chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Myalgia, Pain in extremity, Peripheral coldness
Clinical narrative: Sore arm; Fatigue; Light headed within 6 h; Cold hands; Mild chill 12h after injection severe chill started 18h after injection & lasted about 5 hours; Muscle aches; Sore and swelling armpit and breast same site as the injection site; Sore and swelling armpit and breast same site as the injection site; Sore and swelling armpit and breast same site as the injection site; Sore and swelling armpit and breast same site as the injection site; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a non-contactable consumer, the patient. A 54-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 33026BD) via an unspecified route of administration in left arm on 10Nov2021 at 19:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included perimenopause. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included estradiol (MANUFACTURER UNKNOWN) and norethisterone acetate (NORETHINDRONE ACETATE); both for 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: EL3248) via an unspecified route of administration in the left arm on 03Mar2021 (at the age of 53-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 24Mar2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. On 11Nov2021, the patient experienced sore arm, fatigue, light headed within 6 hours, cold hands and mild chill approximately 12 hours after injection, muscle aches and severe chill started approximately 18h after injection & lasted approximately 5 hours, sore & swelling armpit and breast same site as the injection arm started approximately 18h after injection and persist at the time of submitting this report. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the event mild chill approximately 12hours after injection, severe chill started approximately 18h after injection & lasted approximately 5 hours was resolved on 11Nov2021 and sore arm, fatigue, light headed within 6 hours, cold hands, muscle aches, sore & swelling armpit and breast same site as the injection arm started approximately 18h after injection was resolving at the time of this report. No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Sore arm; Fatigue; Light headed within 6 h; Cold hands; Mild chill 12h after injection severe chill started 18h after injection & lasted about 5 hours; Muscle aches; Sore and swelling armpit and breast same site as the injection site; Sore and swelling armpit and breast same site as the injection site; Sore and swelling armpit and breast same site as the injection site; Sore and swelling armpit and breast same site as the injection site; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a non-contactable consumer, the patient. A 54-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 33026BD) via an unspecified route of administration in left arm on 10Nov2021 at 19:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included perimenopause. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included estradiol (MANUFACTURER UNKNOWN) and norethisterone acetate (NORETHINDRONE ACETATE); both for 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: EL3248) via an unspecified route of administration in the left arm on 03Mar2021 (at the age of 53-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 24Mar2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. On 11Nov2021, the patient experienced sore arm, fatigue, light headed within 6 hours, cold hands and mild chill approximately 12 hours after injection, muscle aches and severe chill started approximately 18h after injection & lasted approximately 5 hours, sore & swelling armpit and breast same site as the injection arm started approximately 18h after injection and persist at the time of submitting this report. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the event mild chill approximately 12hours after injection, severe chill started approximately 18h after injection & lasted approximately 5 hours was resolved on 11Nov2021 and sore arm, fatigue, light headed within 6 hours, cold hands, muscle aches, sore & swelling armpit and breast same site as the injection arm started approximately 18h after injection was resolving at the time of this report. No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Contracted Covid-19; Contracted Covid-19; This is a spontaneous report from a contactable consumer(patient). A 43-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection), intramuscular, administered in arm left on 25Mar2021 (Lot Number: EL3248) as dose 2, single (at the age of 43-year-old) and received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection), intramuscular, administered in arm left on 04Mar2021 (Lot Number: EL3248) as dose 1, single for COVID-19 immunization in Workplace clinic. The patient's medical history was none. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient not had COVID. Concomitant medication included colecalciferol (VIT D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported received within 2 weeks of vaccination. The patient experienced contracted covid-19 on 12Nov2021.The patient was test post vaccination for COVID test. The patient underwent lab test which included PCR was positive (Nasal Swab) on 12Nov2021. No treatment received for the events. Outcome of the event COVID-19 was recovering.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Seizure
Clinical narrative: having seizures; received the booster; This is a spontaneous report from a contactable pharmacist (patient's parent) via medical information.  A 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration on unspecified date in Sep2021 (Batch/Lot number was not reported) (at the age of 23 years) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included brain cancer metastatic (brain cancer survivor). Historical vaccine included COVID-19 vaccine dose 1 and dose 2 (both MANUFACTURER UNKNOWN) on unknown dates for COVID-19 immunization. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication from an unspecified start date and ongoing. It was reported that a month later after receiving the Pfizer covid 19 booster vaccine, patient started having seizures on 23Oct2021. Patient was not hospitalized for the event. No treatments relevant to the event. The outcome of event was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on available limited information and a possible contributory role of suspect product BNT162B2 to the development of event seizure cannot be totally excluded. The case will be reassessed when additional information becomes available. 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.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: I now know 11 people who are dead due to these unnecessary evil non vaccines; This is a spontaneous report from a contactable consumer. This consumer reported for eleven patients. This case is part of a batch of eleven cases reporting dead for BNT162B2. This is the second of eleven people.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter stated that now he knew eleven people who were dead due to these unnecessary evil non-vaccines. The patient died due to unknown cause of death on an unspecified date.  It was not reported if an autopsy was performed.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.; Reported Cause(s) of Death: I now know 11 people who are dead due to these unnecessary evil non vaccines
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Immunisation, SARS-CoV-2 test
Clinical narrative: spontaneous abortion; booster; This is a spontaneous report from a contactable other hcp. This other hcp reported information for mother.This is a maternal report   A 32-years-old pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date was not reported), via an unspecified route of administration on 29Sep2021 as dose 3 (booster), single for covid-19 immunisation. The patient medical history was not reported. The patient did not have covid prior to vaccination. The patients concomitant medications were not reported. It was unknown that the patient received other vaccine in four weeks. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was, and expiration date were not reported), via an unspecified route of administration, on 10Jan2021 (Age at vaccination was 69 years) as dose 2, single and dose 1 via an unspecified route of administration (lot number was, and expiration date were not reported) on 20Dec2020 for COVID-19 immunization. Age at vaccination was 32 years. On 29Sep2021 the patient experienced booster. On an unspecified date patient also experienced spontaneous abortion. The last menstrual date was Nov2021. The mother reported she became pregnant while taking bnt162b2. It was unknown that therapeutic measures were taken or not. Adverse event resulted in doctor or other healthcare professional office. On an unspecified date the patient underwent lab tests and procedures which included sars-cov-2 test with unknown result (If COVID tested post vaccination: Yes, COVID test post vaccination: COVID test type post vaccination: Unknown). The outcome of event was unknown.  The lot number for BNT162B2 was not provided and will be request during follow-up.; Sender's Comments: Based on the available limited information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) booster and reported event abortion spontaneous cannot be fully assessed/exclude. The case will be reassessed if additional information becomes available. 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.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Around October the site started feeling tender; Around October the site started feeling bruised feeling; 3 inch redness, swelling, warmth, itching at site for around 5 days; 3 inch redness, swelling, warmth, itching at site for around 5 days; 3 inch redness, swelling, warmth, itching at site for around 5 days; 3 inch redness, swelling, warmth, itching at site for around 5 days; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the left arm on 28Aug2021 at 13:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, chronic kidney disease (CKD), high cholesterol and fatty liver. 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 COVID-19 vaccine. Concomitant medications included losartan (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN); both for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EF0191) via an unspecified route of administration in the left arm on 06Aug2021 at 13:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 28Aug2021, the patient experienced 3 inch redness, swelling, warmth, itching at site for around 5 days. On an unknown date in Oct2021, reported as around October, the site started feeling tender/bruised feeling. 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 3-inch redness, swelling, warmth, itching at site for around 5 days was resolved on 02Sep2021; while that of the events around October the site started feeling tender/bruised feeling was not resolved at the time of this report. No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Around October the site started feeling tender; Around October the site started feeling bruised feeling; 3 inch redness, swelling, warmth, itching at site for around 5 days; 3 inch redness, swelling, warmth, itching at site for around 5 days; 3 inch redness, swelling, warmth, itching at site for around 5 days; 3 inch redness, swelling, warmth, itching at site for around 5 days; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the left arm on 28Aug2021 at 13:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, chronic kidney disease (CKD), high cholesterol and fatty liver. 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 COVID-19 vaccine. Concomitant medications included losartan (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN); both for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EF0191) via an unspecified route of administration in the left arm on 06Aug2021 at 13:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 28Aug2021, the patient experienced 3 inch redness, swelling, warmth, itching at site for around 5 days. On an unknown date in Oct2021, reported as around October, the site started feeling tender/bruised feeling. 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 3-inch redness, swelling, warmth, itching at site for around 5 days was resolved on 02Sep2021; while that of the events around October the site started feeling tender/bruised feeling was not resolved at the time of this report. No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3592) via an unspecified route of administration in the right arm on 17Sep2021 at 14:15 (at the age of 50-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. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the right arm on 24Aug2021 at 15:15 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient experienced migraine headache on 17Sep2021 at 15:00 (also reported as "from one hour after dose"). First two weeks it was so bad that she could not work. The patient has had a headache every day since second dose always at least a severe headache, most of the time migraine. The patient stated that nothing took away the pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with unspecified pain injection and unspecified migraine medication. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021 post vaccination, the patient underwent test for COVID-19 via nasal swab and the result was unknown. The clinical outcome of the event migraine headache from one hour after dose; has had a headache every day since second dose always at least a severe headache, most of the time migraine was not resolved at the time of this report.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Immunisation
Clinical narrative: This is a spontaneous report from a contactable healthcare professional, the patient. A 40-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8844) via an unspecified route of administration in the left arm on 15Nov2021 at 14:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 21Jan2021 at 12:00 (at the age of 39-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 11Feb2021 at 12:00 (at the age of 39-years-old); both as single dose for COVID-19 immunisation. On 16Nov2021 at 06:00, the patient experienced headache, high level of fatigue, muscle and joint pains, injection site soreness, low grade fever, chills and nausea. 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. The clinical outcome of the events headache, high level of fatigue, muscle and joint pains, injection site soreness, low grade fever, chills and nausea was resolving at the time of this report.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable healthcare professional, the patient. A 40-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8844) via an unspecified route of administration in the left arm on 15Nov2021 at 14:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 21Jan2021 at 12:00 (at the age of 39-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 11Feb2021 at 12:00 (at the age of 39-years-old); both as single dose for COVID-19 immunisation. On 16Nov2021 at 06:00, the patient experienced headache, high level of fatigue, muscle and joint pains, injection site soreness, low grade fever, chills and nausea. 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. The clinical outcome of the events headache, high level of fatigue, muscle and joint pains, injection site soreness, low grade fever, chills and nausea was resolving at the time of this report.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Neutrophilic dermatosis, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the right arm on 14May2021 at 13:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic lymphocytic leukemia (CLL). 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 COVID vaccine. The patient did not receive any concomitant medications. On 20May2021, the patient experienced neutrophilic dermatoses on crotch, legs and feet. 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, the patient had been tested for COVID-19. On an unknown date in Aug2021, the patient underwent SARS-CoV-2 test via nasal swab and the result was negative. The clinical outcome of the event neutrophilic dermatoses on crotch, legs and feet was resolved with sequelae on an unknown date in 2021. The patient also received the second dose of BNT162b2 (COMIRNATY; Lot Number: EW0179) via an unspecified route of administration in the left arm on 04Jun2021 at 13:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation.No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Immunisation
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received third (booster) dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8028) via an unspecified route of administration in the left arm on 15Nov2021 at 18:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol. The patient had no 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. Concomitant medications included rosuvastatin (MANUFACTURER UNKNOWN), ibuprofen (ADVIL), magnesium citrate (MANUFACTURER UNKNOWN) and vitamin b nos (VITAMIN B); all from an unknown date for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6023) via an unspecified route of administration in the left arm on 28Feb2021 (at the age of 49-years-old) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 20Mar2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. On 16Nov2021 at 12:00, the patient experienced headache, sore arm, sore throat, chills, joint and muscle pain, fatigue 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 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, headache, sore arm, sore throat, chills, joint and muscle pain, fatigue and nausea was resolving at the time of this report.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Oropharyngeal pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received third (booster) dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8028) via an unspecified route of administration in the left arm on 15Nov2021 at 18:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol. The patient had no 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. Concomitant medications included rosuvastatin (MANUFACTURER UNKNOWN), ibuprofen (ADVIL), magnesium citrate (MANUFACTURER UNKNOWN) and vitamin b nos (VITAMIN B); all from an unknown date for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6023) via an unspecified route of administration in the left arm on 28Feb2021 (at the age of 49-years-old) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 20Mar2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. On 16Nov2021 at 12:00, the patient experienced headache, sore arm, sore throat, chills, joint and muscle pain, fatigue 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 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, headache, sore arm, sore throat, chills, joint and muscle pain, fatigue and nausea was resolving at the time of this report.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer. A 27-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 15Nov2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. Prior to vaccination, the patient was diagnosed with COVID-19. 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 and also received the second 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 as a single dose for COVID-19 immunisation. On 15Nov2021, the patient experienced fever. The event did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever was unknown at the time of this report. The lot number for BNT162b2 was not provided and will be requested during follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Pain
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient) via company representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date were not reported) via an unspecified route of administration, on unspecified date, as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced fatigue, headache, body aches, overall malaise on an unspecified date. The outcome of the event was unknown at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Ill-defined disorder, Immunisation
Clinical narrative: The patient received the third/booster dose of BNT162b2; The patient reported that they felt like they had been hit by a train; This is a spontaneous report from a non-contactable consumer. An unknown gender patient of unknown age received the third (booster) 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. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. 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 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 on an unknown date as a single dose for COVID-19 immunisation. On an unknown date, the patient reported that they felt like they had been hit by a train. 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 the patient reported that they felt like they had been hit by a train was unknown at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Immunisation, Irritability, Myalgia
Clinical narrative: The patient received the third/booster dose of BNT162b2; Fatigue; Myalgia; Joint pain; Itchiness; Irritability; This is a spontaneous report from a non-contactable consumer, the patient. An adult patient of unknown age and gender received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF884) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) 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: EN5318) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date, the patient experienced fatigue, myalgia, joint pain, itchiness and irritability. 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 fatigue, myalgia, joint pain, itchiness and irritability were resolving at the time of this report. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: The patient received the third/booster dose of BNT162b2; Fatigue; Myalgia; Joint pain; Itchiness; Irritability; This is a spontaneous report from a non-contactable consumer, the patient. An adult patient of unknown age and gender received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF884) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) 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: EN5318) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date, the patient experienced fatigue, myalgia, joint pain, itchiness and irritability. 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 fatigue, myalgia, joint pain, itchiness and irritability were resolving at the time of this report. No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Immunisation, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FM8027) via an unspecified route of administration in the left arm on 17Nov2021 at 12:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included discoid lupus, penicillin allergy and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received unspecified medication within two weeks of vaccination. The patient previously received codeine (MANUFACTURER UNKNOWN) and morphine (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the right arm on 15Mar2021 at 14:00 (at the age of 43-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 05Apr2021 at 14:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On 18Nov2021 at 03:00, the patient experienced fever, chills, headache, extreme body aches, shaking and sweating. 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, headache, extreme body aches, shaking and sweating was not resolved at the time of this report.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FM8027) via an unspecified route of administration in the left arm on 17Nov2021 at 12:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included discoid lupus, penicillin allergy and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received unspecified medication within two weeks of vaccination. The patient previously received codeine (MANUFACTURER UNKNOWN) and morphine (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the right arm on 15Mar2021 at 14:00 (at the age of 43-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 05Apr2021 at 14:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On 18Nov2021 at 03:00, the patient experienced fever, chills, headache, extreme body aches, shaking and sweating. 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, headache, extreme body aches, shaking and sweating was not resolved at the time of this report.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Sensory loss, Vaccination site paraesthesia
Clinical narrative: Pins and needle tingling at injection site; Pins and needle tingling at injection site and radiating to left fingertips / Tingling in the left face from earlobe to nose; loss of tactile feeling in the left cheek; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration in the left arm on 08Nov2021 at 14:00 (at the age of 56-year-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 COVID vaccine. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and rosuvastatin calcium (CRESTOR); both for unspecified indication from unknown date and unknown if ongoing. On 08Nov2021 at 14:00, the patient experienced pins and needle tingling at injection site and radiating to left fingertips, tingling in the left face from earlobe lobe to nose and currently it was loss of tactile feeling in the left cheek. The events resulted in doctor or other healthcare professional office/clinic visit. 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 pins and needle, tingling at injection site, tingling in the left face from earlobe lobe to nose and loss of tactile feeling in the left cheek was not resolved at the time of this report.
Sex: U
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy rash (potentially near groin area); This is a spontaneous report from a contactable consumer. A patient of unknown gender and unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The reporter was unsure if it was an adverse event but was listening to an  podcast and host was talking that they had an itchy rash, potentially near groin area on an unknown date in 2021. It was not known if the patient was recently re-vaccinated but had at least been vaccinated for a while. The clinical outcome of the event itchy rash, potentially near groin area was unknown at the time of report.The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Cardiac failure congestive, Immunisation, Myocardial infarction
Clinical narrative: Booster; Congestive Heart Failure; Arrhythmia; Heart Attack; This is a spontaneous report from a contactable consumer.  An elderly female patient received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration on 22Oct2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included covid-19. Historical vaccine inlcuded bnt162b2 dose 1 on 06Jan2021 and dose 2 on 26Jan2021 both for COVID-19 Immunization.The patient's concomitant medications were not reported. The patient experienced congestive heart failure (death, hospitalization, life threatening) on 26Oct2021, arrhythmia (death, hospitalization, life threatening) on 26Oct2021, heart attack (death, hospitalization, life threatening) on 26Oct2021. Therapeutic measures were taken   Lavix, Nitro paste (nitroglycerin); Transferred back to Long-Term Care Facility. The patient died on 30Oct2021. Autopsy was not performed.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Heart Attack; Arrhythmia; Congestive Heart Failure
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Immunisation, Pain
Clinical narrative: This is a spontaneous report from a non-contactable consumer, the patient. A 30-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 right arm on 16Nov2021 at 15:45 (at the age of 30-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 18Mar2021 (at the age of 29-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 07Apr2021 (at the age of 29-year-old); both as single dose for COVID-19 immunisation. On 17Nov2021 at 09:00, the patient experienced fatigue, slight aches and pains and lower back pain. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fatigue, slight aches and pains and lower back pain was resolved on an unknown date in Nov2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional, the patient. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2589) via an intramuscular route of administration in the left arm on 17Nov2021 at 16:30 (at the age of 60-year-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. On 18Nov2021, the patient experienced fever, chills, fatigue 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 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, fatigue and nausea was resolving at the time of this report.No follow-up attempts are possible. No further information is expected.