chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Pain
Clinical narrative: nausea; loose stools; aching; This is a spontaneous report from a contactable healthcare professional, the patient. A 83-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 arm left on 25Mar2021 at 12:00 (at the age of 83-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, high cholesterol and hypertension (HTN). Concomitant medications included simvastatin (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN) and sertraline hydrochloride (SERTRAL) received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within 4 weeks prior to COVID vaccine. On 26Mar2021 at 14:00, the patient experienced nausea, loose stools and aching. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of the events nausea, loose stools and aching were not resolved at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Face numbness; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318), via an unspecified route of administration in the arm left on 01Apr2021 at 11:00 (at the age of 38-year-old), as a single dose for COVID-19 immunisation. Medical history included factor V deficiency (Factor 5 as reported). Concomitant medications included fluticasone propionate (FLONAZE) from an unknown date for an unknown indication.  The patient had no known allergies (not that I know of, as reported). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 11:15, the patient experienced face numbness from the cheeks down. The patient did not receive any treatment for the event. The clinical outcome of the event face numbness was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Cheilitis, Hypoaesthesia oral, SARS-CoV-2 test
Clinical narrative: When I woke up the morning after the second shot my upper lip was inflated and numb.; When I woke up the morning after the second shot my upper lip was inflated and numb.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on 30Mar2021 at 18.45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included hepatitis B. The patient had no known allergies. Concomitant medications included tenofovir disoproxil fumarate (VIREAD). The patient previously 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 09Mar2021 at 19:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine in four weeks prior to COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had been tested for COVID-19. On 01Apr2021 at 07.00, the patient woke up in the morning after the second shot and experienced inflated and numb upper lips which got much better by noon. The patient did not receive any treatment for the reported events. 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. On 25Mar2021, the patient have undergone nasal swab and the result of the test was negative. The clinical outcome of the events inflated and numb upper lips was resolving at the time of this report.     No further information is expected. Information about lot/batch number cannot be obtained.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph gland on left side 15 days after last vaccination.; This is a spontaneous report received from a contactable consumer, the patient. A 75-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207), via an unspecified route of administration in the left arm on 15Mar2021 at 08:00 (at the age of 75-years-old), as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD). Concomitant medications were not reported. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 22:00, the patient experienced swollen lymph gland on left side. 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 swollen lymph gland on left side. The clinical outcome of the event swollen glands was not resolved at the time of this report.  No follow-up attempts are needed; No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Significant ringing in ears got worse with second vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 63-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the arm left on 29Mar2021 at 11.00, (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm left  on 08Mar2021 at 11:00, (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient medical history included mild hypertension. The concomitant medications include Chlorthalidone (MANUFACTURER UNKNOWN) for an unknown indication from an unknown start date and unknown if ongoing. The patient had no known allergies to medications, food or other products. The patient did not receive any medication within four weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date (after receiving first dose of COVID-19 vaccination), patient experienced significant tinnitus (ringing in ears) and the clinical outcome of the event significant tinnitus was unknown. On 29Mar2021, (after receiving second dose of COVID-19 vaccination) the patient experienced significant tinnitus (ringing in ears) which had become worse after second dose. No therapeutic measures were taken for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event aggravated tinnitus was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness in the arm where injection was administered; tingling in arm where injection was administered; headache; chest pain; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8727) via an unspecified route of administration in the right arm on 27Mar2021 at 10:30 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food, or other products. Concomitant medications included sertraline hydrochloride (SERTRALINE) 25 mg daily for unknown indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01April2021 at 00:00 (4 days after the vaccination), the patient experienced numbness in the arm, tingling in arm where the injection was administered, headache and chest pain. The patient did not receive any treatment for the adverse events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event numbness in the arm, tingling in arm, headache, chest pain was not resolved 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: Headache, Limb discomfort, Tinnitus, Vaccination site pain
Clinical narrative: Pain at shot sight.; Headache; Severe tinnitus in the left ear; Left-arm felt dead and less strong; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER 8732) via an unspecified route of administration in the left arm on 25Mar2021 at 10:00 (at the age of 48-years-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. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021, the patient experienced pain at shot sight, left-arm felt dead and less strong for 2-3 days, headache, severe tinnitus in the left ear, still there 1 week later. The patient was afraid to get the second shot. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of the events pain at shot sight and tinnitus in the left ear were not recovered while that of headache and left-arm felt dead and less strong were resolved on an unknown date in Mar2021.    No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Fatigue, Feeling abnormal, Headache
Clinical narrative: severe body aches, body really hurt; Felt like I had been hit by a truck; Low grade fever; headache; felt foggy; slept most of the day; tired; bruise on arm where the shot was given; lost sense of taste; loss of smell; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 30Mar2021 at 09:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient included COVID-19 for 3 months, but symptoms started around 23Dec2020. The concomitant medications of the patient included Hormone Patch (estrogen), vitamin D calcium supp within two weeks of vaccination. The patient had possibly penicillin allergy and was allergenic to some products like lotions with aloe and PABA. 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 31Mar2021 at 03:00 the patient awakened with severe body aches, felt like hit by a truck, low grade fever and felt like the start of a headache. The patient taken Thereflu and went back to sleep. Again, awakened at 7 in morning, felt the same and taken aspirin. The patient didn't really get better through the day, felt foggy, body really hurt, headache never materialized, slept most of the day. On the next day the patient had still some body aches but not as bad, tired and kind of foggy and big bruise on arm where the vaccine was given. On 23Dec2020, the patient underwent COVID-19 test and the result was negative and lost sense of taste and smell about 2 weeks later. On 20Feb2021, the patient underwent COVID-19 antibodies test and the result was positive. The clinical outcomes of the events severe body aches, felt like hit by a truck, low grade fever, headache, felt foggy, body really hurt, slept, tired, bruise on arm and lost sense of taste and smell was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 antibody test, SARS-CoV-2 test, Somnolence
Clinical narrative: severe body aches, body really hurt; Felt like I had been hit by a truck; Low grade fever; headache; felt foggy; slept most of the day; tired; bruise on arm where the shot was given; lost sense of taste; loss of smell; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 30Mar2021 at 09:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient included COVID-19 for 3 months, but symptoms started around 23Dec2020. The concomitant medications of the patient included Hormone Patch (estrogen), vitamin D calcium supp within two weeks of vaccination. The patient had possibly penicillin allergy and was allergenic to some products like lotions with aloe and PABA. 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 31Mar2021 at 03:00 the patient awakened with severe body aches, felt like hit by a truck, low grade fever and felt like the start of a headache. The patient taken Thereflu and went back to sleep. Again, awakened at 7 in morning, felt the same and taken aspirin. The patient didn't really get better through the day, felt foggy, body really hurt, headache never materialized, slept most of the day. On the next day the patient had still some body aches but not as bad, tired and kind of foggy and big bruise on arm where the vaccine was given. On 23Dec2020, the patient underwent COVID-19 test and the result was negative and lost sense of taste and smell about 2 weeks later. On 20Feb2021, the patient underwent COVID-19 antibodies test and the result was positive. The clinical outcomes of the events severe body aches, felt like hit by a truck, low grade fever, headache, felt foggy, body really hurt, slept, tired, bruise on arm and lost sense of taste and smell was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: severe body aches, body really hurt; Felt like I had been hit by a truck; Low grade fever; headache; felt foggy; slept most of the day; tired; bruise on arm where the shot was given; lost sense of taste; loss of smell; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 30Mar2021 at 09:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient included COVID-19 for 3 months, but symptoms started around 23Dec2020. The concomitant medications of the patient included Hormone Patch (estrogen), vitamin D calcium supp within two weeks of vaccination. The patient had possibly penicillin allergy and was allergenic to some products like lotions with aloe and PABA. 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 31Mar2021 at 03:00 the patient awakened with severe body aches, felt like hit by a truck, low grade fever and felt like the start of a headache. The patient taken Thereflu and went back to sleep. Again, awakened at 7 in morning, felt the same and taken aspirin. The patient didn't really get better through the day, felt foggy, body really hurt, headache never materialized, slept most of the day. On the next day the patient had still some body aches but not as bad, tired and kind of foggy and big bruise on arm where the vaccine was given. On 23Dec2020, the patient underwent COVID-19 test and the result was negative and lost sense of taste and smell about 2 weeks later. On 20Feb2021, the patient underwent COVID-19 antibodies test and the result was positive. The clinical outcomes of the events severe body aches, felt like hit by a truck, low grade fever, headache, felt foggy, body really hurt, slept, tired, bruise on arm and lost sense of taste and smell was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Headache, Nausea, Peripheral swelling, Purpura
Clinical narrative: Nausea; abdominal pain; rash purpura on lower legs; Leg sweling; low grade fever; severe headache; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 17Mar2021 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune disease and penicillin allergy. The patient had received other unspecified medications in two weeks of vaccination. The patient previously 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 24Feb2021 at 11:15 (at the age of 66-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 has been tested for COVID-19 and the result was negative. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021 the patient experienced severe headache. On 27Mar2021 the patient experienced low grade fever, purpuric rash on lower legs and leg swelling. On 28Mar2021 the patient experienced nausea and abdominal pain. On 29Mar2021, patient felt better and also the symptoms was resolved on 30Mar21. On 29Mar2021, the patient underwent lab tests which included covid virus test (nasal swab) and the result was negative. The adverse events did not result in doctor or other healthcare professional office/ clinic visit/ emergency room/ department or urgent care. Therapeutic measures were taken as a result of the reported event was unknown. The clinical outcome of the events severe headache, low grade fever, purpuric rash on lower legs, leg swelling, nausea and abdominal pain were recovered on 30Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Nausea; abdominal pain; rash purpura on lower legs; Leg sweling; low grade fever; severe headache; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 17Mar2021 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune disease and penicillin allergy. The patient had received other unspecified medications in two weeks of vaccination. The patient previously 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 24Feb2021 at 11:15 (at the age of 66-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 has been tested for COVID-19 and the result was negative. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021 the patient experienced severe headache. On 27Mar2021 the patient experienced low grade fever, purpuric rash on lower legs and leg swelling. On 28Mar2021 the patient experienced nausea and abdominal pain. On 29Mar2021, patient felt better and also the symptoms was resolved on 30Mar21. On 29Mar2021, the patient underwent lab tests which included covid virus test (nasal swab) and the result was negative. The adverse events did not result in doctor or other healthcare professional office/ clinic visit/ emergency room/ department or urgent care. Therapeutic measures were taken as a result of the reported event was unknown. The clinical outcome of the events severe headache, low grade fever, purpuric rash on lower legs, leg swelling, nausea and abdominal pain were recovered on 30Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling
Clinical narrative: Left artificial knee swelled up; left knee caused pain; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EP6955) via an unspecified route of administration in the right arm on 27Mar2021 at 14:00 (at the age of 69-years-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. Concomitant medications included naproxen (MANUFACTURER UNKNOWN), tamsulosin (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN), all from unknown date for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204), via an unspecified route in the left arm on 07Mar2021 at 09:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 16:00, two hours after vaccine, the patient experienced left knee (artificial knee, six years ago in great shape), swelled up and pain that continued six days later use crutches on and off at the time of reporting, was improving every day. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the reported events. The clinical outcome of event left knee swelled up and pain were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Malaise, Oropharyngeal pain, Pain in extremity
Clinical narrative: Sore throat; Headache; Low grade fever; Malaise; Lower leg/back pain; Lower leg/back pain; This is a spontaneous report from a contactable pharmacist, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 31Mar2021 at 13:00 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. 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 10Mar2021 at 12:00 (at the age of 37-years-old), as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 01Apr2021 at 14:00, the patient experienced sore throat, headache, low grade fever, malaise, lower leg pain and back pain. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatments for sore throat, headache, low grade fever, malaise, lower leg pain and back pain. The clinical outcomes of the events sore throat, headache, low grade fever, malaise, lower leg pain and back pain were resolving at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Sore throat; Headache; Low grade fever; Malaise; Lower leg/back pain; Lower leg/back pain; This is a spontaneous report from a contactable pharmacist, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 31Mar2021 at 13:00 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. 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 10Mar2021 at 12:00 (at the age of 37-years-old), as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 01Apr2021 at 14:00, the patient experienced sore throat, headache, low grade fever, malaise, lower leg pain and back pain. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatments for sore throat, headache, low grade fever, malaise, lower leg pain and back pain. The clinical outcomes of the events sore throat, headache, low grade fever, malaise, lower leg pain and back pain were resolving at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Headache; Sore arm; Body aches; Chills; Low grade fever; Rash/hives on one finger of left hand; Rash/hives on one finger of left hand; This is a spontaneous report from a contactable consumer, the patient. A 43-years-old non-pregnant female patient received a first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) via an unspecified route of administration in left arm on 26Mar2021 at 10:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no allergies to medications, food, or other products. Concomitant medication included cetirizine hydrochloride (ZYRTEC) for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient had been diagnosed with COVID-19 prior to the vaccination. The patient had not been tested for COVID-19 since the vaccination. On 26Mar2021 at 12:15, the patient experienced headache, sore arm, body aches, chills, low grade fever, rash and hives on one finger of left hand. 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 the result of adverse events. The clinical outcome of the events headache, pain in arm, general body pain, chills, low grade fever, rash and hives was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Headache; Sore arm; Body aches; Chills; Low grade fever; Rash/hives on one finger of left hand; Rash/hives on one finger of left hand; This is a spontaneous report from a contactable consumer, the patient. A 43-years-old non-pregnant female patient received a first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) via an unspecified route of administration in left arm on 26Mar2021 at 10:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no allergies to medications, food, or other products. Concomitant medication included cetirizine hydrochloride (ZYRTEC) for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient had been diagnosed with COVID-19 prior to the vaccination. The patient had not been tested for COVID-19 since the vaccination. On 26Mar2021 at 12:15, the patient experienced headache, sore arm, body aches, chills, low grade fever, rash and hives on one finger of left hand. 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 the result of adverse events. The clinical outcome of the events headache, pain in arm, general body pain, chills, low grade fever, rash and hives was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: DOSE 1: 12Mar201 and Dose 2: 30Mar2021; fever; Chills; Severe headache; This is a spontaneous report from a non-contactable other healthcare professional. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via intramuscular route of administration in the left arm on 30Mar2021 at 15:45 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to sulfa. Concomitant medication included unspecified birth control medication from unknown date . The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an intramuscular route of administration in the left arm on 12Mar2021, 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 31Mar2021, the patient experienced fever, chills and severe headache. 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 event. The clinical outcome of the events fever, chills and severe headache was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Positive effect  chronic lower back pain for 50 years, it is now gone; This is a spontaneous report from a contactable consumer, the patient. A 75-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 right arm on 22Feb2021 at 11:00 (at the age of 75-years-old), as a single dose for COVID-19 immunisation. Medical history included lower pack pain from an accident and surgery in 1971. The patient had no known allergies. Concomitant medications included acetaminophen; codeine phosphate (TYLENOL NO. 3) and levothyroxine (MANUFACTURER UNKNOWN) of dose 125 (units unspecified), both for unknown indications from unknown dates. 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 4 weeks prior to the COVID vaccine. On 22Feb2021, the patient experienced positive effect. The patient had chronic lower back pain for 50 years, which was now gone. No therapeutic measures were taken as a result of the reported event. The clinical outcome of the event unexpected therapeutic benefit was unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache within 2 hours of receiving vaccine. Headache lasted for two days.; This is a spontaneous report from a non-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: EN6204) via an unspecified route of administration in the left arm on 11Mar2021 at 15:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy and adhesive tape allergy. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Mar2021 at 17:30, within 2 hours of vaccination, the patient experienced headache that lasted for two days. The patient did not receive treatment for the reported event. 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. The clinical outcome of headache was recovered on 13Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cough, Fatigue, Nasal congestion, Oropharyngeal pain
Clinical narrative: Body aches; Fatigue; Sore throat; Congestion; 100.2 degree fever; Cough; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male 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 25Mar2021 at 18:00 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient did not received any other medications within 2 weeks of vaccination. 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 31Mar2021 at 17:00, the patient experienced body aches, fatigue, sore throat, congestion, 100.2 degree fever and cough. On 31Mar2021, the patient underwent lab test included body temperature 100.2 degree. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events body aches, fatigue, sore throat, congestion,100.2-degree fever and cough were not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Body aches; Fatigue; Sore throat; Congestion; 100.2 degree fever; Cough; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male 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 25Mar2021 at 18:00 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient did not received any other medications within 2 weeks of vaccination. 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 31Mar2021 at 17:00, the patient experienced body aches, fatigue, sore throat, congestion, 100.2 degree fever and cough. On 31Mar2021, the patient underwent lab test included body temperature 100.2 degree. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events body aches, fatigue, sore throat, congestion,100.2-degree fever and cough were not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Pyrexia, SARS-CoV-2 test
Clinical narrative: Chills; Fever; Fatigue; Weakness; This is a spontaneous report from a non-contactable consumer, the patient.  A 71-year-old patient of unknown gender 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 14:45 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included polycythemia vera. Concomitant medications were not reported. The patient previously received sulfamethoxazole; trimethoprim (BACTRIM), levofloxacin (LEVAQUIN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 11Mar2021 at 16:00, the patient experienced chills, fever, fatigue and weakness. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab test on 14Mar2021 which included polymerase chain reaction (PCR) test via nasal swab and the test result was negative. The patient did not receive any treatment for the events chills, fever, fatigue and weakness. The clinical outcomes of the events chills, fever, fatigue and weakness were resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Oropharyngeal discomfort, Throat irritation
Clinical narrative: Elevated heart rate; Light headiness; Throat felt scratchy; Throat felt  weird; This is a spontaneous report from a contactable consumer via regulatory authority.  A 40-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN), on 01Apr2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not tested for COVID-19.  The patient's medical history and concomitant medications were not reported. On 01Apr2021, the patient experienced elevated heart rate immediately after vaccination, which resolved 30 mins post vaccination and also the patient had a bit of light headiness and throat felt weird/ scratchy a few hours later which resolved in about 10 minutes. 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 elevated heart rate, light headiness, throat felt weird and throat felt scratchy was recovered on 01Apr2021.  No follow-up attempts are needed; information about lot number cannot be obtained.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Vision blurred
Clinical narrative: Blurry vision; Double vision; This is a spontaneous report from a contactable consumer, the patient. A 47-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the right arm on 30Mar2021 at 14:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included COVID-19. Concomitant medication included rosuvastatin (MANUFACTURER UNKNOWN) from unknown date from unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 09Mar2021 at 14:30 (at the age of 47-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. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 30Mar2021 at 1700, after second dose, the patient experienced blurry vision and double vision which lasted for around five hours. The patient did not receive any treatment for the 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 outcome of blurry vision and double vision were resolved on 30Mar2021 at 22:00.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Headache, Pyrexia
Clinical narrative: Severe headache; Body ache in back and especially lower back; Body ache in hips; Fever of 100-102; 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: EN6207) via an unspecified route of administration in the left arm on 20Mar2021 at 10:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had no known allergies. The patient had no known previous history of COVID-19.  Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) 10 mg daily for unknown indication and from unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 22Mar2021 at 15:00 (two days after receiving vaccine), the patient experienced severe headache, body ache in back and especially lower back and hips, and fever of 100-102 (unit unspecified) every day and continuing for 10 days (still ongoing to some extent). The symptoms got improve with treatment Tylenol but fever keeps returning. It ranges in severity; headache cleared after about 5 days but back pain, hip pain and fever come and go. On 25Mar2021, the patient had nasal swab (Novel coronavirus COVID-19 nasal/nasopharynx) test and resulted negative. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken as a result of events and included treatment with acetaminophen (TYLENOL). The clinical outcome of the events severe headache was resolved on 26Mar2021 (cleared after about 5 days); while that of the events fever, back pain and pain in hips was resolving (come and go) at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Severe headache; Body ache in back and especially lower back; Body ache in hips; Fever of 100-102; 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: EN6207) via an unspecified route of administration in the left arm on 20Mar2021 at 10:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had no known allergies. The patient had no known previous history of COVID-19.  Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) 10 mg daily for unknown indication and from unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 22Mar2021 at 15:00 (two days after receiving vaccine), the patient experienced severe headache, body ache in back and especially lower back and hips, and fever of 100-102 (unit unspecified) every day and continuing for 10 days (still ongoing to some extent). The symptoms got improve with treatment Tylenol but fever keeps returning. It ranges in severity; headache cleared after about 5 days but back pain, hip pain and fever come and go. On 25Mar2021, the patient had nasal swab (Novel coronavirus COVID-19 nasal/nasopharynx) test and resulted negative. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken as a result of events and included treatment with acetaminophen (TYLENOL). The clinical outcome of the events severe headache was resolved on 26Mar2021 (cleared after about 5 days); while that of the events fever, back pain and pain in hips was resolving (come and go) at the time of this report.  No follow-up attempts are needed. No further information is expected.