chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: fever 104 degrees Fahrenheit; Chest pain; Shortness of breath; leg swelling; Dizzy; achy muscles; Caller received the first dose on 08 Apr 2021. He received the second dose on 24 Apr 2021.; Caller received the first dose on 08 Apr 2021. He received the second dose on 24 Apr 2021.; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 22-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0171 and Expiry date: Unknown) via an unspecified route of administration on 24Apr2021(at the age of 22-years-old) as Dose 2, Single for COVID-19 immunization. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 08Apr2021(at the age of 22-years-old) as Dose 1, Single for COVID-19 immunization. The patient's medical history was not reported. 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 other medications within 2 weeks of vaccination. The patient did not receive any treatment and diagnosed with COVID 19 and has not been tested for COVID-19 since the vaccination. On 25Apr2021,the patient experienced fever 104 degrees Fahrenheit, chest pain, shortness of breath, achy muscles, leg swelling, dizzy. The patient underwent lab tests and procedures which included blood test: unknown on an unspecified date, electrocardiogram: unknown on an unspecified date, full blood count: unknown on an unspecified date, pyrexia: 104 Fahrenheit on 25Apr2021 104 degrees Fahrenheit ,sars-cov-2 test: unknown on an unspecified date, x-ray: unknown on an unspecified date. Therapeutic measures were taken as a result of fever 104 degrees Fahrenheit (pyrexia) and treatment included Tylenol immediately. She took him to the hospital, and he was given more Tylenol. He was discharged from the emergency room 6-10 hours later. His temperature did go down to 99 and then to normal range. The outcome of events fever 104 degrees Fahrenheit, pain, achy muscles, achy muscles, leg swelling, dizzy was recovered and outcome of shortness of breath recovering while the outcome of inappropriate schedule of vaccine administered and off label use was unknown.  Follow-up needed. Information about batch/lot number has been requested.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Inappropriate schedule of product administration, Myalgia, Off label use, Peripheral swelling
Clinical narrative: fever 104 degrees Fahrenheit; Chest pain; Shortness of breath; leg swelling; Dizzy; achy muscles; Caller received the first dose on 08 Apr 2021. He received the second dose on 24 Apr 2021.; Caller received the first dose on 08 Apr 2021. He received the second dose on 24 Apr 2021.; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 22-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0171 and Expiry date: Unknown) via an unspecified route of administration on 24Apr2021(at the age of 22-years-old) as Dose 2, Single for COVID-19 immunization. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 08Apr2021(at the age of 22-years-old) as Dose 1, Single for COVID-19 immunization. The patient's medical history was not reported. 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 other medications within 2 weeks of vaccination. The patient did not receive any treatment and diagnosed with COVID 19 and has not been tested for COVID-19 since the vaccination. On 25Apr2021,the patient experienced fever 104 degrees Fahrenheit, chest pain, shortness of breath, achy muscles, leg swelling, dizzy. The patient underwent lab tests and procedures which included blood test: unknown on an unspecified date, electrocardiogram: unknown on an unspecified date, full blood count: unknown on an unspecified date, pyrexia: 104 Fahrenheit on 25Apr2021 104 degrees Fahrenheit ,sars-cov-2 test: unknown on an unspecified date, x-ray: unknown on an unspecified date. Therapeutic measures were taken as a result of fever 104 degrees Fahrenheit (pyrexia) and treatment included Tylenol immediately. She took him to the hospital, and he was given more Tylenol. He was discharged from the emergency room 6-10 hours later. His temperature did go down to 99 and then to normal range. The outcome of events fever 104 degrees Fahrenheit, pain, achy muscles, achy muscles, leg swelling, dizzy was recovered and outcome of shortness of breath recovering while the outcome of inappropriate schedule of vaccine administered and off label use was unknown.  Follow-up needed. Information about batch/lot number has been requested.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, X-ray
Clinical narrative: fever 104 degrees Fahrenheit; Chest pain; Shortness of breath; leg swelling; Dizzy; achy muscles; Caller received the first dose on 08 Apr 2021. He received the second dose on 24 Apr 2021.; Caller received the first dose on 08 Apr 2021. He received the second dose on 24 Apr 2021.; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 22-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0171 and Expiry date: Unknown) via an unspecified route of administration on 24Apr2021(at the age of 22-years-old) as Dose 2, Single for COVID-19 immunization. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 08Apr2021(at the age of 22-years-old) as Dose 1, Single for COVID-19 immunization. The patient's medical history was not reported. 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 other medications within 2 weeks of vaccination. The patient did not receive any treatment and diagnosed with COVID 19 and has not been tested for COVID-19 since the vaccination. On 25Apr2021,the patient experienced fever 104 degrees Fahrenheit, chest pain, shortness of breath, achy muscles, leg swelling, dizzy. The patient underwent lab tests and procedures which included blood test: unknown on an unspecified date, electrocardiogram: unknown on an unspecified date, full blood count: unknown on an unspecified date, pyrexia: 104 Fahrenheit on 25Apr2021 104 degrees Fahrenheit ,sars-cov-2 test: unknown on an unspecified date, x-ray: unknown on an unspecified date. Therapeutic measures were taken as a result of fever 104 degrees Fahrenheit (pyrexia) and treatment included Tylenol immediately. She took him to the hospital, and he was given more Tylenol. He was discharged from the emergency room 6-10 hours later. His temperature did go down to 99 and then to normal range. The outcome of events fever 104 degrees Fahrenheit, pain, achy muscles, achy muscles, leg swelling, dizzy was recovered and outcome of shortness of breath recovering while the outcome of inappropriate schedule of vaccine administered and off label use was unknown.  Follow-up needed. Information about batch/lot number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Neutropenia
Clinical narrative: Prolonged neutropenia; This is a spontaneous report from a contactable Physician. A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6204), via Intramuscular route of administration in the Left arm, on13Mar2021 at 06:00 AM, as single dose for COVID-19 Immunisation (age at vaccination:63-year-old). Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9210), via Intramuscular route of administration in the Left arm, on 10Feb2021 at 07:00 AM, as single dose for COVID-19 Immunisation. On 01Apr2021 at 12:00AM, the patient experienced prolonged neutropenia. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was not recovered.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the event Neutropenia and suspect drug 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 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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: she got her first vaccine dose and "1 week later I caught covid".; This is a spontaneous report from a contactable consumer reported for herself. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number & Expiry date not reported) via an unspecified route of administration on Mar2021 as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient is asking for guidance on getting her second vaccine dose after having covid. Reported that back in March she got her first vaccine dose and "1 week later I caught covid". Caller reports that she was treated in the hospital with Remdesivir. Upon follow up (22Jun2021) patient stated in march she had COVID and then she was treated for which rest of year in hospital and was told wait to 90 days to get the 2nd shot. This past Sunday the 90 days were up and when she went to schedule the second shot and she was told "I have to start the series over". Caller reports that she spoke with her doctor who told her he had not heard of that and that he understood that you wait 90 days and then get the second shot. Patient enquired indeed do I need to now take two more dose of the vaccine even though I have one over 90 days ago. The Outcome of event was unknown.   Follow-up(22Jun2021)This is a spontaneous report from a contactable consumer. This Female consumer (patient) reported for herself that: new information was obtained regarding treatment of Covid-19  Follow-up attempts are needed; information about lot/batch number can be obtained
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Glycosylated haemoglobin, Inflammation, Pain in extremity, Vertigo
Clinical narrative: Inflammation arm/face/ left hand; Hand pain more intense; Vertigo; This is a spontaneous report from a Non-contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EL9263) via an intramuscular route of administration in upper right arm on 02Feb2021 at 13:30 as 1st dose, single for covid-19 immunization. Patient medical history included Diabetes from 1993 and its ongoing, Cancer from Jul2017 to Nov2018 and done Chemo, lumpectomy, Radiation, Inflammation in both wrists hands (7 incisions in left hand) on 30May2020, both knees completely replaced (8Oct + 18Nov). Both knees, however right knee collapsed & it had to be redone same day time. Family history included High blood pressure, diabetes, inflammation (back and knees) and stroke. Patients concomitant medications included hydrocodone bitartrate, paracetamol (HYDROCODONE/ACETAMINOPHEN) from 2019 and its ongoing for pain and diclofenac sodium from 2020 and its ongoing for inflammation, take 3 meds for blood pressure, cancer med, diabetes med, HBP med, depression med and cholesterol med. The patient previously took second dose of shingles vaccine on 11Jan2021 for immunization. On 03Feb2021, patient experienced vertigo, vertigo remained on and off, inflammation of arm, face and left hand. Hand pain was more intense. Patient took second dose BNT162b2 on 24Feb2021 (Lot No: EN6200) and experienced fatigue. The patient underwent lab tests and procedures which included Blood pressure measurement: 137/70 mmhg on Dec2020 and HbA1C (Glycosylated haemoglobin): 6.9 on Nov2020. Serious criteria for event Inflammation arm/face/ left hand was reported and hand pain more intense as important medical event and for vertigo it was persistent /significant disability/incapacity. The events did not require any treatment. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: little bit of bleeding, like menses, vaginal bleeding; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient's husband). A 35-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a little bit of bleeding, like menses, vaginal bleeding. Patient had bleeding the following night, after the first dose. The outcome of the event was unknown.  Additional information has been requested and will be provided as it becomes available.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Autoimmune hepatitis, Biopsy liver, Blood immunoglobulin G increased, Blood test
Clinical narrative: diagnosed with autoimmune hepatitis type 1; 10.87 igG index/ spike protein igg 10.87; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6208), via an unspecified route of administration on 16Mar2021 (at the age of 68-year-old) as dose 2, single for COVID-19 immunisation at community hospital (to get protection from covid). Medical history included auto immune hepatitis type one, had fat in her liver, her liver was enlarged from an unknown date and unknown if ongoing. Concomitant medications included azathioprine taken for autoimmune hepatitis from 30Apr2021 to an unspecified stop date. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6201), via an unspecified route of administration on 19Feb2021 (at the age of 68-year-old) as dose 1, single for COVID-19 immunisation at community hospital and no reaction on previous exposure to vaccine. Investigation assessment was provided. It was reported that the patient's doctor called her on an unknown date in Jan2021 to get her liver levels test. The patient was diabetic and gets her liver levels tested four times a year. On an unknown date In Jan2021, her numbers were high, but not that high. She did not have any tumors or anything. She got an ultrasound done that showed she had fat in her liver, and her liver was enlarged. Last week, the patient went for an antibody test. Her test results said spike protein igg 10.87. She got a scan/fibroscan also, saw a hepatologist/ internist doctor at the hospital who ran some tests and did a liver biopsy. The pathologist told her that she had auto immune hepatitis type one. That was the bad news about the auto immune disease. But the good news was that there was an immune suppressor medication that was very successful, that she was taking. She was at stage one. The medication was supposed to make it better, or it may cure her completely. She must be on it for 2 or 3 years and will find out later. She read that the vaccine may not be effective to people with auto immune diseases. She called her immunologist, and he said she can get this test. She got a blood test last Friday, and her results came back on "Friday" evening. The patient would like to know what information Pfizer has on immunosuppressed patients who take the covid vaccine. She was asking what does the 10.7 mean. The reporter did not specify any seriousness for events. The patient underwent lab tests and procedures which included Antibody test, spike protein igg: 10.87 (unknown units), liver biopsy: auto immune hepatitis type one, blood test with unknown results on an unknown date. The patient received the treatment for all events. The outcome of the events was unknown.  Information on lot/batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Fracture, Injury
Clinical narrative: got infected with covid-19; got infected with covid-19; fractured a bone; got hurt; This is a spontaneous report from a contactable other healthcare professional (hcp).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number and expiry date not reported), via an unspecified route of administration in Feb2021 as dose 1, single covid-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient got hurt and had fractured a bone around 3 weeks when she was due for 2nd dose (2021). So, patient waited to recover but got infected with covid-19 (2021). She was better now but asked what steps to take next regarding the dose if she should get the 2nd dose or not. She has an appointment this Saturday (date unspecified) so she would appreciate any guidance as soon as it is available. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Drug causality for suspect drug  in the onset of the reported events cannot be excluded,  in acontext of LOE, for event Covid, other reported events unrelated.
Sex: M
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: Hearing loss; This is a spontaneous report from a contactable consumer (patient). A 31-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0187; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 28May2021 at 16:30 as single dose for COVID-19 immunization at Pharmacy or Drug Store. The patients medical history and concomitant medications were not reported. Patient did not have covid prior vaccination. Patient did not receive any other vaccine in four weeks prior to the COVID vaccine nor any other medications received within 2 weeks of vaccination. On 07Jun2021 at 07:00 the patient experienced hearing loss. No treatment was received for adverse event (AE). Patient had not tested for COVID-19 post the vaccination. The outcome of event was not recovered.  Information on the lot/ batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report received from a contactable Pharmacist. This Pharmacist reported for a male patient via medical information team. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 03Mar2021 as dose 1, single  for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the reporter was a pharmacist and stated he had patient who received his first dose of the Pfizer COVID-19 on 03March2021 and when it was time to get his second dose, he tested positive for COIVD-19 and was advised to wait 3 months before getting his second dose. The reporter would like to know how to proceed and can the patient receive the second dose of the vaccine. The events were reported as non-serious. The patient underwent lab tests and procedures which included COVID-19 test: positive on an unknown date in 2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the reported events and the suspect drug BNT162B2 cannot be excluded.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Ventricular extrasystoles
Clinical narrative: After a couple of days of receiving second dose of covid vaccine, I experienced very high rate of premature ventricular contractions PVCs - cardiologist found normal echocardiogram but 7-day cardiac a; This is a spontaneous report received from a contactable consumer (patient himself). A 47-year-old male patient bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: Unknown and Expiry Date: Unknown) via unspecified route of administration on 01May2021, (at the age of 47-years-old) as Dose 2, Single for COVID-19 immunization. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: Unknown and Expiry Date: Unknown) via unspecified route of administration on an unspecified date (at the age of 47-years-old) as Dose 1, Single for COVID-19 immunization.Patient's medical history and concomitant medications were not reported. He had no known allergies.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. After a couple of days of receiving second dose of COVID vaccine, on 05May2021, he experienced very high rate of premature ventricular contractions PVCs; cardiologist found normal echocardiogram but on 7-day cardiac ambulant EKG monitor showed PVCs at 6% of the time.The adverse events caused doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.Treatment regimen was not given as a result of the adverse events. The patient underwent lab test which included ECG monitoring on unspecified dates.Device date was given reported as 22Jun2021.The outcome of event was recovered on an unspecified date.   Information about lot/Batch number has been requested.; Sender's Comments: Based on the current available information and the consistency with the known safety profile of the suspect product BNT162B2, there is a reasonable possibility that event ventricular extrasystole were related to suspect drug based on the temporal relation between the vaccination and onset of events. 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: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Hallucination, Hyperpyrexia
Clinical narrative: Hallucinating at about hour 9; He had a high temperature; This is a spontaneous report from a non-contactable consumer. A 14-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration in Arm Right on an unspecified date as dose 1, single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration in Arm Right on 21Jun2021 12:00 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no known allergies and other medical history. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 15Jun2021 04:30, the patient experienced hallucinating at about hour 9, he had a high temperature. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. No treatment was received for events. The outcome of events were recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Loss of consciousness, Seizure
Clinical narrative: passed out; convulsions; Her HCP said not to get the second dose.; This is a spontaneous report from a non-contactable consumer (patient, self-reported). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 10Jun2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had the Pfizer covid 19 vaccine and had complications. She passed out and had convulsions on an unspecified date. The patient stated her HCP said not to get the second dose. The patient asked what she could do going forward with that and about her vaccination card. The patient disconnected before agent could ask caller demographics and phone number. Outcome of the events was unknown.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Diabetes mellitus, Drug level, Headache, Magnetic resonance imaging, Seizure
Clinical narrative: seizure/she passed out convulsing; headache; This is a spontaneous report from a contactable consumer (patient). A 20-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0176 and Expiration date: unknown), via an unknown route of administration, in left arm on 01Jun2021 at 12:25 (at the age of 20-years-old) as dose 1, single for covid-19 immunisation. The patient has no medical history. The patient's concomitant medications were not reported. She did various lab tests included drug panel test, test for diabetes, thyroid and MRI: results were not specified. On 01Jun2021, 2 minutes after receiving the vaccine, she got a bad reaction, so she mentioned that she got a seizure and she passed out convulsing and she would like to report this. She also had headache that lasted a while but when she woke up that was gone (improved). She had doctor visit afterwards, doctor recommended not to get the 2nd dose of the vaccine. She received treatment for events no other than Ibuprofen then no the dosage 2 of the 200 mg so 400 2 of them so 400. She wanted to know if the vaccination card needs to be signed off for the 2nd dose even if she is not eligible for it. Outcome of event seizure was unknown, and outcome of event headache was resolved on an unknown date in Jun2021.  Follow up (22Jun2021): This is a Follow up spontaneous report from a Pfizer sponsored program COVAX US support. A contactable 20-year-old female consumer (patient) reported events information.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroid function test
Clinical narrative: seizure/she passed out convulsing; headache; This is a spontaneous report from a contactable consumer (patient). A 20-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0176 and Expiration date: unknown), via an unknown route of administration, in left arm on 01Jun2021 at 12:25 (at the age of 20-years-old) as dose 1, single for covid-19 immunisation. The patient has no medical history. The patient's concomitant medications were not reported. She did various lab tests included drug panel test, test for diabetes, thyroid and MRI: results were not specified. On 01Jun2021, 2 minutes after receiving the vaccine, she got a bad reaction, so she mentioned that she got a seizure and she passed out convulsing and she would like to report this. She also had headache that lasted a while but when she woke up that was gone (improved). She had doctor visit afterwards, doctor recommended not to get the 2nd dose of the vaccine. She received treatment for events no other than Ibuprofen then no the dosage 2 of the 200 mg so 400 2 of them so 400. She wanted to know if the vaccination card needs to be signed off for the 2nd dose even if she is not eligible for it. Outcome of event seizure was unknown, and outcome of event headache was resolved on an unknown date in Jun2021.  Follow up (22Jun2021): This is a Follow up spontaneous report from a Pfizer sponsored program COVAX US support. A contactable 20-year-old female consumer (patient) reported events information.
Age: 33.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dizziness, Dyspnoea, Flushing, Headache, Nausea
Clinical narrative: Severe sharp stabbing pains in my head; Difficulty breathing; Nausea; vomiting; dizziness; injection site pain; Vaccination site redness; Vaccination site swelling; vaccination site itching; face was swollen and flush; face was swollen and flush; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 33-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0217) via an unspecified route of administration, administered in arm left on 12Jun2021 16:45 (at the age of 33-year-old) at dose 2, single for covid-19 immunisation. The patient also received co-suspect Vitamin d nos (VITAMIN D NOS), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient's medical history included, Occipital neuralgia, PCOS. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included acetylsalicylic acid (ASPIRIN) Aspirin 81mg at 81 mg, multivitamins [vitamins nos] (MULTIVITAMINS [VITAMINS NOS]). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took, ceclor, acetazolamide, sulfa antibiotics and received historical vaccine which included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0168) via an unspecified route of administration, administered in arm left on 22May2021 (at the age of 33-year-old) at dose 1, single for covid-19 immunisation. On 13Jun2021 the patient experienced nausea, vomiting, dizziness, injection site pain, redness, swelling and itching, Difficulty breathing, face was swollen and flush, Severe sharp stabbing pains in my head. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 17Jun2021 (covid tested post vaccination: Yes). Adverse event led to emergency room visit and physician office visit. It was unknown whether the patient received treatment for the adverse event. Patient did not have covid prior vaccination. Outcome of all the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: SARS-CoV-2 test, Swelling face, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Severe sharp stabbing pains in my head; Difficulty breathing; Nausea; vomiting; dizziness; injection site pain; Vaccination site redness; Vaccination site swelling; vaccination site itching; face was swollen and flush; face was swollen and flush; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 33-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0217) via an unspecified route of administration, administered in arm left on 12Jun2021 16:45 (at the age of 33-year-old) at dose 2, single for covid-19 immunisation. The patient also received co-suspect Vitamin d nos (VITAMIN D NOS), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient's medical history included, Occipital neuralgia, PCOS. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included acetylsalicylic acid (ASPIRIN) Aspirin 81mg at 81 mg, multivitamins [vitamins nos] (MULTIVITAMINS [VITAMINS NOS]). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took, ceclor, acetazolamide, sulfa antibiotics and received historical vaccine which included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0168) via an unspecified route of administration, administered in arm left on 22May2021 (at the age of 33-year-old) at dose 1, single for covid-19 immunisation. On 13Jun2021 the patient experienced nausea, vomiting, dizziness, injection site pain, redness, swelling and itching, Difficulty breathing, face was swollen and flush, Severe sharp stabbing pains in my head. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 17Jun2021 (covid tested post vaccination: Yes). Adverse event led to emergency room visit and physician office visit. It was unknown whether the patient received treatment for the adverse event. Patient did not have covid prior vaccination. Outcome of all the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site swelling, Vomiting
Clinical narrative: Severe sharp stabbing pains in my head; Difficulty breathing; Nausea; vomiting; dizziness; injection site pain; Vaccination site redness; Vaccination site swelling; vaccination site itching; face was swollen and flush; face was swollen and flush; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 33-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0217) via an unspecified route of administration, administered in arm left on 12Jun2021 16:45 (at the age of 33-year-old) at dose 2, single for covid-19 immunisation. The patient also received co-suspect Vitamin d nos (VITAMIN D NOS), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient's medical history included, Occipital neuralgia, PCOS. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included acetylsalicylic acid (ASPIRIN) Aspirin 81mg at 81 mg, multivitamins [vitamins nos] (MULTIVITAMINS [VITAMINS NOS]). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took, ceclor, acetazolamide, sulfa antibiotics and received historical vaccine which included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0168) via an unspecified route of administration, administered in arm left on 22May2021 (at the age of 33-year-old) at dose 1, single for covid-19 immunisation. On 13Jun2021 the patient experienced nausea, vomiting, dizziness, injection site pain, redness, swelling and itching, Difficulty breathing, face was swollen and flush, Severe sharp stabbing pains in my head. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 17Jun2021 (covid tested post vaccination: Yes). Adverse event led to emergency room visit and physician office visit. It was unknown whether the patient received treatment for the adverse event. Patient did not have covid prior vaccination. Outcome of all the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Dyspnoea, Lethargy, Pain, SARS-CoV-2 test
Clinical narrative: compromised breathing after the first dose; a heart thing; lethargy after the first dose; general achiness after the first dose; This is a spontaneous report from a contactable consumer or other non hcp (patient's friend). A 80-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date (age at vaccination: 79 or 80 years) (Lot number and expiry date was not reported) as dose 1, single for COVID-19 immunization. The patient past Medical history included COVID-19 from Dec2020 to Dec2020 and asthma. There were no concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccination. The patient has not received other medications in two weeks. On an unspecified date, after the first dose of the vaccine, his friend had compromised breathing and his wife took him to the emergency room for his breathing or a heart thing. He was in and out and my have not been related. He was checked out and released. He also experienced lethargy and generalized achiness the day after getting the vaccine on an unspecified date. The compromised breathing lasted for about a week. He started experiencing lethargy the day after getting the vaccine. This lasted for about 8 days. The day after getting the vaccine he felt general achiness. This also lasted about 8 day. The patient underwent lab tests and procedures which includes, tested positive for COVID in Dec2020. The event outcome was recovered for compromised breathing, heart thing after a week and lethargy and general achiness recovered after 8days on unspecified date.   Information on the batch/lot number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: 4 days post vaccine I started with daily urticaria and it is continuing now still; This is a spontaneous report from a contactable consumer or other health care professional (patient). A 42-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EP7533), via an unspecified route of administration (at the age of 42-years), administered in arm left on 09Apr2021 as dose 2, sin-gle for COVID-19 immunization. The patient medical history was not reported. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, was the patient was not diag-nosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. The patient was allergic to amoxicillin but as a child. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient historical vaccine included first dose of bnt162b2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6208), via an unspecified route of administration (at the age of 42-years), administered in arm left on 18Mar2021 as dose 1, single for COVID-19 immunization. On 13Apr2021, the patient experienced 4 days post vac-cine started with daily urticaria and it is continuing nowstill. The treatment was received for the ad-verse event included medrol pak, benadryl, zyrtec. The adverse event result in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events was reported as not re-covered.  Information on Lot/Batch number was available. Additional information has been requested. ; Sender's Comments: Based on the known safety profile and plausible temporal relationship, a possible causal association between the events and the suspect drug BNT162B2 cannot be excluded
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Migraine
Clinical narrative: I have had a migraine for the past week since I received the vaccine.; I have had a migraine for the past week since I received the vaccine.; This is a spontaneous report from a contactable consumer (Pharmacist). This Pharmacist reported for herself.  A 23-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW0183), dose 2 via an unspecified route of administration, administered in right arm on 16Jun2021 at 13:30 (at the age of 23-years-old) as dose 2, single for COVID-19 immunization. Medical history included migraine. Historical vaccine included 1st of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0187) as 1st single dose, administered in right arm, on 25May2021 at 02.30AM. Facility where the most recent COVID-19 vaccine was administered at hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not been tested for COVID-19 nor before neither since the vaccination. Concomitant medications received within 2 weeks of vaccination include ibuprofen (ADVIL MIGRAINE), sumatriptan (SUMATRIPTAN) and omeprazole (OMEPRAZOLE). The patient experienced migraine for the past week since patient received the vaccine on 16Jun2021 at 08:00. On the second day, patient took 800mg of ibuprofen and 1000 mg of Tylenol ES and it did nothing to my migraine. Patient have had to take several sumatriptans since then and it only "dulls" patient migraines but it does not go away. Patient had been trying higher doses of ibuprofen (not exceeding total daily dose) and sumatriptan together, which had managed to allow patient to get through the day, but migraines had not went away. The outcome of the event was not recovered.   Additional Information has been requested.; Sender's Comments: As there is temporal relationship in the case provided, the causal association between the event and the suspect drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Pulmonary congestion, SARS-CoV-2 test
Clinical narrative: On oxygen had major congestion for 3 weeks has subsided; Since the vaccine it will not go down under 250 stays there to 300 with same insulin requirements; This is a spontaneous report from a contactable consumer (patient reported for herself). A 60-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 10May2021 11:00 AM (At the age of 60-year-old) as dose 1, single for COVID-19 immunization. Medical history included oxygen insulin COPD (chronic obstructive pulmonary disease). The patient had known allergies to Amoxicillan. Concomitant medications included Insulin, metformin, furosemide, lisinopril and atorvastatin all taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. On 11May2021 at 07:00 AM, the patient experienced on oxygen had major congestion and Insulin dependent sugars not going down under 250 stays there to 300. The clinical course of the events as follows: on oxygen had major congestion for 3 weeks has subsided. Insulin dependent sugars level was between 110 and 130. Since the vaccine it would not go down under 250 stayed there to 300 with same insulin requirements. The patient visited the physician office for the events. On 18May2021, COVID test post vaccination: Nasal Swab was Negative. The events were not resulted into the seriousness criteria of death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect. The outcome of the event on oxygen had major congestion was resolving and the outcome of other event was not resolved at the time of this report.  Information about lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Pyrexia
Clinical narrative: I lost consciousness and felt down in 9 hours after I got second shot of vaccine; fever/I also had fever for 2 days after vaccination; This is a spontaneous report from a non-contactable consumer (patient) reported for herself. A 30-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0196, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 21Jun2021 at 11:00 am (age at vaccination was 30 years) as 2nd dose, single for COVID-19 immunization. The patient did not have any medical history. The patient did not have any known allergies. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0180, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 31May2021 at 12:00 pm (age at vaccination was 30 years) as 1st dose, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 21Jun2021 at 08:00 pm, the patient lost consciousness and felt down in 9 hours after she got second shot of vaccine, she also had fever for 2 days after vaccination. No treatment was received for the adverse event. The device date was reported as 22Jun2021. The case was reported as non-serious. The outcome of the events was resolved on an unspecified date in Jun2021.  No follow-up attempts are possible; No further information is expected.