chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain for approx. 18 hours and extremely sore arm for 24 hours; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 10Mar2021 at 12:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history was 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. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), montelukast sodium (SINGULAIR), ascorbic acid (VITAMIN C) and vitamin d nos (VITAMIN D), HB medicine (MANUFACTURER UNKNOWN) and ; all were taken for unknown indication from an unknown date and unknown if ongoing. On 11Mar2021 at 01:00, the patient experienced arm pain for approx. 18 hours and extremely sore arm for 24 hours. 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 event arm pain for approx. 18 hours and extremely sore arm for 24 hours was recovered on an unknown date in Mar2021.     No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm on the second day; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6d07) via an unspecified route of administration in the left arm on 10Mar2021 at 16:30 (at the age of 59-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 11Mar2021 at 13:00, on the second day of vaccination, the patient experienced sore arm. 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 sore arm was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: chills; body aches; This is a spontaneous report from a contactable consumer. A male patient of unknown age received 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. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. On 11Mar2021, the patient experienced chills and body aches. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events chills and body aches was unknown at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm is sore at injection site; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 11Mar2021 at 12:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies to medications, food, or other products. 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. On 11Mar2021 at 14:00, the patient experienced arm was sore at injection site. 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 arm was sore at injection site was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: Extreme fatigue; Nausea; This is a spontaneous report from a contactable consumer. A 71-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 05Mar2021 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. 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. 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 11Feb2021 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. On 07Mar2021, the patient experienced extreme fatigue and nausea. 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 not been tested for COVID-19. The clinical outcome of the event extreme fatigue and nausea was recovered on an unknown date in Mar2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm for that day and then the next morning.; This is a spontaneous report from a contactable physician, the patient. A 73-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Feb2021 at 16:15 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and hypercholesteremia. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Feb2021 at 16:15, the patient experienced sore arm for that day and then the next morning. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore arm for that day and then the next morning was recovered on an unknown date in 2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Burning sensation, Fatigue, Neurological symptom
Clinical narrative: Intense burning on the palms of my hands and the soles of my feet; Slight increase in temperature, around 3 degrees; Very painful neurological reaction; Soreness at injection site; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 74-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 10Mar2021 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. Medical history included Kienbock's syndrome. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received codeine (MANUFACTURER UNKNOWN) from an unknown date and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) taken for unknown indication from an unknown start date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: L9266) via an unspecified route of administration in the right arm on 16Feb2021 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. On 10Mar2021, 12 hours after vaccination, the patient was awoken by intense burning on the palms of hands and the soles of her feet, which lasted around 9 hours. The patient had slight increase in temperature, around 3 degrees, but not a real fever. The patient had very painful neurological reaction. No other intense reactions just the usual soreness at injection site and some fatigue. 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. On 10Mar2021, the patient underwent body temperature test and the result was increase in temperature, around 3 degrees (units unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event intense burning on the palms of her hands and the soles of feet, slight increase in temperature, around 3 degrees, very painful neurological reaction, soreness at injection site and fatigue was resolved on an unknown date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Intense burning on the palms of my hands and the soles of my feet; Slight increase in temperature, around 3 degrees; Very painful neurological reaction; Soreness at injection site; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 74-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 10Mar2021 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. Medical history included Kienbock's syndrome. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received codeine (MANUFACTURER UNKNOWN) from an unknown date and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) taken for unknown indication from an unknown start date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: L9266) via an unspecified route of administration in the right arm on 16Feb2021 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. On 10Mar2021, 12 hours after vaccination, the patient was awoken by intense burning on the palms of hands and the soles of her feet, which lasted around 9 hours. The patient had slight increase in temperature, around 3 degrees, but not a real fever. The patient had very painful neurological reaction. No other intense reactions just the usual soreness at injection site and some fatigue. 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. On 10Mar2021, the patient underwent body temperature test and the result was increase in temperature, around 3 degrees (units unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event intense burning on the palms of her hands and the soles of feet, slight increase in temperature, around 3 degrees, very painful neurological reaction, soreness at injection site and fatigue was resolved on an unknown date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams
Clinical narrative: As soon as I closed my eyes I had vivid dreams. I'd wake up and go back to sleep quickly and have vivid dreams again; This is a spontaneous report from a contactable pharmacist, the patient. A 40-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 right arm on 10Mar2021 at 18:30 (at the age of 40-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food, or other products. 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. On 10Mar2021 at 21:15, as soon as patient closed eyes, had vivid dreams and patient would wake up and go back to sleep quickly and would have vivid dreams again. Since the vaccination, the patient had not been tested for COVID-19. 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 event. The clinical outcome of the event vivid dreams was recovered on unknown date of Mar2021 at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Had pain at the back of "my" neck starting from approximately 24 hours after the vaccine that persisted for approximately 2 days; This is a spontaneous report from a contactable healthcare professional, the patient. A 59-year-old male 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 05Mar2021 at 15:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Mar2021 at 21:00, the patient had experienced pain at the back of his neck starting from approximately 24 hours after the vaccine that persisted for approximately 2 days and then had mostly, but not completely dissipated. The event 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event had pain at the back of his neck starting from approximately 24 hours after the vaccine that persisted for approximately 2 days was resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site pruritus
Clinical narrative: The 8th day after shot injection area became very itchy again and hot; Overnight night sweats; Area around injection site is red; A lump it is currently one and 1/2 inches; Itching at injection site/ injection area became very itchy again; Soreness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 03Mar2021 at 13:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included hydrochlorothiazide/ triamterene (TRIAMTERENE HCTZ) for an unknown indication from an unknown date and unknown if ongoing. On 03Mar2021, the patient experienced soreness at injection site 3 days then itching at injection site (06Mar2021) for 2 days and then nothing. The 8th day (on 10Mar2021 at 20:00) after the shot, the injection area became very itchy again and hot. The patient also experienced overnight night sweats and the area around injection site was red, hot, itchy and a lump of one and half inches at the time of reporting. The patient also reported that, 9th day was slightly worse than 8th day. The patient hoping this was normal but she thought it was important that people know all side effects. 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. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event soreness at injection site was recovered on 05Mar2021, while that of itching at injection site/ injection area became very itchy again, hot at injection area, overnight night sweats, area around injection site is red and a lump it is currently one and 1/2 inches was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: The 8th day after shot injection area became very itchy again and hot; Overnight night sweats; Area around injection site is red; A lump it is currently one and 1/2 inches; Itching at injection site/ injection area became very itchy again; Soreness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 03Mar2021 at 13:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included hydrochlorothiazide/ triamterene (TRIAMTERENE HCTZ) for an unknown indication from an unknown date and unknown if ongoing. On 03Mar2021, the patient experienced soreness at injection site 3 days then itching at injection site (06Mar2021) for 2 days and then nothing. The 8th day (on 10Mar2021 at 20:00) after the shot, the injection area became very itchy again and hot. The patient also experienced overnight night sweats and the area around injection site was red, hot, itchy and a lump of one and half inches at the time of reporting. The patient also reported that, 9th day was slightly worse than 8th day. The patient hoping this was normal but she thought it was important that people know all side effects. 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. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event soreness at injection site was recovered on 05Mar2021, while that of itching at injection site/ injection area became very itchy again, hot at injection area, overnight night sweats, area around injection site is red and a lump it is currently one and 1/2 inches was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Migraine, Pain
Clinical narrative: Migraine; Body aches; Hot flashes; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 09Mar2021 at 12:30 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included generalised anxiety disorder and cystitis interstitial. The patient did not have a history of allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included oxybutynin hydrochloride (DITROPAN) and norethisterone acetate, ethinylestradiol, ferrous fumarate (BLISOVI 24 FE), both taken for an unspecified indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Mar2021, the patient experienced migraine, body aches and hot flashes. 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 migraine, body aches and hot flashes were recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise
Clinical narrative: Started feeling fatigue; Chills; Overall body malaise the next morning (March 11th); This is a spontaneous report from a contactable pharmacist, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an intramuscular route of administration in the left arm on 10Mar2021 at 15:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID) and doxycycline (MANUFACTURER UNKNOWN); both for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an intramuscular route of administration in the left arm on 17Feb2021 at 12:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 11Mar2021 at 09:00, the patient started feeling fatigue, chills and overall body malaise the next morning (11Mar2021) and had continued throughout the day. No actual fever. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events started feeling fatigue, chills and overall body malaise the next morning (March 11th) was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 10Feb2021 at 07:00 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included obesity. The patient had no known allergies to medications, food or other products. 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 multi-vitamin (MANUFACTURER UNKNOWN) and ibuprofen (ADVIL); both for an unknown indication, from an unknown date and unknown of ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249) via an unspecified route of administration in the left arm on an unknown date in Jan2021 at 10:00 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. On 10Feb2021 at 15:00, the patient experienced headache that started about 8 hours after receiving the second shot and continued through the next day. On 12Feb2021, 2 days after receiving the second shot, the patient experienced swelling in the lymph node in left arm pit. It was reported that the swelling gradually went down over the course of 2 weeks. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache and swelling in the lymph node in left arm pit was resolved on an unknown date in Feb2021.   No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Oral candidiasis, Oral pain, Oropharyngeal pain
Clinical narrative: Oral thrush; soreness in throat and mouth; soreness in throat and mouth; This is a spontaneous report from a non-contactable consumer, the patient. A 77-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration on 20Feb2021 (at the age of 77-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. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265) via an unspecified route of administration on 27Jan2021 (at the age of 76-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 21Feb2021, the patient experienced oral thrush after second dose and woke up with soreness in throat and mouth. Therapeutic measures were taken as a result of the events. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events oral thrush, soreness in throat and mouth was recovering (as of 11Mar2021).   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Had vertigo on the right side then before rising, Igot up carefully, during the day when I put my head down and in the evening, tilted it up to put eyedrops looked to the left, vertigo on the left side. I had to hold on to something twice; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Mar2021 at 15:45 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included eye shingles from Aug2020, neuralgia, allergy to some nuts (mild), and allergy to grass and pollen. 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 received unspecified concomitant medications. The patient previously took ciprofloxacin (MANUFACTURER UNKNOWN), methylprednisolone (MANUFACTURER UNKNOWN), cobalt (MANUFACTURER UNKNOWN) and chromium (MANUFACTURER UNKNOWN); all for unknown indication on an unknown date and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E19266) via an unspecified route of administration in the left arm on 16Feb2021 at 13:30 as a single dose for COVID-19 immunisation. On 11Mar2021, when the patient awoke at 17:00 had vertigo on the right side. Then before rising, the patient got up carefully. During the day when the patient put her head down and, in the evening, tilted it up to put eyedrops, looked to the left, vertigo on the left side. The patient had to hold on to something twice. 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 event vertigo on the right side and vertigo on the left side was unknown at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Intense stomach cramps; This is a spontaneous report from a contactable healthcare professional. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes. The patient had known allergies to sulphate and latex. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included furosemide (MANUFACTURER UNKNOWN), insulin (MANUFACTURER UNKNOWN), thyroid (ARMOUR THYROID) and potassium (MANUFACTURER UNKNOWN), all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 11Mar2021 at 13:00, the patient experienced intense stomach cramps. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the event stomach cramps was not recovered at the time of report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soar arm; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male 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 10Mar2021 at 18:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure abnormal. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included medication (unspecified) for blood pressure 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 11Mar2021 at 07:00, the patient experienced soar arm. Therapeutic measures were not taken as a result of the event. The event 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 soar arm was resolved on 11Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Arm (site of injection) sore for 48hours; Headache; This is a spontaneous report from a contactable other healthcare professional, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the right arm on 05Mar2021 at 14:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was 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 05Mar2021, the patient experienced headache which started around 8 hours after the dose and lasted for another 12 hours. On 06Mar2021 at 08:00, the patient experienced arm (site of injection) sore for 48 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the event headache which included treatment with Ibuprofen. No therapeutic measures were taken for the event arm (site of injection) sore for 48 hours. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headache was recovered on 06Mar2021. The clinical outcome of the event arm (site of injection) sore was recovered on 08Mar2021 at 08:00.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Episcleritis
Clinical narrative: After both vaccinations, I got nodular episcleritis within 2 days of the vaccines.; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 04Feb2021 at 09:45 (at the age of 65-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 04Mar2021 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The medical history included Gastroesophageal reflux disease (GERD). 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 included pravastatin (MANUFACTURER UNKNOWN) and fish oil(MANUFACTURER UNKNOWN) for unknown indications from unknown dates and unknown if ongoing. On 06Feb2021, within 2 days of the vaccine the patient experienced nodular episcleritis. The event happened after both vaccinations. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were taken as a result of the reported event and included treatment with antibiotic eye drop(unspecified) from an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event nodular episcleritis was resolving at the time of this report.    No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy
Clinical narrative: Very tired; Lethargic; This is a spontaneous report from a non-contactable consumer, the patient. A 17-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had fruit allergy to kiwi. 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 11Mar2021 at 17:00 the patient experienced very tired and lethargic after first dose. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or 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 outcomes of the events very tired and lethargic after first dose were recovering at the time of reporting.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Extreme fatigue with mild nausea and headache.; Extreme fatigue with mild nausea and headache.; Extreme fatigue with mild nausea and headache.; Increasing heat and spreading redness of the injection site peaking on day 7 post vaccination.; Increasing heat and spreading redness of the injection site peaking on day 7 post vaccination.; This is a spontaneous report from a contactable healthcare professional, the patient. A 68-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 02Mar2021 at 12:30 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included sleep apnea, enthesitis, diagnosed with breast cancer on 03Apr2021, arthritis, hypertension well controlled on Lisinopril and known allergies to bee and wasp stings and anaphylaxis 3 times in life, cause unknown each time. Prior to vaccination, the patient was not diagnosed with COVID -19. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) for hypertension from unknown date and unknown if ongoing, and vitamin d nos (VITAMIN D) from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 09Mar2021, 7 days post vaccination, the patient experienced increasing heat and spreading redness of the injection site peaking. On 10Mar2021, 8 days post vaccination, the patient experienced extreme fatigue with mild nausea and headache. On 11Mar2021, 9 days post vaccination, the patient experienced fatigue and headache and redness and heat of arm was 50% less than on day 7. 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 increasing heat and spreading redness of the injection site peaking, extreme fatigue, mild nausea and headache were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pain in extremity
Clinical narrative: Severe pain in left arm; Excessive weakness or tiredness continuously over 24hr following vaccination; Excessive weakness or tiredness continuously over 24hr following vaccination; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 10Mar2021 at 14:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included human immunodeficiency virus (HIV) undetectable. The patient had no known allergies. Concomitant medications included emtricitabine, tenofovir alafenamide fumarate, bictegravir sodium (BIKTARVY) from unknown date for unknown indication 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 10Mar2021 at 17:00, the patient experienced severe pain in left arm and excessive weakness or tiredness continuously over 24 hour following vaccination. 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, severe pain in left arm excessive weakness or tiredness continuously over 24 hour following vaccination were recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Feeling ill after second dose of Pfizer vaccine; This is a spontaneous report from a contactable consumer. A female patient of unknown age received second 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. It was unknown if patient was pregnant at the time of vaccination. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19.On 05Mar2021, it was reported that the patient needed to cancel class due to feeling ill after second dose of Pfizer vaccine. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown whether any therapeutic measures were taken as a result of the event. The clinical outcome of the event feeling ill after second dose of Pfizer vaccine was resolved an unknown date in Mar2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Extreme arm pain, cannot even lift arm or lay on it; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 42-year-old non-pregnant female patient received 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 42-year-old) as a single dose for COVID-19 immunisation. Medical history was 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. Concomitant medications included citalopram hydrobromide (CELEXA), naltrexone hydrochloride/ bupropion hydrochloride (CONTRAVE), lisinopril (MANUFACTURER UNKNOWN), vitamin d not otherwise specified (MANUFACTURER UNKNOWN) and vitamin b complex (MANUFACTURER UNKNOWN) and coq12 (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown dates and unknown if ongoing. On 07Mar2021, the patient experienced extreme arm pain that the patient couldn't even lift the arm or lay on it. The event resulted in doctor or other healthcare professional office or clinic visit. No therapeutic measures were taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extreme arm pain was not recovered 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Energy increased, Heart rate increased, Hypervigilance, Muscle tightness, Psychomotor hyperactivity
Clinical narrative: Extreme hyperactivity and alertness; Extreme hyperactivity and alertness; Heart rate is exacerbated; Arm is sore at the injection site; Neck muscles tight; enthusiastic/ the alertness and energy is concerning; This is a spontaneous report from a 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: UNKNOWN) via an unspecified route of administration in the left arm on 11Mar2021 at 14:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included alpha-gal, attention deficit-hyperactivity disorder, allergy to grains (barley) and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. On 28Feb2021, the patient underwent BinaxNow SARS-CoV-2 test (Test type: Nasal swab) and the result was negative. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included methylphenidate hydrochloride (CONCERTA) of dose 54 mg q.d and 18 mg qd and bupro (MANUFACTURER UNKNOWN); both for unknown indications from unknown dates and unknown if ongoing. On 11Mar2021 at 09:00, 7 hours post vaccination the patient experienced extreme hyperactivity and alertness, even after having consumed 20 oz of red wine (Pinot noir) to try to sleep, the patient was amazingly alert and enthusiastic. Heart rate exacerbated. The patient reported that it felt like she overdosed on ADHD medication (she did not- took all her medication at 06:30 AM EST). The arm was sore at the injection site and neck muscles tight, but the alertness and energy was concerning 7 hours later. 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 extreme hyperactivity and alertness, was amazingly alert and enthusiastic, heart rate exacerbated, arm sore at the injection site and neck muscles tight was unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.