chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Headache, Inflammation, Musculoskeletal pain, Pain
Clinical narrative: Musculoskeletal pain; Inflammation; Bad pain in my right side body; Hand feet chill; Bad headache; This is a spontaneous report from a contactable other healthcare professional, the patient. A 60-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 arm on 01Nov2021 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included a little high pressure and allergy to shellfish (reported as she'll fish). 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 included ompilp (unspecified) for unknown indication from an unknown date and unknown if ongoing. The patient previously received plantago ovata (LAXAT) for unknown indication on an unknown date and experienced drug allergy. On 02Nov2021 at 13:00, the patient experienced bad pain in the right side of the body, hand and feet chill and bad headache. It had been a week, the patient had bad pain in the body and went to the emergency room on 06Nov2021. The patient was discharged with musculoskeletal pain and inflammation and put on 800 milligram (mg) oral IBU for three times a day for pain and inflammation. The patient was totally healthy and had no pains like the one experienced before the patient received the first dose. The events resulted in emergency room/department visit or urgent care. Therapeutic measures were taken as a result of the events pain and inflammation which included treatment with ibuprofen (MANUFACTURER UNKNOWN). On an unknown date in Nov2021, the patient underwent blood sugar test and the result was unknown. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in Nov2021, the patient underwent SARS- CoV-2 test via nasal swab and the result was negative. The clinical outcome of the events bad pain in the right-side body, hand feet chill, bad headache, musculoskeletal pain and inflammation were 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: Peripheral coldness, SARS-CoV-2 test
Clinical narrative: Musculoskeletal pain; Inflammation; Bad pain in my right side body; Hand feet chill; Bad headache; This is a spontaneous report from a contactable other healthcare professional, the patient. A 60-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 arm on 01Nov2021 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included a little high pressure and allergy to shellfish (reported as she'll fish). 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 included ompilp (unspecified) for unknown indication from an unknown date and unknown if ongoing. The patient previously received plantago ovata (LAXAT) for unknown indication on an unknown date and experienced drug allergy. On 02Nov2021 at 13:00, the patient experienced bad pain in the right side of the body, hand and feet chill and bad headache. It had been a week, the patient had bad pain in the body and went to the emergency room on 06Nov2021. The patient was discharged with musculoskeletal pain and inflammation and put on 800 milligram (mg) oral IBU for three times a day for pain and inflammation. The patient was totally healthy and had no pains like the one experienced before the patient received the first dose. The events resulted in emergency room/department visit or urgent care. Therapeutic measures were taken as a result of the events pain and inflammation which included treatment with ibuprofen (MANUFACTURER UNKNOWN). On an unknown date in Nov2021, the patient underwent blood sugar test and the result was unknown. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in Nov2021, the patient underwent SARS- CoV-2 test via nasal swab and the result was negative. The clinical outcome of the events bad pain in the right-side body, hand feet chill, bad headache, musculoskeletal pain and inflammation were not resolved 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: F
Vaccine: COVID19
Symptoms: Immunisation, Intermenstrual bleeding, Pain in extremity, Peripheral swelling, Vaccination site mass
Clinical narrative: The patient received the third/booster dose of BNT162b2; Swollen arm; Sore arm; Continued swelling and lump at injection site; Lump at injection site; Still lump in injection area and some soreness; I started spotting as well days before my menstrual cycle should be coming on; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration in the left arm on 02Nov2021 at 09:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included HBP (high blood pressure) diagnosed in Jun2021. The patient had known allergies to several food products: apples, strawberries and other products noted in allergy tests in past. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), ethinylestradiol/ferrous fumarate/norethisterone acetate (JUNEL FE), fluticasone propionate (FLONASE) and loratadine (OTC CLARITIN) all for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) via an unspecified route of administration in the left arm on 13Jan2021 (at the age of 43-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265) via an unspecified route of administration in the left arm on 03Feb2021 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Nov2021, the patient experienced swollen and sore arm a day or two after shot and continued swelling and lump at injection site several days later into weekend. Still lump in injection area and some soreness. The patient started spotting as well days before her menstrual cycle should be coming on and that was the main reason the patient was submitting this information. The patient believed this booster had in some way contributed to the spotting prior to the official start date of when period should start (the patient was on birth control and usually did not have spotting or early start issues). The events 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. No therapeutic measures were not taken as a result of the events. The clinical outcome of the events swollen and sore arm, continued swelling and lump at injection site, still lump in injection area and some soreness and spotting as well days before her menstrual cycle were resolving at the time of this report.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: The patient received the third/booster dose of BNT162b2; Swollen arm; Sore arm; Continued swelling and lump at injection site; Lump at injection site; Still lump in injection area and some soreness; I started spotting as well days before my menstrual cycle should be coming on; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration in the left arm on 02Nov2021 at 09:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included HBP (high blood pressure) diagnosed in Jun2021. The patient had known allergies to several food products: apples, strawberries and other products noted in allergy tests in past. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), ethinylestradiol/ferrous fumarate/norethisterone acetate (JUNEL FE), fluticasone propionate (FLONASE) and loratadine (OTC CLARITIN) all for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) via an unspecified route of administration in the left arm on 13Jan2021 (at the age of 43-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265) via an unspecified route of administration in the left arm on 03Feb2021 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Nov2021, the patient experienced swollen and sore arm a day or two after shot and continued swelling and lump at injection site several days later into weekend. Still lump in injection area and some soreness. The patient started spotting as well days before her menstrual cycle should be coming on and that was the main reason the patient was submitting this information. The patient believed this booster had in some way contributed to the spotting prior to the official start date of when period should start (the patient was on birth control and usually did not have spotting or early start issues). The events 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. No therapeutic measures were not taken as a result of the events. The clinical outcome of the events swollen and sore arm, continued swelling and lump at injection site, still lump in injection area and some soreness and spotting as well days before her menstrual cycle were resolving at the time of this report.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Immunisation, Pain, Pyrexia
Clinical narrative: Fever; Chills; Achy; The patient received third/booster dose of BNT162b2; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old male patient received the third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 07Nov2021 (at the age of 31-years-old), as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received influenza vaccine (MANUFACTURER UNKNOWN) for immunisation on an unknown date in 2021. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EI3248) via an unspecified route of administration on 03Mar2021 (at the age of 30-years-old) and also second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on 23Mar2021 (at the age of 30-years-old); as a single dose for COVID-19 immunisation. On 08Nov2021, the patient experienced fever, chills and felt achy. 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 fever, chills and achy were 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: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discomfort, Vaccination site pain
Clinical narrative: Pain and stiffness around injection site that lasted about 5 days; Pain and stiffness around injection site that lasted about 5 days; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the first dose COVID-19 VACCINE (MANUFACTURER UNKNOWN; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Nov2021 at 09:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, diagnosed prior to the vaccination. The patient had no known allergies. 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 prior to the vaccination. On 02Nov2021 at 10:00, the patient experienced pain and stiffness around injection site that lasted about 5 days. 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 and stiffness around injection site that lasted about 5 days were resolved on 07Nov2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Hyperhidrosis, Immunisation
Clinical narrative: Next day felt sluggish; Woke up 2 hrs later to sweating; Diarrhea; Stomach aches 5 hours later; then intense and uncontrollable shaking and shivers; then intense and uncontrollable shaking and shivers; The patient received the third/boster dose of BNT162b2.; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Nov2021 at 10:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The medical history included immunization. The patient's known allergies were reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccines within four weeks prior to the vaccination. The concomitant medications included influenza vaccine (MANUFACTURER UNKNOWN) on an unknown date in Oct2021 for immunization. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date and second 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, both as a single dose for COVID-19 immunisation and experienced no adverse reactions. On 07Nov2021 at 15:30, 5 hours later, the patient experienced stomach aches, then intense and uncontrollable shaking and shivers and at 17:30 woke up 2 hours later to sweating and diarrhea. 08Nov2021, next day, he felt sluggish and continued the diarrhea. The patient felt better on 09Nov2021, but stomach aches and diarrhea had continued. The adverse events did not result in a visit to the doctors 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 not been tested for COVID-19. The clinical outcome of the events intense and uncontrollable shaking and shivers, sweating and felt sluggish were resolving, while the clinical outcome of the events stomach aches and diarrhea were not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Sluggishness, Tremor
Clinical narrative: Next day felt sluggish; Woke up 2 hrs later to sweating; Diarrhea; Stomach aches 5 hours later; then intense and uncontrollable shaking and shivers; then intense and uncontrollable shaking and shivers; The patient received the third/boster dose of BNT162b2.; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Nov2021 at 10:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The medical history included immunization. The patient's known allergies were reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccines within four weeks prior to the vaccination. The concomitant medications included influenza vaccine (MANUFACTURER UNKNOWN) on an unknown date in Oct2021 for immunization. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date and second 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, both as a single dose for COVID-19 immunisation and experienced no adverse reactions. On 07Nov2021 at 15:30, 5 hours later, the patient experienced stomach aches, then intense and uncontrollable shaking and shivers and at 17:30 woke up 2 hours later to sweating and diarrhea. 08Nov2021, next day, he felt sluggish and continued the diarrhea. The patient felt better on 09Nov2021, but stomach aches and diarrhea had continued. The adverse events did not result in a visit to the doctors 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 not been tested for COVID-19. The clinical outcome of the events intense and uncontrollable shaking and shivers, sweating and felt sluggish were resolving, while the clinical outcome of the events stomach aches and diarrhea were not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Prostatic specific antigen increased
Clinical narrative: PSA levels went up substantially after the first shot, and even moreso after the second.; This is a spontaneous report from a contactable consumer. A 56-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Mar2021 (at the age of 56-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Apr2021 (at the age of 56-year-old), both as single dose for COVID-19 immunisation. Medical history included prostate cancer which was ongoing at the time of report. It was unknown whether the patient had any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID vaccine and unknown whether the patient received any concomitant medications. On an unknown date in Mar2021, the patient's prostate specific antigen (PSA) levels went up substantially after the first shot, and even more so after the second (shot). The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event PSA levels went up substantially after the first shot, and even more so after the second was unknown at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Immunisation, Myalgia, Vaccination site pain
Clinical narrative: The patient received third/booster dose of BNT162b2; Moderate chill; Muscle pain; Joint pain whole night; Moderate injection site pain; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received third/booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FG3527) via an intramuscular route of administration in the right arm on 06Nov2021 at 11:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes. The patient had 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 did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an intramuscular route of administration in the right arm on 09Feb2021 (at the age of 58-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an intramuscular route of administration in the left arm on 10Mar2021 (at the age of 58-years-old) as single doses for COVID-19 immunisation and did not experience any reactions. On 06Nov2021, the night after receiving the booster dose, the patient experienced moderate chill, muscle pain and joint pain whole night. After taking paracetamol, the symptoms seemed to be under control. But it required continuous taking paracetamol every 6 hours for 2 days. On Day 4 (09Nov2021), these symptoms were gone. The other symptom was moderate injection site pain, started on Day 1 (06Nov2021) and lasted for 3 days. The patient did not experience such reactions after receiving the first 2 COVID vaccine doses. 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 (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events moderate chill, muscle pain and joint pain and moderate injection site pain which lasted for 3 days was resolved on 09Nov2021.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: constant dizzy spells and lightheadness. This never happened prior to the vaccine; This is a spontaneous report from a contactable consumer, the patient. A 37-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 10Oct2021 at 12:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient had no 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 11Oct2021, the patient experienced constant dizzy spells and lightheadness which had never happened prior to the vaccine administration. 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 not been tested for COVID-19. The clinical outcome of the event constant dizzy spells and lightheadness were not resolved at the time of this report. The patient also 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 06Nov2021 at 11:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Immunisation, Joint range of motion decreased, Vertigo
Clinical narrative: I couldn't raise my head off the pillow; on Friday evening I started experiencing dizziness and Vertigo.On Saturday I couldn't raise my head off the pillow, on Sunday very dizzy. I also feel dizzy now.; on Friday evening I started experiencing dizziness and Vertigo.; The patient received third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received the third/booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration in the left arm on 04Nov2021 at 03:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. The medical history included Adult Stills. 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 concomitant medications included anakinra (KINERET) and vitamins (unspecified); both for unknown indications from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN602) via an unspecified route of administration in the left arm on 17Feb2021 (at the age of 68-years-old) and also second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: NIO207) via an unspecified route of administration in the left arm on 10Mar2021 (at the age of 68-years-old) both as a single dose for COVID-19 immunisation. On 04Nov2021 Thursday evening, the patient felt fine. On 05Nov2021 at 18:00 Friday evening, the patient started experience dizziness and vertigo. On 06Nov2021 (Saturday), the patient could not raise her head off the pillow and on 07Nov2021 Sunday, she was very dizzy. The patient also felt dizzy at the time of this report. The adverse events did not result in doctor or other health care professional office/clinic visit and emergency/room or department or urgent care. Therapeutic measures were taken as a result of the reported events included treatment with meclizine (MANUFACTURER UNKNOWN) tablets prescribed by doctor. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness and vertigo were not resolved at the time of this report.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died after getting it; This is a spontaneous report from contactable other healthcare professional. A 16-year-old patient of an unspecified gender received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced died after getting it (the Pfizer vaccine) on an unspecified date. The outcome of the event was fatal. The patient died on an unspecified date.  It was not reported if an autopsy was performed.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified.  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 RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: died after getting it
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hypoaesthesia, Immunisation, Interchange of vaccine products
Clinical narrative: Off-label use (due to interchange); Interchange of the vaccine products; The patient received the third/booster dose of BNT162b2; Headache; Chills; Numbness in left arm; Muscle aches; This is a spontaneous report from a contactable consumer. A 61-year-old non-pregnant female patient received third/booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Nov2021 at 10:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of COVID-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Mar2021 and the second dose received first dose of COVID-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in left arm on an unknown date in Apr2021(at the age of 61-year-old) as a single dose for COVID-19 immunisation. On 08Nov2021, the patient experienced headache, chills, numbness in left arm and muscle aches. 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, chills, numbness in left arm and muscle aches was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Off label use
Clinical narrative: Off-label use (due to interchange); Interchange of the vaccine products; The patient received the third/booster dose of BNT162b2; Headache; Chills; Numbness in left arm; Muscle aches; This is a spontaneous report from a contactable consumer. A 61-year-old non-pregnant female patient received third/booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Nov2021 at 10:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of COVID-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Mar2021 and the second dose received first dose of COVID-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in left arm on an unknown date in Apr2021(at the age of 61-year-old) as a single dose for COVID-19 immunisation. On 08Nov2021, the patient experienced headache, chills, numbness in left arm and muscle aches. 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, chills, numbness in left arm and muscle aches was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: One week after vaccine I began to run a fever ranging between 99 and 101.; Have constant headache, for 5 days still has not gone away.; This is a spontaneous report from a non-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 28Oct2021 at 17:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported as none. 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 medications within two weeks of vaccination. On 04Nov2021 at 05:30, one week after the vaccine, the patient began to run fever ranging between 99 and 101(unspecified units). The patient also had a constant headache for 5 days that had not gone away at the time of this report. It had been 11 days since she received the vaccine. On 04Nov2021, the patient underwent body temperature test and the result was between 99 and 101(unspecified units). 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 not been tested for COVID-19.The clinical outcome of the events fever ranging between 99 and 101 was resolving, while the clinical outcome of the event constant headache 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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Menstruation delayed, Tenderness
Clinical narrative: I did not get my period for over 3 months; An odd bump in left ankle that would swell sometimes, that lasted about 3 months as well.; That area still hurts if I press on it but the bump feels much smaller.; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 07May2021(at the age of 45-years-old) as a single dose for COVID-19 immunisation. The medical history included hypothyroid but being treated with medication. 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 concomitant medication included levothyroxine sodium (LEVOTHYROXIN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 16Apr2021(at the age of 45-years-old) as a single dose for COVID-19 immunisation. On 21May2021, after the second dose, the patient did not get her period for over three months. Although, the patient was in her forties, this had not happened to her before. Also, the patient formed an odd bump in her left ankle that would swell sometimes and had lasted about 3 months as well. That area still hurts if the patient pressed on it but the bump felt much smaller. The adverse events resulted in doctor or other healthcare professional office/clinic visit. 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 event did not get period for over 3 months was resolved on an unknown date in 2021, while the clinical outcome of the event odd bump in left ankle that would swell sometimes was resolving and the clinical outcome of the event that area still hurts if pressed on it was not resolved at the time of this report.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis, SARS-CoV-2 test
Clinical narrative: Appendicitis; This is a spontaneous report received from a non-contactable consumer (patient reported for herself). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (at the age of 51 years old) (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication in four weeks included influenza vaccine (FLU) taken for immunisation. Facility where the most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. No other medications the patient received within 2 weeks of vaccination. The patient experienced appendicitis 9 days after 1st dose (hospitalization, medically significant, life threatening) on an unspecified date. The patient was hospitalized for appendicitis for 2 days. The adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was recovered with lasting effects. Treatment received for the adverse event was Appendectomy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19: Covid test type post vaccination was Nasal Swab (results unknown). The outcome of the event was recovered with sequelae on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Lethargy, Nausea, Rhinorrhoea
Clinical narrative: Lethargy; Sneezing; Eye floaters; Runny nose; Difficulty breathing; Dizzy; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Nov2021 at 13:00 (at the age of 55-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 medication included lisinopril (MANUFACTURER UNKNOWN) 10 mg 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 COVID vaccine. On 05Nov2021, the patient experienced lethargy, sneezing, eye floaters, runny nose, difficulty breathing, dizzy and nausea. 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 events which included treatment with over the counter (OTC) cold medications. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events lethargy, sneezing, eye floaters, runny nose, difficulty breathing, dizzy and nausea 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: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Sneezing, Vitreous floaters
Clinical narrative: Lethargy; Sneezing; Eye floaters; Runny nose; Difficulty breathing; Dizzy; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Nov2021 at 13:00 (at the age of 55-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 medication included lisinopril (MANUFACTURER UNKNOWN) 10 mg 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 COVID vaccine. On 05Nov2021, the patient experienced lethargy, sneezing, eye floaters, runny nose, difficulty breathing, dizzy and nausea. 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 events which included treatment with over the counter (OTC) cold medications. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events lethargy, sneezing, eye floaters, runny nose, difficulty breathing, dizzy and nausea 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: Hypertension
Clinical narrative: hypertensive; This is a spontaneous report from a contactable healthcare professional received via information team. A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced being hypertensive after receiving the second dose of vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Change of bowel habit, Diarrhoea, Pain in extremity, Rhinorrhoea
Clinical narrative: sore arm; change to his bowel movements; diarrhea; constant runny nose; This is a spontaneous report received from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on 21Jan2021 as dose 1, single for COVID-19 immunisation. Medical history included triple bypass, carotid artery surgery, thyroid condition and diabetes. It was reported that the patient was rather active and "not a couch potato". The patient's concomitant medications were not reported. The patient called to report the "peculiar things that were happening" to him after receiving both doses of the Pfizer-Biontech Covid19 vaccine. The patient experienced sore arm, change to his bowel movements which were daily and softer resulting in diarrhea for the remainder of the month, it was reported that the patient had "never been that regular in his life" and constant runny nose on an unspecified date in Jan2021 after the first dose. The outcome of the event constant runny nose was not recovered, and outcome of the other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy
Clinical narrative: lethargy; fatigue; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported) via an unspecified route of administration on 05Jan2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced lethargy and fatigue on an unspecified date in Jan2021. Outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (Age: 70, Unit: Unknown, as reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported) via an unspecified route of administration on 22Feb2021 as dose 1, single for COVID-19 immunisation. Medical history included chronic rhinitis and other allergies, both from an unknown date. The patient's concomitant medications were not reported. The patient experienced sore arm on an unspecified date. The patient was scheduled to receive the second dose on 15Mar2021. The patient was also scheduled to have allergy testing on 23Mar2021 and she  was asking if she should do this after her second dose or if she needs to put the testing off for a while. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, X-ray
Clinical narrative: chills; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age (reported as age:70; unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported) via an unspecified route of administration on 09Feb2021 as dose 1, single for covid-19 immunisation. Medical history included cancer in liver, and chemo, both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient was supposed to get 2nd dose of Pfizer covid vaccination but woke up this morning (date unspecified in 2021) and had some chills, no other real symptoms. Patient wanted to find out if patient should keep my appointment. Patient had to do an internal radiology done last Thursday for cancer in liver (2021), that was fine which patient mentioned as wasn't from first dose. On Thursday and Saturday, patient was feeling great, this morning patient woke up with the chills. The chills were gone, not sure if they were going to come back.  Patient wanted to know if there wass anything about chills and getting the vaccine. The chills were following the procedure with the chemo. The first Pfizer covid vaccine was on 09Feb2021, last Thursday (2021), patient had the chemo done. And didn't have any side effects from the vaccination shot. Patient didn't feel bad, they were 2.5 to 3 hours away from getting, this was not easily scheduled. Patient felt good and didn't have any chills. Patient already spoke to doctor who he said he didn't think there will be any problem, and said he didn't know. The outcome of the event was recovered on an unspecified date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.