Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Eye pruritus, Eye swelling, Skin warm, Swelling face
Clinical narrative: Eyes started to itch; Eyes and face were swollen; Eyes and face were swollen; Swelling in face and warmness and red; Swelling in face and warmness and red/face was warm; This spontaneous case was received on 06-Aug-2021 from other non-health professional (consumer) via communications (reference number: SEQW21-01546) and concerned a 37-year-old, female patient. At the time of initial reporting, the patient was a 45-year-old.  The patient's concurrent conditions included allergy to Neosporin (gramicidin, neomycin sulfate, polymyxin b sulfate). The patient's past medical history included two high risk pregnancies and blood clots. The patient's historical drug included Neosporin (gramicidin, neomycin sulfate, polymyxin b sulfate) after which the patient had face swelling and developed high allergy to this drug. The patient's historical vaccine included flu vaccine after which the patient was admitted to hospital for severe dehydration (refer to case 202102826). The patient was not taking any concomitant medications.  On 10-Jan-2014, the patient was vaccinated with Fluvirin (inactivated influenza virus surface antigen (subunit), egg-derived, influenza vaccine; dose: 0.5 ml, route of administration and anatomical location: not reported) as an immunisation against influenza. The batch number reported was 1309501 and expiry date was Apr-2014.  On the same day, after receiving Fluvirin, the patient went home and noticed that her eyes started to itch. After she looked in the mirror the patient noticed that her eyes and face were swollen, and her face was warm and red. The patient went to emergency room (ER) and received steroids and Benadryl (diphenhydramine hydrochloride). The patient reported that she might have received Pepcid (famotidine), but she was not sure. They observed her for a few hours and let her go home.   On an unspecified date, the patient recovered from events. It was reported that it took several days and lots of Benadryl (diphenhydramine hydrochloride) before the symptoms subsided.  The reporter assessed the events as related. As reported, the patient stated that she experienced adverse events for Fluvirin. It was also reported that the patient was working with her allergist and they were trying to determine what ingredients she was allergic to and if she should get the Covid vaccine.   The case was assessed as non-serious.  This case is linked with case 202102826 (due to the same patient).  Company comment: A female patient developed eye pruritus, eye and face swelling, facial erythema and she was feeling facial warmth on the same day after vaccination with the suspect product Fluvirin. Patient visited emergency room however related diagnostic findings have not been provided. Patient has a history of allergic reactions, however at time of event she was not taking any concomitant medications. Based on suggestive time relationship, causality for the reported events is assessed as possibly related.; Reporter's Comments: Consumer states she experience an adverse event for FLUVIRIN on 10JAN2014. Patient stated she is working with a allergist and she is trying to determine what ingredients she are allergic to. She would like to know the ingredients in the Fluvirin vaccine 2013-1014 season. They are trying to determine if she should get the Covid vaccine. She also mentioned that she is highly allergic to Neosporin and had a similar reaction with face swelling.; Sender's Comments: A female patient developed eye pruritus, eye and face swelling, facial erythema and she was feeling facial warmth on the same day after vaccination with the suspect product Fluvirin. Patient visited emergency room however related diagnostic findings have not been provided. Patient has a history of allergic reactions, however at time of event she was not taking any concomitant medications. Based on suggestive time relationship, causality for the reported events is assessed as possibly related.