Age: 65.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Anaphylactic reaction, Cardio-respiratory arrest, Death, Respiratory tract oedema
Clinical narrative: Initial information received from a literature article on 08-Apr-2019. This case is linked to cases 2019SA111409, 2019SA111401, 2019SA111422, 2019SA111446, 2019SA111441 and 2019SA106595 (same reporter). Literature abstract: Background: Anaphylaxis, a rare and potentially life-threatening hypersensitivity reaction, can occur after vaccination. Objective: We sought to describe reports of anaphylaxis after vaccination made to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. Methods: We identified domestic reports of anaphylaxis within VAERS using a combination of Medical Dictionary for Regulatory Activity queries and Preferred Terms. We performed a descriptive analysis, including history of hypersensitivity (anaphylaxis, respiratory allergies, and drug allergies) and vaccines given. We reviewed all serious reports and all nonserious reports with available medical records to determine if they met the Brighton Collaboration case definition for anaphylaxis or received a physician's diagnosis. Results: During the analytic period, VAERS received 467,960 total reports; 828 met the Brighton Collaboration case definition or received a physician's diagnosis of anaphylaxis: 654 (79%) were classified as serious, and 669 (81%) had medical records available. Of 478 reports in children aged less than 19 years, 65% were male; childhood vaccines were most commonly reported. Of 350 reports in persons aged 19 years or greater, 80% were female, and influenza vaccines were most frequently reported. Overall, 41% of reports described persons with no history of hypersensitivity. We identified 8 deaths, 4 among persons with no history of hypersensitivity. This case involves a 65 years old male patient who experienced anaphylactic reaction, while she received vaccine INFLUENZA VACCINE (TRIVALENT). Medical History: None. Concomitant medications were not reported. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (TRIVALENT) produced by unknown manufacturer (lot number, expiry date, dose, dose in series, route and site of administration were not reported). On an unknown date, the patient developed a serious anaphylactic reaction with symptoms like airway oedema and cardiopulmonary arrest, 15 minutes following the administration of INFLUENZA VACCINE (TRIVALENT). This event was leading to death. No lab data was reported. Final diagnosis was (fatal) anaphylactic reaction. It was not reported if the patient received a corrective treatment. The patient was died on an unknown date. It was unknown if an autopsy was done. However, the cause of death was reported as Anaphylactic reaction. Document held by the sender: none.; Sender's Comments: This literature article describes a case of 65 years old male patient who was died due to anaphylactic reaction after vaccination with INFLUENZA TRIVALENT VACCINE. Time to onset is compatible with the role of vaccine.  However, there was no information regarding lab tests ruling out alternate etiologies. The result of Autopsy should be provided to fully assess the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: Anaphylactic shock.