chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Uncomfortable Tinnitus in both ears; This is spontaneous report from contactable consumer, the patient. A 55-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 left arm on 09Mar2021, at 14:30 PM, (age at vaccination: 55-year-old) as a single dose for COVID-19 immunisation. Medical history included heart murmur, mitral valve prolapse and hashimotos thyroiditis. The patient report that she is allergic to penicillin. 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 received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201), via an unspecified route of administration in left arm on 16Feb2021, at 13:00 PM, (age at vaccination: 55-year-old), as a single dose for COVID-19 immunisation. Concomitant medication included NP Thyroid 45 mg (MANUFACTURER UNKNOWN), Vitamin D (MANUFACTURER UNKNOWN), Melatonin (MANUFACTURER UNKNOWN). On 18Mar2021 at 9:00 AM (started about 9 days after second dose), patient experienced uncomfortable tinnitus in both ears. It was reported that no treatment measures were taken for the events. The clinical outcome of tinnitus was not recovered at the time of this report.   No follow-up attempts possible. No further information expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Somnolence
Clinical narrative: feel bad; she was wearing a 300 lb suit and was exhausted; headache; slept and rested a lot the following day; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), in Feb2021 (at the age of 40-years-old) at 2nd dose, single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included known allergies to gluten and single kidney. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 on an unspecified date for COVID-19 immunisation.  The patient did not have significant side effects after her 2nd dose but felt bad the day after, in Feb2021. She said she felt like she was wearing a 300 lb suit and was exhausted and headache. She did not take her temperature but slept and rested a lot the following day, in Feb2021. Felt better 2 days after vaccination. She did not contact her doctor and did not need follow ups. No treatment was received for the events. The patient had recovered from the events in 2021.   No follow-up attempts are possible. Information about lot/batch cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Pain, Pyrexia
Clinical narrative: I'm currently experiencing headache, chills, fever, body aches and weakness.; I'm currently experiencing headache, chills, fever, body aches and weakness.; I'm currently experiencing headache, chills, fever, body aches and weakness.; I'm currently experiencing headache, chills, fever, body aches and weakness.; I'm currently experiencing headache, chills, fever, body aches and weakness.; This is a spontaneous report received from a contactable consumer. A 40-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via unknown route of administration on the left arm on 18Mar2021 08:15 (age at vaccination was 40-year-old) as single dose for COVID-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via unknown route of administration on the left arm on 26Feb2021 as single dose for COVID-19 immunisation. Medical history of the patient included myasthenia gravies. Patient was allergic to hydromorphone and promethazine. Concomitant medications included prednisone (MANUFACTURER UNKNOWN), CELLCEPT, gamunex (MANUFACTURER UNKNOWN), MESTINON and SOLIRIS. 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 vaccine. On 18Mar2021 at 17:30 after receiving the second dose of vaccine in her left arm, the patient experienced headache, chills, fever, body aches and weakness. The patient did not receive any treatment for the events. The clinical outcome of events headache, chills, fever, body aches and weakness were not resolved at the time of this report.    No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: soreness at injection site; This is a spontaneous report from two contactable consumers. An adult female patient of an unknown age received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. It was unknown if patient received any other vaccines within four weeks prior to the vaccination. Patient did not have COVID prior vaccination. The patient was tested for COVID post vaccination, date and results unknown. On an unspecified date patient experienced soreness at injection site. No treatment was received. Patient recovered from the event on unknown date. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male 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 18Mar2021 at 13:00 as a single dose for COVID-19 immunisation. The patient had no allergies to medications, food or other products. No medical history was reported. Concomitant medication included Emtricitabine ,Tenofovir Alafenamide (DESCOVY), Vitamin D, amphetamine salts (within two weeks of vaccination) for an unknown indication. 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 been tested for COVID-19. On 18Mar2021 at 17:00, patient had flushed face which was more severe on left side (same side as vaccine shot). The clinical outcome of flushed face was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: brain fog; lightheaded; This is a spontaneous report received from a contactable other healthcare professional. A 55-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via unspecified route of administration in left arm on 10Mar2021 at 17:30 for COVID-19 immunisation (at the age of 55-year-old). The patient past medical history included asthma, gastroparesis and hypothyroid. 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 vaccination. The patient had allergies to sulfa and Keflex .The patients concomitant medication included escitalopram (LEXAPRO) ,levothyroxine (LEVOTHYROXINE) rabeprazole (ZEGRID).On 11Mar2021 the patient experienced brain fog and light headed for 4 days after. The patient did not receive any treatment for the events. The clinical outcome of the events brain fog and light headed was resolved on an unknown date. No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Influenza, Myalgia, Pain
Clinical narrative: worst case of the flu; Shakes; aches; headache; muscle pain; Still had a mild temperature; This is a spontaneous report from a contactable consumer, the patient. The A 63-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6225) solution for injection, administered on the arm left on 15Mar2021 19:00 (at the age of 63 years) as a single dose for COVID-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) solution for injection, administered on the arm left on Feb2021 14:00 as a single dose for COVID-19 immunisation. Patients medical history included blood pressure, prostate and cholesterol medications. Concomitant medications were not reported. The patient does not had any allergies to medications, food, or other products. At other facility the most recent COVID-19 vaccine was administered to the patient. The patient does 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. The lab test includes body temperature and the result was max 100.2 degrees. On 15Mar2021 at 22:00, he experienced worst case of the flu. First 24 hours, he felt like the worst case of the flu he has had in decades. Shakes, aches, headache, muscle pain and hard to concentrate. Absolutely miserable. Still had a mild temperature. The patient does not receive any treatment for the adverse event. The clinical outcome of worst case of the flu was resolving. No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: worst case of the flu; Shakes; aches; headache; muscle pain; Still had a mild temperature; This is a spontaneous report from a contactable consumer, the patient. The A 63-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6225) solution for injection, administered on the arm left on 15Mar2021 19:00 (at the age of 63 years) as a single dose for COVID-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) solution for injection, administered on the arm left on Feb2021 14:00 as a single dose for COVID-19 immunisation. Patients medical history included blood pressure, prostate and cholesterol medications. Concomitant medications were not reported. The patient does not had any allergies to medications, food, or other products. At other facility the most recent COVID-19 vaccine was administered to the patient. The patient does 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. The lab test includes body temperature and the result was max 100.2 degrees. On 15Mar2021 at 22:00, he experienced worst case of the flu. First 24 hours, he felt like the worst case of the flu he has had in decades. Shakes, aches, headache, muscle pain and hard to concentrate. Absolutely miserable. Still had a mild temperature. The patient does not receive any treatment for the adverse event. The clinical outcome of worst case of the flu was resolving. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Fatigue, Headache, Lethargy, Somnolence
Clinical narrative: lethargy; sleeping all the day; hoarseness; Constant headache; fatigue; This is a spontaneous report received from a contactable consumer, the patient. A non-pregnant female patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on the left arm on 01Mar2021 at 01:30pm as single dose for COVID-19 immunisation. Medical history included degenerative arthritis/joint disease, chronic pain and allergies to penicillin, aspirin, NSAIDs.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient received unspecified medication within 2 weeks of vaccination stating that too many to fit here. Past drug history included penicillin and aspirin for unknown indication. On 01Mar2021 at 08:00pm, the patient experienced constant headache, fatigue, lethargy, sleeping all the day and hoarseness. No therapeutic measures were taken for the events. The clinical outcome of the events constant headache, fatigue, lethargy, sleeping all the day and hoarseness was not resolved.  No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Eye pruritus, Fatigue, Feeling abnormal, Heart rate increased
Clinical narrative: Still itching spots plus left eye is itchy, dry  and red; Still itching spots plus left eye is itchy, dry and red; Still itching spots plus left eye is itchy, dry and red; BP was high; high heart rate & MAP; high heart rate & MAP; tired; left side of throat felt swollen; feelings of being "out of sorts"; Small patch of itchy rash just under left arm, itchy stomach, left leg also itchy on varicose veins; Mild nausea; Arm soreness at vaccination site; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6208), via an unspecified route of administration, administered in left arm on 14Mar2021 13:15 (at the age of 78 years old) as 2nd dose, 0.3 mL single for covid-19 immunization. Medical history included thyroid nodules, mild macular degeneration, postmenopausal syndrome, high blood pressure (HBP), total hysterectomy w/oophorectomy, gallbladder removal, appendectomy, allergy to penicillin, allergy to contrast dye, allergy to adhesives, and hard of hearing (HOH). Concomitant medications included valsartan (DIOVAN); famotidine (FAMO); pravastatin; estrogens conjugated (PREMARIN); levothyroxine sodium (SYNTHROID); and vitamin D3, all taken for an unspecified indication, start and stop date were not reported. The patient previously took nitrofurantoin (MACRODANTIN), clarithromycin (CLARITIN) and experienced drug drug allergy from both; also previously received the first dose of BNT162B2 (Lot number: EN6201), on 14Feb2021, 13:00, administered in left arm, for COVID-19 immunization. On 14Mar2021 late same day, the patient experienced mild nausea which lasted less than an hour, arm soreness vaccination site. On evening of 15Mar2021, a small patch of itchy rash just under left arm, itchy stomach, left leg also itchy on varicose veins. Upon waking on 16Mar2021 the patient was still itching spots plus left eye was itchy, dry and red; with a bit of nausea, BP was high, no fever, high heart rate and mean arterial pressure (MAP), was tired, left side of throat felt swollen, feelings of being "out of sorts", and her arm no longer hurts at all. The patient took Benadryl and Aleve and all seem better at the moment. She stated she would describe her symptoms as mild although somewhat scary especially the increase in blood pressure and MAP. Her oxygen was normal at 95-97. The patient was recovering from the events.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Mean arterial pressure increased, Nausea, Ocular hyperaemia, Oxygen saturation
Clinical narrative: Still itching spots plus left eye is itchy, dry  and red; Still itching spots plus left eye is itchy, dry and red; Still itching spots plus left eye is itchy, dry and red; BP was high; high heart rate & MAP; high heart rate & MAP; tired; left side of throat felt swollen; feelings of being "out of sorts"; Small patch of itchy rash just under left arm, itchy stomach, left leg also itchy on varicose veins; Mild nausea; Arm soreness at vaccination site; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6208), via an unspecified route of administration, administered in left arm on 14Mar2021 13:15 (at the age of 78 years old) as 2nd dose, 0.3 mL single for covid-19 immunization. Medical history included thyroid nodules, mild macular degeneration, postmenopausal syndrome, high blood pressure (HBP), total hysterectomy w/oophorectomy, gallbladder removal, appendectomy, allergy to penicillin, allergy to contrast dye, allergy to adhesives, and hard of hearing (HOH). Concomitant medications included valsartan (DIOVAN); famotidine (FAMO); pravastatin; estrogens conjugated (PREMARIN); levothyroxine sodium (SYNTHROID); and vitamin D3, all taken for an unspecified indication, start and stop date were not reported. The patient previously took nitrofurantoin (MACRODANTIN), clarithromycin (CLARITIN) and experienced drug drug allergy from both; also previously received the first dose of BNT162B2 (Lot number: EN6201), on 14Feb2021, 13:00, administered in left arm, for COVID-19 immunization. On 14Mar2021 late same day, the patient experienced mild nausea which lasted less than an hour, arm soreness vaccination site. On evening of 15Mar2021, a small patch of itchy rash just under left arm, itchy stomach, left leg also itchy on varicose veins. Upon waking on 16Mar2021 the patient was still itching spots plus left eye was itchy, dry and red; with a bit of nausea, BP was high, no fever, high heart rate and mean arterial pressure (MAP), was tired, left side of throat felt swollen, feelings of being "out of sorts", and her arm no longer hurts at all. The patient took Benadryl and Aleve and all seem better at the moment. She stated she would describe her symptoms as mild although somewhat scary especially the increase in blood pressure and MAP. Her oxygen was normal at 95-97. The patient was recovering from the events.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Rash pruritic, Vaccination site pain
Clinical narrative: Still itching spots plus left eye is itchy, dry  and red; Still itching spots plus left eye is itchy, dry and red; Still itching spots plus left eye is itchy, dry and red; BP was high; high heart rate & MAP; high heart rate & MAP; tired; left side of throat felt swollen; feelings of being "out of sorts"; Small patch of itchy rash just under left arm, itchy stomach, left leg also itchy on varicose veins; Mild nausea; Arm soreness at vaccination site; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6208), via an unspecified route of administration, administered in left arm on 14Mar2021 13:15 (at the age of 78 years old) as 2nd dose, 0.3 mL single for covid-19 immunization. Medical history included thyroid nodules, mild macular degeneration, postmenopausal syndrome, high blood pressure (HBP), total hysterectomy w/oophorectomy, gallbladder removal, appendectomy, allergy to penicillin, allergy to contrast dye, allergy to adhesives, and hard of hearing (HOH). Concomitant medications included valsartan (DIOVAN); famotidine (FAMO); pravastatin; estrogens conjugated (PREMARIN); levothyroxine sodium (SYNTHROID); and vitamin D3, all taken for an unspecified indication, start and stop date were not reported. The patient previously took nitrofurantoin (MACRODANTIN), clarithromycin (CLARITIN) and experienced drug drug allergy from both; also previously received the first dose of BNT162B2 (Lot number: EN6201), on 14Feb2021, 13:00, administered in left arm, for COVID-19 immunization. On 14Mar2021 late same day, the patient experienced mild nausea which lasted less than an hour, arm soreness vaccination site. On evening of 15Mar2021, a small patch of itchy rash just under left arm, itchy stomach, left leg also itchy on varicose veins. Upon waking on 16Mar2021 the patient was still itching spots plus left eye was itchy, dry and red; with a bit of nausea, BP was high, no fever, high heart rate and mean arterial pressure (MAP), was tired, left side of throat felt swollen, feelings of being "out of sorts", and her arm no longer hurts at all. The patient took Benadryl and Aleve and all seem better at the moment. She stated she would describe her symptoms as mild although somewhat scary especially the increase in blood pressure and MAP. Her oxygen was normal at 95-97. The patient was recovering from the events.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Lymphadenopathy
Clinical narrative: Pain in left breast near armpit; Suspect swollen lymph nodes; This is a spontaneous report received from a contactable consumer. An 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206, Dose number: 2) via unknown route of administration on the left arm on 16Mar2021 at 11:15 hours as a single first dose for COVID-19 immunisation. The patient's past drug history included  first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW6198) via an unspecified route of administration on 24Feb2021 at 15:15 hours as single first dose for COVID-19 immunisation. Medical history included arthritis. The patient did not receive any other vaccines within 4 weeks prior to the 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 ZYRTEC, Rousuvastatin (MANUFACTURER UNKNOWN), Vitamin D (MANUFACTURER UNKNOWN), XHANCE for an unknown indication since an unspecified date and was unknown if ongoing. On 17Mar2021 at 7:00 hours, the patient experienced pain in left breast near armpit. The pain was still present 2 days after the vaccine. The patient suspected it was swollen lymph nodes but the patient was concerned about another cause and was concerned it would persist. The clinical outcome of the events pain in left breast near armpit and suspect swollen lymph nodes was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Headache, Hypertension, Hypoaesthesia, Palpitations
Clinical narrative: head numb; face numb; neck numb; heart racing; Pain behind eyes; Pain on the top of head; Blood pressure high; This is a spontaneous report received from contactable consumer, a patient. A 72-year-old female patient received a first single dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE ; Lot number: EP7534) ( vaccination at the age of 72-year-old) via an unspecified route of administration to left arm on 03Mar2021 at 10:30am for COVID-19 immunisation. The patients medical history included glaucoma. The patient had sensitivity to medications and also had allergies to glue, smoke, perfume, molds and pollen. The patient did not received any other vaccine prior to the covid-19 vaccine. The patient took Lumigan and adopt eye drops as a concomitant medications within two weeks of vaccination. The patient was not pregnant. The patient was not diagnosed with covid-19, prior to vaccination. Since the vaccination, patient had not tested positive for covid-19. On 16Mar2021, the patient had experienced head, face and neck was lightly numbed this lasted until patient went to the bed, patient also had heart racing which was lasted for 45 minutes. After an hour, patient could not catch breath. Breathing was normal but the oxygen was not getting into her body. This was lasted about 1-2 hours. And her BP was above than her normal. The patient also had pain behind the eyes, pain on the top of head and sore arm. The clinical outcome of these events were recovering at this time of report.   No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Vaccination site haemorrhage
Clinical narrative: lot of blood came running down from right arm; black a blue bruise on the site; This is a spontaneous report from a contactable Consumer, the patient. A 72-year-old non-pregnant female patient received first dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administration in right arm on 09Mar2021 at 15:00, as a single dose for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medications included ramipril (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN) and metoprolol (MANUFACTURER UNKNOWN) all for an unknown indication from unknown dates. The patient was not allergic 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. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. On 09Mar2021, the patient experienced vaccination site bleeding and bruise. The clinical outcome of vaccination site bleeding and bruise was not recovered. The patient didn't receive any treatment for the events.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Day 2 fever; chills; Body aches; Headache; Super tired; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration on 16Mar2021 at 0.3ml single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Relevant medical history and concomitant medications were unknown. it was unknown if the patient was tested for COVID-19 prior or since the vaccination. On 17Mar2021 the patient experienced fever, chills, body aches, headaches and super tired. It was unknown whether a treatment was received. The events resolved on an unspecified date in Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: Pain in arms and legs; Fever at 99.6 Fahrenheit; Chills; Headache; Tiredness; This is a spontaneous report from contactable consumer (patient).   A 62-year-old female patient received BNT162b2 (BNT162B2), via an unspecified route of administration, administered in the left arm, on 16Mar2021 at 09:15 A.M. (Batch/Lot Number: EN6203), at the age of 62 years old, as 2nd single dose, for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included asthma. There were no known allergies to report. The patient had not experienced COVID-19 prior to vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC R), and montelukast sodium (SINGULAIR) on the night before vaccination (on 15Mar2021). The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The 1st single dose of BNT162b2 (lot number EL3247) was administered always in the left arm, on 23Feb2021 at 09:15 A.M. On 17Mar2021, at 12:00 PM, the patient started having pain in arms and legs, fever  at 99.6 fahrenheit, chills, headache and tiredness, all considered normal side effects. The patient recovered from all the events on an unspecified date in Mar2021. No treatment was needed. The patient had not tested positive for COVID- 19 post vaccination.  Information on Lot/Batch number was available. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Pain in arms and legs; Fever at 99.6 Fahrenheit; Chills; Headache; Tiredness; This is a spontaneous report from contactable consumer (patient).   A 62-year-old female patient received BNT162b2 (BNT162B2), via an unspecified route of administration, administered in the left arm, on 16Mar2021 at 09:15 A.M. (Batch/Lot Number: EN6203), at the age of 62 years old, as 2nd single dose, for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included asthma. There were no known allergies to report. The patient had not experienced COVID-19 prior to vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC R), and montelukast sodium (SINGULAIR) on the night before vaccination (on 15Mar2021). The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The 1st single dose of BNT162b2 (lot number EL3247) was administered always in the left arm, on 23Feb2021 at 09:15 A.M. On 17Mar2021, at 12:00 PM, the patient started having pain in arms and legs, fever  at 99.6 fahrenheit, chills, headache and tiredness, all considered normal side effects. The patient recovered from all the events on an unspecified date in Mar2021. No treatment was needed. The patient had not tested positive for COVID- 19 post vaccination.  Information on Lot/Batch number was available. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Malaise
Clinical narrative: I was very very sick yesterday and I don't feel great today; I was very very sick yesterday and I don't feel great today; This is a spontaneous report from a contactable consumer (paitent) A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 15Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient stated " I was very sick yesterday (on 16Mar2021) and I don't feel great today" (on 17Mar2021) .The outcome of the events was unknown
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Suspected COVID-19
Clinical narrative: chills; no appetite; feeling very weak; I had covid last year, I am feeling the same way; This is a spontaneous report from a non-contactable consumer or other non hcp (Patient). A female patient (Age: 41, Unit: Unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Lot number: not reported), dose 1 via an unspecified route of administration on 20Mar2021 as 1st dose single for COVID-19 immunization. Medical history included covid-19 from 2020 to an unknown date. The patient's concomitant medications were not reported. It was reported that, on 20Mar2021, she had side effects, after receiving the first dose of the Pfizer vaccine. Caller stated, "Last night she got chills and had covid last year, felt the same way, no appetite and feeling very weak". She was afraid that she got the covid again, and also scared, caller asked if she should be tested, or go to urgent care. Caller No longer had chills now, just loss of appetite and weakness. Caller had no shortness of breath. The outcome of the events chills was resolved on an unknown date in 2021 and for events just loss of appetite and weakness it was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: cold sore; This is a spontaneous report from a contactable Nurse and reported for herself. A female patient of an age 55 (Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on 12Mar2021 as 1st single dose for COVID-19 immunization. Patient's medical and concomitant medication history were not reported. On 17Mar2021, five days later patient developed a cold sore which never had been before. "Patient asked, Is this a side effect of the vaccine? And patient can receive second dose of the vaccine?". The outcome of the event was unknown.   No follow up attempts are possible. Information about lot/batch number cannot be Obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; This is a spontaneous report received from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: UNKNOWN) via unspecified route of administration in the left arm on 17Mar2021 at 14:25 hrs, as a single dose for COVID-19 immunisation. Patient medical history included chronic hip and back pain. Patient did not receive any other vaccines within 4 weeks. Concomitant medications included simvastin(MANUFACTURER UNKNOWN), amlodipine(MANUFACTURER UNKNOWN), oxycodone(MANUFACTURER UNKNOWN), morphine sulfate(MANUFACTURER UNKNOWN) . Patient was not have COVID-19 prior to vaccination and  patient had not tested positive for COVID-19 since the vaccination. Patient experienced vomiting on 18Mar2021 at 07:30 hrs. Patient did not recieve treatment for the reported events. The clinical outcome of the event vomiting was recovered .   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Rash
Clinical narrative: Rash developed in same area; Back of thighs felt like pins & needles; This is a spontaneous report received from a contactable consumer, the patient. A 64-years-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 left arm on 14Mar2021 at 13:15 (at the age of 64-years-old), as a single dose for COVID-19 immunisation. Medical history included anaphylaxis reaction to food in 2015. Concomitant medications taken within 2 weeks of vaccination included levothyroxine (MANUFACTURER UNKNOWN). 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 tested positive for COVID-19. The patient did not received any other vaccines within 4 weeks prior to the COVID-19 vaccination. On 15Mar2021 (Monday) at 21:00, the patient experienced back of thighs felt like pins & needles. On 16Mar2021 (Tuesday) rash developed in the same area. No therapeutic measures were taken for the events. The outcome of the back of thighs felt like pins & needles and rash developed in same area was not resolved. No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, SARS-CoV-2 test, Somnolence
Clinical narrative: Headache; Fatigue; Chills; Drowsiness; This is a spontaneous report received from a non-contactable consumer, the patient. A 24-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown, Solution for injection), via an unspecified route of administration on an unknown date (at the age of 24-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. The patient underwent lab test which included nasal swab test on an unknown date and the test result was unknown. On 17Mar2021, the patient had experienced headache, fatigue, chills and drowsiness. The patient was treated with paracetamol (TYLENOL) for adverse events headache, fatigue, chills and drowsiness. The clinical outcome of the events headache, fatigue, chills and drowsiness was recovered in Mar2021.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.   Amendment: This follow-up report is being submitted to amend previously reported information: Unknown removed from suspect vaccine Lot# field. Final sentence Information about lot/batch number cannot be obtained. No further information is expected. updated as No follow-up attempts are possible, information about lot/batch number cannot be obtained. per SER055.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Chills, Fatigue, Neck pain
Clinical narrative: Chills; Fever of 100 degrees; Soreness in shoulders; Soreness in neck; Mild stomach ache; Lingering tiredness; This is a spontaneous report from a contactable Consumer, the patient. A 76 years old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID 19 mRNA VACCINE; Lot no: EN6205) via an unspecified route of administration through the right arm for COVID 19 immunisation on 06Mar2021 at 15:30 PM. The patient past drug history includes BNT162B2 (PFIZER-BIONTECH COVID 19 mRNA VACCINE; Lot no: EN6201) received through the right arm. The patient medical history includes Afib (Atrial fibrillation), diabetes and Age (Acute gastroenteritis). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID 19 prior to vaccination. The patient has not been tested for COVID 19 since the vaccination. On 07Mar2021 at 15:30 PM, The patient experienced chills, fever of 100 degrees, lingering tiredness, mild stomach ache, soreness in the neck, soreness in the shoulders. No treatment measures received for the adverse events. The clinical outcome of all events was recovered. No follow up attempts are needed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills; Fever of 100 degrees; Soreness in shoulders; Soreness in neck; Mild stomach ache; Lingering tiredness; This is a spontaneous report from a contactable Consumer, the patient. A 76 years old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID 19 mRNA VACCINE; Lot no: EN6205) via an unspecified route of administration through the right arm for COVID 19 immunisation on 06Mar2021 at 15:30 PM. The patient past drug history includes BNT162B2 (PFIZER-BIONTECH COVID 19 mRNA VACCINE; Lot no: EN6201) received through the right arm. The patient medical history includes Afib (Atrial fibrillation), diabetes and Age (Acute gastroenteritis). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID 19 prior to vaccination. The patient has not been tested for COVID 19 since the vaccination. On 07Mar2021 at 15:30 PM, The patient experienced chills, fever of 100 degrees, lingering tiredness, mild stomach ache, soreness in the neck, soreness in the shoulders. No treatment measures received for the adverse events. The clinical outcome of all events was recovered. No follow up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache
Clinical narrative: Very tired; Fatigue; Headache; Joint pain; This is a spontaneous report from a non-contactable consumer, the patient. A 35-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 right arm on 13Mar2021 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any medications within 2 weeks of vaccination: The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 17Mar2021 (5 days after the vaccine), the patient felt very tired, fatigue, headache and joint pain. Therapeutic measures were not taken for the events. The clinical outcome of the very tired, fatigue, headache and joint pain was not resolved.   No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Injection site pain; Severe chills; Joint pain; Muscle pain; Low grade fever; This is a spontaneous report received from a non-contactable consumer, the patient. A 62-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198), via an unspecified route of administration in the left arm on 15Mar2021 at 10:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. 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 previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200), via an unspecified route of administration in the left arm on 25Feb2021, as a single dose for COVID-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200), via an unspecified route of administration in the left arm on 25Feb2021, as a single dose for COVID-19 immunisation. On 15Mar2021, the patient experienced injection site pain, low grade fever, severe chills, joint pain and muscle pain. The patient reported injection site pain for 3 days, low grade fever for 2 days, severe chills for 3 hours occurring approximately 14 hours after injection, joint and muscle pain for 2 days. The patient did not receive any treatment for the reported events. The clinical outcome of the events injection site pain, severe chills, fever, joint pain and muscle pain was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever; muscle aches; Nausea; Diarrhea; headache; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch Number: EN6198), via unspecified route of administration in the left arm on 26Feb2021 at 12:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history includes Rheumatoid Arthritis(was on immunosuppressant medications past 3 years) and allergies to Penicillin and Sulfa drugs. Prior to vaccination, the patient was diagnosed with COVID-19 and has not been tested for COVID-19 since the vaccination. Past drug history include allergies to BACTRIM, ENBREL and HUMIRA. The patients concomitant medications include XELJANZ XR from unknown dates for unknown indication and concomitant therapy include Immunosuppressant medications since past 3 years for Rheumatoid Arthritis. On 26Feb2021 at 16:00, on the same day of vaccination, the patient experienced Fever, Muscle aches, Nausea, Diarrhea and Headache close to a full week following vaccine. The Clinical outcome of the Fever, Muscle aches, Nausea, Diarrhea and Headache were recovered with lasting effects.   No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Alanine aminotransferase, Alanine aminotransferase increased, Aspartate aminotransferase, Aspartate aminotransferase increased, Weight
Clinical narrative: AST and ALT for liver was tagged as high; AST and ALT for liver was tagged as high; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in deltoid right on 12Mar2021 10:00 (at the age of 76 years old) (Batch/Lot Number: EL9267) as 1st dose, single dose for COVID-19 immunization and palbociclib (IBRANCE, 75 mg tablet), oral from an unspecified date (reported as almost 4 years ago) (Batch/Lot number was not reported) and ongoing at 75 mg, cyclic (once daily for 21 days) for metastatic breast cancer that has gone to the bone and lung. Medical history included metastatic breast cancer that has gone to the bone and lung. There were no concomitant medications. On 12Mar2021, AST and ALT for liver was tagged as high. AST was 13 in Feb2021, 47 in 15Mar2021. ALT was 11 in Feb2021 and 48 in 15Mar2021. The action taken in response to the events for palbociclib was dose not changed. Patient is taking Ibrance and Ibrance requires her to have a blood test done before starting the next round of Ibrance so she went to have it done. Patient will have blood redrawn in a week, they said to call and advise in case there are. No additional vaccines administered on same date of the Pfizer suspect. Adverse Event (AE) did not require any visit to emergency room or physician office. Patient had a video appointment scheduled already. No prior vaccinations (within 4 weeks). Outcome of the events was unknown.  No follow-up attempts are possible; no further information is expected.
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Cough, Fatigue, Illness, Lethargy
Clinical narrative: Sick; Lethargic; I ran a fever of 101; I have not felt well; I feel like i have covid19 all over again.; Cough is horrific, it kept me up all night long; tired; This is a spontaneous report from a contactable consumer (patient).  A 51-year-old patient of unknown gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: En6204), via an unspecified route of administration in left arm on 12Mar2021 at 12 am (at the age of 51-year-old) as a single dose for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient's 2 weeks prior vaccination included Effexor. The patient's medical history includes that the patient tested for COVID-19 prior vaccination. The concomitant medications were not reported.  The consumer stated, "So I have the vaccine done on 12March, and  I feel like i have covid19 all over again. Very tired with a horrible cough (on 12March, 01:00 AM). The next day (on 13Mar2021) I was very sick I was like just lethargic and tired. Then I ran a fever of 101, I have not felt well since I had it, and yesterday I developed like horrible cough and I just feel like I have Covid all over again. I just don't know what else I am supposed to do because this cough is horrific, it kept me up all night long so I am just looking for some direction."  The patient had not tested covid post vaccination. The patient visited physician office due to the events  and also not receive treatment for events "I feel like i have covid19 all over again. Very tired with a horrible cough, and I have not felt well". The outcome of the events was not resolved for event "I feel like i have covid19 all over again, I have not felt well, Cough is horrific, it kept me up all night long, and tired". The outcome of rest event was unknown.  No follow-up attempts are possible. No further information is expected.