chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test
Clinical narrative: Chills; Nausea; Fatigue; Headache; Bitter taste in mouth; Cough; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30155BA) via an unspecified route of administration in the left arm on 28Sep2021 at 14:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to penicillin and contrast dye. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), finasteride (MANUFACTURER UNKNOWN) and assorted vitamins (unspecified); all for an unknown indication on an unknown date and unknown if ongoing. On 28Sep2021 at 17:00, the patient experienced chills, nausea, fatigue, headache, bitter taste in mouth and cough. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 30Sep2021, the patient underwent nasal swab test for COVID-19 and the result was negative. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events chills, nausea, fatigue, headache, bitter taste in mouth and cough was resolving at the time of this report.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Lethargy, Pyrexia
Clinical narrative: Mild fever; Trouble sleeping; Lethargy; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an intramuscular route of administration in the arm left on 30Sep2021 at 15:00 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. The medical history included penicillin allergy and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included cetirizine hydrochloride (CETRIZINE) and ibuprofen (MANUFACTURER UNKNOWN), all from unknown dates, for unknown indications and unknown if ongoing. On 01Oct2021, the patient experienced mild fever, trouble sleeping and lethargy. 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 mild fever, trouble sleeping and lethargy were resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Photopsia, Visual impairment
Clinical narrative: identified visual disturbance in the right eye consisting of flashing lights; identified visual disturbance in the right eye consisting of flashing lights; This is a spontaneous report from a contactable consumer, the patient and from a contactable consumer. A 66-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration on 30Sep2021 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. It was unknown whether the patient had any known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received other medication within two weeks of vaccination was reported as uncertain. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Oct2021 at 08:00, the patient experienced identified visual disturbance in the right eye consisting of flashing lights. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events identified visual disturbance in the right eye consisting of flashing lights was unknown at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Influenza like illness, Lymphadenitis, Myalgia, Pain in extremity
Clinical narrative: Fever; vomiting; muscle aches; joint aches; flu-like symptoms/Felt like a bad case of the flu.; sore arm; inflamed lymph nodes; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 29Sep2021 at 13:00 (at the age of 70-year-old), as a single dose for COVID-19 immunisation. Medical history included pemphigus vulgaris and irritable bowel syndrome (IBS). 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. The patient previously received tetanus vaccine (MANUFACTURER UNKNOWN) for immunisation on unknown date and experienced allergy to vaccine. On 29Sep2021 at 15:00, the patient experienced fever, vomiting, muscle aches, joint aches, flu-like symptoms, sore arm, inflamed lymph nodes and felt like a bad case of the flu. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever, vomiting, muscle aches, joint aches, flu-like symptoms, sore arm, inflamed lymph nodes was resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever; vomiting; muscle aches; joint aches; flu-like symptoms/Felt like a bad case of the flu.; sore arm; inflamed lymph nodes; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 29Sep2021 at 13:00 (at the age of 70-year-old), as a single dose for COVID-19 immunisation. Medical history included pemphigus vulgaris and irritable bowel syndrome (IBS). 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. The patient previously received tetanus vaccine (MANUFACTURER UNKNOWN) for immunisation on unknown date and experienced allergy to vaccine. On 29Sep2021 at 15:00, the patient experienced fever, vomiting, muscle aches, joint aches, flu-like symptoms, sore arm, inflamed lymph nodes and felt like a bad case of the flu. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever, vomiting, muscle aches, joint aches, flu-like symptoms, sore arm, inflamed lymph nodes was resolving 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: Chills, Condition aggravated, Fatigue, Heavy menstrual bleeding, Pyrexia
Clinical narrative: very heavy menstruation; worsening arthritis pain; fatigue; chills; low grade fever; broke out in a rash; This is a spontaneous report from a contactable consumer (patient). This is a spontaneous report from a Pfizer-sponsored program. A 41-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included immunocompromised with pre lupus, obesity, and arthritis and shingles. There were no concomitant medications. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation and experienced very heavy menstruation, worsening arthritis pain, fatigue, chills, and low-grade fever. The patient experienced very heavy menstruation, worsening arthritis pain, fatigue, chills, and low-grade fever, also broke out in a rash along the same dermatome as a previous shingles outbreak. The patient wanted to know should I avoid the booster based on the possible shingles outbreak. The outcome of all events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: very heavy menstruation; worsening arthritis pain; fatigue; chills; low grade fever; broke out in a rash; This is a spontaneous report from a contactable consumer (patient). This is a spontaneous report from a Pfizer-sponsored program. A 41-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included immunocompromised with pre lupus, obesity, and arthritis and shingles. There were no concomitant medications. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation and experienced very heavy menstruation, worsening arthritis pain, fatigue, chills, and low-grade fever. The patient experienced very heavy menstruation, worsening arthritis pain, fatigue, chills, and low-grade fever, also broke out in a rash along the same dermatome as a previous shingles outbreak. The patient wanted to know should I avoid the booster based on the possible shingles outbreak. The outcome of all events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy rash developed 24 hours after injection/ Initially around ankles, wrists, and knees/ 2 days later the rash expanded to thighs and calf; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) via an unspecified route of administration in the left arm on 25Sep2021 at 11:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took azithromycin (Z-PAK) and experienced drug allergy. On 26Sep2021 at 18:00, 24 hours after injection, the patient developed itchy rash, initially it was around ankles, wrists, and knees. On 28Sep2021, 2 days later, the rash expanded to thighs and calf. The event did not result in doctor or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event itchy rash initially around ankles, wrists, and knees and 2 days later the rash expanded to thighs and calf was not resolved at the time of the report.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Vaginal bleeding; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Sep2021 at 12:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified birth control pills-low estrogen (MANUFACTURER UNKNOWN) 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: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in Sep2021 at 12:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 01Oct2021 at 12:30, the patient experienced vaginal bleeding. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event vaginal bleeding 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: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Malaise, Pyrexia
Clinical narrative: Headache; Fever (99); Tired; Feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant female patient of unspecified age received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8839) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS), gastritis and high blood pressure ("Hi" BP). The patient had known allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously took hydrocodone bitartrate; paracetamol (VICODIN) and sulfur (MANUFACTURER UNKNOWN); both taken for unknown indications and experienced drug allergy. On 30Sep2021, the patient had headache, fever (99), was tired and was feeling unwell. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 30Sep2021, the patient underwent body temperature test and the result was 99 (unspecified units). Therapeutic measures were not taken as a result of the events. The clinical outcome of the events headache, fever (99), tired and feeling unwell was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: Lost my taste and smell; Lost my taste and smell; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Sep2021 at 15:00 (at the age of 23-year-old), as a single dose for COVID-19 immunisation. The patient had no medical history and 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. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Sep2021 at 15:00 (at the age of 22-year-old), as a single dose for COVID-19 immunisation. On 29Sep2021 at 20:00, the patient lost her taste and smell. 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, lost taste and smell was resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Headache, Immunisation
Clinical narrative: Muscle aches; Joint aches; Headache; Fatigue; Foggy feeling; Nasal drippage; Nasal congestion; Arm pain; Dose received- 3; Dose received- 3; This is a spontaneous report from a contactable healthcare professional, the patient.  A 31-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Sep2021 at 16:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included depression and anxiety. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL), lamotrigine (LAMICTAL), caffeine, mepyramine maleate, paracetamol (MIDOL) and vitamin d nos (VITAMIN D); all 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. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 25Jan2021 at 08:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation and the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Jan2021 at 08:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. On 01Oct2021 at 06:00, the patient experienced muscle and joint aches next day, headache, fatigue, foggy feeling, nasal drippage and congestion and arm pain. 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 muscle and joint aches, headache, fatigue, foggy feeling, nasal drippage and congestion and arm pain was resolving at the time of this report.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nasal congestion, Off label use, Pain in extremity, Rhinorrhoea
Clinical narrative: Muscle aches; Joint aches; Headache; Fatigue; Foggy feeling; Nasal drippage; Nasal congestion; Arm pain; Dose received- 3; Dose received- 3; This is a spontaneous report from a contactable healthcare professional, the patient.  A 31-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Sep2021 at 16:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included depression and anxiety. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL), lamotrigine (LAMICTAL), caffeine, mepyramine maleate, paracetamol (MIDOL) and vitamin d nos (VITAMIN D); all 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. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 25Jan2021 at 08:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation and the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Jan2021 at 08:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. On 01Oct2021 at 06:00, the patient experienced muscle and joint aches next day, headache, fatigue, foggy feeling, nasal drippage and congestion and arm pain. 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 muscle and joint aches, headache, fatigue, foggy feeling, nasal drippage and congestion and arm pain was resolving at the time of this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Headache, Immunisation, Myalgia
Clinical narrative: Fever for 2 days / As high as 103.3 / Every 6 hours for 36 hours; Headache; Muscle and joint pain; Muscle and joint pain; Pain at injection; The patient received a third/booster dose; The patient received a third/booster dose; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30130BA) via an unspecified route of administration in the left arm on 01Oct2021 at 12:30 (at the age of 61-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 did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration on 01Mar2021 (at the age of 60-years-old) and also previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration on 31Mar2021 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. On 02Oct2021, the patient experienced fever for two days, as high as 103.3, every 6 hours for 36 hours, headache, muscle and joint pain and pain at injection. 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 event fever which included fever reducing medication. On 02Oct2021, the patient underwent body temperature test and the result was 103.3 (unspecified units). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever as high as 103.3, every 6 hours for 36 hours was resolved with sequalae on 04Oct2021 while headache, muscle and joint pain and pain at injection was resolved with sequelae on an unknown date in Oct2021 at the time of this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pyrexia, Vaccination site pain
Clinical narrative: Fever for 2 days / As high as 103.3 / Every 6 hours for 36 hours; Headache; Muscle and joint pain; Muscle and joint pain; Pain at injection; The patient received a third/booster dose; The patient received a third/booster dose; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30130BA) via an unspecified route of administration in the left arm on 01Oct2021 at 12:30 (at the age of 61-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 did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration on 01Mar2021 (at the age of 60-years-old) and also previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration on 31Mar2021 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. On 02Oct2021, the patient experienced fever for two days, as high as 103.3, every 6 hours for 36 hours, headache, muscle and joint pain and pain at injection. 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 event fever which included fever reducing medication. On 02Oct2021, the patient underwent body temperature test and the result was 103.3 (unspecified units). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever as high as 103.3, every 6 hours for 36 hours was resolved with sequalae on 04Oct2021 while headache, muscle and joint pain and pain at injection was resolved with sequelae on an unknown date in Oct2021 at the time of this report.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Arthralgia, Body temperature, Body temperature increased, Fatigue
Clinical narrative: Patient was administered Booster dose 3, BNT162b2; Patient was administered Booster dose 3, BNT162b2; Headache; Extreme fatigue; Joint aches; No taste; Temp 103; This is a spontaneous report from a contactable nurse, the patient. A 62-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the right arm on 01Oct2021 at 15:00(at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included Meniere's disease and known allergies to penicillin (PCN) and sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included omeprazole (PRILOSEC), celecoxib (CELEBREX), sertraline hydrochloride (ZOLOFT), hydrochlorothiazide (HCTZ), levothyroxine sodium (SYNTHROID), fenofibrate (MANUFACTURER UNKNOWN), rosuvastatin calcium (CRESTOR), vitamins nos (MVI), calcium (MANUFACTURER UNKNOWN), colecalciferol (VITAMIN D3), ascorbic acid (VITAMIN C), cyanocobalamin (B12), potassium (MANUFACTURER UNKNOWN), temazepam (RESTORIL) and unspecified probiotics; all from unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously took morphine (MANUFACTURER UNKNOWN) and streptomycin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the second dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an intramuscular route of administration in the left arm on 28Jan2021 at 09:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation and also received the first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an intramuscular route of administration in the left arm on 06Jan2021 at 09:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. On 02Oct2021 at 10:00, the patient experienced headache, extreme fatigue, joint aches, temp 103 and no taste. On the same day, the patient underwent body temperature test and the result was 103 (unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headache, extreme fatigue, joint aches, temp 103 and no taste was resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Off label use
Clinical narrative: Patient was administered Booster dose 3, BNT162b2; Patient was administered Booster dose 3, BNT162b2; Headache; Extreme fatigue; Joint aches; No taste; Temp 103; This is a spontaneous report from a contactable nurse, the patient. A 62-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the right arm on 01Oct2021 at 15:00(at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included Meniere's disease and known allergies to penicillin (PCN) and sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included omeprazole (PRILOSEC), celecoxib (CELEBREX), sertraline hydrochloride (ZOLOFT), hydrochlorothiazide (HCTZ), levothyroxine sodium (SYNTHROID), fenofibrate (MANUFACTURER UNKNOWN), rosuvastatin calcium (CRESTOR), vitamins nos (MVI), calcium (MANUFACTURER UNKNOWN), colecalciferol (VITAMIN D3), ascorbic acid (VITAMIN C), cyanocobalamin (B12), potassium (MANUFACTURER UNKNOWN), temazepam (RESTORIL) and unspecified probiotics; all from unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously took morphine (MANUFACTURER UNKNOWN) and streptomycin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the second dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an intramuscular route of administration in the left arm on 28Jan2021 at 09:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation and also received the first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an intramuscular route of administration in the left arm on 06Jan2021 at 09:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. On 02Oct2021 at 10:00, the patient experienced headache, extreme fatigue, joint aches, temp 103 and no taste. On the same day, the patient underwent body temperature test and the result was 103 (unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headache, extreme fatigue, joint aches, temp 103 and no taste was resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Hiccups
Clinical narrative: Hiccups for 2 days after vaccination; This is a spontaneous report from a contactable consumer. An adult male patient of unknown age 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. Medical history and concomitant medications were not reported. It was not reported if the patient received any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date the patient experienced hiccups for two days after vaccination. The clinical outcome of the event hiccups or two days after vaccination was resolved on an unknown date.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Within 10 minutes of shot ears ringing very loudly and has continued for 3 weeks and counting; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date in 2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included slight ear ringing but not like a train going through the patient brain like now. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in 2021, within 10 minutes of shot, the patient experienced ears ringing very loudly and has continued for 3 weeks and counting. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event ears ringing very loudly and has continued for 3 weeks and counting was not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pruritus, Swelling, Vaccination site swelling
Clinical narrative: Swelling and redness.; Swelling and redness.; Pain and itching; Pain and itching; Large swollen area at injection site; Off-label use; This was a booster. Received the first 2 doses in March.; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3592) via an unspecified route of administration in the left arm on 29Sep2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date in Mar2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date in Mar2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 29Sep2021, the patient experienced swelling, redness, pain, itching and large swollen area at injection site. The patient reported pain and itching all were still occurring at the time of this report. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling, redness, pain, itching and large swollen area at injection site was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Fatigue, Hyperhidrosis, Lymphadenopathy, Swelling
Clinical narrative: Extreme fatigue; Bilateral axillary lymph node swelling; Hot/cold sweats; Supraclavicular left sided swelling; Hot/cold sweats; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 1840707-03792) via an unspecified route of administration in the left arm on 27Sep2021 at 12:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid, polycystic ovarian syndrome (PCOS), postural orthostatic tachycardia syndrome (POTTS), ehlers-danlos syndrome (EDS) and eosinophilic esophagitis (EOE). The patient had known allergies to eggs, milk, fish, peanuts, lobster, gluten and penicillin. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), liothyronine sodium (CYTOMEL) and ethinylestradiol/norethisterone acetate (LOESTRIN); all for unknown indications from an unknown date and unknown if ongoing. The patient previously took amoxicillin/clavulanic acid (AUGMENTIN) on an unknown date and experienced drug allergy. On 29Sep2021 at 05:30, the patient experienced extreme fatigue, bilateral axillary lymph node swelling, supraclavicular left sided swelling and hot/cold sweats. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme fatigue, bilateral axillary lymph node swelling, supraclavicular left sided swelling, hot/cold sweats was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Tremor, Vaccination site bruising
Clinical narrative: Tremors; Body aches; Sore arm with quarter size bruise at injection site; Sore arm with quarter size bruise at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 69-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 301308A) via an unspecified route of administration in the left arm on 30Sep2021 at 10:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to alpha-gal allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1685) via an unspecified route of administration on 15Jan2021 (at the age of 68-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) via an unspecified route of administration on 05Feb2021 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. On 30Sep2021 at 18:30, the patient experienced tremors, body aches, sore arm with quarter size bruise at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tremors, body aches, sore arm with quarter size bruise at injection site was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain, Pain in extremity
Clinical narrative: Sore arm; Body pain; Migraine; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date (at the age of 37-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 concomitant medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. On an unknown date, 1st day, the patient experienced sore arm and Couldn't touch or lay on it. 2nd day, the patient experienced body pain and was still Couldn't touch or lay on that same arm. 3-4 day, the patient experienced migraine set in for 2 days, less arm and body pain. 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 event migraine set in for 2 days was resolved on an unknown date and of the events sore arm, Couldn't touch or lay on it and body pain was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Lip swelling
Clinical narrative: Lips swelling; strong taste of having chewed rubber bands on lips and inside mouth; This is a spontaneous report from a contactable consumer, the patient. An 80-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 01Oct2021 at 11:15 (at the age of 80-year-old), as a single dose for COVID-19 immunisation. Medical history included foramen ovale patent (PFO), osteoporosis, osteopenia, high blood pressure, high cholesterol, acid reflux and known allergies reported as many. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included unspecified medications received within two weeks of vaccination. On 01Oct2021 at 16:30, the patient experienced lips swelling and strong taste of having chewed rubber bands, on lips and inside mouth. The patient described it as maddening. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lips swelling and strong taste of having chewed rubber bands on lips and inside mouth was not resolved at the time of this report  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 70.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Body temperature, Chills, Fatigue, Headache, Insomnia
Clinical narrative: chills; fever was up to 102; nausea; headache; Took long time trying to get to sleep; Felt drained most of that day; This is a spontaneous report from a contactable Consumer or other non-HCP. A 70-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: FD8448), via an unspecified route of administration, administered in Arm right on 28Sep2021 at 13:30 (age at vaccination was 70 years) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation; influenza vaccine inact split 3v (FLUZONE HIGH DOSE) (NDC:49281-0121-65) via an unspecified route of administration, administered in Arm right on 28Sep2021 as flu shot. The patient medical history included atrial fibrillation. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient does not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications was received within 2 weeks of vaccination. No known allergies reported. The concomitant medications were none. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE and as dose 2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot: unknown) as DOSE 2, SINGLE for covid-19 immunization. On 28Sep2021 at 21:30, the patient experienced chills, fever was up to 102, nausea, headache, took long time trying to get to sleep, woke often. In morning fever broke and back to normal. Felt drained most of that day but no other issues. Therapeutic measures were taken as a result of event included paracetamol (TYLENOL) for fever. Outcome of the events were recovered.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Nausea, Pyrexia
Clinical narrative: chills; fever was up to 102; nausea; headache; Took long time trying to get to sleep; Felt drained most of that day; This is a spontaneous report from a contactable Consumer or other non-HCP. A 70-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: FD8448), via an unspecified route of administration, administered in Arm right on 28Sep2021 at 13:30 (age at vaccination was 70 years) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation; influenza vaccine inact split 3v (FLUZONE HIGH DOSE) (NDC:49281-0121-65) via an unspecified route of administration, administered in Arm right on 28Sep2021 as flu shot. The patient medical history included atrial fibrillation. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient does not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications was received within 2 weeks of vaccination. No known allergies reported. The concomitant medications were none. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE and as dose 2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot: unknown) as DOSE 2, SINGLE for covid-19 immunization. On 28Sep2021 at 21:30, the patient experienced chills, fever was up to 102, nausea, headache, took long time trying to get to sleep, woke often. In morning fever broke and back to normal. Felt drained most of that day but no other issues. Therapeutic measures were taken as a result of event included paracetamol (TYLENOL) for fever. Outcome of the events were recovered.  Follow-up attempts are completed. No further information is expected.