Reporte zur Charge UH894AB

Symptomtext

angioedema; arm swelled up; Initial information regarding an unsolicited valid serious case was received from a consumer (patient) on 28-Dec-2020. This case involves female patient of an unknown age who experienced arm swelled up (peripheral swelling) and angioedema, while she received vaccine INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE [FLUZONE]. The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown. On 30-Sep-2013, the patient received suspect INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE [lot number: UH894AB and expiration date: unknown] at an unknown dose and frequency via unknown route and unknown site for prophylactic vaccination. On an unknown date, (latency unknown) patient had a reaction as the arm swelled up (peripheral swelling). Patient was on a lot of vitamin D and then got the vaccines; that she had angioedema but had not had it in a few years. The event angioedema was assessed as medically significant as per important medical event (IME) list. It was not reported if the patient received a corrective treatment. The outcome of the both events was unknown. There will be no information available regarding batch number in this case.; Sender's Comments: This case concerns a patient of unknown age who experienced swelling of her arm and had angioedema after vaccination with FLUZONE. The time to onset is unknown. Moreover, there is no information on patient's allergic history and lab tests do not rule out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.