Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Blood creatinine, Blood creatinine increased, Blood culture, Bradycardia
Clinical narrative: BRADYCARDIA; DIVERTICULITIS; HYPOXIA; COVID-19 INFECTION; FLANK PAIN; HYPOTENSION; FATIGUE; BLOOD CULTURE; BLOOD CREATININE INCREASED; FIBRIN D DIMER; PLATELET COUNT DECREASED; SARS-COV-2 TEST POSITIVE; ANTICOAGULANT THERAPY; INTERVENTIONAL PROCEDURE; This spontaneous report received from a health care professional by a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID 2157446) concerned a 74 years old male patient of an unspecified race and ethnic origin. 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 administration not reported, batch number: 1805018, expiry: unknown) dose was not reported, 01 total, administered on 05-MAR-2021 for an unspecified indication. No concomitant medications were reported.  On 14-FEB-2022, the patient experienced covid-19 infection, diverticulitis, fatigue, bradycardia, flank pain, hypotension, hypoxia, anticoagulant therapy, blood creatinine increased (162), fibrin d dimer (759), blood culture, interventional procedure, platelet count decreased (42-132) and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test positive. Laboratory data included: Blood culture (NR: not provided) Not reported. On an unspecified date he was hospitalized for 3 days. Patient presented to the emergency department per complaints of fatigue, flank pain, bradycardia, hypotension, and hypoxia from their primary care physician office. Work up was concerning for COVID-19 pneumonia, diverticulitis, acute kidney injury (AKI), chronic obstructive pulmonary disease (COPD) exacerbation, congestive heart failure (CHF) exacerbation or possible sepsis. Broad spectrum antibiotics, intravenous (IV) fluid resuscitation, breathing treatments, rate control, blood cultures were all initiated drawn. Patient improved quickly, oxygenating appropriately on room air with appropriate vitals responding appropriately to interventions. Discharge plans were initiated with continued outpatient antibiotics to treat diverticulitis and discharged to home. On an unspecified date, treatment medications included: carvedilol, warfarin, salbutamol, bumetanide, tamsulosin, ipratropium, fluticasone, acetylsalicylic acid, and furosemide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the anticoagulant therapy, blood creatinine increased, blood culture, bradycardia, covid-19 infection, diverticulitis, fatigue, fibrin d dimer, flank pain, hypotension, hypoxia, interventional procedure, platelet count decreased and SARS-CoV-2 test positive was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000221873. The suspected product quality complaint has been confirmed to be the reported allegation was not confirmed and the root cause was determined to be not manufacturing related. based on the PQC evaluation/investigation performed.  Additional information was received from Central Complaint Vigilance Department on 17-MAR-2022. The following information was updated and incorporated into case narrative: Product quality complaint investigation result added, AER at unit updated.; Sender's Comments: V1: Additional information received in this version updates: Product quality complaint investigation result added, AER at unit updated. The follow up information does not change the company causality of the previously reported events. 20220327370-covid-19 vaccine ad26.cov2.s- Bradycardia, hypoxia, diverticulitis, anticoagulant therapy, blood creatinine increased, blood culture,  covid-19 infection, fatigue, fibrin d dimer, flank pain, hypotension, interventional procedure, platelet count decreased and SARS-CoV-2 test positive. 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). Therefore, this event(s) is considered unassessable.