Received Dec 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HBHEPB | HIB + HEP B (COMVAX) | MERCK & CO. INC. | UNK | — | OT |
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
Lip swelling; This Spontaneous report was received from an Other health professional and referred to a 4 month old Male patient. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unknown date, patient was vaccinated with a dose of Rotavirus Vaccine, Live pentavalent (ROTATEQ); a dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) as prophylactic vaccination; and a dose of Nirsevimab (BEYFORTUS) as respiratory syncytial virus (RSV) prevention (lot #, expiration date, strength, route of administration, anatomical location not provided for any vaccine). On an unknown date after vaccination, the patient experienced Lip swelling. At the reporting time, the outcome of the event was unknown. Causality assessment between the event of lip swelling and the suspected vaccines was not reported.
Beyfortus