Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer, Mental status changes, Oxygen saturation, Platelet count decreased, Pneumonia bacterial
Clinical narrative: ACUTE KIDNEY INJURY; PNEUMONIA BACTERIAL; RESPIRATORY DISTRESS; COVID-19; COUGH; DYSPNOEA; MENTAL STATUS CHANGES; PLATELET COUNT DECREASED; FIBRIN D DIMER; ANTICOAGULANT THERAPY; POSITIVE AIRWAY PRESSURE THERAPY; SARS-COV-2 TEST POSITIVE; TROPONIN; This spontaneous report received from a health care professional via a Regulatory Authority via Vaccine Adverse Event Reporting System (VAERS) (VAERS reference number: 2254715) concerned a 81 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s.(dose number in series 1) (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: unknown) dose was not reported, 1 total administered on 17-JUN-2021 for an unspecified indication. Drug start period was reported as 292 days. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. (dose number in series 1). The patient received additional booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on 18-NOV-2021 for an unspecified indication. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Treatment medications (dates unspecified) included: dexamethasone, heparin, and remdesivir. No concomitant medications were reported. On 05-APR-2022, the patient experienced acute kidney injury, anticoagulant therapy, covid-19, cough, dyspnoea, fibrin d dimer, mental status changes, platelet count decreased, pneumonia bacterial, positive airway pressure therapy, respiratory distress (patient was placed on BiPAP (bilevel positive airway pressure) with improvement of oxygenation to 96 percent), sars-cov-2 test positive and troponin due to this she was hospitalized (date unspecified and number of days 10 days) (all events with dose number in series 2). Laboratory data included: Fibrin D dimer (NR: not provided) 6 444, and Troponin (NR: not provided) 29 PLTS 103, Oxygen saturation (NR: not provided) 79 percent.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the acute kidney injury, covid-19, cough, dyspnoea, mental status changes, platelet count decreased, pneumonia bacterial, respiratory distress, sars-cov-2 test positive, troponin, positive airway pressure therapy, fibrin d dimer and anticoagulant therapy was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). This report was associated with product quality complaint. The suspected product quality complaint has been confirmed to be batch and lot tested and found within specifications, the reported allegation was not confirmed and the root cause was determined to be not manufacturing related Based on the evaluation/investigation performed.  Additional information received from Complaint department on 06-JUN-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V3:  This follow up version was created to update following information: Product quality complaint investigation result. This added information does not alter the causality of previous reported event.  20220514924-Covid-19 vaccine ad26.cov2.s- acute kidney injury, pneumonia bacterial, respiratory distress, covid-19, cough, dyspnoea, mental status changes, platelet count decreased, sars-cov-2 test positive, troponin, positive airway pressure therapy, fibrin d dimer, anticoagulant therapy -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.