Reporte zur Charge U3604BA

Symptomtext

throat became constricted; anaphalactic reaction to flu vaccine; her tongue swollen; Initial information was received on 22-Jan-2021 regarding an unsolicited valid serious case from a consumer/non-hcp (healthcare professional). This case involves an 84 years old female patient whose throat became constricted (throat tightness), anaphalactic reaction (anaphylactic reaction) and her tongue swollen (swollen tongue), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE]. The medical history, medical treatments, past vaccinations, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot U3604BA and expiration date was not reported) via unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a serious throat became constricted (throat tightness), 10 years following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient was hospitalized for this event. On 22-Jan-2011, the patient developed a serious anaphalactic reaction (anaphylactic reaction) and her tongue was swollen (swollen tongue), 10 years following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient was hospitalized for these events. It was reported that she was told to find out the ingredients of that vaccine and then her doctor would compare it to the current Covid vaccines to determine if any of the ingredients are the same. Laboratory data was not reported. It was not reported if the patient received any corrective treatment or not. The outcome of the events was unknown at the time of reporting.; Sender's Comments: This case involves an 84 years old female patient who experienced throat tightness, anaphylactic reaction and swollen tongue, after vaccination with FLUZONE HIGH DOSE. The time to onset is unclear. The patient's medical history, medical condition at time of vaccination, concomitant medication and lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.