Age: 54.0
Sex: M
Vaccine: FLUA4
Symptoms: Death, Overdose
Clinical narrative: Death (unknown cause); This clinical trial case initially received on 16-May-2024, was reported by a health professional and concerns an adult male subject. Weight: 67 kg; Height: 208 cm  The subject was enrolled in the study   Past medical history included Left bicep tenodesis. At the time of the event the subject had Anxiety. Concomitant medication: alprazolam for anxiety.  Administration of company suspect drug(s): On 28-Nov-2023, at 12:43, the subject received aQIVc HD vs QIVr vs aQIV for Prophylaxis of influenza, Dose regimen: 0.5 ml, Route of administration: Intramuscular, Anatomical location: left deltoid.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 25-Apr-2024, four months and 29 days after receiving the blinded study vaccine aQIVc HD  vs QIVr vs aQIV, the subject experienced  death (unknown cause) (outcome: Fatal, stop date: 27-Apr-2024). The subject died due to a drug overdose, as reported.  Non-drug treatment/Other action taken:  aQIVc HD  vs QIVr vs aQIV action taken: Not Applicable  The subject died on 27-Apr-2024. Cause of death: Drug overdose. The site's medical history of the subject did not record any substance abuse problems. It was unknown if an autopsy was performed. The emergency contact was contacted but there was no answer. Medical records have been requested. The site was unaware of clinical signs and symptoms that led to fatal outcome, and was still waiting on medical request, death certificate and autopsy results.  At the time of follow-up reporting, on 09-Jul-2024, death certificate, autopsy report and any public records were not available to the public and emergency contact had no access to the records as well.  At the time of follow-up reporting, on 20-Jul-2024, autopsy was added as No.  On 30-Jul-2024, subject public records were searched for again online. No records or death certificates were found.  Reporter's assessment: The reporter considered the event Death (unknown cause) as severe and serious due to seriousness criterion of fatal outcome. The event was assessed as not related to the study vaccine and the alternative cause for the event was reported as 'Other'.  The subject remained blinded in the study.  Follow up (30-May-2024) from the investigator: Event summary description updated. Site was unsure of which drug overdose subject had due to information being unknown. The narrative was updated accordingly.  Follow-up (07-Jun-2024) received from the Investigator: The event verbatim was changed from Drug overdose death' to Death' and the event was recoded - LLT changed from Drug overdose' to Death'. The narrative was updated accordingly.  Follow up (06-Jul-2024) received from the Investigator: On Event tab, verbatim for the SAE was changed from 'Death' to 'Death (unknown cause)' and LLT changed from 'Death' to 'Unknown cause of death'. If death certificate has been provided further asked to be confirmed. The narrative was amended accordingly.  Follow up (09-Jul-2024) received from the Investigator: The event summary description was updated and the narrative was amended accordingly.  Follow-up (20-Jul-2024) received from the Investigator: Autopsy done populated with no. Narrative was amended accordingly.  Follow-up (31-Oct-2024) received from the Investigator: end date of event updated, date of death updated and narrative updated accordingly.; Reporter's Comments: An adult subject died due to drug overdose four months and 29 days after receiving the blinded study vaccine aQIVc HD  vs QIVr vs aQIV. Reportedly, an autopsy was not performed. In line with Investigator's causality assessment, the Sponsor assessed the event as not related, based on biological implausibility. Listedness was assessed using IB version 4.; Reported Cause(s) of Death: Drug overdose