Received Apr 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (TRUMENBA) | PFIZER\WYETH | 1 | — | OT |
Redness and swelling at the injection site and it is very warm and painful; Redness and swelling at the injection site and it is very warm and painful; Redness and swelling at the injection site and it is very warm and painful; Redness and swelling at the injection site and it is very warm and painful; This is a spontaneous report received from an Other HCP. A 16-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), on 13Sep2024 as dose 1, 0.5 ml single (Batch/Lot number: unknown) at the age of 16 years intramuscular, in arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE WARMTH (non-serious), VACCINATION SITE PAIN (non-serious) all with onset Sep2024, outcome "recovered" and all described as "Redness and swelling at the injection site and it is very warm and painful". Additional information: Reported as, All three of them have had redness and swelling at the injection site and it is very warm and painful. When probed to clarify if three patients experienced the same adverse events from Trumenba, Pfizer sales representative confirmed the same. Pfizer sales representative believed there was no any 4-week prior vaccination. Regarding event Start date, stated, "Like the next day". Pfizer sales representative stated, It was, for each dose that was given, they started seeing that either later on that evening or the following day. Pfizer sales representative stated, The one (first patient) that just experienced it on 08Apr, yes. She started feeling it on 09Apr, so she is still experiencing it, the other ones are not. Investigations: No. Relatedness of drug to event: Source of assessment; Primary source reporter, Method of assessment; Global introspection, Result of Assessment; Yes. The information on the batch/lot number for meningococcal group b Rlp2086 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500077881 Same reporter/drug/AE, different patient;US-PFIZER INC-202500078175 Same reporter/drug/AE, different patient;
Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Other Conditions: No