Received Nov 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | 1 | LL839505 | — |
she is having redness in her leg; Four-month-old patient received Abrysvo; This is a spontaneous report received from a Nurse. A 4-month-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 03Nov2025 at 17:00 as dose 1, 0.5 ml single (Lot number: LL8395, Expiration Date: 31May2026) at the age of 4 months intramuscular and (Lot number: LL839505) for immunisation. The patient didn't receive nirsevimab (BEYFORTUS [NIRSEVIMAB]). The patient's relevant medical history was not reported. Concomitant medication(s) included: PREVNAR 20 intramuscular taken for immunisation, start date: 03Nov2025, stop date: 03Nov2025; PEDIARIX intramuscular taken for immunisation, start date: 03Nov2025, stop date: 03Nov2025; PEDVAXHIB intramuscular taken for immunisation, start date: 03Nov2025, stop date: 03Nov2025; ROTARIX oral taken for immunisation, start date: 03Nov2025, stop date: 03Nov2025. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 03Nov2025, outcome "unknown", described as "Four-month-old patient received Abrysvo"; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "she is having redness in her leg". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: It does not look like there is any history of medication or any diagnosis. The nurse was just calling for some direction on a patient who had come into their office that day. The four-month-old patient received Abrysvo (NDC number of Abrysvo: 0069034405) (instead of Beyfortus) which is the incorrect dosage for that age. The patient got the Abrysvo after reconstituting it was 0.5 mL. The baby had the Bayley-4 Test. The baby was not indicated for Abrysvo, so the reporter inquired about what the next steps should be for this patient (if they will have the immunity to RSV with this vaccine or do they need to come back and get Beyfortus). Follow-up (04Nov2025): This is a spontaneous follow-up report received from a Nurse. Updated information: General data (Reporter slider added), Event data (new event Vaccination site erythema), Product data (new suspect drug (Beyfortus ) and concomitant medications reported)
PREVNAR 20; PEDIARIX; PEDVAXHIB; ROTARIX
Test Date: 20251103; Test Name: Bayley-4 test; Result Unstructured Data: Test Result:Unknown results