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Life Threatening? No
Write-up: HCP was informed by the police that a patient that received the vaccine died.; vomit was a little amount of blood; This case was reported by a physician via call center representative and described the occurrence of unknown cause of death in a 45-year-old male patient who received Flu Seasonal QIV Dresden (Influsplit Tetra 2019/2020) for prophylaxis. On 4th November 2019, the patient received Influsplit Tetra 2019/2020. On an unknown date, less than a week after receiving Influsplit Tetra 2019/2020, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). In November 2019, the outcome of the unknown cause of death was fatal. The patient died in November 2019. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Influsplit Tetra 2019/2020. Additional case details were reported as follows: The reporter was a healthcare assistant. The age at vaccination was not reported, however the patient could be 44 or 45 years. The reporter informed that as per her knowledge, the patient did not use any other medication. The healthcare professional (HCP) was informed by the police that the patient died, not sure if it happened on 4th or 5th November 2019. The HCP was contacted for batch number. This was a potential legal case. The reporter consented to follow up and it was preferred via email. This case has been linked with case DE2019EME202247, reported by same reporter. Follow up information received form physician on 6th November 2019: The patient''s historical condition included neurodermitis. Historical drug included creams, if required and hepatitis vaccination. In 2019, globuli against lactose intolerance were detected. In November 2019, less than a week after receiving Influsplit Tetra, the patient vomited with a little amount of blood. Till the evening of 4th November 2019, the patient worked and was in contact with his girlfriend. The patient died in the night from 4th November 2019 to 5th November 2019. The patient has obviously vomited, in the vomit was a little amount of blood. It was reported that obduction would be done. The physician would provide the batch number with the adverse event from which she would fill out and send back. A colleague from the medical department would contact her as well, as the physician had also a medical question. Physician wanted a quality investigation of the vaccine and it was requested to forward the case to the Quality department. Due to the physician, there was a timely relation between the vaccination and the death of the patient. The reporter considered the unknown cause of death to be possibly related to Influsplit Tetra 2019/2020. It was unknown if the reporter considered the vomiting blood to be related to Influsplit Tetra 2019/2020.; Reported Cause(s) of Death: Death NOS
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