chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Formication, Hypoaesthesia
Clinical narrative: Crawling feeling under skin all over body.; Tingling and numbness in different areas of the body.; Tingling and numbness in different areas of the body.; Nausea; Dizziness; Elevated blood pressure; This is a spontaneous report from a contactable nurse, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 59267-1000-1) via an unspecified route of administration in the left arm on 28Sep2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included vitamin d nos (VITAMIN D) and one a day prenatal vitamin (unspecified); both for unknown indication from an unknown date and unknown if ongoing. On 05Oct2021, the patient experienced crawling feeling under skin all over body, tingling and numbness in different areas of the body, nausea, dizziness and elevated blood pressure. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events crawling feeling under skin all over body, tingling and numbness in different areas of the body, nausea, dizziness, elevated blood pressure were unknown at the time of this report.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia
Clinical narrative: Crawling feeling under skin all over body.; Tingling and numbness in different areas of the body.; Tingling and numbness in different areas of the body.; Nausea; Dizziness; Elevated blood pressure; This is a spontaneous report from a contactable nurse, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 59267-1000-1) via an unspecified route of administration in the left arm on 28Sep2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included vitamin d nos (VITAMIN D) and one a day prenatal vitamin (unspecified); both for unknown indication from an unknown date and unknown if ongoing. On 05Oct2021, the patient experienced crawling feeling under skin all over body, tingling and numbness in different areas of the body, nausea, dizziness and elevated blood pressure. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events crawling feeling under skin all over body, tingling and numbness in different areas of the body, nausea, dizziness, elevated blood pressure were unknown at the time of this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pneumonia
Clinical narrative: Caller states both of them contracted Covid-19 19AUG2021; Caller states both of them contracted Covid-19 19AUG2021; pneumonia; This is a spontaneous report from a Pfizer-sponsored program [Regulatory Authority Support]. A contactable consumer reported for himself that a 65-year-old male patient received 1st of BNT162B2 on an unspecific date in 2021 and 2nd dose on an unspecific date in Feb2021 at single dose for covid-19 immunization. Medical history was cancer. Concomitant drug was not reported. Caller states he and his wife had both doses of the Pfizer BioNTech Covid-19 Vaccine in Feb2021. Caller states both of them contracted Covid-19 on 19Aug2021. Caller states they were not hospitalized but were recovering for about 3 weeks. Caller reports having "Covid cough and phlegm." Caller states he was given a "Z-Pak and an inhaler." Caller states he and his wife are now recovered, but would like to get the booster dose of the Pfizer BioNTech Covid-19 Vaccine. Caller states his doctor would not know whether he and his wife should get the booster dose or not, and his doctor would also just ask Pfizer. The caller is 65 years old and they got COVID and now the caller is wondering where they can get and if they are eligible for the booster. He is a cancer survivor. The husband and wife were both hospitalized (as reported) on 19Aug2021 and the caller is the husband. Caller reporting on the Pfizer COVID vaccine and mentioned that he received the two series of the Pfizer shots to prevent COVID earlier in the year around Feb2021, he had the last of the two around Feb2021. On 19Aug2021 he contracted COVID, he wasn't hospitalized (as reported) but had 2 weeks trying to recover. He did have pneumonia too but had the COVID congestion and cough and received the the z-pack inhalers. Outcome of the event was recovered in Sep2021.  The lot number for BNT162b2 was not provided and will be requested during follow up
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Creutzfeldt-Jakob disease
Clinical narrative: development of Cruetzfeldt-Jakobs Disease; This is a spontaneous report from a contactable consumer. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via unspecified route in right arm on Mar2021 at 10:00 AM at patient age of 67-year-old as single dose for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had no known allergies. The patient medical history and concomitant medication was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via unspecified route in right arm on Mar2021 at 10:00 AM at patient age of 67-year-old as single dose for COVID-19 immunisation. The patient experienced development of Cruetzfeldt-Jakobs Disease in May2021. The event resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. It was unknown if patient received treatment. The patient has not been tested for COVID-19 post vaccination. The outcome of the event was not recovered.     The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Acute disseminated encephalomyelitis, Loss of bladder sensation, Magnetic resonance imaging, Muscular weakness, Myelitis transverse
Clinical narrative: This is a spontaneous report from a Contactable Physician. A 75-year-old male patient received the third dose of BNT162B2 (BNT162B2, Lot No. FF2587) intramuscular at single dose on 24Sep2021 for COVID-19 immunization (75-year-old at the time of vaccination). Relevant history included HTN, HLD, OA, HX cervical spine fusion. No known drug allergy. Relevant concomitant drug included amlodipine, hydralazine, atorvastatin calcium (LIPITOR) and lisinopril. The patient previously received first dose of BNT162B2 (Lot No. EN6201) intramuscular at single dose on 05Feb2021 for COVID-19 immunisation, the second dose of BNT162B2 (Lot No. EN6201) intramuscular at single dose on 26Feb2021 for COVID-19 immunisation. The patient had also received Flu Vaccine on 23Sep2021. The patient experienced transverse myelitis vs ADEM per MRI with contrast on cervical/thoracic spine; paraplegia in bil LE; bil UE weakness and progressive loss of sensation up to T4; loss of bladder continence since 26Sep2021. The events reported as serious due to hospitalization (15 days). The outcome of events was not resolved.  Treatment therapy included IV solumedrol; plasmapheresis, IVIG. The patient did not have COVID prior vaccination. The patient had NAAT on 05Oct2021 with negative result (Nasal Swab). MRI on 05Oct2021 showed transverse myelitis vs ADEM per MRI with contrast on cervical/thoracic spine.; Sender's Comments: Based on the information available, a possible contributory role of suspect product BNT162B2 to the reported all the reported 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 RAs, Ethics Committees, and Investigators, as appropriate
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Paraplegia, SARS-CoV-2 antibody test, Sensory loss, Urinary incontinence
Clinical narrative: This is a spontaneous report from a Contactable Physician. A 75-year-old male patient received the third dose of BNT162B2 (BNT162B2, Lot No. FF2587) intramuscular at single dose on 24Sep2021 for COVID-19 immunization (75-year-old at the time of vaccination). Relevant history included HTN, HLD, OA, HX cervical spine fusion. No known drug allergy. Relevant concomitant drug included amlodipine, hydralazine, atorvastatin calcium (LIPITOR) and lisinopril. The patient previously received first dose of BNT162B2 (Lot No. EN6201) intramuscular at single dose on 05Feb2021 for COVID-19 immunisation, the second dose of BNT162B2 (Lot No. EN6201) intramuscular at single dose on 26Feb2021 for COVID-19 immunisation. The patient had also received Flu Vaccine on 23Sep2021. The patient experienced transverse myelitis vs ADEM per MRI with contrast on cervical/thoracic spine; paraplegia in bil LE; bil UE weakness and progressive loss of sensation up to T4; loss of bladder continence since 26Sep2021. The events reported as serious due to hospitalization (15 days). The outcome of events was not resolved.  Treatment therapy included IV solumedrol; plasmapheresis, IVIG. The patient did not have COVID prior vaccination. The patient had NAAT on 05Oct2021 with negative result (Nasal Swab). MRI on 05Oct2021 showed transverse myelitis vs ADEM per MRI with contrast on cervical/thoracic spine.; Sender's Comments: Based on the information available, a possible contributory role of suspect product BNT162B2 to the reported all the reported 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 RAs, Ethics Committees, and Investigators, as appropriate
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: feeling tired; achy; chills; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events with three doses; this is 3rd of 3 reports.  A 67-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration in 2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included cardiac amyloidosis from an unknown date and unknown if ongoing, otherwise healthy and active. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration in 2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation and experienced fatigue, pain and chills. Concomitant medication included tafamidis meglumine (VYNDAQEL) taken for cardiac amyloidosis, start and stop date were not reported. The patient experienced feeling tired (non-serious) in 2021, achy (non-serious) in 2021, chills (non-serious) in 2021. 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101317667 same patient and AEs, different drug dose.;US-PFIZER INC-202101317669 same patient and AEs, different drug dose.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immunisation, Off label use
Clinical narrative: This is a spontaneous report from a noncontactable physician (patient). A 55-year-old (non-pregnant) female patient received the third (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# FF8841), at the age of 55, via an unspecified route of administration, in the left arm, on Oct 8, 2021, at 18:00, single dose for COVID-19 immunisation. No medical history or allergies reported. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EL1284), at the age of 55, via an unspecified route of administration, in the left arm, on Jan 23, 2021, at 08:00, single dose, for COVID-19 immunization; and the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EH9899), at the age of 55, via an unspecified route of administration, in the right arm, on Jan 2, 2021, at 09:00, single dose, for COVID-19 immunisation. On Oct 9, 2021, at 17:00, patient experienced chills. The events did not result in doctor or other healthcare professional office/clinic visit/emergency room/department or urgent care. No therapeutic measures taken as a result of the events. Since the vaccination, patient has not tested for COVID-19. The clinical outcome of the event chills resolved on an unknown date in Oct 2021. No follow-up attempts possible. No further information expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Palpitations
Clinical narrative: The night following the vaccine "my" heart was racing at 112 BPM; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 27Aug2021 at 17:00 (at the age of 65-years-old), as a single dose for COVID-19 immunisation. Medical history includes known allergies to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On 28Aug2021 at 21:30, the patient experienced the night following the vaccine, heart was racing at 112 BPM (beats per minute). On the same day, the patient underwent heart rate measurement and the result was 112 BPM (beats per minute). Therapeutic measures were not taken as a result of the event. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event heart was racing at 112 BPM (beats per minute) was resolved on an unknown date in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid after receiving booster dose Vaccine; Tested positive for Covid after receiving booster dose Vaccine; booster dose; This is a spontaneous report from an agency from a contactable consumer (patient). This female of unspecified age received the first, the second and the third (booster) doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), all at single dose on an unspecified date for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient tested positive for Covid after receiving booster dose Pfizer Covid 19 Vaccine. Patient stated she was positive with Covid also and got Covid from her husband, which was why the patient was coughing every once in a while. The outcome of events was unknown.  The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: contracted Covid-19 19AUG2021; contracted Covid-19 19AUG2021; This spontaneous report from a Pfizer-sponsored program, a contactable consumer reported for himself and his wife. This is for his wife. A 9-decade-old (almost 80-year-old) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as single dose, dose 1 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient contracted COVID-19 on 19Aug2021 with outcome of recovered in Sep2021. Patient was not hospitalized for the event.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Dizziness, Fatigue, Hypersomnia
Clinical narrative: Fever for 48 hours; Slept for 24 hours; Slight nausea; no appetite; arm, muscle joint pain; arm, muscle joint pain; arm, muscle joint pain; Continued fatigue; some dizziness; feeling unwell; This is a spontaneous report from a contactable consumer (patient). This 74-year-old female patient (no pregnant) received 3rd dose of BNT162B2 (Lot Number= FF2589), at the age of 74 years old, on 16Oct2021 04:15 PM, Vaccine location in Left arm, at single dose for covid-19 immunization. Other vaccine on the same date was 1st dose of Fluzone HD 65+, vaccine location=Left arm for immunization. Medical history was Diabetes. Concomitant drugs were not reported. No covid prior vaccination. No covid tested post vaccination. No Known allergies. Historical vaccine was 1st dose of BNT162B2 on 23Feb2021 (lot Number= EL9266), 2nd dose of BNT162B2 on 16Mar2021 (lot Number=EM6206), at single dose for covid-19 immunization. Fever for 48 hours. Slept for 24 hours except for when husband woke me to see if I was still alive. Slight nausea, no appetite, arm, muscle joint pain. Continued fatigue, some dizziness, just feeling unwell from 16Oct2021 09:00 PM. No treatment. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Fever for 48 hours; Slept for 24 hours; Slight nausea; no appetite; arm, muscle joint pain; arm, muscle joint pain; arm, muscle joint pain; Continued fatigue; some dizziness; feeling unwell; This is a spontaneous report from a contactable consumer (patient). This 74-year-old female patient (no pregnant) received 3rd dose of BNT162B2 (Lot Number= FF2589), at the age of 74 years old, on 16Oct2021 04:15 PM, Vaccine location in Left arm, at single dose for covid-19 immunization. Other vaccine on the same date was 1st dose of Fluzone HD 65+, vaccine location=Left arm for immunization. Medical history was Diabetes. Concomitant drugs were not reported. No covid prior vaccination. No covid tested post vaccination. No Known allergies. Historical vaccine was 1st dose of BNT162B2 on 23Feb2021 (lot Number= EL9266), 2nd dose of BNT162B2 on 16Mar2021 (lot Number=EM6206), at single dose for covid-19 immunization. Fever for 48 hours. Slept for 24 hours except for when husband woke me to see if I was still alive. Slight nausea, no appetite, arm, muscle joint pain. Continued fatigue, some dizziness, just feeling unwell from 16Oct2021 09:00 PM. No treatment. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Angiogram pulmonary, Immunisation, Off label use, Pain in extremity, Pulmonary embolism
Clinical narrative: booster dose; booster dose; right calf pain; bilateral PE / SOB; This is a spontaneous reporter from a contactable physician. A 71-year-old female patient received BNT162B2 (COMIRNATY) dose 3 on unknown date (reported as 3 weeks ago) at booster dose for COVID-19 immunisation. The patient medical history included prior massive pulmonary embolism (PE) in 1996 associated with hysterectomy (treated with AC for 6-12 months and then off anticoagulation since), chronic lower extremities (LE) edema and venous stasis. The patient concomitant medications included influenza vaccine (Flu shot) in Oct2021 (reported as 2 weeks ago) at unspecified dosage for Immunization. The patient previously received 2 doses of the BNT162B2 (COVID-19 vaccine) for COVID-19 immunisation without incident. The patient experienced short of breath (SOB) and right calf pain on 18Oct2021. The patient was seen in her physicians office on 19Oct2021. Pulmonary CT angiogram on 19Oct2021 revealed bilateral PE and she was started on anticoagulation. Patient and physician questioned if the PE could have been due to the BNT162B2 booster shot. Otherwise, the patient was in good health (except for prior remote postoperative PE) and not on any other medications. The outcome of event was unknown.     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 the drug temporal relationship, the causality between the events - pulmonary embolism, off label use, immunisation and the suspect drug "BNT162B2" 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.
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: BI-lateral Pulmonary Emboli; This is a spontaneous reporter from a contactable physician via Pfizer Sales Representative. The physician reported same events for 4 patients (3 patients were male, 1 was female). This is for one of 3 male patients. An elderly male (age at 70 or older) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) at single dose for COVID-19 immunisation on unknown date. Relevant history and concomitant drug was unknown. The patient experienced BI-lateral Pulmonary Emboli (serious due to medically important) on unknown date. The outcome of event was unknown.     The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: The information provided is limited and does not allow a meaningful medical assessment of the case. However, based on the available information in the case, a possible contributory role of the suspect product BNT162B2 to the development of reported event of Pulmonary embolism cannot be completely excluded. The case will be reassessed further upon receipt of additional information. 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.,Linked Report(s) : US-PFIZER INC-202101406989 Same reporter, different patient/event.
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: BI-lateral Pulmonary Emboli; This is a spontaneous reporter from a contactable Physician via Pfizer Sales Representative.  The physician reported same events for 4 patients (3 patients were male, 1 was female). This is for one of 3 male patients. An elderly male (age at 70 or older) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) at single dose for COVID-19 immunisation on unknown date. Relevant history and concomitant drug was unknown. The patient experienced BI-lateral Pulmonary Emboli (serious due to medically important) on unknown date. The outcome of event was unknown.     The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the Serious event Pulmonary Embolism and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug 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.,Linked Report(s) : US-PFIZER INC-202101406989 Same reporter, same drug, same event, different patient;US-PFIZER INC-202101406989 Same reporter, different patient/event.
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: BI-lateral Pulmonary Emboli; This is a spontaneous report from a contactable physician via a company representative. The physician reported same events for four patients in his practice. This is the fourth of four reports. An elder female patient of an unknown age (70 or older) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unworn date via an unknown route for Covid-19 immunization. Medical history and concomitant drug were not provided. This patients in the reporting physician's practice got the Pfizer COVID-19 vaccine and developed BI-lateral Pulmonary Emboli within a month of the vaccine.  Outcome of the event was unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event pulmonary embolism cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-202101406989 Same reporter, different patient/event.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: fainted; This is a spontaneous report from a contactable consumer (patient). This consumer reported different events for both doses of BNT162B2. This is the second report for first dose.  A 32-year-old male patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown), at the age of 32 years old, via an unspecified route of administration in left arm on 27Sep2021 at single dose for COVID-19 immunisation. Medical history included seasonal allergy. Patient had no epilepsy no history of that whatsoever. There were no concomitant medications. The patient experienced fainted in Sep2021. He was not with anybody he just thought he fainted and they said that was normal at the pharmacy. No treatment received. Outcome of events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101407743 same patient and drug, different event separated in time
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: progressive idiopathic neuropathy; This is a spontaneous report from contactable consumers (one is patient). This male patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6199) via intramuscular at single dose in left arm on 02Mar2021 for covid-19 immunisation. The first dose was on 08Feb2021 (Batch/Lot number: EL9262) via intramuscular in left arm and experienced some numbness in both knees. Medical history included peripheral neuropathy from 2005 and ongoing, very mild on bottom of both feet, began in 2005 but did not advance or change until patient had the vaccine. Prior vaccinations (within 4 weeks) was none. Concomitant drugs was none. After 2nd dose in March, feet became numb and some neuropathy symptoms in both arms (numbness, tingling, feeling of warmth in right arm) in Mar2021. Tingling and numbness had intensified some what to this date (14Oct2021). Patient was diagnosed by neurologist with progressive idiopathic peripheral neuropathy. No treatment prescribed by medical doctors. Specific relevant test for thromboembolic events with thrombocytopenia was unknown. The outcome of event was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Disease recurrence, Guillain-Barre syndrome
Clinical narrative: in remission for 30 years and it came back within 3 months, he had Guillain Barre; in remission for 30 years and it came back within 3 months, he had Guillain Barre; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Guillain Barre which was in remission for 30 years. The patient's concomitant medications were not reported.  Patient was in remission for 30 years and it came back within 3 months, he had Guillain Barre. Outcome of the event was unknown.  The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, dose number unknown, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that he was "a guy sitting in a chair" and "he was a genius". On an unspecified date after vaccination, the patient had a stroke "and now is just a regular guy". The event outcome was unknown at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Breakthrough case of covid-19 even though he was vaccinated; Breakthrough case of covid-19 even though he was vaccinated; This is a spontaneous report from a non-contactable consumer (patient's child).  A male patient of an unspecified age received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, lot number: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Breakthrough case of COVID-19 even though he was vaccinated on an unspecified date. Required hospitalization. Event took place after use of product. Unsure if this patient took the Pfizer vaccine or another vaccine for covid. Reporting just in case. Also this was reported within the required 24hr timeframe. Outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Rash
Clinical narrative: rash on his leg and stomach; tired; This is a spontaneous report from a contactable consumer (patient) who reported events after second and third dose of the vaccine. This case is for event after the third dose.  A 71-year-old male patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;; Lot number was not reported), via an unspecified route of administration in Arm Right on 19Oct2021 at 12:15 (at 71 years) as single dose for covid-19 immunization. Medical history included ongoing glaucoma (took 2 eye drops, unspecified drug) and had bee allergies and was desensitized years ago. Concomitant medication included atorvastatin taken for an unspecified indication, start and stop date were not reported.  Previously on 06Feb2021 (at 70 years) the  patient took first dose of bnt162b2 (lot EL9264) in the right arm for covid-19 immunisation; on 27Feb2021 (at 70 years) the patient received the second dose of bnt162b2 (lot EN6203) in the right arm for covid-19 immunisation and experienced tired. On 19Oct2021 the patient experienced tired; on 20Oct2021 patient experienced rash on his leg and stomach. The patient called his pharmacist and they said to take Benadryl so he did. No Emergency Room or Physician Office.Outcome of the events was recovering. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101410901 Same patient, same drug with different dose, different AE
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Condition aggravated, Headache, Injury
Clinical narrative: Severe headache; agonizing pain in the neck; agonizing pain in the back; Agonizing pain in the wrists/pain in the joints; Sites of previous injuries seem to be aggravated after taking vaccine; Sites of previous injuries seem to be aggravated after taking vaccine; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 34-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 17Oct2021 at 08:00 (Batch/Lot number was not reported, age at the time of vaccination: 34-year-old) as DOSE NUMBER UNKNOWN, SINGLE, via an unspecified route of administration, administered in Arm Left on 26Sep2021 at 08:00 (Batch/Lot number was not reported, age at the time of vaccination: 34-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation administered at Pharmacy or Drug Store. Medical history included injury from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced severe headache, agonizing pain in the neck, agonizing pain in the back, agonizing pain in the wrists/pain in the joints and sites of previous injuries seem to be aggravated after taking vaccine on an unknown date in 2021. It was unknown whether patient received treatment or not. It was unknown whether patient received any other vaccines within 4 weeks prior to the COVID vaccine or not. It was unknown whether prior to vaccination, the patient diagnosed with COVID-19 or not and not know whether since the vaccination, the patient been tested for COVID-19 or not also The outcome of all events was reported as not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Severe headache; agonizing pain in the neck; agonizing pain in the back; Agonizing pain in the wrists/pain in the joints; Sites of previous injuries seem to be aggravated after taking vaccine; Sites of previous injuries seem to be aggravated after taking vaccine; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 34-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 17Oct2021 at 08:00 (Batch/Lot number was not reported, age at the time of vaccination: 34-year-old) as DOSE NUMBER UNKNOWN, SINGLE, via an unspecified route of administration, administered in Arm Left on 26Sep2021 at 08:00 (Batch/Lot number was not reported, age at the time of vaccination: 34-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation administered at Pharmacy or Drug Store. Medical history included injury from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced severe headache, agonizing pain in the neck, agonizing pain in the back, agonizing pain in the wrists/pain in the joints and sites of previous injuries seem to be aggravated after taking vaccine on an unknown date in 2021. It was unknown whether patient received treatment or not. It was unknown whether patient received any other vaccines within 4 weeks prior to the COVID vaccine or not. It was unknown whether prior to vaccination, the patient diagnosed with COVID-19 or not and not know whether since the vaccination, the patient been tested for COVID-19 or not also The outcome of all events was reported as not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rheumatoid arthritis
Clinical narrative: Pain; Rheumatoid arthritis flare up; This is a solicited report from a marketing program (FACILITATED COLLECT) based on information received by Pfizer (manufacturer control number: 21K-163-4116776-00) form a contactable consumer (patient).  A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via intramuscular on 24Sep2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from 11Jun2021 (Batch/Lot number was not reported) and ongoing, at citrate free, 40 mg, 1 in 2 wk for moderate to severe Rheumatoid arthritis. Medical history was not reported. Concomitant medication included methotrexate taken for an unspecified indication, start and stop date were not reported. In Sep2021, the patient experienced rheumatoid arthritis flare. On 24Sep2021, the patient experienced lot of pain. On 29Sep2021, the lot of pain resolved. In Sep2021, the rheumatoid arthritis flare resolved. Pfizer Biontech Covid-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The outcome of events was recovered. The action taken in response to the events for adalimumab was dose not changed. The reporter's causality for the events of lot of pain and rheumatoid arthritis flare with adalimumab was not provided. The reporter's causality for the events of lot of pain and rheumatoid arthritis flare with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was possible.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information and a possible contributory role of the suspect product BNT162B2 to the development of the Rheumatoid arthritis and pain cannot be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID with symptoms; tested positive for COVID with symptoms; This is a spontaneous report from a contactable physician.  A 53-year-old female patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) at single dose for COVID-19 immunization 6 months plus after finishing full 2 doses series. Relevant history and concomitant drugs were unknown. Relevant history included smoker. Relevant concomitant drug was unknown.  Patient presented with flu like symptoms with 1 day of receiving the booster shot and subsequently tested positive for COVID. Patient still had shortness of breath 10 days later. The final 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: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chills, Decreased appetite, Delirium, Insomnia
Clinical narrative: Delirious; Chills; Nausea; Aches; Could not get out of bed for toilet unassisted; Trouble sleeping; No appetite; Lost 10 pounds in 10 days; This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6200) at single dose via an unwon route in left arm on 18Feb2021 at 81-year-old for Covid-19 immunization. Medical history included Pacemaker since 30Aug2017, right Total Hip Replace on 04May2020, ongoing antiseizure, ongoing bladder (as reported), ongoing swelling ankles. Concomitant drugs included levetiracetam (KEPPRA) for anti-seizure, tamsulosin hydrochloride (FLOMAX) for bladder, hydrochlorothiazide (MICROZIDE) for swelling ankles, all ongoing. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9262) on 28Jan2021 in left arm at 81-year-old for Covid-19 immunization. Patient had no other prior vaccinations (within 4 weeks). Relevant tests included MRI on 04May2020: RT. Hip Replacement.  blood test was taken on 04May2020. On 20Feb2021 (reported as day 1 reactions; also reported as "02Feb2021"), patient experienced delirious, chills, nausea, aches, could not get out of bed for toilet unassisted. Following 9 days, patient experienced trouble sleeping, continued nausea, aches, no appetite, lost 10 pounds in 10 days. No treatment was received. COVID-19 Swab on an unknown date: negative. Outcome of the events trouble sleeping, no appetite, lost 10 pounds was resolve on 02Mar2021. Outcome of the events was resolved on 02Mar2021 with duration of 10 days. Seriousness criteria was reported as "1".  No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Magnetic resonance imaging, Nausea, Pain, SARS-CoV-2 test
Clinical narrative: Delirious; Chills; Nausea; Aches; Could not get out of bed for toilet unassisted; Trouble sleeping; No appetite; Lost 10 pounds in 10 days; This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6200) at single dose via an unwon route in left arm on 18Feb2021 at 81-year-old for Covid-19 immunization. Medical history included Pacemaker since 30Aug2017, right Total Hip Replace on 04May2020, ongoing antiseizure, ongoing bladder (as reported), ongoing swelling ankles. Concomitant drugs included levetiracetam (KEPPRA) for anti-seizure, tamsulosin hydrochloride (FLOMAX) for bladder, hydrochlorothiazide (MICROZIDE) for swelling ankles, all ongoing. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9262) on 28Jan2021 in left arm at 81-year-old for Covid-19 immunization. Patient had no other prior vaccinations (within 4 weeks). Relevant tests included MRI on 04May2020: RT. Hip Replacement.  blood test was taken on 04May2020. On 20Feb2021 (reported as day 1 reactions; also reported as "02Feb2021"), patient experienced delirious, chills, nausea, aches, could not get out of bed for toilet unassisted. Following 9 days, patient experienced trouble sleeping, continued nausea, aches, no appetite, lost 10 pounds in 10 days. No treatment was received. COVID-19 Swab on an unknown date: negative. Outcome of the events trouble sleeping, no appetite, lost 10 pounds was resolve on 02Mar2021. Outcome of the events was resolved on 02Mar2021 with duration of 10 days. Seriousness criteria was reported as "1".  No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: Delirious; Chills; Nausea; Aches; Could not get out of bed for toilet unassisted; Trouble sleeping; No appetite; Lost 10 pounds in 10 days; This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6200) at single dose via an unwon route in left arm on 18Feb2021 at 81-year-old for Covid-19 immunization. Medical history included Pacemaker since 30Aug2017, right Total Hip Replace on 04May2020, ongoing antiseizure, ongoing bladder (as reported), ongoing swelling ankles. Concomitant drugs included levetiracetam (KEPPRA) for anti-seizure, tamsulosin hydrochloride (FLOMAX) for bladder, hydrochlorothiazide (MICROZIDE) for swelling ankles, all ongoing. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9262) on 28Jan2021 in left arm at 81-year-old for Covid-19 immunization. Patient had no other prior vaccinations (within 4 weeks). Relevant tests included MRI on 04May2020: RT. Hip Replacement.  blood test was taken on 04May2020. On 20Feb2021 (reported as day 1 reactions; also reported as "02Feb2021"), patient experienced delirious, chills, nausea, aches, could not get out of bed for toilet unassisted. Following 9 days, patient experienced trouble sleeping, continued nausea, aches, no appetite, lost 10 pounds in 10 days. No treatment was received. COVID-19 Swab on an unknown date: negative. Outcome of the events trouble sleeping, no appetite, lost 10 pounds was resolve on 02Mar2021. Outcome of the events was resolved on 02Mar2021 with duration of 10 days. Seriousness criteria was reported as "1".  No follow-up attempts are possible. No further information is expected.