Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19 immunisation, Cardiac failure congestive, Coma, Diabetes mellitus
Clinical narrative: HAD CONGESTIVE HEART ISSUES; DIABETES; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; BUILD UP OF FLUID IN LUNGS; HIT HIS HEAD/ HEAD INJURY; COMA; FELL; This spontaneous report received from a consumer through company representative concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported.  The patient received two doses of covid-19 vaccine (unspecified manufacturer) (Dose number in series 1) (form of admin, route of admin and batch number were not reported, expiry: UNKNOWN) dose and start therapy dates were not reported, two doses administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with two doses of covid-19 vaccine (Dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin and batch number were not reported, expiry: UNKNOWN) dose and start therapy date were not reported, 1 total administered for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 2). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient suffered with diabetes, fluid build up in legs and had congestive heart issues (Dose number in series 2). On OCT-2022, patient could not move, blood pressure kept getting lower, dropped so fast that the patient fell and hit his head, ended up in comma and never regained consciousness. The patient passed from build up of fluid in lungs and head injury (Dose number in series 2). Laboratory data (dates unspecified) included: Blood pressure Kept getting lower. On OCT-2022, the patient died from head injury, and build up of fluid in lungs (Dose number in series 2). It was unknown whether an autopsy was performed or not. It was reported as "My husband had stayed updated with shots and boosters suffered with Diabetes. Believe shots caused fluid build up in legs etc. Had congestive heart issues. Treated months for problems, could not move in October. Blood pressure kept getting lower. Dropped so fast he fell hit his head, ended up in comma never regained consciousness. Passed from build up of fluid in lungs and head injury by October" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of hit his head/ head injury and build up of fluid in lungs on OCT-2022, had not recovered from coma, and the outcome of diabetes, revaccination with different covid-19 vaccine, had congestive heart issues and fell was not reported. This report was serious (Death, and Other Medically Important Condition). This case is a duplicate of 20221251972.  It was determined that Manufacturer Case Number 20221251972 was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number 20221249901.; Sender's Comments: V0- 20221249901- Build up of fluid in lungs, Had congestive heart issues, Diabetes, Coma, Fell. The event has a unknown/unclear  temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.  V0- 20221249901- Hit his head/ head injury- The case causality is considered INCONSISTENT. Rationale: The event of fall gives a more plausible explanation than vaccine; Reported Cause(s) of Death: HEAD INJURY; BUILD UP OF FLUID IN LUNGS