Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site erythema, Vaccination site rash
Clinical narrative: Received the vaccine subcutaneously; injection was barely under the skin; Injection was barely under the skin; red, raised patch; Injection was barely under the skin; red, raised patch; This is a spontaneous report received from a nurse from medical information team.  A 79-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 16Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years subcutaneous, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Height changed (thinks she is getting shorter)" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: influenza vaccine (DOSE NUMBER UNKNOWN; Manufacturer: Sanofi; subcutaneous in left arm), administration date: 10Sep2024, when the patient was 79-year-old, for Immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE RASH (non-serious) all with onset 16Oct2024, outcome "unknown" and all described as "Injection was barely under the skin; red, raised patch"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 16Oct2024, outcome "unknown", described as "Received the vaccine subcutaneously; injection was barely under the skin".  Causality for "received the vaccine subcutaneously; injection was barely under the skin" was determined associated to device constituent of BNT162b2 omicron (kp.2).  Additional Information: There are no other conditions (as reported), other medications, or investigations. The patient who is a retired nurse recently received the Comirnaty vaccine as routine health care in which the MA administered it. This is the first dose of Comirnaty the patient received (does not usually get vaccines there, just this one). It was painless and after she got home, she could see the injection was barely under the skin. The patient saw a red, raised patch. The patient presumes that the correct dose was administered. The patient contacted the facility that administered the vaccine and spoke with a PA who did not deny that she received the vaccine subcutaneously (it was not given correctly). The patient presumes correct dose was administered, just subcutaneous rather than intramuscular. The patient has researched online and read that her coverage is reduced if the vaccine is administered subcutaneously. The patient was concerned as she has a big family and helps several other people who are ill and would like to be protected. The patient was asking if there is any efficacy data regarding the administration of Comirnaty subcutaneously. The patient asked does she need to receive any additional vaccines if her dose of Comirnaty was administered subcutaneously. The patient would like to know, mainly, if she is safely covered. It would be nice if she could find out, how much this is going on everywhere. The patient does not see what to do. It was below what is recommended. The patient further asked what the recommendations are and would there be follow-up with the clinic.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.