chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: lack of efficacy; diagnosed with Covid 19 virus; occasional cough that wasn't terrible; 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 mRNA VACCINE; Lot Number: EN6200) on 28Feb2021 and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) on 21Mar2021 and third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) on 22Aug2021 via an unspecified route of administration, administered in left arm (at the age of 60 years) as a single dose for COVID-19 immunisation. The patient's medical history included Multiple sclerosis, Chronic obstructive pulmonary disease, Overweight, immune compromised, and Supraventricular tachycardia from an unknown date and unknown if ongoing. The patient's concomitant medication included METOPROLOL taken for a Supraventricular tachycardia, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Oct202 the patient experienced occasional cough that was not terrible and on 04Oct2021 the patient diagnosed with Covid 19 virus. Patient was diagnosed with the Covid 19 virus, and she was wondering if Pfizer was keeping track of people who had breakthrough cases of the Covid 19 virus. Patient had her Covid 19 vaccine booster also. When probing medical history and concomitant medications patient took a betablocker for supraventricular tachycardia so she did not really know if she had high blood pressure or not because the betablocker helps with that. Patient took the betablocker for a long time. The betablocker is Metoprolol 50mg daily. The patient went and had the Regeneron treatment. She did not know the dosage and stated it was a small IV bag, much smaller than the big fat normal IV bag. The Regeneron only took about 20-22 minutes to drip. Patient had the Regeneron treatment. Patient had been around about 10 people in the last week and contacted them all and so far, only one woman had tested positive for the Covid 19 virus, and that woman was asymptomatic. As far as the reporter knew only the reporter and the other woman have had positive results. The patient did let everyone know that she had tested positive for the Covid 19 virus. Reporter reported that the patient had left her house in 20 months and this time she wasn't as careful. The patient underwent lab tests and procedures which included Covid 19 virus PCR test on 03Oct2021 and resulted positive and Covid 19 virus Rapid test was performed on 04Oct2021 and resulted positive. The outcome of the events was unknown.  Follow-Up (07Oct2021) attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Headache, Pyrexia
Clinical narrative: severe headache; chills; fever; stomach pain; This is a spontaneous report from a contactable Nurse via the Regulatory Authority. This 52-year-old male Consumer reported himself.  A 52-years-old female patient received second dose of bnt162b2(PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: not reported, Expiry date: unknown) via an unspecified route of administration, on 05Oct2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date on Oct2021, the patient experienced chills, fever, stomach pain, and a severe headache. It was reported that patient had the second dose of the Pfizer covid vaccine yesterday, and it was okay until I was going to bed. I started having chills, fever, stomach pain, and a severe headache. She asked How long are these supposed to last. The Centers for Disease Control and Prevention provides information regarding Possible Side Effects After Getting a COVID-19 Vaccine. Side effects after your second shot may be more intense than the ones you experienced after your first shot. These side effects are normal signs that your body is building protection and should go away within a few days. Beyond what is described in the <Pfizer-Biontech Covid Vaccine> Prescribing Information, Pfizer does not have information on how long what you are experiencing may last. There may be many factors to consider including your medical history and medical condition. We all react differently to medicine, and therefore we are unable to specifically say when your symptoms may be relieved. The outcome of the events were unknown.  The lot number for BNT162B2 was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report from a contactable consumer or other non-health care professional. The reporter reported for 2 of his neighbor. This report is for the 1st neighbor. A 60-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date, as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced stroke, the same day of vaccination. Reporter mentioned were the most affected by the shot but did not give any specifics. The event was medically significant. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.   The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Throat clearing, Urticaria
Clinical narrative: I had an allergic reaction to my 2nd COVID shot; her arm turned red and she started having hives that went to her face, neck and her ear on the side of the shot; her arm turned red and she started having hives that went to her face, neck and her ear on the side of the shot; she had to keep clearing her throat.; This is a spontaneous report from a contactable consumer (patient reported for self). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient reported of having a history of anaphylactic shock previously after taking Cipro. She reported that the first time she had Cipro she had no reaction but the second time she had a terrible reaction. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient was asking if it was ok to take the booster shot if she had an allergic reaction to the 2nd dose of the covid vaccine. 5 minutes after getting the vaccine, her arm turned red and she started having hives that went to her face, neck and her ear on the side of the shot and she had to keep clearing her throat on an unknown date. She was at the hospital already so they did everything there. She didn't had the reaction 1st that was just 2nd time and she was at the hospital and they addressed and gave her steroids and all the stuff. Therapeutic measures were taken as a result the events. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Break thru Covid.; Break thru Covid.; This is a spontaneous report received from a contactable consumer (patient's parent). A 17-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EW0177) via an unspecified route of administration at left arm on 08Jun2021 as dose 2, single and received first dose via an unspecified route of administration at left arm on 17May2021 (Lot Number: EW0177) as dose 1, single for COVID-19 immunisation. Medical history included None. There were no concomitant medications. Patient did not receive any other medications in two weeks. No Known allergies. Patient did not receive any other vaccines in four weeks prior to COVID-19 vaccination. Patient do not have COVID-19 prior to vaccination. Since vaccination patient got COVID-19. The patient experienced break thru covid on 04Oct2021. The patient underwent lab tests and procedures which included Covid test/Antigen Rapid Test (SARS-CoV-2 test): Positive (Nasal Swab) on 04Oct2021. Patient visit the physician office visit for the events. Patient did not receive any treatment for the events. Seriousness criteria-Results in death/Seriousness criteria-Life threatening/Seriousness criteria-Caused/prolonged hospitalization/Seriousness criteria-Disabling/Incapacitating/Seriousness criteria-Congenital anomaly/birth defect all were reported as no. Outcome of events was Recovering/Resolving  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough Covid; Breakthrough Covid; This is a spontaneous report from a contactable consumer (patient). A 70-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9267), via an unspecified route of administration in left arm on 16Feb2021 at 12:00 PM (at the age of 70 years old, not pregnant at the time of vaccination) as dose 2, single and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: F69263), via an unspecified route of administration in left arm on 26Jan2021 on 12:00 PM (at the age of 69 years old) for covid-19 immunisation. Medical history included heart disease (stent in LAD in Sep2018), stent placement from Sep2018 to an unknown date. The patient had known allergies to statins. Concomitant medications in two weeks included alirocumab (PRALUENT). The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 08Aug2021 at 10:00 AM patient experienced breakthrough covid. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): positive on 09Aug2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not received treatment due to the events. The outcome of events was recovered on an unspecified date in 2021.
Sex: M
Vaccine: COVID19
Symptoms: Neoplasm
Clinical narrative: asked if it will get rid of his tumor; This is a spontaneous report from a non-contactable consumer (patient himself) report from a Pfizer-sponsored program.  A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date, NDC number was not reported), dose 1 via an unspecified route of administration on an unspecified date May2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of the Pfizer COVID vaccine about 5 months ago. He has not received 2nd dose and not sure what to do and said something about it is not for the COVID and asked if it will get rid of his tumor on an unspecified date. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pain
Clinical narrative: Shingles; Pain was excruciating in the same way that my shingle pain was 3 years ago; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot Number: FF2589), via an unspecified route of administration, administered in arm left on an unspecified date at 20:00 (8 o clock pm) as DOSE 2, SINGLE for covid-19 immunization at pharmacy/drug store. Patient medical history included High cholesterol and had shingle pain (3 years ago) from an unknown date and unknown if ongoing. Patient concomitant medication included rosuvastatin (ROSUVASTATIN) 5 mg once daily, taken for high cholesterol, start and stop date were not reported. Patient historical vaccine included received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: FF2588), via an unspecified route of administration, administered in arm right (upper right arm) on 01Sep2021 as DOSE 1, SINGLE for covid-19 immunization. On 04Oct2021, the patient developed shingles and thought it was re occurring and the pain was excruciating in the same way that patient's shingle pain was 3 years ago. The pain started about 12 hours after had her second dose, the pain started and intensified for about 24 hours. 24 hours later, the pain was almost gone. It was reported that patient took olives, and she did not know what olives are. The outcome of events was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: bronchitis; diagnosed with COVID after having been administered 2 doses of Pfizer Covid Vaccination; COVID; This is a spontaneous report from a contactable consumer (patient).  A 49-year-old female patient received bnt162b2 (PIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm right on 18Aug2021 at 18:00 (Batch/Lot Number: FC3181) (age at vaccination 48-year-old) as dose 2, single, dose 1 via an unspecified route of administration, administered in arm right on 28Jul2021 at 18:00 (Batch/Lot Number: FA6780) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications was reported as none. The patient had diagnosed with covid after having been administered 2 doses of pfizer covid vaccination and covid on 03Oct2021 and bronchitis on an unspecified date. The patient underwent lab tests and procedures which included COVID-19 SARs PCR Test sars-cov-2 test: positive for covid on 03Oct2021. Therapeutic measures included Z-Pak was taken for bronchitis. The patient was seen in an urgent care for this event bronchitis, but has not had any visit to the emergency room or hospitalization. The outcome of the event covid after having been administered 2 doses of pfizer covid vaccination and covid was not recovered and the outcome of bronchitis was unknown.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: the results came back as positive for COVID-19/ COVID-19 PCR test; the results came back as positive for COVID-19/ COVID-19 PCR test; This is a spontaneous report from a Contactable Consumer or other non-health care professional (Patient).  A patient with unspecified age and gender has received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Batch no: not reported/ Lot number: EN6203) via unspecified route of administration on 11Mar2021 as dose 2, single for covid-19 immunization at health facility. The patient medical history and concomitant medication were not reported. Historical vaccine included patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Batch no: not reported/ Lot number: EL3247) via unspecified route of administration on 18Feb2021 as dose 1, single for covid-19 immunization. On 04Oct2021, Patient began experiencing fatigue, chills, fever, and a runny nose. Patient went to a local health clinic for a COVID-19 PCR test on 05Oct2021 and the results came back as positive for COVID-19 at afternoon on 06Oct2021. Patient was made aware of the positive COVID test at approximately 4:30 pm on 06Oct2021. No new symptoms have developed. Outcome of the event Covid-19 was unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Vertebral artery dissection
Clinical narrative: spontaneous Vertebral artery dissection in both left and right arteries within two weeks of receiving the second dose; This resulted in a stroke; This is a spontaneous report from a contactable consumer (patient).  A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left at the age of 37-year-old in May2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  Facility type of vaccine was Hospital. Medical history included Chronic regional pain disorder, orthostatic hypotension, COVID-19 (prior vaccination). Patient was not pregnant. The patient's concomitant medications were unspecified drugs (The patient received other medications within 2 weeks of vaccination). The patient previously took first dose bnt162b2 (Location of injection: Arm Right; Vaccine Administration Time: 12:00 PM) at the age of 37-year-old in Apr2021 for COVID-19 immunisation, acetylsalicylic acid (ASPRIN) and experienced drug allergy, NSAIDS and experienced drug allergy, clarithromycin (MACROBID) and experienced drug allergy.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced ''spontaneous Vertebral artery dissection in both left and right arteries within two weeks of receiving the second dose. This resulted in a stroke.'' (hospitalization, disability, life threatening) on 17Jun2021. The patient was hospitalized for events for 2 days. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of events (Radiology of varying sorts, anticoagulation, ICU). Ae resulted in [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. The outcome of events was recovered with sequelae in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Death, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a non-contactable nurse. This report was received via a sales representative.  An elderly male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The Elderly male patient was showing signs of COVID. A COVID test was run and results were negative. Patient received COVID vaccination. Patient later admitted to hospital and died. Event took place after use of product. The patient died on an unspecified date.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on possible dose- event relationship post-vaccination  the causal role of BNT162B2 vaccine cannot be excluded for the reported events.The event will be confirmed with autopsy reports.  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; Reported Cause(s) of Death: died
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles- I had shingles that presented on my V 1 nerve; This is a spontaneous report from a contactable consumer. A 36-year-old female (non-pregnant) patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH, COVID-19 Vaccine, Solution for injection, Batch/Lot number: EL9267 and Expiration date: Not reported), via an unspecified route of administration, administered in Arm Left on Feb2021 as DOSE 2, SINGLE (age at vaccination 36-year-old) for covid-19 immunisation. The patient medical was none. There were no concomitant medications. No patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine and No other medications the patient had received within 2 weeks of vaccination. The patient historical vaccine includes received BNT162B2 (BNT162B2, PFIZER-BIONTECH, COVID-19 Vaccine, Solution for injection, Batch/Lot number: EL9263 and Expiration date: Not reported), via an unspecified route of administration, administered in Arm Left on Feb2021 at 2.00 PM as DOSE 1, SINGLE (age at vaccination 35-year-old) for covid-19 immunisation. Prior to vaccination, was the patient diagnosed with COVID-19 was No. Since the vaccination, has the patient been tested for COVID-19 was No. It was reported that she had shingles that presented on her V1 nerve on 21May2021. The events resulted in emergency and physician office visit. Therapeutic measures were taken as a result of shingles included Valtrex and Gabapentin. The outcome of the event was recovered.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: A good friend of mine died from the vaccine; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. A good friend of the reporter died from the vaccine (death, medically significant) on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: A good friend of mine died from the vaccine
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Menstruation delayed
Clinical narrative: monthly cycle was off for this month; blood pressure went up after first dose/Has been getting readings of 170/110, which are not within her historical range where she was regularly 120/80; This is a spontaneous report from a non-contactable consumer (patient). A 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number was unknown), via an unspecified route of administration, administered in arm on 13Sep2021 as dose 1, single for COVID-19 immunization (at the age of 24-year-old). The patient medical history and concomitant medications were not reported. No vaccines in 4 weeks prior, and no problems in past. Only has had her childhood vaccines, like HPV in her teen-age years. Historical vaccine included Flu. On an unspecified date in Sep2021, the patient blood pressure went up. Has been getting readings of 170/110, which are not within her historical range where she was regularly 120/80. It has been persistent since she received the shot and she has only had this first dose. States she received the first dose on 13Sep2021. Noticed blood pressure increase between the 20th and 27th, 1-2 weeks post vaccination. The initial reading was 170/110. Patient just went to the doctor today and it's about 160/100 and is going to schedule to get an echocardiogram on Saturday to look at her heart. On an unspecified date, the patient's monthly cycle was off for this month. She was in good health and normal weight and no issues prior to this. No visit of emergency room (ER). Patient visited physician office. On an unspecified date in Sep2021, the patient underwent lab tests and procedures which included blood pressure measurement: 170/110, blood pressure measurement: 120/80 and blood pressure measurement: went up. On 06Oct2021, blood pressure measurement: 160/100. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Feeling abnormal, Investigation, Laboratory test
Clinical narrative: Mixed Connective tissue disease; significant fatigue; no appetite; foggy head; isolated palpitations; lost 15 pounds; This is a spontaneous report from a contactable physician. A 74-years-old female patient received BNT162B2 (COMIRNATY, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. Medical history included covid-19 from Nov2020 to an unknown date that had COVID last November, Mild fatigue only. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (COMIRNATY) as dose 1, single on Mar2021 (at the age of 74-year-old) for covid-19 immunisation without problems. The patient experienced mixed connective tissue disease, significant fatigue, no appetite, foggy head, isolated palpitations, lost 15 pounds. The patient underwent lab tests and procedures which included cardiac workup: unknown result, Lab work: unknown, weight: lost 15 pounds. The outcome of the event for significant fatigue, no appetite was recovering and outcome for foggy head was not recovered, rest all event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events  Mixed connective tissue diseaseand 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.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Mixed connective tissue disease, Palpitations, Weight, Weight decreased
Clinical narrative: Mixed Connective tissue disease; significant fatigue; no appetite; foggy head; isolated palpitations; lost 15 pounds; This is a spontaneous report from a contactable physician. A 74-years-old female patient received BNT162B2 (COMIRNATY, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. Medical history included covid-19 from Nov2020 to an unknown date that had COVID last November, Mild fatigue only. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (COMIRNATY) as dose 1, single on Mar2021 (at the age of 74-year-old) for covid-19 immunisation without problems. The patient experienced mixed connective tissue disease, significant fatigue, no appetite, foggy head, isolated palpitations, lost 15 pounds. The patient underwent lab tests and procedures which included cardiac workup: unknown result, Lab work: unknown, weight: lost 15 pounds. The outcome of the event for significant fatigue, no appetite was recovering and outcome for foggy head was not recovered, rest all event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events  Mixed connective tissue diseaseand 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: Appendicitis
Clinical narrative: Appendicitis; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 49-year-old non-pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, (Batch/Lot Number: Unknown)), dose 1 via an unspecified route of administration, administered in right arm on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history included covid prior to vaccination. Concomitant medications included Dispersal sertraline hydrochloride (ZOLOFT), bupropion hydrochloride (WELLBUTRIN), acetylsalicylic acid (ASPIRIN (E.C.)) and gabapentin. Patient had no known allergies. Patient did not receive any other vaccines within 4 weeks to the COVID vaccine. Patient was tested positive prior vaccination and was not tested post vaccination. The patient experienced appendicitis on 02Oct2021. Patient received treatment and visited emergency room for the event. Outcome of appendicitis was recovering.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: He and his wife both tested positive; He and his wife both tested positive; This is a spontaneous report from a Pfizer-sponsored program Support from a contactable consumer(patient himself). A 66-years-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration on Feb2021 (at the age of 66 years old )as dose 2, single for COVID-19 immunization. The patient previously received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization . Medical history included pulmonary embolism , chronic obstructive pulmonary disease, pneumonia, influenza. The patient's concomitant medications were not reported. Call transferred from (Name) with DSU NTID: (ID) REPORTUM: # who originally received the call as a transfer from (name) with Covax US support CEP 159558. She reports a consumer, 66 years of age, having had his 2nd dose of the Pfizer COVID 19 Vaccine in February, his wife received hers a few days after his. He and his wife both tested positive. He tested positive for COVID-19 on 23Aug2021. The caller states he did talk with his HCP and they advised him to wait until November to get the booster shot and scheduled him for his flu shot on 19Oct2021. The caller also notes having spoke with his pharmacist today that advised him to wait "3 months after the last COVID bout." He states he also asked the pharmacist has anyone had the vaccine, caught COVID and then caught COVID again, but she was unable to answer this question and he did not pursue answers from Pfizer MI regarding it either. The caller states he is "glad I got the vaccine because I would have been pushing up daisies." He states "August COVID was horrendous, the worst I've ever had. I've had pneumonia and the flu and that was really bad. I'm back to mask and hand sanitizer protocol, delivering my groceries. Back to all my safety measures before the vaccine, locked in my house. The patient underwent lab tests and procedures which included sars-cov-2 test on 23Aug2021 positive. The outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up .; Sender's Comments: Linked Report(s) : -PFIZER INC-202101333814 same reporter/drug/event, different patients
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium, Blood potassium decreased, Ischaemic stroke
Clinical narrative: Ischemic stroke/Stroke; Potassium was also low; This is a spontaneous report from a contactable nurse. A 24-years-old female patient received bnt162b2 (Pfizer Covid vaccine), dose 2 via an unspecified route of administration, administered in deltoid left on 28Jul2021 at her 24-years-old (Lot Number: FE1510) as dose 2, single for covid-19 immunisation. There were no concomitant medications, no other vaccine, no medical history. Historical Vaccine included first dose bnt162b2 on 24Jun2021 at her 24-years-old for covid-19 immunisation(First vaccine, Lot: FD5613, Site: right deltoid).  The patient experienced ischemic stroke/stroke on 06Oct2021 two months after second vaccine with outcome of recovering which was assessed as serious with hospitalization, life threatening , potassium was also low on an unspecified date with outcome of unknown.  The patient was hospitalized for ischemic stroke/stroke from 06Oct2021 and still admitted. Emergency Room required and then admitted to the hospital, no physician office. No relevant tests . Therapeutic measures were taken as a result of ischemic stroke/stroke. It seemed after some treatment, the patient has improved. Patient was in the ICU.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship,  a possible causal relationship between the event Ischemic stroke 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.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable Pharmacist (patient) reported for herself via Medical Information Team. A 63-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported, Expiry Date, NDC number: Unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 18Mar2021 (at the age of 63 years-old) as DOSE 2, SINGLE for prevention of COVID-19. Time the Vaccination was given in the afternoon. Historical vaccine included bnt162b2 (COMIRNATY, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date in Feb2021 (at the age of 63 years-old) as DOSE 1, SINGLE for COVID-19 immunisation. No medical history (including any illness at time of vaccination) and other products were reported. Had no family medical history relevant to adverse event. For US Only: Vaccination Facility Type was Fairground, Vaccine was administered at Military Facility/national guard, the patient took no Prior Vaccinations (within 4 weeks). The patient stated that In Jun2021 she was diagnosed with shingles and was calling to know if the diagnosis is related to the vaccine, was wondering if she gets the booster, would she get shingles again. Seriousness criteria of event shingles was reported as Other medically important condition/ Medically significant. The Adverse event did not require a visit to Emergency Room but require a visit to Physician Office. The patient had no adverse event following prior vaccinations. No relevant tests and no Investigation Assessment were reported. Outcome of event was recovered (took about 2.5 months) on an unspecified date in 2021. Relatedness of drug to reaction(s)/event(s): Reaction assessed: Shingles, Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Related.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Herpes zoster and the 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
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, Vaccination failure
Clinical narrative: tested positive for COVID; tested positive for COVID; loss of smell; This is a spontaneous report from a contactable other hcp. A 50-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN5318), via intramuscular on 18Feb2021 (age at the time of vaccination was 50-year-old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN5318), via intramuscular on 28Jan2021 (age at the time of vaccination was 50-year-old) as dose 1, single for COVID-19 immunisation. On 05Oct2021, the patient experience loss of smell. On 07Oct2021, patient tested positive for COVID. The patient underwent lab tests and procedures which included nasal swab Covid test resulted positive on 05Oct2021. It was unknown if patient received treatment for the event. The clinical outcome was recovering for the events.  No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event s drug ineffective and covid19 cannot be totally excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested  positive for Covid-19 disease before she received her 2nd Pfizer vaccine; tested  positive for Covid-19 disease before she received her 2nd Pfizer vaccine; This is a spontaneous report from a non-contactable consumer (patient) from a program. A female patient of an unspecified age received bnt162b2 (COMIRNATY, solution for injection, Lot number was not reported) via an unspecified route of administration, on an unspecified date, as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient tested positive for covid-19 disease before she received her 2nd Pfizer vaccine. The event was assessed by the consumer as non-serious. The patient underwent lab tests and procedures which included sars-cov-2 test positive on an unspecified date. Outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: body shooting pain; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8730), intramuscular in right arm on 19Mar2021 13:00 (at the age of 44-years-old) as dose 1, single for COVID-19 immunization. Medical history included Congestive heart failure (CHF) congenital from 14Jun1976 and ongoing (medication maintained) and chronic obstructive pulmonary disease from 2004 and ongoing (nebulizer inhaler). The patient's concomitant medications were not reported. The patient experienced body shooting pain (medically significant) on 20Mar2021 06:00. No treatment was received for the event. Outcome of event was resolved on 30Mar2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alpha-1 antitrypsin deficiency, Asthenia, Fatigue, Feeling hot, Headache
Clinical narrative: I had a red rash around injection site which felt warm/ a red blotch around the injection site; It is 3 inches around swollen and itchy; It is 3 inches around swollen and itchy; The injection site is swollen mainly on Tuesday.; headache; antitrypsin deficiency; tired and weak/ Fatigue; tired and weak; the injection site was a little swollen and itchy.; My doctor said I had Lyme's disease and I got it from a tick.; Monday my arm became sore.; I had a red rash around injection site which felt warm; This is a spontaneous report from contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (FIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: not reported), dose 3 via an unspecified route of administration on 03Oct2021 14:00 as dose 3 (booster), single for covid-19 immunisation. Medical history included sepsis (she was hospitalized a few years ago with a blood infection). The patient concomitant medications were not reported. The patient previously took first dose of bnt162b2 on an unspecified date and then second dose of bnt162b2 on an unspecified date for covid-19 immunisation with reported reactions of headache, fatigue, asthenia, feeling abnormal. The patient experienced my doctor said i had lyme disease and i got it from a tick, monday my arm became sore, i had a red rash around injection site which felt warm on 04Oct2021; i had a red rash around injection site which felt warm/ a red blotch around the injection site, it is 3 inches around swollen and itchy, the injection site is swollen mainly on Tuesday, headache, antitrypsin deficiency, tired and weak/ fatigue, tired and weak, the injection site was a little swollen and itchy on 05Oct2021. The outcome of events was recovering.  Follow up(07Oct2021): no new event   Follow up(07Oct2021): new events (rash, swelling, soreness, itchy)  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Lyme disease, Pain in extremity, Pruritus, Swelling, Vaccination site pruritus
Clinical narrative: I had a red rash around injection site which felt warm/ a red blotch around the injection site; It is 3 inches around swollen and itchy; It is 3 inches around swollen and itchy; The injection site is swollen mainly on Tuesday.; headache; antitrypsin deficiency; tired and weak/ Fatigue; tired and weak; the injection site was a little swollen and itchy.; My doctor said I had Lyme's disease and I got it from a tick.; Monday my arm became sore.; I had a red rash around injection site which felt warm; This is a spontaneous report from contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (FIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: not reported), dose 3 via an unspecified route of administration on 03Oct2021 14:00 as dose 3 (booster), single for covid-19 immunisation. Medical history included sepsis (she was hospitalized a few years ago with a blood infection). The patient concomitant medications were not reported. The patient previously took first dose of bnt162b2 on an unspecified date and then second dose of bnt162b2 on an unspecified date for covid-19 immunisation with reported reactions of headache, fatigue, asthenia, feeling abnormal. The patient experienced my doctor said i had lyme disease and i got it from a tick, monday my arm became sore, i had a red rash around injection site which felt warm on 04Oct2021; i had a red rash around injection site which felt warm/ a red blotch around the injection site, it is 3 inches around swollen and itchy, the injection site is swollen mainly on Tuesday, headache, antitrypsin deficiency, tired and weak/ fatigue, tired and weak, the injection site was a little swollen and itchy on 05Oct2021. The outcome of events was recovering.  Follow up(07Oct2021): no new event   Follow up(07Oct2021): new events (rash, swelling, soreness, itchy)  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling
Clinical narrative: I had a red rash around injection site which felt warm/ a red blotch around the injection site; It is 3 inches around swollen and itchy; It is 3 inches around swollen and itchy; The injection site is swollen mainly on Tuesday.; headache; antitrypsin deficiency; tired and weak/ Fatigue; tired and weak; the injection site was a little swollen and itchy.; My doctor said I had Lyme's disease and I got it from a tick.; Monday my arm became sore.; I had a red rash around injection site which felt warm; This is a spontaneous report from contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (FIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: not reported), dose 3 via an unspecified route of administration on 03Oct2021 14:00 as dose 3 (booster), single for covid-19 immunisation. Medical history included sepsis (she was hospitalized a few years ago with a blood infection). The patient concomitant medications were not reported. The patient previously took first dose of bnt162b2 on an unspecified date and then second dose of bnt162b2 on an unspecified date for covid-19 immunisation with reported reactions of headache, fatigue, asthenia, feeling abnormal. The patient experienced my doctor said i had lyme disease and i got it from a tick, monday my arm became sore, i had a red rash around injection site which felt warm on 04Oct2021; i had a red rash around injection site which felt warm/ a red blotch around the injection site, it is 3 inches around swollen and itchy, the injection site is swollen mainly on Tuesday, headache, antitrypsin deficiency, tired and weak/ fatigue, tired and weak, the injection site was a little swollen and itchy on 05Oct2021. The outcome of events was recovering.  Follow up(07Oct2021): no new event   Follow up(07Oct2021): new events (rash, swelling, soreness, itchy)  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.