chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Sore throat; Nausea; Stomach cramps; Metallic taste; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Sep2021 at 13:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included bowel obstruction (BO). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 16Sep2021 at 14:00, the patient experienced sore throat, nausea, stomach cramps, metallic taste, and headache. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On 21Sep2021, the patient underwent COVID-19 test via nasal swab and the result was pending. Therapeutic measures were taken as a result of the events which included unspecified treatment. The clinical outcome of the events sore throat, nausea, stomach cramps, metallic taste, and headache were recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, SARS-CoV-2 test
Clinical narrative: Lost all taste and smell; Lost all taste and smell; This is a spontaneous report from a contactable pharmacist, the patient. A 64-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on 03Mar2021 at 12:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on 10Feb2021 at 19:15 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. On or about 01Apr2021 at 00:00, the patient lost all taste and smell and as of 22Sep2021, it had not returned. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 18Sep2021, the patient underwent access bio antigen test via nasal swab and the result was negative. The clinical outcome of the events lost all taste and smell was not resolved at the time of this report.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dermatitis allergic, Lymphadenitis, Pyrexia
Clinical narrative: Left axillary lymphadenitis; Fever max 101 for 4 days; Allergic rash ten days post vaccination; This is a spontaneous report from a non-contactable physician, the patient. A 40-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Sep2021 at 12:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included sulfamethoxazole, trimethoprim (BACTRIM DS) for an unknown indication from an unknown date and unknown if ongoing. On 09Sep2021 at 18:00, the patient experienced left axillary lymphadenitis, fever max 101 for 4 days and allergic rash ten days post vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with unspecified antibiotics and antihistamine. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events left axillary lymphadenitis, fever max 101 for 4 days and allergic rash ten days post vaccination was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Intermenstrual bleeding
Clinical narrative: Unexpected / off-cycle vaginal bleeding and cramping for 5 days; Unexpected / off-cycle vaginal bleeding and cramping for 5 days; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient 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 13Sep2021 at 12:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The medical history included hypertension. The patient had no known allergies (NKA). Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included unspecified antihypertensive medications and unspecified birth control medication; both from unknown date and unknown if ongoing. On 15Sep2021 at 06:00, the patient experienced an unexpected off-cycle vaginal bleeding and cramping for 5 days after vaccination. The event 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events unexpected off-cycle vaginal bleeding and cramping for 5 days was recovered on 20Sep2021.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Menstruation irregular, Urinary tract infection
Clinical narrative: Lower back pain; Urinary tract infection; Irregular period; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration on 03Sep2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported as not applicable. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications included norethisterone acetate, ethinylestradiol, ferrous fumarate (TAYTULLA), acetylcysteine (NAC), and levomefolic acid (L-METHYLFOLATE); all taken for unspecified indications from unknown dates and unknown if ongoing. On 05Sep2021, the patient experienced lower back pain, urinary tract infection, irregular period. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included an unspecified treatment. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events lower back pain, urinary tract infection, irregular period were unknown at the time of the report.  No follow-up attempts are possible. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever; Vomiting; This is a spontaneous report from a non-contactable consumer, the patient. A 15-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the left arm on 17Sep2021 at 17:00 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the left arm on 20Aug2021 at 17:00 (at the age of 15-years-old), as a single dose for COVID-19 immunisation. On 18Sep2021, the patient experienced fever and vomiting. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events fever and vomiting was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Headache, Myalgia, Pain
Clinical narrative: Body aches; Joint pain; 101.5 fever; Muscle pain; Injection site pain; Headache; This is a spontaneous report from a contactable consumer, the patient. A 26-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 21Sep2021 at 16:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. 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. On 22Sep2021 at 02:00, the patient experienced body aches, joint pain, 101.5 fever (units unspecified), muscle pain, injection site pain and headache. The events 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, joint pain, 101.5 fever, muscle pain, injection site pain and headache were not recovered at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Body aches; Joint pain; 101.5 fever; Muscle pain; Injection site pain; Headache; This is a spontaneous report from a contactable consumer, the patient. A 26-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 21Sep2021 at 16:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. 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. On 22Sep2021 at 02:00, the patient experienced body aches, joint pain, 101.5 fever (units unspecified), muscle pain, injection site pain and headache. The events 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, joint pain, 101.5 fever, muscle pain, injection site pain and headache were not recovered at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Menstrual cycle earlier; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Jul2021 (at the age of 35-years-old) as a single dose and also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Aug2021, the patient had menstrual cycle 7 days earlier than usual. The patient always had 35 days cycles and at the time of the report, it was 28 days cycle. The event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported event. The clinical outcome of the event menstrual cycle earlier was unknown at the time of this report.   The lot numbers for BNT162b2, were not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Dramatic increase in tinnitus, continuous, unresolved; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 10:00 (at the age of 49-years-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0121) via an unspecified route of administration in the left arm on 30Apr2021 at 10:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included gastroesophageal reflux disease (GERD), endometriosis, and tinnitus which was ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received mepivacaine hydrochloride (CARBOCAINE) from an unknown date for an unknown indication and experienced drug allergy. On an unknown date in Apr2021 at 20:00, the patient experienced a dramatic increase in tinnitus, continuous and unresolved. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event dramatic increase in tinnitus, continuous, unresolved was not recovered at the time of this report.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: 36 hours after shot woke up with extreme dizziness, still experiencing it; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2587) via an unspecified route of administration in the left arm on 17Sep2021 at 14:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer. The patient had unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 19Sep2021 at 08:00, 36 hours after the shot, the patient woke up with extreme dizziness, still experiencing it. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the event and included treatment with ondansetron (ZOFRAN) and dimenhydrinate (DRAMAMINE). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event 36 hours after shot woke up with extreme dizziness, still experiencing it was not resolved at the time of this report.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: One family member who is dying today after being taken off the ventilator. The dying family member was vaccinated with the Pfizer vaccine; This is a spontaneous report from a Pfizer sponsored program CEP 159558.. A non-contactable consumer reported that a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported.  Reporter was concerned about taking the vaccine, she has a few family members who took the vaccine and got sick afterwards and has one family member who is dying today after being taken off the ventilator. The dying family member was vaccinated with the Pfizer vaccine. Read beginning of ISI. Reporter disconnected, had to take a call from family member about dying family member. Will fax AE to report family members sick and family member dying after vaccine. Event onset date was 22Sep2021. It was not reported if Autopsy Done. The outcome of the event was fatal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: One family member who is dying today after being taken off the ventilator. The dying family member was vaccinated with the Pfizer vaccine
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Intermenstrual bleeding
Clinical narrative: Menstrual spotting; Menstrual spotting and cramping; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Sep2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  Concomitant medication included prucalopride succinate (MOTEGRITY) for an unknown indication from an unknown date and unknown if ongoing. On an unknown date in Sep2021, the patient experienced menstrual spotting and cramping. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events menstrual spotting and cramping was not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Flatulence, Headache, Hypokinesia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 30-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 30, via an unspecified route of administration, left arm, on Sep 18, 2021, at 13:00, single dose, for COVID-19 immunisation. The patient has no medical history or known allergies. Prior to the vaccination, patient was not diagnosed with COVID-19. Concomitant medications reported as not applicable. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On Sep 18, 2021, at 19:00, patient could not raise her left arm high as it was so sore. She had real bad fatigue, a migraine for about 6 or so hours after she got the shot and off and on headache. The patient was very nauseous for three days and had a build-up of gas after the shot. The patient also had chills since she got it, sore throat and she felt like a cold. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, patient has not tested for COVID-19. No therapeutic measures taken as a result of the events. The outcome of nausea recovered on Sep 21, 2021 (duration of 3 days). The clinical outcome of could not raise her left arm high as it was so sore, real bad fatigue, migraine, off and on headache, build-up of gas, chills since she got it, sore throat and felt like a cold: not recovered at the time of report. The batch/lot numbers for, BNT162B2, not provided and will be requested during follow-up.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nasopharyngitis, Nausea, Oropharyngeal pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 30-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 30, via an unspecified route of administration, left arm, on Sep 18, 2021, at 13:00, single dose, for COVID-19 immunisation. The patient has no medical history or known allergies. Prior to the vaccination, patient was not diagnosed with COVID-19. Concomitant medications reported as not applicable. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On Sep 18, 2021, at 19:00, patient could not raise her left arm high as it was so sore. She had real bad fatigue, a migraine for about 6 or so hours after she got the shot and off and on headache. The patient was very nauseous for three days and had a build-up of gas after the shot. The patient also had chills since she got it, sore throat and she felt like a cold. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, patient has not tested for COVID-19. No therapeutic measures taken as a result of the events. The outcome of nausea recovered on Sep 21, 2021 (duration of 3 days). The clinical outcome of could not raise her left arm high as it was so sore, real bad fatigue, migraine, off and on headache, build-up of gas, chills since she got it, sore throat and felt like a cold: not recovered at the time of report. The batch/lot numbers for, BNT162B2, not provided and will be requested during follow-up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia
Clinical narrative: Heartburn; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 09Apr2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies to penicillin and sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 10Apr2021, the patient experienced heartburn. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the event which included treatment with unspecified antacid and omeprazole (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event heartburn was resolved on an unspecified date in 2021. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the right arm on 30Apr2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: Tinnitus increased to 4 sounds; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the left arm on 18Aug2021 at 15:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included tinnitus and allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were reported as not applicable (N/A). On 24Aug2021 at 06:30, the patient experienced tinnitus increased to 4 sounds. 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. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient underwent COVID-19 test via nasal swab and the result was unknown. The clinical outcome of the event tinnitus increased to 4 sounds was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 34, via an unspecified route of administration, left arm, on Sep 16, 2021, at 16:00, single dose, for COVID-19 immunisation. No medical history or allergies reported. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 34, via an unspecified route of administration, right arm, on Aug 24, 2021, at 10:00, single dose, for COVID-19 immunisation. On Sep 17, 2021, at 09:00 (the following day of vaccination), patient experienced pruritis (itching all over body but primarily torso and back). It became worse during the night. It persisted for a week and slowly became more mild. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures taken as a result of the events. Since the vaccination, patient has not tested for COVID-19. The outcome of pruritis (itching all over body but primarily torso and back): recovering at the time of the report. The lot number for BNT162B2 not provided and will be requested during follow-up.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: Vomiting several times in a short amount of time; Severe headache; Fever; 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 right arm on 22Sep2021 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose 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. On 23Sep2021 at 04:45, the patient experienced vomiting several times in a short amount of time, severe headache and fever.  It was unknown whether therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vomiting several times, severe headache and fever were resolving at the time of reporting.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gastrooesophageal reflux disease, Non-cardiac chest pain, SARS-CoV-2 test, Vomiting
Clinical narrative: Exasperated GERD/ increased episodes of reflux; Reflux related chest pain.; Increased episodes of vomiting; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the left arm on 02Sep2021 at 09:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic gastro-oesophageal reflux disease (GERD) which was ongoing. It was unknown if the patient had any allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included proton pump inhibitor (PPI) omeprazole (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 03Sep2021 at 00:00, the patient experienced exasperated GERD symptoms such as increased episodes of vomiting, increased episodes of reflux, reflux induced vomiting, and reflux related chest pain. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with an increased dose of unspecified PPI. Since the vaccination, the patient had been tested for COVID-19. On 10Sep2021, the patient underwent a nasal swab test and the result was negative. The clinical outcome of the event exasperated GERD/ increased episodes of reflux, increased episodes of vomiting, reflux related chest pain was unknown at the time of this report.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Chest pain, Condition aggravated, Diarrhoea, Dyspnoea
Clinical narrative: Exasperated GERD/ increased episodes of reflux; Reflux related chest pain.; Increased episodes of vomiting; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the left arm on 02Sep2021 at 09:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic gastro-oesophageal reflux disease (GERD) which was ongoing. It was unknown if the patient had any allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included proton pump inhibitor (PPI) omeprazole (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 03Sep2021 at 00:00, the patient experienced exasperated GERD symptoms such as increased episodes of vomiting, increased episodes of reflux, reflux induced vomiting, and reflux related chest pain. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with an increased dose of unspecified PPI. Since the vaccination, the patient had been tested for COVID-19. On 10Sep2021, the patient underwent a nasal swab test and the result was negative. The clinical outcome of the event exasperated GERD/ increased episodes of reflux, increased episodes of vomiting, reflux related chest pain was unknown at the time of this report.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gastrooesophageal reflux disease, Vomiting
Clinical narrative: Exasperated GERD/ increased episodes of reflux; Reflux related chest pain.; Increased episodes of vomiting; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the left arm on 02Sep2021 at 09:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic gastro-oesophageal reflux disease (GERD) which was ongoing. It was unknown if the patient had any allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included proton pump inhibitor (PPI) omeprazole (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 03Sep2021 at 00:00, the patient experienced exasperated GERD symptoms such as increased episodes of vomiting, increased episodes of reflux, reflux induced vomiting, and reflux related chest pain. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with an increased dose of unspecified PPI. Since the vaccination, the patient had been tested for COVID-19. On 10Sep2021, the patient underwent a nasal swab test and the result was negative. The clinical outcome of the event exasperated GERD/ increased episodes of reflux, increased episodes of vomiting, reflux related chest pain was unknown at the time of this report.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Body temperature, Diarrhoea, Headache, Myalgia
Clinical narrative: Severe pain in abdomen; Severe body/muscle pain; Severe body/muscle pain; Fever 102; Vomiting; Diarrhea; Facial swelling; Severe headache; This is a spontaneous report from a contactable other healthcare professional, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the left arm on 21Sep2021 at 12:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included common variable immunodeficiency, non-converter of vaccines, COVID-19 and allergy to penicillin (PCN). Prior to the vaccination, the patient was diagnosed with COVID-19. Prior the vaccination, the patient had been tested for COVID-19. On 13Sep2021, the patient underwent COVID-19 test via nasal swab and the result was negative. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received influenza vaccine (FLU) for immunisation on an unknown date and experienced allergy. The patient previously also received midazolam hydrochloride (VERSED), pethidine hydrochloride (DEMEROL) and clarithromycin (BIAXIN); all for unknown indication and experienced drug allergy.  On 22Sep2021 at 14:30, the patient experienced severe pain in abdomen, severe body pain/ muscle pain, fever 102 (unspecified units), vomiting/diarrhea, facial swelling and severe headache. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the events severe pain in abdomen, severe body pain/muscle pain, fever 102 (unspecified units), vomiting/diarrhea, facial swelling and severe headache was not resolved at the time of this report.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test, Swelling face, Vomiting
Clinical narrative: Severe pain in abdomen; Severe body/muscle pain; Severe body/muscle pain; Fever 102; Vomiting; Diarrhea; Facial swelling; Severe headache; This is a spontaneous report from a contactable other healthcare professional, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the left arm on 21Sep2021 at 12:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included common variable immunodeficiency, non-converter of vaccines, COVID-19 and allergy to penicillin (PCN). Prior to the vaccination, the patient was diagnosed with COVID-19. Prior the vaccination, the patient had been tested for COVID-19. On 13Sep2021, the patient underwent COVID-19 test via nasal swab and the result was negative. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received influenza vaccine (FLU) for immunisation on an unknown date and experienced allergy. The patient previously also received midazolam hydrochloride (VERSED), pethidine hydrochloride (DEMEROL) and clarithromycin (BIAXIN); all for unknown indication and experienced drug allergy.  On 22Sep2021 at 14:30, the patient experienced severe pain in abdomen, severe body pain/ muscle pain, fever 102 (unspecified units), vomiting/diarrhea, facial swelling and severe headache. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the events severe pain in abdomen, severe body pain/muscle pain, fever 102 (unspecified units), vomiting/diarrhea, facial swelling and severe headache was not resolved at the time of this report.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Back pain, Chest discomfort, Chills
Clinical narrative: Lost sense of taste; Lost sense of smell; Chest tightness; upper back pain; light congestion; tiredness; headache; muscle pain; chills; feeling unwell; This is a spontaneous report from a contactable consumer (patient reported himself). A male patient of an unspecified age received first dose of BNT162B2 (COVID 19, Pfizer, Formulation: Solution for injection, Lot number: EL9261) via an unspecified route of administration on 22Jan2021 03:30 PM to left arm at single dose for covid-19 immunization. The patient's medical history and known allergies were reported none. Concomitant medication included diphtheria vaccine toxoid/tetanus vaccine toxoid (TD) on 09Jan2021 to his left arm (other vaccine in four weeks). No Covid prior and post vaccination. On 23Jan2021 06.00 PM, the patient experienced chest sightedness/upper back pain, light congestion, tiredness, headache, muscle pain, chills and feeling unwell; on 26Jan2021, lost sense of smell, and on 28Jan2021 lost sense of taste. The patient did not take any treatment in response to the events. Outcome of the events was recovering.  Follow-up (07May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Myalgia, Nasal congestion
Clinical narrative: Lost sense of taste; Lost sense of smell; Chest tightness; upper back pain; light congestion; tiredness; headache; muscle pain; chills; feeling unwell; This is a spontaneous report from a contactable consumer (patient reported himself). A male patient of an unspecified age received first dose of BNT162B2 (COVID 19, Pfizer, Formulation: Solution for injection, Lot number: EL9261) via an unspecified route of administration on 22Jan2021 03:30 PM to left arm at single dose for covid-19 immunization. The patient's medical history and known allergies were reported none. Concomitant medication included diphtheria vaccine toxoid/tetanus vaccine toxoid (TD) on 09Jan2021 to his left arm (other vaccine in four weeks). No Covid prior and post vaccination. On 23Jan2021 06.00 PM, the patient experienced chest sightedness/upper back pain, light congestion, tiredness, headache, muscle pain, chills and feeling unwell; on 26Jan2021, lost sense of smell, and on 28Jan2021 lost sense of taste. The patient did not take any treatment in response to the events. Outcome of the events was recovering.  Follow-up (07May2021): Follow-up attempts completed. No further information expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Itching sore arm; Itching sore arm; The initial case was missing the following minimum criteria: No Adverse Effect. Upon receipt of follow-up information on (12Mar2021), this case now contains all required information to be considered valid. This is a spontaneous report from a Pfizer-sponsored program a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular route on 05Feb2021 (Lot Number: F2L8982, Expiration date: Not reported) as dose 1, single (at the age of 77-years-old) and on 06Mar2021 (Lot Number: EP6955, Expiration date: Not reported) as dose 2, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included allergy shots for allergy in the left arm. The patient experienced itching sore arm on 05Feb2021. No treatment was received by the patient for these events. The patient also had the same events on 06Mar2021 after the second vaccination. These events were considered as non-serious and the outcome of events was recovered in Feb2021 since reported as 2 plus days.   No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Vaccination site pain
Clinical narrative: Very sore left arm; body aches; headache; chills; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN6201, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 20Feb2021 at 16:30 (at the age of 78-years-old) as dose 2, single for COVID-19 immunisation. Medical history included arthritis, high blood pressure, and high cholesterol. The patient previously took codeine and experienced allergy. The patient's concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection; Lot number: EL9262, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 30Jan2021 at 16:30 (at the age of 78-years-old) for COVID-19 immunisation. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. On 20Feb2021 at 20:00, the patient experienced very sore left arm, body aches, headache, and chills. Therapeutic measures were taken as a result of the events which included paracetamol (TYLENOL). Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Feb2021.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Thirst
Clinical narrative: headache; increased thirst; This is a spontaneous report from a non-contactable consumer (patient). An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, it was unknown if the patient has been diagnosed with COVID-19 and post vaccination, it was unknown if the patient has been tested for COVID-19. On an unspecified date, the patient experienced headache and increased thirst. It was reported that it persist for one day. It was unknown if the patient received therapeutic measures. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tired the next morning after the second shot; This is a spontaneous report from a non-contactable other healthcare professional (patient) received via Regulatory Authority. A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 16Feb2021 (Lot Number: EN5318; at the age of 26 years old) as dose 2, single for COVID-19 immunisation. Medical history included COVID-19. She was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. She did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162B2 on 26Jan2021, administered in the left arm on 26Jan2021 (Lot Number: EN5318; at the age of 26 years old) for COVID-19 immunisation and experienced sore arm. On 17Feb2021, the patient experienced tired the next morning after the second shot. She has not been tested for COVID-19 since the vaccination. No therapeutic measures were taken as a result of the event. The patient recovered from the event on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Feeling hot
Clinical narrative: patch of red; patch of red/ mildly warm; This is a spontaneous report from a contactable consumer (patient) received via. An 88-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm, on 19Feb2021 at 04:30 PM (Lot Number: EN6200) (at the age of 88 years old) as dose 2, single for COVID-19 immunisation in a hospital. Medical history included hernia from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient has no known allergies. Concomitant medications included lisinopril; lovastatin; hydrochlorothiazide; atenolol (ATENO), all taken for an unspecified indication, start and stop date were not reported. The patient was previously administered the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm, on 29Jan2021 at 05:00 PM (Lot Number: EN9581) (at the age of 88 years old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Feb2021, the patient reported that about two inches down the arm from the injection site toward the elbow, there was a patch of red about three inches by three and one-half inches, not raised, no bumps, mildly warm. The events resulted to physician office visit. The patient did not receive any treatment. The patient was recovering from the events.  No follow-up attempts are needed. No further information is expected.