chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: I started having whole body hives which is like your body is like burning and itching; I started having whole body hives which is like your body is like burning and itching; I started having whole body hives which is like your body is like burning and itching; I am having this allergy; My skin has rashes and it is red and itchy; My skin has rashes and it is red and itchy; So, then after my second vaccination, I started to have it much often; After this vaccination my system went very down; I am scared to die after this vaccination; I can't work right now; This is a spontaneous report received from a contactable consumer (patient).A 31-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 19Apr2021 (Batch/Lot Number: EW0170) as 2nd dose, single for covid-19 immunization.The patient received first dose of BNT162 (PFIZ-ER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: ER8730, Expiration date: unknown), via unspecified route of administration on 22Mar2021 as 1st dose, single for covid-19 immunization.Medical history included on 28 March, the patient started to have hives on whole body and it was anytime, it was like at night ,like your body is like burning and itching, it got worse almost everyday and patient having this allergy. Concomitant medications were not reported. On an unspecified date after the second dose, patient started to have it much often, woke up with few little on my face and cannot work right now. It was reported that nothing really helped, not even allergy medicine (Benadryl). After this vaccination the patient's system went very down and she was scared to die after this vaccination. The patient's skin has rashes, and it was red and itchy. It was reported that patient got two doses and three days after her first dose, she started having whole body hives which is like your body is like burning and itching. So, then after second vaccination, she started to have it much often and today and woke up with few little on my face which (voice not clear). She cannot work right now and cannot contact her physician, and nothing really helped, not even her allergy medicine (Benadryl) and never ever had this before the vaccination. The patient further stated she need to report and need some help because she was scared to die after this vaccination. Her skin has rashes and it is red and itchy, she need to go doctor because it was very dangerous from allergy you can literally die and she cannot go because the doctor was out of country and it was very difficult to go out of this country right now. The outcome of events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program SUPPORT. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had the first dose last 16Apr2021 and was scheduled for the second dose on Friday 07May2021. He tested positive for COVID-19 last week on an unspecified date in 2021 and he was not sure if he was fully cleared from it since he was still having a hard time breathing. Patient wanted to know if he should get his second dose this Friday or he should reschedule it. Outcome of the events was unknown.  Information about the Lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Coma, Meningitis bacterial, Paralysis
Clinical narrative: bacterial meningitis; paralysis; he ended up in a coma.; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced paralysis after getting the first dose of the vaccine, then was later diagnosed with bacterial meningitis. The patient said his doctors said it was a possibility that it was linked to the vaccine because it was the only thing he did differently that day. Symptoms came on quickly and he ended up in a coma. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: Within 5 hrs of vaccination, developed acute and persistent tinnitus. Also some loss of hearing acuity.; Within 5 hrs of vaccination, developed acute and persistent tinnitus. Also some loss of hearing acuity.; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old female patient received bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration, administered in right arm on 15Apr2021 14:00 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 15Apr2021 19:00 within 5 hrs of vaccination, the patient developed acute and persistent tinnitus and some loss of hearing acuity. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications the within 2 weeks of vaccination. Adverse event result in doctor or other healthcare professional office/clinic visit. Patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, patient has not been tested for COVID-19.  Information on the lot/batch number has been requested
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage urinary tract, Urine analysis
Clinical narrative: Had some blood clot in his urine; This is a spontaneous report received from a contactable consumer. A male patient with age reported as 52 (unknown unit) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via unspecified route of administration on unspecified date in 2021 (reported as Monday or Tuesday) as 1st dose, single for COVID-19 immunisation. The patient's medical history included diabetic. The patient had not had COVID in the past. The patient's concomitant medications were not reported. Reporter stated that she had some questions. Her husband and she got the Pfizer shot and they didn't have anything, everything was fine. They had one family member and he was 52 and diabetic (history) and he worked in an area where he was out of range at the time of this report, so they could not talk to him for about like next half an hour. So, this week, he had the Pfizer shot and he was also put on two new medications (unspecified medications) right after that. He woke and he went to his work today and then he called, and he had some blood clot in his urine. The first thing they thought of was the company which they didn't had (further clarification unknown). So, they just need to know that new medication, also he was diabetic (history) and he had been on the same medication forever and there was no problem but the two new medication that he was put on (sentence incomplete). About lot number reporter stated that she did not have all that. They were just concerned, and reporter was kind of like, reporter asked if he should go to emergency room with the blood clot showed up in the urine or could that just be a urinary tract infection (UTI). It was his first COVID shot and he had not had COVID in the past. Reporter further stated, the two new drugs that he started, they just wanted to know if they need to worry about blood clot like if it could from the shot or it could be from the two drugs that he was taking. Reporter further asked if this was something that he should go to the emergency room. Reporter also asked if blood clot was possible due to Pfizer vaccine or it could be a urinary tract infection. She just wanted to know if Pfizer vaccine did cause blood clot like the Johnson and Johnson did (further clarification unknown). About vaccination date of second shot reporter stated in two weeks or something she did not know. The outcome of the event was unknown.  Information about the lot/batch number has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Rash papular, Skin disorder, Vision blurred
Clinical narrative: shortness of breath; experienced white and pink bumps on her face around her lips; experienced white and pink bumps on her face around her lips; she experienced aches and pain in her joints; blurred vision on and off; This is a spontaneous report from a non-contactable consumer (patient). A 80-years-old-female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 23Feb2021 (79-years-old) as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  It was reported that patient did not have her medications, but she did state that she has had several Botox injections in the area on her face where she experienced the reaction. The 2nd day after the first dose of the vaccine (24Feb2021) she experienced white and pink bumps on her face around her lips. She also had some shortness of breath and called 911. She was admitted to the hospital. The ruled out COVID infection and Pneumonia. On the 3rd day while hospitalized she experienced aches and pain in her joints. She was discharged after 3 days. Her symptoms have subsided. She is only complaining on some blurred vision on and off. She received her first dose on 23Feb2021. Her Doctor told her she should not get the 2nd dose. Therapeutic measures were taken as a result of shortness of breath, experienced white and pink bumps on her face around her lips, she experienced aches and pain in her joints. The outcome of event she experienced aches and pain in her joints was recovering, while other events was unknown. It was reported that patient had several Botox injections in the area on her face where she experienced the reaction.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Coronavirus test, Drug ineffective
Clinical narrative: tested Covid positive 6 weeks after 2nd dose of Pfizer vaccine; tested Covid positive 6 weeks after 2nd dose of Pfizer vaccine; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (batch/lot number and expiration date were not reported) as the 1st dose, single, and then via an unspecified route of administration on an unspecified date (batch/lot number and expiration date were not reported) as the 2nd dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested Covid positive 6 weeks after 2nd dose of Pfizer vaccine on an unspecified date. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
Sex: M
Vaccine: UNK
Symptoms: Drug interaction
Clinical narrative: Since getting the vaccine her husbands medication seems to be ineffective; Since getting the vaccine her husbands medication seems to be ineffective; This is a spontaneous report from a contactable consumer (patient's wife). A 49-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number unknown), via an unspecified route of administration on 01Feb2021 at single dose for COVID-19 immunization. Medical history included Parkinson's disease for which patient took carbidopa/levodopa. Reporter stated that since getting the vaccine, patient's medication seems to be ineffective, dosage has been adjusted, he has went to the doctor and emergency room. There Is something blocking the abospriton of the carbidopa/ levodopa?     No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Mononucleosis heterophile test, Oropharyngeal pain, Pharyngeal abscess, Pharyngitis, SARS-CoV-2 test
Clinical narrative: Retropharyngeal abscess; she got a throat infection, like an abscess; sore throat; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 21 years of age), via an unspecified route of administration, administered in arm left on 18Apr2021 08:15 (Batch/Lot Number: EW0161) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included allergies. The patient had no other medical history but mentioned diabetes and high blood pressure as family history. Concomitant medication included cetirizine hydrochloride (CETRIZINE) which the patient does not take every day, only randomly for allergies and had been taking it for years (ongoing). She had no history of previous immunizations with the Pfizer vaccine. There were no additional vaccines administered on same date of the covid vaccine was given. She had no prior vaccination within four weeks of covid vaccine. The patient received the first dose on 18Apr2021. Then about a week later, she got a throat infection, like an abscess (on 30Apr2021). She had been taking antibiotics and steroids since Friday. She started feeling her sore throat on 27Apr2021, which was a little more than a week after the Covid vaccine. She doesn't know if the sore throat was because of the vaccine or not. She went to the doctor on 30Apr2021, they told her she had an abscess behind her pharynx, it was clarified as a retropharyngeal abscess. She was given antibiotics and steroids, which she has been taking since 30Apr2021. She does not know if the throat infection she had was in correlation with the vaccine or if it was a coincidence. She just wanted to know if it is safe to take the second dose. When they gave her the antibiotics and the steroid, the medication started working that same exact day. The next day, clarified as Saturday (01May2021), she didn't have the sore throat anymore. The second dose of the vaccine was scheduled for this Sunday. She was wondering if it was safe to still take the second dose even if she was taking antibiotics and the steroids. When asked about the tests she mentioned that she thought it kind of looked like Covid symptoms since she had a sore throat, but it came back negative. She also had a Mono test which was negative and a strep test which was negative. The doctor then looked in her throat and said that it looked like an abscess so that was how it was determined she had a retropharyngeal abscess. It was then that she was put on the antibiotics and the steroids. She clarified that the steroid was prednisone and the antibiotic is clindamycin. She is still taking both. Therapeutic measures were taken as a result of the events. The outcome of sore throat was recovered on 01May2021 while the outcome of other events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Streptococcus test
Clinical narrative: Retropharyngeal abscess; she got a throat infection, like an abscess; sore throat; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 21 years of age), via an unspecified route of administration, administered in arm left on 18Apr2021 08:15 (Batch/Lot Number: EW0161) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included allergies. The patient had no other medical history but mentioned diabetes and high blood pressure as family history. Concomitant medication included cetirizine hydrochloride (CETRIZINE) which the patient does not take every day, only randomly for allergies and had been taking it for years (ongoing). She had no history of previous immunizations with the Pfizer vaccine. There were no additional vaccines administered on same date of the covid vaccine was given. She had no prior vaccination within four weeks of covid vaccine. The patient received the first dose on 18Apr2021. Then about a week later, she got a throat infection, like an abscess (on 30Apr2021). She had been taking antibiotics and steroids since Friday. She started feeling her sore throat on 27Apr2021, which was a little more than a week after the Covid vaccine. She doesn't know if the sore throat was because of the vaccine or not. She went to the doctor on 30Apr2021, they told her she had an abscess behind her pharynx, it was clarified as a retropharyngeal abscess. She was given antibiotics and steroids, which she has been taking since 30Apr2021. She does not know if the throat infection she had was in correlation with the vaccine or if it was a coincidence. She just wanted to know if it is safe to take the second dose. When they gave her the antibiotics and the steroid, the medication started working that same exact day. The next day, clarified as Saturday (01May2021), she didn't have the sore throat anymore. The second dose of the vaccine was scheduled for this Sunday. She was wondering if it was safe to still take the second dose even if she was taking antibiotics and the steroids. When asked about the tests she mentioned that she thought it kind of looked like Covid symptoms since she had a sore throat, but it came back negative. She also had a Mono test which was negative and a strep test which was negative. The doctor then looked in her throat and said that it looked like an abscess so that was how it was determined she had a retropharyngeal abscess. It was then that she was put on the antibiotics and the steroids. She clarified that the steroid was prednisone and the antibiotic is clindamycin. She is still taking both. Therapeutic measures were taken as a result of the events. The outcome of sore throat was recovered on 01May2021 while the outcome of other events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cerebrovascular accident
Clinical narrative: Patient had a stroke after the covid vaccine; it was A-Fib that lead to his stroke; This is a spontaneous report from a contactable consumer. A 91-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization and experienced sludgy thick stool. It was reported that the patient had a stroke on an unspecified date after the second dose of COVID vaccine. Patient was brought to the emergency room and was told that it was an A-fib (atrial fibrillation) that lead to his stroke. The patient was hospitalized and received treatment (unspecified) for the events reported. Outcome of events recovered on an unspecified date.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clot; This is a spontaneous report from a contactable healthcare professional and a physician.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration on an unspecified date as unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter had a patient who may have had a possible side effect. It was reported that the patient may be experiencing a blood clot on an unspecified date. The reporter wanted further direction on whether or not an anticoagulant can be given. Anatomical location of blood clot is unknown. The outcome of the event was unknown.   Information on the batch/lot number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of blood clot due to temporal relationship.  Case will be re-assessed upon the additional information provided. 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: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Tardive dyskinesia, Tremor
Clinical narrative: started doing this shaking, almost like a tardive dyskinesia effect or something; started doing this shaking, almost like a tardive dyskinesia effect or something; This is a spontaneous report from a contactable consumer (patient's mother). A 23-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Mar2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included autism. The patient's concomitant medications were not reported. On an unspecified date, the patient started doing this shaking, almost like a tardive dyskinesia effect or something. The reporter wanted to know if this was part of the side effects that people have reported. She has never seen him doing this before. The caller clarified that she was not sure if the tardive dyskinesia was new because he has been kept from her for a year due to COVID, so she doesn't know. She saw her 2 weeks ago and she noticed this behavior. She has never seen this before. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: I have post menopausal bleeding.; This is a spontaneous report from a non-contactable consumer (patient). A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: ER8733, expiry date not reported), via an unspecified route of administration, administered in left arm on 17Apr2021 as first dose, single for covid-19 immunisation. Medical history included patient had an adverse reaction to aloe many years ago and have not had her period in 2 years. The patient's concomitant medications were not reported. The first dose of was administered in a doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no other medications the patient received within 2 weeks of vaccination. The patient had no covid prior to vaccination. Patient had post menopausal bleeding on 02May2021. Patient have not had her period in 2 years and have started a very heavy flow period. Patient have contacted her doctor and have a pelvic ultra sound scheduled. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if treatment was received in response to the event. Since the vaccination, the patient has not been tested for COVID-19. Patient was not pregnant at the time of the vaccination and of the report. The event  post menopausal bleeding was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Full blood count, Headache, Immune thrombocytopenia
Clinical narrative: developed a worsening of their ITP; developed a worsening of their ITP; Rash; Headache; Chills; her platelet count was at 37,000; This is a spontaneous report from a contactable pharmacist. A 73-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 73 years old on 16Mar2021 at single dose for COVID-19 immunization. Medical history included medical diabetes mellitus with mild leukopenia without recurrent infection since 2005, Moderate thrombocytopenia. Concomitant medications were reported as none. The patient developed a worsening of her ITP, which was clarified as Idiopathic thrombocytopenic purpura on 23Mar2021. They thought the worsening of this condition was attributed to the vaccine. She was referring to the Pfizer BioNTech COVID-19 vaccine. The pharmacist made the comment the patient probably had her first dose around 23Feb2021, however, this cannot be confirmed. Pharmacist was unsure of the date when the patient had her first dose. The patient had reported she had a lot of side effects including rash, headache, chills on 23Mar2021. The last lab was done on 26Jan2021 and the patient's platelet count at that time was 88,000. She had a scheduled routine dental procedure and had a CBC done (in Mar2021) approximately 1 week after receiving the second dose of the COVID-19 vaccine. When the patient had labs done on 22Mar2021 (after receiving her second dose), her platelet count was at 37,000. The patient's platelet count stayed low like this after multiple labs were drawn. On 23Mar2021, her platelet count was at 44,000; On 29Mar2021, her platelet count was at 36,000; On 16Apr2021, her platelet count was at 26,000; On 22Apr2021, her platelet count was at 32,000. The patient was started on Dexamethasone 40mg orally for 4 days as treatment for the events. On 26Apr2021, her platelet count bounced back up to 64,000. On 03May2021, the patient's platelet count was at 125,000. The outcome of event platelet count low was resolving while outcome of other events were unknown.  Follow-up attempts are needed; information about lot/batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine causality between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 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  Committees and Investigators, as appropriate.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased, Rash
Clinical narrative: developed a worsening of their ITP; developed a worsening of their ITP; Rash; Headache; Chills; her platelet count was at 37,000; This is a spontaneous report from a contactable pharmacist. A 73-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 73 years old on 16Mar2021 at single dose for COVID-19 immunization. Medical history included medical diabetes mellitus with mild leukopenia without recurrent infection since 2005, Moderate thrombocytopenia. Concomitant medications were reported as none. The patient developed a worsening of her ITP, which was clarified as Idiopathic thrombocytopenic purpura on 23Mar2021. They thought the worsening of this condition was attributed to the vaccine. She was referring to the Pfizer BioNTech COVID-19 vaccine. The pharmacist made the comment the patient probably had her first dose around 23Feb2021, however, this cannot be confirmed. Pharmacist was unsure of the date when the patient had her first dose. The patient had reported she had a lot of side effects including rash, headache, chills on 23Mar2021. The last lab was done on 26Jan2021 and the patient's platelet count at that time was 88,000. She had a scheduled routine dental procedure and had a CBC done (in Mar2021) approximately 1 week after receiving the second dose of the COVID-19 vaccine. When the patient had labs done on 22Mar2021 (after receiving her second dose), her platelet count was at 37,000. The patient's platelet count stayed low like this after multiple labs were drawn. On 23Mar2021, her platelet count was at 44,000; On 29Mar2021, her platelet count was at 36,000; On 16Apr2021, her platelet count was at 26,000; On 22Apr2021, her platelet count was at 32,000. The patient was started on Dexamethasone 40mg orally for 4 days as treatment for the events. On 26Apr2021, her platelet count bounced back up to 64,000. On 03May2021, the patient's platelet count was at 125,000. The outcome of event platelet count low was resolving while outcome of other events were unknown.  Follow-up attempts are needed; information about lot/batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine causality between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 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  Committees and Investigators, as appropriate.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Mental impairment, Movement disorder, Muscular weakness
Clinical narrative: after shot, his mind suddenly went blank, followed with the inability to move his legs at all; Legs became weak. Within 15 minutes of the shot. Went home and rested with weakness in left leg; after shot, his mind suddenly went blank, followed with the inability to move his legs at all; slight numbness; tingling; pain; legs have been heavy; central vestibular disorder; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 16Apr2021 10:15 (Lot Number: ER8731) as 2nd dose, single for covid-19 immunisation. Medical history included Epilepsy, Migraine, Central Vestibular Disorder, and Known allergies: Sulpha Drugs and Shellfish. Historical Vaccine included first dose of bnt162b2 (lot number:ER8727, Administration date= 26Mar2021, Administration time= 12:15 AM, Dose number= 1, Vaccine location= Left arm) for COVID-19 immunisation; Adacel (DTAP) PMC (Sanofi) (vaccine date=11Mar2021, lot number=C5667AA, dose number=1, vaccine location=Left Arm) for immunisation. After bnt162b2 first dose, the pateint had Legs became weak; Could move them, but not stand up on them; Lasted approximately 2-3 hours; Reaction occurred within 15 minutes after the shot; Nurses made her go to the emergency room (ER). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included clonazepam taken for an unspecified indication, start and stop date were not reported; lacosamide taken for an unspecified indication, start and stop date were not reported; lamotrigine taken for an unspecified indication, start and stop date were not reported; omeprazole taken for an unspecified indication, start and stop date were not reported. After bnt162b2 second dose, the patient experienced Legs became week. Within 15 minutes of the shot. Went home and rested with weakness in left leg. Day after shot, his mind suddenly went blank, followed with the inability to move his legs at all. He could feel them. There was slight numbness, tingling, and pain, but he was not able to move them. He was transported to the ER via ambulance. This reaction lasted about 4 hours. Since then his legs have been heavy and the progress he had made with his central vestibular disorder has thrown him back to almost square one and his physical therapy is now not helping as it did. The adverse events (AE) resulted in Emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered with sequelae.  Information on Lot/Batch number was available. Additional information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Vestibular disorder
Clinical narrative: after shot, his mind suddenly went blank, followed with the inability to move his legs at all; Legs became weak. Within 15 minutes of the shot. Went home and rested with weakness in left leg; after shot, his mind suddenly went blank, followed with the inability to move his legs at all; slight numbness; tingling; pain; legs have been heavy; central vestibular disorder; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 16Apr2021 10:15 (Lot Number: ER8731) as 2nd dose, single for covid-19 immunisation. Medical history included Epilepsy, Migraine, Central Vestibular Disorder, and Known allergies: Sulpha Drugs and Shellfish. Historical Vaccine included first dose of bnt162b2 (lot number:ER8727, Administration date= 26Mar2021, Administration time= 12:15 AM, Dose number= 1, Vaccine location= Left arm) for COVID-19 immunisation; Adacel (DTAP) PMC (Sanofi) (vaccine date=11Mar2021, lot number=C5667AA, dose number=1, vaccine location=Left Arm) for immunisation. After bnt162b2 first dose, the pateint had Legs became weak; Could move them, but not stand up on them; Lasted approximately 2-3 hours; Reaction occurred within 15 minutes after the shot; Nurses made her go to the emergency room (ER). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included clonazepam taken for an unspecified indication, start and stop date were not reported; lacosamide taken for an unspecified indication, start and stop date were not reported; lamotrigine taken for an unspecified indication, start and stop date were not reported; omeprazole taken for an unspecified indication, start and stop date were not reported. After bnt162b2 second dose, the patient experienced Legs became week. Within 15 minutes of the shot. Went home and rested with weakness in left leg. Day after shot, his mind suddenly went blank, followed with the inability to move his legs at all. He could feel them. There was slight numbness, tingling, and pain, but he was not able to move them. He was transported to the ER via ambulance. This reaction lasted about 4 hours. Since then his legs have been heavy and the progress he had made with his central vestibular disorder has thrown him back to almost square one and his physical therapy is now not helping as it did. The adverse events (AE) resulted in Emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered with sequelae.  Information on Lot/Batch number was available. Additional information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Throat tightness
Clinical narrative: tightening in her throat area; hard to swallow; This is a spontaneous report received from a contactable consumer (patient). A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 (at 40 years old) (Batch/Lot Number: EN6205) as 1st dose, single for covid-19 immunisation. Medical history included allergy to shellfish from an unknown date. The patient had no concomitant medications. After first shot, patient felt tightening in her throat area for a short period where it was kind of hard to swallow and she took a Benadryl and it went away. The outcome of the events was recovered. No History of all previous immunization with the Pfizer vaccine considered as suspect. No Additional Administered Vaccines.  No AE(s) required a visit to Emergency Room or Physician Office. No Prior Vaccinations (within 4 weeks). No AEs following prior vaccinations.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dysphagia, Throat tightness
Clinical narrative: Tightening in her throat area; Hard to swallow; Felt tightening in her throat area/hard to swallow/after the second dose it came on later and lasted longer and was more intense; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EB8737; Expiration date was not reported) on the left arm on 09Apr2021 as a single dose, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store (not a military facility). Medical history included shellfish allergy. The patient had no concomitant medications. The patient had previously receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6205; Expiration date was not reported) on the left arm on 19Mar2021 (when the patient was 40 years old) for COVID-19 immunization, and had felt tightening in her throat area and hard to swallow. On 09Apr2021, after the second dose of vaccination, the patient also had felt tightening in her throat area and hard to swallow; but it came on later and lasted longer, and was more intense. The events were reported to be serious (medically signficant). The patient had received diphenhydramine (BENADRYL) as treatment for the events. The outcome of the events was recovered on 09Apr2021.  Information on lot/batch number was available. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: I am post menopausal, I am bleeding and have period like symptoms; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), at 52 years old via an unspecified route of administration, administered in Arm Left on 28Apr2021 10:30 as 2nd dose, single for COVID-19 immunization in a public health department. Medical history included diagnosed with COVID-19 and post menopausal both from an unknown date. Concomitant medications include an unspecified medication taken within two weeks of vaccination. The patient received the first dose of bnt162b2 on 07Apr2021 11:00 AM for COVID-19 immunization. On 04May2021 08:30, the patient reported that she is post menopausal, was bleeding and have period like symptoms. The reporter considered the event as non-serious. No treatment was given. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Pain, Pain in extremity, Pruritus, Thrombosis
Clinical narrative: Blood Clot; right leg was red & hot; right leg was red & hot; itching; Pain; This is a spontaneous report from a contactable consumer. A 63-year-old patient of an unspecified gender received second dose of BNT162B2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included covid-19 from 28Mar2021 to an unknown date. The patient's concomitant medications were not reported. The patient experienced blood clot, right leg was red & hot, itching and pain all on unspecified date. On 28Mar2021 I caught covid-19. The staff next at united states penitentiary put me in quarantine until 14Apr2021. They did not do anything for me what so ever while I had covid-19. Shorty after I became better (on my own) I took the exist shot of the vaccine Pfizer. 3 weeks later in the end of  this month I took the second vaccine shot. My right leg in my blood vein started burning me up. My right leg was red & hot so I went to commissary to purchase ORAJEL to put my leg to kill the pain and itching. I then put a sick call in to the prison nurse, she came the next day and said you have a blood clot and if it moves to let her know. 3 days later or more she was back in the housing unit and I ask her what she was going to do about my blood clot. She said oh you found have a blood clot you just have the big viens. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea
Clinical narrative: My breathing became more labored; cough; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 53-years-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), via an unspecified route of administration, administered in left arm on 07May2021 14:15 as single dose for COVID-19 immunization. The patient's medical history included anxiety, seasonal allergy, rubber sensitivity, allergic to latex, take monthly allergy shots for pollen and pollutants from an unknown date. Concomitant medications included fluoxetine 40 mg, ethinylestradiol, ferrous fumarate, norethisterone acetate, cetirizine hydrochloride taken for an unspecified indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07May2021 at 16:00, two hours after vaccination, the patient experienced cough. Not a bad cough just more of the feeling to clear throat. 30 min later the cough was more persistent and felt it in lungs, breathing became more labored. The patient used 3 pumps of Albuterol Inhaler and breathing became normal 30 min later, still had a mild cough until bedtime. The patient woke up this morning feeling fine. The patient did not take treatment for cough. Device Date : 08May2021. On an unspecified date in May2021, the patient was recovered from the events.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hypothermia, Myalgia, Tinnitus
Clinical narrative: Hypothermia; Full body muscle ache; Tinnitus; This is a spontaneous report from a non-contactable other hcp (patient). A 36-year-old non-pregnant female patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine), via an unspecified route of administration on 02Apr2021 13:15 (Batch/Lot number was not reported) unknown dosage #, single dose for COVID-19 immunization. Medical history included thyroid disorder and food allergy (artificial color shrimp mango some preservatives) from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine taken for an unspecified indication, start and stop date were not reported. The patient experienced hypothermia for few hours, full body muscle ache and tinnitus on 01May2021 with outcome of recovering. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be totally excluded.  Medical history of thyroid disorder may provide a plausible alternative explanation for the events.  The case will be reassessed if additional information becomes 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.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Illness, Pneumonia
Clinical narrative: lung infection; felt sick; This is a solicited report from a non-Pfizer sponsored program FACILITATED COLLECT received by Pfizer . A contactable consumer (patient) reported that a 56-year-old female patient received second dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), intramuscular on an unspecified date at single dose for COVID-19 immunisation, upadacitinib(RINVOQ) oral from an unspecified date at an unspecified dose and frequency for moderate to severe rheumatoid arthritis. The medical history and concomitant medications were not reported. The Historical Vaccine was first dose BNT162B2 for Covid-19 immunization. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient Took her 2nd COVID-19 vaccine, Pfizer, felt sick since she took it, then went to her primary physician and she has a lung infection and was on a round of 10 days antibiotics. The action taken in response to the event for upadacitinib was unknown. The outcome of the events was unknown. The reporter's causality for the events was not provided.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about batch number cannot be obtained.; Sender's Comments: There is a probable causal relationship between BNT162B2 and the event, Pneumonia based on temporal association. The impact of this report on 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 Ethic committees, and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Myalgia, Off label use, Product use issue
Clinical narrative: I am a breastfeeding mother of 23 months old daughter; I am a breastfeeding mother of 23 months old daughter; I am also 11 weeks pregnant when I took first dose of vaccine; muscle pain; This is a spontaneous report received from a contactable consumer (patient).  A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0168) via unspecified route of administration in left arm on 06May2021 at 18:15 PM (age at vaccination 34-year-old) as single dose for COVID-19 immunization. Medical history included asthma (asthma not active currently) and drug hypersensitivity (known allergies: Ibuprofen, paracetamol). She was pregnant at the time of vaccination. Concomitant medication included pre-natal vitamins (medications in two weeks). No other vaccine in four weeks. Reporter states that, I am a breastfeeding mother of 23 months old daughter. I am also 11 weeks pregnant when I took first dose of vaccine on 06May21. I checked with Gyn and Pediatrician before taking vaccine. I had usual muscle pain 08May2021 at 03:00 PM after vaccine and I continued breastfeeding. No treatment was given for events. No COVID prior vaccination. Patient has not tested COVID post vaccination. The outcome of event myalgia was not recovered, whereas unknown for other events.  Information on Lot/Batch number was available. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021519339 same reporter/drug with different AE/patient