Received Oct 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | 1 | — | LA |
| TDAP | TDAP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | RA |
Itchy at injection site; possible infection at injection site; This is a spontaneous report received from a Nurse from a sales representative. A 20-year-old patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 17Sep2025 as dose 1, single (Batch/Lot number: unknown) at the age of 20 years, in left arm for immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), on 17Sep2025 as unk, single, in right arm. The patient's relevant medical history included: "AdHD" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Sulfa antibiotics Allergy" (unspecified if ongoing). Concomitant medication(s) included: PRE NATAL FORMULA. The following information was reported: VACCINATION SITE PRURITUS (medically significant) with onset 19Sep2025, outcome "recovered" (22Sep2025), described as "Itchy at injection site"; VACCINATION SITE INFECTION (medically significant) with onset 19Sep2025, outcome "recovered" (22Sep2025), described as "possible infection at injection site". The events "itchy at injection site" and "possible infection at injection site" required emergency room visit. Therapeutic measures were taken as a result of vaccination site pruritus, vaccination site infection. Clinical course: Itchy at injection site to the point of going to the ER. Doctor gave antibiotic due to possible infection at injection site. The patient received treatment for the adverse event with Keflex. Causality for "itchy at injection site" and "possible infection at injection site" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: The event vaccination site pruritus, and vaccination site infection are conservatively assessed as related to the suspect drug RSV VACCINE PROT.SUBUNIT PREF 2V based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. 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.
Medical History/Concurrent Conditions: ADHD; Anxiety; Depression; Sulfonamide allergy
PRE NATAL FORMULA