Received Apr 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
Multiple sclerosis (MS) pseudorelapse; This literature report (initial receipt 25-Mar-2025) concerns a unknown patient who was diagnosed with relapsing multiple sclerosis (RMS). Patients with RMS aged 18-55 years were grouped into three cohorts: cohort 1 (C1) received the influenza vaccine (trade name, manufacturer and lot number not reported - to be requested upon follow up) >/= 2 weeks before starting ofatumumab (OMB); cohort 2 (C2) received the vaccine >/= 4 weeks after starting OMB; and cohort 3 (C3) was currently being treated with interferon/glatiramer acetate and received the influenza vaccine =4 weeks after enrollment. One patient from cohort 2 experienced a serious adverse event (AE) (Multiple sclerosis (MS) pseudorelapse).; Reporter's Comments: Causality : Related. Due to the spontaneous nature of the case, it is considered related for reporting purposes. The event Multiple sclerosis pseudo relapse has no biological or pharmacological plausible relation for the product contributing to the event. The nature of underlying disease with tendency to relapse provide an alternative explanation.
Comments: None
Ofatumumab