chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Brain fog, CSF oligoclonal band present, Dyspepsia, Hypoaesthesia
Clinical narrative: transverse myelitis; neuropathy from his waist down; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar event for two patients. This is the first of two reports.  A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (at the age of 41 years old) via an unspecified route of administration, administered in Arm Right on 24May2021 (Batch/Lot Number: EW0186) as dose 2, single for covid-19 immunisation. The patient has no medical history and concomitant medications. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EW0176) via an unspecified route of administration in the left arm on 03May2021 10:00 (at the age of 41 years old) for COVID-19 immunization and experienced brain fog, a lot of digestive issues and still has a huge knot on his left arm and it has remained the same and is as hard as a rock (the patient had the 2nd dose administered in his right arm and it has no knot on that arm). No additional vaccines administered on same date of the Pfizer suspect and no prior vaccinations within 4 weeks. The patient was diagnosed with transverse myelitis on 09Sep2021 per his 'MyChart'. The patient that stated they have been doings tests and treatment running over the last few months. The patient had four MRIs, a spinal tap and blood tests. The results of the MRI showed white matter on his spine at T2 and the neurologist diagnosed him with transverse myelitis. For the first symptoms of transverse myelitis, he lost all feeling in his legs and had numbness and tingling and now neuropathy from his waist down and that happened on 16Aug2021 and the hospital emergency room visit was on 19Aug2021 in the hospital outpatient and saw his doctor on 16Aug2021. On 17Aug2021, they did the MRI and thought this was Guillian Barre syndrome as it has the same side effects but ruled out Guillian Barre syndrome. He went on 19Aug2021 for admission to the emergency room and had tingling up to his chest and down to his feet including all his extremities and spent two nights in the hospital admitted on 19Aug2021 and discharged on 21Aug2021. The only other thing was that until he took the vaccine, he had not been to the HCP in two years for anything and since he took the vaccine not counting all the follow up visits to the doctor five times for different ongoing symptoms and since then he has been doing research. The patient stated that in hospitals and with doctors, his neurologist said they had a spike in cases of transverse myelitis since people have been taking the vaccine; his chiropractor said there has been a spike in his patients coming to him for relief as well in the last 8-10 months. The outcome of the event transverse myelitis was not recovered while the other event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101312448 same reporter/drug, similar event, different patients
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test normal, Lumbar puncture normal, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal abnormal, Mass
Clinical narrative: transverse myelitis; neuropathy from his waist down; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar event for two patients. This is the first of two reports.  A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (at the age of 41 years old) via an unspecified route of administration, administered in Arm Right on 24May2021 (Batch/Lot Number: EW0186) as dose 2, single for covid-19 immunisation. The patient has no medical history and concomitant medications. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EW0176) via an unspecified route of administration in the left arm on 03May2021 10:00 (at the age of 41 years old) for COVID-19 immunization and experienced brain fog, a lot of digestive issues and still has a huge knot on his left arm and it has remained the same and is as hard as a rock (the patient had the 2nd dose administered in his right arm and it has no knot on that arm). No additional vaccines administered on same date of the Pfizer suspect and no prior vaccinations within 4 weeks. The patient was diagnosed with transverse myelitis on 09Sep2021 per his 'MyChart'. The patient that stated they have been doings tests and treatment running over the last few months. The patient had four MRIs, a spinal tap and blood tests. The results of the MRI showed white matter on his spine at T2 and the neurologist diagnosed him with transverse myelitis. For the first symptoms of transverse myelitis, he lost all feeling in his legs and had numbness and tingling and now neuropathy from his waist down and that happened on 16Aug2021 and the hospital emergency room visit was on 19Aug2021 in the hospital outpatient and saw his doctor on 16Aug2021. On 17Aug2021, they did the MRI and thought this was Guillian Barre syndrome as it has the same side effects but ruled out Guillian Barre syndrome. He went on 19Aug2021 for admission to the emergency room and had tingling up to his chest and down to his feet including all his extremities and spent two nights in the hospital admitted on 19Aug2021 and discharged on 21Aug2021. The only other thing was that until he took the vaccine, he had not been to the HCP in two years for anything and since he took the vaccine not counting all the follow up visits to the doctor five times for different ongoing symptoms and since then he has been doing research. The patient stated that in hospitals and with doctors, his neurologist said they had a spike in cases of transverse myelitis since people have been taking the vaccine; his chiropractor said there has been a spike in his patients coming to him for relief as well in the last 8-10 months. The outcome of the event transverse myelitis was not recovered while the other event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101312448 same reporter/drug, similar event, different patients
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myelitis transverse, Neuropathy peripheral, Pain in extremity, Paraesthesia, Paraplegia
Clinical narrative: transverse myelitis; neuropathy from his waist down; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar event for two patients. This is the first of two reports.  A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (at the age of 41 years old) via an unspecified route of administration, administered in Arm Right on 24May2021 (Batch/Lot Number: EW0186) as dose 2, single for covid-19 immunisation. The patient has no medical history and concomitant medications. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EW0176) via an unspecified route of administration in the left arm on 03May2021 10:00 (at the age of 41 years old) for COVID-19 immunization and experienced brain fog, a lot of digestive issues and still has a huge knot on his left arm and it has remained the same and is as hard as a rock (the patient had the 2nd dose administered in his right arm and it has no knot on that arm). No additional vaccines administered on same date of the Pfizer suspect and no prior vaccinations within 4 weeks. The patient was diagnosed with transverse myelitis on 09Sep2021 per his 'MyChart'. The patient that stated they have been doings tests and treatment running over the last few months. The patient had four MRIs, a spinal tap and blood tests. The results of the MRI showed white matter on his spine at T2 and the neurologist diagnosed him with transverse myelitis. For the first symptoms of transverse myelitis, he lost all feeling in his legs and had numbness and tingling and now neuropathy from his waist down and that happened on 16Aug2021 and the hospital emergency room visit was on 19Aug2021 in the hospital outpatient and saw his doctor on 16Aug2021. On 17Aug2021, they did the MRI and thought this was Guillian Barre syndrome as it has the same side effects but ruled out Guillian Barre syndrome. He went on 19Aug2021 for admission to the emergency room and had tingling up to his chest and down to his feet including all his extremities and spent two nights in the hospital admitted on 19Aug2021 and discharged on 21Aug2021. The only other thing was that until he took the vaccine, he had not been to the HCP in two years for anything and since he took the vaccine not counting all the follow up visits to the doctor five times for different ongoing symptoms and since then he has been doing research. The patient stated that in hospitals and with doctors, his neurologist said they had a spike in cases of transverse myelitis since people have been taking the vaccine; his chiropractor said there has been a spike in his patients coming to him for relief as well in the last 8-10 months. The outcome of the event transverse myelitis was not recovered while the other event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101312448 same reporter/drug, similar event, different patients
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspepsia, Feeling abnormal, Vaccination site induration
Clinical narrative: transverse myelitis; neuropathy from his waist down; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar event for two patients. This is the first of two reports.  A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (at the age of 41 years old) via an unspecified route of administration, administered in Arm Right on 24May2021 (Batch/Lot Number: EW0186) as dose 2, single for covid-19 immunisation. The patient has no medical history and concomitant medications. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EW0176) via an unspecified route of administration in the left arm on 03May2021 10:00 (at the age of 41 years old) for COVID-19 immunization and experienced brain fog, a lot of digestive issues and still has a huge knot on his left arm and it has remained the same and is as hard as a rock (the patient had the 2nd dose administered in his right arm and it has no knot on that arm). No additional vaccines administered on same date of the Pfizer suspect and no prior vaccinations within 4 weeks. The patient was diagnosed with transverse myelitis on 09Sep2021 per his 'MyChart'. The patient that stated they have been doings tests and treatment running over the last few months. The patient had four MRIs, a spinal tap and blood tests. The results of the MRI showed white matter on his spine at T2 and the neurologist diagnosed him with transverse myelitis. For the first symptoms of transverse myelitis, he lost all feeling in his legs and had numbness and tingling and now neuropathy from his waist down and that happened on 16Aug2021 and the hospital emergency room visit was on 19Aug2021 in the hospital outpatient and saw his doctor on 16Aug2021. On 17Aug2021, they did the MRI and thought this was Guillian Barre syndrome as it has the same side effects but ruled out Guillian Barre syndrome. He went on 19Aug2021 for admission to the emergency room and had tingling up to his chest and down to his feet including all his extremities and spent two nights in the hospital admitted on 19Aug2021 and discharged on 21Aug2021. The only other thing was that until he took the vaccine, he had not been to the HCP in two years for anything and since he took the vaccine not counting all the follow up visits to the doctor five times for different ongoing symptoms and since then he has been doing research. The patient stated that in hospitals and with doctors, his neurologist said they had a spike in cases of transverse myelitis since people have been taking the vaccine; his chiropractor said there has been a spike in his patients coming to him for relief as well in the last 8-10 months. The outcome of the event transverse myelitis was not recovered while the other event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101312448 same reporter/drug, similar event, different patients
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Since the vaccination, the patient been tested for COVID-19 test on 28Sep2021 with positive result; Since the vaccination, the patient been tested for COVID-19 test on 28Sep2021 with positive result; This is a spontaneous report from a contactable health care professional (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in left arm on 25Mar2021 16:30 (Batch/Lot Number: EP6955) (at the age of 41 years old) as dose 2, single and intramuscular, administered in left arm on 03Mar2021 14:20 (also reported as 14:30) (Lot Number: EN6204) (at the age of 41 years old) as dose 1, single, for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was in Public Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history included allergy (reaction to unspecified drug). Concomitant medications included Taynelo (as reported). The patient hadn't been sick. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19 test on 28Sep2021 with positive result. On 28Sep2021, patient experienced vaccination failure and COVID-19. The patient underwent lab tests and procedures which included COVID-19 Test: positive on 28Sep2021. The outcome of the events was unknown.; Sender's Comments: Based on the available information, the causal association between the events vaccination failure, COVID-19 and the suspect drug BNT162B2 cannot be excluded.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Herpes zoster
Clinical narrative: Patient presents with shingles on chin area; oozing blisters; This is a spontaneous report from a contactable Nurse. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: 30155BA), via an intramuscular route of administration, administered in Arm Right on 30Sep2021 18:30 as Dose 2, single for COVID-19 immunization (at the age of 27-year-old). The patient medical history included seizure and anaemia. The patient concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: 2AA165969), via an intramuscular route of administration, administered in Arm Left on 02Sep2021 10:00 as Dose 1, single for COVID-19 immunization (at the age of 27-year-old). It was reported that patient was not a pregnant at the time of vaccination. She did not take any other vaccine within 4 weeks prior COVID vaccination. She took multiple other medications due to seizure disorder in two weeks prior COVID vaccination. She was not diagnosed with COVID-19 prior vaccination and was not tested with COVID-19 post vaccination. The patient previously took Biaxin and Cipro (Ciprofloxacin) and experienced drug allergy. On 01Oct2021 06:00, the patient experienced presents with shingles on chin area and oozing blisters COVID vaccination. The patient has visited the Physician Office as a result of events. Therapeutic measures as a result of events were unknown. The outcome of the events was unknown.
Age: 49.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Allergic respiratory symptom, Bell's palsy, Dyspepsia, Fatigue, Fibromyalgia
Clinical narrative: Bell's palsy; Rheumatoid arthritis flare up; Fatigue; Numbness in toes; Heartburn; Allergic respiratory symptom; Fibromyalgia; Mobility decreased; This is a solicited report from the marketing program Facilitated Collect based on information received by Pfizer from AbbVie (manufacturer control number: 21K-163-4062444-00), received from a contactable consumer (patient).   A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 23Jul2021 (Batch/Lot number was not reported) as dose 1, single at 49 years old, and intramuscular on 13Aug2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported), at unspecified dose for Moderate to severe rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. The patient previously took Humira for rheumatoid arthritis and experienced misfire with a pen exploded and sprayed the in the eyes and face. On an unspecified date in 2021, after both the 1st and 2nd dose of bnt162b2, the patient experienced Bell's palsy, rheumatoid arthritis flare up, numbness in toes, fatigue, heartburn, allergic respiratory symptom, fibromyalgia, and mobility decreased. The action taken in response to the events for adalimumab was unknown. The outcome of the event rheumatoid arthritis flare up was recovered on an unspecified date in 2021, for the event fatigue was recovering, for the event mobility decreased was unknown, while for the rest of the events was not recovered. The reporter's causality for adalimumab with event rheumatoid arthritis flare up was reasonable possibility, for the event mobility decreased was not reported while for the rest of the events was no reasonable possibility. The reporter's causality for bnt162b2 with all the events was not related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on a temporal association and know drug safety profile, the causal association between the events Bell's palsy and fatigue and the suspect drug BNT162B2 cannot be totally excluded. The other events are more likely intercurrent or due to development of underlying medical condition and are assessed as unrelated to the suspect drug BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a 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: 49.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Hypoaesthesia, Mobility decreased, Rheumatoid arthritis
Clinical narrative: Bell's palsy; Rheumatoid arthritis flare up; Fatigue; Numbness in toes; Heartburn; Allergic respiratory symptom; Fibromyalgia; Mobility decreased; This is a solicited report from the marketing program Facilitated Collect based on information received by Pfizer from AbbVie (manufacturer control number: 21K-163-4062444-00), received from a contactable consumer (patient).   A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 23Jul2021 (Batch/Lot number was not reported) as dose 1, single at 49 years old, and intramuscular on 13Aug2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported), at unspecified dose for Moderate to severe rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. The patient previously took Humira for rheumatoid arthritis and experienced misfire with a pen exploded and sprayed the in the eyes and face. On an unspecified date in 2021, after both the 1st and 2nd dose of bnt162b2, the patient experienced Bell's palsy, rheumatoid arthritis flare up, numbness in toes, fatigue, heartburn, allergic respiratory symptom, fibromyalgia, and mobility decreased. The action taken in response to the events for adalimumab was unknown. The outcome of the event rheumatoid arthritis flare up was recovered on an unspecified date in 2021, for the event fatigue was recovering, for the event mobility decreased was unknown, while for the rest of the events was not recovered. The reporter's causality for adalimumab with event rheumatoid arthritis flare up was reasonable possibility, for the event mobility decreased was not reported while for the rest of the events was no reasonable possibility. The reporter's causality for bnt162b2 with all the events was not related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on a temporal association and know drug safety profile, the causal association between the events Bell's palsy and fatigue and the suspect drug BNT162B2 cannot be totally excluded. The other events are more likely intercurrent or due to development of underlying medical condition and are assessed as unrelated to the suspect drug BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a 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: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clot; This is a spontaneous report from a non-contactable consumer report from a Pfizer-sponsored program. A patient of unspecified age and gender received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The family member (patient) received the COVID-19 vaccine and developed a blood clot on an unspecified date. The reporter was unsure of what vaccine they had. The reporter stated that her Mom cannot have the vaccine due to severe rheumatoid arthritis, and Dad was thinking about it. The reporter just wanted to be educated on all the vaccines to make an informative decision. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: U
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: Developed cancer; This is a spontaneous report from a non-contactable consumer (family member) report from a Pfizer-sponsored program COVAX US Support. A patient of unspecified age and gender received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced developed cancer on an unspecified date. The reporter was unsure of what vaccine they had. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Osteoarthritis, Pain, Pruritus, Pyrexia
Clinical narrative: Osteoarthritis knees; Legs itchy; Fever/running a temp; General body pain/body ache; This is a solicited report from a non-interventional study (FACILITATED COLLECT) based on information received by Pfizer (Manufacturer control number: 21K-163-3977066-00). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), intramuscular on 15Mar2021 as dose 1, single, for COVID-19 immunization; and adalimumab (HUMIRA), subcutaneous, with therapy dates, dose and frequency unspecified, for psoriatic arthritis. Medical history included being a non-alcoholic; non-tobacco user; and inflammation. Concomitant medication included meloxicam. On an unspecified date in 2021, the patient had osteoarthritis knees; legs were itchy; fever/running a temp; and general body pain/body ache. In Jun2021, the patient underwent knee surgery and was doing her physical therapy due to the osteoarthritis in the knees. She agreed to have physician contacted. In 2021, patient had second knee surgery; she was doing great but her knees were tight. The patient was using a cane. She had knee surgery and there might have been some arthritis left in her knees, because they were stiff, her healthcare professional was monitoring this. The patient had received paracetamol (TYLENOL) as treatment for fever and body ache; and unspecified treatment for itchy legs. The outcome of the events was unknown.  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.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the  event Osteoarthritis and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Investigation, Laboratory test, Physical examination
Clinical narrative: hard for him to talk to me; he got Bell''s palsy; This is a spontaneous report from a contactable consumer (reporter's husband). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 50-years-old, via an unspecified route of administration, administered in Arm Left on 18Sep2021 (Batch/Lot Number: FF8839) as dose 1, single for COVID-19 immunization. Medical history included blood pressure high, which is under control, halfway under control, blood cholesterol abnormal and blood pressure abnormal. Concomitant medications included atorvastatin calcium (LIPITOR) taken for blood cholesterol abnormal; and lisinopril taken for blood pressure abnormal; both start and stop date were not reported. The patient got Bell's palsy less than 24 hours after the first shot, they recommended that he doesn't get the second shot. It was on the 19Sep2021 right when he got up off bed the reporter thought he had a stroke, because his face completely looked like he had stroke. He got a pretty bad case of Bell's palsy. He has had it for almost 2 weeks, he has called the doctor, they put him on pills twice and he was advised not to get the second shot or anything else until the doctor says okay. He was supposed to get the second shot on 09Oct2021, but the doctor said no and so did the pharmacist, she said if the doctor said no, they cannot give it until he is clear to get it. He has got two physical exam, has got blood work done and everything came out fine. The doctor did a lab test for the first day he was in to get it checked out, his cholesterol was fine, his blood pressure was perfect, the doctor gave him prednisone (treatment) and some antibiotic (treatment) that he had to take for seven days and then he just put him on another week on prednisone again. The patient was still experiencing the event, he was on his second week. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Gait inability, Palpitations, Syncope
Clinical narrative: fainting spells; severe heart problems; can no longer walk up a flight of steps; Heart palpitations; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in Jun2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took the dose 1 of BNT162B2 on unspecified date for COVID-19 immunization. In Jun2021, the patient experienced fainting spells, severe heart problems, can no longer walk up a flight of steps, and heart palpitations. The patient got the second Pfizer vaccine in June. Since that the patient had severe heart problems. The patient can no longer walk up a flight of steps. The patient had fainting spells and heart palpitations. The outcome of the events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 49.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Immunisation, Off label use, Suspected COVID-19, Vaccination site pain
Clinical narrative: Vaccination site pain; booster; Off label use; COVID-19; COVID-19; This is a solicited report from a non-interventional study report from FACILITATED COLLECT based on the information received by Pfizer from regulatory authority (MFR Control No. 21K-163-4102071-00).  A contactable consumer (patient) reported that a 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 intramuscular on an unspecified date (Batch/Lot number was not reported) as dose 3 (booster), single (at the age of 49-years-old) for COVID-19 immunization; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for moderate to severe adult Crohn's disease. Medical history included, none. The patient's concomitant medications were not reported. Historical Vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 and dose 2 intramuscular on unspecified dates (Batch/Lot number was not reported) both as single doses (at the age of 49-years-old) for COVID-19 immunization. Solicited report from the (country) by a consumer of a 49-year-old female with events of non-serious patient had a sore arm after getting booster shot and COVID-19 with Humira (Adalimumab). There was no reported medical history. On an unknown date, the patient experienced patient had a sore arm after getting booster shot. In Sep2021, the patient experienced COVID-19. On an unknown date, patient had a sore arm after getting booster shot resolved. PFIZER BIONTECH COVID-19 VACCINE (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. On unknown date, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown results on Sep2021. Action taken for HUMIRA was unknown. The outcome of the event COVID-19 was Not recovered/not resolved while for Vaccination site pain was Recovered/resolved on an unspecified date.  Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the events of patient had a sore arm after getting booster shot and COVID-19 was not provided.  Causality for PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN): The reporter's causality for the events of patient had a sore arm after getting booster shot and COVID-19 was Possible.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on available information and a possible contributory role of suspect product BNT162B2 to the development of events drug ineffective, suspected covid19 and vaccination site pain cannot be totally excluded.
Sex: U
Vaccine: COVID19
Symptoms: Diplopia, Ulcerative keratitis, VIth nerve paralysis
Clinical narrative: coroneal ulcer in the left eye; cranial nerve VI palsy; Double vision in the right eye; This is a spontaneous report from a Pfizer-sponsored program, Pfizer . A contactable consumer (patient) reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date in Mar2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on an unspecified date in Feb2021 (Batch/Lot number was not reported) for COVID-19 immunisation. On an unspecified date in 2021, the patient developed cranial nerve VI palsy and double vision in the right eye. The patient also developed a coroneal ulcer (corneal ulcer) in the left eye on an unspecified date in Sep2021. The outcome of the events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: Rash; shingles; This is a spontaneous report received from a contactable consumer (patient) who reported for herself.   A 60-year-old female received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EL3246) via an unspecified route of administration, administered in left arm on 06Jan2021 (age at the time of vaccination was 59-years-old) as dose 1, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had no prior vaccination within 4 weeks. On 21Jan2021, the patient experienced shingles and on 23Jan2021, rash. The consumer was calling for more information about the Pfizer BioNTech Covid19 Booster Dose. Per caller, she had her 1st dose of the vaccine back in January 2021 and 2 weeks after the 1st dose, she developed shingles on the vaccinated arm, went up to her neck, across her chest, got one on her ear (inside the ear canal). She had to wait a little longer to get the 2nd dose which was done on 16Feb2021, but she had no adverse reaction to her 2nd dose. She wants to know if this was true. The additional information: The caller had the Pfizer COVID vaccine and about two weeks after getting it she broke out in shingles. The physician didn't think it was related. It was odd because the usual place was around the trunk, but hers were on her arm where she got the vaccine. She got one inside of her ear. They went up her neck and across her chest. Then, she got the second dose, but didn't have a reaction. Now she was contemplating getting a third dose. She was not sure because she got some information from a friend. Her friend knew someone who got shingles after the vaccine, and it went in their ear too. It was reported, and they were told that was a problem. She doesn't have their information to report again. Her first dose was the 06Jan2021 with Lot: EL3246. She got it in her left arm. She developed shingles 2 weeks after. Her symptoms started 21Jan2021, Thursday. On 23Jan2021, her rash showed up. The shingles lasted about 3 weeks. Additional vaccines was not administered on Same Date of the Pfizer Suspect. After the second dose she had no reaction to that. Her second dose was 16 Feb 2021 with lot: EL9265. She got that one in her right arm. Patient was not visited to emergency room but visited to physician office, went to urgent care. The clinical outcome of shingles was recovered on an unspecified date in 2021; while the clinical outcome of rash was unknown.  Investigation Assessment: No  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101318208 same reporter/drug/AE, different patient
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: the daughter had both doses of the Pfizer covid 19 vaccine/ tested positive for covid on 24Sep2021; the daughter had both doses of the Pfizer covid 19 vaccine/ tested positive for covid on 24Sep2021; This is a spontaneous report from a contactable consumer (parent) via medical information team. A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) on an unspecified date, at dose 1, single and on Mar2021 at dose 2, single (at the age of 34-years-old) both via an unspecified route of administration for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had both doses of the vaccine and tested positive for covid on 24sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 24Sep2021. The outcome of the events was unknown.   The lot number for [bnt162b2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: The second one flared up my neuropathy badly; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, Pfizer . 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 was not reported) as dose 2, single for COVID-19 immunisation. Medical history included neuropathy. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. On an unspecified date, the patient experienced the second one flared up my neuropathy badly. It was also reported by the patient that was having lots of pain and barely able to walk. The outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: "my daughter's mother had the covid shot and she tends to get sick whenever she gets around him"; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported that a female patient of an unspecified age received bnt162b2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller wanted to know if Comirnaty is available since she was advised that it is not available anywhere. She wanted to know the differences between Comirnaty and Pfizer biontech covid-19 vaccine since it says on the opening spiel that it is legally distinct. She has a problem with companies mandating/forcing employees to take the covid-19 shot since the available shot from Pfizer is not Comirnaty or the fda-approved vaccine. The caller's verbatim is "my daughter's mother had the covid shot and she tends to get sick whenever she gets around him. We're trying to figure out a detox, to try to get the poison out of his body because she's only 4." The outcome of the event was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Pain in extremity, Vaccination site erythema, Vaccination site infection
Clinical narrative: Red patch below the injection spot; Sick; Sore arm; Infected; This is a spontaneous report from a contactable consumer. This 87-year-old consumer (patient) reported that: A 87-year-old patient of an unspecified gender received bnt162b2 (BNT162B2), via an unspecified route of administration on 29Sep2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization.   The patient's medical history was not reported. Historical vaccine included BNT162B2 (first and second dose, lot numbers were unknown) for COVID-19 immunization. The patient's concomitant medications were not reported. The patient had Pfizer Booster on Wednesday(29Sep2021) and was very sick on Thursday (30Sep2021), but within the listed possible side effects. Friday (01Oct2021) patient felt fine, but woke up last night (30Sep2021)  with sore arm. This morning (02Oct2021) there was a very large red patch below the injection spot. Went to Dr and he said it was infected and prescribed an antibiotic. The patient had no significant reaction from the first two shots, who was very healthy 87 year-old. Outcome of sick on 30Sep2021 was recovered on 01Oct2021. Outcome of sore arm, large red patch below the injection spot and infection was unknown. A very large red patch below the injection spot induced physician office visit.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: I tested positive for covid-19 7 days ago on September 27th.; I tested positive for covid-19 7 days ago on 27Sep2021; This is a spontaneous report from a Pfizer-sponsored program Pfizer, by a contactable consumer (patient).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number was not reported) as single dose and dose 1 via an unspecified route of administration on 13Apr2021 (Batch/Lot number was not reported) as as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that: I want to report that I have been fully vaccinated with Pfizer against COVID-19 since 13Apr2021 and I tested positive for COVID-19 7 days ago on 27Sep2021. I have been bed bound and incapable of taste, smell and a heavily congested nose and chest. No fever to report. The outcome of the events was unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 27Sep2021.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms for a few days; This is a spontaneous report from a contactable other health care professional and a consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on an unknown date for Covid-19 immunization. Medial history included rheumatoid arthritis. Concomitant drug included tofacitinib citrate (XELJANZ XR 11 mg) at 11 mg daily orally from May2019 for rheumatoid arthritis. Patient reported 1 night hospitalization for left knee replacement surgery, completed Jun2021, with tofacitinib citrate (XELJANZ) held for 8 weeks per MD order. Patient recalled "some" worsening of rheumatoid arthritis symptoms, improved as of 04Oct2021, no complications reported. Patient reported flu like symptoms for a few days after covid vaccine. Outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Ankylosing spondylitis, Neuralgia
Clinical narrative: Nerve pain; Spondylitis ankylosing aggravated; This is a solicited report from the marketing program FACILITATED COLLECT based on information received by Pfizer from (Mfr. Control No.: 21K-163-4103326-00).  A contactable consumer (patient) reported that a 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on Apr2021 (Batch/Lot number was not reported) and dose 1 intramuscular on Mar2021 (Batch/Lot number was not reported) both as single doses for COVID-19 immunization; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unknown dose, single for ankylosing spondylitis. The patient's medical history and concomitant medications were not reported. The patient experienced spondylitis ankylosing aggravated on 2021, nerve pain on Aug2021. Solicited report from the by a consumer of a 43 year old female with events of non-serious Ankylosing Spondylitis Flare Up and Nerve Pain In Lower Back with HUMIRA (ADALIMUMAB). In 2021, the patient experienced Ankylosing Spondylitis Flare Up. In Aug2021, the patient experienced Nerve Pain In Lower Back. In 2021, the Ankylosing Spondylitis Flare Up and Nerve Pain In Lower Back Resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In Mar2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/ Biontech. In Apr2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer/ Biontech. The action taken in response to the events for adalimumab was unknown. The outcome of the events was recovered in 2021.  Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event of ankylosing spondylitis flare up with HUMIRA (ADALIMUMAB) was no reasonable possibility. The reporter's causality for the events of nerve pain in lower back was not provided.  Causality for PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN): The reporter's causality for the event of ankylosing spondylitis flare up with PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was Possible. The reporter's causality for the events of nerve pain in lower back was Possible.  No follow up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Considering a temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported events Ankylosing spondylitis aggravated and neuralgia 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