Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thrombocytopenia
Clinical narrative: ACUTE KIDNEY INJURY; ACUTE RESPIRATORY FAILURE; CHRONIC KIDNEY DISEASE; THROMBOCYTOPENIA; INSULIN-REQUIRING TYPE 2 DIABETES MELLITUS; COVID-19; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAERS ID: 1814711) concerned a 55 year old male of 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, intramuscular, batch number: 1802068 expiry: UNKNOWN) dose was not reported, frequency 1 total administered on 01-APR-2021 on left arm for an unspecified indication. Drug start period was 204 days. No concomitant medications were reported.  On 22-OCT-2021, the patient experienced acute kidney injury, acute respiratory failure (acute hypoxemic respiratory failure due to COVID-19), chronic kidney disease (stage III), insulin-requiring type 2 diabetes mellitus, thrombocytopenia and covid-19 (suspected clinical vaccination failure) and was hospitalized (date unspecified).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from acute kidney injury, acute respiratory failure, covid-19, chronic kidney disease, insulin-requiring type 2 diabetes mellitus, and thrombocytopenia, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000201376. The suspected product quality complaint has been confirmed to be Disposition: Undetermined. The reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information received from Central Complaint Vigilance department on 16-NOV-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V2: Additional version created for follow up information as- Product quality complaint investigation result. This updated information does not alter the causality of previously reported events 20211115317-covid-19 vaccine ad26.cov2.s-acute kidney injury, acute respiratory failure, covid-19, chronic kidney disease, insulin-requiring type 2 diabetes mellitus, and thrombocytopenia. 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). 20211115317-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. 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: SPECIAL SITUATIONS