Reporte zur Charge U3734AA

Symptomtext

arm was really red, painful, swollen and on fire; nauseated; sleepy;Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Medical Information (Reference number- 00585546) and transmitted to Sanofi on 03-May-2021. This case involves a 64 years old female patient whose arm was really red, painful, swollen and on fire (inflammation), was nauseated (nausea) and sleepy (somnolence) after receiving INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE] and while being treated with DIPHENHYDRAMINE HYDROCHLORIDE [BENADRYL]. It is unknown if the patient had any medical history, concomitant disease or risk factor. Medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On 19-Oct-2010, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE (lot U3734AA, Suspension for injection) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patients arm was really red, painful, swollen and on fire (inflammation) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE. The patient took 2 (ADVIL [IBUPROFEN]), however the swelling increased for 2 hours, until it was so bad that she was scared, and had to go to the emergency room (ER). In the ER, her arm was really swollen, red, and on fire. The patient thought she received Benadryl (date unspecified) and then she was nauseated (nausea), she thought that they inserted an intravenous (IV) but she was not sure because she was so sleepy (somnolence) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE and being treated with DIPHENHYDRAMINE HYDROCHLORIDE. She was then discharged (date unspecified). The health care professional (HCP) that discharged her stated that she should not receive any more flu shots because they now contain the avian bird flu H1N1 and she had a reaction and her next reaction could be much worse. She asked if it was a specific batch that landed her in the ER after her Fluzone injection on 19-Oct-2010. There was difficulty reading the Lot and what was on the vial, due to the writing being small. The events were non-serious The reporter stated that she wanted to visit her mother in the nursing home but the management was insisting that she receive the coronavirus (COVID) vaccine in order to see her mother. The patient stated that she had a reaction to the H1N1 portion of the 2010 Fluzone vaccine and she believed that the COVID vaccines have the H1N1 in them and will make her sick One of the HCP's in a white lab coat stated to the patient that it must be why so many people are having reactions to the COVID vaccines because so many people got sick after getting the Flu vaccines with the added H1N1. It is unknown if the patient experienced any additional symptoms/events It is unknown if there were lab data/results available At time of reporting, the outcome of events was unknown.