Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Pruritus, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Redness; Swelling; Itching; Did not receive the Pfizer COVID-19 vaccine formulated for adults in the deltoid muscle / Vaccinator mistakenly injected it between their shoulder and elbow area; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 71-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (primary immunization series complete; manufacturer unknown), for COVID-19 immunisation, reactions: "Redness", "Swelling"; Bnt162b2 (dose number unknown (booster), single; lot number: unknown), for COVID-19 immunisation, reactions: "Redness", "Swelling"; Smallpox shot (all upper arm from when she got a smallpox shot (unspecified) as a child), reaction: "Small keloid scar". The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 08Dec2023, outcome "unknown", described as "Did not receive the Pfizer COVID-19 vaccine formulated for adults in the deltoid muscle / Vaccinator mistakenly injected it between their shoulder and elbow area"; PRURITUS (non-serious) with onset 09Dec2023, outcome "unknown", described as "Itching"; VACCINATION SITE ERYTHEMA (non-serious) with onset 09Dec2023, outcome "unknown", described as "Redness"; VACCINATION SITE SWELLING (non-serious) with onset 09Dec2023, outcome "unknown", described as "Swelling". Additional information: The patient was asking whether she should get revaccinated if they she did not receive the Pfizer COVID-19 vaccine formulated for adults in the deltoid muscle, specifically the 2023-3024 formula. She also wants to know the recommended interval for revaccination. The patient received the vaccine on the previous Friday prior to the time of the report (08Dec2023). She had always received Pfizer vaccines, so it was a new vaccine for her. She never had anything different since the beginning of COVID-19 and fortunately she has not had COVID-19 until now. The patient reported that when she asked the vaccinator to inject the vaccine in a specific region (to dodge) as she has a small keloid scar on her upper arm from when she a smallpox shot (unspecified) as a child, the vaccinator mistakenly injected it between her shoulder and elbow area. She doesn't like to watch the vaccination so she just turned her head and the shot was given. She did not think anything about it and went home. When she looked, the injection was about halfway down her arm in between her shoulder and elbow which she has never received a vaccine in that region before. She never had a vaccine that low before. She didn't think too much about it at the time except it was really low on her arm and she took the band-aid off and it looked fine. The next morning, she had developed a fairly big red patch of egg-shaped and had swelling there as well but she did not think too much of that because she has had some redness and swelling each time she have gotten the shot. She experienced redness and swelling, similar to her previous vaccinations, but this time, the swelling continued to grow and became a large round circle about 3 to 3 1/2 inches in size. It has this has itched. In the past, she never had any itching its just been red and swollen. She visited a pharmacy, where the pharmacist was not concerned about the redness and swelling but was more concerned about the injection site. They are concerned about whether the vaccine is still effective and if it is affecting her immune system.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300445550 same patient and vaccine; different dose and event;US-PFIZER INC-202300445540 same patient and vaccine; different dose and event;