Age: 85.0
Sex: F
Vaccine: RSV
Symptoms: Allergic reaction to excipient, Erythema, Pruritus, Rash erythematous
Clinical narrative: itching/pruritus; redder and itchier; pretty large erythematous area; allergic reaction to a component; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team.  An 85-year-old female patient received pf-06928316 (ABRYSVO), on 08Sep2023 at 17:57 as dose 1, single (Lot number: HF5014, Expiration Date: 28Feb2025) at the age of 85 years intramuscular, in right deltoid for immunisation, respiratory syncytial virus immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PRURITUS (medically significant), outcome "not recovered", described as "itching/pruritus"; ERYTHEMA (medically significant), outcome "not recovered", described as "redder and itchier"; RASH ERYTHEMATOUS (medically significant), outcome "unknown", described as "pretty large erythematous area"; ALLERGIC REACTION TO EXCIPIENT (medically significant), outcome "unknown", described as "allergic reaction to a component". Therapeutic measures were taken as a result of pruritus.  Clinical course: The caller stated the patient mentioned she had redness, she has some erythema but said it is about palm size so it is large. Then she has itching, but the caller thinks she is scratching it which is making it redder and itchier. She has an itch cream on it. The itching is what is concerning her most because she does not see it listed as an adverse reaction. The caller is more worried about the patient's itching and stated maybe it is an allergic reaction to a component. The caller stated she saw on the website under adverse reactions that redness the size of over 100 mm happens in about in 0.1% of people, so that part is addressed, so she feels like that part is probably normal. She stated she will have the patient report to her doctor and decide whether they need to follow up. The patient may be scratching it because she is nervous about it. It is a pretty large erythematous area so she can recommend she is seen by somebody. Calling about Abrysvo, caller is a pharmacist and had a patient call, caller knows swelling and redness is common, but patient reported having redness the size of palm of hand as well as itching from it, almost like an allergic reaction. Caller doesn't see pruritus listed. Caller stated this is not an emergency, patient is fine, just worried about how big the spot was.   The information on the batch/lot number for pf-06928316 has been requested and will be submitted if and when received.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event based on the known safety profile and temporal association. Events are possibly not related to the devise.   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.