Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test
Clinical narrative: DEATH; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer (Patient's wife) via a company representative via social media concerned a male of unspecified age, race and ethnic origin. Initial information was processed along with additional information received on 07-DEC-2022. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total administered, start therapy date were not reported for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26. cov2. s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total administered, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  Reporter stated that, " you and family are very lucky indeed my husband got his shots contacted covid tested positive on Jan 31streceived meds, took them as recommended by Drs 9 days later went to ER ( difficulty breathing Feb 12th) was put on Covid unit NO visitors for 17 days 29th of Feb was moved to ICU AND DIED days after his birthday on March 10 2022. Soooo NO the vaccine doesn't work for everyone Very happy you feel safe and confident with your jab. I by the way refused to take the vaccine we had covid at the same time and we both have health issues! ". On 31-JAN-2022, the patient tested positive for covid-19 which resulted into confirmed covid-19 infection (Dose number in series 2). The patient received medicines as recommended by doctors but 9 days later, on 12-FEB-2022 patient went to Emergency room (Hospitalized) due to difficulty of breathing and he was hospitalized for 26 days. He was put on covid-19 unit and no visitors were allowed for 17 days, later he was moved to ICU on 29-FEB-2022. Days after his birthday on 10-MAR-2022, the patient died from unknown cause of death. It was unknown whether autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection was not reported. This report was serious (Death, and Hospitalization Caused/Prolonged). This report was associated with product quality complaint 90000261984. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0-20221212111-Died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable. V0-20221212111- Confirmed Covid 19 infection. The event is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. Therefore, this event is considered inconsistent with vaccine administration.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH