chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Low grade fever 100; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 14Apr2021 at 11:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, GERD (Gastro-oesophageal reflux disease), fatty liver and hypertension. The patient had known allergies to Ampicillin. Concomitant medications included metformin (MANUFACTURER UNKNOWN), glimepiride (MANUFACTURER UNKNOWN), liraglutide (VICTOZA), empagliflozin (JARDIANCE) and riboflavin, thiamine hydrochloride, ursodeoxycholic acid (URSO); taken for unknown indication on unknown date, unknown if ongoing. 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 25Mar2021 at 11:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 15Apr2021, at 11:30 the patient experienced low grade fever (100) and body aches. The patient underwent lab tests and procedures, which included body temperature on 15Apr2021 and resulted 100 (unknown units). 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 outcome of the event low grade fever (100) and body aches was recovered on unknown date in Apr2021.    No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: Low grade fever 100; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 14Apr2021 at 11:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, GERD (Gastro-oesophageal reflux disease), fatty liver and hypertension. The patient had known allergies to Ampicillin. Concomitant medications included metformin (MANUFACTURER UNKNOWN), glimepiride (MANUFACTURER UNKNOWN), liraglutide (VICTOZA), empagliflozin (JARDIANCE) and riboflavin, thiamine hydrochloride, ursodeoxycholic acid (URSO); taken for unknown indication on unknown date, unknown if ongoing. 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 25Mar2021 at 11:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 15Apr2021, at 11:30 the patient experienced low grade fever (100) and body aches. The patient underwent lab tests and procedures, which included body temperature on 15Apr2021 and resulted 100 (unknown units). 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 outcome of the event low grade fever (100) and body aches was recovered on unknown date in Apr2021.    No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Full body hives; This is a spontaneous report from a contactable consumer, the patient. A 29-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 11Apr2021 at 14:30 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included montelukast (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC) taken for unknown indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 21Mar2021 at 14:30 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. On 15Apr2021 at 05:30, the patient experienced full body hives. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event full body hives was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lip swelling
Clinical narrative: Lips swelling a day after second vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 14Apr2021 at 15:45 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included lip injections on 15Mar2021. The patient had no known allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 23Mar2021 at 12:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. On 15Apr2021 at 19:00, the patient experienced lips swelling a day after second vaccine. The patient had lip injections on 15Mar2021. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lips swelling was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Nausea; Chills; Fever; Headache; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 14:00(at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin, sulfonamide and Kiwi; all from an unknown date.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included citalopram hydrobromide (CELEXA) and terbinafine (MANUFACTURER UNKNOWN); both from an unknown date for an unspecified indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 16:00, the patient experienced nausea, chills, fever and headache. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, chills, fever and headache was recovered on an unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, SARS-CoV-2 test negative, Upper respiratory tract infection
Clinical narrative: unwell with chest and head infection; unwell with chest and head infection; bad upper respiratory infection; cough; unwell with chest and head infection; bad diarrhea; headache; This is a spontaneous report from a contactable consumer (patient herself). A non-pregnant 61-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, administered in left arm on 03Apr2021 13:30 (Batch/Lot Number: ER8734) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was not reported. No COVID prior vaccination. The patient's concomitant medications were not reported. No other vaccine in 4 weeks. Patient previously took iodine for an unspecified indication and experienced known allergies. On 04Apr2021, the day after shot had bad diarrhea and headache but on 05Apr2021, the second day after shot, patient came down with a bad upper respiratory infection. Went to doctor she gave her some pills for the cough. Patient have been unwell with chest and head infection. Never coughed so much in her life. The adverse event resulted in doctor or other healthcare professional office/clinic visit and treated with benzonatate.  COVID was tested post vaccination via nasal swab on 09Apr2021 with result negative. Facility type vaccine was Public Health facility. The outcome of the events was not recovered at the time of report.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Diarrhoea, Headache, Infection, Lower respiratory tract infection
Clinical narrative: unwell with chest and head infection; unwell with chest and head infection; bad upper respiratory infection; cough; unwell with chest and head infection; bad diarrhea; headache; This is a spontaneous report from a contactable consumer (patient herself). A non-pregnant 61-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, administered in left arm on 03Apr2021 13:30 (Batch/Lot Number: ER8734) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was not reported. No COVID prior vaccination. The patient's concomitant medications were not reported. No other vaccine in 4 weeks. Patient previously took iodine for an unspecified indication and experienced known allergies. On 04Apr2021, the day after shot had bad diarrhea and headache but on 05Apr2021, the second day after shot, patient came down with a bad upper respiratory infection. Went to doctor she gave her some pills for the cough. Patient have been unwell with chest and head infection. Never coughed so much in her life. The adverse event resulted in doctor or other healthcare professional office/clinic visit and treated with benzonatate.  COVID was tested post vaccination via nasal swab on 09Apr2021 with result negative. Facility type vaccine was Public Health facility. The outcome of the events was not recovered at the time of report.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, SARS-CoV-2 test, Upper respiratory tract infection
Clinical narrative: unwell with chest and head infection; unwell with chest and head infection; bad upper respiratory infection; cough; unwell with chest and head infection; bad diarrhea; headache; This is a spontaneous report from a contactable consumer (patient herself). A non-pregnant 61-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, administered in left arm on 03Apr2021 13:30 (Batch/Lot Number: ER8734) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was not reported. No COVID prior vaccination. The patient's concomitant medications were not reported. No other vaccine in 4 weeks. Patient previously took iodine for an unspecified indication and experienced known allergies. On 04Apr2021, the day after shot had bad diarrhea and headache but on 05Apr2021, the second day after shot, patient came down with a bad upper respiratory infection. Went to doctor she gave her some pills for the cough. Patient have been unwell with chest and head infection. Never coughed so much in her life. The adverse event resulted in doctor or other healthcare professional office/clinic visit and treated with benzonatate.  COVID was tested post vaccination via nasal swab on 09Apr2021 with result negative. Facility type vaccine was Public Health facility. The outcome of the events was not recovered at the time of report.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Body aches; Low grade fever; Chills; Nausea; Headache; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 12Apr2021 at 08:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received an unspecified vaccine within four weeks prior to the COVID vaccine. Concomitant medications included unspecified birth control medication from an unknown date for an unknown indication and unknown if ongoing. On 12Apr2021 at 20:30, the patient experienced low grade fever, chills, nausea, body aches and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events low grade fever, chills, nausea, body aches and headache were recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: High frequency ringing in head.; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 03Apr2021 at 13:00 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medication within two weeks. On 03Apr2021, the patient experienced high frequency ringing in head. The noise that had persisted since approximately 4 hours after vaccine. The patient did not receive any treatment for the reported event. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event high frequency ringing in head was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Skin exfoliation
Clinical narrative: pregnant; Large pain full rash developed 4 daysafter injection and has continued tospread now 10 days later; This is a spontaneous report from a contactable consumer (patient). A 36-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route of administration on 02Apr2021 at 16:00 (at the age of 36-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history included irritable bowel syndrome with diarrhoea (IBS-D), cholecystectomy kidney stones and COVID-19. The patient concomitant medications included prenatal vitamins (MANUFACTURER UNKNOWN). The patient's last menstrual period was 25Aug2020 and due date was 13Jun2021. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Apr2021, 4 days after vaccination, the patient developed large painful rash and had continued to spread 10 days later. The patient received the vaccine during 29 weeks of pregnancy and hence maternal exposure during pregnancy, third trimester. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. The outcome of the event large painful rash was not resolved and other event was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Maternal exposure during pregnancy, Rash
Clinical narrative: pregnant; Large pain full rash developed 4 daysafter injection and has continued tospread now 10 days later; This is a spontaneous report from a contactable consumer (patient). A 36-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route of administration on 02Apr2021 at 16:00 (at the age of 36-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history included irritable bowel syndrome with diarrhoea (IBS-D), cholecystectomy kidney stones and COVID-19. The patient concomitant medications included prenatal vitamins (MANUFACTURER UNKNOWN). The patient's last menstrual period was 25Aug2020 and due date was 13Jun2021. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Apr2021, 4 days after vaccination, the patient developed large painful rash and had continued to spread 10 days later. The patient received the vaccine during 29 weeks of pregnancy and hence maternal exposure during pregnancy, third trimester. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. The outcome of the event large painful rash was not resolved and other event was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Dehydration, Dizziness, Dry mouth, Fatigue
Clinical narrative: Tired; Stomach growling; Dry mouth; Dizziness; Racing heart; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the arm left on 13Apr2021(at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety and food allergy for mango. Concomitant medications included vitamin b nos (VITAMIN B). Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021, the patient felt tired within an hour. Before bedtime he might have felt empty stomach, stomach growling. Next morning during breakfast he felt dry mouth, tired, a short period of dizziness followed by racing heart for 30 seconds. The patient called doctor and they informed him to stay hydrated. The patient have since and no more dizziness but still have off and on dry mouth, feel less full after meals, off and on tiredness (as reported). Therapeutic measures were not taken as a result of these events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tired, stomach growling, dry mouth, dizziness and racing heart was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Hunger, Palpitations, Thirst, Tremor
Clinical narrative: Tired; Stomach growling; Dry mouth; Dizziness; Racing heart; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the arm left on 13Apr2021(at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety and food allergy for mango. Concomitant medications included vitamin b nos (VITAMIN B). Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021, the patient felt tired within an hour. Before bedtime he might have felt empty stomach, stomach growling. Next morning during breakfast he felt dry mouth, tired, a short period of dizziness followed by racing heart for 30 seconds. The patient called doctor and they informed him to stay hydrated. The patient have since and no more dizziness but still have off and on dry mouth, feel less full after meals, off and on tiredness (as reported). Therapeutic measures were not taken as a result of these events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tired, stomach growling, dry mouth, dizziness and racing heart was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dry mouth, Fatigue, Hunger, Palpitations
Clinical narrative: Tired; Stomach growling; Dry mouth; Dizziness; Racing heart; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the arm left on 13Apr2021(at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety and food allergy for mango. Concomitant medications included vitamin b nos (VITAMIN B). Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021, the patient felt tired within an hour. Before bedtime he might have felt empty stomach, stomach growling. Next morning during breakfast he felt dry mouth, tired, a short period of dizziness followed by racing heart for 30 seconds. The patient called doctor and they informed him to stay hydrated. The patient have since and no more dizziness but still have off and on dry mouth, feel less full after meals, off and on tiredness (as reported). Therapeutic measures were not taken as a result of these events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tired, stomach growling, dry mouth, dizziness and racing heart was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus in right ear.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 30Mar2021 at 13:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. The patient had unspecified medical history. The patient has taken unspecified concomitant medications. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 09:00, the patient experienced tinnitus in right ear. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with steroids and antibiotic from an unknown date. On 14Apr2021, the patient underwent SARS COV 2 AB, TOTAL SPIKE SEMI QN COVID-19 test (Blood test) and the result was positive. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event tinnitus in right ear was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: Tinnitus in right ear.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 30Mar2021 at 13:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. The patient had unspecified medical history. The patient has taken unspecified concomitant medications. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 09:00, the patient experienced tinnitus in right ear. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with steroids and antibiotic from an unknown date. On 14Apr2021, the patient underwent SARS COV 2 AB, TOTAL SPIKE SEMI QN COVID-19 test (Blood test) and the result was positive. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event tinnitus in right ear was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Dizziness, Nausea
Clinical narrative: Lightheadedness/Dizziness; Felt a warm flush when received dose; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the right arm on 16Apr2021 at 16:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 26Mar2021 at 16:15 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 16Apr2021 at 17:30, the patient experienced lightheadedness/dizziness that had persisted into the day after. Felt a warm flush when received dose. Dizziness had even occurred when sitting still. Dizziness came in waves, worsened when the patient moves suddenly. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of events lightheadedness/dizziness and felt a warm flush was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Hot flush
Clinical narrative: Lightheadedness/Dizziness; Felt a warm flush when received dose; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the right arm on 16Apr2021 at 16:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 26Mar2021 at 16:15 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 16Apr2021 at 17:30, the patient experienced lightheadedness/dizziness that had persisted into the day after. Felt a warm flush when received dose. Dizziness had even occurred when sitting still. Dizziness came in waves, worsened when the patient moves suddenly. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of events lightheadedness/dizziness and felt a warm flush was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chills, Headache, Herpes zoster, Myalgia
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 12Apr2021 at 09:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included shellfish allergy and drug allergy (Sulfa drugs). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 22Mar2021 at 12:15 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 the patient experienced shingles. Therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shingles was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 12Apr2021 at 09:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included shellfish allergy and drug allergy (Sulfa drugs). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 22Mar2021 at 12:15 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 the patient experienced shingles. Therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shingles was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 12Apr2021 at 09:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included shellfish allergy and drug allergy (Sulfa drugs). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 22Mar2021 at 12:15 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 the patient experienced shingles. Therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shingles was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Myalgia, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 30-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot# EM0170), at the age of 30, via an unspecified route of administration, left arm, on Apr 16, 2021, at 09:45, single dose, for COVID-19 immunisation. Medical history included pollen allergy. Prior to vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medication within two weeks of vaccination. On Apr 16, 2021, at 20:15, patient experienced fever (37ºC), severe pain on the upper right arm, back pain and whole body chill. No therapeutic measures taken as a result of the events. Since the vaccination, patient has not tested for COVID-19. The outcome of the fever resolved after 2 days on Apr 18, 2021; while the outcome of back pain, pain in arm and chills: unknown (at the time of this report). No follow-up attempts needed. No further information expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Body temperature, Chills, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 30-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot# EM0170), at the age of 30, via an unspecified route of administration, left arm, on Apr 16, 2021, at 09:45, single dose, for COVID-19 immunisation. Medical history included pollen allergy. Prior to vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medication within two weeks of vaccination. On Apr 16, 2021, at 20:15, patient experienced fever (37ºC), severe pain on the upper right arm, back pain and whole body chill. No therapeutic measures taken as a result of the events. Since the vaccination, patient has not tested for COVID-19. The outcome of the fever resolved after 2 days on Apr 18, 2021; while the outcome of back pain, pain in arm and chills: unknown (at the time of this report). No follow-up attempts needed. No further information expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Hypoaesthesia, Joint range of motion decreased, Loss of personal independence in daily activities
Clinical narrative: I noticed my left hand wasn't fully functioning (as if my hand had fallen asleep and wasn't fully "awake").; Some slight pain in my arm socket when moving my arm in some directions.; Sometimes, would also get numbness or tinglingdown in arm and in fingers,; Sometimes, I would also get numbness or tingling down my arm and in my fingers.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 16Apr2021 at 13:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient did not have any known medical history. The patient had no known allergies to food, medication or other product. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included calcium (MANUFACTURER UNKNOWN), ergocalciferol (VITAMIN d2) and multivitamin (MANUFACTURER UNKNOWN) all started on unknown dates and for unspecified indications. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 16Apr2021 at 13:30 the patient experienced the left hand wasn't fully functioning (as if hand had fallen asleep and wasn't fully awake) within minutes of receiving the injection in the upper left arm. About an hour later, she noticed some slight pain in the arm socket when moving arm in some directions. Over the course of the night, the pain (very sharp) became worse to the point where it was excruciating to try to undress for bed. Sometimes, she would also get numbness or tingling down in the arm and in the fingers, similar to after had hit to the funny bone really was hard. She could only sleep on her back because any other position was too painful. On 17Apr2021, the numbness and tingling have stopped, but the arm socket still had sharp pain if moved. So, she kept the arm stable against her body (from elbow up); if that was done, it didn't hurt at all. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the event(s). The clinical outcome of the events numbness in the arm and fingers and tingling were recovered on 17April2021. The clinical outcome of the event pain in arm and arm discomfort was not recovered, at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Pain in extremity, Paraesthesia
Clinical narrative: I noticed my left hand wasn't fully functioning (as if my hand had fallen asleep and wasn't fully "awake").; Some slight pain in my arm socket when moving my arm in some directions.; Sometimes, would also get numbness or tinglingdown in arm and in fingers,; Sometimes, I would also get numbness or tingling down my arm and in my fingers.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 16Apr2021 at 13:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient did not have any known medical history. The patient had no known allergies to food, medication or other product. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included calcium (MANUFACTURER UNKNOWN), ergocalciferol (VITAMIN d2) and multivitamin (MANUFACTURER UNKNOWN) all started on unknown dates and for unspecified indications. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 16Apr2021 at 13:30 the patient experienced the left hand wasn't fully functioning (as if hand had fallen asleep and wasn't fully awake) within minutes of receiving the injection in the upper left arm. About an hour later, she noticed some slight pain in the arm socket when moving arm in some directions. Over the course of the night, the pain (very sharp) became worse to the point where it was excruciating to try to undress for bed. Sometimes, she would also get numbness or tingling down in the arm and in the fingers, similar to after had hit to the funny bone really was hard. She could only sleep on her back because any other position was too painful. On 17Apr2021, the numbness and tingling have stopped, but the arm socket still had sharp pain if moved. So, she kept the arm stable against her body (from elbow up); if that was done, it didn't hurt at all. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the event(s). The clinical outcome of the events numbness in the arm and fingers and tingling were recovered on 17April2021. The clinical outcome of the event pain in arm and arm discomfort was not recovered, at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Oedema peripheral
Clinical narrative: Swollen under armpit; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 15Apr2021 at 11:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E6955) via an unspecified route of administration in the left arm on 26Mar2021 at 10:00 (at the age of 41-years-old) as a single dose, for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 16:00, the patient experienced swollen under armpit. The event resulted in emergency room/department or urgent care. It was unknown if patient received treatment for the event. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the event swollen under armpit was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swelling
Clinical narrative: Swollen under armpit; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 15Apr2021 at 11:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E6955) via an unspecified route of administration in the left arm on 26Mar2021 at 10:00 (at the age of 41-years-old) as a single dose, for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 16:00, the patient experienced swollen under armpit. The event resulted in emergency room/department or urgent care. It was unknown if patient received treatment for the event. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the event swollen under armpit was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site pain, Injection site swelling, Neck pain, Pruritus
Clinical narrative: Continuous severe pain in arm; Severe pain in shoulder; Joint mobility restriction; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 29Mar2021 at 11:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. The patient had known allergies. 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 08Mar2021 at 10:45 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Mar2021, the patient experienced continuous severe pain in arm, severe pain in shoulder and joint mobility restriction. The events resulted in emergency room/department or urgent care visit. Therapeutic measures were taken as a result of events and included treatment with unspecified medication (shot). The clinical outcome of the event continuous severe pain in arm, severe pain in shoulder and joint mobility restriction was not resolved.  No follow-up attempts are needed. No further information is expected.