Received Apr 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (TRUMENBA) | PFIZER\WYETH | 3 | — | 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 08Apr2025 as dose 3, 0.5 ml, single (Batch/Lot number: unknown) at the age of 16 years intramuscular, in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: trumenba (DOSE 1, SINGLE), administration date: 28Jun2024, for Immunisation; trumenba (DOSE 2, SINGLE), administration date: 05Aug2024, for Immunisation. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 09Apr2025, outcome "not recovered" and all described as "Redness and swelling at the injection site and it is very warm and painful". Additional information: 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 stated, "The first dose was given on 28Jun2024 (June 28th, 2024)." Indication: Pfizer sales representative stated, "It is recommended and the physician assistance recommended it. It is a vaccine." Pfizer sales representative stated, "Back to the first one, she actually had a total of three doses, so I am going to give you those other two doses as well. The second dose that she had was on 05Aug2024 (August 5th, 2024) and the third dose was given on 08Apr2025 (April 8th, 2025)." When probed to clarify the start date of events for first patient as 09Apr2025, Pfizer sales representative stated, "Yes." Still experiencing: Pfizer sales representative stated, "The one (first patient) that was vaccinated on 08Apr2025, yes. She started feeling it on 09Apr2025, so she is still experiencing it, the other ones are not. Causality: Pfizer sales representative stated, "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-202500077862 Same reporter/drug/AE, different patient;US-PFIZER INC-202500078175 Same reporter/drug/AE, different patient;