chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Coagulopathy, Hypertension, Interchange of vaccine products, Off label use
Clinical narrative: High blood pressure; clotting disorder; did change and get a different vaccine.; did change and get a different vaccine.; This is a spontaneous report from a contactable consumer (Patient) or other non-HCP.  A male patient of an unspecified age received dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced High blood pressure, clotting disorder and did change and get a different vaccine. Additional Information: After getting 1st dose on 11Mar2021, basically 4.5 minutes after first dose, the patient had an increase in blood pressure and spike in pulse, High blood pressure and pulse lasted a couple of months, until May. She also had a clotting disorder. She wanted to know if these were normal side effects and how long can they last long after the vaccine. Was it safe to get the second dose. Can she switch to a different vaccine. Her doctor said it was not safe. Her Doctor spoke to the pharmacist and said she cant switch to another brand. Callers doctor told her that the pharmacist put information in VAERS, it was not specific. Her name was not on the report. When she called the CDC, they were concerned they didn't document symptoms as they occurred, she reported all medications including blood thinner she was on. The pharmacist was minimizing and said that her blood pressure was only 150. She states that in fact it continued to 200, she usually run 130/80. She said she did not want anyone to have to go through this. She was good with having another vaccine when she knew, she did not have a response. As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. The clinical outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: second dose was administered this past March/ A few weeks age we both contracted the virus; second dose was administered this past March/ A few weeks age we both contracted the virus; This is a spontaneous report from a contactable consumer. This consumer reported similar events for himself and his wife. A male patient of an unspecified age received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration in Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that, on an unknown date, a few weeks before this report, he contracted the virus (COVID-19). He was not aware he had the virus and infected one of his friends. He could have infected other people. Luckily, he got out the alarm and they were all self-isolated. He doesn't remember ever hearing the virus could be disseminated by a vaccinated person. The event outcome was unknown at the time of the report.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101419694 Same reporter/vaccine/event, different patient
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: tested positive for Covid-19/runny nose and sore throat began; tested positive for Covid-19/runny nose and sore throat began; This is a spontaneous report from a contactable pharmacist (patient). A non-pregnant 40-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose, intramuscularly, administered in arm left on 05Mar2021 10:00 (Lot Number: EN6205) at the age of 40 years old, as dose 1, single dose, and second dose, intramuscularly, administered in arm left on 26Mar2021 10:00 (Lot Number: ER8727) at the age of 40 years old, as dose 2, single dose for covid-19 immunisation. Medical history included known allergies: Penicillin, Sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. There was no other vaccine in four weeks. Other medications in two weeks includes multivitamin. On 13Oct2021, runny nose and sore throat began. On 14Oct2021, tested positive for Covid-19 (Nasal Swab). Events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Vaccination failure and COVID-19  cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: a few weeks ago we both contracted the virus; a few weeks ago we both contracted the virus; This is a spontaneous report from a contactable consumer (reporter's wife) A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient a few weeks ago "we both contracted the virus" in 2021 with outcome of unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101426769 same reporter and event, different patient.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Immunisation, Maternal exposure during pregnancy, Pain
Clinical narrative: Arm Soreness; Body aches; Chills; Fatigue; Maternal exposure during pregnancy, second trimester; Received third dose of vaccine; This is a spontaneous report from a contactable pharmacist. A 31-year-old pregnant female patient received third dose (booster) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an intramuscular route of administration in the left arm on 20Oct2021 at 16:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to sulfa. The patient was 29 weeks pregnant and the due date was 01Jan2022. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was reported at eluxadoline (VIBERZI) from an unknown date, for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6000), via an unspecified route of administration on 25Mar2021 (at the age of 30-years-old), as a single dose for COVID-19 immunisation and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN8730), via an unspecified route of administration on 16Apr2021 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. On 21Oct2021 at 02:00 the patient experienced arm soreness, body aches, chills, and fatigue for approximately 24 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events which included treatment with acetaminophen (MANUFACTURER UNKNOWN) on an unknown date and unknown if ongoing. The clinical outcome of the events arm soreness, body aches, chills, and fatigue was resolved on an unknown date in Oct2021.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm Soreness; Body aches; Chills; Fatigue; Maternal exposure during pregnancy, second trimester; Received third dose of vaccine; This is a spontaneous report from a contactable pharmacist. A 31-year-old pregnant female patient received third dose (booster) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an intramuscular route of administration in the left arm on 20Oct2021 at 16:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to sulfa. The patient was 29 weeks pregnant and the due date was 01Jan2022. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was reported at eluxadoline (VIBERZI) from an unknown date, for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6000), via an unspecified route of administration on 25Mar2021 (at the age of 30-years-old), as a single dose for COVID-19 immunisation and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN8730), via an unspecified route of administration on 16Apr2021 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. On 21Oct2021 at 02:00 the patient experienced arm soreness, body aches, chills, and fatigue for approximately 24 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events which included treatment with acetaminophen (MANUFACTURER UNKNOWN) on an unknown date and unknown if ongoing. The clinical outcome of the events arm soreness, body aches, chills, and fatigue was resolved on an unknown date in Oct2021.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness
Clinical narrative: covid positive; covid positive; still very sick; This is a spontaneous report from a contactable consumer (patient's sister). A female patient of an unspecified age 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 and bnt162b2 (COMIRNATY, 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 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced covid positive, still very sick. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on unspecified date. Outcome of the events was unknown.  The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: PCR results Tested Positive for COVID-19 on 10/2.; PCR results Tested Positive for COVID-19 on 10/2.; This is a spontaneous report from a contactable consumer, the patient. This 43-year-old male patient reported that he received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot: EL3247, Expiry date: 31May2021) in the left arm on 22Feb2021 (at the age of 42-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot: EL3247, Expiry date: 31May2021) in the left arm on 15Mar2021 (at the age of 42-years-old); both via intramuscular route as single doses for COVID-19 immunization. The patient had no medical history and no known allergies. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient tested positive for COVID-19. Date of start of reaction/event was reported as 28Sep2021. The adverse event resulted in doctor or other healthcare professional office/clinic visit. There was no treatment received. Lab data included COVID-19 test PCR nasal swab on 29Sep2021 with positive result and COVID-19 test PCR on 02Oct2021 with positive result. The outcome of the event was recovered with lasting effects. Since the vaccination, the patient has been tested for COVID-19.   Investigation results were received from the Product Quality complaints Group for compound BNT162B2 COVID-19 vaccine suspension for intramuscular 2ML multiple dose vial x1, Lot-# (CR): EL3247. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EL3247 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of  complaint history for the reported lot. The final scope included the reported finished goods lot EL3247, fill lot EL3230, and the formulated drug product lot EL3223. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Follow-up (29Oct2021): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: lost parent to Covid; lost parent to Covid; This is a spontaneous report from a non-contactable consumer (daughter) via sales representative. This consumer reported similar events for both parents. This is one of her parents cases. 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. The daughter recently lost parent to covid and not sure if this was a fresh or the vaccine side effects. The outcome of events was fatal. 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.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101440332 same drug and AE., different patient; Reported Cause(s) of Death: lost parent to Covid; lost parent to Covid
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cardiac disorder, Cardiac flutter, Feeling abnormal, Heart rate
Clinical narrative: feeling funny, like my heart is fluttery; feeling funny, like my heart is fluttery; make my heart rate go up. Almost like my heart is weak; make my heart rate go up. Almost like my heart is weak; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported, expiry date: unknown) as dose number unknown, single for COVID-19 immunisation. Medical history included covid-19 from 25Nov2020 to an unknown date (I had Covid back in 25Nov2020). 3 months later in Mar2021, had an episode in which my blood pressure went up very high one time, lasted a couple of days and then went back to normal. The patient's concomitant medications were not reported. On unspecific date in 2021 the patient experienced feeling funny, like my heart is fluttery, and make my heart rate go up almost like my heart is weak.  Patient received the Pfizer Covid vaccine in April, and ever since have been feeling funny, like her heart was fluttery, don't have pain or short of breath. it feels better when go for a walk, and make my hear rate go up. Almost like my heart is weak". Had these side effects been reported. Patient was asking whether she need the booster shot, she don't have any medical conditions, and do not feel like Ineed it. On an unspecific date the patient underwent lab tests and procedures which included blood pressure measurement: normal went back to normal, and heart rate: go up on my heart rate go up. Almost like my heart is weak. On Mar2021blood pressure measurement: high ;blood pressure went up very high one time, lasted a couple of days. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.  No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: feeling funny, like my heart is fluttery; feeling funny, like my heart is fluttery; make my heart rate go up. Almost like my heart is weak; make my heart rate go up. Almost like my heart is weak; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported, expiry date: unknown) as dose number unknown, single for COVID-19 immunisation. Medical history included covid-19 from 25Nov2020 to an unknown date (I had Covid back in 25Nov2020). 3 months later in Mar2021, had an episode in which my blood pressure went up very high one time, lasted a couple of days and then went back to normal. The patient's concomitant medications were not reported. On unspecific date in 2021 the patient experienced feeling funny, like my heart is fluttery, and make my heart rate go up almost like my heart is weak.  Patient received the Pfizer Covid vaccine in April, and ever since have been feeling funny, like her heart was fluttery, don't have pain or short of breath. it feels better when go for a walk, and make my hear rate go up. Almost like my heart is weak". Had these side effects been reported. Patient was asking whether she need the booster shot, she don't have any medical conditions, and do not feel like Ineed it. On an unspecific date the patient underwent lab tests and procedures which included blood pressure measurement: normal went back to normal, and heart rate: go up on my heart rate go up. Almost like my heart is weak. On Mar2021blood pressure measurement: high ;blood pressure went up very high one time, lasted a couple of days. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.  No follow-up attempts possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Red blood cell abnormality
Clinical narrative: red blood cell problems; This is a spontaneous report from a contactable consumer or other non hcp (patient's daughter). This is the report for the reporter's father. A male patient of an unspecified age received a dose of bnt162b2 (COMIRNATY, formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date patient experienced red blood cell problems. The patient underwent lab tests and procedures which included red blood cell was unknown results. The outcome of event was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.  Follow-up activities closed. Batch/lot number not available for [vaccine/BNT162B2].
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Magnetic resonance imaging, Nausea, SARS-CoV-2 test, Vaccination site hypoaesthesia
Clinical narrative: nausea; pain and numbness at the injection site (left arm); pain and numbness at the injection site (left arm); pain and numbness at the injection site (left arm); vomiting; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration, administered in Arm Left on 13Jan2021 08:30 (Lot Number: EK9231, expiration date unknown) at age of 49 years old as a single dose for covid-19 immunisation.  Medical history included known allergies: Penicillin. The patient's concomitant medications were not reported. The day of his first shot, the patient experienced nausea, pain and numbness at the injection site (left arm), vomiting, all on 13Jan2021 08:30. The patient underwent lab tests and procedures which included MRI (magnetic resonance imaging): unknown results, x-ray: unknown results, both on an unknown date, Nasal Swab: negative on 01Sep2021. Therapeutic measures were taken as a result of all events. The outcome of the events was not recovered. All events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. All events were reported as being life threatening and disability. The patient was not COVID prior vaccination. There was no other vaccine in four weeks. No other medications received in two weeks. Clinical course: The day of patient's first shot, he experienced nausea, pain and numbness at the injection site (left arm), and vomiting. It subsided a few days later. After his second dose, experienced the same discomfort; with the exception of symptoms and pain lasting longer, and more frequently. In Aug2021, he begin experiencing more pain and numbness in his left arm, chest, hand/fingers. In Oct, the pain became unbearable, so he went to the emergency room at which time an MRI was administered. he was informed he had a blood clot in his left ring finger, and possibly thrombosis. He had sense been prescribed blood thinner, pain medications, and a referral to a hand and a blood specialist.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting, X-ray
Clinical narrative: nausea; pain and numbness at the injection site (left arm); pain and numbness at the injection site (left arm); pain and numbness at the injection site (left arm); vomiting; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration, administered in Arm Left on 13Jan2021 08:30 (Lot Number: EK9231, expiration date unknown) at age of 49 years old as a single dose for covid-19 immunisation.  Medical history included known allergies: Penicillin. The patient's concomitant medications were not reported. The day of his first shot, the patient experienced nausea, pain and numbness at the injection site (left arm), vomiting, all on 13Jan2021 08:30. The patient underwent lab tests and procedures which included MRI (magnetic resonance imaging): unknown results, x-ray: unknown results, both on an unknown date, Nasal Swab: negative on 01Sep2021. Therapeutic measures were taken as a result of all events. The outcome of the events was not recovered. All events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. All events were reported as being life threatening and disability. The patient was not COVID prior vaccination. There was no other vaccine in four weeks. No other medications received in two weeks. Clinical course: The day of patient's first shot, he experienced nausea, pain and numbness at the injection site (left arm), and vomiting. It subsided a few days later. After his second dose, experienced the same discomfort; with the exception of symptoms and pain lasting longer, and more frequently. In Aug2021, he begin experiencing more pain and numbness in his left arm, chest, hand/fingers. In Oct, the pain became unbearable, so he went to the emergency room at which time an MRI was administered. he was informed he had a blood clot in his left ring finger, and possibly thrombosis. He had sense been prescribed blood thinner, pain medications, and a referral to a hand and a blood specialist.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough case of SARS-CoV2. 26OCt2021; Breakthrough case of SARS-CoV2. 26Oct2021; This is a spontaneous report from a contactable consumer (patient). A 46-years-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 intramuscular, administered in Arm Right on 17Feb2021 (at the age of 46-years-old) (Batch/Lot Number: EN5318) as DOSE 2, SINGLE, dose 1 intramuscular, administered in Arm Right on 27Jan2021 (Batch/Lot Number: EN5318) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced breakthrough case of sars-cov2 (vaccination failure) on 26Oct2021 20:00. The patient underwent lab tests and procedures which included rapid COVID-19 Antigen test (Nasal Swab) was positive on 26Oct2021. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any treatment for adverse event. Prior vaccination patient did not tested for covid. Seriousness of event was reported as non serious by the reporter. Outcome of event was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Fatigue, Nasal congestion, Pulmonary embolism, Pyrexia
Clinical narrative: a Acute MI of the LAD; pulmonary embolism that resulted in sudden death; sudden death; symptoms of fatigue; fever; congestion; This is a spontaneous report from a contactable consumer (patient's wife) reported for her husband (the patient). A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 27Sep2021 10:00 (Lot Number: 301358A) at the age of 62-year-old as single dose for covid-19 immunization at a Pharmacy or Drug Store. Medical history included COVID prior vaccination, Asthma, Atrial fibrillation (A-fib), Hyperlipidemia, bradycardia, Obstructive Sleep Apnea, Mild mitral and tricuspid regurgitation. No known allergies. Concomitant medications included apixaban (ELIQUIS); atorvastatin calcium (LIPITOR); digoxin; flecainide; and tadalafil (CIALIS); all taken for unspecified indications, start and stop dates were not reported. No other vaccine in four weeks. Historical vaccine included bnt162b2, dose 1 on 06Sep2021 11:00 (Lot Number: 301308A) at the age of 62-year-old for covid-19 immunization. The reporter's husband had a Acute MI (myocardial infarction) of the LAD (left anterior descending) on 03Oct2021, six days after second Covid-19 and pulmonary embolism that resulted in sudden death. He experienced symptoms of fatigue, fever, congestion after both vaccines. The above mentioned events were reported as started from On 03Oct2021 17:30, and resulted in patient died. No treatment for the above mentioned events. The patient died on 03Oct2021. Also reported death causes as Acute MI and pulmonary embolism. An autopsy was performed that remarked "Acute MI to LAD". No COVID tested post vaccination.; Reported Cause(s) of Death: congestion; fever; sudden death; symptoms of fatigue; pulmonary embolism; a Acute MI of the LAD; Autopsy-determined Cause(s) of Death: Acute MI to LAD
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Sudden death
Clinical narrative: a Acute MI of the LAD; pulmonary embolism that resulted in sudden death; sudden death; symptoms of fatigue; fever; congestion; This is a spontaneous report from a contactable consumer (patient's wife) reported for her husband (the patient). A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 27Sep2021 10:00 (Lot Number: 301358A) at the age of 62-year-old as single dose for covid-19 immunization at a Pharmacy or Drug Store. Medical history included COVID prior vaccination, Asthma, Atrial fibrillation (A-fib), Hyperlipidemia, bradycardia, Obstructive Sleep Apnea, Mild mitral and tricuspid regurgitation. No known allergies. Concomitant medications included apixaban (ELIQUIS); atorvastatin calcium (LIPITOR); digoxin; flecainide; and tadalafil (CIALIS); all taken for unspecified indications, start and stop dates were not reported. No other vaccine in four weeks. Historical vaccine included bnt162b2, dose 1 on 06Sep2021 11:00 (Lot Number: 301308A) at the age of 62-year-old for covid-19 immunization. The reporter's husband had a Acute MI (myocardial infarction) of the LAD (left anterior descending) on 03Oct2021, six days after second Covid-19 and pulmonary embolism that resulted in sudden death. He experienced symptoms of fatigue, fever, congestion after both vaccines. The above mentioned events were reported as started from On 03Oct2021 17:30, and resulted in patient died. No treatment for the above mentioned events. The patient died on 03Oct2021. Also reported death causes as Acute MI and pulmonary embolism. An autopsy was performed that remarked "Acute MI to LAD". No COVID tested post vaccination.; Reported Cause(s) of Death: congestion; fever; sudden death; symptoms of fatigue; pulmonary embolism; a Acute MI of the LAD; Autopsy-determined Cause(s) of Death: Acute MI to LAD
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Renal failure, SARS-CoV-2 test
Clinical narrative: Renal failure; This is spontaneous report from a contactable consumer (patient). An 18-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the second dose via an unspecified route of administration on 23May2021 (Batch/Lot Number: EW0177) as single dose for covid-19 immunisation. Medical history included reaction: allergy from an unknown date, COVID-19 from unspecified date (Prior to vaccination, was the patient diagnosed with COVID-19?: Yes). Concomitant medications were reported as none. No other vaccine in four weeks. No other medications in two weeks. The patient previously received the first dose of BNT162B2 (Batch/Lot No: Er8734) on 29Apr2021 at the age of 18 years old for COVID-19 Immunization. The patient experienced renal failure on 04Jun2021. The patient was hospitalized for renal failure for 11 days. Treatment received included blood transfusions and dialysis. The event resulted in Emergency room/department or urgent care. The event was reported as serious due to hospitalization and life-threatening. The patient underwent lab tests and procedures which included Nasal Swab: negative on 02Jul2021. Therapeutic measures were taken as a result of renal failure. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Ewing's sarcoma, Pleural effusion, Pyrexia, SARS-CoV-2 test
Clinical narrative: Ewing Sarcoma in 3 tumor surrounding right lung; fever; persistent cough; Pleural effusion; scoliosis; This is a spontaneous report from a contactable consumer (patient). This 14-year-old female patient received the second dose of  BNT162B2 (lot number unknown) at left arm at single dose for COVID-19 immunisation on 17Jun2021 at 15:00. Relevant history included known allergies to Etoposide chemo medicine. Relevant concomitant drug was unknown. The patient previously received the first dose of BNT162B2 for COVID-19 immunisation on 27May2021 at 15:00  at left arm. The patient was not pregnant. The patient was  diagnosed as scoliosis in Jul2021.  On 16Aug2021, the patient experienced persistent cough and fever, then emergency visit to hospital for pleural effusion from lung cavity and diagnosis of Ewing Sarcoma in 3 tumor surrounding right lung.  The events resulted in Emergency room/department or urgent care.  The patient was hospitalized for 35 days. The events were considered as life-threatening.  Treatment therapy included Chemotherapy. The outcome of event scoliosis was unknown. The outcome of other events was not resolved. Lab tests included Covid-19 RT-PCR test on 20Aug2021 with negative result (Nasal Swab),  COVID-19 PCR COMBO on 10Sep2021 and on 27Oct2021, both with negative result (Nasal Swab), RAPID SARS-COV-2 on 13Oct2021 with negative result (Nasal Swab).  The patient did not receive any other vaccines within 4 weeks prior to the COVID.  The patient did not receive any other medications within 2 weeks of vaccination.  Prior to vaccination, the patient was not diagnosed with COVID-19.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Scoliosis
Clinical narrative: Ewing Sarcoma in 3 tumor surrounding right lung; fever; persistent cough; Pleural effusion; scoliosis; This is a spontaneous report from a contactable consumer (patient). This 14-year-old female patient received the second dose of  BNT162B2 (lot number unknown) at left arm at single dose for COVID-19 immunisation on 17Jun2021 at 15:00. Relevant history included known allergies to Etoposide chemo medicine. Relevant concomitant drug was unknown. The patient previously received the first dose of BNT162B2 for COVID-19 immunisation on 27May2021 at 15:00  at left arm. The patient was not pregnant. The patient was  diagnosed as scoliosis in Jul2021.  On 16Aug2021, the patient experienced persistent cough and fever, then emergency visit to hospital for pleural effusion from lung cavity and diagnosis of Ewing Sarcoma in 3 tumor surrounding right lung.  The events resulted in Emergency room/department or urgent care.  The patient was hospitalized for 35 days. The events were considered as life-threatening.  Treatment therapy included Chemotherapy. The outcome of event scoliosis was unknown. The outcome of other events was not resolved. Lab tests included Covid-19 RT-PCR test on 20Aug2021 with negative result (Nasal Swab),  COVID-19 PCR COMBO on 10Sep2021 and on 27Oct2021, both with negative result (Nasal Swab), RAPID SARS-COV-2 on 13Oct2021 with negative result (Nasal Swab).  The patient did not receive any other vaccines within 4 weeks prior to the COVID.  The patient did not receive any other medications within 2 weeks of vaccination.  Prior to vaccination, the patient was not diagnosed with COVID-19.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Thrombocytopenia
Clinical narrative: Severe thrombocytopenia (life-threatening); This is a spontaneous report from a contactable pharmacist. A 24-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FD8448), via an unspecified route of administration at the age of 24-year-old administered in arm left on 04Sep2021 at single dose for covid-19 immunisation. Medical history included obesity. The patient's concomitant medications were not reported. There was no other vaccine in four weeks. The patient previously received first dose of BNT162B2(COMIRNATY, Batch/Lot number: FD8448) at the age of 24-year-old on 14Aug2021 at left arm for COVID-19 immunisation. The patient experienced severe thrombocytopenia on 12Sep2021. Adverse event resulted in Emergency room/department or urgent care, hospitalization and life threatening. The patient was hospitalized for event for 16 days. The patient underwent lab tests COVID-19 Rapid Abbott IDNow: negative on 22Oct2021. Adverse event was treatment included a lot of medications and products. The outcome of event was recovering.; Sender's Comments: Based on the temporal relationship the role of the vaccine BNT162B2 in contributing to the reported event severe thrombocytopenia cannot be completely 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: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest
Clinical narrative: Cardiac arrest; This is a spontaneous report from a contactable physician. A 28-year-old female patient received the third dose of BNT162B2 at 28-year-old, intramuscularly on 01Oct2021 (Batch/Lot Number: EW0168) at single dose (booster) for COVID-19 immunisation. Medical history was none. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ethinylestradiol/ferrous fumarate/norethisterone (NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously received the first dose of BNT162B2, intramuscularly on 03Jan2021 (lot number: EL0142) at 27-year-old, and the second dose intramuscularly on 23Jan2021 (lot number: EL9262) at 27-year-old for COVID-19 immunisation. The patient experienced cardiac arrest on 15Oct2021. Unwitnessed at home. When found, patient passed away already without any signs of calling 911 or rescue. No treatment received. Since the vaccination, the patient had not been tested for COVID-19. The patient died on 15Oct2021. An autopsy was performed and results were not provided.; Reported Cause(s) of Death: Cardiac arrest
Age: 61.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Deafness unilateral, Magnetic resonance imaging, Nausea, Vertigo
Clinical narrative: Left ear hearing loss; Vertigo; Nausea; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 intramuscular, administered in Arm Left on 16Oct2021 11:30 (Batch/Lot Number: FF2590) as DOSE 3 (BOOSTER), SINGLE (at the age of 61 years) for covid-19 immunisation. Medical history included ongoing diabetes and ongoing hypertension. Concomitant medications included influenza vaccine (FLU VACCINE VII); lisinopril (LISINOPRIL); and metformin (METFORMIN), all taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of BNT162B2 on 01Mar2021 (Lot: EL-3247) and second dose on 24Mar2021 (lot: EP-6955) for Covid-19 immunisation. The patient experienced left ear hearing loss, vertigo and nausea on 19Oct2021 07:30. The patient was hospitalized from Oct2021 to Oct2021 due to the events. The patient underwent lab tests and procedures which included magnetic resonance imaging (MRI): unknown results in 2021, and  sars-cov-2 test via nasal swab: negative on 21Oct2021. Therapeutic measures were taken as a result of the events (treatment reported as IV, MRI, sofran etc). It was also reported that the events resulted to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome of the events was not recovered.    Follow-up attempts are completed. No further information is expected. Information about batch/lot already obtained.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Died from heart inflammation two months after receiving his Pfizer Covid-19 vaccine; This is a spontaneous report from a contactable consumer. A male patient (Reporter's uncle) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (Batch/Lot Number: Unknown) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. He had died from heart inflammation two months after receiving his Pfizer COVID-19 vaccine. It is unknown if autopsy was done. Outcome of the event was fatal.  Reporter implied that the two were related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: heart inflammation
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymph node pain, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Swollen lymph node under left armpit; Swollen lymph node under left armpit, painful!; Booster; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration in the left arm on 29Oct2021 at 17:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included lactose allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included unspecified medication for birth control (MANUFACTURER UNKNOWN) from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 24Feb2021 at 13:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 17Mar2021 at 13:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. On 30Oct2021 at 05:00, the patient experienced swollen lymph node under left armpit which was painful. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in Oct2021, the patient underwent test for COVID-19 via nasal swab test and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event swollen lymph node under left armpit which was painful was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Neuralgia
Clinical narrative: ear pain on the side I got the shot; neuralgia on the inside of my head; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 19Feb2021 (Batch/Lot number was not reported, age at the time of vaccination: 70-year-old) as DOSE 1, SINGLE for covid-19 immunisation.The patient medical history and concomitant medications were not reported.The patient experienced ear pain on the side i got the shot, neuralgia on the inside of my head on 19Feb2021.The patient received her first Pfizer Covid-19 Vaccination last Friday, 19FEB2021. On Friday night (19Feb2021) she began experiencing "ear pain on the side I got the shot, in my scull, like you would brush your head, like neuralgia on the inside of my head." Patient stated the pain is still there and asked was this common. And also asked if there is any information regarding MRI with contrast? Would an MRI with contrast interfere with the efficacy of the vaccine? Should she wait till after she get her second vaccine to get the MRI. The outcome of events was reported as not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Musculoskeletal stiffness
Clinical narrative: some difficulty swallowing; neck stiffness; This is a spontaneous report from a non-contactable consumer or other non hcp (patient).  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date: unknown) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. Patient medical history included high blood pressure, diabetes mellitus and swollen lymph nodes.Concomitant medications were not reported. On an unspecified date, patient stated he had some neck stiffness and some difficulty swallowing. He said he knew that these might be due to swollen lymph nodes but it was only on the left side and he got injected on the right side. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route, administered in left arm on 25Feb2021 at 13:30 as Dose 1, Single (at the age of 45-year-old) for Covid-19 immunization at workplace clinic. Medical history included covid-19 prior to vaccination. The patient had no known allergies. The patient had received other medicine (unspecified) within two weeks of vaccination. The patient had no received other vaccine in four weeks prior to vaccination. The patient was not tested Covid post vaccination. On 26Feb2021 05:30, the patient experienced sore throat. AE did not resulted in emergency room/physician visit. The patient had not received any treatment medication for resulted event. The outcome of the event was not recovered.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Pain in extremity
Clinical narrative: arm sore but it's not unbearable (muscle pain); he's also very tired but not overly tired; he slept all day; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, 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 immunisation. The patient medical history and concomitant medications were not reported. On unknown date the patient experienced arm sore but it's not unbearable (muscle pain), he's also very tired but not overly tired, he slept all day. He doesn't have chills or joint pain. 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.