chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage, Pyrexia
Clinical narrative: started her period/has not had a period in over a year/had been bleeding very bad on period/ hasn't had her period in over a year but she has been bleeding a lot down there; Fever/  Running a High Fever; This is a spontaneous report from a contactable consumer (patient's son). A 50-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 04May2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's son called to report that his mother received the second dose on an unspecified date and on 05May2021 she experienced a fever and has started her period. The reporter stated that the patient has not had a period in over a year. The patient had been bleeding very bad on period and she kept getting all that and she has been running a high fever. She hasn't had her period in over a year but she has been bleeding a lot down there. The reporter was wondering if he should take her to the hospital or if this was just normal. The patient did not receive treatment for the events. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac failure congestive
Clinical narrative: Congestive heart failure, in AFIB; Congestive heart failure, in AFIB; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on 21Apr2021 (at the age of 59-years-old) as 1 st dose, single for covid-19 immunisation. Prior to vaccination, patient was not diagnosed with COVID-19 and since vaccination, patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history and concomitant medications were not reported. The reported Events were congestive heart failure, in AFib on 03May2021, hospitalization not prolonged. The events resulted to emergency room/department or urgent care. Received unspecified treatment for the events. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Blood pressure increased, Blood pressure measurement, Cardiac monitoring, Echocardiogram
Clinical narrative: TIA/Mini stroke; Blood pressure went up to 240/130; Loss of memory; Everything is foggy; Lips and tongue started tingling; Stinging lips; She is not taking the second vaccine. She reported that the card has a reminder to return date to go back in April and states she did not go and is not going to get the 2nd dose; This is a spontaneous report from a contactable consumer (the patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in left arm on 21Mar2021 10:30 (at the age of 61 years old), 1st dose, single for COVID-19 immunization. Medical history included diabetes and ankle problem from an unknown date and unknown if ongoing, and bariatric sleeve from 2018 to an unknown date. Concomitant medications included all her normal medications and medications for high blood pressure (not specified). The patient reported that she was administered with the first dose of the vaccine on 21Mar2021 and on the same day, her lips and tongue started tingling during the observation period after the administration. The patient also reported a few days later on 02Apr2021 that she had a transient ischemic attack (TIA), which was also described as mini stroke. The patient also reported that she has not been administered the 2nd dose. She is not taking the second vaccine. She reported that the card has a reminder to return date to go back in April and states she did not go and is not going to get the 2nd dose. She also complained since day one on 21Mar2021 about the stinging lips and tingling tongue. She was hospitalized with the mini stroke, she was admitted 02Apr2021 and discharged 04Apr2021. Another thing was loss of memory on 02Apr2021, from the time the ambulance picked her up and took her to the local hospital she recalls that, but she doesn't recall that hospital to being transferred 6-7 hours later. She stated she doesn't recall anything, it's like a blank. She was transferred from one hospital to another and the 1st hospital she recalled getting there, her mom worked there, but she doesn't recall the 6 hours in between or the ambulance ride to a different town. She stated everything is foggy. She still has problems remembering, it's better but she still has problems remembering like if she is talking to somebody and gets sidetracked, she doesn't recall what she was saying. The patient reported that her blood pressure went up to 240/130 on 02Apr2021 when the ambulance picked her up. She reported that since 2018 her blood pressure was always normal until after the vaccination. The patient underwent a heart monitor, brain scan EEG, an MRI and echocardiogram/EKG on an unknown date, with unknown results. The outcome of the events "Stinging lips" and "Lips and tongue started tingling" was recovered on 02Apr2021, and unknown outcome for other events.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Electroencephalogram, Feeling abnormal, Lip pain, Magnetic resonance imaging, Paraesthesia oral
Clinical narrative: TIA/Mini stroke; Blood pressure went up to 240/130; Loss of memory; Everything is foggy; Lips and tongue started tingling; Stinging lips; She is not taking the second vaccine. She reported that the card has a reminder to return date to go back in April and states she did not go and is not going to get the 2nd dose; This is a spontaneous report from a contactable consumer (the patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in left arm on 21Mar2021 10:30 (at the age of 61 years old), 1st dose, single for COVID-19 immunization. Medical history included diabetes and ankle problem from an unknown date and unknown if ongoing, and bariatric sleeve from 2018 to an unknown date. Concomitant medications included all her normal medications and medications for high blood pressure (not specified). The patient reported that she was administered with the first dose of the vaccine on 21Mar2021 and on the same day, her lips and tongue started tingling during the observation period after the administration. The patient also reported a few days later on 02Apr2021 that she had a transient ischemic attack (TIA), which was also described as mini stroke. The patient also reported that she has not been administered the 2nd dose. She is not taking the second vaccine. She reported that the card has a reminder to return date to go back in April and states she did not go and is not going to get the 2nd dose. She also complained since day one on 21Mar2021 about the stinging lips and tingling tongue. She was hospitalized with the mini stroke, she was admitted 02Apr2021 and discharged 04Apr2021. Another thing was loss of memory on 02Apr2021, from the time the ambulance picked her up and took her to the local hospital she recalls that, but she doesn't recall that hospital to being transferred 6-7 hours later. She stated she doesn't recall anything, it's like a blank. She was transferred from one hospital to another and the 1st hospital she recalled getting there, her mom worked there, but she doesn't recall the 6 hours in between or the ambulance ride to a different town. She stated everything is foggy. She still has problems remembering, it's better but she still has problems remembering like if she is talking to somebody and gets sidetracked, she doesn't recall what she was saying. The patient reported that her blood pressure went up to 240/130 on 02Apr2021 when the ambulance picked her up. She reported that since 2018 her blood pressure was always normal until after the vaccination. The patient underwent a heart monitor, brain scan EEG, an MRI and echocardiogram/EKG on an unknown date, with unknown results. The outcome of the events "Stinging lips" and "Lips and tongue started tingling" was recovered on 02Apr2021, and unknown outcome for other events.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Transient ischaemic attack
Clinical narrative: TIA/Mini stroke; Blood pressure went up to 240/130; Loss of memory; Everything is foggy; Lips and tongue started tingling; Stinging lips; She is not taking the second vaccine. She reported that the card has a reminder to return date to go back in April and states she did not go and is not going to get the 2nd dose; This is a spontaneous report from a contactable consumer (the patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in left arm on 21Mar2021 10:30 (at the age of 61 years old), 1st dose, single for COVID-19 immunization. Medical history included diabetes and ankle problem from an unknown date and unknown if ongoing, and bariatric sleeve from 2018 to an unknown date. Concomitant medications included all her normal medications and medications for high blood pressure (not specified). The patient reported that she was administered with the first dose of the vaccine on 21Mar2021 and on the same day, her lips and tongue started tingling during the observation period after the administration. The patient also reported a few days later on 02Apr2021 that she had a transient ischemic attack (TIA), which was also described as mini stroke. The patient also reported that she has not been administered the 2nd dose. She is not taking the second vaccine. She reported that the card has a reminder to return date to go back in April and states she did not go and is not going to get the 2nd dose. She also complained since day one on 21Mar2021 about the stinging lips and tingling tongue. She was hospitalized with the mini stroke, she was admitted 02Apr2021 and discharged 04Apr2021. Another thing was loss of memory on 02Apr2021, from the time the ambulance picked her up and took her to the local hospital she recalls that, but she doesn't recall that hospital to being transferred 6-7 hours later. She stated she doesn't recall anything, it's like a blank. She was transferred from one hospital to another and the 1st hospital she recalled getting there, her mom worked there, but she doesn't recall the 6 hours in between or the ambulance ride to a different town. She stated everything is foggy. She still has problems remembering, it's better but she still has problems remembering like if she is talking to somebody and gets sidetracked, she doesn't recall what she was saying. The patient reported that her blood pressure went up to 240/130 on 02Apr2021 when the ambulance picked her up. She reported that since 2018 her blood pressure was always normal until after the vaccination. The patient underwent a heart monitor, brain scan EEG, an MRI and echocardiogram/EKG on an unknown date, with unknown results. The outcome of the events "Stinging lips" and "Lips and tongue started tingling" was recovered on 02Apr2021, and unknown outcome for other events.
Sex: F
Vaccine: COVID19
Symptoms: Embolic stroke
Clinical narrative: thromboembolic stroke; This is a spontaneous report from a contactable pharmacist. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at 1st dose, single for COVID-19 immunization. Medical history included hemophilia A. Concomitant medication included factor VII for hemophilia A. The patient with hemophilia A, usually gives herself activated factor VII before vaccines. So, she did, and a couple minutes later, she received the first dose of the Pfizer COVID vaccine. 48 minutes after, she suffered a thromboembolic stroke and was now hospitalized. The pharmacist was told by the patient as well as a biologist with Pfizer who has severe hemophilia that they read somewhere (unidentified source) that the Pfizer vaccine was contraindicated in people with bleeding disorders. The pharmacist would like to know, on behalf of a patient, whether the Pfizer COVID vaccine is contraindicated in persons with bleeding disorders such as hemophilia A. The outcome of the event was unknown.   Information on the lot/ batch number has been requested.; 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 thromboembolic stroke  cannot be totally 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: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis, Computerised tomogram, Urine analysis, White blood cell count
Clinical narrative: She was diagnosed with appendicitis; This is a spontaneous report received from a contactable consumer (parent; patient's mother). A 19-year-old female patient (daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 24Apr2021 at 11:00 (at the age of 19 years old) (Lot Number: ER8736, unknown expiration) as 1st dose, single for COVID-19 immunization.  Medical history and concomitant medication reported as none.  One week after the vaccine dose, the patient went to the ED with pain and vomiting on 02May2021. She was diagnosed with appendicitis after running some tests on 02May2021 and had her appendix has been removed on the same day she was admitted. The reporter asked if there was any further information about more patients getting appendicitis after the Pfizer vaccine and if the patient should get the second shot. One of her daughter's friends knew someone else who got the shot and got appendicitis, so the reporter wanted to know if it was a common side effect or coincidence. The reporter has no identifying information about her daughter's friend who knew someone that got the shot and had appendicitis. No additional vaccines administered on same date of the Pfizer suspect. They knew from the blood test something was wrong, the patient's WBC results were too high on 02May2021. The regular range was between 4.31-10.16 but the result was 22.03 units per microliter, she was not sure what the units mean. The patient's urine test results (unknown results) were not explained to the reporter and the CAT scan confirmed positive for appendicitis on 02May2021.  No prior vaccinations within 4 weeks. The patient was recuperating from it with no more complications. The events require emergency room visit. The patient was recovering from the events.  The events were assessed as serious (hospitalization from 02May2021 to 03May2021)  Information on lot/batch number was available. Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid after the first dose of the Pfizer Covid 19 Vaccine; tested positive for Covid after the first dose of the Pfizer Covid 19 Vaccine; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive for Covid after the first dose of the Pfizer Covid 19 Vaccine. The patient received remdesivir as treatment. The reporter asked if the patient can still receive the second dose of the vaccine. The outcome of the adverse events was unknown.  Information about the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective, COVID-19 and the suspect vaccine BNT162B2.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Flushing, Heart rate, Heart rate increased, Wheezing
Clinical narrative: difficulty breathing; face was flushed; heart rate went up; Wheezing; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left, at the age of 57 years, on 26Apr2021 (Batch/Lot Number: EW0170) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included autoimmune thyroiditis, allergies, hay fever, allergies to grasses, cheese and weeds; all from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN) taken for autoimmune thyroiditis, start and stop date were not reported and an unspecified Antihistamine. The patient stated that 45 minutes later (26Apr2021) he stated that his face was flushed, his heart was beating fast, he was wheezing and had difficulty breathing but, not severe. He states that these conditions were not serious enough to seek medical attention and reports that they were gone by the end of the next day. The patient reported 5 hours after shot at his symptoms were at about 50 percent of what they were, By the next morning, they were down to about 10 percent and by the end of the day, on 27Apr2021, they were gone. The patient would like to know if this will keep him from getting his second dose of the vaccine. The patient underwent lab tests and procedures which included heart rate: increase on 26Apr2021. The outcome of the events was recovered on 27Apr2021.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Muscle twitching
Clinical narrative: Bell's palsy; Eye twitching; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 27Jan2021 13:00 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. Medical history included high blood pressure and acid reflux. Other than those, patient was "pretty healthy." Patient was not diagnosed with COVID prior vaccination. Concomitant medications included irbesartan, pantoprazole, meloxicam, and biotin. Patient reported that she had Bell's palsy when she was in college. When she was teaching years later, she noticed that every year when she got the flu shot, her eye would twitch for about 8 or more weeks after the shot. She finally connected the fact that it was happening every year after the shot so she saw a neurologist. She was told that an egg derivative was used in the flu shot, which was connected to Epstein bar disease, which was connected to Bell's palsy. She was told to stop getting the flu shot so she quit getting the flu shot and never had another occurrence until after getting the COVID Pfizer shot. On 29Jan2021, the patient experienced bell's palsy and eye twitching. The twitch appeared a few days after getting the shot, but seemed mild enough, but as of late it has become quite an annoyance. The only thing she can attribute it to was the COVID vaccine. She was a little leery of getting a booster if necessary. No treatment was received. Outcome of the events was not recovered. Patient was not tested for COVID post vaccination.  Information about lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 screening, Fatigue, Pain in extremity, X-ray
Clinical narrative: Super tired; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8730), via an unspecified route of administration, administered in Arm Left on 29Mar2021 as 1st dose, single for COVID-19 immunization. Medical history included ongoing outbreaks on lip (oral herpes) began having outbreaks on her lip when she was 39. The patient had a family history of Fib (atrial fibrillation) from an unknown date reported that her mother has a fib but it's not genetic. Concomitant medication included valaciclovir hydrochloride taken for oral herpes from an unspecified start date and ongoing. On 29Mar2021, the patient experienced sore arm for 2 days and on 30Mar2021 experienced super tired. The reporter considered the events as medically significant. The patient underwent lab tests and procedures which included covid-19 screening: negative and X-ray: normal both on Apr2021. The outcome of the event sore arm was recovered on 31Mar2021 while for the event super tired was recovered on 30Mar2021.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Eating disorder, Oral discomfort, Speech disorder, Swollen tongue
Clinical narrative: mouth and tongue started feeling like she ate or drank something way too hot felt burning; mouth and tongue started feeling like she ate or drank something way too hot felt burning; tongue was swollen; tongue was swollen and really red; tongue was swollen and really red making it difficult to speak; can't taste plus eating was difficult; can't taste plus eating was difficult; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 30Apr2021 at 16:30 (Lot Number: EW0167) as 1st dose, single for covid-19 immunization, administered at the hospital. Medical history included rheumatoid arthritis. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient previously took Xarelto and experienced allergies: adverse reaction to Xarelto. On 01May2021 at 17:00, patient's mouth and tongue started feeling like she ate or drank something way too hot felt burning, have it another day or two and getting worse; her tongue was swollen and really red making it difficult to speak the swelling and redness was nearly an inch and can't taste plus eating was difficult because it feels like she burnt her mouth and very uncomfortable. The patient didn't have any of these symptoms before the vaccine and initially not worried as both of her daughters are nurses and has heard of it but nothing to this extreme. The patient was advised to contact her doctor on 07May2021 or if worse, urgent care. The events resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was not recovered.; Sender's Comments: Considering a plausible temporal relationship, a causal association between the reported events 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: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tongue discomfort, Tongue erythema
Clinical narrative: mouth and tongue started feeling like she ate or drank something way too hot felt burning; mouth and tongue started feeling like she ate or drank something way too hot felt burning; tongue was swollen; tongue was swollen and really red; tongue was swollen and really red making it difficult to speak; can't taste plus eating was difficult; can't taste plus eating was difficult; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 30Apr2021 at 16:30 (Lot Number: EW0167) as 1st dose, single for covid-19 immunization, administered at the hospital. Medical history included rheumatoid arthritis. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient previously took Xarelto and experienced allergies: adverse reaction to Xarelto. On 01May2021 at 17:00, patient's mouth and tongue started feeling like she ate or drank something way too hot felt burning, have it another day or two and getting worse; her tongue was swollen and really red making it difficult to speak the swelling and redness was nearly an inch and can't taste plus eating was difficult because it feels like she burnt her mouth and very uncomfortable. The patient didn't have any of these symptoms before the vaccine and initially not worried as both of her daughters are nurses and has heard of it but nothing to this extreme. The patient was advised to contact her doctor on 07May2021 or if worse, urgent care. The events resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was not recovered.; Sender's Comments: Considering a plausible temporal relationship, a causal association between the reported events 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: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gingival erythema, Oral discomfort, Oral mucosal erythema, Tongue erythema
Clinical narrative: mouth and tongue started feeling like she ate or drank something way too hot felt burning; mouth and tongue started feeling like she ate or drank something way too hot felt burning; tongue was swollen; tongue was swollen and really red; tongue was swollen and really red making it difficult to speak; can't taste plus eating was difficult; can't taste plus eating was difficult; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 30Apr2021 at 16:30 (Lot Number: EW0167) as 1st dose, single for covid-19 immunization, administered at the hospital. Medical history included rheumatoid arthritis. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient previously took Xarelto and experienced allergies: adverse reaction to Xarelto. On 01May2021 at 17:00, patient's mouth and tongue started feeling like she ate or drank something way too hot felt burning, have it another day or two and getting worse; her tongue was swollen and really red making it difficult to speak the swelling and redness was nearly an inch and can't taste plus eating was difficult because it feels like she burnt her mouth and very uncomfortable. The patient didn't have any of these symptoms before the vaccine and initially not worried as both of her daughters are nurses and has heard of it but nothing to this extreme. The patient was advised to contact her doctor on 07May2021 or if worse, urgent care. The events resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was not recovered.; Sender's Comments: Considering a plausible temporal relationship, a causal association between the reported events and suspect drug bnt162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid virus after first Covid vaccine; Tested positive for Covid virus after first Covid vaccine; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient's son). This consumer reported similar events for his parents. This is the 2nd of two reports.  A female patient of an unspecified age received bnt162b2 (Pfizer Covid 19 vaccine), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for Covid virus in 2021 after first Covid vaccine. Outcome of the events was unknown. The patient underwent lab tests and procedures which included COVID-19: positive in 2021.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021504750 same reporter, product and events, different patient
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bronchitis, Chest X-ray
Clinical narrative: Bronchitis; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6202; Expiration date was not reported) on the right arm, on 03Mar2021 (19:10) as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included pacemaker, high blood pressure, and was diabetic; all were ongoing. Concomitant medication included metformin. In Mar2021, after the first dose of vaccination, the patient had bronchitis. The patient's bronchitis got real bad, and he fought it for three to four weeks. The physician had given him some pills to be taken one every day, and a stronger steroid that had knocked the bronchitis out of the patient. The event, bronchitis, was assessed as serious (medically significant). The event had resulted into a physician office visit. The patient had a chest x-ray on an unspecified date in 2021 (results were not provided). The outcome of the event was recovered on 20Apr2021. The patient was scheduled to receive the second dose of vaccination on 24Mar2021 or 26Mar2021 ("or something like that"). The physician advised the patient to get the second dose until he was better from the bronchitis.  No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Magnetic resonance imaging head abnormal, Seizure
Clinical narrative: Seizure; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 17Mar2021 (Batch/Lot Number: EN6206) as 1ST DOSE, SINGLE and then on 14Apr2021 (Batch/Lot Number: ER8733) as 2ND DOSE, SINGLE; both dose administered via an unspecified route in the right arm for COVID-19 immunisation. The patient had no prior vaccinations within 4 weeks. Medical history included pain and inflammation and has a little problem hearing. The patient had no other medical history and no family medical history. Concomitant medication included ongoing etodolac taken for pain and inflammation. The patient was in good health and everything. He got the first shot on 17Mar2021, and 17 days later, he had a seizure on 04Apr2021. He has never had seizures in his whole life. He had the second vaccine on 14Apr2021 and had a second seizure 17 days later on 01May2021. Patient had both seizure in the afternoon. The patient further reported that he was taking a medicine that was supposed to keep him from having another seizure. It was Lev, and he can't read the rest. It looks like pmr, then acetam. He started taking that when he had the first seizure. The patient also mentioned that they did a brain magnetic resonance imaging (MRI) and bloodwork. He doesn't remember the exact date. The patient was taken to the emergency room by an ambulance. He was hospitalized both times. He doesn't remember how long he was in the hospital the first time. The second time he was there for 5 to 6 hours. They cut him loose pretty quick. The patient was first hospitalized from 04Apr2021 to an unknown date and then hospitalized again on 01May2021 for seizure. Therapeutic measures were taken as a result of seizure. The outcome of the event was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Coordination abnormal, Disorientation, Disturbance in attention, Dizziness, Fatigue
Clinical narrative: racing heart; dizziness; disorientation; blurred vision; forearm muscle pain/lower leg muscle pain; fatigue; loss of strength and coordination in fingers and arms/ residual arm & leg weakness; loss of coordination.; right lower lip became numb; difficulty with concentration; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient (non-pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in the right arm on 26Apr2021 at 02:30 AM as single dose for COVID-19 immunisation. Medical history included lumbar disc degeneration, spinal surgeries x2, stem cell injection (lumbar disc) a little over a year ago, allergies to shellfish. Concomitant medications reported as none. No other vaccine in four weeks. None other medications in two weeks. No Covid prior vaccination. No Covid tested post vaccination. On 26Apr2021 at 14:30 PM, (reported as after approx 15 min), racing heart, dizziness, disorientation, blurred vision (inability to focus), forearm muscle pain, fatigue affecting ability to perform my job, loss of strength and coordination in fingers and arms, right lower lip became numb, lower leg muscle pain and loss of coordination. Symptoms that continued to persist after 10 days were right lower lip numbness, difficulty with concentration and fatigue that was affecting my ability to perform my job, and some residual arm & leg weakness and coordination. Events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Unknown if treatment received for events. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Muscular weakness, Myalgia, Palpitations, Vision blurred
Clinical narrative: racing heart; dizziness; disorientation; blurred vision; forearm muscle pain/lower leg muscle pain; fatigue; loss of strength and coordination in fingers and arms/ residual arm & leg weakness; loss of coordination.; right lower lip became numb; difficulty with concentration; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient (non-pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in the right arm on 26Apr2021 at 02:30 AM as single dose for COVID-19 immunisation. Medical history included lumbar disc degeneration, spinal surgeries x2, stem cell injection (lumbar disc) a little over a year ago, allergies to shellfish. Concomitant medications reported as none. No other vaccine in four weeks. None other medications in two weeks. No Covid prior vaccination. No Covid tested post vaccination. On 26Apr2021 at 14:30 PM, (reported as after approx 15 min), racing heart, dizziness, disorientation, blurred vision (inability to focus), forearm muscle pain, fatigue affecting ability to perform my job, loss of strength and coordination in fingers and arms, right lower lip became numb, lower leg muscle pain and loss of coordination. Symptoms that continued to persist after 10 days were right lower lip numbness, difficulty with concentration and fatigue that was affecting my ability to perform my job, and some residual arm & leg weakness and coordination. Events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Unknown if treatment received for events. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Loss of consciousness, Magnetic resonance imaging, Memory impairment
Clinical narrative: stroke like symptoms; similar to migraines; mini-strokes; Passing Out; Blind spots in her vision; Nausea; Believes it effected her memory; stroke like symptoms; similar to migraines; mini-strokes; This is a spontaneous report received from a contactable consumer. A 59-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 16Apr2021 (Lot Number: EW0153; Expiration Date: 31Jul2021) as 1ST DOSE, SINGLE for covid-19 immunisation (Age at vaccination: 59 years).  Medical history included ongoing strokes, ongoing third and fourth Nerve Palsy. Concomitant medications included dabigatran etexilate mesilate (PRADAXA) taken for blood thinner; metoprolol for Stroke, Heart regulation; lovastatin taken for Stroke, Heart regulation. The patient states that she went to the Emergency Room on 17Apr2021 and then went again on either 18Apr2021 or 19Apr2021. The patient states she does not know if she was admitted or not. States that she thinks she just was in the emergency room the time that she was there. Says that after the Covid Vaccine she was having stroke like symptoms; similar to migraines; mini-strokes. She was passing out, had nausea, blind spots in her vision, and she believes it effected her memory. The events occurred on 17Apr2021. Also, she said on her first emergency room visit they did a CT Scan and on her second emergency room visit they did a MRI and both was not reported. States they told her there was no issues. The patient underwent lab tests and procedures which included CT Scan: and MRI: not reported on Apr2021. Outcome of the event vision impairment was not recovered while outcome of the event nausea was recovered on Apr2021. Outcome of the event memory impairment was recovering while outcome of the remaining events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Visual impairment
Clinical narrative: stroke like symptoms; similar to migraines; mini-strokes; Passing Out; Blind spots in her vision; Nausea; Believes it effected her memory; stroke like symptoms; similar to migraines; mini-strokes; This is a spontaneous report received from a contactable consumer. A 59-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 16Apr2021 (Lot Number: EW0153; Expiration Date: 31Jul2021) as 1ST DOSE, SINGLE for covid-19 immunisation (Age at vaccination: 59 years).  Medical history included ongoing strokes, ongoing third and fourth Nerve Palsy. Concomitant medications included dabigatran etexilate mesilate (PRADAXA) taken for blood thinner; metoprolol for Stroke, Heart regulation; lovastatin taken for Stroke, Heart regulation. The patient states that she went to the Emergency Room on 17Apr2021 and then went again on either 18Apr2021 or 19Apr2021. The patient states she does not know if she was admitted or not. States that she thinks she just was in the emergency room the time that she was there. Says that after the Covid Vaccine she was having stroke like symptoms; similar to migraines; mini-strokes. She was passing out, had nausea, blind spots in her vision, and she believes it effected her memory. The events occurred on 17Apr2021. Also, she said on her first emergency room visit they did a CT Scan and on her second emergency room visit they did a MRI and both was not reported. States they told her there was no issues. The patient underwent lab tests and procedures which included CT Scan: and MRI: not reported on Apr2021. Outcome of the event vision impairment was not recovered while outcome of the event nausea was recovered on Apr2021. Outcome of the event memory impairment was recovering while outcome of the remaining events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Computerised tomogram, Constipation, Dyspnoea, Fluid retention
Clinical narrative: Shortness of breath; Unable to pass stool; Extreme water retention; Excessive mucus drainage; swollen legs, feet ,thighs and stomach that remains after 4 visits to ER not resolved; swollen legs, feet ,thighs and stomach that remains after 4 visits to ER not resolved; This is a spontaneous report from contactable consumer (patient) reported for himself. A 54-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 08Apr2021 14:00 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunization, at the age of vaccination of 54 years old.  Medical history included sleep apnoea syndrome, irritable bowel syndrome, high blood pressure, congestive heart failure, diabetes. Patient known allergies included Sulfa drugs and Lisinopril. Concomitant medications included metformin; hydrochlorothiazide, omeprazole, Blood the (as reported), all taken for an unspecified indication, start and stop date were not reported.  The patient experienced shortness of breath after 2 min walk, unable to pass stool, extreme water retention, excessive mucus drainage, swollen legs, feet ,thighs and stomach that remains after 4 visits to ER not resolved, all on an unspecified date with outcome of not recovered.  The patient was hospitalized for events for 4 days. The patient underwent lab tests which included computerised tomogram Cat scan): unknown result magnetic resonance imaging (MRI): unknown result, x-ray: unknown result, all on unknown date. No other vaccine in four weeks. The events resulted in: Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. Treatment received for events. No Covid prior vaccination. No Covid tested post vaccination.  Information about the Lot/batch number has been requested.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Peripheral swelling, Secretion discharge, X-ray
Clinical narrative: Shortness of breath; Unable to pass stool; Extreme water retention; Excessive mucus drainage; swollen legs, feet ,thighs and stomach that remains after 4 visits to ER not resolved; swollen legs, feet ,thighs and stomach that remains after 4 visits to ER not resolved; This is a spontaneous report from contactable consumer (patient) reported for himself. A 54-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 08Apr2021 14:00 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunization, at the age of vaccination of 54 years old.  Medical history included sleep apnoea syndrome, irritable bowel syndrome, high blood pressure, congestive heart failure, diabetes. Patient known allergies included Sulfa drugs and Lisinopril. Concomitant medications included metformin; hydrochlorothiazide, omeprazole, Blood the (as reported), all taken for an unspecified indication, start and stop date were not reported.  The patient experienced shortness of breath after 2 min walk, unable to pass stool, extreme water retention, excessive mucus drainage, swollen legs, feet ,thighs and stomach that remains after 4 visits to ER not resolved, all on an unspecified date with outcome of not recovered.  The patient was hospitalized for events for 4 days. The patient underwent lab tests which included computerised tomogram Cat scan): unknown result magnetic resonance imaging (MRI): unknown result, x-ray: unknown result, all on unknown date. No other vaccine in four weeks. The events resulted in: Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. Treatment received for events. No Covid prior vaccination. No Covid tested post vaccination.  Information about the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Off label use, Product use issue, Vaccination site pain
Clinical narrative: breasfeeding mom; breasfeeding mom; Pain at injeciton site; Back pain; This is a spontaneous report from a contactable consumer (patient's husband) via a Pfizer sponsored program. This consumer reported for information for both mother and baby. This is the maternal report. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on May2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient's medical hisrtory and  concomitant medications were not reported. Reporter stated they were concerned of lack of effect. She received the 2nd dose of the covid vaccine 2 days ago (May2021), she had pain at the injection site, back pain, and she was a breasfeeding mom on May2021. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021506631 baby case