Received Jun 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MNQ | MENINGOCOCCAL CONJUGATE (MENVEO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | UNK | IM / LA |
injection site was hot; injection site was red; injection site was swollen; injection site was painful; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. Concomitant products included Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Daptacel) and Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Daptacel). On 13-MAR-2025, the patient received Menveo (intramuscular, left arm). On 13-MAR-2025, immediately after receiving Menveo, the patient experienced injection site warmth (Verbatim: injection site was hot), injection site erythema (Verbatim: injection site was red), injection site swelling (Verbatim: injection site was swollen) and injection site pain (Verbatim: injection site was painful). On 16-MAR-2025, the outcome of the injection site warmth, injection site erythema, injection site swelling and injection site pain were resolved. It was unknown if the reporter considered the injection site warmth, injection site erythema, injection site swelling and injection site pain to be related to Menveo. It was unknown if the company considered the injection site warmth, injection site erythema, injection site swelling and injection site pain to be related to Menveo. Additional Information: GSK Receipt Date: 02-JUN-2025 The patient mother was the reporter. The patient mother stated that her son, 11 years old, received Menveo vaccine on 13 MAR 2025. The reporter stated almost immediately a space measuring about 3 by 4 below the injection site was hot, red, swollen and painful which resolved approximately in 3 days. The reporter also stated when her son received another vaccine containing diphtheria (Daptacel) he had the same type of reaction. The reporter mentioned this reaction occurred after receiving dose 4 and 5 in the dose vaccination series of Daptacel. The reporter did have her son examined by his Primary care physician (PCP) and the Primary care physician stated this reaction could be a histamine type reaction. The reporter also stated that her son is scheduled for an examination with an allergy doctor.
Daptacel; Daptacel