Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Feeling abnormal, Hypersensitivity, Musculoskeletal discomfort, Taste disorder
Clinical narrative: Anaphylaxis; She had the very violent allergies; Felt like when someone is in the hospital and gets an IV and has coldness in vein; Neck did not feel right; Taste in mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I am allergic to soy" (unspecified if ongoing), notes: I am allergic to soy. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01), for COVID-19 immunization; Bnt162b2 (Dose:02), for COVID-19 immunization; Bnt162b2 (Dose:03), for COVID-19 immunization. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "Anaphylaxis"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "She had the very violent allergies"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Felt like when someone is in the hospital and gets an IV and has coldness in vein"; MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "unknown", described as "Neck did not feel right"; TASTE DISORDER (non-serious), outcome "unknown", described as "Taste in mouth". Therapeutic measures were taken as a result of anaphylactic reaction, hypersensitivity.  Clinical course: It was reported that she just got the COVID-19 vaccine and she mentioned that she had the very violent allergies. And she wanted to verify if, in other bivalent vaccine if there is soy in ingredient. Patient had already taken 3 allergy pills (intent: treatment). Because this was my fourth shot. But it was the first shot of the bivalent version. And this shot felt completely different form the other three. The other three, nothing, no problem. Something they had changed in this shot. Calling about the Pfizer COVID-19 vaccine, said caller got the shot yesterday and caller could taste the shot after getting the shot. Has a food allergy to soy and thinks that might be the problem. Has gotten 3 shots before this shot and had no reactions with those 3 shots, confirmed 3 previous shots were also the Pfizer COVID-19 vaccine, this was caller's 4th dose total yesterday. Caller's main concern was because soy causes anaphylaxis for caller, so was concerned that what caller was experiencing was anaphylaxis in slower form, doesn't always get full reaction right away, sometimes slow. Also concerned that vaccine was administered improperly. Yesterday caller was stopped because the person caller was speaking with could not tell caller if the ingredients were derived from soy and told caller that department was closed. Primary concern, since formula changed, the first 3 shots were original version, and yesterday's shot was the bivalent, the newer one. Noticed when took Band-Aid off yesterday evening blood on Band-Aid, never noticed before with the other shots. Immediately after received shot, felt like when someone was in the hospital and gets an IV and has coldness in vein. Neck did not feel right, could taste in mouth, like in the dentist when freezing gums, how someone can taste that, caller could taste when caller got the shot, thought did the person by accident put vaccine in caller's vein? Normally when getting vaccine, squeeze the skin and inject in fleshy muscle part of arm.  Product complaint included initially reported could taste the shot after getting the shot. Has food allergy to soy and thought was if there was soy but could not find any derivatives, said no egg, no latex, but did not mention soy. No additional information provided, declined to complete follow up report. Initial process of elimination. Then thought maybe got injected into vein instead of fatty muscle tissue, could that be causing the taste and cold feeling as vaccine was going into system and also stated never felt this before in other 3 shots. Caller was not having to take allergy medicine, however caller was able to sleep. Attempted to clarify and confirm details provided by caller. Wants to find out about the ingredients, that ingredients do not contain soy.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.