chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Headache, Hypoaesthesia, Hypoaesthesia oral, Loss of personal independence in daily activities
Clinical narrative: Cerebellar stroke; blockage of the blood vessel at the back of his neck; extreme vertigo; Headache; Sleepiness; unable to walk; he can't stand; he can't go to the bathroom on his own; rapid eye movements left to right; Numbness in face; Numbness of tongue; vomiting; This is a spontaneous report from a contactable consumer (patient's son-in-law) via medical information team. A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm on 22Aug2021 (Batch/Lot Number: FC3182) as dose 1, single for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient was a healthy person before the vaccination and always had good blood pressure. On 13Sep2021, the patient had a cerebellar stroke involving blockage of the blood vessel at the back of his neck. On 13Sep2021, patient had extreme vertigo, headache, and sleepiness. On an unspecified date in Sep2021, unable to walk, he can't stand, he can't go to the bathroom on his own, had rapid eye movements left to right, numbness in face, numbness of tongue, and vomiting. The patient went to the emergency room for the events. On 18Sep2021 the patient was hospitalized for cerebellar stroke involving blockage of the blood vessel at the back of his neck and was given an unspecified treatment. The reporter says his father in law probably had other symptoms but he is not sure what those are, his step mother in law is at the hospital visiting with him, he hasn't been able to see him due to only one person being allowed to be there due to COVID restrictions. The outcome of the events cerebellar stroke involving blockage of the blood vessel at the back of his neck was not recovered while for the rest of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, Vertigo, Vomiting
Clinical narrative: Cerebellar stroke; blockage of the blood vessel at the back of his neck; extreme vertigo; Headache; Sleepiness; unable to walk; he can't stand; he can't go to the bathroom on his own; rapid eye movements left to right; Numbness in face; Numbness of tongue; vomiting; This is a spontaneous report from a contactable consumer (patient's son-in-law) via medical information team. A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm on 22Aug2021 (Batch/Lot Number: FC3182) as dose 1, single for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient was a healthy person before the vaccination and always had good blood pressure. On 13Sep2021, the patient had a cerebellar stroke involving blockage of the blood vessel at the back of his neck. On 13Sep2021, patient had extreme vertigo, headache, and sleepiness. On an unspecified date in Sep2021, unable to walk, he can't stand, he can't go to the bathroom on his own, had rapid eye movements left to right, numbness in face, numbness of tongue, and vomiting. The patient went to the emergency room for the events. On 18Sep2021 the patient was hospitalized for cerebellar stroke involving blockage of the blood vessel at the back of his neck and was given an unspecified treatment. The reporter says his father in law probably had other symptoms but he is not sure what those are, his step mother in law is at the hospital visiting with him, he hasn't been able to see him due to only one person being allowed to be there due to COVID restrictions. The outcome of the events cerebellar stroke involving blockage of the blood vessel at the back of his neck was not recovered while for the rest of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: pain at the injection site; fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient) received from Pfizer medical information team. A male patient of an unspecified age received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 22Sep2021 at dose 3 (booster), single for covid-19 immunisation. Medical history included family history of cardiac issues. Concomitant medication included apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported. Reporter asking if the Eliquis he takes could have a negative interaction with the Pfizer BioNTech Covid-19 Vaccine. Patient previously received first dose and second dose of bnt162b2 vaccine for covid-19 immunization on an unspecified date in Jan2021 and got the flu vac-cine a month ago and is scheduled for a pneumonia vaccine in Oct2021 or Nov2021. Reporter asking if there is a conflict with getting the Pfizer BioNTech Covid-19 Vaccine around the same time as other vaccines. On an unspecified date in Sep2021 the patient experienced pain at the injection site and fatigue. Reporter asking what percentage of individuals experienced myocarditis and pericarditis after get-ting the Pfizer BioNTech Covid-19 Vaccine. Reporter stated he has a family history of cardiac issues. Reporter stated he received a booster dose of Pfizer BioNTech Covid-19 Vaccine yesterday (22Sep2021) after receiving his primary vaccination series of Pfizer BioNTech Covid-19 Vaccine in Jan2021. Reporter stated he has experienced pain at the injection site and fatigue since receiving the booster dose. Reporter asking what percentage of individuals experienced fatigue after getting the booster dose of Pfizer BioNTech Covid-19 Vaccine. Reporter stated he is aware that the Pfizer BioNTech Covid-19 Vaccine booster dose is available for individuals 65 and older. Reporter asking if that means people less than 65 years old cannot get it. Briefly mentioned some fatigue but was in another part of what the caller was saying. Could be related to the booster shot. Outcome of the events was unknown.  Batch/ lot number not provided, it will be requested during follow-up activities.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Iritis, Uveitis
Clinical narrative: uveitis/iritis; uveitis/iritis; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 vaccine), dose 1 via an unspecified route of administration, administered in Arm Left on 27Aug2021 16:00 (Batch/Lot Number: FC3183) at the age of 42-years-old as dose 1, single for covid-19 immunisation. Medical history included diabetes insipidus, central hypothyroidism, pituitary brain tumor, sleep apnea, trigeminal neuralgia, ovian cysts, growth hormone deficiency and glucose intolerance. The patient is not pregnant at the time of vaccination. The patient's concomitant medications were not reported.  The patient previously took codeine and experienced drug hypersensitivity, sulfamethoxazole and experienced drug hypersensitivity, cephalexin hydrochloride and experienced drug hypersensitivity. On 01Sep2021, the patient experienced intense pain in the left eye, when exposed to light her left eye felt like it was being stabbed with a knife, her eye also looked almost like blood shot and the white part of her eye looked pinkish. The doctor diagnosed her with uveitis/iritis. The patient received steroid eye drops as treatment. The outcome of the event was recovering.  Follow-up (27Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Vaccine related myocarditis; This is a spontaneous report from a contactable consumer.  A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not reported), via an unspecified route of administration on 02Sep2021 (at the age of 63-year-old ) as single dose for covid-19 immunisation.   Medical history and concomitant drugs were unknown. On 02Sep2021 the patient experienced vaccine related myocarditis. The event resulted in Doctor or other healthcare professional office/clinic visit. Treatment was received.  The outcome of the event was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Haemorrhage urinary tract, Heavy menstrual bleeding
Clinical narrative: Bleeding consisted of clots; Heavy menstrual bleeding; cramping; This is a spontaneous report from a contactable nurse (patient). A 37-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FF2587), via an unspecified route of administration, administered in arm left on 17Sep2021 at 15:00 (at the age of 37-years-old) as dose 2, single for COVID-19 immunisation. Medical history included irritable bowel syndrome, migraine, known allergies: penicillin, Food allergies and bee venom. The patient previously received the first dose of BNT162B2 (Batch/Lot Number: FL3180), administered in right arm on 27Aug2021 at 03:00 PM (at the age of 37-years-old) for COVID-19 immunisation. On 18Sep2021 at 07:00, the patient experienced heavy menstrual bleeding out of character/mid cycle for patient; on prescription contraception that typically causes no periods. Bleeding consisted of clots, with cramping, onset 1 day after vaccination. Therapeutic measures were taken as a result of all events. The outcome of the events was not recovered.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of bleeding consisted of clots. 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
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: He then 'came down with COVID'; He then 'came down with COVID'; This is a spontaneous report from a contactable consumer (patient).   A 64-year-male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Sep2021, at single dose, for COVID-19 immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, in 2021, after the first dose, the patient experienced COVID-19 described as "He then 'came down with covid' and was treated with Regeneron and 'now he is negative'". The patient recovered from the adverse event on an unspecified date, in 2021.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Overdose, Product preparation error
Clinical narrative: erroneously received an overdose entire undiluted vial of Pfizer Covid 19/No diluent, resulting in higher than authorized dose; erroneously received an overdose entire undiluted vial of Pfizer Covid 19/No diluent, resulting in higher than authorized dose; This is a spontaneous report from a contactable pharmacist. A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Aug2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE (at the age of 48 years) for covid-19 immunisation. The patient medical history and concomitant medications. The patient erroneously received an overdose entire undiluted vial of Pfizer Covid 19. No diluent, resulting in higher than authorized dose (i.e., 0.3 ml of undiluted vaccine administered). Administration error occurred on 06Aug2021.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the event cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: 1st shot of the Comirnaty vaccine 4 weeks ago/might go into Covid; 1st shot of the Comirnaty vaccine 4 weeks ago/might go into Covid; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date in 2021 as dose 1, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient experienced 1st shot of the Comirnaty vaccine 4 weeks ago/might go into COVID on an unspecified date in 2021. It was reported the patient received the 1st shot of the Comirnaty vaccine 4 weeks ago where she got a cold that she said might go into Covid. She decided not to get the 2nd shot out of fear and that she should never have gotten the 1st shot in the first place. With this, the patient wanted to have more information regarding her understanding that a molecule is injected and that it contains DNA which produces spike protein. She also asked for information if in case those that she mentioned has a malfunction inside her body. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: 2 grand mal seizures; This is a spontaneous report from a contactable consumer reported for herself. An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 86-years-old, via an unspecified route of administration, administered in Arm Left on 04Mar2021 10:00 (Batch/Lot Number: EN6200) as dose 1, single for COVID-19 immunization. The patient was not pregnant. Medical history included heart attack, pacemaker, stroke, non epileptic episodes. Concomitant medications included metoprolol succinate; escitalopram; and omeprazole; all taken for an unspecified indication, start and stop date were not reported. The patient previously took Codeine and experienced allergies. The patient experienced 2 grand mal seizures on 06Mar2021 13:00 (within 5 days after). The events resulted in emergency room/department or urgent care visit, and no treatment received. The patient had no prior vaccination and did not test post vaccination. The outcome of the events was recovered with sequelae.   Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pulmonary embolism, Pyrexia
Clinical narrative: Pulmonary embolism; Shortness of breath; Fever; This is a spontaneous report from a non-contactable pharmacist. A 61-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: 30130BA), intramuscularly in the arm left on 03Sep2021 (at the age of 61-years-old) at dose 2, single for COVID-19 immunisation. The patient was not pregnant. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162b2 (lot number: ew0185) intramuscularly in the arm left on 13Aug2021 for COVID-19 immunisation. The patient experienced shortness of breath, fever and pulmonary embolism on 10Sep2021. The events were reported as non-serious. The adverse events resulted in emergency room/department or urgent care visit. A treatment was received for the adverse events and included ELIQUIS. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Pulmonary embolism, dyspnea and pyrexia 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Decreased appetite, Dizziness, Feeling abnormal, Fibrin D dimer
Clinical narrative: After lunch experienced near syncopal collapse; right arm pain and tingling/both hands tingling; Continued to feel lightheaded- near syncopal; brain fog; anorexia; Headache; throat and chest tightness; throat and chest tightness; nausea; palpitations; Immediate face tingling/right arm pain and tingling/both hands tingling; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration, administered in the right arm on 15Sep2021 at 16:45 (Batch/Lot Number: FC3183) single, for COVID-19 immunization. Medical history included postpartum disorder in Jan2021. The patient was not pregnant, did not have COVID prior to vaccination, had no known allergies, had no other vaccines in four weeks, and no other medications in two weeks. There were no concomitant medications. On 15Sep2021 at 17:00, the patient experienced immediate face tingling, nausea, and throat and chest tightness after injection. Additional symptoms included headache, brain fog, anorexia, and palpitations. The next day, on 16Sep2021, right arm pain and tingling. Two days later, Friday, both hands were also tingling. On 17Sep2021, after lunch, she experienced near syncopal collapse requiring emergency services, ambulance, and emergency room evaluation. Testing included negative troponin and D-dimer. She continued to feel lightheaded - near syncopal. The patient returned to the ER on Sunday, 19Sep2021, for persistent symptoms plus chest tightness and nausea, which responded to IV fluids. She was seen by PCP in the clinic the next two days, was advised high salt diet and 3-4 liters of oral hydration. As of time of the report, autonomic testing was scheduled for the following week. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient tested negative for COVID via nasal swab on 17Sep2021. Outcome of the events was not recovered.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity, Palpitations, Paraesthesia
Clinical narrative: After lunch experienced near syncopal collapse; right arm pain and tingling/both hands tingling; Continued to feel lightheaded- near syncopal; brain fog; anorexia; Headache; throat and chest tightness; throat and chest tightness; nausea; palpitations; Immediate face tingling/right arm pain and tingling/both hands tingling; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration, administered in the right arm on 15Sep2021 at 16:45 (Batch/Lot Number: FC3183) single, for COVID-19 immunization. Medical history included postpartum disorder in Jan2021. The patient was not pregnant, did not have COVID prior to vaccination, had no known allergies, had no other vaccines in four weeks, and no other medications in two weeks. There were no concomitant medications. On 15Sep2021 at 17:00, the patient experienced immediate face tingling, nausea, and throat and chest tightness after injection. Additional symptoms included headache, brain fog, anorexia, and palpitations. The next day, on 16Sep2021, right arm pain and tingling. Two days later, Friday, both hands were also tingling. On 17Sep2021, after lunch, she experienced near syncopal collapse requiring emergency services, ambulance, and emergency room evaluation. Testing included negative troponin and D-dimer. She continued to feel lightheaded - near syncopal. The patient returned to the ER on Sunday, 19Sep2021, for persistent symptoms plus chest tightness and nausea, which responded to IV fluids. She was seen by PCP in the clinic the next two days, was advised high salt diet and 3-4 liters of oral hydration. As of time of the report, autonomic testing was scheduled for the following week. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient tested negative for COVID via nasal swab on 17Sep2021. Outcome of the events was not recovered.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, SARS-CoV-2 test, Throat tightness, Troponin
Clinical narrative: After lunch experienced near syncopal collapse; right arm pain and tingling/both hands tingling; Continued to feel lightheaded- near syncopal; brain fog; anorexia; Headache; throat and chest tightness; throat and chest tightness; nausea; palpitations; Immediate face tingling/right arm pain and tingling/both hands tingling; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration, administered in the right arm on 15Sep2021 at 16:45 (Batch/Lot Number: FC3183) single, for COVID-19 immunization. Medical history included postpartum disorder in Jan2021. The patient was not pregnant, did not have COVID prior to vaccination, had no known allergies, had no other vaccines in four weeks, and no other medications in two weeks. There were no concomitant medications. On 15Sep2021 at 17:00, the patient experienced immediate face tingling, nausea, and throat and chest tightness after injection. Additional symptoms included headache, brain fog, anorexia, and palpitations. The next day, on 16Sep2021, right arm pain and tingling. Two days later, Friday, both hands were also tingling. On 17Sep2021, after lunch, she experienced near syncopal collapse requiring emergency services, ambulance, and emergency room evaluation. Testing included negative troponin and D-dimer. She continued to feel lightheaded - near syncopal. The patient returned to the ER on Sunday, 19Sep2021, for persistent symptoms plus chest tightness and nausea, which responded to IV fluids. She was seen by PCP in the clinic the next two days, was advised high salt diet and 3-4 liters of oral hydration. As of time of the report, autonomic testing was scheduled for the following week. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient tested negative for COVID via nasal swab on 17Sep2021. Outcome of the events was not recovered.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: suspected COVID-19 with symptoms; suspected COVID-19 with symptoms; This is a spontaneous report from a non contactable consumer (patient).   A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot numbers not reported), dose 1 via an unspecified route of administration on Mar2021 (at the age of 55-year-old) as single dose and dose 2 via an unspecified route of administration on Apr2021 as single dose for covid-19 immunisation.  Medical history included multiple sclerosis. Concomitant medication(s) included ocrelizumab (OCREVUS) taken for an unspecified indication.  The patient reported Covid-19 breakthrough infection in Jul2021 after receiving two doses of Pfizer covid-19 vaccine, one in Mar2021 and one in Apr2021. On 08Sep2021, the patient reported felt like she had COVID again because she had some of the same symptoms as when she had Covid in Jul2021 including weakness, fever, pounding headache, and  coughing.  The outcome was recovering.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness, Palpitations
Clinical narrative: Heart pounding; Sick; I dont really feel quiet normal; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 21Sep2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient received the Pfizer vaccine on 21Sep2021, (yesterday) and her/his heart has been pounding since. Patient dont know if that was a normal side effect because he/she dont really feel quiet normal. paient feel sick. Thank you for being so concerned about her/his health because my heart been pounding all day and now he/she got to make another phone call. The outcome of the events was unknown.  Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Epistaxis, Pneumonia, Vomiting
Clinical narrative: pneumonia; throwing up; nose bleeds; lost her sense of taste and smell; lost her sense of taste and smell; This is a spontaneous report from a contactable nurse. An adult female patient received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization and tofacitinib citrate (XELJANZ XR), via an unspecified route of administration from Jun2019 (Batch/Lot number was not reported; Expiration Date: 11Feb2022) to an unspecified date, at 11 mg, 1x/day for rheumatoid arthritis. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced Pneumonia, throwing up, nose bleeds, lost her sense of taste and smell on 2021. Reporter added, "a couple of months ago 8 days after getting second covid vaccine she got pnuemonia and was throwing up, kept getting nose bleeds and lost her sense of taste and smell. Physician told her to hold her xeljanz til she got better." Physician is aware. The action taken in response to the events for tofacitinib citrate was temporarily withdrawn on an unspecified date. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pruritus, Urticaria
Clinical narrative: Broke out in hives on back, but, arms and legs; Where the hives were skin itched and felt hot to touch; Where the hives were skin itched and felt hot to touch; This is a spontaneous report from a non contactable consumer reported for herself. A 47-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 09Sep2021 (Batch/Lot Number: FC3183) at the age of 47 years as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hodgkin's disease, grass allergy, pollen allergy, dust allergy, mite allergy, allergy to animal. Concomitant medication included estradiol (ESTRADIOL). Historical Vaccine included BNT162B2 administered on 19Aug2021 at the age of 47 years, dose 1 (Batch/lot number: FA6780) Anatomical Location: Arm left Reported Event: felt sick, tired, and extreme headache about 12 hours after shot lasted 24 hours. On 09Sep2021 patient broke out in hives on back, but, arms and legs 4 hours after dose hives would go away and come back for 8 days where the hives were skin itched and felt hot to touch. Outcome of events is recovering. Therapeutic measures were taken: Benadryl.Prior to vaccination, was the patient diagnosed with COVID-19: No. nce the vaccination, has the patient been tested for COVID-19: No  No follow-up attempts are possible. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101259965 as same reporter/patient/drug, different dose/event
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Herpes virus infection
Clinical narrative: Herpes outbreak; Herpes outbreak; This is a spontaneous report from a contactable consumer or other non hcp.   A 37-years-old female non-Pregnant patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), dose 1 via an unspecified route of administration on Aug2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included herpes simplex, erythema multiforme. Concomitant medication(s) included cannabis (CANNABIS). The patient had Known allergies Tetracycline & erythromycin. Age at the time of Vaccination: 37 years. The patient was not pregnant at the time of vaccination The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. On 23Aug2021, 07:45 PM the patient experienced, After the first vaccine she had a Herpes Outbreak After the second vaccine, fainted within 2 minutes of receiving the shot & have had mental confusion ever since.1 week after the second shot, now had an outbreak of Erythema Multiformae, a secondary condition related to Herpes. Currently, the RA is investigating a connection between the Vaccines and activin Herpes and Erythema Multiformae outbreaks after Vaccines. The outcome of the events was not recovered. Therapeutic measures were taken Anti-Viral Medication as a result of herpes outbreak (disease recurrence), herpes outbreak (herpes virus infection).  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Malaise, Product administered at inappropriate site, Pyrexia, Tremor
Clinical narrative: First dose received intramuscularly on right thigh; ran a slight fever; I got sick; felt like sickly and terrible; shaking; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0167), intramuscularly in the right thigh on 10Aug2021 (at the age of 38-year-old), dose 1, single for COVID-19 immunisation. Medical history included pulmonary embolism, hypokalaemia (also reported as potassium, calcium), Hashimoto's disease, and blood clot. Concomitant medication included levothyroxine sodium (LEVOTHYROXINE), apixaban (ELIQUIS), vitamins (reported as vitamins for potassium and phosphorous), prenatal vitamins (has more of everything in it). The patient did not receive other vaccines four weeks prior to COVID-19 Vaccine. In Aug2021, after the first shot, the patient got sick. The patient felt like sickly and terrible. The patient was shaking, ran a slight fever and then everything ended. The outcome of the events was recovered in Aug2021.  No follow-up attempts are possible; No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Headache, Myalgia, Pain in extremity
Clinical narrative: she was still having problems catching her breath until sometime in Jun2021.; Fever; Muscle aches; Joint aches; Headache; Sore arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Left on 30Mar2021 at 11:15 (Batch/Lot Number: ER8732) as dose 2, single for covid-19 immunization (at the age of 53-years-old). Medical history included pre-diabetic (diagnosed about three years ago), tachycardia (she had this condition before she had covid 19 in Oct2020; it felt like she would pass out and she was nauseous) and overweight from an unknown date and unknown if ongoing and Covid-19 from Oct2020 (states she still has not regained her sense of smell that she lost during this illness) to an unknown date and high cholesterol (was diagnosed about 10 years ago) from 2011 to an unknown date. She also stated that before she had Covid 19 in Oct2020, she had the condition in which episodes became more frequent on day 4 of having Covid 19, from once a month, to weekly, daily, then multiple times a day; states it felt like she would pass out and she was nauseous. The concomitant medications included diabetes medication and a blood pressure pill for an unspecified indication and start and stop dates were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6199) via an unspecified route of administration, administered in Arm Left on 09Mar2021, as single dose for COVID-19 immunization (at the age of 52years old) and experienced trouble breathing, atelectasis, cardiac ablation and the patient was hospitalized on 12Mar2021 with pericardial effusion and mild bilateral atelectasis. The patient previously also received Shingles vaccine for prophylaxis around 3 years ago at the age of around 50-years-old and experienced flu like symptoms for about three days. It was reported that after receiving the second dose of vaccine the patient experienced mild symptoms such as fever, muscle aches, joint aches, headache, and sore arm on an unspecified date in 2021 and patient was still having problems catching her breath until sometime in Jun2021 from an unspecified date in Mar2021. She stated that after the second dose of the Covid 19 Vaccine her mild symptoms lasted for 2 days. The patient underwent lab tests and procedures which included blood test which showed inflammation and CT scan with die (computerised tomogram) which showed pericardial effusion; mild bilateral atelectasis and D-Dimer (fibrin d dimer) which result was elevated, all were in Mar2021 and echocardiogram which showed Aericarditis and atelectasis on an unspecified date in 2021. The outcome of the event breathing difficult was recovered on Jun2021 and was recovered from rest of the other events on an unspecified date in 2021.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: she was still having problems catching her breath until sometime in Jun2021.; Fever; Muscle aches; Joint aches; Headache; Sore arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Left on 30Mar2021 at 11:15 (Batch/Lot Number: ER8732) as dose 2, single for covid-19 immunization (at the age of 53-years-old). Medical history included pre-diabetic (diagnosed about three years ago), tachycardia (she had this condition before she had covid 19 in Oct2020; it felt like she would pass out and she was nauseous) and overweight from an unknown date and unknown if ongoing and Covid-19 from Oct2020 (states she still has not regained her sense of smell that she lost during this illness) to an unknown date and high cholesterol (was diagnosed about 10 years ago) from 2011 to an unknown date. She also stated that before she had Covid 19 in Oct2020, she had the condition in which episodes became more frequent on day 4 of having Covid 19, from once a month, to weekly, daily, then multiple times a day; states it felt like she would pass out and she was nauseous. The concomitant medications included diabetes medication and a blood pressure pill for an unspecified indication and start and stop dates were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6199) via an unspecified route of administration, administered in Arm Left on 09Mar2021, as single dose for COVID-19 immunization (at the age of 52years old) and experienced trouble breathing, atelectasis, cardiac ablation and the patient was hospitalized on 12Mar2021 with pericardial effusion and mild bilateral atelectasis. The patient previously also received Shingles vaccine for prophylaxis around 3 years ago at the age of around 50-years-old and experienced flu like symptoms for about three days. It was reported that after receiving the second dose of vaccine the patient experienced mild symptoms such as fever, muscle aches, joint aches, headache, and sore arm on an unspecified date in 2021 and patient was still having problems catching her breath until sometime in Jun2021 from an unspecified date in Mar2021. She stated that after the second dose of the Covid 19 Vaccine her mild symptoms lasted for 2 days. The patient underwent lab tests and procedures which included blood test which showed inflammation and CT scan with die (computerised tomogram) which showed pericardial effusion; mild bilateral atelectasis and D-Dimer (fibrin d dimer) which result was elevated, all were in Mar2021 and echocardiogram which showed Aericarditis and atelectasis on an unspecified date in 2021. The outcome of the event breathing difficult was recovered on Jun2021 and was recovered from rest of the other events on an unspecified date in 2021.
Sex: F
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: got blisters as well; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer. A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on unspecified date at single dose (dose number unknown) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. The reporter stated that a good friend's mother (the patient) got blisters as well on unspecified date after receiving Pfizer covid vaccine. The extent of blisters was unknown. Outcome of the event was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Disease recurrence, Erythema multiforme, Syncope
Clinical narrative: Fainted; Mental confusion; Now have an outbreak of Erythemia Multiformae, a secondary condition related to Herpes.; Now have an outbreak of Erythemia Multiformae, a secondary condition related to Herpes.; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, in Left Arm, on 13Sep2021 at 19:45 (at the age of  37-year-old) as DOSE 2, SINGLE for covid-19 immunization.  Medical history included, Herpes Simplex Outbreaks occasionally, Erythema Multiforme. Concomitant medication included Medical Cannabis. The patient was allergic to Tetracycline & erythromycin. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: not reported), on Aug2021 (at the age of 37-year-old) as DOSE 1, SINGLE for covid-19 immunization and experienced Herpes Outbreak. The patient was not pregnant at time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. The Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 13Sep2021, After the second vaccine, patient fainted within 2 minutes of receiving the shot & have had mental confusion ever since. On Sep2021, 1 week after the second shot, patient now have an outbreak of Erythemia Multiformae, a secondary condition related to Herpes. The outcome of the events was unknown at time of report.  The lot number for BNT162B2, was not provided and will be requested during follow up
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Tongue pruritus
Clinical narrative: Lips felt numb; Tongue itching; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 22Sep2021 12:30 (at the age of 58-year-old) as dose 1, single for COVID-19 immunisation.  Medical history included vitiligo and unspecified known allergies. There were no concomitant medications. On 22Sep2021 at 12:30 the patient experienced lips felt numb and tongue itching. It was reported that tongue started itching immediately and lips felt numb like when your gums are numbed by the dentist and it affects your lips. The events were treated with Benadryl given by nurse. The events were resolving.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Malaise, Night sweats, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive COVID test on 21Sep2021; positive COVID test on 21Sep2021; woke up with a sweat on 20Sep; Felt not well on 19Sep; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN0150) via an unspecified route of administration in left arm on 21Apr2021 (at the age of 32-year-old) at single dose for COVID-19 immunisation. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN0150) via an unspecified route of administration in left arm on 31Mar2021 (at the age of 32-year-old) at single dose for COVID-19 immunisation. Relevant medical history included psoriasis. Concomitant medications included multivitamin. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 19Sep2021 the patient felt not well and woke up with a sweat on 20Sep2021. On 21Sep2021 he was diagnosed with breakthrough positive COVID test. No treatment was received. Nasal swab (antigen test) on 21Sep2021 was positive. The patient was recovering at the time of report.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: First dose: little spacey, lightheaded; First dose: little spacey, lightheaded; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: ER8733), via an unspecified route of administration, administered in Deltoid Left on 30Mar2021 (received at the age of 66-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included GI (gastrointestinal) bleeds and irritable bowel. Concomitant medications were not reported. Historical vaccines included Pneumonia 23 in 2020 and Influenza shot in 2020. Last year (2020), since she is now a senior citizen, when they gave her the Pneumonia 23, the tech who gave it to her, gave it too close to her shoulder bone, gave it too high, gave it 2 inches too high, it got all red and swollen and hot to touch and came across, 6 inches across towards her chest and breast, blamed it on her not putting it on the right spot. She also had the Senior Influenza shot, and that got a little red, which she never had that before either. The patient experienced little spacey, lightheaded on 30Mar2021 after receiving the first dose of bnt162b2. She stated with the first dose she was fine; she got a little spacey or lightheaded or something as soon as they put the stuff in her arm. The events began and ended 30Mar2021. The events lasted for about 5 minutes. She confirmed she recovered completely. Outcome of the event was recovered on 30Mar2021. The reporter assessed the events as serious (medically significant).; Sender's Comments: Based on plausible dose- event relationship post-vaccination  the causal role of BNT162B2 vaccine cannot be excluded for the reported events  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate