Age: 0.5
Sex: M
Vaccine: MENB
Symptoms: Irritability, Off label use, Product administered to patient of inappropriate age, Pyrexia, Wrong product administered
Clinical narrative: a 6 month old patient received a dose of Trumenba inadvertently today; They were supposed to give Vaxelis but they garbed the wrong vaccine (Trumenba) and then accidentally give this baby Trumenba; Patient experienced fever starting the night of 31May2022 lasting 48 hours with the highest temperature reaching 101.5 F.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) from medical information team.  A 6-month-old male patient received meningococcal group b Rlp2086 (TRUMENBA), on 31May2022 as dose number unknown, single (Lot number: ER2622, Expiration Date: Jan2024) at the age of 6 months for immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PYREXIA (non-serious) with onset 31May2022, outcome "recovered" (Jun2022), described as "Patient experienced fever starting the night of 31May2022 lasting 48 hours with the highest temperature reaching 101.5 F."; WRONG PRODUCT ADMINISTERED (non-serious) with onset 31May2022, outcome "unknown", described as "They were supposed to give Vaxelis but they garbed the wrong vaccine (Trumenba) and then accidentally give this baby Trumenba"; OFF LABEL USE (non-serious) with onset 31May2022, outcome "unknown", described as "a 6 month old patient received a dose of Trumenba inadvertently today". The patient underwent the following laboratory tests and procedures: Body temperature: (31May2022) 101.5 Fahrenheit. Therapeutic measures were taken as a result of pyrexia.  Additional information included: Reaction / Event as Reported by the Primary Source for Translation: They were supposed to give Vaxelis but they garbed the wrong vaccine (Trumenba) and then accidentally give this baby Trumenba. Outcome of reaction/event at the time of last observation: Unknown. Medicinal Product Name as Reported by the Primary Source: Trumenba. Action(s) taken with drug: Unknown. Batch/lot number: ER2622. Name as Reported by the Primary Source: Vaxelis. Action(s) taken with drug: Unknown. Batch/lot number: Unknown. Reporter stated, "Today we had a vaccine that was accidentally given to a patient. This patient was suppose to receive a Vaxelis vaccine (Captured as suspect product) but our MA accidently grab the Trumenba vaccine and gave it to this patient and that is just six months old and we are just calling to find out you know like how bad is this? Do we need to watch for?" Reporter stated, "No, the patient was six months, not six years, six months old and was accidentally given Trumenba. Well, they were suppose to give Vaxelis but they grabbed the wrong vaccine and then accidentally give this baby Trumenba which is like a teenager's shot for meningitis (Voice overlapping). So, we want to find out what we need to do?" Manufacturer of Vaxelis: Reporter stated, "Sanofi, but that's not the one that the baby received, that's the one it was suppose to get but it was accidentally given Trumenba from Pfizer instead."Reporter was informed about Pfizer Drug Safety. Reporter was informed about Pfizer Medical information Department for the concern and offered the number. In response: Reporter stated, "Yes that would be fine." In response to further probing: Reporter stated, "Not right now." Further probing could not be done as reporter was unwilling to provide further information hence, product details, purchase details and other details were unknown and limited information was available over the call. QR Comment: Reporter type was not available over the call, hence reporter type was captured as consumer or non-healthcare professional by default. Patient experienced fever starting the night of 31May2022 lasting 48 hours with the highest temperature reaching 101.5 F. No fevers today. He responded to Ibuprofen and Tylenol. HCP reports infant being fussy and irritable since dose.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow up (31May2022): This is a spontaneous follow-up report received from a contactable consumer. This consumer reported for a patient that:  Updated information included: New event "Wrong vaccine administered" and Lot and Expiry date added.   No follow-up attempts are possible. No further information is expected.  Follow-up (03Jun2022): This is a spontaneous follow-up report received from a contactable Physician. This Physician reported for a patient that: Updated information includes: New reporter added, Gender added, Lab data added, Event Medically Confirmed updated, New event Fever added.  No follow-up attempts are needed. No further information is expected.