chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Blood test, Muscular weakness, Myalgia
Clinical narrative: pt felt throat was closing off; feeling in skin that everything was extremely painful (pt was having fever of 101); feeling in skin that everything was extremely painful (pt was having fever of 101); Intense pain in skin lasted a day; mylagia; arthralgia; developed a weak right grip after one week; more generalized weakness overall; This is a spontaneous report from a contactable other hcp. A 41-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Right on 27Mar2021 10:15 (Batch/Lot Number: ER8732) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included migraine, anxiety and borderline glaucoma from an unknown date and unknown if ongoing Preglaucoma. Concomitant medication included clonazepam and escitalopram. The patient previously took penicillin [penicillin nos] and experienced hypersensitivity. The patient did not have COVID prior vaccination. On 27Mar2021 14:15, The patient experienced pt felt throat was closing off, feeling in skin that everything was extremely painful, feeling in skin that everything was extremely painful (pt was having fever of 101), intense pain in skin lasted a day, myalgia, arthralgia, developed a weak right grip after one week, more generalized weakness overall (asthenia). Four hours after first Covid 19 immunization- The patient felt throat was closing off but this resolved without treatment. She also had feeling in skin that everything was extremely painful (patient was having fever of 101). Intense pain in skin lasted a day. Fever, mylagia, arthralgia, and weakness lasted about a week. Patient developed a weak right grip after one week from first COVID shot and had more generalized weakness overall. The patient underwent lab tests and procedures which included blood test: negative on 25May2021 COVID test type post vaccination: Blood test, COVID test name post vaccination: SARS-CoV-2-Ab was unknown, COVID test date: 25May2021, COVID test result: Negative , polymerase chain reaction: negative on 30Mar2021 COVID test post vaccination: COVID test type post vaccination: Nasal Swab, COVID test name post vaccination: PCR at (place withheld), COVID test date: 30Mar2021, COVID test result: Negative, sars-cov-2 antibody test: unknown on 25May2021, sars-cov-2 test: negative on 25May2021. The patient did not received treatment for events. The outcome of events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pain of skin, Polymerase chain reaction, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: pt felt throat was closing off; feeling in skin that everything was extremely painful (pt was having fever of 101); feeling in skin that everything was extremely painful (pt was having fever of 101); Intense pain in skin lasted a day; mylagia; arthralgia; developed a weak right grip after one week; more generalized weakness overall; This is a spontaneous report from a contactable other hcp. A 41-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Right on 27Mar2021 10:15 (Batch/Lot Number: ER8732) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included migraine, anxiety and borderline glaucoma from an unknown date and unknown if ongoing Preglaucoma. Concomitant medication included clonazepam and escitalopram. The patient previously took penicillin [penicillin nos] and experienced hypersensitivity. The patient did not have COVID prior vaccination. On 27Mar2021 14:15, The patient experienced pt felt throat was closing off, feeling in skin that everything was extremely painful, feeling in skin that everything was extremely painful (pt was having fever of 101), intense pain in skin lasted a day, myalgia, arthralgia, developed a weak right grip after one week, more generalized weakness overall (asthenia). Four hours after first Covid 19 immunization- The patient felt throat was closing off but this resolved without treatment. She also had feeling in skin that everything was extremely painful (patient was having fever of 101). Intense pain in skin lasted a day. Fever, mylagia, arthralgia, and weakness lasted about a week. Patient developed a weak right grip after one week from first COVID shot and had more generalized weakness overall. The patient underwent lab tests and procedures which included blood test: negative on 25May2021 COVID test type post vaccination: Blood test, COVID test name post vaccination: SARS-CoV-2-Ab was unknown, COVID test date: 25May2021, COVID test result: Negative , polymerase chain reaction: negative on 30Mar2021 COVID test post vaccination: COVID test type post vaccination: Nasal Swab, COVID test name post vaccination: PCR at (place withheld), COVID test date: 30Mar2021, COVID test result: Negative, sars-cov-2 antibody test: unknown on 25May2021, sars-cov-2 test: negative on 25May2021. The patient did not received treatment for events. The outcome of events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test, Throat tightness
Clinical narrative: pt felt throat was closing off; feeling in skin that everything was extremely painful (pt was having fever of 101); feeling in skin that everything was extremely painful (pt was having fever of 101); Intense pain in skin lasted a day; mylagia; arthralgia; developed a weak right grip after one week; more generalized weakness overall; This is a spontaneous report from a contactable other hcp. A 41-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Right on 27Mar2021 10:15 (Batch/Lot Number: ER8732) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included migraine, anxiety and borderline glaucoma from an unknown date and unknown if ongoing Preglaucoma. Concomitant medication included clonazepam and escitalopram. The patient previously took penicillin [penicillin nos] and experienced hypersensitivity. The patient did not have COVID prior vaccination. On 27Mar2021 14:15, The patient experienced pt felt throat was closing off, feeling in skin that everything was extremely painful, feeling in skin that everything was extremely painful (pt was having fever of 101), intense pain in skin lasted a day, myalgia, arthralgia, developed a weak right grip after one week, more generalized weakness overall (asthenia). Four hours after first Covid 19 immunization- The patient felt throat was closing off but this resolved without treatment. She also had feeling in skin that everything was extremely painful (patient was having fever of 101). Intense pain in skin lasted a day. Fever, mylagia, arthralgia, and weakness lasted about a week. Patient developed a weak right grip after one week from first COVID shot and had more generalized weakness overall. The patient underwent lab tests and procedures which included blood test: negative on 25May2021 COVID test type post vaccination: Blood test, COVID test name post vaccination: SARS-CoV-2-Ab was unknown, COVID test date: 25May2021, COVID test result: Negative , polymerase chain reaction: negative on 30Mar2021 COVID test post vaccination: COVID test type post vaccination: Nasal Swab, COVID test name post vaccination: PCR at (place withheld), COVID test date: 30Mar2021, COVID test result: Negative, sars-cov-2 antibody test: unknown on 25May2021, sars-cov-2 test: negative on 25May2021. The patient did not received treatment for events. The outcome of events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 23.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Activated partial thromboplastin time, Chest pain, Electrocardiogram, Full blood count, International normalised ratio
Clinical narrative: Severe chest pain, pain in left arm radiating down causing arm to go numb in lower half of arm. Vomiting due to extreme chest pain. Severe crushing pain. Testing showed myo-peri carditis due to modern vaccine.
Age: 23.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Metabolic function test, Myocarditis, Pericardial effusion, Pericarditis, Troponin increased
Clinical narrative: Severe chest pain, pain in left arm radiating down causing arm to go numb in lower half of arm. Vomiting due to extreme chest pain. Severe crushing pain. Testing showed myo-peri carditis due to modern vaccine.
Age: 23.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Angiogram pulmonary, Cardiovascular evaluation, Chest X-ray, Chest discomfort, Chest pain
Clinical narrative: Severe chest pain, pain in left arm radiating down causing arm to go numb in lower half of arm. Vomiting due to extreme chest pain. Severe crushing pain. Testing showed myo-peri carditis due to modern vaccine.
Age: 23.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Hypoaesthesia, Metabolic function test, Myocarditis
Clinical narrative: Severe chest pain, pain in left arm radiating down causing arm to go numb in lower half of arm. Vomiting due to extreme chest pain. Severe crushing pain. Testing showed myo-peri carditis due to modern vaccine.
Age: 23.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Pain, Pain in extremity, SARS-CoV-2 antibody test, Scan with contrast, Vomiting
Clinical narrative: Severe chest pain, pain in left arm radiating down causing arm to go numb in lower half of arm. Vomiting due to extreme chest pain. Severe crushing pain. Testing showed myo-peri carditis due to modern vaccine.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy skin abnormal, Blood test, Condition aggravated, Eczema, Eosinophilic pustular folliculitis
Clinical narrative: signs of eosinophilic pustular folliculitis; Angry itchy rashes all over face and now body; This is a spontaneous report from a contactable consumer or other non hcp. A 37-years-old non-pregnant female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9267) via an unspecified route of administration in Arm Left on 12Mar2021 13:00 (age at vaccination:37 Years) as DOSE 1, SINGLE for covid-19 immunisation (at hospital). Patient was not pregnant at the time of vaccination, patient didn't receive other vaccines within 4 weeks prior to vaccination, patient received other medications was birth control within 2 weeks of vaccination. Medical history included eczema from an unknown date and unknown if ongoing, herpes zoster from an unknown date and unknown if ongoing, allergy to plants (Birch tree allergy) from an unknown date and unknown if ongoing known allergies: Birch tree allergy. On 12Mar2021 16:00 the patient experienced signs of eosinophilic pustular folliculitis, angry itchy rashes all over face and now body. Patient had physician office visit for the events. Therapeutic measures were taken as a result of signs of eosinophilic pustular folliculitis, angry itchy rashes all over face and now body was topical steroids. Patient was not diagnosed with COVID-19 prior to vaccination, patient was not tested with COVID-19 to post vaccination. The outcome of the events eosinophilic pustular folliculitis, rash pruritic was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic, Skin weeping, Ultrasound scan
Clinical narrative: signs of eosinophilic pustular folliculitis; Angry itchy rashes all over face and now body; This is a spontaneous report from a contactable consumer or other non hcp. A 37-years-old non-pregnant female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9267) via an unspecified route of administration in Arm Left on 12Mar2021 13:00 (age at vaccination:37 Years) as DOSE 1, SINGLE for covid-19 immunisation (at hospital). Patient was not pregnant at the time of vaccination, patient didn't receive other vaccines within 4 weeks prior to vaccination, patient received other medications was birth control within 2 weeks of vaccination. Medical history included eczema from an unknown date and unknown if ongoing, herpes zoster from an unknown date and unknown if ongoing, allergy to plants (Birch tree allergy) from an unknown date and unknown if ongoing known allergies: Birch tree allergy. On 12Mar2021 16:00 the patient experienced signs of eosinophilic pustular folliculitis, angry itchy rashes all over face and now body. Patient had physician office visit for the events. Therapeutic measures were taken as a result of signs of eosinophilic pustular folliculitis, angry itchy rashes all over face and now body was topical steroids. Patient was not diagnosed with COVID-19 prior to vaccination, patient was not tested with COVID-19 to post vaccination. The outcome of the events eosinophilic pustular folliculitis, rash pruritic was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: signs of eosinophilic pustular folliculitis; Angry itchy rashes all over face and now body; This is a spontaneous report from a contactable consumer or other non hcp. A 37-years-old non-pregnant female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9267) via an unspecified route of administration in Arm Left on 12Mar2021 13:00 (age at vaccination:37 Years) as DOSE 1, SINGLE for covid-19 immunisation (at hospital). Patient was not pregnant at the time of vaccination, patient didn't receive other vaccines within 4 weeks prior to vaccination, patient received other medications was birth control within 2 weeks of vaccination. Medical history included eczema from an unknown date and unknown if ongoing, herpes zoster from an unknown date and unknown if ongoing, allergy to plants (Birch tree allergy) from an unknown date and unknown if ongoing known allergies: Birch tree allergy. On 12Mar2021 16:00 the patient experienced signs of eosinophilic pustular folliculitis, angry itchy rashes all over face and now body. Patient had physician office visit for the events. Therapeutic measures were taken as a result of signs of eosinophilic pustular folliculitis, angry itchy rashes all over face and now body was topical steroids. Patient was not diagnosed with COVID-19 prior to vaccination, patient was not tested with COVID-19 to post vaccination. The outcome of the events eosinophilic pustular folliculitis, rash pruritic was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Eosinophilic pustular folliculitis, Rash pruritic
Clinical narrative: signs of eosinophilic pustular folliculitis; Angry itchy rashes all over face and now body; This is a spontaneous report from a contactable consumer or other non hcp. A 37-years-old non-pregnant female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9267) via an unspecified route of administration in Arm Left on 12Mar2021 13:00 (age at vaccination:37 Years) as DOSE 1, SINGLE for covid-19 immunisation (at hospital). Patient was not pregnant at the time of vaccination, patient didn't receive other vaccines within 4 weeks prior to vaccination, patient received other medications was birth control within 2 weeks of vaccination. Medical history included eczema from an unknown date and unknown if ongoing, herpes zoster from an unknown date and unknown if ongoing, allergy to plants (Birch tree allergy) from an unknown date and unknown if ongoing known allergies: Birch tree allergy. On 12Mar2021 16:00 the patient experienced signs of eosinophilic pustular folliculitis, angry itchy rashes all over face and now body. Patient had physician office visit for the events. Therapeutic measures were taken as a result of signs of eosinophilic pustular folliculitis, angry itchy rashes all over face and now body was topical steroids. Patient was not diagnosed with COVID-19 prior to vaccination, patient was not tested with COVID-19 to post vaccination. The outcome of the events eosinophilic pustular folliculitis, rash pruritic was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Amnesia, Blood test normal, Computerised tomogram normal, Electroencephalogram normal, Encephalopathy
Clinical narrative: Diagnosis: autoimmune encephalitis or post vaccine induced inflammation.; One week after second Pfizer vaccine (@12Mar2021), I suffered sudden onset short-term memory loss.; Diagnosis: autoimmune encephalitis or post vaccine induced inflammation.; This is spontaneous report from a contactable other health care professional (patient). A 41-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route at left arm on 05Mar2021 at 12:00 pm (lot number: EN6205) (age at vaccination 41-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported and concomitant medication were none. The patient had no known allergies. The patient received historical vaccine first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unknown route at left arm on 12Feb2021 at 12:00 pm (lot number: EN6201) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. After one week of second Pfizer vaccine, the patient suffered from sudden onset short-term memory loss, diagnosis: autoimmune encephalitis or post vaccine induced inflammation on 12Mar2021 at 04:00 pm. The events resulted for doctor or other healthcare professional office/clinic visit. The patient received prednisone as treatment for the events. The patient laboratory investigation included SARS-CoV2 Antibodies Nucleocapsid was negative on 06May2021. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.; Sender's Comments: Based on temporal association and known safety profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), to the event autoimmune encephalitis cannot be completely excluded.The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging normal
Clinical narrative: Diagnosis: autoimmune encephalitis or post vaccine induced inflammation.; One week after second Pfizer vaccine (@12Mar2021), I suffered sudden onset short-term memory loss.; Diagnosis: autoimmune encephalitis or post vaccine induced inflammation.; This is spontaneous report from a contactable other health care professional (patient). A 41-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route at left arm on 05Mar2021 at 12:00 pm (lot number: EN6205) (age at vaccination 41-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported and concomitant medication were none. The patient had no known allergies. The patient received historical vaccine first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unknown route at left arm on 12Feb2021 at 12:00 pm (lot number: EN6201) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. After one week of second Pfizer vaccine, the patient suffered from sudden onset short-term memory loss, diagnosis: autoimmune encephalitis or post vaccine induced inflammation on 12Mar2021 at 04:00 pm. The events resulted for doctor or other healthcare professional office/clinic visit. The patient received prednisone as treatment for the events. The patient laboratory investigation included SARS-CoV2 Antibodies Nucleocapsid was negative on 06May2021. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.; Sender's Comments: Based on temporal association and known safety profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), to the event autoimmune encephalitis cannot be completely excluded.The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Amnesia, Encephalitis autoimmune, Inflammation, SARS-CoV-2 test
Clinical narrative: Diagnosis: autoimmune encephalitis or post vaccine induced inflammation.; One week after second Pfizer vaccine (@12Mar2021), I suffered sudden onset short-term memory loss.; Diagnosis: autoimmune encephalitis or post vaccine induced inflammation.; This is spontaneous report from a contactable other health care professional (patient). A 41-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route at left arm on 05Mar2021 at 12:00 pm (lot number: EN6205) (age at vaccination 41-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported and concomitant medication were none. The patient had no known allergies. The patient received historical vaccine first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unknown route at left arm on 12Feb2021 at 12:00 pm (lot number: EN6201) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. After one week of second Pfizer vaccine, the patient suffered from sudden onset short-term memory loss, diagnosis: autoimmune encephalitis or post vaccine induced inflammation on 12Mar2021 at 04:00 pm. The events resulted for doctor or other healthcare professional office/clinic visit. The patient received prednisone as treatment for the events. The patient laboratory investigation included SARS-CoV2 Antibodies Nucleocapsid was negative on 06May2021. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.; Sender's Comments: Based on temporal association and known safety profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), to the event autoimmune encephalitis cannot be completely excluded.The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Amnesia, Anti-thyroid antibody, Blood test, Electroencephalogram, Loss of consciousness
Clinical narrative: Diagnosis: autoimmune encephalitis or post vaccine induced inflammation.; One week after second Pfizer vaccine (@12Mar2021), I suffered sudden onset short-term memory loss.; Diagnosis: autoimmune encephalitis or post vaccine induced inflammation.; This is spontaneous report from a contactable other health care professional (patient). A 41-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route at left arm on 05Mar2021 at 12:00 pm (lot number: EN6205) (age at vaccination 41-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported and concomitant medication were none. The patient had no known allergies. The patient received historical vaccine first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unknown route at left arm on 12Feb2021 at 12:00 pm (lot number: EN6201) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. After one week of second Pfizer vaccine, the patient suffered from sudden onset short-term memory loss, diagnosis: autoimmune encephalitis or post vaccine induced inflammation on 12Mar2021 at 04:00 pm. The events resulted for doctor or other healthcare professional office/clinic visit. The patient received prednisone as treatment for the events. The patient laboratory investigation included SARS-CoV2 Antibodies Nucleocapsid was negative on 06May2021. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.; Sender's Comments: Based on temporal association and known safety profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), to the event autoimmune encephalitis cannot be completely excluded.The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lumbar puncture, Magnetic resonance imaging, Positron emission tomogram, Ultrasound pelvis, White blood cell count
Clinical narrative: Diagnosis: autoimmune encephalitis or post vaccine induced inflammation.; One week after second Pfizer vaccine (@12Mar2021), I suffered sudden onset short-term memory loss.; Diagnosis: autoimmune encephalitis or post vaccine induced inflammation.; This is spontaneous report from a contactable other health care professional (patient). A 41-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route at left arm on 05Mar2021 at 12:00 pm (lot number: EN6205) (age at vaccination 41-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported and concomitant medication were none. The patient had no known allergies. The patient received historical vaccine first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unknown route at left arm on 12Feb2021 at 12:00 pm (lot number: EN6201) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. After one week of second Pfizer vaccine, the patient suffered from sudden onset short-term memory loss, diagnosis: autoimmune encephalitis or post vaccine induced inflammation on 12Mar2021 at 04:00 pm. The events resulted for doctor or other healthcare professional office/clinic visit. The patient received prednisone as treatment for the events. The patient laboratory investigation included SARS-CoV2 Antibodies Nucleocapsid was negative on 06May2021. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.; Sender's Comments: Based on temporal association and known safety profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), to the event autoimmune encephalitis cannot be completely excluded.The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, COVID-19, Joint stiffness, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19, 3 days after being vaccinated; stiff joints; joint pain; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient complains about stiff joints and joint pain. On an unspecified date, the patient already did a report online about having COVID-19, 3 days after being vaccinated. The patient was wondering if they were gathering data on patients who received COVID vaccine and developed COVID and the patient symptoms. The patient additionally questioned that do they knew if those who contracted COVID after fully vaccinated had issues with joint pain. The case was reported as non-serious. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, COVID-19, Drug ineffective, Joint stiffness
Clinical narrative: COVID-19; COVID-19, 3 days after being vaccinated; stiff joints; joint pain; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient complains about stiff joints and joint pain. On an unspecified date, the patient already did a report online about having COVID-19, 3 days after being vaccinated. The patient was wondering if they were gathering data on patients who received COVID vaccine and developed COVID and the patient symptoms. The patient additionally questioned that do they knew if those who contracted COVID after fully vaccinated had issues with joint pain. The case was reported as non-serious. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Chest pain, Chills, Computerised tomogram, Electrocardiogram
Clinical narrative: Myocarditis; This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received bnt162b2 (COVID-19 Vaccine), dose 2 via an unspecified route of administration on 01May2021 (Lot Number: EW1069) as dose 2, single at the age of 24-year-old for COVID-19 immunisation. No medical history. Concomitant medications were not reported. Historic vaccine was bnt162b2 received via an unspecified route of administration on 10Apr2021 (Lot Number: ER8737) as dose 1, single at the age of 24-year-old for COVID-19 immunization. The patient got myocarditis and hospital bills came concerned that it happened just after (Incomplete Sentence). So, in 01May2021 he got the second dose of the COVID vaccine (Clarified as Pfizer COVID Vaccine) and three days later he was at the hospital for myocarditis for few days, the hospital bill cost him over three thousand dollars that was after insurance deduction and he thought Pfizer was responsible for this and he shouldn't be having to pay the bill. The patient experienced myocarditis on 04May2021. The patient was hospitalized for myocarditis from 04May2021. The outcome of event was unknown.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Enzyme level test, Heart rate increased, Pain, Pyrexia, Ultrasound scan
Clinical narrative: Myocarditis; This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received bnt162b2 (COVID-19 Vaccine), dose 2 via an unspecified route of administration on 01May2021 (Lot Number: EW1069) as dose 2, single at the age of 24-year-old for COVID-19 immunisation. No medical history. Concomitant medications were not reported. Historic vaccine was bnt162b2 received via an unspecified route of administration on 10Apr2021 (Lot Number: ER8737) as dose 1, single at the age of 24-year-old for COVID-19 immunization. The patient got myocarditis and hospital bills came concerned that it happened just after (Incomplete Sentence). So, in 01May2021 he got the second dose of the COVID vaccine (Clarified as Pfizer COVID Vaccine) and three days later he was at the hospital for myocarditis for few days, the hospital bill cost him over three thousand dollars that was after insurance deduction and he thought Pfizer was responsible for this and he shouldn't be having to pay the bill. The patient experienced myocarditis on 04May2021. The patient was hospitalized for myocarditis from 04May2021. The outcome of event was unknown.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received bnt162b2 (COVID-19 Vaccine), dose 2 via an unspecified route of administration on 01May2021 (Lot Number: EW1069) as dose 2, single at the age of 24-year-old for COVID-19 immunisation. No medical history. Concomitant medications were not reported. Historic vaccine was bnt162b2 received via an unspecified route of administration on 10Apr2021 (Lot Number: ER8737) as dose 1, single at the age of 24-year-old for COVID-19 immunization. The patient got myocarditis and hospital bills came concerned that it happened just after (Incomplete Sentence). So, in 01May2021 he got the second dose of the COVID vaccine (Clarified as Pfizer COVID Vaccine) and three days later he was at the hospital for myocarditis for few days, the hospital bill cost him over three thousand dollars that was after insurance deduction and he thought Pfizer was responsible for this and he shouldn't be having to pay the bill. The patient experienced myocarditis on 04May2021. The patient was hospitalized for myocarditis from 04May2021. The outcome of event was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Biopsy lung, Chest pain, Dyspnoea, Gastrointestinal tract biopsy
Clinical narrative: On May 4, 2021, I had  a sharp pain in my chest that radiated around to the back, SOB, extreme tiredess and lack of energy.  The next day, I still had pain and it felt a little lower into my abdomen. The following day I saw my cardiologist. I had an Echo and an EKG that were normal. I had an Endo with the discovery of grandulomas. I was referred to Pulmonologist for evaluation on 05/21/2021. Slight abnormal heartbeat and fluid in the bottom of my lungs. I was then referred to an Oncologist on 05/24/2021.  All doctors met and referred me to Chief Thoracic Surgeon for a Wedge Biopsy.   I also had swelling of my eyes and eyelids so I made an appointment with Optomotrist on 05/26/2021 & 05/29/2021 and was prescribed Prednisolone to be used 4 x per day in both eyes until my eyes cleared on 06/14/2021. After my eyes cleared, I had a problem with a stuffed nostral for a couple of weeks; it was still on going when I had my surgery in late June. I saw Opthmologist on 07/23/2021 no lesions found but Xiidra Eye drops for dry eye. I saw Pulmonologist on 08/09/2021 who will monitor and treat me for Sacoidosis. I saw Neurologist on 08/11/2021 that ordered an MRI Brain-results pending.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Granuloma, Oesophagogastroduodenoscopy abnormal, Positron emission tomogram, Sarcoidosis, Uveitis
Clinical narrative: On May 4, 2021, I had  a sharp pain in my chest that radiated around to the back, SOB, extreme tiredess and lack of energy.  The next day, I still had pain and it felt a little lower into my abdomen. The following day I saw my cardiologist. I had an Echo and an EKG that were normal. I had an Endo with the discovery of grandulomas. I was referred to Pulmonologist for evaluation on 05/21/2021. Slight abnormal heartbeat and fluid in the bottom of my lungs. I was then referred to an Oncologist on 05/24/2021.  All doctors met and referred me to Chief Thoracic Surgeon for a Wedge Biopsy.   I also had swelling of my eyes and eyelids so I made an appointment with Optomotrist on 05/26/2021 & 05/29/2021 and was prescribed Prednisolone to be used 4 x per day in both eyes until my eyes cleared on 06/14/2021. After my eyes cleared, I had a problem with a stuffed nostral for a couple of weeks; it was still on going when I had my surgery in late June. I saw Opthmologist on 07/23/2021 no lesions found but Xiidra Eye drops for dry eye. I saw Pulmonologist on 08/09/2021 who will monitor and treat me for Sacoidosis. I saw Neurologist on 08/11/2021 that ordered an MRI Brain-results pending.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal lymphadenopathy, Abdominal pain lower, Asthenia, Back pain, Biopsy lung
Clinical narrative: On May 4, 2021, I had  a sharp pain in my chest that radiated around to the back, SOB, extreme tiredess and lack of energy.  The next day, I still had pain and it felt a little lower into my abdomen. The following day I saw my cardiologist. I had an Echo and an EKG that were normal. I had an Endo with the discovery of grandulomas. I was referred to Pulmonologist for evaluation on 05/21/2021. Slight abnormal heartbeat and fluid in the bottom of my lungs. I was then referred to an Oncologist on 05/24/2021.  All doctors met and referred me to Chief Thoracic Surgeon for a Wedge Biopsy.   I also had swelling of my eyes and eyelids so I made an appointment with Optomotrist on 05/26/2021 & 05/29/2021 and was prescribed Prednisolone to be used 4 x per day in both eyes until my eyes cleared on 06/14/2021. After my eyes cleared, I had a problem with a stuffed nostral for a couple of weeks; it was still on going when I had my surgery in late June. I saw Opthmologist on 07/23/2021 no lesions found but Xiidra Eye drops for dry eye. I saw Pulmonologist on 08/09/2021 who will monitor and treat me for Sacoidosis. I saw Neurologist on 08/11/2021 that ordered an MRI Brain-results pending.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy lung abnormal, Blood test normal, Cardiac stress test normal, Chest pain, Computerised tomogram thorax abnormal
Clinical narrative: On May 4, 2021, I had  a sharp pain in my chest that radiated around to the back, SOB, extreme tiredess and lack of energy.  The next day, I still had pain and it felt a little lower into my abdomen. The following day I saw my cardiologist. I had an Echo and an EKG that were normal. I had an Endo with the discovery of grandulomas. I was referred to Pulmonologist for evaluation on 05/21/2021. Slight abnormal heartbeat and fluid in the bottom of my lungs. I was then referred to an Oncologist on 05/24/2021.  All doctors met and referred me to Chief Thoracic Surgeon for a Wedge Biopsy.   I also had swelling of my eyes and eyelids so I made an appointment with Optomotrist on 05/26/2021 & 05/29/2021 and was prescribed Prednisolone to be used 4 x per day in both eyes until my eyes cleared on 06/14/2021. After my eyes cleared, I had a problem with a stuffed nostral for a couple of weeks; it was still on going when I had my surgery in late June. I saw Opthmologist on 07/23/2021 no lesions found but Xiidra Eye drops for dry eye. I saw Pulmonologist on 08/09/2021 who will monitor and treat me for Sacoidosis. I saw Neurologist on 08/11/2021 that ordered an MRI Brain-results pending.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry eye, Dyspnoea, Echocardiogram normal, Electrocardiogram normal, Endoscopy abnormal
Clinical narrative: On May 4, 2021, I had  a sharp pain in my chest that radiated around to the back, SOB, extreme tiredess and lack of energy.  The next day, I still had pain and it felt a little lower into my abdomen. The following day I saw my cardiologist. I had an Echo and an EKG that were normal. I had an Endo with the discovery of grandulomas. I was referred to Pulmonologist for evaluation on 05/21/2021. Slight abnormal heartbeat and fluid in the bottom of my lungs. I was then referred to an Oncologist on 05/24/2021.  All doctors met and referred me to Chief Thoracic Surgeon for a Wedge Biopsy.   I also had swelling of my eyes and eyelids so I made an appointment with Optomotrist on 05/26/2021 & 05/29/2021 and was prescribed Prednisolone to be used 4 x per day in both eyes until my eyes cleared on 06/14/2021. After my eyes cleared, I had a problem with a stuffed nostral for a couple of weeks; it was still on going when I had my surgery in late June. I saw Opthmologist on 07/23/2021 no lesions found but Xiidra Eye drops for dry eye. I saw Pulmonologist on 08/09/2021 who will monitor and treat me for Sacoidosis. I saw Neurologist on 08/11/2021 that ordered an MRI Brain-results pending.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye swelling, Fatigue, Granuloma, Heart rate irregular, Lung disorder
Clinical narrative: On May 4, 2021, I had  a sharp pain in my chest that radiated around to the back, SOB, extreme tiredess and lack of energy.  The next day, I still had pain and it felt a little lower into my abdomen. The following day I saw my cardiologist. I had an Echo and an EKG that were normal. I had an Endo with the discovery of grandulomas. I was referred to Pulmonologist for evaluation on 05/21/2021. Slight abnormal heartbeat and fluid in the bottom of my lungs. I was then referred to an Oncologist on 05/24/2021.  All doctors met and referred me to Chief Thoracic Surgeon for a Wedge Biopsy.   I also had swelling of my eyes and eyelids so I made an appointment with Optomotrist on 05/26/2021 & 05/29/2021 and was prescribed Prednisolone to be used 4 x per day in both eyes until my eyes cleared on 06/14/2021. After my eyes cleared, I had a problem with a stuffed nostral for a couple of weeks; it was still on going when I had my surgery in late June. I saw Opthmologist on 07/23/2021 no lesions found but Xiidra Eye drops for dry eye. I saw Pulmonologist on 08/09/2021 who will monitor and treat me for Sacoidosis. I saw Neurologist on 08/11/2021 that ordered an MRI Brain-results pending.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head, Nasal congestion, Positron emission tomogram abnormal, Pulmonary function test normal, Pulmonary mass
Clinical narrative: On May 4, 2021, I had  a sharp pain in my chest that radiated around to the back, SOB, extreme tiredess and lack of energy.  The next day, I still had pain and it felt a little lower into my abdomen. The following day I saw my cardiologist. I had an Echo and an EKG that were normal. I had an Endo with the discovery of grandulomas. I was referred to Pulmonologist for evaluation on 05/21/2021. Slight abnormal heartbeat and fluid in the bottom of my lungs. I was then referred to an Oncologist on 05/24/2021.  All doctors met and referred me to Chief Thoracic Surgeon for a Wedge Biopsy.   I also had swelling of my eyes and eyelids so I made an appointment with Optomotrist on 05/26/2021 & 05/29/2021 and was prescribed Prednisolone to be used 4 x per day in both eyes until my eyes cleared on 06/14/2021. After my eyes cleared, I had a problem with a stuffed nostral for a couple of weeks; it was still on going when I had my surgery in late June. I saw Opthmologist on 07/23/2021 no lesions found but Xiidra Eye drops for dry eye. I saw Pulmonologist on 08/09/2021 who will monitor and treat me for Sacoidosis. I saw Neurologist on 08/11/2021 that ordered an MRI Brain-results pending.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary oedema, Sarcoidosis, Scan with contrast abnormal, Surgery, Swelling of eyelid
Clinical narrative: On May 4, 2021, I had  a sharp pain in my chest that radiated around to the back, SOB, extreme tiredess and lack of energy.  The next day, I still had pain and it felt a little lower into my abdomen. The following day I saw my cardiologist. I had an Echo and an EKG that were normal. I had an Endo with the discovery of grandulomas. I was referred to Pulmonologist for evaluation on 05/21/2021. Slight abnormal heartbeat and fluid in the bottom of my lungs. I was then referred to an Oncologist on 05/24/2021.  All doctors met and referred me to Chief Thoracic Surgeon for a Wedge Biopsy.   I also had swelling of my eyes and eyelids so I made an appointment with Optomotrist on 05/26/2021 & 05/29/2021 and was prescribed Prednisolone to be used 4 x per day in both eyes until my eyes cleared on 06/14/2021. After my eyes cleared, I had a problem with a stuffed nostral for a couple of weeks; it was still on going when I had my surgery in late June. I saw Opthmologist on 07/23/2021 no lesions found but Xiidra Eye drops for dry eye. I saw Pulmonologist on 08/09/2021 who will monitor and treat me for Sacoidosis. I saw Neurologist on 08/11/2021 that ordered an MRI Brain-results pending.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound abdomen normal
Clinical narrative: On May 4, 2021, I had  a sharp pain in my chest that radiated around to the back, SOB, extreme tiredess and lack of energy.  The next day, I still had pain and it felt a little lower into my abdomen. The following day I saw my cardiologist. I had an Echo and an EKG that were normal. I had an Endo with the discovery of grandulomas. I was referred to Pulmonologist for evaluation on 05/21/2021. Slight abnormal heartbeat and fluid in the bottom of my lungs. I was then referred to an Oncologist on 05/24/2021.  All doctors met and referred me to Chief Thoracic Surgeon for a Wedge Biopsy.   I also had swelling of my eyes and eyelids so I made an appointment with Optomotrist on 05/26/2021 & 05/29/2021 and was prescribed Prednisolone to be used 4 x per day in both eyes until my eyes cleared on 06/14/2021. After my eyes cleared, I had a problem with a stuffed nostral for a couple of weeks; it was still on going when I had my surgery in late June. I saw Opthmologist on 07/23/2021 no lesions found but Xiidra Eye drops for dry eye. I saw Pulmonologist on 08/09/2021 who will monitor and treat me for Sacoidosis. I saw Neurologist on 08/11/2021 that ordered an MRI Brain-results pending.