chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: My fiance has now fainted 3x times 32 hours after having his second dose.; This is a spontaneous report received from a non-contactable consumer reported for 30-year-old male consumer (reporter's fiance). A 30-years-old male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID 19 VACCINE), via an unspecified route of administration, administered in Arm Left on 16May2021 15:00 (at 30 years old age) (Lot Number: EW0173) at single dose for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID 19 VACCINE), via an unspecified route of administration, administered in Arm Left on 25Apr2021 15:00 (at 30 years old age) (Lot Number: EW0172) at single dose for covid-19 immunisation.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Reporter's fiance had now fainted 3x times 32 hours after having his second dose. The last time was just after a couple minutes of standing and he started to sieze before coming to. They wouldn't be able to work today because we need to monitor it. Reporter would bring him to the ER if it continued. Adverse event start date was 18May2021. Adverse event start time was 03:00 AM. No treatment was received for the adverse event. The event did not result in death and caused/prolonge hospitalization, was not Life threatening, disabling/incapacitating, congenital anomaly/birth defect. Facility where the most recent COVID-19 vaccine was administered was Public Health Clinic/Veterans. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Heavy menstrual bleeding
Clinical narrative: After the second shot I had another period that was normal flow for two days and then EXTREMELY heavy flow for four days which sent me to the hospital for a blood transfusion.; EXTREMELY heavy flow for four days; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot Number: er8730), dose 2 via an unspecified route of administration, administered in Arm Right on 24Mar2021 18:00 as 2nd dose, single for covid-19 immunisation. Medical history included menopausal, MS (multiple sclerosis), hasimotos, autoimune liver disease, known allergies to Mango. Concomitant medications included fingolimod hydrochloride (GILENYA); ursodiol (URSODIOL); atorvastatin calcium (LIPITOR) and blood pressure. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in left arm on 05Mar2021 18:30 for COVID-19 Immunization. The patient has been menopausal for 9 years.  After the first shot I had a period that was very heavy flow for two days and normal flow for three days. After the second shot I had another period that was normal flow for two days and then EXTREMELY heavy flow for four days which sent me to the hospital for a blood transfusion. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The adverse event result in emergency room/department or urgent care, hospitalization. The patient received treatment for the adverse event included blood transfusion, tranexamic acid. The outcome of the events was resolved in 2021.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Myocarditis, SARS-CoV-2 test, Troponin
Clinical narrative: myopericarditis; This is a spontaneous report from a contactable Physician. An 18-year-old male patient received his second dose of bnt162b2 (Pfizer-BioNTech Covid-19 vaccine) as an intramuscular single dose in left arm on 10May2021 14:30 (lot number unknown) for COVID-19 immunisation. The patient received his first injection as an intramuscular single dose in left arm on 16Apr2021 02:45 pm (lot number unknown) at age of 18-year-old for Covid-19 immunization. The patient's medical history included asthma and morbid obesity (BMI 47). Patient had no known allergies. Concomitant medications included salbutamol (ALBUTEROL HFA). The patient did not receive other vaccine in four weeks. Patient developed chest pain and was admitted to the hospital with myopericarditis. The event started at 03:00 am on 13May2021. He had elevated troponin and an abnormal EKG. He improved with NSAIDS and Colchicine. The patient was hospitalized for 3 days and recovered from the event on an unspecified date. The patient had no Covid prior vaccination and had real time PCR via nasal swab on 13May2021 with negative result.   Information about the Lot/batch number has been requested.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported event myopericarditis along with its symptoms and the use of BNT162B2 cannot be fully excluded. However, the  patients state of morbid obesity and asthma maybe considered risk factors. The limited information available precludes further assessment.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Authorities, Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Erectile dysfunction, Fatigue, Headache
Clinical narrative: Impotency; Diarrhea; Fever; Chills; Headache; Fatigue; This is a spontaneous report from a contactable consumer (patient). A male patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EWO167; Expiration Date: Aug2021), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported side effects with the vaccine. On an unspecified date, the patient had impotency, diarrhea, fever, chills, headache, and fatigue. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Impotency; Diarrhea; Fever; Chills; Headache; Fatigue; This is a spontaneous report from a contactable consumer (patient). A male patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EWO167; Expiration Date: Aug2021), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported side effects with the vaccine. On an unspecified date, the patient had impotency, diarrhea, fever, chills, headache, and fatigue. The outcome of the events was unknown.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle pain; This is a spontaneous report received from a non-contactable consumer (patient). This is the first of two reports regarding first dose. A 42-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported), at the age of 42 years,  as single dose for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced muscle pain after 1st vaccination (non-serious) on an unspecified date with outcome of unknown. No follow attempts are possible. Information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021565062 same reporter/patient different vaccine dose/AE
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: got a heavy period maybe 4 times in the month after the Covid 19 vaccine; This is a spontaneous report from a contactable female consumer. This consumer is reporting for 3 Patients. This one of the 3 reports (Sister's friend) A female patient of an unspecified age received BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot number was not reported) as UNKNOWN ,SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Her sister's friend who is a nurse and works in the hospital got a heavy period maybe 4 times in the month after the Covid 19 vaccine on an unspecified date. Outcome of the event is unknown.  Additional information is requested.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Inappropriate schedule of product administration, Infectious mononucleosis, Liver injury, Pyrexia
Clinical narrative: Severe bloody nose for hours; fever of 103.7 for 9 days leading to two day hospitalization; Providers believe vaccine caused dormant mononucleosis to surface which caused extreme liver damage; Providers believe vaccine caused dormant mononucleosis to surface which caused extreme liver damage; administration_date=07/May/2021, administration_time=01:00 PM, dose_number=2; administration_date=23/Apr/2021, dose_number=1; This is a spontaneous report from a contactable consumer. A 35-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 07May2021 01:00 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 on 23Apr2021 in right arm for COVID-19 immunization. On 07May2021, the patient experienced severe bloody nose for hours, fever of 103.7 for 9 days leading to two day hospitalization, providers believe vaccine caused dormant mononucleosis to surface which caused extreme liver damage. The events were assessed as serious (hospitalization, and disability). The patient was hospitalized for 2 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 14May2021, sars-cov-2 test: negative   on 15May2021   , sars-cov-2 test: negative   on 16May2021. Therapeutic measures were taken as a result of the events: medication, ultrasounds, blood work, IV, antibioti. The outcome of the events was recovered with sequel.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Severe bloody nose for hours; fever of 103.7 for 9 days leading to two day hospitalization; Providers believe vaccine caused dormant mononucleosis to surface which caused extreme liver damage; Providers believe vaccine caused dormant mononucleosis to surface which caused extreme liver damage; administration_date=07/May/2021, administration_time=01:00 PM, dose_number=2; administration_date=23/Apr/2021, dose_number=1; This is a spontaneous report from a contactable consumer. A 35-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 07May2021 01:00 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 on 23Apr2021 in right arm for COVID-19 immunization. On 07May2021, the patient experienced severe bloody nose for hours, fever of 103.7 for 9 days leading to two day hospitalization, providers believe vaccine caused dormant mononucleosis to surface which caused extreme liver damage. The events were assessed as serious (hospitalization, and disability). The patient was hospitalized for 2 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 14May2021, sars-cov-2 test: negative   on 15May2021   , sars-cov-2 test: negative   on 16May2021. Therapeutic measures were taken as a result of the events: medication, ultrasounds, blood work, IV, antibioti. The outcome of the events was recovered with sequel.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Right side of face went completely numb as if i haded received a novacaine shot; This is a spontaneous report from a contactable consumer (patient herself).  A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6204) via an unspecified route of administration, administered in right arm, on 05Mar2021 at 08:45 (at the age of 58 years old) as 1st dose, single, for COVID-19 immunisation. The patient's medical history included migraine and known allergies to sulpha medications. Concomitant medications included bupropion; and, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); both were 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. On 12Mar2021, it was reported that the patient's right side of face went completely numb as if she had received a novacaine shot. The patient received stroke protocol and testing as the treatment. The patient has not been tested for COVID-19 since the vaccination and it was unknown if she was diagnosed with COVID-19 prior to vaccination. The outcome of the event was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster oticus
Clinical narrative: Ramsay Hunt syndrome 3 days after second vaccine shot; This is a spontaneous report from a contactable consumer(patient). A 25-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12May2021 (at age 25-years-old) (Batch/Lot Number: Unknown) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient was not pregnant. The patient experienced Ramsay Hunt syndrome 3 days after second vaccine shot on 15May2021. Treatment was received for the event that resulted to doctor/ healthcare professional clinic visit and emergency room/urgent care. Outcome was not recovered. Patient was not diagnosed with COVID prior to vaccination.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Myocarditis, SARS-CoV-2 test
Clinical narrative: myocarditis; chest pain; shortness of breath; This is a spontaneous report from a contactable physician. This physician reported similar events for two patients. This is the first of two reports.  A 16-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06May2021 (Batch/Lot number was not reported) (at the age of 16-year-old) as single dose for COVID-19 immunisation.  Medical history was none.  Prior to vaccination the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported.  The patient previously took ceftriaxone and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation.  On 08May2021, the patient experienced myocarditis, chest pain and shortness of breath.  The patient was hospitalized for 4 days due to the events.  The patient underwent lab tests and procedures which included COVID-19 test (nasal swab): negative on 09May2021.  Therapeutic measures were taken as a result of the events and included treatment with ibuprofen. The patient outcome of the events was recovering.  Information on lot/batch number has been requested.; Sender's Comments: Based on temporal association a contributory  role of  BNT162B2 to the reported myocarditis, chest pain and shortness of breath cannot  be totally excluded.  Additional information is needed to  better assess the report.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021565275 same reporter/AEs/vaccine, different patient.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Deafness unilateral, Dizziness, Ear discomfort, Ear pain
Clinical narrative: swelling of lymph nodes; loss of hearing in right ear; right ear began to feel full with pressure/pain; right ear began to feel full with pressure/pain; dizziness; vertigo; ringing in right ear (tinnitus); This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 20Apr2021 (Lot Number: EW0171) (at the age of 26-year-old) as single dose for COVID-19 immunisation.  Medical history included non-alcoholic fatty liver disease, allergies, asthma, autism, sensory integration disorder, appendectomy, pilonidal cyst removal, all from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19. The patient's concomitant medications were not reported.  The patient previously took penicilline, tetracycline, amoxillin [amoxicillin sodium] and hydrocodone.  The patient experienced dizziness/vertigo within a couple of hours of first vaccine on 20Apr2021. Developed ringing in right ear (tinnitus) on same day. By 21Apr2021, right ear began to feel full with pressure/pain. All symptoms continued with swelling of lymph nodes and loss of hearing in right ear by 22Apr2021. The events were assessed as serious, disabling. The patient saw otolaryngologist (ENT) for hearing test and evaluation on 27Apr2021, hearing test showed substantial loss of hearing in right ear. Steroids were prescribed and taken. The patient underwent lab test and procedures which included magnetic resonance imaging (MRI): unknown results on an unspecified date. Dizziness/vertigo either resolved on 29Apr2021. The patient outcome of the other events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Magnetic resonance imaging, Tinnitus, Vertigo
Clinical narrative: swelling of lymph nodes; loss of hearing in right ear; right ear began to feel full with pressure/pain; right ear began to feel full with pressure/pain; dizziness; vertigo; ringing in right ear (tinnitus); This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 20Apr2021 (Lot Number: EW0171) (at the age of 26-year-old) as single dose for COVID-19 immunisation.  Medical history included non-alcoholic fatty liver disease, allergies, asthma, autism, sensory integration disorder, appendectomy, pilonidal cyst removal, all from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19. The patient's concomitant medications were not reported.  The patient previously took penicilline, tetracycline, amoxillin [amoxicillin sodium] and hydrocodone.  The patient experienced dizziness/vertigo within a couple of hours of first vaccine on 20Apr2021. Developed ringing in right ear (tinnitus) on same day. By 21Apr2021, right ear began to feel full with pressure/pain. All symptoms continued with swelling of lymph nodes and loss of hearing in right ear by 22Apr2021. The events were assessed as serious, disabling. The patient saw otolaryngologist (ENT) for hearing test and evaluation on 27Apr2021, hearing test showed substantial loss of hearing in right ear. Steroids were prescribed and taken. The patient underwent lab test and procedures which included magnetic resonance imaging (MRI): unknown results on an unspecified date. Dizziness/vertigo either resolved on 29Apr2021. The patient outcome of the other events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus - constant ringing in both ears; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in the left arm on 03Apr2021 13:00 (Lot Number: EW0151) as 1st dose, single dose for covid-19 immunization. The patient has no medical history. The patient was not diagnosed with COVID-19 prior to vaccination The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine in a hospital. The patient experienced tinnitus - constant ringing in both ears which started within about a week of injection (09Apr2021) and has been going on for 7 weeks. The adverse event result in doctor or other healthcare professional office/clinic visit and the event was considered serious with seriousness criteria of disability. The patient has not been tested for COVID-19 since the vaccination. The patient did not received treatment. The outcome of the events was not recovered.   No follow-up attempts are possible, information on the lot/batch number cannot be request. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, Kawasaki's disease, Myocarditis, Oropharyngeal pain
Clinical narrative: Fevers; Headaches; Chest pressure; Rash on palms and soles; Myopericarditis; Possible atypical Kawasaki disease; Sore throat; This is a spontaneous report from a contactable physician. An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, on 07May2021 (at the age of 18 years), as first dose, single dose, for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. On the day of the first dose of vaccine (07May2021), the patient developed sore throat. The next day (08May2021), the patient had fevers and sore throat, developed headaches and chest pressure. Fevers persisted for 5 days so presented to emergency department with rash on palms and soles, diagnosed with myopericarditis, possible atypical Kawasaki disease; all started on 08May2021. The events were considered serious per hospitalization in May2021 for 8 days. Treatment received for the adverse events included vancomycin, ceftriaxone, intravenous immunoglobulins (IVIG), ibuprofen, aspirin, and dobutamine. Since the vaccination, the patient has been tested for COVID-19 (nasal swab) that was negative on 12May2021. The patient was recovering from the events.  Information about lot or batch number cannot be obtained. No further information expected.; Sender's Comments: Based on current information available, the event myopericarditis, Kawasaki disease, sore throat, pyrexia, headache, chest pressure and rash mostly represented intercurrent condition in this patient, unrelated to Bnt162b2.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash, SARS-CoV-2 test
Clinical narrative: Fevers; Headaches; Chest pressure; Rash on palms and soles; Myopericarditis; Possible atypical Kawasaki disease; Sore throat; This is a spontaneous report from a contactable physician. An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, on 07May2021 (at the age of 18 years), as first dose, single dose, for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. On the day of the first dose of vaccine (07May2021), the patient developed sore throat. The next day (08May2021), the patient had fevers and sore throat, developed headaches and chest pressure. Fevers persisted for 5 days so presented to emergency department with rash on palms and soles, diagnosed with myopericarditis, possible atypical Kawasaki disease; all started on 08May2021. The events were considered serious per hospitalization in May2021 for 8 days. Treatment received for the adverse events included vancomycin, ceftriaxone, intravenous immunoglobulins (IVIG), ibuprofen, aspirin, and dobutamine. Since the vaccination, the patient has been tested for COVID-19 (nasal swab) that was negative on 12May2021. The patient was recovering from the events.  Information about lot or batch number cannot be obtained. No further information expected.; Sender's Comments: Based on current information available, the event myopericarditis, Kawasaki disease, sore throat, pyrexia, headache, chest pressure and rash mostly represented intercurrent condition in this patient, unrelated to Bnt162b2.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Disease recurrence, Dyspnoea, Myocarditis, SARS-CoV-2 test
Clinical narrative: myocarditis; myocarditis; chest pain; shortness of breath; This is a spontaneous report from a contactable physician. This physician reported similar events for two patients. This is the second of two reports. A 17-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01May2021 (Batch/Lot number was not reported) as 2nd dose, single dose (at the age of 17-years-old) for COVID-19 immunization. Medical history included myocarditis from 2019 to an unknown date. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for COVID-19 immunization. Patient admitted to hospital with chest pain and shortness of breath, diagnosed with myocarditis on 05May2021. The patient was hospitalized for 6 days. Treatment received for the adverse events include metoprolol, amiodarone, ketorolac, IVIG. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 05May2021. The outcome of the events was recovering. The events were considered as serious (hospitalization).  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  Information on the lot/ batch number has been requested.; Sender's Comments: Myocarditis is not uncommon disease in young population.  This 17-year-old male patient had medical history of myocarditis from 2019.  Based on information available, the reported recurrence of myocarditis with symptoms of chest pain and shortness of breath was not considered as causally related to the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE).  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.,Linked Report(s) : PFIZER INC-2021565225 same reporter/AEs/vaccine, different patient.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Pulmonary embolism; This is a spontaneous report from a non-contactable pharmacist. A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0177; Expiration date was not reported) on 15May2021 (13:45) as a 1st dose, single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included allergies to sulfa. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 17May2021, the patient had pulmonary embolism. The event had resulted into an emergency room/department or urgent care. The patient had received enoxaparin (LOVENOX) as treatment for the event. The outcome of the event was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of pulmonary embolism due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this patient.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including pulmonary angiogram, VQ scan, chest CT/MRI and coagulation panel, counteractive treatment measures and concomitant medications including any history of use of oral contraceptives. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: First dose: Had headaches after receiving the first dose Pfizer Covid Vaccine and they literally only lasted a day; This is a spontaneous report from a contactable consumer or other non-health professional (patient). A 37-years-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Batch/Lot Number: EW0158, expiration date not reported) via an unspecified route of administration, administered in Arm Left on 23Apr2021 (age at vaccination 37-year-old) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient had no medical history and no concomitant medications. Patient did not have COVID or anything like that. Family history was reported as one of the patient sisters had Covid. The patient stated she had to receive the Pfizer Covid Vaccine because the patient was on the list, because of genetics and testing positive for stomach cancer in genetic testing. Patient stated its weird, a lot of cancer going on right now. On 25Apr2021 patient had headaches after receiving the first dose Pfizer Covid Vaccine and they literally only lasted a day. The patient stated she received the first dose Pfizer Covid Vaccine on Friday, 23APR2021 and the headaches began that Sunday, 25Apr2021. Reportedly, patient took second dose of Pfizer Covid Vaccine on 14May2021. There were no prior vaccination within 4 weeks of vaccination. The patient recovered from the headache, just made sure to stay hydrated and took Ibuprofen. There was no investigation assessment or relevant tests. The outcome of the event was recovered on 26Apr2021.  Follow up needed, further information has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Pleurisy, SARS-CoV-2 test
Clinical narrative: Pleurisy in her left lung; Brain fog; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8729), via an unspecified route of administration, administered in the left arm on 15Apr2021 (at the age of 26-years-old) as 1st dose, single for COVID-19 immunization. Medical history included acid reflux and allergy to honey. The patient was not pregnant at the time of vaccination. Concomitant medications received within 2 weeks of vaccination included ibuprofen (ADVIL 12 HOUR) and cetirizine hydrochloride (ZYRTEC). The patient previously took sulfamethoxazole/trimethoprim (BACTRIUM DS). The patient reported that after receiving the shot, she started to have brain fog for a couple of days and she knows that she have pleurisy in her since - both on 21Apr2021. It has been a month and it hasn't gone away. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were treated with prescription ibuprofen so far. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. On 18May2021, the patient has been tested for COVID-19 with pending results. The outcome of the events was not recovered.  Follow-up attempts are needed. Further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Myalgia, Nerve injury, Pleurisy, Tinnitus
Clinical narrative: Pleurisy in her left lung; Brain fog; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8729), via an unspecified route of administration, administered in the left arm on 15Apr2021 (at the age of 26-years-old) as 1st dose, single for COVID-19 immunization. Medical history included acid reflux and allergy to honey. The patient was not pregnant at the time of vaccination. Concomitant medications received within 2 weeks of vaccination included ibuprofen (ADVIL 12 HOUR) and cetirizine hydrochloride (ZYRTEC). The patient previously took sulfamethoxazole/trimethoprim (BACTRIUM DS). The patient reported that after receiving the shot, she started to have brain fog for a couple of days and she knows that she have pleurisy in her since - both on 21Apr2021. It has been a month and it hasn't gone away. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were treated with prescription ibuprofen so far. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. On 18May2021, the patient has been tested for COVID-19 with pending results. The outcome of the events was not recovered.  Follow-up attempts are needed. Further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: 36% sudden hearing loss in left ear; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6199) via an unspecified route of administration, administered in Arm Left on 12Mar2021 12:00 (at the age of 61-year-old) as 1st dose, single for COVID-19 immunisation.  Medical history included allergy to sulfa antibiotics. Patient was not pregnant. Concomitant medications included escitalopram oxalate (LEXAPRO) and levothyroxine (LEVOTHYROXINE); both taken for an unspecified indication. The patient experienced 36% sudden hearing loss in left ear on 18Apr2021. The event resulted in physician office visit and she was currently using a hearing aid. Outcome of event was not recovered.   Follow up needed, further information has been requested.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Deafness unilateral, Magnetic resonance imaging, Tinnitus
Clinical narrative: sudden onset of hearing loss in right ear; within minutes tinnitus decibel increased substantially in right ear and developed in left ear.; This is a spontaneous report from a contactable consumer (patient's parent). A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 11May2021 at the age of 26 years old (Batch/Lot Number: EW0176, Expiration date: unknown) as the 2nd dose, single for COVID-19 immunization. The patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) administered in the left arm on 20Apr2021 at the age of 26 years old (Batch/Lot number: EW0171, Expiration date: unknown) for COVID-19 immunization and experienced dizziness/vertigo within a couple of hours on 20Apr2021; tinnitus (ringing in right ear) on same day; and right ear began to feel full with pressure/pain by 21Apr2021 in the morning (am), which all continued with swelling of lymph nodes and loss of hearing in right ear by 22Apr2021. The facility where the most recent COVID-19 vaccine was administered was at the pharmacy or drug store. Relevant medical history included non-alcoholic fatty liver disease, asthma, autism, appendectomy, pilonidal cyst removal, sensory integration disorder, allergies, allergy to Penicillin, and allergy to all Sulfa medications and all Cephalosporins; all from an unknown date and unknown if ongoing. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) and montelukast sodium (SINGULAIR), both taken for an unspecified indication, start and stop date were not reported. The patient previously took tetracycline, amoxicillin sodium (AMOXILLIN), and hydrocodone and experienced allergy from these drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11May2021, the patient received the second dose of Pfizer vaccine and within minutes tinnitus decibel increased substantially in right ear and developed in left ear. Tinnitus stopped in left ear and lowered to decibel level he has had since first shot in right ear. The patient was diagnosed with sudden onset of hearing loss in right ear on an unspecified date and magnetic resonance imaging (MRI) showed no tumour. All symptoms were ongoing with no prognosis of resolution. Both the events resulted in disability. The adverse events did result in a doctor or other healthcare professional office/clinic visit. The patient underwent further lab tests and procedures, which included a second hearing test with unknown results on an unspecified date. The patient received treatment for the adverse events, which included a prescription for steroid pack. The patient was not recovered from both the events.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Arrhythmia, Chest discomfort, Chest pain, Heart rate increased
Clinical narrative: felt like he could collapse, He felt like he was going into cardiac arrest; heart beat increased really fast; He felt his heart beating up to his neck; had slight chest pain; feeling uncomfortable in his chest; anxious; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 17May2021 13:50 (Batch/Lot Number: EW0178) (at the age of 31 years old) as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. Medical history was none. There were no prior vaccinations within 4 weeks. There were no family history and no relevant tests. The patient's concomitant medications were not reported. Patient took the first dose of the COVID vaccine. About 25 minutes after, all of a sudden, his heartbeat increased really fast. He could not figure out what was going on. He had slight chest pain as well. It started out with him feeling uncomfortable in his chest. He told his wife that something was wrong. He was driving and had to pull over on the side of the road. The total episode lasted two to three minutes. He felt like he was going into cardiac arrest. His wife called 911. Within five minutes, they were there. They checked him out, and everything was normal. He thinks that normally his heart beats 70 to 80 beats per minute. His heart felt like it was beating 200 beats per minute. He felt his heart beating up to his neck. He felt like he could collapse. He clarifies that his heart was beating very fast for about 30 seconds. After that, his heart was still beating fast, but it started going down. Then after two minutes, it started going back to normal. His heart was still beating fast because he was still very anxious. He thinks the anxiety after ward was making his heart pump very fast. He was going to talk with his doctor next week to get checked out and find out if he has any underlying heart problems. He has never had any heart issues in the past. The outcome of events was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: felt like he could collapse, He felt like he was going into cardiac arrest; heart beat increased really fast; He felt his heart beating up to his neck; had slight chest pain; feeling uncomfortable in his chest; anxious; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 17May2021 13:50 (Batch/Lot Number: EW0178) (at the age of 31 years old) as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. Medical history was none. There were no prior vaccinations within 4 weeks. There were no family history and no relevant tests. The patient's concomitant medications were not reported. Patient took the first dose of the COVID vaccine. About 25 minutes after, all of a sudden, his heartbeat increased really fast. He could not figure out what was going on. He had slight chest pain as well. It started out with him feeling uncomfortable in his chest. He told his wife that something was wrong. He was driving and had to pull over on the side of the road. The total episode lasted two to three minutes. He felt like he was going into cardiac arrest. His wife called 911. Within five minutes, they were there. They checked him out, and everything was normal. He thinks that normally his heart beats 70 to 80 beats per minute. His heart felt like it was beating 200 beats per minute. He felt his heart beating up to his neck. He felt like he could collapse. He clarifies that his heart was beating very fast for about 30 seconds. After that, his heart was still beating fast, but it started going down. Then after two minutes, it started going back to normal. His heart was still beating fast because he was still very anxious. He thinks the anxiety after ward was making his heart pump very fast. He was going to talk with his doctor next week to get checked out and find out if he has any underlying heart problems. He has never had any heart issues in the past. The outcome of events was recovered.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased
Clinical narrative: could not use his arm; This is spontaneous report from a contactable consumer. A 90-year-old male patient received Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) (Solution for injection in pre-filled syringe) via an unspecified route of administration on an unspecified date, at single dose for Immunization. Patient medical history included ongoing Congestive heart failure. Concomitant medications were not reported. It was reported that, reaction with pneumonia vaccine, could not use his arm for a few days on an unspecified date and they told him that was normal. She does not know the name of the vaccine she thinks it was the pneumococcal and does not have lot, ndc, or expiration. Outcome of event was unknown.  Pfizer is a marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] has submitted the same report to the regulatory authorities.  No follow-up attempts are needed. No further information is expected.