chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Nasal congestion
Clinical narrative: Nasal congestion; Swelling of lips; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 39-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. It was unknown whether the patient received any medication within two weeks of vaccination. On an unknown date, the patient experienced nasal congestion and swelling of lips. The events resulted in emergency room/department visit or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events nasal congestion and swelling of lips was resolved on an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Herpes zoster, Musculoskeletal pain, Myalgia, Neuralgia
Clinical narrative: Affected the muscles in chest.; Shingles flair up; Nerve pain; Just dont feel right still.; Terrible muscle pain in legs; This is a spontaneous report from a non-contactable consumer, the patient. A 56-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 04Aug2021 at 12:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included shingles. 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 medications within 2 weeks prior to the vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 16Aug2021, two weeks after the vaccine, the patient experienced terrible muscle pain in legs and also had affected the muscles in chest. She also had shingles flair up, still had nerve pain now and just did not feel right still. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 15Sep2021, the patient underwent SARS-CoV2 test (nasal swab) and the result was negative. Since the vaccination, the patient had been tested for COVID-19.The clinical outcome of the events terrible muscle pain in legs, had affected the muscles in chest, also shingles flair up, she still had nerve pain now and just did not feel right still were not resolved 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Affected the muscles in chest.; Shingles flair up; Nerve pain; Just dont feel right still.; Terrible muscle pain in legs; This is a spontaneous report from a non-contactable consumer, the patient. A 56-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 04Aug2021 at 12:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included shingles. 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 medications within 2 weeks prior to the vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 16Aug2021, two weeks after the vaccine, the patient experienced terrible muscle pain in legs and also had affected the muscles in chest. She also had shingles flair up, still had nerve pain now and just did not feel right still. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 15Sep2021, the patient underwent SARS-CoV2 test (nasal swab) and the result was negative. Since the vaccination, the patient had been tested for COVID-19.The clinical outcome of the events terrible muscle pain in legs, had affected the muscles in chest, also shingles flair up, she still had nerve pain now and just did not feel right still were not resolved 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: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Breast pain, Fatigue, Migraine, Pain in extremity
Clinical narrative: Fatigue; Left arm, breast and back pain; Breast and back pain; Back pain; Some swelling; Migraine; This is a spontaneous report from a contactable healthcare professional, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 13Sep2021 at 15:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy, and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Sep2021, the patient experienced fatigue, also left arm, breast and back pain as well as some swelling for two weeks and migraine for three days. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event migraine was resolved on 17Sep2021, after a duration of three days, while that of some swelling was resolved on an unknown date in 2021 after a duration of two weeks. The clinical outcome of the events fatigue and left arm, breast and back pain was resolving at the time of this report. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Oct2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Fatigue; Left arm, breast and back pain; Breast and back pain; Back pain; Some swelling; Migraine; This is a spontaneous report from a contactable healthcare professional, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 13Sep2021 at 15:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy, and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Sep2021, the patient experienced fatigue, also left arm, breast and back pain as well as some swelling for two weeks and migraine for three days. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event migraine was resolved on 17Sep2021, after a duration of three days, while that of some swelling was resolved on an unknown date in 2021 after a duration of two weeks. The clinical outcome of the events fatigue and left arm, breast and back pain was resolving at the time of this report. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Oct2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Racing heart / Now has to take heart meds; This is a spontaneous report from a contactable consumer, the patient. A 15-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 on an unknown date and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in right arm on an unknown date 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. The patient did not receive any medication within two weeks of vaccination. On an unknown date, the patient experienced racing heart, he then had to take heart medications. The event resulted in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the event and included treatment with heart medications. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event racing heart was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow-up.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Blurred vision; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2587) via an unspecified route of administration in the left arm on an unknown date in Oct2021 at 11:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and unspecified allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in Oct2021, the patient experienced blurred vision  for about 15 minutes. The event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were 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 blurred vision was resolved on an unknown date in Oct2021.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Lymph node pain, Lymphadenopathy, Migraine
Clinical narrative: Migraine; Nausea; Vomiting; Fever; Swollen and painful lymph node in armpit of same arm of injection; Swollen and painful lymph node in armpit of same arm of injection; Tenderness at injection site; Tired; Off label use; A third (booster) dose of BNT162b2 was administered subsequent to the Initial 2 dose regimen of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 30Sep2021 (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 prescription oral birth control from an unknown date and unknown if ongoing and influenza vaccine (MANUFACTURER UNKNOWN) on 15Sep2021 for an unknown indication. 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 27Jan2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on 17Feb2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced drug allergy The patient received influenza vaccine within four weeks prior to the COVID-19 vaccine. On 01Oct2021, the patient experienced migraine, nausea and vomiting, fever, swollen and painful lymph node in armpit of same arm of injection, tenderness at injection site and tired. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events migraine, nausea and vomiting, fever, swollen and painful lymph node in armpit of same arm of injection, tenderness at injection site and tired 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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Off label use, Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: Migraine; Nausea; Vomiting; Fever; Swollen and painful lymph node in armpit of same arm of injection; Swollen and painful lymph node in armpit of same arm of injection; Tenderness at injection site; Tired; Off label use; A third (booster) dose of BNT162b2 was administered subsequent to the Initial 2 dose regimen of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 30Sep2021 (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 prescription oral birth control from an unknown date and unknown if ongoing and influenza vaccine (MANUFACTURER UNKNOWN) on 15Sep2021 for an unknown indication. 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 27Jan2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on 17Feb2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced drug allergy The patient received influenza vaccine within four weeks prior to the COVID-19 vaccine. On 01Oct2021, the patient experienced migraine, nausea and vomiting, fever, swollen and painful lymph node in armpit of same arm of injection, tenderness at injection site and tired. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events migraine, nausea and vomiting, fever, swollen and painful lymph node in armpit of same arm of injection, tenderness at injection site and tired 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Peripheral swelling
Clinical narrative: have a lump under my arm; I have swelling under my left arm; This is a spontaneous report from a contactable consumer or other non-health-care-professional.  A 61-year-old female patient received BNT162B2 (Pfizer COVID-19 Vaccine Formulation: Solution for injection Batch/Lot Number: 30145BA Expiration Date: Unknown) via an unspecified route of administration, administered in Left Arm on 30Sep2021 as (At the age of 61-year-old) dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient calling because she took the shot (Covid Vaccine) on 30Sep2021 and she have a lump under his arm, a big lump under his arm that was the side effect she do not know how long it going to last but so already have an issue with his arms so she have a big lump so, she just wanted to report it, she call Pfizer and wait in a long line, when you have a symptom you should go straight through the Pfizer, it make you feel like you go through regular appointment, you should go under regular appointment we should have phone number of the Pfizer to go straight through, she have swelling under his left arm. It was reported that patient was not received any tenement for events, she does not know what to take, and that why she is calling what should she do for swelling. The Outcome of both events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, SARS-CoV-2 test
Clinical narrative: Excessive hair shedding. Clumps of hair falling out during shower. Noticeable hair thinning; This is a spontaneous report from a contactable other healthcare professional, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an intramuscular route of administration in the left arm on 10Sep2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an intramuscular route of administration in left arm on 20Aug2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. On 12Sep2021, the patient had excessive hair shedding. Clumps of hair falling out during shower and noticeable hair thinning. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 16Sep2021, the patient underwent an antigen test by nasal swab and the result was found to be negative. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events excessive hair shedding, clumps of hair falling out during shower and noticeable hair thinning was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Infertility, Menstruation delayed, Menstruation irregular
Clinical narrative: After the second dose my period was irregular for two cycles.; After the second dose my period was irregular for two cycles. Now after the second dose Im very late; I am unable to get pregnant.; This is a spontaneous report from a contactable nurse, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 14Jan2021 at 12:30 (at the age of 35-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 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 24Dec2021 at 09:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 17Feb2021, after the second dose, the patient's period was irregular for two cycles, now after the second dose she was very late. The patient was unable to get pregnant. It did get more regular after a few months; she would still take the shot but wanted to report it as it has happened twice now and the patient was usually regular. 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 period was irregular for two cycles, now after the second dose she was very late and she was unable to get pregnant was resolving at the time of this report. The patient also received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 27Sep2021 at 14:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle swelling, Myalgia, Pain in extremity
Clinical narrative: Painful arm/deltoid; Painful arm/deltoid; Swelling in muscle; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 36-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30145BA) via an unspecified route of administration in the left arm on 30Sep2021 at 00:45 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit disorder (ADD) and known allergies to mold, seasonal and pet dander. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications included fish oil (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), ascorbic acid (VIT C), multivitamin injection (MVI) (MANUFACTURER UNKNOWN) and vitamin b complex (B COMPLEX); all from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 30Sep2021 at 20:00, the patient experienced painful arm/deltoid and swelling in muscle. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain in arm/deltoid and muscle swelling was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Severe stomach pains; Diarrhea; This is a spontaneous report from a non-contactable consumer and a contactable consumer, pfizer employee.  A 23-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration on 04Oct2021 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, diagnosed prior to the vaccination. It was unknown whether the patient received other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 04Oct2021, the patient experienced severe stomach pains and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether 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 severe stomach pains and diarrhea were 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: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pain
Clinical narrative: Body hurts; It is difficult to feel like I'm getting enough air; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 04Oct2021 at 10:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. 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 right arm on an unknown date, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 04Oct2021 at 20:00, the patient's body hurt and it was difficult to feel like he was getting enough air. 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 body hurt and it was difficult to feel like he was getting enough air was not resolved 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Insomnia, Pyrexia
Clinical narrative: Could not sleep; Got chills around 24 hours post injection; Feels feverish but temp has not gone above 100F; This is a spontaneous report from a contactable consumer, Pfizer colleague. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an intramuscular route of administration on 04Oct2021 at 11:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID -19. It was unknown whether the patient did receive any other vaccines within four weeks prior to the vaccination. It was unknown if the patient received any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an intramuscular route of administration on an unknown date as a single dose for COVID-19 immunisation and had no adverse events. On 05Oct2021 at 11:00, the patient could not sleep, got chills around 24 hours post injection, felt feverish but temperature has not gone above 100 Fahrenheit (F). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/ department or urgent care. On 05Oct2021 at 11:00, the patient underwent body temperature test and the result was temperature has not gone above 100 Fahrenheit (unspecified units). 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 could not sleep, got chills around 24 hours post injection and feels feverish but temperature has not gone above 100F 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.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Off label use, Pain
Clinical narrative: Major body aches; Dose received: 3; Dose received: 3; This is a spontaneous report from a contactable consumer, the patient. A male patient of unspecified age received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19.  It was unknown if the patient received any other vaccine within four weeks prior to the COVID vaccine. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in as a single dose for COVID-19 immunisation and the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 05Oct2021, the patient experienced major body aches. It was unknown whether therapeutic measures were taken as a result of the event. The clinical outcome of the event major body aches was unknown at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Immunisation, Nausea
Clinical narrative: Chills; Fatigue; Body aches; Headache; Nausea; Vomiting; Off label use; Booster dose administered; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30155BA) via an unspecified route of administration in the left arm on 01Oct2021 at 11:15 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. The medical history included high blood pressure. 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 had received unspecified medications within two weeks of 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 an unknown date in Jan2021 at 08:00 (at the age of 73-years-old) and 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 06Mar2021 at 08:30 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. On 02Oct2021 at 08:30, the patient experienced chills, fatigue, body aches, headache, nausea and vomiting. On an unknown date in 2021, the patient underwent SARS-CoV-2 test via nasal swab and the result was negative. The adverse 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 reported events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events chills, fatigue, body aches, headache, nausea and vomiting were resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain, SARS-CoV-2 test, Vomiting
Clinical narrative: Chills; Fatigue; Body aches; Headache; Nausea; Vomiting; Off label use; Booster dose administered; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30155BA) via an unspecified route of administration in the left arm on 01Oct2021 at 11:15 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. The medical history included high blood pressure. 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 had received unspecified medications within two weeks of 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 an unknown date in Jan2021 at 08:00 (at the age of 73-years-old) and 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 06Mar2021 at 08:30 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. On 02Oct2021 at 08:30, the patient experienced chills, fatigue, body aches, headache, nausea and vomiting. On an unknown date in 2021, the patient underwent SARS-CoV-2 test via nasal swab and the result was negative. The adverse 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 reported events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events chills, fatigue, body aches, headache, nausea and vomiting were resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Juvenile idiopathic arthritis
Clinical narrative: Polyarticular Juvenile Idiopathic Arthritis Flare Up In Both; This is a solicited report based on the information received by Pfizer (Mfr. Control No.:21K-163-4100177-00). A contactable 19-year-old female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 19Feb2021 (at a age 19-year-old), as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 12Mar2021 (at 19-year-old), as dose 2,single for COVID-19 immunization and adalimumab (Humira) at an unknown dose via subcutaneous route for Moderate to severe polyarticular juvenile idiopathic arthritis. The patient's medical history and concomitant medications were not reported. On an unknown date the patient experienced polyarticular juvenile idiopathic arthritis flare up in both knees and hips. The event outcome was unknown.    The reporter assessed the causality for BNT162B2 as probably and of adalimumab as no reasonable possibility with the event, The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts were possible, information about lot/batch number could not be obtained.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Juvenile idiopathic arthritis and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Lymph node pain, Lymphadenopathy, Off label use
Clinical narrative: Fatigue and ache; Fatigue and ache; Swollen lymph and painful node in armpit and breast on the same side as vaccination. Approximately a mandarin-orange-sized swelling of the lymph node.; Swollen and painful lymph node in armpit and breast on the same side as vaccination; Off label use; A third (booster) dose of BNT162b2 is administered subsequent to the Initial 2 dose regimen of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Oct2021 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included dexamfetamine sulfate (ZENZEDI), lamotrigine (LAMICTAL) and ibuprofen (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose 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 and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 01Apr2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 03Oct2021, day after vaccination, the patient experienced fatigue and ache, swollen and painful lymph node in armpit and breast on the same side as vaccination, approximately a mandarin-orange-sized swelling of the lymph node. On 03Oct2021, the patient underwent pain scale test and the result was pain on scale of 1-10 was a 4. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events, fatigue and ache, swollen and painful lymph node in armpit and breast on the same side as vaccination, approximately a mandarin-orange-sized swelling of the lymph node was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain assessment
Clinical narrative: Fatigue and ache; Fatigue and ache; Swollen lymph and painful node in armpit and breast on the same side as vaccination. Approximately a mandarin-orange-sized swelling of the lymph node.; Swollen and painful lymph node in armpit and breast on the same side as vaccination; Off label use; A third (booster) dose of BNT162b2 is administered subsequent to the Initial 2 dose regimen of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Oct2021 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included dexamfetamine sulfate (ZENZEDI), lamotrigine (LAMICTAL) and ibuprofen (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose 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 and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 01Apr2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 03Oct2021, day after vaccination, the patient experienced fatigue and ache, swollen and painful lymph node in armpit and breast on the same side as vaccination, approximately a mandarin-orange-sized swelling of the lymph node. On 03Oct2021, the patient underwent pain scale test and the result was pain on scale of 1-10 was a 4. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events, fatigue and ache, swollen and painful lymph node in armpit and breast on the same side as vaccination, approximately a mandarin-orange-sized swelling of the lymph node was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Headache, Neurological examination, SARS-CoV-2 test
Clinical narrative: Severe headaches; Fatigue; This is a spontaneous report from a contactable healthcare professional, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the left arm on 16Sep2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Sep2021, the patient experienced severe headaches and fatigue. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with unspecified medications, neurological evaluation and blood work. Since the vaccination, the patient had been tested for COVID-19. On 30Sep2021, the patient underwent SARS-COV-2 test (nasal swab) and the result was negative. On an unknown date in 2021, the patient underwent neurological examination and blood test and the results were unknown. The clinical outcome of the events severe headache and fatigue was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Night sweats, Vaccination site pain
Clinical narrative: Heavy night sweats; Joint pain; Sore injection site; This is a spontaneous report from a contactable consumer, the patient. A 40-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 04Oct2021 at 19:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and known allergies to yeast and penicillin. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. 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 an unknown date in Sep2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation and received codeine (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. On 04Oct2021, the patient experienced heavy night sweats, joint pain and sore injection site. 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 heavy night sweats, joint pain and sore injection site was unknown at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Lip swelling, Myalgia, Peripheral swelling
Clinical narrative: Swelling of face, lips, neck, hands and feet.; Swelling of face, lips, neck, hands and feet.; Swelling of face, lips, neck, hands and feet.; Swelling of face, lips, neck, hands and feet.; Hives; Fever; Joint pain; Muscle pain; Uncontrollable itching on palms of hands and bottoms of feet.; Headache; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date, 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 atorvastatin (MANUFACTURER UNKNOWN), propranolol (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and metronidazole (FLAGYL); all from unknown dates for unknown indications and unknown if ongoing. 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 right arm on an unknown date, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in Sep2021, the patient experienced swelling of face, lips, neck, hands and feet, hives, fever, joint and muscle pain, uncontrollable itching on palms of hands and bottoms of feet and headache. The patient reported that hives were ongoing and other symptoms cleared up within a week to week in a half. The events resulted in emergency room/department visit 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 in Sep2021, the patient underwent nasal swab test and the result was negative. The clinical outcome of the events swelling of face, lips, neck, hands and feet, fever, joint and muscle pain, uncontrollable itching on palms of hands and bottoms of feet and headache was resolved on an unknown date in 2021; while that of the event hives was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.