chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Decreased activity, Fatigue, Nausea, Vaccination site bruising, Vaccination site haematoma
Clinical narrative: Mild Nausea; Injection site bruised; Hematoma at site; Very painful all around injection site for 2 weeks; Extreme fatigue; Kept me from usual activities; 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: 0011A) via an unspecified route of administration in the left arm on 17Mar2021 at 13:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, fibromyalgia, spondylolisthesis and bursitis. Concomitant medications included folic acid (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN) and fluoxetine (MANUFACTURER UNKNOWN), all from unknown date for unspecified indication and unknown if ongoing. The patient previously received codeine (MANUFACTURER UNKNOWN) and local anesthesia w/ 1% (weight by) lidocaine (MANUFACTURER UNKNOWN), both on unknown date for unspecified indication and experienced allergy. 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 18Mar2021, the patient experienced mild nausea, injection site bruised, hematoma at site and very painful all-around injection site for 2 weeks. From 18Mar2021 to 20Mar2021, the patient had 3 days of extreme fatigue which kept her from usual activities. The patient resumed activities on fourth day (21Mar2021). 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 events nausea, injection site bruised, hematoma at site and very painful all-around injection site was recovered after 2 weeks on an unknown date in Apr2021 and the event extreme fatigue was recovered on 20Mar2021 while that of the event decreased activity was recovered on 21Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild Nausea; Injection site bruised; Hematoma at site; Very painful all around injection site for 2 weeks; Extreme fatigue; Kept me from usual activities; 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: 0011A) via an unspecified route of administration in the left arm on 17Mar2021 at 13:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, fibromyalgia, spondylolisthesis and bursitis. Concomitant medications included folic acid (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN) and fluoxetine (MANUFACTURER UNKNOWN), all from unknown date for unspecified indication and unknown if ongoing. The patient previously received codeine (MANUFACTURER UNKNOWN) and local anesthesia w/ 1% (weight by) lidocaine (MANUFACTURER UNKNOWN), both on unknown date for unspecified indication and experienced allergy. 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 18Mar2021, the patient experienced mild nausea, injection site bruised, hematoma at site and very painful all-around injection site for 2 weeks. From 18Mar2021 to 20Mar2021, the patient had 3 days of extreme fatigue which kept her from usual activities. The patient resumed activities on fourth day (21Mar2021). 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 events nausea, injection site bruised, hematoma at site and very painful all-around injection site was recovered after 2 weeks on an unknown date in Apr2021 and the event extreme fatigue was recovered on 20Mar2021 while that of the event decreased activity was recovered on 21Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Erythema, Feeling cold, Flushing, Pain in extremity
Clinical narrative: chills; face, neck and head are itchy; red rash on back head and face; Bad arm pain to touch; cold; minor arm redness/swelling at shot site; minor arm redness/swelling at shot site; This is a spontaneous report from a non-contactable consumer, the patient. A 61-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 06Apr2021 at 12:45 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, blood pressure high and overweight. The patient was allergic to pets, latex, alcohol, skin products and seasonal allergy. The patient previously received sulfadiazine (SULFA) on an unspecified date for an unspecified indication and experienced drug allergy. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN) 7.5 mg. Prior to the vaccination, the patient was diagnosed with COVID-19 was unknown. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 06Apr2021 at 18:30, the patient experienced chills, face, neck and head are itchy, red rash on back head and face, bad arm pain to touch, vaccination site erythema, vaccination site swelling and cold.  The patient reported in order of occurrence, chills, face and neck hot and itchy, red rash on face, back itchy, red rash across back, head itchy. The patient could not tell if it was rash. She experienced bad arm pain to touch, not usual shot arm pain, the patient could not lay on left side to sleep. She felt cold all night, used 2 blankets instead of usual 1; fitful sleep. As of this writing: arm pain was better but minor arm redness/swelling at shot site; face and neck hot; neck/back/head itchy, rash on neck/back but not as red as yesterday; felt cold. No therapeutic measures were taken as a result of the events. The adverse event 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 for the events chills, itchy, red rash, pain in arm, vaccination site erythema, vaccination site swelling and cold were recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Pruritus, Rash, Rash erythematous, Sleep disorder
Clinical narrative: chills; face, neck and head are itchy; red rash on back head and face; Bad arm pain to touch; cold; minor arm redness/swelling at shot site; minor arm redness/swelling at shot site; This is a spontaneous report from a non-contactable consumer, the patient. A 61-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 06Apr2021 at 12:45 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, blood pressure high and overweight. The patient was allergic to pets, latex, alcohol, skin products and seasonal allergy. The patient previously received sulfadiazine (SULFA) on an unspecified date for an unspecified indication and experienced drug allergy. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN) 7.5 mg. Prior to the vaccination, the patient was diagnosed with COVID-19 was unknown. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 06Apr2021 at 18:30, the patient experienced chills, face, neck and head are itchy, red rash on back head and face, bad arm pain to touch, vaccination site erythema, vaccination site swelling and cold.  The patient reported in order of occurrence, chills, face and neck hot and itchy, red rash on face, back itchy, red rash across back, head itchy. The patient could not tell if it was rash. She experienced bad arm pain to touch, not usual shot arm pain, the patient could not lay on left side to sleep. She felt cold all night, used 2 blankets instead of usual 1; fitful sleep. As of this writing: arm pain was better but minor arm redness/swelling at shot site; face and neck hot; neck/back/head itchy, rash on neck/back but not as red as yesterday; felt cold. No therapeutic measures were taken as a result of the events. The adverse event 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 for the events chills, itchy, red rash, pain in arm, vaccination site erythema, vaccination site swelling and cold were recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tenderness
Clinical narrative: chills; face, neck and head are itchy; red rash on back head and face; Bad arm pain to touch; cold; minor arm redness/swelling at shot site; minor arm redness/swelling at shot site; This is a spontaneous report from a non-contactable consumer, the patient. A 61-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 06Apr2021 at 12:45 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, blood pressure high and overweight. The patient was allergic to pets, latex, alcohol, skin products and seasonal allergy. The patient previously received sulfadiazine (SULFA) on an unspecified date for an unspecified indication and experienced drug allergy. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN) 7.5 mg. Prior to the vaccination, the patient was diagnosed with COVID-19 was unknown. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 06Apr2021 at 18:30, the patient experienced chills, face, neck and head are itchy, red rash on back head and face, bad arm pain to touch, vaccination site erythema, vaccination site swelling and cold.  The patient reported in order of occurrence, chills, face and neck hot and itchy, red rash on face, back itchy, red rash across back, head itchy. The patient could not tell if it was rash. She experienced bad arm pain to touch, not usual shot arm pain, the patient could not lay on left side to sleep. She felt cold all night, used 2 blankets instead of usual 1; fitful sleep. As of this writing: arm pain was better but minor arm redness/swelling at shot site; face and neck hot; neck/back/head itchy, rash on neck/back but not as red as yesterday; felt cold. No therapeutic measures were taken as a result of the events. The adverse event 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 for the events chills, itchy, red rash, pain in arm, vaccination site erythema, vaccination site swelling and cold were recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Nasopharyngitis, Pain in extremity, Pruritus, Rash erythematous
Clinical narrative: chills; face, neck and head are itchy; red rash on back head and face; Bad arm pain to touch; cold; minor arm redness/swelling at shot site; minor arm redness/swelling at shot site; This is a spontaneous report from a non-contactable consumer, the patient. A 61-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 06Apr2021 at 12:45 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, blood pressure high and overweight. The patient was allergic to pets, latex, alcohol, skin products and seasonal allergy. The patient previously received sulfadiazine (SULFA) on an unspecified date for an unspecified indication and experienced drug allergy. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN) 7.5 mg. Prior to the vaccination, the patient was diagnosed with COVID-19 was unknown. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 06Apr2021 at 18:30, the patient experienced chills, face, neck and head are itchy, red rash on back head and face, bad arm pain to touch, vaccination site erythema, vaccination site swelling and cold.  The patient reported in order of occurrence, chills, face and neck hot and itchy, red rash on face, back itchy, red rash across back, head itchy. The patient could not tell if it was rash. She experienced bad arm pain to touch, not usual shot arm pain, the patient could not lay on left side to sleep. She felt cold all night, used 2 blankets instead of usual 1; fitful sleep. As of this writing: arm pain was better but minor arm redness/swelling at shot site; face and neck hot; neck/back/head itchy, rash on neck/back but not as red as yesterday; felt cold. No therapeutic measures were taken as a result of the events. The adverse event 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 for the events chills, itchy, red rash, pain in arm, vaccination site erythema, vaccination site swelling and cold were recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: chills; face, neck and head are itchy; red rash on back head and face; Bad arm pain to touch; cold; minor arm redness/swelling at shot site; minor arm redness/swelling at shot site; This is a spontaneous report from a non-contactable consumer, the patient. A 61-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 06Apr2021 at 12:45 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, blood pressure high and overweight. The patient was allergic to pets, latex, alcohol, skin products and seasonal allergy. The patient previously received sulfadiazine (SULFA) on an unspecified date for an unspecified indication and experienced drug allergy. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN) 7.5 mg. Prior to the vaccination, the patient was diagnosed with COVID-19 was unknown. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 06Apr2021 at 18:30, the patient experienced chills, face, neck and head are itchy, red rash on back head and face, bad arm pain to touch, vaccination site erythema, vaccination site swelling and cold.  The patient reported in order of occurrence, chills, face and neck hot and itchy, red rash on face, back itchy, red rash across back, head itchy. The patient could not tell if it was rash. She experienced bad arm pain to touch, not usual shot arm pain, the patient could not lay on left side to sleep. She felt cold all night, used 2 blankets instead of usual 1; fitful sleep. As of this writing: arm pain was better but minor arm redness/swelling at shot site; face and neck hot; neck/back/head itchy, rash on neck/back but not as red as yesterday; felt cold. No therapeutic measures were taken as a result of the events. The adverse event 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 for the events chills, itchy, red rash, pain in arm, vaccination site erythema, vaccination site swelling and cold were recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Heart rate increased
Clinical narrative: Heart rate increased. The highest was at 150 and it stabilized at around 90-100; Dizzy; This is a spontaneous report from a contactable consumer (patient). This 27-year-old female patient received dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number 7533) via an unspecified route of administration on 07Apr2021 at 14:00 (at the age of 27-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included gallstones, removed gallbladder, scoliosis, sciatica pain, gastritis, migraines, and depression. The patient was allergic to narcotics and nickel The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included sumatriptan, amitriptyline, fluticasone propionate (FLONASE), and loratadine from unknown dates for unknown indications. The patient previously received atomoxitene hydrochloride (STRATTERA) from an unknown date for an unknown indication and experienced allergy. On 07Apr2021 at 14:00 immediately after taking the first vaccine the patient experienced heart rate increased and became dizzy. The events were reported as non-serious. The patient was not hospitalized for the events. The patient visited a doctor or other healthcare professional office/clinic visit as a result of the events. It went and came in waves but the highest was at 150 and it stabilized around 90 to 100. Only after the patient was treated with a diphenhydramine (BENADRYL) shot did it decrease to the 80s range. The outcomes of heart rate increased and dizzy were unknown. It was also reported that since the vaccination the patient had not been tested for COVID-19.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased
Clinical narrative: Heart rate increased. The highest was at 150 and it stabilized at around 90-100; Dizzy; This is a spontaneous report from a contactable consumer (patient). This 27-year-old female patient received dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number 7533) via an unspecified route of administration on 07Apr2021 at 14:00 (at the age of 27-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included gallstones, removed gallbladder, scoliosis, sciatica pain, gastritis, migraines, and depression. The patient was allergic to narcotics and nickel The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included sumatriptan, amitriptyline, fluticasone propionate (FLONASE), and loratadine from unknown dates for unknown indications. The patient previously received atomoxitene hydrochloride (STRATTERA) from an unknown date for an unknown indication and experienced allergy. On 07Apr2021 at 14:00 immediately after taking the first vaccine the patient experienced heart rate increased and became dizzy. The events were reported as non-serious. The patient was not hospitalized for the events. The patient visited a doctor or other healthcare professional office/clinic visit as a result of the events. It went and came in waves but the highest was at 150 and it stabilized around 90 to 100. Only after the patient was treated with a diphenhydramine (BENADRYL) shot did it decrease to the 80s range. The outcomes of heart rate increased and dizzy were unknown. It was also reported that since the vaccination the patient had not been tested for COVID-19.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Chills, Erythema, Feeling hot, Pyrexia
Clinical narrative: Arm swelling; High fever 102.5; Arm swelling and red; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 06Apr2021 at 10:15 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient previously 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 16Mar2021 at 18:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation and took azithromycin (ZITHROMAX) on an unknown date for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 04:00, the patient experienced high fever 102.5, arm swelling and red. On 07Apr2021 at 04:00, the patient's body temperature was reported as 102.5 (units unspecified). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events high fever 102.5, arm swelling and red was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Arm swelling; High fever 102.5; Arm swelling and red; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 06Apr2021 at 10:15 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient previously 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 16Mar2021 at 18:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation and took azithromycin (ZITHROMAX) on an unknown date for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 04:00, the patient experienced high fever 102.5, arm swelling and red. On 07Apr2021 at 04:00, the patient's body temperature was reported as 102.5 (units unspecified). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events high fever 102.5, arm swelling and red was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Arm swelling; High fever 102.5; Arm swelling and red; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 06Apr2021 at 10:15 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient previously 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 16Mar2021 at 18:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation and took azithromycin (ZITHROMAX) on an unknown date for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 04:00, the patient experienced high fever 102.5, arm swelling and red. On 07Apr2021 at 04:00, the patient's body temperature was reported as 102.5 (units unspecified). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events high fever 102.5, arm swelling and red was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Asthenia, Malaise, Tinnitus
Clinical narrative: Ringing in my ears/Severe ringing in my ears/Tinnitus; Tired no energy for four days; Tired no energy for four days; This is a spontaneous report from a contactable consumer (patient) via regulatory authority. This 65-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6205) via an unspecified route of administration in the left arm on 09Mar2021 at 09:15 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included irregular heart beat under control and blood pressure under control, both from unknown dates and unknown if ongoing. The patient had no allergies to food, drugs or other products, was not diagnosed with COVID-19 prior to vaccination and had not received any other vaccines in the four weeks prior to the COVID vaccine. Concomitant medications included nebivolol hydrochloride (BYSTOLIC 10mg), losartan 50 mg, and montelukast sodium (SINGULAIR 10 mg), all from unknown dates for unknown indications. The patient previously received the first dose of BNT162B2 (lot number EL9266) on 16Feb2021 at 12:00 (at 65-years-old) for COVID-19 immunisation. On 15Mar2021 at 12:00 the patient experienced being tired, having no energy for four days, and then ringing in his ears started and now (as of 07Apr2021) had turned into severe ringing in his ears; further reporting his left ear was the worst. The patient stated he went to an ear, nose, and throat (ENT) doctor who said he had tinnitus which had developed after the second vaccine injection. The patient reported it had become serious to the present. No treatment was received for the events. The clinical outcomes of the events were not recovered. Since vaccination the patient had not been tested for COVID-19.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Fatigue, Tinnitus
Clinical narrative: Ringing in my ears/Severe ringing in my ears/Tinnitus; Tired no energy for four days; Tired no energy for four days; This is a spontaneous report from a contactable consumer (patient) via regulatory authority. This 65-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6205) via an unspecified route of administration in the left arm on 09Mar2021 at 09:15 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included irregular heart beat under control and blood pressure under control, both from unknown dates and unknown if ongoing. The patient had no allergies to food, drugs or other products, was not diagnosed with COVID-19 prior to vaccination and had not received any other vaccines in the four weeks prior to the COVID vaccine. Concomitant medications included nebivolol hydrochloride (BYSTOLIC 10mg), losartan 50 mg, and montelukast sodium (SINGULAIR 10 mg), all from unknown dates for unknown indications. The patient previously received the first dose of BNT162B2 (lot number EL9266) on 16Feb2021 at 12:00 (at 65-years-old) for COVID-19 immunisation. On 15Mar2021 at 12:00 the patient experienced being tired, having no energy for four days, and then ringing in his ears started and now (as of 07Apr2021) had turned into severe ringing in his ears; further reporting his left ear was the worst. The patient stated he went to an ear, nose, and throat (ENT) doctor who said he had tinnitus which had developed after the second vaccine injection. The patient reported it had become serious to the present. No treatment was received for the events. The clinical outcomes of the events were not recovered. Since vaccination the patient had not been tested for COVID-19.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Balance disorder, Dehydration, Lymph node pain, Lymphadenopathy
Clinical narrative: spiked a fever of 103.5/lasted 3 days; had a severely painful and swollen lymph node under my left armpit; had a severely painful and swollen lymph node under my left armpit; pain all over my body; nauseous; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot unknown, second dose) solution for injection intramuscular in the left arm on 01May2021 at 16:30 (at the age of 30-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included pulmonary embolism, foot surgery, shoulder surgery, hypothyroidism, and allergy: dates. Concomitant medications included levothyroxine sodium (SYNTHROID), citalopram, cetirizine hydrochloride (ZYRTEC) and colecalciferol (VITAMIN D). Past drug history included known allergy: vancomycin. Historical vaccine included BNT162B2 (first dose) for COVID-19 vaccination on 10Apr2021 with no adverse effect reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 01May2021 at 07:30 PM, the patient spiked a fever of 103.5 F, lasted 3 days (went down briefly after taking OTC medication), had a severely painful and swollen lymph node under my left armpit, pain all over my body, and nauseous. The events resulted in an emergency room/department or urgent care visit. Treatment for the events included taking over the counter (OTC) medication and fluids. The outcome of the events was recovered with sequel in May2021. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: spiked a fever of 103.5/lasted 3 days; had a severely painful and swollen lymph node under my left armpit; had a severely painful and swollen lymph node under my left armpit; pain all over my body; nauseous; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot unknown, second dose) solution for injection intramuscular in the left arm on 01May2021 at 16:30 (at the age of 30-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included pulmonary embolism, foot surgery, shoulder surgery, hypothyroidism, and allergy: dates. Concomitant medications included levothyroxine sodium (SYNTHROID), citalopram, cetirizine hydrochloride (ZYRTEC) and colecalciferol (VITAMIN D). Past drug history included known allergy: vancomycin. Historical vaccine included BNT162B2 (first dose) for COVID-19 vaccination on 10Apr2021 with no adverse effect reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 01May2021 at 07:30 PM, the patient spiked a fever of 103.5 F, lasted 3 days (went down briefly after taking OTC medication), had a severely painful and swollen lymph node under my left armpit, pain all over my body, and nauseous. The events resulted in an emergency room/department or urgent care visit. Treatment for the events included taking over the counter (OTC) medication and fluids. The outcome of the events was recovered with sequel in May2021. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Lymph node pain, Lymphadenopathy, Nausea, Pain
Clinical narrative: spiked a fever of 103.5/lasted 3 days; had a severely painful and swollen lymph node under my left armpit; had a severely painful and swollen lymph node under my left armpit; pain all over my body; nauseous; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot unknown, second dose) solution for injection intramuscular in the left arm on 01May2021 at 16:30 (at the age of 30-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included pulmonary embolism, foot surgery, shoulder surgery, hypothyroidism, and allergy: dates. Concomitant medications included levothyroxine sodium (SYNTHROID), citalopram, cetirizine hydrochloride (ZYRTEC) and colecalciferol (VITAMIN D). Past drug history included known allergy: vancomycin. Historical vaccine included BNT162B2 (first dose) for COVID-19 vaccination on 10Apr2021 with no adverse effect reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 01May2021 at 07:30 PM, the patient spiked a fever of 103.5 F, lasted 3 days (went down briefly after taking OTC medication), had a severely painful and swollen lymph node under my left armpit, pain all over my body, and nauseous. The events resulted in an emergency room/department or urgent care visit. Treatment for the events included taking over the counter (OTC) medication and fluids. The outcome of the events was recovered with sequel in May2021. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: spiked a fever of 103.5/lasted 3 days; had a severely painful and swollen lymph node under my left armpit; had a severely painful and swollen lymph node under my left armpit; pain all over my body; nauseous; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot unknown, second dose) solution for injection intramuscular in the left arm on 01May2021 at 16:30 (at the age of 30-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included pulmonary embolism, foot surgery, shoulder surgery, hypothyroidism, and allergy: dates. Concomitant medications included levothyroxine sodium (SYNTHROID), citalopram, cetirizine hydrochloride (ZYRTEC) and colecalciferol (VITAMIN D). Past drug history included known allergy: vancomycin. Historical vaccine included BNT162B2 (first dose) for COVID-19 vaccination on 10Apr2021 with no adverse effect reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 01May2021 at 07:30 PM, the patient spiked a fever of 103.5 F, lasted 3 days (went down briefly after taking OTC medication), had a severely painful and swollen lymph node under my left armpit, pain all over my body, and nauseous. The events resulted in an emergency room/department or urgent care visit. Treatment for the events included taking over the counter (OTC) medication and fluids. The outcome of the events was recovered with sequel in May2021. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Underdose
Clinical narrative: Administered 0.5 mL of vaccine, not 0.3 mL; This is a spontaneous report from a contactable other healthcare professional. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0162) via an unspecified route of administration of 0.5 ml in the left arm on 08Apr2021 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 08Apr2021, the patient was administered 0.5 mL of vaccine and not 0.3 mL (inappropriate dose of vaccine administered). The clinical outcome of the event inappropriate dose of vaccine administered was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Administered 0.5 mL of vaccine, not 0.3 mL; This is a spontaneous report from a contactable other healthcare professional. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0162) via an unspecified route of administration of 0.5 ml in the left arm on 08Apr2021 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 08Apr2021, the patient was administered 0.5 mL of vaccine and not 0.3 mL (inappropriate dose of vaccine administered). The clinical outcome of the event inappropriate dose of vaccine administered was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: constant, low volume buzzing, whistling in my head. Tinnitus? Didn't start until after second vaccine. Has not changed in freguency or intensity as of this reporting.; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the arm left on 22Apr2021 at 14:30 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient received unspecified medication within two weeks of vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the arm left on 01Apr2021 at 08:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation and penicillin and nickel on unknown date for unknown indication. 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 25Apr2021 at 20:00 after the second vaccination, the patient experienced constant, low volume buzzing, whistling in my head. Tinnitus? Has not changed in frequency or intensity as of this reporting. The clinical outcome of the event ear buzzing was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Administered 0.5 mL of vaccine, not 0.3 mL; This is a spontaneous report from a contactable healthcare professional. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the right arm on 08Apr2021 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported.  On 08Apr2021, the patient was administered 0.5 mL of vaccine, not 0.3 mL (inappropriate dose of drug administered). The clinical outcome of the event administered 0.5 mL of vaccine, not 0.3 mL (inappropriate dose of drug administered) was resolved at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Blood pressure decreased, Blood pressure measurement, Dizziness, Fall
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 72-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ENG206 and expiration date was not reported), first dose via an unspecified route of administration, administered in Arm Left on 13Mar2021 (at the age of 72 years) as single for covid-19 immunisation. Medical history included ongoing drug hypersensitivity and states he was diagnosed about 25 years ago. Family history was none reported. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. On 13Mar2021 the patient States that within 2 minutes of receiving the Covid Vaccine, he was sitting down, and his forehead became very wet and cold and States his left side became numb and it is not as bad, but it happens at least two times a week and his blood pressure dropped. This was his first dose of the Covid Vaccine and the doctor suggested for him not to take the second dose. Adverse Event(s) did not require a visit to Emergency Room but did require Physician Office visit. The outcome of the event His left side became numb was not recovered, while the outcome of the rest of the events was unknown. No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Feeling cold, Headache, Herpes zoster, Hyperhidrosis
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 72-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ENG206 and expiration date was not reported), first dose via an unspecified route of administration, administered in Arm Left on 13Mar2021 (at the age of 72 years) as single for covid-19 immunisation. Medical history included ongoing drug hypersensitivity and states he was diagnosed about 25 years ago. Family history was none reported. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. On 13Mar2021 the patient States that within 2 minutes of receiving the Covid Vaccine, he was sitting down, and his forehead became very wet and cold and States his left side became numb and it is not as bad, but it happens at least two times a week and his blood pressure dropped. This was his first dose of the Covid Vaccine and the doctor suggested for him not to take the second dose. Adverse Event(s) did not require a visit to Emergency Room but did require Physician Office visit. The outcome of the event His left side became numb was not recovered, while the outcome of the rest of the events was unknown. No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 72-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ENG206 and expiration date was not reported), first dose via an unspecified route of administration, administered in Arm Left on 13Mar2021 (at the age of 72 years) as single for covid-19 immunisation. Medical history included ongoing drug hypersensitivity and states he was diagnosed about 25 years ago. Family history was none reported. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. On 13Mar2021 the patient States that within 2 minutes of receiving the Covid Vaccine, he was sitting down, and his forehead became very wet and cold and States his left side became numb and it is not as bad, but it happens at least two times a week and his blood pressure dropped. This was his first dose of the Covid Vaccine and the doctor suggested for him not to take the second dose. Adverse Event(s) did not require a visit to Emergency Room but did require Physician Office visit. The outcome of the event His left side became numb was not recovered, while the outcome of the rest of the events was unknown. No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Blood pressure measurement, Cold sweat, Fatigue, Hypotension
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 72-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ENG206 and expiration date was not reported), first dose via an unspecified route of administration, administered in Arm Left on 13Mar2021 (at the age of 72 years) as single for covid-19 immunisation. Medical history included ongoing drug hypersensitivity and states he was diagnosed about 25 years ago. Family history was none reported. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. On 13Mar2021 the patient States that within 2 minutes of receiving the Covid Vaccine, he was sitting down, and his forehead became very wet and cold and States his left side became numb and it is not as bad, but it happens at least two times a week and his blood pressure dropped. This was his first dose of the Covid Vaccine and the doctor suggested for him not to take the second dose. Adverse Event(s) did not require a visit to Emergency Room but did require Physician Office visit. The outcome of the event His left side became numb was not recovered, while the outcome of the rest of the events was unknown. No follow-up attempts are needed. No further information is expected.