chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Myalgia, Pyrexia
Clinical narrative: Muscle pain / tightness on left side; Left ear feeling like it has fluid in it; Slightly elevated temperature; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 13Mar2021 at 09:15 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient had unspecified medical history. The patient had unspecified allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included unspecified medications within 2 weeks of vaccination. The patient previously received the first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via an unspecified route of administration in the left arm on 20Feb2021 at 15:45 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Mar2021, the patient experienced muscle pain/tightness on left side, left ear felt like it had fluid in it and slightly elevated temperature. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of muscle pain/tightness on left side, left ear felt like it has fluid in it and slightly elevated temperature were 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
Symptoms: Body temperature abnormal, Chills, Headache, Hyperhidrosis, Nausea
Clinical narrative: Tinnitus; Temperature; Body aches; Sweating; Headache; Nausea; Chills; This is a spontaneous report from a contactable other healthcare professional. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1686) via an unspecified route of administration in the arm on 06Jan2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EH9899) via an intramuscular route of administration in the left arm on 18Dec2020 at 10:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. On 07Jan2021 at 21:00, the patient experienced tinnitus, temperature, headache, nausea, body aches, chills and sweating.The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient underwent nasal swab test and the result was unknown. The clinical outcome of the events temperature, headache, nausea, body aches, chills and sweating was resolved on 09Jan2021 at 21:00, after the duration of 48 hours. The clinical outcome of the event tinnitus was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test, Tinnitus
Clinical narrative: Tinnitus; Temperature; Body aches; Sweating; Headache; Nausea; Chills; This is a spontaneous report from a contactable other healthcare professional. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1686) via an unspecified route of administration in the arm on 06Jan2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EH9899) via an intramuscular route of administration in the left arm on 18Dec2020 at 10:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. On 07Jan2021 at 21:00, the patient experienced tinnitus, temperature, headache, nausea, body aches, chills and sweating.The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient underwent nasal swab test and the result was unknown. The clinical outcome of the events temperature, headache, nausea, body aches, chills and sweating was resolved on 09Jan2021 at 21:00, after the duration of 48 hours. The clinical outcome of the event tinnitus was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling
Clinical narrative: Swelling (feet, legs, fingers); Soreness in rear end; This is a spontaneous report from a contactable consumer, the patient. A 26-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 11Mar2021 at 10:45 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified medications for birth control and attention deficit hyperactivity disorder from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Mar2021, the patient experienced swelling (feet, legs, fingers) and soreness in rear end. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling (feet, legs, fingers) and soreness in rear end was unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: 2 weeks after 2nd shot, daily headaches; Moderate fatigue from 16:00 until following morning; This is a spontaneous report from a non-contactable consumer, the patient. A male patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 26Feb2021 at 15:00, as a single dose for COVID-19 immunisation. Medical history included autoimmune urticaria. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks prior to the 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: EN6203) via an unspecified route of administration in the right arm on 02Feb2021 at 15:00 as a single dose for COVID-19 immunisation. On 15Mar2021 at 16:00, 2 weeks after the second shot, the patient experienced daily headaches and moderate fatigue until following morning. The patient did not receive any treatment for the events reported. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events 2 weeks after 2nd shot, daily headaches and moderate fatigue from 16:00 until following morning were not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Arm muscle pain; This is a spontaneous report from a non-contactable consumer, the patient. An unknown gender patient of unknown age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Mar2021 at 09:15 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. On an unknown date in Mar2021, the patient experienced arm muscle pain. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event arm muscle pain was unknown at the time of this report.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Hypoaesthesia, Muscle tightness, Nausea
Clinical narrative: Pain in left arm that has increased; Numbness; Tingling; Feel tired; Lack of strength; Having neck tightness left sideseems to be affect; Fatigue; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 01Mar2021 at 13:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient previously took morphine (MANUFACTURER UNKNOWN) on unknown date for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 03Mar2021 at 00:00 the patient experienced pain in left arm that had increased over time with numbness and tingling, felt tired and lack of strength also had neck tightness and left side seems to be affected, and also experienced fatigue and nausea. The events did not result in doctor or other healthcare professional office/clinic, 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 pain in left arm that had increased over time with numbness, tingling, felt tired and lack of strength also had neck tightness and left side seems to be affected, and also experienced fatigue and nausea was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Pain in left arm that has increased; Numbness; Tingling; Feel tired; Lack of strength; Having neck tightness left sideseems to be affect; Fatigue; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 01Mar2021 at 13:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient previously took morphine (MANUFACTURER UNKNOWN) on unknown date for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 03Mar2021 at 00:00 the patient experienced pain in left arm that had increased over time with numbness and tingling, felt tired and lack of strength also had neck tightness and left side seems to be affected, and also experienced fatigue and nausea. The events did not result in doctor or other healthcare professional office/clinic, 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 pain in left arm that had increased over time with numbness, tingling, felt tired and lack of strength also had neck tightness and left side seems to be affected, and also experienced fatigue and nausea was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Lymph node pain
Clinical narrative: A very 'heavy' left arm hard to lift above head; very tender nodes under arms; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 15Mar2021 at 13:15 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Feb2021 at 13:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. On 16Mar2021 at 06:00, the patient experienced a very heavy left arm which was hard to lift above head and very tender nodes under arms. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events a very heavy left arm which was hard to lift above head and very tender nodes under arms was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo beginning 8 hours after vaccination, lasting 24 hrs; This is a spontaneous report from a non-contactable consumer, the patient. A 75-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on an unknown date in Mar2021 (at the age of 75-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. 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 medications within two weeks of vaccination. On an unknown date in Mar2021, the patient experienced vertigo beginning 8 hours after the vaccination and lasted for 24 hours. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event vertigo was recovered on an unknown date in Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metal taste in mouth; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Mar2021 at 15:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any concomitant medications within two weeks of vaccination. 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 an unspecified date in Mar2021 (also reported as at 15:45), the patient experienced metal taste in mouth. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event metal taste in mouth was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Headache; sore arms started 3 hours after the vaccine; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Mar2021 at 14:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included mild gastritis and allergy to shellfish. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included minerals nos, vitamins nos (CENTRUM), vitamin d nos (MANUFACTURER UNKNOWN) and ferrous sulfate (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing. The patient previously received oxycodone hydrochloride (CODIN) on unknown date for unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Mar2021 at 17:30, 3 hours after the vaccine, the patient experienced sore arms. On 11Mar2021 at 12:00, around noon, the patient experienced headache. On 12Mar2021, around noon, again the patient experienced headache. On 13Mar2021, from noon to night and on 14Mar2021, in the evening, the patient experienced headache. On 15Mar2021 from around 16:00 to evening, the patient experienced headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with paracetamol (TYLENOL) on 15Mar2021 around 19:00. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arms and headache was recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen Lymphnode on left side of lower neck area; This is a spontaneous report from a non-contactable consumer, the patient. A 46-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 11Mar2021 at 13:00 (at the age of 46-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 did not receive concomitant  medications. 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: UNKNOWN) via an unspecified route of administration in the left arm on 18Feb2021 at 12:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 12Mar2021 at 20:00, the patient experienced swollen lymph node on left side of lower neck area. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph node on left side of lower neck area was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills/Shivering; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 13Mar2021 at 16:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history and 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 COVID vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 20Feb2021 at 18:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 14Mar2021 at 01:00, after taking the second dose, the patient experienced chills/shivering. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills/shivering was resolved without any intervention or treatment the same night on 14Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 73-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 on 23Feb2021 (at the age of 73-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. It was not reported whether the patient received 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: UNKNOWN) via an unspecified route of administration on 05Feb2021 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. On 24Feb2021, the patient experienced headache. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headache was unknown at the time of this report.   No follow-up attempts are possible,  information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at injected location; This is a spontaneous report from a non-contactable consumer. A 30-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL6199) via an unspecified route of administration in the left arm on 13Mar2021 at 12:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included TYLENOL and VITAMIN D (MANUFACTURER UNKNOWN); both from unknown date for unknown indication and unknown if ongoing. On 13Mar2021 at 14:30, the patient experienced pain at injected location. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pain at injected location was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: The patient had the shivers for over 8 hours and couldn't get warm; This is a spontaneous report from a non-contactable consumer. An unspecified aged male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient had received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On an unknown date in Feb2021, the patient experienced shivers for over 8 hours and could not get warm. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event shivers was recovered on an unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, SARS-CoV-2 antibody test
Clinical narrative: Headache; Chills; Nausea; Vomiting; Body aches; Pain at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 12Mar2021 at 10:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine and COVID-19 antibody test positive. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included vita fusion women's vitamins (MANUFACTURER UNKNOWN) and magnesium (MANUFACTURER UNKNOWN) all for unknown indication from an unknown date and unknown if ongoing. On 12Mar2021 at 22:00 the patient experienced headache, chills, nausea, vomiting, body aches and pain at injection site. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. On an unknown date, the patient underwent COVID-19 antibody test and the result was positive. The clinical outcome of the event headache, chills, nausea, vomiting, body aches and pain at injection site were resolving at the time of report.   No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: Headache; Chills; Nausea; Vomiting; Body aches; Pain at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 12Mar2021 at 10:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine and COVID-19 antibody test positive. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included vita fusion women's vitamins (MANUFACTURER UNKNOWN) and magnesium (MANUFACTURER UNKNOWN) all for unknown indication from an unknown date and unknown if ongoing. On 12Mar2021 at 22:00 the patient experienced headache, chills, nausea, vomiting, body aches and pain at injection site. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. On an unknown date, the patient underwent COVID-19 antibody test and the result was positive. The clinical outcome of the event headache, chills, nausea, vomiting, body aches and pain at injection site were resolving at the time of report.   No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: Sore injection site; Body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female 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 14Mar2021 at 16:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication was not reported. On 15Mar2021, the patient experienced sore injection site and body aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the event sore injection site and body aches was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Nauseous, dizzy.; Dizzy; This is a spontaneous report from a non-contactable consumer, the patient. A 86-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 25Feb2021 (at the age of 86-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to iodine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On an unknown date in 2021, the patient experienced nauseous and dizzy. Since the vaccination, the patient has not been tested for COVID-19. The clinical outcome of the event nauseous and dizzy was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Impaired work ability
Clinical narrative: extremely dizzy and lightheaded; had to take off work the next day due to the dizziness.; 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: EN6207) via an unspecified route of administration in the arm left on 14Mar2021 at 13:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid disorder and high cholesterol. Patient had no known allergies. Concomitant medications included meloxicam (MANUFACTURER UNKNOWN) and esomeprazole (NEXIUM); both taken for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Mar2021 at 18:30 the patient experienced extremely dizzy and lightheaded within 30 hours of taking vaccine, the patient had to take off work the next day due to the dizziness, its been 4 days (when reported), still slightly lightheaded when turning the head, but able to work. The clinical outcome of the event extremely dizzy and lightheaded within 30 hours of taking vaccine, the patient had to take off work the next day due to the dizziness was recovering at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe headaches; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Feb2021 at 11:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included SERTRALINE, taken for an unknown indication from an unknown date and unknown if ongoing. On 28Feb2021, the patient experienced severe headaches. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of severe headache and included treatment with unspecified medicine. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe headaches was not recovered at the time of this report.   No follow-up attempts are required, information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: very negligible side effects like a headache; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL9262, Expiration date: unknown), via an unspecified route of administration, administered in Arm Right on 19Feb2021 13:40 (age at vaccination was 64 years) as dose 1, single for COVID-19 immunization. The patient's medical history included breast cancer female (she is a former breast cancer patient) and mastectomy from an unspecified date in 2009 to an unspecified date in 2009. Concomitant medication included valsartan (DIOVAN) taken for hypertension, levothyroxine sodium (SYNTHROID), mesalamine taken for irritable bowel syndrome and metformin taken for glucose tolerance impaired, start and stop date were not reported. On 19Feb2021, after first dose patient experienced very negligible side effects like a headache. Patient received second dose on 12MAR2021 at 13:45 for COVID-19 immunization. No treatment was received for the adverse event. The outcome of the event was recovered on an unspecified date in2021.  Follow-up attempts completed. No further information expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nasopharyngitis, Nausea
Clinical narrative: Nausea; cold; Chills; This is a spontaneous report from a contactable consumer (Patient) via a Program. A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) dose 2, via an unspecified route of administration on 10Mar2021 (age at vaccination: 71years-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported and concomitant medications were not reported. Historical vaccine included dose 1 of bnt162b2 (Lot number was not reported) on 17Feb2021. She experienced nausea, colds, and chill a day after the 2nd dose that is on 11Mar2021, while her husband experienced the same symptoms 2 days after the 2nd dose. The outcome of the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden
Clinical narrative: husband is bedridden and coming through an ambulance; This is a spontaneous report from a contactable consumer (Patient wife) from sponsored program. A 74-years-old male patient (husband) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 24Feb2021 (at the age of 74-years-old) as dose 1, single for COVID-19 immunization. Medical history included, patient had a severe COPD and multiple strokes even before the first dose of the vaccine; both from an unknown date and unknown if ongoing. Concomitant medications were not reported. On an unspecified date, after first dose of the vaccine, the patient experienced bedridden and coming through an ambulance. Reporter stated that patient is coming home from the hospital tomorrow (at the time of report, unspecified date). He needs to get his second shot but his husband is bedridden and coming through an ambulance. Reporter would like to know that if a nurse can come to their house to administer the second dose for patient. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Extreme fatigue for two weeks; This is spontaneous report received from consumer (Patient). A 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Not reported), via an unspecified route of administration on 07Feb2021 at 2:00 PM (at the age of 69-years-old) as dose 2, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL3247), via an unspecified route of administration, administered in left arm on 20Jan2021 at 2:00 PM (at the age of 69-years-old) as dose 1, single for COVID-19 immunisation and experienced more intense fatigue. On an unspecified date after second dose, the patient experienced extreme fatigue for two weeks. The patient stated that the fatigue was more intense with the first vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nasopharyngitis, Nausea
Clinical narrative: Nausea; cold; chills; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (Patient's wife). An 82-years-old male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 10Mar2021 (at the age of 83 years old) (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Previously the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 17Feb2021 (at the age of 82 years old) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. On 12Mar2021, the patient experienced nausea, cold and chills. The reporter stated they have had both doses of the vaccine. A day after her dose she had nausea, cold, and chills, her husband (the patient) experienced the same symptoms as her (nausea, cold and chills) 2 days after the 2nd dose. The outcome of all the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: swelling, like a little bubble on the middle knuckle of the index finger of Left hand/ pointer on left hand pointer finger the index finger is swollen; This is a spontaneous report received from a contactable male consumer (Patient). A 67-year-old male patient received first dose of bnt162b2 (Pfizer-Biontech Covid-19 Mrna Vaccine; Solution for injection; Lot Number: Unknown), via an unspecified route of administration, administered in left arm as dose 1, single on 11Mar2021 between 11:30 AM and 12:30 PM (at the age of 67-year-old) for covid-19 immunisation. Medical history included prostate cancer from 2014 (back in 2014 and 2015), blood cholesterol, acid reflux, pain in rigidity knee and glaucoma, Surviving cancer patient. Concomitant medications included ongoing atorvastatin (ATORVASTATIN) for blood cholesterol (been taking the last couple of years); ongoing pantoprazole sodium sesquihydrate (PANTAZOLE) for gastrooesophageal reflux disease (been taking the last couple of years or so longer); ongoing ibuprofen, diphenhydramine citrate (IBUPROFEN, DIPHENHYDRAMINE CITRATE) for arthralgia (he was supposed to take this almost every day for the past 3 or 4 years), ongoing latanoprost (LATANOPROST) for glaucoma (took for years), sulatildemalol for glaucoma (took for years) and Bremonizol for glaucoma (took for years) all from an unspecified start date and ongoing. The patient had not received any other vaccines prior to the COVID vaccine within 4 weeks. No adverse events reported following prior vaccinations. Patient was a 67-year-old male who received the first dose of the Pfizer BioNtech Covid 19 vaccine on 11Mar2021. The next day 12Mar2021 swelling, like a little bubble on the middle knuckle of the pointer on left hand pointer finger the index finger and was still there. Patient thought it would go down and had been a week and a few days. He wanted to know if this could be a side effect from the shot since he had nothing from before receiving the shot. He stated the swelling has not went down. It hasn't gotten bigger or smaller and it doesn't hurt. He was scheduled to receive the second dose on 01Apr2021. The adverse event did not result in any emergency Room or physician office. He stated he just takes regular medications that he has been taking before and after shot. He stated they assured him it would not be a problem so he has been taking them before and after the vaccine. He stated but he has not taken medication for the adverse event. He stated he wished he was at home so he could provide all the information of the medications. At the time of this report, the outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: Dizziness; Nausea; Vertigo; This is a spontaneous report from a contactable consumer, the patient. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient received 1st dose of Covid vaccine last Tuesday and 4 days later he started experiencing vertigo, dizziness and nausea and was still experiencing. The patient was called because he was worried about the 2nd dose make him sicker than the 1st and was wondered if there was anything he could take to stop any possible side effects. The outcome of the events was not recovered.  No follow-up attempts were needed, information about lot/batch number could not be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient). A 59-year-old female patient received the 1st dose of BNT162B2 (Comirnaty, solution for injection; batch/lot# not reported), via an unspecified route of administration, on Mar 10, 2021, single dose, for COVID-19 immunisation. The patient's medical and concomitant medications not reported. On an unspecified date, patient experienced migraine (last Thursday). She was advised to take steroids today for 6 days. Patient wanted to know if they are going to cause a problem with the COVID-19 vaccine. The outcome of the event: unknown. Additional information on batch/lot number requested. No follow-up attempts needed. No further information expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue-very tired; This is a spontaneous report from a non-contactable consumer. A 41-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot/batch number and expiration date not reported), via an unspecified route of administration in left arm on 18Mar2021 at 13:00 (at the age of 41-year-old) at single dose for COVID-19 immunisation. The patient's medical history was not reported. It was unknown if the patient had any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. Concomitant medications included TYLENOL, multivitamin, and other unknown medications. On 18Mar2021 at 15:00, the patient experienced fatigue-very tired approximately 2 hours after took Pfizer COVID-19 vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fatigue-very tired was recovered in Mar2021.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected. This follow-up report is being submitted to amend previously reported information, patient received first dose of BNT162b2 in US.