chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis, Pyrexia
Clinical narrative: pericarditis; headache; fever; having trouble breathing; chest pain; tingling down his arms; This is a spontaneous report from a contactable consumer. An 18-year-old male patient received second dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 04May2021 at 16:00 (Batch/Lot Number: ER8736) as 2ND DOSE, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no Covid prior to vaccination and was not tested post vaccination. The patient experienced Pericarditis, headache, fever, having trouble breathing, chest pain and tingling down his arms all on 06May2021. It was reported that the patient had all the normal reactions to a significant extent, the headache, the fever, etc. But two nights after the vaccination he was having trouble breathing, he had chest pain, and tingling down his arms. The next day, patient was taken to urgent care and was diagnosed with pericarditis. The patient underwent lab tests and procedures which included EKG (electrocardiogram): pericarditis on 06May2021 (EKG showing Pericarditis and 10 days  of medication). Therapeutic measures were taken as a result of all the events. The outcome of all the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Dystonia
Clinical narrative: dystonic reaction; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced dystonic reaction on an unspecified date with outcome of unknown.   Information on the lot/batch number has been requested.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Depression
Clinical narrative: Extreme anxiety and depression; Extreme anxiety and depression; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 16Feb2021 17:00 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunization. The patient medical history included ear infection. Patient had no known allergies. Concomitant medication included hydrocortisone, neomycin sulfate, polymyxin b sulfate (ANTIBIOTIC EAR) taken for ear infection. The patient was not diagnosed with COVID-19 prior to vaccination. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. The patient experienced extreme anxiety and depression on 16Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was hospitalized for the events for 1 day. Therapeutic measures were taken as the result of the events which included treatment with anti-anxiety depression meds. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: miscarriage; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 15Apr2021 16:00 (Batch/Lot Number: EW1058) as 2nd dose, single or covid-19 immunisation. The first dose was received on 15Mar2021 17:00 (lot number: ENLe208). The patient's medical history was not reported. Concomitant medications were none. No other vaccine was administered in 4 weeks. Six days after receiving the 2nd shot of the Covid vaccine from Pfizer, patient conceived on 21Apr2021. After 4 weeks and 4 days of pregnancy, patient had a miscarriage on 08May2021 14:30. While a miscarriage can happen at the early stages of pregnancy, this stage was exactly when the placenta was forming and patient was wondering that the rumors about the COVID vaccine rejecting the protein of the placenta were correct. No treatment was given. Outcome of the event was not recovered. Patient did not have covid prior to vaccination and had not been tested post-vaccination.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Dyspnoea, Fatigue, Hyperthyroidism
Clinical narrative: Overactive thyroid; Shortness of breath; Chest tightness; Fever; Fatigue; Anxiety; Panic; This is a spontaneous report from a contactable consumer (patient). A 20-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0151), via an unspecified route of administration in left arm, on 15Apr2021, as second dose, single, for COVID-19 immunization. The patient's medical history included asthma and allergies to tree nuts and penicillin. The patient's concomitant medications included fluticasone propionate (FLOVENT), salbutamol sulfate (ALBUTEROL), and an unspecified multivitamin. The patient previously took montelukast sodium (SINGULAIR) and bacitracin/ neomycin sulfate/ polymyxin B sulfate (TRIPLE ANTIBIOTIC Ointment) and experienced allergies to both; and the first dose of BNT162B2 (Lot Number: ER8727) on 19Mar2021 at the age of 20 years for COVID-19 immunization (right arm). The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. On 15Apr2021, the patient experienced initial anxiety or panic after shot was given. On 16Apr2021 (next day), the patient had fever and fatigue. The second day after (17Apr2021), the patient had shortness of breath and chest tightness. After several trips to the emergency room, the primary care physician (PCP) did laboratory tests that diagnosed an overactive thyroid (17Apr2021). Symptoms still remain and are being treated by an endocrinologist. Treatments included methimazole, lorazepam (ATIVAN), and diltiazem. The adverse events resulted in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient has not been tested for COVID-19 post vaccination. The patient had not recovered from the events.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Panic reaction, Pyrexia
Clinical narrative: Overactive thyroid; Shortness of breath; Chest tightness; Fever; Fatigue; Anxiety; Panic; This is a spontaneous report from a contactable consumer (patient). A 20-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0151), via an unspecified route of administration in left arm, on 15Apr2021, as second dose, single, for COVID-19 immunization. The patient's medical history included asthma and allergies to tree nuts and penicillin. The patient's concomitant medications included fluticasone propionate (FLOVENT), salbutamol sulfate (ALBUTEROL), and an unspecified multivitamin. The patient previously took montelukast sodium (SINGULAIR) and bacitracin/ neomycin sulfate/ polymyxin B sulfate (TRIPLE ANTIBIOTIC Ointment) and experienced allergies to both; and the first dose of BNT162B2 (Lot Number: ER8727) on 19Mar2021 at the age of 20 years for COVID-19 immunization (right arm). The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. On 15Apr2021, the patient experienced initial anxiety or panic after shot was given. On 16Apr2021 (next day), the patient had fever and fatigue. The second day after (17Apr2021), the patient had shortness of breath and chest tightness. After several trips to the emergency room, the primary care physician (PCP) did laboratory tests that diagnosed an overactive thyroid (17Apr2021). Symptoms still remain and are being treated by an endocrinologist. Treatments included methimazole, lorazepam (ATIVAN), and diltiazem. The adverse events resulted in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient has not been tested for COVID-19 post vaccination. The patient had not recovered from the events.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Postmenopausal haemorrhage
Clinical narrative: post menopausal menstrual heavy period a week after the first dosage; Also reporting a headache and sore arm with the first one; Also reporting a headache and sore arm with the first one; This is a spontaneous report from a non-contactable consumer. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right, on 13Mar2021 03:30 (Batch/Lot Number: EN6206) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications included vitamins nos taken for an unspecified indication, start and stop date were not reported.  On an unspecified date, the patient reported a post menopausal menstrual heavy period a week after the first dosage and second period two weeks after the second dose. It had been 11 months since her last period.  Also reporting a headache and sore arm with  the first dose. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Severe migraines for two weeks which persist for night and day.did not go away after many forms of opioids; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 08Apr2021 08:00 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunization. The patient has no medical history and concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications within 2 weeks of vaccination. The patient previously took metronidazole (FLAGYL [METRONIDAZOLE]) and experienced allergies. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Mar2021 08:00 in the left arm for covid-19 immunization. On 28Apr2021 17:00, the patient experienced severe migraines for two weeks which persist for night and day. This did not go away after many forms of opioids were taken, only subsided after steroids. The patient never had a history of headaches or migraines. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was treated with opioids, muscle relaxers, and steroids. The outcome of the event was recovering.  Information on the batch/lot number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased
Clinical narrative: Increase in blood pressure/ spiked; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and fetus/baby. This is the maternal report. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 03May2021 as 2nd dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took Penicillin and experienced Allergy. The patient previously received TDAP vaccine on 03Mar2021 and first dose of BNT162B2 on 02Apr2021 for COVID-19 immunisation and experienced Increase in blood pressure/preeclampsia (11:00 AM, lot number: Ep7833). The patient experienced increase in blood pressure in May2021. Blood pressure returned to normal levels 3 weeks post-partum and spiked again after 2nd shot on 03May2021. Treatment was received for the event which included BP medication. The patient was hospitalized for 7 days for the event. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the event was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021516156 same report, mother/fetus case.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Premature baby
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and fetus/baby. This is a fetus/baby report. A 39-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 02Apr2021 11:00 (Batch/Lot Number: Ep7833) for COVID-19 immunization. Last Menstrual Date: 15Aug2020. Deliver due date was on 22May2021. Medical history included allergies Penicillin. Concomitant medication(s) included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP). The mother was hospitalized for delivered baby at 33 weeks 5 days on 08Apr2021 (premature baby) for 7 days. The mother reported she became pregnant while taking BNT162B2. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021514102 same report, mother/fetus case.; US-PFIZER INC-2021516155 same report, mother/fetus case.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: Tested positive for Covid-19 had a runny nose; Drug ineffective; This is a spontaneous report from a contactable physician received via a sales representative. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first and second dose both via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included ongoing diabetes mellitus. Concomitant medications were not reported. Physician's mother-in-law was visiting  and was able to get her the Pfizer Covid vaccine while here. She traveled back home to her country. She was exposed to her daughter who then tested positive for Covid. Mother, had a runny nose and felt fine. She tested positive for Covid-19 as well. The reporter was not sure how many days or weeks post 2nd dose she was until she was exposed, but she had a super mild breakthrough case. The mother-in-law is high risk for Covid. She had only Covid symptom and felt fine. The outcome of the event was unknown.   The event occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, the reported events drug ineffective and COVID 19 are possibly related to PFIZER-BIONTECH COVID-19 VACCINE.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Peripheral swelling, Renal pain, Ultrasound scan
Clinical narrative: Left arm and hand swelling; shingles; kidney pain; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 09Mar2021 11:00 (batch/lot number: EN6206) as 2nd dose, single for covid-19 immunisation. Medical history included breast cancer and Lyme's disease. The patient was not pregnant. Concomitant medication included trastuzumab (HERCEPTIN). The patient received first dose of bnt162b2 on 16Feb2021, 01:00 for covid-19 immunisation. On 09Mar2021 17:00, the patient experienced left arm and hand swelling, shingles and kidney pain. The events were considered serious due to disability. The patient received treatment for the events. The patient underwent lab tests and procedures which included ultrasound with unknown results on an unspecified date. 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 and since the vaccination, the patient had not been tested for COVID-19. Outcome of events was not recovered.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pulmonary embolism, SARS-CoV-2 test, Thrombosis
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 31Mar2021 09:00 (at the age of 35-year-old) (Batch/Lot Number: ER8730) as 2ND DOSE, SINGLE for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Medical history included hypertension. Concomitant medication included ascorbic acid, beta carotene, biotin, boron, calcium, calcium pantothenate, chloride, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, iron, lycopene, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon dioxide, thiamine, tin, tocopheryl acetate, vanadium, vitamin k nos, zinc (CENTRUM MEN). The patient previously took bactrim and experienced allergies. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN 6206), administered in left arm on 10Mar2021 at 08:45 AM (at the age of 35-year-old) as 1ST DOSE, SINGLE for COVID-19 immunization. On 27Apr2021 at 08:00 AM, the patient experienced bilateral embolisms (blood clots in lungs) and also had blood clot in left leg. Symptoms before diagnosis included dry cough, coughing up blood, chills, fever, body aches, and body pains. The events caused hospitalization. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures which included COVID-19 test via nasal swab post vaccination which was negative on 29Apr2021 and on 07May2021. Therapeutic measures were taken as a result of bilateral pulmonary embolisms and had blood clot in left leg, chills, and body aches/body pains which included Lovenox injection (blood thinner) and Tylenol for pain. The patient was recovering from all events.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Migraine, Suspected COVID-19
Clinical narrative: suspected COVID-19 with symptoms; suspected COVID-19 with symptoms; migraine; This is a spontaneous report from a contactable consumer (patient's mother). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 20Apr2021 as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was scheduled to have surgery on an unspecified date (Thursday) and on 23May2021 for an unspecified reason and the reporter would like to know how long can the second dose scheduled for second dose 21May2021 be delayed. It was reported that on an unspecified date after the first dose, patient had mild symptoms similar to COVID infection symptoms, except with a migraine. The reporter did not feel it was out of the ordinary. The outcome of the events was unknown.   Information on lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Malaise, Nausea, Pyrexia
Clinical narrative: fainted; feeling horrible; dizzy; ringing in ears; nausea; chills; fever; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0175), via an unspecified route of administration, administered in Arm Left on 04May2021 09:45 (58-years-old) as 2nd dose, single for COVID-19 immunization. The patient medical history was not reported. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No known allergies. Facility where the most recent COVID-19 vaccine was administered was Clinic (Public Health Clinic/Veterans Administration facility). Concomitant medication included levothyroxine sodium (SYNTHYROID) and multivitamin. The patient previously took first dose of bnt162b2  (lot number: EW0164) , on 13Apr2021 01:30 PM at 58-years-old, on Left arm for COVID-19 immunization. The patient was fine until 17 hours after the second dose. She woke up around 3 am feeling horrible, got up to go to bathroom.  She was very dizzy, had ringing in ears, nausea, then fainted. She had chills and fever for the next ~ 12 hours. Events started on 05May2021 03:15. No treatment was given. The outcome of the events was recovered.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Tinnitus
Clinical narrative: fainted; feeling horrible; dizzy; ringing in ears; nausea; chills; fever; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0175), via an unspecified route of administration, administered in Arm Left on 04May2021 09:45 (58-years-old) as 2nd dose, single for COVID-19 immunization. The patient medical history was not reported. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No known allergies. Facility where the most recent COVID-19 vaccine was administered was Clinic (Public Health Clinic/Veterans Administration facility). Concomitant medication included levothyroxine sodium (SYNTHYROID) and multivitamin. The patient previously took first dose of bnt162b2  (lot number: EW0164) , on 13Apr2021 01:30 PM at 58-years-old, on Left arm for COVID-19 immunization. The patient was fine until 17 hours after the second dose. She woke up around 3 am feeling horrible, got up to go to bathroom.  She was very dizzy, had ringing in ears, nausea, then fainted. She had chills and fever for the next ~ 12 hours. Events started on 05May2021 03:15. No treatment was given. The outcome of the events was recovered.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Discomfort, Dizziness, Fall
Clinical narrative: She fell to the floor at home and went "unconscious"; She fell to the floor at home and went "unconscious"; feel uncomfortable; Dizzy; Headache; Felt severe pounding in the heart; Fast heart beat; Felt cold in hands and feet; She had fever later that day 101.4 F; She had chest pain when deep breathing after the fall; This is a spontaneous report from a non-contactable consumer (patient). An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07May2021 (Batch/Lot Number: Unknown) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient is not pregnant at time of Vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. It was unknown if the patient did receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 first dose on an unspecified date (lot: not reported) for covid-19 immunisation. It was reported that on Friday (07May2021), the patient received 2nd dose of Pfizer Covid vaccine and felt fine. But on next day (Saturday 08May2021) morning, she started to feel uncomfortable, dizzy, headache. She felt severe pounding in the heart and fast heart beat, felt cold in hands and feet. She fell to the floor at home and went "unconscious". Her husband took her up and gave her electrolyte drink and she slowly regained consciousness. She had fever later that day 101.4 F and took Tylenol.  She had chest pain when deep breathing after the fall. Today (09May2021) her fever from vaccination recovered but she still feels chest pain from the fall, planning to see her family doctor next week. The outcome of the event she had fever later that day 101.4 f was recovered; for the event She fell to the floor at home and went "unconscious" was recovering; for all other events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Heart rate increased, Loss of consciousness, Palpitations
Clinical narrative: She fell to the floor at home and went "unconscious"; She fell to the floor at home and went "unconscious"; feel uncomfortable; Dizzy; Headache; Felt severe pounding in the heart; Fast heart beat; Felt cold in hands and feet; She had fever later that day 101.4 F; She had chest pain when deep breathing after the fall; This is a spontaneous report from a non-contactable consumer (patient). An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07May2021 (Batch/Lot Number: Unknown) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient is not pregnant at time of Vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. It was unknown if the patient did receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 first dose on an unspecified date (lot: not reported) for covid-19 immunisation. It was reported that on Friday (07May2021), the patient received 2nd dose of Pfizer Covid vaccine and felt fine. But on next day (Saturday 08May2021) morning, she started to feel uncomfortable, dizzy, headache. She felt severe pounding in the heart and fast heart beat, felt cold in hands and feet. She fell to the floor at home and went "unconscious". Her husband took her up and gave her electrolyte drink and she slowly regained consciousness. She had fever later that day 101.4 F and took Tylenol.  She had chest pain when deep breathing after the fall. Today (09May2021) her fever from vaccination recovered but she still feels chest pain from the fall, planning to see her family doctor next week. The outcome of the event she had fever later that day 101.4 f was recovered; for the event She fell to the floor at home and went "unconscious" was recovering; for all other events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: She fell to the floor at home and went "unconscious"; She fell to the floor at home and went "unconscious"; feel uncomfortable; Dizzy; Headache; Felt severe pounding in the heart; Fast heart beat; Felt cold in hands and feet; She had fever later that day 101.4 F; She had chest pain when deep breathing after the fall; This is a spontaneous report from a non-contactable consumer (patient). An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07May2021 (Batch/Lot Number: Unknown) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient is not pregnant at time of Vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. It was unknown if the patient did receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 first dose on an unspecified date (lot: not reported) for covid-19 immunisation. It was reported that on Friday (07May2021), the patient received 2nd dose of Pfizer Covid vaccine and felt fine. But on next day (Saturday 08May2021) morning, she started to feel uncomfortable, dizzy, headache. She felt severe pounding in the heart and fast heart beat, felt cold in hands and feet. She fell to the floor at home and went "unconscious". Her husband took her up and gave her electrolyte drink and she slowly regained consciousness. She had fever later that day 101.4 F and took Tylenol.  She had chest pain when deep breathing after the fall. Today (09May2021) her fever from vaccination recovered but she still feels chest pain from the fall, planning to see her family doctor next week. The outcome of the event she had fever later that day 101.4 f was recovered; for the event She fell to the floor at home and went "unconscious" was recovering; for all other events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Hypoaesthesia, Hypoaesthesia oral, SARS-CoV-2 test
Clinical narrative: face, eyes, and one side lips started dropping; numbness on her left face, head, inside mouth, and left hand; numbness on her left face, head, inside mouth, and left hand; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunization.  Medical history included allergies to sulfa drugs. There were no concomitant medications.  The patient also received first dose of BNT162B2 on unspecified date for COVID-19 immunization.  After a week of the second dose on unspecified date, the patient had to go to the ER. There was numbness on her left face, head, inside mouth, and left hand. Her face, eyes, and one side lips started dropping. The patient received antiviral and steroid as treatment for the events.  The patient has no COVID prior to vaccination and was tested for COVID via nasal swab post vaccination with negative result on unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Hypersomnia, Illness, Paranasal sinus discomfort
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration, administered in arm left on 08Apr2021 14:30 (batch/lot number EW0153 and expiry date unknown) at 53 years of age as 1st dose, single for COVID-19 immunization in other facility. Medical history included known allergies many but did not react to vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included meloxicam, omeprazole, levocetirizine; all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient informed that he was quite sick after the 1st dose and he suffered from exhaustion and sleeping 15 to 17 hours a day, and a heavy cough, and a minor sinus pressure, for the first 2.5 weeks after the 1st dose. The patient noticed a very faint high pitch in his ears a few days before the 2nd shot but dismissed it as an aberration. The adverse events were reported serious which caused disability or permanent damage. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was unknown.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration, administered in arm left on 08Apr2021 14:30 (batch/lot number EW0153 and expiry date unknown) at 53 years of age as 1st dose, single for COVID-19 immunization in other facility. Medical history included known allergies many but did not react to vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included meloxicam, omeprazole, levocetirizine; all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient informed that he was quite sick after the 1st dose and he suffered from exhaustion and sleeping 15 to 17 hours a day, and a heavy cough, and a minor sinus pressure, for the first 2.5 weeks after the 1st dose. The patient noticed a very faint high pitch in his ears a few days before the 2nd shot but dismissed it as an aberration. The adverse events were reported serious which caused disability or permanent damage. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asymptomatic COVID-19, Disease recurrence, Exposure to SARS-CoV-2, Illness
Clinical narrative: This is a spontaneous report from a contactable consumer for husband. A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Apr2021 (Lot Number: ER8727) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included Parkinson symptoms, COVID-19 from Jan 2021. He has Parkinson symptoms and he had COVID-19 back in January (history), on 01 Feb 2021, he tested negative and he just got the Pfizer vaccine a week ago on Monday (26Apr2021). Now when he had COVID he was almost asymptomatic. He did not have very many symptoms but he tested positive. They were all positive here at house and since he got the vaccine, he has Parkinson symptoms, the medications (Unspecified Medications) that he took was not working anymore. The trimmer was not under control, had to go to the ER twice and the medication only last 1 to 2 hours, when it should last longer. They called his doctor, the doctor even changed the dose, even changed the type of pill, thought may be the pill (Unspecified Medication) is too big that is not absorbing fast enough. He put him back on some other Carbidopa, Levodopa that dissolves a lot faster for absorption. The medication he takes for his Parkinson symptoms is not really working.  So, at the ER all they do is give him Morphine and sedative to calm him down and send him home. He come home and that wear off and he started shaking, some of the Parkinson symptoms, he got the trimmers, his muscle spasm is really bad. His leg and feet locked up, he can't walk up, his arm hurts, so many symptoms that he did not have before the vaccine, so we are wondering if the vaccine is blocking somehow the medication that he takes to treat the trimmers. He was sick right now. He got joint pain. Outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Parkinsonism
Clinical narrative: This is a spontaneous report from a contactable consumer for husband. A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Apr2021 (Lot Number: ER8727) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included Parkinson symptoms, COVID-19 from Jan 2021. He has Parkinson symptoms and he had COVID-19 back in January (history), on 01 Feb 2021, he tested negative and he just got the Pfizer vaccine a week ago on Monday (26Apr2021). Now when he had COVID he was almost asymptomatic. He did not have very many symptoms but he tested positive. They were all positive here at house and since he got the vaccine, he has Parkinson symptoms, the medications (Unspecified Medications) that he took was not working anymore. The trimmer was not under control, had to go to the ER twice and the medication only last 1 to 2 hours, when it should last longer. They called his doctor, the doctor even changed the dose, even changed the type of pill, thought may be the pill (Unspecified Medication) is too big that is not absorbing fast enough. He put him back on some other Carbidopa, Levodopa that dissolves a lot faster for absorption. The medication he takes for his Parkinson symptoms is not really working.  So, at the ER all they do is give him Morphine and sedative to calm him down and send him home. He come home and that wear off and he started shaking, some of the Parkinson symptoms, he got the trimmers, his muscle spasm is really bad. His leg and feet locked up, he can't walk up, his arm hurts, so many symptoms that he did not have before the vaccine, so we are wondering if the vaccine is blocking somehow the medication that he takes to treat the trimmers. He was sick right now. He got joint pain. Outcome of the events was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Epistaxis, Headache, Pain, Rectal haemorrhage
Clinical narrative: Spontaneous bleed- nose and rectum; Dizziness; Spontaneous bleed- nose and rectum; Headache; Aches; This is a spontaneous report from a non-contactable consumer (patient herself). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6198) via an unspecified route of administration, administered in left arm on 25Feb2021 at 08:15 A.M. (at the age of 75 years old) as 1st dose single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient receive other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and the patient has not been tested for COVID-19 since the vaccination. On 26Feb2021, it was reported that the patient experienced spontaneous bleeding in nose and rectum. The patient also experienced dizziness, headache and aches. Therapeutic measures were taken as a result of spontaneous bleeding in nose and rectum, dizziness, headache, aches. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Overdose
Clinical narrative: Sharp heart pains; She did check for the brand she was getting and that it said 3 mL where it is the correct dose; This is a spontaneous report from a contactable consumer reported for self. This female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration as 1ST DOSE, 3ML SINGLE for covid-19 immunisation. The patient called to ask questions about the Pfizer-BioNTech Covid-19 Vaccine. She took the first shot of the Pfizer-BioNTech Covid-19 Vaccine and she wanted to know what does it mean when they had an orange label on the syringe? She is not talking about a protective cover to keep you from sticking yourself with an old needle; the orange label was a paper. They have the syringes already prefilled for convenience. She knows in hospitals, which is where she went and got her shot-at a hospital; she knows everything is color coded; so what does the orange label on the syringe mean? She did ask to see if it was a Pfizer shot or not and it did say Pfizer-BioNTech; but the tag was orange and the syringes were in a ziplock bag and they were just tossing them around. Her syringe came from all the way down at cubicle 6 and she was at cubicle 1. She should have walked out then and didn't, she went ahead and took it. She did check for the brand she was getting and that it said 3 mL where it is the correct dose; because she saw where someone gave the incorrect dose to like 42 people so she made sure it was Pfizer and the right amount, 3mL. She reported she did have adverse event of sharp heart pains. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Had a seizure after getting their vaccine; This is a spontaneous report from a non-contactable other HCP. A patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), UNKNOWN, SINGLE for covid-19 immunisation. The patient had a seizure getting vaccine. The patient reportedly had a known seizure problem. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Took first dose on March 6th 2021 and after that tested Positive for Covid; Took first dose on 06Mar2021 and after that tested Positive for Covid; This is a spontaneous report from a Pfizer- sponsored program. A contactable consumer (patient's daughter) reported that a female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration (lot number unknown) on 06Mar2021 at single dose for COVID-19 immunization. Patient medical history and concomitant medication were not reported. The reporter stated that her mother (patient) took the first dose on 06Mar2021 and after that on unspecified date in 2021, patient tested positive for COVID-19. Patient received a course of treatment for the event.  Reporter was unsure for the lot number (unsure if it is EM9810 or EM4810). Reporter was asking the specific date that her Mom can receive the second dose. Outcome of the event was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy (left face); This is a spontaneous report from a contactable nurse (patient). A non-pregnant 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 08Apr2021 (at the age of 58 years old) (Lot Number: ER8737, unknown expiration) as 2nd dose, single for COVID-19 immunization.  Medical history and concomitant medications reported as none.  The patient also received first dose of BNT162B2 in left arm on 18Mar2021 (at the age of 58 years old; Lot number: EP6955, unknown expiration) for COVID-19 immunization. The patient experienced Bell's palsy (left face) on 05May2021, 3 weeks following second dose. The patient confirmed that she never had it before. The patient received valacyclovir and prednisone as treatment for the event. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not yet recovered from the event.   Information on lot/batch number was available. Additional information has been requested.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported Bell's palsy and the use of BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program COVAX US Support.  A contactable consumer (Patient's wife) reported for her husband that a 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1 via an unspecified route of administration, administered in arm left on 22Apr2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization.  Medical history included diabetes mellitus from 2004 to an unknown date Verbatim: diabetes, hypertension from 2003 to an unknown date Verbatim: Blood pressure high. Concomitant medications included metformin (METFORMIN NDC: 65862-0010-05, LOT: MTSC20156a, EXP: discard by April 2022) 1000mg a day by mouth taken for diabetes mellitus from 2004 to an unspecified stop date for almost 20 years since approximately 2004; Humalog Kwikpen insulin lispro (INSULIN LISPRO, Manufacturer: Lilly, NDC: 0002-8799-01, LOT: D255549C, EXP: June 2023) 3mL(caller says he has been taking this two days), taken for diabetes mellitus from May 2021 to an unspecified stop date; amlodipine (AMLODIPINE) taken for blood pressure measurement for 10 years, start and stop date were not reported; glipizide (GLIPIZIDE, Manufacturer: Apotex Corporation) taken for diabetes mellitus, start and stop date were not reported; lisinopril (LISINOPRIL, Manufacturer: Lupin) taken for blood pressure measurement, start and stop date were not reported; apixaban (ELIQUIS, Manufacturer: Bristol-Meyers, NDC: Unknown, LOT: ABQ4087S, EXP: April 2023) taken as a blood thinner, start and stop date were not reported; dulaglutide (TRULICITY) taken for an unspecified indication, start and stop date were not reported. The patient experienced high blood sugars after first dose of vaccine/high blood sugars of 300-350/waking up with blood sugars from 300-400, his sugar right now is 298/blood sugar was 382 when he woke up this morning (blood glucose increased) (medically significant) on 23Apr2021. The caller says that her husband's blood sugars have been high since the next day after the shot, and have not been better. The patient underwent lab tests and procedures which included blood glucose increased: 382 on 06May2021, blood glucose increased: 298 on 06May2021. Therapeutic measures were taken as a result of high blood sugars after first dose of vaccine/high blood sugars of 300-350/waking up with blood sugars from 300-400, his sugar right now is 298/blood sugar was 382 when he woke up this morning. His normal blood sugar is 160. The clinical outcome of high blood sugars was unknown. The reporter seriousness for high blood sugars after first dose of vaccine was unknown. Information about lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Suspected COVID-19
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0172 and expiration date not provided), via an unspecified route of administration, administered in Arm Left on 07May2021 12:30 as 2ND DOSE, SINGLE for COVID-19 immunization. The patient's medical history included exhaustion in Jan 2021, memory issues in Jan 2021, dizzy spells in Jan 2021, and COVID-19 in Jan 2021. The patient was not pregnant at time of Vaccination. The patient's concomitant medications were not reported. The patient was The patient historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in Arm Left first dose on 15Apr2021 for COVID-19 immunization. On 07May2021 01:00, the patient experienced Painful shocking/stabbing feeling throughout entire body, tinnitus, fever, chills, body aches, headache, and covid symptoms. No treatment was given to the events. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.