chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Vaccination site pain
Clinical narrative: Injection site pain (mild); Developed pain/sensitivity to touch (mild) around whole left shoulder from back of shoulder (trapezoid to collarbone); Moderate pain under left armpit; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via unspecified route of administration in left arm on 17Mar2021 at 19:30 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history and concomitant medications. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. On 18Mar2021, the patient experienced injection site pain (mild). On day 2-3 on an unknown date in Mar2021, the patient developed pain/sensitivity to touch (mild) around his whole left shoulder from back of shoulder (trapezoid to collarbone) with moderate pain under left armpit. The armpit pain was totally resolved after day 4, but general mild pain/sensitivity around left shoulder from left trapezoid to front of left collarbone persists even to the day of this report. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event armpit pain was resolved on an unknown date in Mar2021 (after day 4) while that of vaccination site pain and shoulder pain was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea; Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in the left arm on 23Mar2021 at 18:15 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and allergy (not specified). Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced nausea and vomiting on 24Mar2021 at 06.00. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of nausea and vomiting was resolved on unknown date. No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: fever; fatigue; body ache; chills; headache; This is a spontaneous report received from a contactable consumer, the patient. A 27-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in left arm on 22Mar2021 at 17:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid and COVID-19. The patient received thyroid medication and birth control within two weeks of vaccination. The patient did not have allergies to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 23Mar2021 at 12:30, the patient had experienced chills, headache, body ache, and fatigue. On 24Mar2021 at 01:00, the patient experienced fever, body aches, headache and was tossing and turning. Therapeutic measures were taken as a result of events and included Ibuprofen and patient went back to sleep around 04:00. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chills, headache, body ache, fever and fatigue was resolving at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: wake up every night and have difficulty to fall back to sleep again.; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on 10Mar2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15Mar2021, the patient woke up every night and had difficulty falling back to sleep again. The patient did not receive any treatment for the reported event. The clinical outcome of the event of wake up every night and have difficulty to fall back to sleep again was not resolved at the time of this report. Information on lot/batch number has been requested. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac discomfort
Clinical narrative: Heart feels a little off (feel a sensation every so often); This is spontaneous report received from a contactable healthcare professional (patient). A 32-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in left arm on 19Mar2021 (at the age of 32-years-old) as a single dose (dose number unknown) for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 19Mar2021, the patient heart felt little off and did not think it was a beating issue but more of felt like a sensation every so often. The patient did not receive any treatment for the event. The clinical outcome of the event heart feels a little off (feel a sensation every so often) was not recovered.  No follow-up attempts are needed; Information about lot number cannot be obtained.   Amendment: This follow-up report is being submitted to amend previously reported information: patient details (name) was updated and event LLT Heart disorder was recoded to LLT Cardiac discomfort.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hot flush, Pain in extremity
Clinical narrative: heat flashes that feel like a fever; Arm pain; off and on headaches; This is a spontaneous report received from a contactable pharmacist. A 31-year-old, male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP6955), via intramuscular route administration in left arm on 23Mar2021 at 1500 (at the age of 31-year-old), as a single dose for COVID-19 immunisation. Medical history included migraines. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not tested positive for COVID-19 since having the vaccine. The Patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021, the patient experienced arm pain, off and on headaches and intermittent heat flashes that felt like a fever. No therapeutic measures were not taken for the events. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events arm pain, headache and hot flashes was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm Soreness; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 23Mar2021 at 13:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 infection prior to vaccination. The patient was allergic with penicillin. No concomitant medications were reported. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. On 23March2021 at 16:30, the patient experienced arm soreness. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse event. The clinical outcome of the arm soreness was not resolved at the time of this report.   No follow up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, SARS-CoV-2 test
Clinical narrative: Arm Soreness; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 23Mar2021 at 13:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 infection prior to vaccination. The patient was allergic with penicillin. No concomitant medications were reported. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. On 23March2021 at 16:30, the patient experienced arm soreness. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse event. The clinical outcome of the arm soreness was not resolved at the time of this report.   No follow up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6203) via an unspecified route of administration in right arm on 18Mar2021 at 13:15 (at the age of 50-year-old), as a single dose for COVID-19 immunisation. Medical history included raynaud's disease. Patient was allergic to amoxicillin and penicillin. Concomitant medication received within two weeks of vaccination included multi vitamins from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6203), via an unspecified route of administration in left arm on 25Feb2021 at 15:00 (at the age of 50-years-old), as a single dose for COVID-19 immunisation.  Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 at 18:00, patient experienced fatigue. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of fatigue was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Headache, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; headache; ache; I have no taste at all; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 17Mar2021 at 11:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Patient had no relevant medical history. Patient did not receive any other medications within 2 weeks of vaccination The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number EN6203) via an unspecified route of administration in the left arm on 24Feb2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, was the patient not diagnosed with COVID-19. Patient has no known allergies to food, medications or other products. On 18Mar2021 at 4:00 the patient experienced ache, fever, headache and no taste. She had no taste at all and had the typical reactions of fever, headache, body aches. It's been a week and still patient had no taste. The patient underwent COVID-19 virus test (BD Max) on 22Mar2021 and the result was negative. The patient had not received any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome for ache, fever, headache and taste loss was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Malaise, Myalgia
Clinical narrative: Headache; Chills; Muscle ache; Joint ache; Left arm pain; Feeling "sick"; Slight fever; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: EN6207), via an unspecified route administration in the left arm on 19Mar2021 at 12:45 (at the age of 78-years-old), as a single dose for COVID-19 immunisation. Medical history included allergy to mites, grass pollen, cats and latex (skin contact). Concomitant medications included multiple vitamins (MANUFACTURER UNKNOWN), losartan potassium (MANUFACTURER UNKNOWN) and bifidobacterium infantis; lactobacillus acidophilus (PROBIOTICS); all from unknown dates for unspecified indications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: EN6205), via an unspecified route administration in the left arm on 26Feb2021 at 00:15 (at the age of 78-years-old), as a single dose for COVID-19 immunisation and received doxycycline hyclate (MANUFACTURER UNKNOWN) and potassium dichromate (MANUFACTURER UNKNOWN); both on unknown dates for unspecified indications and experienced drug allergy. On 19March2021 at 14:00, the patient experienced headache, chills, muscle ache, joint ache, left arm pain, feeling sick and slight fever. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events headache, chills, muscle ache, joint ache, painful left arm, feeling sick, fever was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Headache; Chills; Muscle ache; Joint ache; Left arm pain; Feeling "sick"; Slight fever; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: EN6207), via an unspecified route administration in the left arm on 19Mar2021 at 12:45 (at the age of 78-years-old), as a single dose for COVID-19 immunisation. Medical history included allergy to mites, grass pollen, cats and latex (skin contact). Concomitant medications included multiple vitamins (MANUFACTURER UNKNOWN), losartan potassium (MANUFACTURER UNKNOWN) and bifidobacterium infantis; lactobacillus acidophilus (PROBIOTICS); all from unknown dates for unspecified indications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: EN6205), via an unspecified route administration in the left arm on 26Feb2021 at 00:15 (at the age of 78-years-old), as a single dose for COVID-19 immunisation and received doxycycline hyclate (MANUFACTURER UNKNOWN) and potassium dichromate (MANUFACTURER UNKNOWN); both on unknown dates for unspecified indications and experienced drug allergy. On 19March2021 at 14:00, the patient experienced headache, chills, muscle ache, joint ache, left arm pain, feeling sick and slight fever. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events headache, chills, muscle ache, joint ache, painful left arm, feeling sick, fever was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea; This is a spontaneous report from a non-contactable consumer. A non-pregnant female patient of unspecified 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. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea on 21Mar2021. The patient did not receive treatment for the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of nausea was resolved on unknown date in Mar2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Head discomfort, Hyperhidrosis, Memory impairment, Night sweats
Clinical narrative: diaphoretic; severe head pressure /severehead pressure on head, eyes andears for 7 days; room spinning; night sweatsx3 days; heart kicked my ribs; Put clothes in washer/dryer forgot to start it.; Light sensative less; chills x7 days; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old patient of unspecified gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via an unspecified route of administration on the left arm on 01Mar2021 at 15:00 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and multiple sclerosis (MS-mild). The patient had known allergies to penicillin, erythromycin, cleocin, sulfa, flushot and IV dye. The patient received metoprolol (MANUFACTURER UNKNOWN), triamterene/hcl (MANUFACTURER UNKNOWN), rosuvastatin (MANUFACTURER UNKNOWN) and calc (MANUFACTURER UNKNOWN) within 2 weeks prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 02Mar2021 at 03:45 diaphoretic, light sensitive severe head pressure, room spinning, night sweats for 3 days, chills for 7 days, heart kicked ribs 5 times in 4 days, severe head pressure on head, eyes and ears for 7 days, less up to day 15. The patient put clothes in washer/dryer forgot to start it and light sensitive less but lasting through day21, wore sunglasses in the house. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were for taken for the events. The clinical outcome of all the events was resolving at the time of report.   No follow-up attempts are needed; No further information is expected.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Palpitations, Photophobia, Vertigo
Clinical narrative: diaphoretic; severe head pressure /severehead pressure on head, eyes andears for 7 days; room spinning; night sweatsx3 days; heart kicked my ribs; Put clothes in washer/dryer forgot to start it.; Light sensative less; chills x7 days; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old patient of unspecified gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via an unspecified route of administration on the left arm on 01Mar2021 at 15:00 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and multiple sclerosis (MS-mild). The patient had known allergies to penicillin, erythromycin, cleocin, sulfa, flushot and IV dye. The patient received metoprolol (MANUFACTURER UNKNOWN), triamterene/hcl (MANUFACTURER UNKNOWN), rosuvastatin (MANUFACTURER UNKNOWN) and calc (MANUFACTURER UNKNOWN) within 2 weeks prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 02Mar2021 at 03:45 diaphoretic, light sensitive severe head pressure, room spinning, night sweats for 3 days, chills for 7 days, heart kicked ribs 5 times in 4 days, severe head pressure on head, eyes and ears for 7 days, less up to day 15. The patient put clothes in washer/dryer forgot to start it and light sensitive less but lasting through day21, wore sunglasses in the house. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were for taken for the events. The clinical outcome of all the events was resolving at the time of report.   No follow-up attempts are needed; No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Headache; Fatigue; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ep7534) via an unspecified route of administration in the left arm on 24Mar2021 at 11:45 (at the age of 38-year-old), as a single dose for COVID-19 immunisation. Patients medical history was not reported. Concomitant medications included birth control (MANUFACTURER UNKNOWN), anti-depressant (MANUFACTURER UNKNOWN) from on unknown dates and for an unknown indication. The facility where the patient received the vaccine was other. The patient had no known allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 24Mar2021 at 15:30, the patient experienced headache, fatigue and nausea. The patient did not receive any treatment for the events. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, fatigue and nausea was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Pain
Clinical narrative: Body aches; Chills; 101.9 temp; This is a spontaneous report received from a contactable consumer, the patient. A 43-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6204), via an unspecified route of administration in the left arm on 23Mar2021 at 14:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included amlodipine 5 mg (MANUFACTURER UNKNOWN) and valsartan 80 mg (MANUFACTURER UNKNOWN), for unknown indications from unknown dates. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 24Mar2021 at 14:00, the patient experienced chills, body aches and had 101.9 temp. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events chills, body aches and 101.9 temp. The clinical outcomes of the events chills, body aches and 101.9 temp were unknown.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Influenza like illness, Motion sickness
Clinical narrative: motion sickness; Chills; Slight fever; Tiredness; Weakness; Flu like symptoms; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received second dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6206) via an unspecified route of administration in the left arm as a single dose on 13Mar2021 at 11:00 (at the age of 32-year-old) for COVID-19 immunisation. The medical history and concomitant medications were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN 6198), via an unspecified route of administration in the left arm on 20Feb2021 at 11:00, as a single dose for COVID-19 immunisation. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Laboratory test included nasal swab on early March (for work) and the result was not provided. On 13Mar2021, the patient experienced mild flu like symptoms. On 15Mar2021, the patient experienced chills, slight fever, tiredness and weakness. On 15Mar2021 at 09:45, he had motion sickness while driving to a worksite (highway driving). The patient did not receive any treatment for the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the reported events flu like symptoms, chills, slight fever, tiredness, weakness and motion sickness were recovered on an unknown date in Mar2021.   No follow-up attempts possible. No further information expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Viral test
Clinical narrative: motion sickness; Chills; Slight fever; Tiredness; Weakness; Flu like symptoms; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received second dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6206) via an unspecified route of administration in the left arm as a single dose on 13Mar2021 at 11:00 (at the age of 32-year-old) for COVID-19 immunisation. The medical history and concomitant medications were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN 6198), via an unspecified route of administration in the left arm on 20Feb2021 at 11:00, as a single dose for COVID-19 immunisation. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Laboratory test included nasal swab on early March (for work) and the result was not provided. On 13Mar2021, the patient experienced mild flu like symptoms. On 15Mar2021, the patient experienced chills, slight fever, tiredness and weakness. On 15Mar2021 at 09:45, he had motion sickness while driving to a worksite (highway driving). The patient did not receive any treatment for the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the reported events flu like symptoms, chills, slight fever, tiredness, weakness and motion sickness were recovered on an unknown date in Mar2021.   No follow-up attempts possible. No further information expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness in left arm near injection site; This is a spontaneous report received from a contactable consumer, the patient. A 49-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in left arm on 23Mar2021 at 17:45, as a single dose for COVID-19 immunisation. The patients medical was not reported. The concomitant medications taken within two weeks of vaccination included escitalopram oxalate (LEXAPRO), atorvastatin calcium (LIPITOR), eszopiclone (LUNESTA), psyllium (METAMUCIL), omeprazole (PRILOSEC). No other vaccines are taken within four weeks of vaccination. Prior to vaccination, the patient did not have any symptoms associated with COVID-19. Since having the vaccine, patient had not tested positive for COVID-19. On 23Mar2021 at 17:45, the patient experienced soreness in left arm near injection site. No therapeutic measures were taken. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event vaccination site pain was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Heart rate increased, Myalgia
Clinical narrative: Increased heart rate; Chills; Muscle pain; Nausea; Headache; fever of 100.5; This is a spontaneous report received from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) (at the age of 27-years-old) via an unspecified route in the left arm on 23Mar2021, at 12:15 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were reported as no. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine and did not received any other medications within 2 weeks of vaccination. The patient did not have allergies to medications, food or other products. On 23Mar2021 at 13:15, the patient had a fever of 100.5 (unspecified units) within 1 hour of shot lasted for about 8 hours followed by chills and muscle pain, increased heart rate, nausea and headache. The patient did not receive any treatment for the reported events. Adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of fever of 100.5, chills and muscle pain, increased heart rate, nausea and headache was resolving at the time of report.  Information on lot/batch number has been requested. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Increased heart rate; Chills; Muscle pain; Nausea; Headache; fever of 100.5; This is a spontaneous report received from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) (at the age of 27-years-old) via an unspecified route in the left arm on 23Mar2021, at 12:15 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were reported as no. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine and did not received any other medications within 2 weeks of vaccination. The patient did not have allergies to medications, food or other products. On 23Mar2021 at 13:15, the patient had a fever of 100.5 (unspecified units) within 1 hour of shot lasted for about 8 hours followed by chills and muscle pain, increased heart rate, nausea and headache. The patient did not receive any treatment for the reported events. Adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of fever of 100.5, chills and muscle pain, increased heart rate, nausea and headache was resolving at the time of report.  Information on lot/batch number has been requested. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: injection site arm soreness; Extremely tired the remainder of the day and also the next day; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER2613), via an unspecified route of administration in the left arm on 23Mar2021 at 09:00 (at the age of 59-years-old), as a single dose for COVID-19 immunisation. Medical history included diabetes. The patient was allergic to penicillin. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN), thioctic acid (ALPHA LIPOIC ACID) and Co-Q10 (MANUFACTURER UNKNOWN); all from unknown dates for unspecified indications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Mar2021 at 11:00, the patient experienced injection site arm soreness, extremely tired the remainder of the day and also the next day. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events vaccination site pain and tiredness was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Chills, Culture throat, Headache, Pain
Clinical narrative: Vomiting; Strong headache; chills; Gas/ bloating; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 20Mar2021 at 15:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient was allergic to penicillin. There were no concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 27Feb2021 at 17:15 (at an unspecified age) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested positive for COVID-19. On 20Mar2021 at 17:30 the patient experienced vomiting, chills, strong headache, gas/ bloating and body aches. No treatment was received for the reported events. On an unspecified date, the patient had undergone COVID-19 saliva test and the result was negative. The clinical outcome of vomiting, chills, strong headache, gas/ bloating and body aches was resolved on an unspecified date in Mar2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; Strong headache; chills; Gas/ bloating; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 20Mar2021 at 15:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient was allergic to penicillin. There were no concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 27Feb2021 at 17:15 (at an unspecified age) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested positive for COVID-19. On 20Mar2021 at 17:30 the patient experienced vomiting, chills, strong headache, gas/ bloating and body aches. No treatment was received for the reported events. On an unspecified date, the patient had undergone COVID-19 saliva test and the result was negative. The clinical outcome of vomiting, chills, strong headache, gas/ bloating and body aches was resolved on an unspecified date in Mar2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Dyspnoea
Clinical narrative: Severe shortness of breath; Wet cough; Weakness; This is a spontaneous report received from a contactable consumer, the patient. A 21-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 23Mar2021 at 08:15 as a single dose (at the age of 21-years-old) for COVID-19 immunisation. Medical history included asthma. The patient had a history of allergy to penicillin. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 24Mar2021 at 08:00, the patient had experienced severe shortness of breath, wet cough and weakness. The patient did not receive any treatment for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events severe shortness of breath, wet cough, weakness was not resolved at the time of this report.  Information on lot/batch number has been requested. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gout
Clinical narrative: gout flair up in right foot; 3rd day after shot, right knee was hurting for several days; This is a spontaneous report received from a contactable consumer, the patient. A 27-Year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) as a single dose via an unspecified route of administration in his left arm on 12Mar2021at 10:45AM (at the age of 27-year-old), for COVID-19 immunisation. The patients medical history included immune compromised, no functioning pituitary gland. The patient was allergic to iodine. Concomitant medications included hydrocortisone(MANUFACTURER UNKINOWN), levothyroxine(MANUFACTURER UNKNOWN), testosterone(MANUFACTURER UNKNOWN). The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not tested positive for COVID-19 since having the vaccine. The patient had not diagnosed with COVID-19 prior to vaccination.  On 15Mar2021, the patient reported that he had right knee pain and gout flare up in right foot. It was reported that on 3rd day after vaccination the right knee was hurting for several days and then after 3-4 days later, he could not walk due to a gout flare up in right foot. Therapeutic measure were provided for the reported events with unspecified medications. The clinical outcome right knee pain and gout flare was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Cellulitis; Left arm redness/pain/swelling 8cm worse after 3-4 days; Left arm redness/pain/swelling 8cm worse after 3-4 days; Left arm redness/pain/swelling 8cm worse after 3-4 days; This is a spontaneous report received from a contactable physician. A 72-years-old female patient (not pregnant) received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EN6207), intramuscularly in Arm Left on 19Mar2021 (at the age of 72-years-old) as dose 2, single for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medications included hydrochlorothiazide, lisinopril (LISINOPRIL AND HYDROCHLOROTHIAZIDE) taken for an unspecified indication, start and stop date were not reported. The patient previously took penicillin and erythromycin and experienced drug hypersensitivity. The patient previously took first dose of bnt162b2 (Lot: EN6207) on 25Feb2020 at 12:00 PM (at the age of 72-yesr-old) in the Left arm for COVID-19 immunisation. The patient experienced cellulitis and Left arm redness/pain/swelling 8cm worse after 3-4 days, on 20Mar2021. The event Cellulitis assessed as serious (medically significant) and while others was non-serious. Treatment was received for the events as antibiotic- Keflex. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. Patient visited doctor or other healthcare professional office/clinic visit. The outcome of the events was reported as unknown.; Sender's Comments: Considering a plausible temporal relationship, a possible contributory role of suspect product Comirnaty  to the reported 'COVID 19' cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: arm soreness; fatigue; fever (100 degrees); chills; This is a spontaneous report received from a contactable consumer, the patient. A 41-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route administration on 24Mar2021 at 10:00, (at the age of 41-years-old) as a single dose, for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medications within two weeks prior to the vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route administration on 01Mar2021, (at the age of 41-years-old) as a single dose, for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 24Mar2021 at 21:00 (11 hours after the dose), the patient had very predictable response to the 2nd dose as he experienced severe arm soreness, fatigue, mild fever (100 degrees, units unspecified), chills. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measure was taken as result of events and included the treatment with Tylenol and slept. It was reported that, one day after vaccination only mild arm soreness remained. The clinical outcome of the event arm soreness was not resolved and for events fatigue, fever (100 degrees) and chills were recovering at the time of this report.   No follow-up attempts are needed. No further information was expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: ER3727), via unspecified route of administration in left arm on 23Mar2021 at 08:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and no known allergies were reported. The patient was not taking any concomitant medications within 2 weeks of vaccination. The patient had not taken any other vaccine within four weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021, after the vaccination, the patient experienced sore arm. The event did not result in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the adverse event. The clinical outcome of the event sore arm was recovering.   No follow-up attempts needed. No further information is expected.