Received Jul 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | 4 | — | — |
| VARCEL | VARICELLA (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
Rash; Hives; This is a spontaneous report received from a Physician. A 15-month-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 08May2025 as dose 4, single (Batch/Lot number: unknown) at the age of 15 months for immunisation; varicella zoster vaccine (VARICELLA VACCINE), on 08May2025 as dose number unknown, single) for immunisation. The patient's relevant medical history included: "Ear infection" (unspecified if ongoing). Concomitant medication(s) included: AMOXICILLIN taken for ear infection, start date: 05May2025. Vaccination history included: Prevnar 20 (dose 1), for Immunization; Prevnar 20 (dose 2), for Immunization; Prevnar 20 (dose 3), for Immunization. The following information was reported: URTICARIA (medically significant) with onset 09May2025, outcome "recovered" (14May2025), described as "Hives"; RASH (medically significant) with onset 09May2025, outcome "recovered" (14May2025). Therapeutic measures were taken as a result of rash, urticaria. Clinical course: The reporter clarified, it was Pfizer varicella vaccine. It was the one usually given to 15 month olds. The reporter was not the person who gave vaccine to the patient, the pediatrician did. This Pediatrician sent patient to reporter, as allergist, to evaluate what have given this reaction. The reporter was later asked to evaluate if rash was related to the varicella vaccine. The reporter was asking Pfizer how to evaluate whether there was allergy to vaccine and, if the vaccine can be given. The patient was given Zyrtec by the pediatrician for events rash, hives, and, by 14May2025, everything was gone. The reporter clarified that the rash and hives were gone. The seriousness criteria was nothing critical, patient was not in respiratory distress. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: The events rash, and urticaria conservatively assessed as related to the suspect drug PNEUMOCOCCAL 20-VAL CONJ VAC (DIPHT CRM197 PROTEIN) 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: Ear infection
AMOXICILLIN