Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram abdomen abnormal, Computerised tomogram thorax abnormal, Decreased appetite, Dizziness, Echocardiogram
Clinical narrative: ABDOMINAL DISCOMFORT; DECREASED APPETITE; EPIGASTRIC DISCOMFORT; PERICARDITIS; CHEST DISCOMFORT; COMPUTERISED TOMOGRAM ABDOMEN ABNORMAL; COMPUTERISED TOMOGRAM THORAX ABNORMAL; ATRIAL FLUTTER; ATRIAL FIBRILLATION; PERICARDIAL EFFUSION; VOMITING; ECHOCARDIOGRAM; ELECTROCARDIOGRAM ABNORMAL; EXPOSURE TO SARS-COV-2; PERICARDIAL DRAINAGE; ANTICOAGULANT THERAPY; DIZZINESS; This spontaneous report received from a health care professional via a Regulatory Authority [Vaccine adverse event reporting system, VAERS ID:1821442] concerned a 75 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: cardio Tea Influenza Virus Vaccines, fatigue, myalgia, and breathing issues, and concurrent conditions included: hypothyroidism, osteoarthritis, hearing loss, osteopenia, mixed hyperlipidemia, asthma, esophageal reflux, herpes simplex virus/HSV infection, coronary atherosclerosis, lumbar degenerative disc disease, palpitations, penicillin allergy, sulfa sulfonamide antibiotics, hives, and agatston, and other pre-existing medical conditions included: None The patient was previously treated with influenza vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown and expiry unknown) dose was not reported, 1 total, administered on 12-AUG-2021 for an unspecified indication. (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Concomitant medications included aciclovir, malus SPP, vinegar extract, and paracetamol.  VAERs reported the following AEs, all with an onset date 22-AUG-2021, with an outcome not recovered:  abdominal discomfort, anticoagulant, therapy, atrial fibrillation, atrial flutter, chest discomfort, CT abdomen abnormal, CT thorax abnormal, decreased appetite, dizziness, echocardiogram, echo abnormal, epigastric discomfort, exposure to SARS-CoV-2, pericardial drainage, pericardial effusion, pericarditis, and vomiting. On an unspecified date the patient's husband was diagnosed with Covid. The patient did not develop symptoms and was not tested for Covid. Late AUG-2021-early-SEP-2021, the patient developed dizziness and was lightheaded, which was a real change for her. On 18-OCT-2021, the patient had progressive chest fullness when returning from trip to lake with family and friends.  She went to the ER and was diagnosed with pericarditis.  Colchicine and ASA 650 BID x1 were initiated. On 20-OCT-2021, the patient had progressive epigastric abdominal discomfort and a poor appetite.  She called her physician's office, and the ASA dose was titrated down to 325 mg.   From 20-OCT-2021 to 25 OCT-2021, she had progressive chest fullness, epigastric discomfort, poor appetite, emesis, and difficulty being flat in bed. From 24-OCT-2021 to 25-OCT-2021, CT CAP and ECG showed pericardial effusion, atrial flutter fibrillation was newly diagnosed.   On an unspecified date, a pericardiocentesis was performed.    The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from abdominal discomfort, anticoagulant therapy, atrial fibrillation, atrial flutter, chest discomfort, computerised tomogram abdomen abnormal, computerised tomogram thorax abnormal, decreased appetite, dizziness, echocardiogram, electrocardiogram abnormal, epigastric discomfort, exposure to sars-cov-2, pericardial drainage, pericardial effusion, pericarditis, and vomiting. This report was serious (Hospitalization Caused / Prolonged).  Version created to amend previously reported information on 05-Nov-2021.Upon review following information was amended: patient (disease-palpitation capture continuing yes), suspect vaccine indication updated, Dose series added (event and product tab), event onset date and narrative updated accordingly.; Sender's Comments: V1: This Version created to amend previously reported information on 05-Nov-2021. Upon review following information was amended: patient (disease-palpitation capture continuing yes), suspect vaccine indication updated, Dose series added(event and product tab), event onset date and narrative updated accordingly. This updated information does not alter the causality of previously reported events.   20211115271- COVID-19 VACCINE AD26.COV2.S- Atrial fibrillation, pericardial effusion, pericarditis, anticoagulant therapy, atrial flutter, chest discomfort, computerised tomogram abdomen abnormal, computerised tomogram thorax abnormal, decreased appetite, dizziness, echocardiogram, electrocardiogram abnormal, exposure to sars-cov-2, pericardial drainage. 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).  20211115271-COVID-19 VACCINE AD26.COV2.S- abdominal discomfort, epigastric discomfort. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY  20211115271-COVID-19 VACCINE AD26.COV2.S- Vomiting. This event is labeled and is therefore considered potentially related.