chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Fever; chills; headache; muscle aches; joint pain; nausea; unable to sleep; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the left arm on 22Mar2021 at 08:45 (at the age of 68-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroid, hypertension and hypercholesterolemia. The patient had a history of allergy to doxycycline, fragrance, pollen and grasses. Concomitant medication included levothyroxine sodium (SYNTHROID), simvastatin (UNKNOWN MANUFACTURER), metoprolol (UNKNOWN MANUFACTURER) and cetirizine hydrochloride (ZYRETEC) and iron (UNKNOWN MANUFACTURER) all for unknown indication received within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration on 01Mar2021 at 09:00 (at the age of 68-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021 at 18:00, the patient experienced fever (101.5) (unspecified units), chills, headache, muscle aches, joint pain, nausea and unable to sleep. The patient did not receive 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 fever (101.5), chills, headache, muscle aches, joint pain, nausea and unable to sleep was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on back and arms; This is a spontaneous report received from a contactable consumer, the patient. A 57-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL 9261), via an unspecified route of administration in the left arm on 08Mar2021 at 11:30 (at the age of 57-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL 3302), via an unspecified route of administration in the left arm on 08Feb2021 at 11:45 as a single dose for COVID-19 immunisation. The patient had no known allergies to medications, food, or other products. 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 has not been tested for COVID-19. On 13Mar2021 at 15:00, the patient experienced hives on back and arms five days after second dose that still persisted. No therapeutic measures were taken for the 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 the event hives on back and arms was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: I was not supposed to start my period for 17 days; i started heavily bleeding; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6203) via an unspecified route of administration in the right arm on 22Mar2021 at 06:00 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. The patients medical history included suspected COVID-19 prior to vaccination. The patient was allergic to sulfa medications. Concomitant medications included norgestimate/ethinyl estradiol (ORTHO TRI CYCLEN LO) and fluoxetine (MANUFACTURER UNKNOWN) both for unknown indications started on an unknown date. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EM9809) via an unspecified route of administration in the left arm on 25Feb2021 at 06:00 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines in four weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was diagnosed with COVID-19 on an unknown date. The patient was not tested for COVID-19 since the vaccination. On 23Mar2021 at 09:00 hours the patient reported that she was on birth control that regulates her menstrual cycle and she was not supposed to start her period for 17 days but the patient experienced heavily bleeding on the same day of the vaccination. The patient never had periods earlier than scheduled in the past 8 years. The patient did not receive any treatment for the events reported. 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 irregular periods and heavy periods was not resolved at the time of the report. No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Lip swelling
Clinical narrative: Swollen lips; stabbing pain on right breast; This is a spontaneous report from a contactable consumer, the patient. A 35-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in the right arm on 21Mar2021 at 17:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included as myomectomy to remove uterine fibroids on an unknown date in Oct2020 and had lip injection one year ago. Concomitant medication included PEPCID for unspecified indication. The patient was not allergic to any medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in the right arm on 21Feb2021 at 17:00 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 was not tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 22Mar2021 at 16:00, the patient experienced swollen lips and stabbing pain on right breast (same side as vaccination). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of adverse events. The clinical outcome of swollen lips and stabbing pain on right breast was recovering.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Runny nose; Slight sore throat right side of throat; Tired; This is a spontaneous report received from a contactable other health care professional. A 66-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route and in left arm on 19Mar2021 at 13:45 PM (at the age of 66-years-old) as a single dose for COVID-19 immunisation. The patient medical history included thyroiditis (thyroid meds (unspecified drugs). The patient had known allergy with Wellbutrin. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route and in left arm on 26Feb2021 as a single dose for COVID-19 immunisation. The patient received other vaccine within four weeks prior to the vaccination (as reported). 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. The patient did not receive any other medications within two weeks of vaccination. On 23Mar2021, at 16:45, the patient experienced runny nose, slight sore throat right side of throat and tired. 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 runny nose, sore throat and tiredness was not resolved at the time of report. No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Myalgia, Pyrexia
Clinical narrative: Chills; Fatigue; Muscle aches; Lack of appetite; Fever; This is a spontaneous report from a non-contactable consumer, the patient. A 65-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified route of administration in the left arm on 05Mar2021 at 09:15 (at the age of 65-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9266), via an unspecified route of administration in the left arm on 12Feb2021 at 11:30, as a single dose for COVID-19 immunisation. The patient experienced chills, fatigue, muscle aches, lack of appetite and fever on 06Mar2021 at 01:00. The patient did not receive any treatment for the events. The clinical outcome of the events chills, fatigue, muscle aches, appetite lost and fever was resolved on an unknown date in Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Insomnia, Somnolence
Clinical narrative: Less sleepy the following day after; Extreme sleepiness; Still tired the next day; This is a spontaneous report received from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534), via an unspecified route of administration in the left arm on 20Mar2021 at 13:30 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history included suffered with chronic system neurological Lyme disease (10 years ago) and concurrent condition included hypothyroid. The patient did not have any allergies to medications, food, or other products. The patient's concomitant medication included levothyroxine sodium (LEVOXYL) for an unknown indication from an unknown date. The patient previously received the first dose of BNT162b2(PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot no: UNKNOWN), via an unspecified route of administration on an unspecified date 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 not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 21Mar2021, the patient experienced extreme sleepiness and tiredness. On 22Mar2021 the patient experienced less sleepy. The patient reported that she had extreme sleepiness the following day, was still tired the next day, but less so and less sleepy the following day after that. The patient did not received treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the extreme sleepiness, tired and less sleepy were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Chills, Fatigue, Headache
Clinical narrative: Chills; Fatigue; Nausea; Weakness; Headache; GI distress; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), via an unspecified route of administration in the left arm on 17Mar2021 at 18:00 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included migraine, asthma, GERD, obesity. The patient was allergic to avocado, shellfish, penicillin. Concomitant medications included lansoprazole (MANUFACTURER UNKNOWN) , montelukast sodium (SINGULAIR), erenumab (AIMOVIG), nortriptyline (MANUFACTURER UNKNOWN); all from unknown dates for unspecified indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: C1821), via an unspecified route of administration in the left arm on 24Feb2021 at 18:00, (at the age of 40-years-old), as a single dose for COVID-19 immunisation. 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 had not tested for COVID-19. On 21Mar2021 at 18:00, the patient experienced chills, fatigue, nausea, weakness, headache and GI distress. 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 chills, fatigue, nausea, weakness, headache and distress gastrointestinal was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Chills; Fatigue; Nausea; Weakness; Headache; GI distress; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), via an unspecified route of administration in the left arm on 17Mar2021 at 18:00 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included migraine, asthma, GERD, obesity. The patient was allergic to avocado, shellfish, penicillin. Concomitant medications included lansoprazole (MANUFACTURER UNKNOWN) , montelukast sodium (SINGULAIR), erenumab (AIMOVIG), nortriptyline (MANUFACTURER UNKNOWN); all from unknown dates for unspecified indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: C1821), via an unspecified route of administration in the left arm on 24Feb2021 at 18:00, (at the age of 40-years-old), as a single dose for COVID-19 immunisation. 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 had not tested for COVID-19. On 21Mar2021 at 18:00, the patient experienced chills, fatigue, nausea, weakness, headache and GI distress. 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 chills, fatigue, nausea, weakness, headache and distress gastrointestinal was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Fatigue, Headache, Hypersensitivity
Clinical narrative: chills; Headache; body fatigue and aches; body fatigue and aches; Moved on next day to same symptoms I had with covid; Started off as allergy reaction; Scratchy throat; sinuses closed off; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 47-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER2613), via an intramuscular route of administration (at the age of 47-years), administered in arm left on 22Mar2021 14:15 as dose 1, single for COVID-19 immunization. Medical history included allergy from only pollens, pet dander, covid-19, allergies from an unknown date and unknown if ongoing. Concomitant medications included cetirizine taken for allergies route: pill from an unspecified start date and ongoing. The patient was not had Covid prior vaccination, and the test was not performed post vaccination. The patient took other vaccine within four weeks which included allergy shot on 17Mar2021. On 23Mar2021 07:00, the day after both shots I had serious body fatigue and aches, chills and a headache. Symptoms lasted the entire day and eventually subsided the next morning. On 22Mar2021 17:00, the patient stated that he started off as allergy reaction, scratchy throat, sinuses closed off and moved on next day to same symptoms I had with covid. No fever though. The treatment was received for the adverse events included flonase spray for allergies and tylenol. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Dec2020, sars-cov-2 test: negative on Jan2021. The vaccination facility type was reported as public health clinic/veterans administration facility. The clinical outcome for the events body fatigue and aches, chills and a headache was reported as recovered on 24Mar2021 while for other events reported as recovering.  Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test, Sinus disorder, Throat irritation
Clinical narrative: chills; Headache; body fatigue and aches; body fatigue and aches; Moved on next day to same symptoms I had with covid; Started off as allergy reaction; Scratchy throat; sinuses closed off; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 47-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER2613), via an intramuscular route of administration (at the age of 47-years), administered in arm left on 22Mar2021 14:15 as dose 1, single for COVID-19 immunization. Medical history included allergy from only pollens, pet dander, covid-19, allergies from an unknown date and unknown if ongoing. Concomitant medications included cetirizine taken for allergies route: pill from an unspecified start date and ongoing. The patient was not had Covid prior vaccination, and the test was not performed post vaccination. The patient took other vaccine within four weeks which included allergy shot on 17Mar2021. On 23Mar2021 07:00, the day after both shots I had serious body fatigue and aches, chills and a headache. Symptoms lasted the entire day and eventually subsided the next morning. On 22Mar2021 17:00, the patient stated that he started off as allergy reaction, scratchy throat, sinuses closed off and moved on next day to same symptoms I had with covid. No fever though. The treatment was received for the adverse events included flonase spray for allergies and tylenol. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Dec2020, sars-cov-2 test: negative on Jan2021. The vaccination facility type was reported as public health clinic/veterans administration facility. The clinical outcome for the events body fatigue and aches, chills and a headache was reported as recovered on 24Mar2021 while for other events reported as recovering.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nausea, Paraesthesia, Vaccination site rash
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 50 years-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 21Mar2021, (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient was allergic to shrimps. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medications (unspecified) within two weeks of vaccination. On 21Mar2021 at 09:00, the patient experienced tingling in left arm, left side of face and head and partial numbness of left side of face, mild rash at injection site and nausea. These events lasted for the day of vaccination and the next day. No therapeutic measures were taken for adverse 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 events tingling of left arm, left side of face and head, partial numbness of left side of face, mild rash at injection site and nausea was resolved on 22Mar2021. No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Headache, Muscle tightness, Musculoskeletal stiffness, Throat tightness
Clinical narrative: Within 5 minutes had a headache; metallic taste in mouth; jaw muscles felt tight; shoulder muscles felt tight; throat tightened up.; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient 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 23Mar2021 at 13:15 (at the age of 48-year-old), as single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medications included indapamide (MANUFACTURER UNKNOWN), potassium chloride (MANUFACTURER UNKNOWN) vitamin C (MANUFACTURER UNKNOWN) and vitamin (MANUFACTURER UNKNOWN). The patient had allergies to computed tomography (CT) contrast dye, and Celecoxib (CELEBREX). Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 13:15, within 5 minutes the patient experienced headache and got a strange medicine/metallic taste in mouth, a few minutes later, jaw and shoulder muscles felt tight and throat tightened up. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient received treatment with 25mg of benadryl for the adverse event. The clinical outcome of within 5 minutes headache and got a strange medicine/metallic taste in mouth, jaw and shoulder muscles felt tight and throat tightened up was resolving. No follow-up attempts are possible; No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on chest, stomach, & legs; This is a spontaneous report from a contactable consumer, the patient. A 49-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9266), via unspecified route of administration on 23Mar2021 (at the age of 49 years old), as a single dose for COVID-19 immunisation. The patient previously received first dose of BNT162b2 (PFIZER COVID-19 mRNA VACCINE BIONTECH, Lot number: EL9265) via an unspecified route of administration in right arm on 02Feb2021 at 12:00 (at the age of 49 years old), as a single dose for COVID-19 immunisation. The medical history of the patient included hypertension. The patient had not received any medication within 2 weeks of vaccination. The patient was not diagnosed with COVID-19, prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient had no known allergies to medications, food or other products. The patient had not tested for COVID-19, since the vaccination. On 14Mar2021 at 12:00, the patient experienced tinnitus in both ears. The vaccine was administered outside the range of 19-42 days after the first dose.  No therapeutic measures were taken as result of 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 tinnitus in both ears was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature fluctuation, Dizziness, Dry mouth, Dry throat
Clinical narrative: fluctuating temperature; blurry vision; dry mouth; dry upper throat; lightheadness; tingling inside mouth and aroundjaws area.; This is a spontaneous report from contactable consumer, the patient. A 35-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA; Lot Number: unknown), via an unspecified route of administration on 20Mar2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient had a medical history of allergies to penicillin, dairy and mango. The concomitant medications were not reported. 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 20Mar2021 (5-10 minutes after vaccine administration), the patient experienced blurry vision, dry mouth and upper throat, followed by light-headedness, and tingling inside mouth and around jaws area. The light-headedness went away within five minutes, the dry mouth and tingling feeling held longer, later that day had more episodes of light-headedness. The patient experienced following day on (21Mar2021) (Sunday), while felt ok for most part, had fluctuating temperature that was sometimes high and sometimes normal, and had a few more light-headedness episodes, neither continued into Monday except for one lightheaded episode. The patient added that she was not stressed prior to vaccination, her whole family was vaccinated in (country name), and not had any issues. 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 events of blurry vision, dry mouth and upper throat, light-headedness, tingling and fluctuating temperature was recovered on an unknown date in Mar2021.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vision blurred
Clinical narrative: fluctuating temperature; blurry vision; dry mouth; dry upper throat; lightheadness; tingling inside mouth and aroundjaws area.; This is a spontaneous report from contactable consumer, the patient. A 35-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA; Lot Number: unknown), via an unspecified route of administration on 20Mar2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient had a medical history of allergies to penicillin, dairy and mango. The concomitant medications were not reported. 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 20Mar2021 (5-10 minutes after vaccine administration), the patient experienced blurry vision, dry mouth and upper throat, followed by light-headedness, and tingling inside mouth and around jaws area. The light-headedness went away within five minutes, the dry mouth and tingling feeling held longer, later that day had more episodes of light-headedness. The patient experienced following day on (21Mar2021) (Sunday), while felt ok for most part, had fluctuating temperature that was sometimes high and sometimes normal, and had a few more light-headedness episodes, neither continued into Monday except for one lightheaded episode. The patient added that she was not stressed prior to vaccination, her whole family was vaccinated in (country name), and not had any issues. 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 events of blurry vision, dry mouth and upper throat, light-headedness, tingling and fluctuating temperature was recovered on an unknown date in Mar2021.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart racing; This is a spontaneous report received from a contactable healthcare professional. A 59-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration on 19Mar2021 (at the age of 59-year) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 19Mar2021, during her 15 minutes waiting period after the injection, the patient began to experience heart racing. Heart racing onset was 5 minutes after injection. The patient denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, light-headedness, dizziness, facial swelling, lip swelling and tongue swelling. Heart racing was briefly lasted and resolved by the time she arrived to the medical bay. Treatment for this event included water and close monitoring until end of her observation time. The follow up response to treatment was excellent. The patient was discharged and was stable to go home and follow up with primary care physician (PCP). The clinical outcome of the event heart racing was resolved on 19Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Pyrexia
Clinical narrative: severe chills; weakness; temperature was about 38C.; This is a spontaneous report from a contactable consumer, the patient. A 65-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6204) via unspecified route of administration in the arm left on 21Mar2021 at 11:00 (at the age of 65-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Mar2021 at 02:00, the patient experienced severe chills on the night after the vaccination, she woke up at about 02:00 with severe chills. The next day she was sleepy and weak and the temperature was about 38C. She felt some weakness even the day after. The treatment for the reported events included TYLENOL and ibuprophen. 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 severe chills, weakness and high temperature was recovered on an unspecified date.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dysphonia, Pain, Pain in extremity, Pyrexia
Clinical narrative: fever; sore arm in the location of the injection.; hoarse throat & raspyvoice; aches all over my body.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: ER2613) via an unspecified route of administration in the left arm on 20Mar2021 at 10:30 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and suspected COVID-19 on 22Dec2020. The patient was non-allergic to medication, food or other products. Concomitant medications included Flovent diskus of 250 microgram (mcg) and albuterol (MANUFACTURER UNKNOWN) both for an unknown indication from an unknown date. The patient had not received 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 tested for COVID-19. On 20Mar2021 at 19:00, the patient experienced sore arm in the location of the injection, very sore/aches all over body and fever/aches had lasted approximately up to 36 hours. The patient experienced hoarse throat raspy voice, which patient had assumed due to it. The patient had not received any treatment for the events. On an 22Dec2020, the patient had tested for COVID-19 which resulted in positive and on 21Mar2021, the patient had tested for body temperature which resulted in 100.3-degree Fahrenheit. 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 any treatment for the events. The clinical outcome of the events fever and general body pain were resolved with sequelae on 23Mar2021 at 07:00 whereas that of the events sore arm in the location of the injection, hoarse throat & raspy were resolved with sequelae on an unknown date.   No follow-up attempts are possible; No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: fever; sore arm in the location of the injection.; hoarse throat & raspyvoice; aches all over my body.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: ER2613) via an unspecified route of administration in the left arm on 20Mar2021 at 10:30 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and suspected COVID-19 on 22Dec2020. The patient was non-allergic to medication, food or other products. Concomitant medications included Flovent diskus of 250 microgram (mcg) and albuterol (MANUFACTURER UNKNOWN) both for an unknown indication from an unknown date. The patient had not received 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 tested for COVID-19. On 20Mar2021 at 19:00, the patient experienced sore arm in the location of the injection, very sore/aches all over body and fever/aches had lasted approximately up to 36 hours. The patient experienced hoarse throat raspy voice, which patient had assumed due to it. The patient had not received any treatment for the events. On an 22Dec2020, the patient had tested for COVID-19 which resulted in positive and on 21Mar2021, the patient had tested for body temperature which resulted in 100.3-degree Fahrenheit. 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 any treatment for the events. The clinical outcome of the events fever and general body pain were resolved with sequelae on 23Mar2021 at 07:00 whereas that of the events sore arm in the location of the injection, hoarse throat & raspy were resolved with sequelae on an unknown date.   No follow-up attempts are possible; No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea
Clinical narrative: intense nausea; fatigue; chills; headache; 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: ER8730) via unspecified route of administration in the left arm on 19Mar2021 at 16:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via unspecified route of administration in the left arm on 23Feb2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021, 12-24 hours after shot, the patient experienced fatigue, chills and headache. The next day on 21Mar2021, 36-48 hours after shot, complete improvement was seen followed by relapse of fatigue, chills, and intense nausea on the following day on 22Mar2021 (72 hours after shot). Treatment was not received for the reported events. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the headache was resolved on 21Mar2021 and outcome of fatigue, chills and nausea was unknown at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Anal incontinence, Dizziness, Paraesthesia
Clinical narrative: left leg and foot have tingled; semi-dizzy after the injection; involuntary bowel movement after injection.; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in left arm on 17Mar2021 at 12:00, (at the age of 62-years) as single dose for COVID-19 immunisation. Medical history included C5, C6 quadriplegia and spinal cord injury in 1977. The patient did not have allergies to medications, food, or other products. 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 received other unspecified medications within two weeks. The patient experienced left leg and foot have tingled, felt semi-dizzy after the injection, and I had an involuntary bowel movement moments after injection on 17Mar2021.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 left leg and food had tingled, felt semi-dizzy and had an involuntary bowel movement was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: began to have vertigo symptoms/mild case of vertigo; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL9269), via an unspecified route of administration on 05Feb2021 (at the age of 57-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration on 26Feb2021 (at the age of 57-years-old); as a single dose for COVID-19 immunisation. Medical history included prone to vertigo, trigeminal neuralgia, and small fiber neuropathy. The patient was allergic to penicillin. Concomitant medication were not reported. The patient previously received codeine (MANUFACTURER UNKNOWN) and erythromycin (MANUFACTURER UNKNOWN); both on unknown dates for unspecified indications and experienced drug allergy. 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 four weeks prior to the COVID-19 vaccine. On 05Feb2021, 40 minutes after the first dose of the vaccine, the patient experienced vertigo symptoms, everything was spinning for about 1.5 days. On 01Mar2021 at 05:00, approximately 2.5 days after the second dose the patient experienced a mild case of vertigo and was able to move around slowly without help. The 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 event. The clinical outcome of the event vertigo was resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Palpitations, SARS-CoV-2 test
Clinical narrative: Heart palpitations; Cheeks flushed; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in the right arm on 19Mar2021 at 11:15 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulphur products, penicillin and COVID-19. The patient did not receive any other medication within 2 weeks of vaccination. Prior to 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 vaccination. On 19Mar2021 at 12:30, the patient experienced heart palpitations within 30 minutes of taking the shot and also flushed cheeks. 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. No therapeutic measures were taken as a result of the events. The clinical outcome of the heart palpitations and flushed cheeks was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Left arm and leg falling asleep. Numbness in left leg; Tingling sensation in left leg into foot; This is a spontaneous report from a contactable nurse, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ep7534), via an unspecified route of administration on left arm on 23Mar2021 at 09:45 (at the age of 52-year-old), as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient was allergic to lisinopril, ULTRAM, and ROBAXIN. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), LEXAPRO, NORVASC for unknown indications. 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 did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 23Mar2021 at 12:00, about 14 to 15 hours after injection, patient noticed that left arm and leg falling asleep. Patient still had numbness and tingling sensation in left leg into foot. The patient did not receive any treatment for the event. 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 numbness and tingling sensation in left leg was not recovered. No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at injection site; This is a spontaneous report received from a contactable consumer, the patient. A 70-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route administration in left arm on 21Mar2021 at 07:15, (at the age of 70-years-old) as a single dose, for COVID-19 immunisation. Medical history includes asthma, prolactinoma, hypertension. The patient was allergic to honey. Concomitant drug includes montelukast (SINGULAIR), clopidogrel (PLAVIX), celecoxib (CELEBREX), atorvastatin (LIPITOR), ZESTORETIC and P (unspecified medication), all drugs started on an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within two weeks prior to the vaccination. 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 21Mar2021 at 16:00, the patient experienced severe pain at injection site which began 8 hours after shot and continued about 24 hours. 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 any treatment for event. The clinical outcome of the event pain at injection site was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information was expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Flatulence, Lethargy, Myalgia, Nausea
Clinical narrative: gas; gas that resulted in throwing up bile (was on a empty stomach); all day fatigue; muscle aches; slight lethargy; sight injection pain; nausea; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6204), via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 17:30 (at the age of 34-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure, lupus, narcolepsy and sinus/allergies. 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. Concomitant medications included antianxiety medication, antidepressant medication, sinus allergy medication, vit (vitamins) and medication for HBP, all from unknown dates. On an unknown date in Mar2021 at 20:30, the patient experienced mild symptoms that include sight injection pain within four hours that was not as painful as the next day. The next day after about one hour after being awake she had nausea and gas that resulted in throwing up bile (was on an empty stomach), remained nauseous for about two more hours, all day fatigue, muscle aches, and slight lethargy. Therapeutic measures were taken for the events gas that resulted in throwing up bile included Gas-X pill. 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 sight injection pain, nausea, gas that resulted in throwing up bile, fatigue, muscle aches and slight lethargy was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.