unknown date for unspecified indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 24Apr2021 at 16:30 hours (at the age of 25-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15May2021 at 21:00 hours the patient experienced dizziness, disorientation, body aches, switching between feeling too hot and too cold, headache, nausea and extreme tiredness. No therapeutic measures were taken a s a result of the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event dizziness, disorientation, body aches, switching between feeling too hot and too cold, headache, nausea, pain and extreme tiredness was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Body temperature, Chest discomfort, Chills, Dizziness
Clinical narrative: Headache; fever of 101; Chills; Strange dreams; Insomnia; several bowel movements; hemorrhoids; Fatigue; all over body pain; Dizziness; tightness in chest; Difficulty breathing; muscle pain in injected arm; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the right arm on 15May2021 at 11:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), baclofen (MANUFACTURER UNKNOWN), zolpidem tartrate (AMBIEN), omeprazole (MANUFACTURER UNKNOWN) and ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the right arm on 24Apr2021 at 11:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15May2021 at 14:30, the patient experienced headache, fever of 101, chills, strange dreams, insomnia, several bowel movements which caused haemorrhoids, fatigue, all over body pain, dizziness, fatigue, tightness in chest, difficulty breathing and muscle pain in injected arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events headache, fever of 101, chills, strange dreams, insomnia, several bowel movements, hemorrhoids, fatigue, all over body pain, dizziness, tightness in chest, difficulty breathing and muscle pain in injected arm were recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Frequent bowel movements, Haemorrhoids, Headache
Clinical narrative: Headache; fever of 101; Chills; Strange dreams; Insomnia; several bowel movements; hemorrhoids; Fatigue; all over body pain; Dizziness; tightness in chest; Difficulty breathing; muscle pain in injected arm; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the right arm on 15May2021 at 11:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), baclofen (MANUFACTURER UNKNOWN), zolpidem tartrate (AMBIEN), omeprazole (MANUFACTURER UNKNOWN) and ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the right arm on 24Apr2021 at 11:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15May2021 at 14:30, the patient experienced headache, fever of 101, chills, strange dreams, insomnia, several bowel movements which caused haemorrhoids, fatigue, all over body pain, dizziness, fatigue, tightness in chest, difficulty breathing and muscle pain in injected arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events headache, fever of 101, chills, strange dreams, insomnia, several bowel movements, hemorrhoids, fatigue, all over body pain, dizziness, tightness in chest, difficulty breathing and muscle pain in injected arm were recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Pain, Pyrexia
Clinical narrative: Headache; fever of 101; Chills; Strange dreams; Insomnia; several bowel movements; hemorrhoids; Fatigue; all over body pain; Dizziness; tightness in chest; Difficulty breathing; muscle pain in injected arm; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the right arm on 15May2021 at 11:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), baclofen (MANUFACTURER UNKNOWN), zolpidem tartrate (AMBIEN), omeprazole (MANUFACTURER UNKNOWN) and ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the right arm on 24Apr2021 at 11:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15May2021 at 14:30, the patient experienced headache, fever of 101, chills, strange dreams, insomnia, several bowel movements which caused haemorrhoids, fatigue, all over body pain, dizziness, fatigue, tightness in chest, difficulty breathing and muscle pain in injected arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events headache, fever of 101, chills, strange dreams, insomnia, several bowel movements, hemorrhoids, fatigue, all over body pain, dizziness, tightness in chest, difficulty breathing and muscle pain in injected arm were recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate decreased, Heart rate irregular, Vision blurred
Clinical narrative: Blurry Vision; Irregular heartbeats; Low heart rate "41-47"; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: EW0176) via an unspecified route of administration in the left arm on 16May2021 at 11:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, asthma and penicillin allergy. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16May2021 at 11:10, the patient experienced irregular heartbeats, Low heart rate "41-47" detected on apple watch series 6, this happened 10min after injection and subsided about 1hour later.  On16May2021 at 17:30, the patient experienced blurry vision. She was fasting for 18hours at time of injection, but drinking plenty of water. Therapeutic measures were taken as a result of AE(s) and included treatment with cold compress and a bottle of water. The clinical outcome of the event irregular heartbeats, low heart rate "41-47" was recovered on 16May2021 at 12:10. The clinical outcome of the event blurry vision was unknown at time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness in the arm that received the vaccination; This is a spontaneous report from a contactable consumer. A 12-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0185) via intramuscular route of administration in the left arm on 16May2021 at 09:30 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. The patient had medical history of known allergies to Lactose intolerance. Concomitant medication included tilactase (LACTAID) from an unknown date for unknown indication. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16May2021 at 17:00, the patient experienced soreness in the arm that received the vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of soreness in the arm that received the vaccination was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Oropharyngeal pain, Product administered at inappropriate site, Pyrexia
Clinical narrative: Fatigue; Congestion; Headache; Low grade fever; Sore throat; Anatomical location at left leg; This is a spontaneous report from a contactable consumer, the parent. A 12-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0168) via an unspecified route of administration in the leg left on 15May2021 at 09:00 (at the age of 12-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and penicillin allergy. Concomitant medications included cyanocobalamin (B12) on unknown date for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was administered in the left leg hence there was a medication error (vaccine administered at the inappropriate site). On 15May2021 at 15:00 the patient experienced fatigue, congestion, headache, low grade fever and sore throat. On 16May2021, the patient underwent rapid antigen test for COVID-19 virus and the result was found to be negative. On 16May2021, the patient underwent PCR test for COVID-19 and the result was pending. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events fatigue, congestion, headache, low grade fever and sore throat were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Upper respiratory tract congestion
Clinical narrative: Fatigue; Congestion; Headache; Low grade fever; Sore throat; Anatomical location at left leg; This is a spontaneous report from a contactable consumer, the parent. A 12-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0168) via an unspecified route of administration in the leg left on 15May2021 at 09:00 (at the age of 12-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and penicillin allergy. Concomitant medications included cyanocobalamin (B12) on unknown date for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was administered in the left leg hence there was a medication error (vaccine administered at the inappropriate site). On 15May2021 at 15:00 the patient experienced fatigue, congestion, headache, low grade fever and sore throat. On 16May2021, the patient underwent rapid antigen test for COVID-19 virus and the result was found to be negative. On 16May2021, the patient underwent PCR test for COVID-19 and the result was pending. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events fatigue, congestion, headache, low grade fever and sore throat were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Blood pressure increased, Body temperature, Body temperature fluctuation
Clinical narrative: Constantly changing temperature (goes up and down between 98 and 100); Weird issues with my hearing; Flared up temporomandibular joint; Elevated heart rate; Elevated blood pressure (usually at 120. Now it was at 138); Inflamed muscles; Body aches; Weight loss - despite trying to eat a lot more to compensate for it.; Bowel issues; Taste buds altered. I don't taste pineapples and other fruits correctly; Weakness; Fatigue; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the arm left on 04May2021 at 09:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient took doxycycline on an unknown date for unknown indication and experienced drug allergy. Concomitant medications included ALLEGRA, montelukast (MANUFACTURER UNKNOWN) and omeprazole (MANUFACTURER UNKNOWN) received within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the arm left on 21Apr2021 at 11:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04May2021 at 18:00, the patient experienced constantly changing temperature (goes up and down between 98 and 100), fatigue, weird issues with hearing, flared up temporomandibular joint (TMJ) that has not been present for years, elevated heart rate, elevated blood pressure (usually at 120. It was at 138 at the time of report), these are still going on, 2 weeks after the shot, inflamed muscles, body aches, weakness, weight loss - despite trying to eat a lot more to compensate for it, bowel issues and taste buds altered. The patient don not taste pineapples and other fruits correctly. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events constantly changing temperature (goes up and down between 98 and 100), fatigue, weird issues with hearing, flared up temporomandibular joint (TMJ), elevated heart rate, elevated blood pressure (usually at 120. It was at 138 at the time of report), inflamed muscles, body aches, weakness, weight loss, bowel issues and taste buds altered were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Heart rate increased, Hypoacusis, Inappropriate schedule of product administration, Myositis
Clinical narrative: Constantly changing temperature (goes up and down between 98 and 100); Weird issues with my hearing; Flared up temporomandibular joint; Elevated heart rate; Elevated blood pressure (usually at 120. Now it was at 138); Inflamed muscles; Body aches; Weight loss - despite trying to eat a lot more to compensate for it.; Bowel issues; Taste buds altered. I don't taste pineapples and other fruits correctly; Weakness; Fatigue; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the arm left on 04May2021 at 09:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient took doxycycline on an unknown date for unknown indication and experienced drug allergy. Concomitant medications included ALLEGRA, montelukast (MANUFACTURER UNKNOWN) and omeprazole (MANUFACTURER UNKNOWN) received within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the arm left on 21Apr2021 at 11:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04May2021 at 18:00, the patient experienced constantly changing temperature (goes up and down between 98 and 100), fatigue, weird issues with hearing, flared up temporomandibular joint (TMJ) that has not been present for years, elevated heart rate, elevated blood pressure (usually at 120. It was at 138 at the time of report), these are still going on, 2 weeks after the shot, inflamed muscles, body aches, weakness, weight loss - despite trying to eat a lot more to compensate for it, bowel issues and taste buds altered. The patient don not taste pineapples and other fruits correctly. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events constantly changing temperature (goes up and down between 98 and 100), fatigue, weird issues with hearing, flared up temporomandibular joint (TMJ), elevated heart rate, elevated blood pressure (usually at 120. It was at 138 at the time of report), inflamed muscles, body aches, weakness, weight loss, bowel issues and taste buds altered were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Taste disorder, Temporomandibular joint syndrome, Weight decreased
Clinical narrative: Constantly changing temperature (goes up and down between 98 and 100); Weird issues with my hearing; Flared up temporomandibular joint; Elevated heart rate; Elevated blood pressure (usually at 120. Now it was at 138); Inflamed muscles; Body aches; Weight loss - despite trying to eat a lot more to compensate for it.; Bowel issues; Taste buds altered. I don't taste pineapples and other fruits correctly; Weakness; Fatigue; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the arm left on 04May2021 at 09:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient took doxycycline on an unknown date for unknown indication and experienced drug allergy. Concomitant medications included ALLEGRA, montelukast (MANUFACTURER UNKNOWN) and omeprazole (MANUFACTURER UNKNOWN) received within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the arm left on 21Apr2021 at 11:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04May2021 at 18:00, the patient experienced constantly changing temperature (goes up and down between 98 and 100), fatigue, weird issues with hearing, flared up temporomandibular joint (TMJ) that has not been present for years, elevated heart rate, elevated blood pressure (usually at 120. It was at 138 at the time of report), these are still going on, 2 weeks after the shot, inflamed muscles, body aches, weakness, weight loss - despite trying to eat a lot more to compensate for it, bowel issues and taste buds altered. The patient don not taste pineapples and other fruits correctly. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events constantly changing temperature (goes up and down between 98 and 100), fatigue, weird issues with hearing, flared up temporomandibular joint (TMJ), elevated heart rate, elevated blood pressure (usually at 120. It was at 138 at the time of report), inflamed muscles, body aches, weakness, weight loss, bowel issues and taste buds altered were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Dyspnoea, Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0164), at the age of 60, via an unspecified route of administration, left arm, on May 15, 2021, at 16:00, single dose, for COVID-19 immunisation. Medical history included no other health issues. The patient does not have any allergies to food, medications or other products. Patient did not receive any other medications within two weeks of vaccination. The patient previously received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot#EW0158), at the age of 60, via an unspecified route of administration, left arm, on Apr 24, 2021, at 16:00, single dose, for COVID-19 immunisation. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On May 16, 2021, at 10:00, patient experienced temperature of 100.6ºF, chills, weakness, muscle pain, some muscle failure, nausea, vomiting and shortness of breath. No therapeutic measures taken as a result of the events. On May 16, 2021, patient underwent lab tests, which include body temperature and the result was 100.6ºF. The outcome of 100.6ºF, chills, weakness, muscle pain, some muscle failure, nausea, vomiting and shortness of breath: not recovered (at the time of report). No follow-up attempts needed. No further information expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0164), at the age of 60, via an unspecified route of administration, left arm, on May 15, 2021, at 16:00, single dose, for COVID-19 immunisation. Medical history included no other health issues. The patient does not have any allergies to food, medications or other products. Patient did not receive any other medications within two weeks of vaccination. The patient previously received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot#EW0158), at the age of 60, via an unspecified route of administration, left arm, on Apr 24, 2021, at 16:00, single dose, for COVID-19 immunisation. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On May 16, 2021, at 10:00, patient experienced temperature of 100.6ºF, chills, weakness, muscle pain, some muscle failure, nausea, vomiting and shortness of breath. No therapeutic measures taken as a result of the events. On May 16, 2021, patient underwent lab tests, which include body temperature and the result was 100.6ºF. The outcome of 100.6ºF, chills, weakness, muscle pain, some muscle failure, nausea, vomiting and shortness of breath: not recovered (at the time of report). No follow-up attempts needed. No further information expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Menstruation irregular
Clinical narrative: Metrorrhagia 24 hours post vaccine.; Period was not due for at least one more week.; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 14May2021 at 08:15 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included celiac disease,  COVID-19 and allergy to gluten. The patient did not take any concomitant medication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 23Apr2021 at 08:15 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15May2021 at 08:15, 24 hours post vaccine the patient experienced metrorrhagia and Period was not due for at least one more week. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event metrorrhagia and irregular periods was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, SARS-CoV-2 test
Clinical narrative: series of rashes across back, shoulders, and buttocks; constantly itch; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0169), via an unspecified route of administration in the left arm on 01May2021 at 08:45 (at the age of 36-year-old), as a single dose for COVID-19 immunisation. Medical history was not available and the patient did not have a history of allergies to any food or medications or other products. The patient did not receive any other medications within two weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8729), via an unspecified route of administration in the left arm on 09Apr2021 at 08:45 (at the age of 36-year-old), as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had been tested for COVID-19. On 05May2021, patient experienced series of rashes across back, shoulders, and buttocks and constantly itch for a couple of hours and then go away and start again the next day. On 20Oct2020, the patient underwent lab tests and procedures which included COVID test (Nasal swab) and the result was negative. No therapeutic measures were taken for the events. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event series of rashes across my back, shoulders, and buttocks and constantly itch was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Fever; headache; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer (reported for her daughter). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 11May2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in May2021, the patient experienced fever and headache. Therapeutic measures were taken as a result of events included treatment with Tylenol. The second dose was scheduled on 01Jun2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: red rash around the shot site; red rash around the shot site that itches; red rash around the shot site thatitches and is slightly swollen; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0171) via an unspecified route of administration in the left arm on 07May2021 at 14:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. . Concomitant medication included prenatal (unspecified; MANUFACTURER UNKNOWN); from unknown date and just taking prenatal in case they decide. The patient previously took Tylenol and experienced drug allergy (sometimes). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16May2021, 9 days after the shot, the patient had a red rash around the shot site that itches and was slightly swollen. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events red rash around the shot site that itches and is slightly swollen were not recovered at the time of this report.      No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: "Injection site on arm sore"; "Pain when lifting past parallel"; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 20Apr2021 at 12:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known allergies. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced injection site on arm sore for a month after second shot and pain when lifting past parallel. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events "injection site on arm sore" and "pain when lifting past parallel" were recovered on an unknown date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.