chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombophlebitis superficial, Ultrasound scan
Clinical narrative: BLOOD CLOTS NEARBY RIGHT THIGH; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total administered in an unspecified date in 2021, around April for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in 2021, after vaccination, the patient experienced blood clots nearby right thigh and later blood clot increased in centimeters. The physician advised her to take rivaroxaban (Xarelto). The patient was bit nervous and stated that she never experienced blood disorder issue before. The patient also has send her reports for further review. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots nearby right thigh was not reported. This report was serious (Other Medically Important Condition).  This case was reassessed as serious based on additional information received from the patient on 04-JUN-2021, the following information was updated and incorporated into case narrative: event added (blood clots nearby right thigh), product tab: suspect added, vaccine facility added and narrative updated. Upon review following information was amended: Source added as spontaneous, deleted the disease history, deleted events such as off label use and incorrect initiation dose of rivaroxaban, Drug Xarelto added as drug used to treat AE.; Sender's Comments: V2: 20210612004-covid-19 vaccine ad26.cov2.s-blood clots nearby right thigh . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS NEARBY RIGHT THIGH; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total administered in an unspecified date in 2021, around April for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in 2021, after vaccination, the patient experienced blood clots nearby right thigh and later blood clot increased in centimeters. The physician advised her to take rivaroxaban (Xarelto). The patient was bit nervous and stated that she never experienced blood disorder issue before. The patient also has send her reports for further review. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots nearby right thigh was not reported. This report was serious (Other Medically Important Condition).  This case was reassessed as serious based on additional information received from the patient on 04-JUN-2021, the following information was updated and incorporated into case narrative: event added (blood clots nearby right thigh), product tab: suspect added, vaccine facility added and narrative updated. Upon review following information was amended: Source added as spontaneous, deleted the disease history, deleted events such as off label use and incorrect initiation dose of rivaroxaban, Drug Xarelto added as drug used to treat AE.; Sender's Comments: V2: 20210612004-covid-19 vaccine ad26.cov2.s-blood clots nearby right thigh . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19, TDAP
Symptoms: Chest discomfort, Chest pain, Computerised tomogram thorax normal, Echocardiogram normal, Exposure during pregnancy
Clinical narrative: Patient in 3rd trimester of pregnancy received TDAP and Covid vaccine on 6/2/21 in accordance with CDC guidelines.  On 6/4/21 developed squeezing chest pain and work up revealed myocarditis.  Patient hospitalized for 24 hours  and discharged home following treatment with steroids.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19, TDAP
Symptoms: Inappropriate schedule of product administration, Myocarditis, Troponin increased
Clinical narrative: Patient in 3rd trimester of pregnancy received TDAP and Covid vaccine on 6/2/21 in accordance with CDC guidelines.  On 6/4/21 developed squeezing chest pain and work up revealed myocarditis.  Patient hospitalized for 24 hours  and discharged home following treatment with steroids.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19, TDAP
Symptoms: Chest discomfort, Chest pain, Exposure during pregnancy, Myocarditis
Clinical narrative: Patient in 3rd trimester of pregnancy received TDAP and Covid vaccine on 6/2/21 in accordance with CDC guidelines.  On 6/4/21 developed squeezing chest pain and work up revealed myocarditis.  Patient hospitalized for 24 hours  and discharged home following treatment with steroids.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Peripheral swelling, Skin tightness
Clinical narrative: Patient states that she believes she had a seizure on 6/24/201 that resulted in her biting her tongue while she slept.  Patient has been in contact with her neurologist, but has not been able to speak to them regarding the possible correlation between the vaccine and her seizure.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Seizure, Tongue biting
Clinical narrative: Patient states that she believes she had a seizure on 6/24/201 that resulted in her biting her tongue while she slept.  Patient has been in contact with her neurologist, but has not been able to speak to them regarding the possible correlation between the vaccine and her seizure.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Patient states that she believes she had a seizure on 6/24/201 that resulted in her biting her tongue while she slept.  Patient has been in contact with her neurologist, but has not been able to speak to them regarding the possible correlation between the vaccine and her seizure.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Peripheral swelling, Skin tightness
Clinical narrative: Itching and swelling at sight
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Seizure, Tongue biting
Clinical narrative: Itching and swelling at sight
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Itching and swelling at sight
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Bundle branch block right, Chest pain, Electrocardiogram abnormal, Pain
Clinical narrative: (6/11/21):  15 year old that presents 6/11/21 as a transfer from outside hospital for chest pain with elevated troponin. Patient woke up this morning with a burning chest pain that he states radiated down his left arm. He went to the local hospital where his troponin was found to be elevated. His chest pain resolved in local ER and has not returned. No shortness of breath. No prior medical problems. He received his 2nd dose of Pfizer COVID vaccine on Tuesday, 6/8/21. Developed headache Wednesday, 6/9/21 and felt normal Thursday 6/10/21, before the chest pain.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: (6/11/21):  15 year old that presents 6/11/21 as a transfer from outside hospital for chest pain with elevated troponin. Patient woke up this morning with a burning chest pain that he states radiated down his left arm. He went to the local hospital where his troponin was found to be elevated. His chest pain resolved in local ER and has not returned. No shortness of breath. No prior medical problems. He received his 2nd dose of Pfizer COVID vaccine on Tuesday, 6/8/21. Developed headache Wednesday, 6/9/21 and felt normal Thursday 6/10/21, before the chest pain.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Echocardiogram normal, Electrocardiogram normal, Headache, Troponin I increased
Clinical narrative: (6/11/21):  15 year old that presents 6/11/21 as a transfer from outside hospital for chest pain with elevated troponin. Patient woke up this morning with a burning chest pain that he states radiated down his left arm. He went to the local hospital where his troponin was found to be elevated. His chest pain resolved in local ER and has not returned. No shortness of breath. No prior medical problems. He received his 2nd dose of Pfizer COVID vaccine on Tuesday, 6/8/21. Developed headache Wednesday, 6/9/21 and felt normal Thursday 6/10/21, before the chest pain.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Ear pain, Electrocardiogram, Headache, Hypoaesthesia
Clinical narrative: Fever; Headache; Numbness; Tingling; Ear pain; This spontaneous case was reported by a health care professional and describes the occurrence of HEADACHE (Headache), HYPOAESTHESIA (Numbness), PARAESTHESIA (Tingling), EAR PAIN (Ear pain) and PYREXIA (Fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004m20a and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Nerve damage (Nerve damage in back), Neuropathy (Neuropathy in bilateral legs) and Mitral valve prolapse.   On 13-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced HEADACHE (Headache) (seriousness criterion hospitalization), HYPOAESTHESIA (Numbness) (seriousness criterion hospitalization), PARAESTHESIA (Tingling) (seriousness criterion hospitalization) and EAR PAIN (Ear pain) (seriousness criterion hospitalization). On an unknown date, the patient experienced PYREXIA (Fever) (seriousness criterion hospitalization). The patient was treated with AMLODIPINE for Blood pressure high, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache), HYPOAESTHESIA (Numbness), PARAESTHESIA (Tingling), EAR PAIN (Ear pain) and PYREXIA (Fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 225/95 (High) Blood pressure elevated 225/95 and 160 (High) Blood pressure elevated 160. On an unknown date, Body temperature: 100.5 (High) Ran a fever (100.5). On an unknown date, Electrocardiogram: inconclusive (Inconclusive) EKG.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication use information were not provided by reporter.  Patient had prescribed over the counter drugs like gabapentin and metoprolol.  After second dose of vaccine patient was suffered with pressure behind her left eye. Action taken with mRNA-1273 in response to the events were not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test, Ocular discomfort, Pain, Paraesthesia, Pyrexia
Clinical narrative: Fever; Headache; Numbness; Tingling; Ear pain; This spontaneous case was reported by a health care professional and describes the occurrence of HEADACHE (Headache), HYPOAESTHESIA (Numbness), PARAESTHESIA (Tingling), EAR PAIN (Ear pain) and PYREXIA (Fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004m20a and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Nerve damage (Nerve damage in back), Neuropathy (Neuropathy in bilateral legs) and Mitral valve prolapse.   On 13-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced HEADACHE (Headache) (seriousness criterion hospitalization), HYPOAESTHESIA (Numbness) (seriousness criterion hospitalization), PARAESTHESIA (Tingling) (seriousness criterion hospitalization) and EAR PAIN (Ear pain) (seriousness criterion hospitalization). On an unknown date, the patient experienced PYREXIA (Fever) (seriousness criterion hospitalization). The patient was treated with AMLODIPINE for Blood pressure high, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache), HYPOAESTHESIA (Numbness), PARAESTHESIA (Tingling), EAR PAIN (Ear pain) and PYREXIA (Fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 225/95 (High) Blood pressure elevated 225/95 and 160 (High) Blood pressure elevated 160. On an unknown date, Body temperature: 100.5 (High) Ran a fever (100.5). On an unknown date, Electrocardiogram: inconclusive (Inconclusive) EKG.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication use information were not provided by reporter.  Patient had prescribed over the counter drugs like gabapentin and metoprolol.  After second dose of vaccine patient was suffered with pressure behind her left eye. Action taken with mRNA-1273 in response to the events were not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure measurement, Body temperature, Ear pain, Electrocardiogram, Headache
Clinical narrative: Fever; Headache; Numbness; Tingling; Ear pain; This spontaneous case was reported by a health care professional and describes the occurrence of HEADACHE (Headache), HYPOAESTHESIA (Numbness), PARAESTHESIA (Tingling), EAR PAIN (Ear pain) and PYREXIA (Fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004m20a and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Nerve damage (Nerve damage in back), Neuropathy (Neuropathy in bilateral legs) and Mitral valve prolapse.   On 13-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced HEADACHE (Headache) (seriousness criterion hospitalization), HYPOAESTHESIA (Numbness) (seriousness criterion hospitalization), PARAESTHESIA (Tingling) (seriousness criterion hospitalization) and EAR PAIN (Ear pain) (seriousness criterion hospitalization). On an unknown date, the patient experienced PYREXIA (Fever) (seriousness criterion hospitalization). The patient was treated with AMLODIPINE for Blood pressure high, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache), HYPOAESTHESIA (Numbness), PARAESTHESIA (Tingling), EAR PAIN (Ear pain) and PYREXIA (Fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 225/95 (High) Blood pressure elevated 225/95 and 160 (High) Blood pressure elevated 160. On an unknown date, Body temperature: 100.5 (High) Ran a fever (100.5). On an unknown date, Electrocardiogram: inconclusive (Inconclusive) EKG.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication use information were not provided by reporter.  Patient had prescribed over the counter drugs like gabapentin and metoprolol.  After second dose of vaccine patient was suffered with pressure behind her left eye. Action taken with mRNA-1273 in response to the events were not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Pyrexia
Clinical narrative: Fever; Headache; Numbness; Tingling; Ear pain; This spontaneous case was reported by a health care professional and describes the occurrence of HEADACHE (Headache), HYPOAESTHESIA (Numbness), PARAESTHESIA (Tingling), EAR PAIN (Ear pain) and PYREXIA (Fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004m20a and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Nerve damage (Nerve damage in back), Neuropathy (Neuropathy in bilateral legs) and Mitral valve prolapse.   On 13-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced HEADACHE (Headache) (seriousness criterion hospitalization), HYPOAESTHESIA (Numbness) (seriousness criterion hospitalization), PARAESTHESIA (Tingling) (seriousness criterion hospitalization) and EAR PAIN (Ear pain) (seriousness criterion hospitalization). On an unknown date, the patient experienced PYREXIA (Fever) (seriousness criterion hospitalization). The patient was treated with AMLODIPINE for Blood pressure high, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache), HYPOAESTHESIA (Numbness), PARAESTHESIA (Tingling), EAR PAIN (Ear pain) and PYREXIA (Fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 225/95 (High) Blood pressure elevated 225/95 and 160 (High) Blood pressure elevated 160. On an unknown date, Body temperature: 100.5 (High) Ran a fever (100.5). On an unknown date, Electrocardiogram: inconclusive (Inconclusive) EKG.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication use information were not provided by reporter.  Patient had prescribed over the counter drugs like gabapentin and metoprolol.  After second dose of vaccine patient was suffered with pressure behind her left eye. Action taken with mRNA-1273 in response to the events were not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, CHOL
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Individual contacted  06/27 to report event s/p 2nd Pfizer COVID-19 injection. Caller shared she experienced left arm pain 3 days following injection, pain persists in left arm and is constant, unable to reach above shoulder level, unable to lay on left side, complains of weakness in left arm, unable to sleep, complains of weight loss and "acid reflux" since receiving vaccine.  Denies any fever, rash, cough, cold symptoms  s/p vaccine.  She states she has treated with her PCP and Occupational Therapy for her complaints with no relief, she relates PC and OT have diagnosed her with "bursitis".
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, CHOL
Symptoms: Bursitis, Gastrooesophageal reflux disease, Insomnia, Mobility decreased, Muscular weakness
Clinical narrative: Individual contacted  06/27 to report event s/p 2nd Pfizer COVID-19 injection. Caller shared she experienced left arm pain 3 days following injection, pain persists in left arm and is constant, unable to reach above shoulder level, unable to lay on left side, complains of weakness in left arm, unable to sleep, complains of weight loss and "acid reflux" since receiving vaccine.  Denies any fever, rash, cough, cold symptoms  s/p vaccine.  She states she has treated with her PCP and Occupational Therapy for her complaints with no relief, she relates PC and OT have diagnosed her with "bursitis".
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, CHOL
Symptoms: Pain in extremity, Weight decreased
Clinical narrative: Individual contacted  06/27 to report event s/p 2nd Pfizer COVID-19 injection. Caller shared she experienced left arm pain 3 days following injection, pain persists in left arm and is constant, unable to reach above shoulder level, unable to lay on left side, complains of weakness in left arm, unable to sleep, complains of weight loss and "acid reflux" since receiving vaccine.  Denies any fever, rash, cough, cold symptoms  s/p vaccine.  She states she has treated with her PCP and Occupational Therapy for her complaints with no relief, she relates PC and OT have diagnosed her with "bursitis".
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, CHOL
Symptoms: Arthralgia, Joint range of motion decreased, Loss of personal independence in daily activities, Pain in extremity, Paraesthesia
Clinical narrative: Individual contacted  06/27 to report event s/p 2nd Pfizer COVID-19 injection. Caller shared she experienced left arm pain 3 days following injection, pain persists in left arm and is constant, unable to reach above shoulder level, unable to lay on left side, complains of weakness in left arm, unable to sleep, complains of weight loss and "acid reflux" since receiving vaccine.  Denies any fever, rash, cough, cold symptoms  s/p vaccine.  She states she has treated with her PCP and Occupational Therapy for her complaints with no relief, she relates PC and OT have diagnosed her with "bursitis".
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, CHOL
Symptoms: Arthralgia, Headache, Loss of personal independence in daily activities, Mobility decreased, Pain
Clinical narrative: Individual contacted  06/27 to report event s/p 2nd Pfizer COVID-19 injection. Caller shared she experienced left arm pain 3 days following injection, pain persists in left arm and is constant, unable to reach above shoulder level, unable to lay on left side, complains of weakness in left arm, unable to sleep, complains of weight loss and "acid reflux" since receiving vaccine.  Denies any fever, rash, cough, cold symptoms  s/p vaccine.  She states she has treated with her PCP and Occupational Therapy for her complaints with no relief, she relates PC and OT have diagnosed her with "bursitis".
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, CHOL
Symptoms: Pain in extremity, Sleep disorder, X-ray limb
Clinical narrative: Individual contacted  06/27 to report event s/p 2nd Pfizer COVID-19 injection. Caller shared she experienced left arm pain 3 days following injection, pain persists in left arm and is constant, unable to reach above shoulder level, unable to lay on left side, complains of weakness in left arm, unable to sleep, complains of weight loss and "acid reflux" since receiving vaccine.  Denies any fever, rash, cough, cold symptoms  s/p vaccine.  She states she has treated with her PCP and Occupational Therapy for her complaints with no relief, she relates PC and OT have diagnosed her with "bursitis".
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Injection site pain, Seizure
Clinical narrative: Seizure; This is a spontaneous report from a contactable physician reported for a 42-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left arm on 15Jun2021 at 18:00 (Batch/Lot Number: Ew0191), at the age of 42-years-old, as dose 2, single for Covid-19 immunisation. The patient has no medical history and no know allergies. The patient has no Covid prior to vaccination. Concomitant medication included benzylpenicillin potassium (PFIZERPEN) taken for an unspecified indication from 05May2021 to 05May2021. The patient previously took first dose of BNT162B2 on 05May2021 (Lot number EW0177) for Covid-19 immunisation. The patient experienced seizure on 15Jun2021 at 18:00 with outcome of unknown. The patient underwent lab test which included Covid-19: negative on an unspecified date. Therapeutic measures were taken as a result of seizure. The event resulted to visit emergency room/ department or urgent care. Patient was not Covid tested post vaccination.   Information about lot/batch number is available; Follow-up attempts are needed
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Seizure
Clinical narrative: Seizure; This is a spontaneous report from a contactable physician reported for a 42-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left arm on 15Jun2021 at 18:00 (Batch/Lot Number: Ew0191), at the age of 42-years-old, as dose 2, single for Covid-19 immunisation. The patient has no medical history and no know allergies. The patient has no Covid prior to vaccination. Concomitant medication included benzylpenicillin potassium (PFIZERPEN) taken for an unspecified indication from 05May2021 to 05May2021. The patient previously took first dose of BNT162B2 on 05May2021 (Lot number EW0177) for Covid-19 immunisation. The patient experienced seizure on 15Jun2021 at 18:00 with outcome of unknown. The patient underwent lab test which included Covid-19: negative on an unspecified date. Therapeutic measures were taken as a result of seizure. The event resulted to visit emergency room/ department or urgent care. Patient was not Covid tested post vaccination.   Information about lot/batch number is available; Follow-up attempts are needed
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood test, Chest pain, Echocardiogram, Electrocardiogram, Immunoglobulin therapy
Clinical narrative: Myocarditis; Heart enzymes were elevated; Chest pains; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 13-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0180) via an unspecified route of administration administered in left arm on 04Jun2021 at 09:45 am (at the age of 13-years-old) as dose 2, single for COVID-19 immunization. The patient medical history was none, had no known allergies and had no concomitant medications received within 2 weeks of vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0179) on 14May2021 at 09:45 am as dose 1 single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 05Jun2021, the patient experienced chest pains that started Saturday night and admitted to hospital on 06Jun2021. Patient was diagnosed with Myocarditis which was a directly linked to the vaccine and heart enzymes were elevated. The patient underwent lab tests and procedures which included myocardial necrosis marker elevated on 06Jun2021, sars-cov-2 test: negative on 06Jun2021 Nasal Swab post vaccination. The reporter considered the events as serious with seriousness criteria resulted in emergency room/department or urgent care and 4 days in Hospitalization. Therapeutic measures were taken as a result of events with IVIG (Intravenous immunoglobulin). The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Myocardial necrosis marker increased, Myocarditis, Vaccination complication
Clinical narrative: Myocarditis; Heart enzymes were elevated; Chest pains; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 13-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0180) via an unspecified route of administration administered in left arm on 04Jun2021 at 09:45 am (at the age of 13-years-old) as dose 2, single for COVID-19 immunization. The patient medical history was none, had no known allergies and had no concomitant medications received within 2 weeks of vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0179) on 14May2021 at 09:45 am as dose 1 single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 05Jun2021, the patient experienced chest pains that started Saturday night and admitted to hospital on 06Jun2021. Patient was diagnosed with Myocarditis which was a directly linked to the vaccine and heart enzymes were elevated. The patient underwent lab tests and procedures which included myocardial necrosis marker elevated on 06Jun2021, sars-cov-2 test: negative on 06Jun2021 Nasal Swab post vaccination. The reporter considered the events as serious with seriousness criteria resulted in emergency room/department or urgent care and 4 days in Hospitalization. Therapeutic measures were taken as a result of events with IVIG (Intravenous immunoglobulin). The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anxiety, Atrial enlargement, Body temperature increased, C-reactive protein increased, Chest pain
Clinical narrative: Myocarditis; Heart enzymes were elevated; Chest pains; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 13-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0180) via an unspecified route of administration administered in left arm on 04Jun2021 at 09:45 am (at the age of 13-years-old) as dose 2, single for COVID-19 immunization. The patient medical history was none, had no known allergies and had no concomitant medications received within 2 weeks of vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0179) on 14May2021 at 09:45 am as dose 1 single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 05Jun2021, the patient experienced chest pains that started Saturday night and admitted to hospital on 06Jun2021. Patient was diagnosed with Myocarditis which was a directly linked to the vaccine and heart enzymes were elevated. The patient underwent lab tests and procedures which included myocardial necrosis marker elevated on 06Jun2021, sars-cov-2 test: negative on 06Jun2021 Nasal Swab post vaccination. The reporter considered the events as serious with seriousness criteria resulted in emergency room/department or urgent care and 4 days in Hospitalization. Therapeutic measures were taken as a result of events with IVIG (Intravenous immunoglobulin). The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Echocardiogram normal, Electrocardiogram T wave abnormal, Fatigue, Headache, Immunoglobulin therapy
Clinical narrative: Myocarditis; Heart enzymes were elevated; Chest pains; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 13-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0180) via an unspecified route of administration administered in left arm on 04Jun2021 at 09:45 am (at the age of 13-years-old) as dose 2, single for COVID-19 immunization. The patient medical history was none, had no known allergies and had no concomitant medications received within 2 weeks of vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0179) on 14May2021 at 09:45 am as dose 1 single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 05Jun2021, the patient experienced chest pains that started Saturday night and admitted to hospital on 06Jun2021. Patient was diagnosed with Myocarditis which was a directly linked to the vaccine and heart enzymes were elevated. The patient underwent lab tests and procedures which included myocardial necrosis marker elevated on 06Jun2021, sars-cov-2 test: negative on 06Jun2021 Nasal Swab post vaccination. The reporter considered the events as serious with seriousness criteria resulted in emergency room/department or urgent care and 4 days in Hospitalization. Therapeutic measures were taken as a result of events with IVIG (Intravenous immunoglobulin). The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Influenza like illness, Intensive care, Myalgia, Neutrophil percentage increased, Respiratory disorder
Clinical narrative: Myocarditis; Heart enzymes were elevated; Chest pains; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 13-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0180) via an unspecified route of administration administered in left arm on 04Jun2021 at 09:45 am (at the age of 13-years-old) as dose 2, single for COVID-19 immunization. The patient medical history was none, had no known allergies and had no concomitant medications received within 2 weeks of vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0179) on 14May2021 at 09:45 am as dose 1 single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 05Jun2021, the patient experienced chest pains that started Saturday night and admitted to hospital on 06Jun2021. Patient was diagnosed with Myocarditis which was a directly linked to the vaccine and heart enzymes were elevated. The patient underwent lab tests and procedures which included myocardial necrosis marker elevated on 06Jun2021, sars-cov-2 test: negative on 06Jun2021 Nasal Swab post vaccination. The reporter considered the events as serious with seriousness criteria resulted in emergency room/department or urgent care and 4 days in Hospitalization. Therapeutic measures were taken as a result of events with IVIG (Intravenous immunoglobulin). The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Troponin increased
Clinical narrative: Myocarditis; Heart enzymes were elevated; Chest pains; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 13-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0180) via an unspecified route of administration administered in left arm on 04Jun2021 at 09:45 am (at the age of 13-years-old) as dose 2, single for COVID-19 immunization. The patient medical history was none, had no known allergies and had no concomitant medications received within 2 weeks of vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0179) on 14May2021 at 09:45 am as dose 1 single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 05Jun2021, the patient experienced chest pains that started Saturday night and admitted to hospital on 06Jun2021. Patient was diagnosed with Myocarditis which was a directly linked to the vaccine and heart enzymes were elevated. The patient underwent lab tests and procedures which included myocardial necrosis marker elevated on 06Jun2021, sars-cov-2 test: negative on 06Jun2021 Nasal Swab post vaccination. The reporter considered the events as serious with seriousness criteria resulted in emergency room/department or urgent care and 4 days in Hospitalization. Therapeutic measures were taken as a result of events with IVIG (Intravenous immunoglobulin). The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chest pain, Myocardial necrosis marker, Myocardial necrosis marker increased, Myocarditis, SARS-CoV-2 test
Clinical narrative: Myocarditis; Heart enzymes were elevated; Chest pains; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 13-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0180) via an unspecified route of administration administered in left arm on 04Jun2021 at 09:45 am (at the age of 13-years-old) as dose 2, single for COVID-19 immunization. The patient medical history was none, had no known allergies and had no concomitant medications received within 2 weeks of vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0179) on 14May2021 at 09:45 am as dose 1 single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 05Jun2021, the patient experienced chest pains that started Saturday night and admitted to hospital on 06Jun2021. Patient was diagnosed with Myocarditis which was a directly linked to the vaccine and heart enzymes were elevated. The patient underwent lab tests and procedures which included myocardial necrosis marker elevated on 06Jun2021, sars-cov-2 test: negative on 06Jun2021 Nasal Swab post vaccination. The reporter considered the events as serious with seriousness criteria resulted in emergency room/department or urgent care and 4 days in Hospitalization. Therapeutic measures were taken as a result of events with IVIG (Intravenous immunoglobulin). The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abnormal uterine bleeding, Blood test abnormal, Contusion, Epistaxis, Immunoglobulin therapy
Clinical narrative: Non-stop flow of period bleeding like peeing Blood after second vaccine; Thrombocytopenia Diagnosis after second vaccine; Bruised all over the body after second vaccine; Platelet level was 5on blood test after second vaccine; Nose Bleeding; Oral Purpura on the Lip after second vaccine; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Non-stop flow of period bleeding like peeing Blood after second vaccine) and THROMBOCYTOPENIA (Thrombocytopenia Diagnosis after second vaccine) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced EPISTAXIS (Nose Bleeding) and ORAL PURPURA (Oral Purpura on the Lip after second vaccine). On 19-May-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Non-stop flow of period bleeding like peeing Blood after second vaccine) (seriousness criteria hospitalization, medically significant and life threatening). On 27-May-2021, the patient experienced THROMBOCYTOPENIA (Thrombocytopenia Diagnosis after second vaccine) (seriousness criteria medically significant and life threatening), CONTUSION (Bruised all over the body after second vaccine) and PLATELET COUNT DECREASED (Platelet level was 5on blood test after second vaccine). The patient was hospitalized from 27-May-2021 to 28-May-2021 due to HEAVY MENSTRUAL BLEEDING. At the time of the report, HEAVY MENSTRUAL BLEEDING (Non-stop flow of period bleeding like peeing Blood after second vaccine), THROMBOCYTOPENIA (Thrombocytopenia Diagnosis after second vaccine), EPISTAXIS (Nose Bleeding), ORAL PURPURA (Oral Purpura on the Lip after second vaccine), CONTUSION (Bruised all over the body after second vaccine) and PLATELET COUNT DECREASED (Platelet level was 5on blood test after second vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Platelet count: 5 (Low) 5.         No concomitant medications were reported. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Oral purpura, Platelet count decreased, Purpura, Transfusion
Clinical narrative: Non-stop flow of period bleeding like peeing Blood after second vaccine; Thrombocytopenia Diagnosis after second vaccine; Bruised all over the body after second vaccine; Platelet level was 5on blood test after second vaccine; Nose Bleeding; Oral Purpura on the Lip after second vaccine; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Non-stop flow of period bleeding like peeing Blood after second vaccine) and THROMBOCYTOPENIA (Thrombocytopenia Diagnosis after second vaccine) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced EPISTAXIS (Nose Bleeding) and ORAL PURPURA (Oral Purpura on the Lip after second vaccine). On 19-May-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Non-stop flow of period bleeding like peeing Blood after second vaccine) (seriousness criteria hospitalization, medically significant and life threatening). On 27-May-2021, the patient experienced THROMBOCYTOPENIA (Thrombocytopenia Diagnosis after second vaccine) (seriousness criteria medically significant and life threatening), CONTUSION (Bruised all over the body after second vaccine) and PLATELET COUNT DECREASED (Platelet level was 5on blood test after second vaccine). The patient was hospitalized from 27-May-2021 to 28-May-2021 due to HEAVY MENSTRUAL BLEEDING. At the time of the report, HEAVY MENSTRUAL BLEEDING (Non-stop flow of period bleeding like peeing Blood after second vaccine), THROMBOCYTOPENIA (Thrombocytopenia Diagnosis after second vaccine), EPISTAXIS (Nose Bleeding), ORAL PURPURA (Oral Purpura on the Lip after second vaccine), CONTUSION (Bruised all over the body after second vaccine) and PLATELET COUNT DECREASED (Platelet level was 5on blood test after second vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Platelet count: 5 (Low) 5.         No concomitant medications were reported. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.