Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect route of product administration, Vaccination site erythema
Clinical narrative: It was in the subQ (subcutaneous) he believes; Had a local reaction/ a large red angry reaction in the high upper arm/ a large red angry reaction to the skin on his right upper arm and it covered almost the entire upper arm; This is a spontaneous report received from a Physician from medical information team.  An 82-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 82 years subcutaneous, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Asthma", start date: 1958 (ongoing). There were no concomitant medications. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (medically significant) with onset 12Nov2023, outcome "unknown", described as "It was in the subQ (subcutaneous) he believes"; VACCINATION SITE ERYTHEMA (medically significant) with onset Nov2023, outcome "recovered" (Nov2023), described as "Had a local reaction/ a large red angry reaction in the high upper arm/ a large red angry reaction to the skin on his right upper arm and it covered almost the entire upper arm". Therapeutic measures were not taken as a result of vaccination site erythema.  Additional information: The patient experienced a local reaction with the Pfizer COVID19 Vaccine. He described it happened a day or two after the dose and was a large red angry reaction in the high upper arm. He wanted to know if this allergic reaction would cause him any danger for the next potential vaccine. The patient was also interested in knowing which ingredients were shared between Abrysvo and Comirnaty to see if it's something he should avoid. It was further reported that he believe that the dose it was in the subQ (Subcutaneous). The patient clarified that he was calling about Pfizer COVID19 vaccine and he had a local reaction and wanted to know if it was truly an allergic reaction and if he is in danger of getting the next vaccine when it is available. States he hopes to get the RSV vaccine but since they are both provided by Pfizer, asks if there is something in them both that he should avoid. Clarified later in the call he has not yet received the RSV vaccine. The local reaction began 12Nov2023; caller clarified later in the call that he had the Pfizer COVID19 vaccine administered on 12 Nov2023 and the local reaction began a day or two after that shot and he had a large red angry reaction to the skin on his right upper arm and it covered almost the entire upper arm and gradually went away over a week or more and he had no other reaction; the local reaction was the same location of where the Pfizer COVID19 vaccine was administered. The reporter considered the event as medically significant because it made him wonder if it was a true allergic reaction then the next might be more severe and involve systemic symptoms. The caller was asked the dosage and route of administration and states it was in the subQ (subcutaneous) he believes because it did not go into the muscle and went right below the insertion below the deltoid. For the causality: States it is directly related and he also spoke with his pharmacist and she said about 18 percent of patients develop that kind of rash; has no lots, expiry dates, NDC numbers, vaccine names or patient specific information to provide for those patients. Has not require treatment for the reported event.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Based on known drug safety profile, and close temporal association the event vaccination site erythema is assessed as related to the suspect drug BNT162B2 OMI XBB.1.5. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.