Received Oct 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (TRUMENBA) | PFIZER\WYETH | 2 | GF4142 | OT / LA |
the pain at the site; the swelling at the site; they administered Trumenba subcutaneously instead intramuscularly; This is a spontaneous report received from a Nurse from medical information team. An 18-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), on 04Feb2025 at 09:30 as dose 2, 0.5 ml single (Lot number: GF4142, Expiration Date: 30Aug2025) at the age of 18 years subcutaneous, in left arm for immunisation, Device Lot Number: GF4142, Device Expiration Date: 30Aug2025. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Meningococcal vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Immunization. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 04Feb2025 at 09:30, outcome "unknown", described as "they administered Trumenba subcutaneously instead intramuscularly"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "the pain at the site"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "the swelling at the site". Therapeutic measures were taken as a result of vaccination site pain, vaccination site swelling. Additional information: the nurse administered Trumenba subcutaneously instead intramuscularly, the NDC number was 0005010001. The patient was taking Tylenol and Ibuprofen for the pain at the site; Ibuprofen was also for the swelling at the site and other than that she was not taking any other medications at this time. The reporter stated that the patient mom probably gave her 500 of Tylenol and 400 of Ibuprofen, every 4 to 6 hours alternating. The patient did at her wellness. She had some lab work done, it all came back to normal. Follow-up (14Mar2025): Follow-up attempts are completed. Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities.