chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Vertigo; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 30Mar2021 at 10:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient does not have any allergies to medications, food, or other product. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) since an unknown date and for an unknown indication. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 09Mar2021 at 10:00 (at the age of 68-years-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 COVID vaccine. On 02Apr2021, the patient experienced vertigo and dizziness. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events vertigo and dizziness was not resolved at the time of reporting.    No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dyspnoea, Fatigue, Headache, Peripheral swelling
Clinical narrative: severe headache; fatigue; Shortness of breath; swelling and rash on left leg; rash on left leg; pain upper stomach area; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the right arm on 20Mar2021 at 11:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin and pork. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), rosuvastatin (MANUFACTURER UNKNOWN) and thyro all from unknown dates for unspecified indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 27Feb2021 (at the age of 63-years-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 been tested for COVID-19. On 23Mar2021 at 15:00, the patient experienced shortness of breath, swelling and rash on left leg, severe headache, fatigue and pain upper stomach area. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with inhaler and additional oral allergy medication. On 09Apr2021, the patient underwent nasal swab test for COVID-19 and the result was negative. The clinical outcome of the events shortness of breath, swelling and rash on left leg, severe headache, fatigue and pain upper stomach area was recovered with sequelae on unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test
Clinical narrative: severe headache; fatigue; Shortness of breath; swelling and rash on left leg; rash on left leg; pain upper stomach area; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the right arm on 20Mar2021 at 11:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin and pork. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), rosuvastatin (MANUFACTURER UNKNOWN) and thyro all from unknown dates for unspecified indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 27Feb2021 (at the age of 63-years-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 been tested for COVID-19. On 23Mar2021 at 15:00, the patient experienced shortness of breath, swelling and rash on left leg, severe headache, fatigue and pain upper stomach area. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with inhaler and additional oral allergy medication. On 09Apr2021, the patient underwent nasal swab test for COVID-19 and the result was negative. The clinical outcome of the events shortness of breath, swelling and rash on left leg, severe headache, fatigue and pain upper stomach area was recovered with sequelae on unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: felt dizzy and had to go to bed earlier; arm was also sore; This is a spontaneous report from a non-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: ER2613) via an unspecified route of administration in the left arm on 05Apr2021 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to chamomile. Concomitant medications were not reported. Prior to the vaccination, the patient was not tested positive for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Apr2021, 3-4 hours after receiving the vaccine, the patient felt dizzy and had to go to bed earlier than she normally did and arm was also sore. 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, emergency room/department or urgent care. The clinical outcome of the event felt dizzy and had to go to bed earlier was recovered in 2021. The clinical outcome of the event arm was also sore was recovered on 06Apr2021.   No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelids pruritus, Pruritus, Rash erythematous
Clinical narrative: Red itchy eyelids; Red raised rash on face and upper chest; Itchy; This is a spontaneous report from a contactable nurse, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: TP7533) via an unspecified route of administration in the left arm on 10Apr2021 at 13:45 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol, environmental allergy, toothpaste allergy and cosmetic allergy. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), gliclazide (DIAZIDE), cetirizine hydrochloride (ZYRTEC), montelukast sodium (SINGULAIR) and atorvastatin calcium (ATORVAS) on unknown date for unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: END6805) via an unspecified route of administration in the left arm on 20Mar2021 at 12:15 (at the age of 56-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 COVID vaccine. On 10Apr2021 the patient experienced red itchy eyelids, red raised rash on face and upper chest and itchy that had lasted 3 days so far. Therapeutic measures were taken as a result of events which included treatment with hydrocortisone (2.5), Benadryl and allergy medications. The clinical outcome of the events red itchy eyelids, red raised rash on face and upper chest and itchy was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Mild dizziness; Headache; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration on 23Mar2021 at 09:00 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications included lisdexamfetamine mesilate (VYVANSE) for unknown indication from an unknown date and unknown if ongoing. 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 24Mar2021 at 14:00 the patient experienced headache and mild dizziness. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event mild dizziness and headache was recovered on an unknown date in 2021. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration on 13Apr2021 (at the age of 26-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vitreous floaters
Clinical narrative: Seeing floaters in my vision all of a sudden.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ew0153) via an unspecified route of administration in the right arm on 09Apr2021 at 15:30(at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient had no known allergies to medications, food, or other products. It was not reported whether the patient had received any other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er2613) via an unspecified route of administration in the left arm on 20Mar2021 at 13:00(at the age of 37-years-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 12Apr2021 at 13:00, the patient experienced floaters in her vision all of a sudden. 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 event seeing floaters in vision all of a sudden was not resolved at the time of report.   No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Pain
Clinical narrative: Flu-like symptoms; achiness; severe chills; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 08Apr2021 at 09:00 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included none. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) for unknown indication from unknown start date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient not had any known allergies to medication, food or any other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 18Mar2021 at 09:00 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. On 08Apr2021 at 12:00 the patient experienced Flu-like symptoms - achiness, fatigue, severe chills and they lasted approximately 12 hours. 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 the events. The clinical outcome of the events Flu-like symptoms - achiness, fatigue, severe chills were recovered on 09Apr2021, approximately after the duration of 12 hours.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: began having very bad diarrhea about 7 days after first dose of the Pfizer vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 02Apr2021 at 10:00 (at the age of 46-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included escitalopram oxalate (LEXAPRO) and quetiapine fumarate (SEROQUEL); both for unspecified indication from unknown date and unknown if still ongoing. 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. The patient had no known allergies to medications, food or other products. The clinical course was reported as follows: on 08Apr2021 at 08:00, about 7 days after first dose of the Pfizer vaccine, the patient experienced very bad diarrhea. 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 event. The clinical outcome of the event very bad diarrhea was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Feeling of body temperature change, Headache
Clinical narrative: Extreme pain at injection site; Extreme pain spreading up through neck; Extreme pain spreading down to fingertips on same arm; fever (101); Alternating periods of overheating extreme cold; fatigue; severe headache; severe body pain; Shoulder pain and joint pain.; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 09Apr2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines. The patient was allergic to penicillin and sulfa. Concomitant medications included ibuprofen (MOTRIN). The patient previously received  the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 19Mar2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient also previously received clindamycin (MANUFACTURER UNKNOWN) 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 10Apr2021, less than 24 hours after injection, the patient experienced extreme pain at injection site spreading up through neck and down to fingertips on same arm, fever, alternating periods of overheating and extreme cold, fatigue, severe headache, severe body and joint pain. Then four days post injection, arm and should pain, stabbing pains through neck and finger tips, persistent headache and fatigue were ongoing. On the same day, the patient underwent body temperature measurement and result was 101 (unspecified units). 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 reported events which included treatment with MOTRIN and ice packs. The patient took rest, liquids, applied ice packs for overheating and extra layers when very cold. The clinical outcomes of the events extreme pain at injection site spreading up through neck and down to fingertips on same arm, shoulder pain, fever, alternating periods of overheating and extreme cold, fatigue, severe headache, severe body and joint pain were resolving.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: Extreme pain at injection site; Extreme pain spreading up through neck; Extreme pain spreading down to fingertips on same arm; fever (101); Alternating periods of overheating extreme cold; fatigue; severe headache; severe body pain; Shoulder pain and joint pain.; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 09Apr2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines. The patient was allergic to penicillin and sulfa. Concomitant medications included ibuprofen (MOTRIN). The patient previously received  the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 19Mar2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient also previously received clindamycin (MANUFACTURER UNKNOWN) 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 10Apr2021, less than 24 hours after injection, the patient experienced extreme pain at injection site spreading up through neck and down to fingertips on same arm, fever, alternating periods of overheating and extreme cold, fatigue, severe headache, severe body and joint pain. Then four days post injection, arm and should pain, stabbing pains through neck and finger tips, persistent headache and fatigue were ongoing. On the same day, the patient underwent body temperature measurement and result was 101 (unspecified units). 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 reported events which included treatment with MOTRIN and ice packs. The patient took rest, liquids, applied ice packs for overheating and extra layers when very cold. The clinical outcomes of the events extreme pain at injection site spreading up through neck and down to fingertips on same arm, shoulder pain, fever, alternating periods of overheating and extreme cold, fatigue, severe headache, severe body and joint pain were resolving.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash vesicular, SARS-CoV-2 test
Clinical narrative: Rash; Vesicular cluster of eruptions on left mid axillary line and near the epigastrium on the left in a dermatomal fashion; This is a spontaneous report from a contactable pharmacist. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via intramuscular route of administration in the right arm on 01Apr2021 at 12:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient was allergic to sulfa drugs. Concomitant medications included Multi Vitamin Injection (MVI) (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC), both taken for unspecified indications from unknown dates. The patient previously took clarithromycin and experienced drug allergy. 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 28Dec2020, the patient underwent COVID-19 test Polymerase Chain Reaction (PCR) and the result was negative. 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 05Apr2021, the patient experienced rash, vesicular cluster of eruptions on left mid axillary line and near the epigastrium on the left in a dermatomal fashion. She denied any pain prior to the eruption. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the  event and included treatment with valacyclovir and Hydrocortisone (HC) cream. The clinical outcome of the event rash and vesicular cluster of eruptions on left mid axillary line and near the epigastrium on the left in a dermatomal fashion was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature, Dizziness, Lymphadenopathy, Pyrexia
Clinical narrative: Large red itchy patch at injection site, started small and is now the size of a softball.; Large red itchy patch at injection site, started small and is now the size of a softball.; Injection site was very raised and painful also.; Injection site was very raised and painful also.; Had dizziness and a 102 fever for 2.5 days; Had dizziness and a 102 fever for 2.5 days; Had swollen lymph node in left armpit and armpit pain.; Had swollen lymph node in left armpit and armpit pain.; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8734) via an unspecified route of administration in the left arm on 07Apr2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient previously took penicillin for unknown indication and experienced penicillin allergy. Concomitant medications taken within two weeks of vaccination included fluoxetine hydrochloride (PROZAC), spironolactone (MANUFACTURER UNKNOWN) and buspirone hydrochloride (BUSPAR) all from unknown date for unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ep7534) via an unspecified route of administration in the left arm on 17Mar2021 at 13:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. 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 08Apr2021 at 06:00, the patient experienced large red itchy patch at injection site, started small and was the size of a softball at the time of report. Injection site was very raised and painful also. The patient had dizziness and a 102 (units unspecified) fever for 2.5 days. The patient had swollen lymph node in left armpit and armpit pain. It had been 6 days post injection at the time of report and most symptoms had subsided except pain/redness/itchiness at injection site. The current remaining symptoms were mild. 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. Since the vaccination, the patient had been tested for COVID-19. The patient underwent Rapid test for COVID-19 via nasal swab on 10Apr2021 and the result was negative. The clinical outcome of the events large red itchy patch at injection site, started small and was the size of a softball at the time of report, injection site was very raised and painful also, dizziness and a 102 (units unspecified) fever for 2.5 days, swollen lymph node in left armpit and armpit pain was resolving at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Large red itchy patch at injection site, started small and is now the size of a softball.; Large red itchy patch at injection site, started small and is now the size of a softball.; Injection site was very raised and painful also.; Injection site was very raised and painful also.; Had dizziness and a 102 fever for 2.5 days; Had dizziness and a 102 fever for 2.5 days; Had swollen lymph node in left armpit and armpit pain.; Had swollen lymph node in left armpit and armpit pain.; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8734) via an unspecified route of administration in the left arm on 07Apr2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient previously took penicillin for unknown indication and experienced penicillin allergy. Concomitant medications taken within two weeks of vaccination included fluoxetine hydrochloride (PROZAC), spironolactone (MANUFACTURER UNKNOWN) and buspirone hydrochloride (BUSPAR) all from unknown date for unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ep7534) via an unspecified route of administration in the left arm on 17Mar2021 at 13:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. 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 08Apr2021 at 06:00, the patient experienced large red itchy patch at injection site, started small and was the size of a softball at the time of report. Injection site was very raised and painful also. The patient had dizziness and a 102 (units unspecified) fever for 2.5 days. The patient had swollen lymph node in left armpit and armpit pain. It had been 6 days post injection at the time of report and most symptoms had subsided except pain/redness/itchiness at injection site. The current remaining symptoms were mild. 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. Since the vaccination, the patient had been tested for COVID-19. The patient underwent Rapid test for COVID-19 via nasal swab on 10Apr2021 and the result was negative. The clinical outcome of the events large red itchy patch at injection site, started small and was the size of a softball at the time of report, injection site was very raised and painful also, dizziness and a 102 (units unspecified) fever for 2.5 days, swollen lymph node in left armpit and armpit pain was resolving at the time of report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: she's experiencing a little bit of fever and muscle ache; she's experiencing a little bit of fever and muscle ache; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) reported for herself. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: unknown, expiry date: unknown) via unspecified route of administration on 08Apr2021 as dose 1, single for Covid-19 immunisation. Patients medical history and concomitant medications were not reported. The patient was asking what medicine she could take since she was experiencing a little bit of fever and muscle ache on an unspecified date. The patient also asked if it was okay to take Ibuprofen. The outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Dizziness, Ear discomfort, Vision blurred
Clinical narrative: Vision went very blurry/could not see anything in front; Splotchy almost. Black and white; Felt dizzy; Right ear was affected, underwater like; Blood pressure 79/50 and again 70/48/ Which is very low for me; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 05Apr2021 at 10:30 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic cough due to GERD (gastroesophageal reflux disease)/silent reflux (currently under Dr's care for that), GERD and COVID-19. Concomitant medications included pantoprazole (MANUFACTURER UNKNOWN), famotidine (MANUFACTURER UNKNOWN), rosuvastatin (MANUFACTURER UNKNOWN) and gabapentin (MANUFACTURER UNKNOWN) for unknown indication and from an unknown date. The patient previously received Z-PACK (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the arm left on 09Mar2021 at 09:30 (at the age of 61-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 06Apr2021 at 09:30, the morning after the shot the patient was sitting in bed, and her Vision went very blurry/could not see anything in front. Splotchy almost. Black and white. The patient felt dizzy too. The patient right ear was affected, underwater like. The patient thought it lasted about 2 minutes then passed. That happened two more times. The patient checked the blood pressure (BP) shortly after, and it was 79/50 (unspecified units) and again 70/48 (unspecified units). Which was very low for the patient. The patient had just been to the doctor the day before and BP was excellent. The patient had done nothing out of the ordinary for morning routine. It happened 3 times and then it never happened again. 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. The clinical outcome of the events vision went very blurry/could not see anything in front, right ear was affected, underwater like, blood pressure 79/50 and again 70/48, splotchy almost. Black and white and felt dizzy was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Vision went very blurry/could not see anything in front; Splotchy almost. Black and white; Felt dizzy; Right ear was affected, underwater like; Blood pressure 79/50 and again 70/48/ Which is very low for me; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 05Apr2021 at 10:30 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic cough due to GERD (gastroesophageal reflux disease)/silent reflux (currently under Dr's care for that), GERD and COVID-19. Concomitant medications included pantoprazole (MANUFACTURER UNKNOWN), famotidine (MANUFACTURER UNKNOWN), rosuvastatin (MANUFACTURER UNKNOWN) and gabapentin (MANUFACTURER UNKNOWN) for unknown indication and from an unknown date. The patient previously received Z-PACK (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the arm left on 09Mar2021 at 09:30 (at the age of 61-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 06Apr2021 at 09:30, the morning after the shot the patient was sitting in bed, and her Vision went very blurry/could not see anything in front. Splotchy almost. Black and white. The patient felt dizzy too. The patient right ear was affected, underwater like. The patient thought it lasted about 2 minutes then passed. That happened two more times. The patient checked the blood pressure (BP) shortly after, and it was 79/50 (unspecified units) and again 70/48 (unspecified units). Which was very low for the patient. The patient had just been to the doctor the day before and BP was excellent. The patient had done nothing out of the ordinary for morning routine. It happened 3 times and then it never happened again. 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. The clinical outcome of the events vision went very blurry/could not see anything in front, right ear was affected, underwater like, blood pressure 79/50 and again 70/48, splotchy almost. Black and white and felt dizzy was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Epistaxis, Headache, Lethargy, Nausea
Clinical narrative: Headaches; Chills; Lethargy; Nausea; Nosebleeds; 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: EW0153) via an unspecified route of administration in the left arm on 05Apr2021 at 14:15 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications included fish oil (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 15Mar2021 at 14:15 (at the age of 25-years-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 06Apr2021 at 04:00, the patient experienced headaches, chills, lethargy, nausea, nosebleeds. 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 events. The clinical outcome of the events headaches, chills, lethargy, nausea, nosebleeds was recovered with sequelae.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: Gout, big toe, flare up.  worse one so far; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 08Apr2021 (at the age of 50-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. 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 COVID vaccine. On 09Apr2021, the patient experienced gout, big toe, flare up which was worse one so far. 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 gout, big toe, flare up, worse one so far was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: abd. cramps/abdomen still feels "touchy"; diarrhea; chills; loss of appetite; sore throat; fatigue; Sore injection site; right arm pain; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8729), via an unspecified route of administration in the left arm on 08Apr2021 at 10:45 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, thoracic aortic aneurysm, septic shock survivor on 2019, secondary to pyelonephritis and kidney stone, hip and knee replacement surgeries secondary to osteoarthritis and obesity. The patient received unspecified medication within two weeks of vaccination. The patient had allergic to (unspecified ) medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 14:00, the patient experienced sore injection site and right arm pain first 2 days. On 11Apr2021, 3rd day after vaccination, the patient experienced Abd. cramps, diarrhea, chills, loss of appetite, sore throat, fatigue. The patient also reported that, 6th day since vaccination, and she was still not back to 100%, still fatigued, and abdomen still feels "touchy", appetite slowly improving and no fever through all this. No therapeutic measures were taken as the result of adverse events. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events sore injection site and right arm pain, Abd. cramps, diarrhea, chills, loss of appetite, sore throat and fatigue was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity, Vaccination site pain
Clinical narrative: abd. cramps/abdomen still feels "touchy"; diarrhea; chills; loss of appetite; sore throat; fatigue; Sore injection site; right arm pain; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8729), via an unspecified route of administration in the left arm on 08Apr2021 at 10:45 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, thoracic aortic aneurysm, septic shock survivor on 2019, secondary to pyelonephritis and kidney stone, hip and knee replacement surgeries secondary to osteoarthritis and obesity. The patient received unspecified medication within two weeks of vaccination. The patient had allergic to (unspecified ) medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 14:00, the patient experienced sore injection site and right arm pain first 2 days. On 11Apr2021, 3rd day after vaccination, the patient experienced Abd. cramps, diarrhea, chills, loss of appetite, sore throat, fatigue. The patient also reported that, 6th day since vaccination, and she was still not back to 100%, still fatigued, and abdomen still feels "touchy", appetite slowly improving and no fever through all this. No therapeutic measures were taken as the result of adverse events. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events sore injection site and right arm pain, Abd. cramps, diarrhea, chills, loss of appetite, sore throat and fatigue was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: Headache; Dizziness; Body aches; Chills; Exhaustion; Brain fog; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 12Apr2021 at 15:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications of the patient were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 23Mar2021 at 14:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 19:00, the patient experienced headache, dizziness, body aches, chills, exhaustion and brain fog. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of headache, dizziness, body aches, chills, exhaustion and brain fog was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Headache; Dizziness; Body aches; Chills; Exhaustion; Brain fog; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 12Apr2021 at 15:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications of the patient were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 23Mar2021 at 14:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 19:00, the patient experienced headache, dizziness, body aches, chills, exhaustion and brain fog. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of headache, dizziness, body aches, chills, exhaustion and brain fog was recovering 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: Abdominal discomfort, Abdominal pain, Back pain, Fatigue, Vaccination site pain
Clinical narrative: Upset stomach; lower abdominal cramps; back ache; Pain at the injection site; tireness; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the right arm on 09Apr2021 at 10:45 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any medication within two weeks of vaccination. The patient previously took Epinephrine (MANUFACTURER UNKNOWN) started on unknown date and experienced drug 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 12Apr2021 at 06:30 the patient experienced upset stomach, lower abdominal cramps, back ache, pain at the injection site and tiredness. No therapeutic measures were taken as a result of the reported 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 events upset stomach, lower abdominal cramps, back ache, pain at the injection site and tiredness were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.