Received Jul 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (TRUMENBA) | PFIZER\WYETH | UNK | — | OT |
Patient experienced Fatigue/recurrent Fatigue; her arm where she received the vaccine is tender, swollen and warm; her arm where she received the vaccine is tender, swollen and warm; her arm where she received the vaccine is tender, swollen and warm; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 2025-APL-0001286. A 27-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), on 07Jul2025 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation; pegcetacoplan (PEGCETACOPLAN), on 05Apr2023 (ongoing) as 1080 mg, 2x/week (twice weekly as directed) (Lot number: 2117470, Expiration Date: 31Jul2026) subcutaneous for paroxysmal nocturnal haemoglobinuria. The patient's relevant medical history included: "Fatigue" (unspecified if ongoing). Concomitant medication(s) included: SOLIRIS; PENICILLIN NOS; FOLIC ACID. The following information was reported: FATIGUE (non-serious) with onset 08Jul2025, outcome "recovering", described as "Patient experienced Fatigue/recurrent Fatigue"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 08Jul2025, outcome "not recovered" and all described as "her arm where she received the vaccine is tender, swollen and warm". The action taken for pegcetacoplan was dosage not changed. Additional information: On an unknown date, the patient experienced Fatigue. The patient stated she has been fatigued this past week. She stated since school ended for the summer she has been slacking in taking her folic acid. However, since starting to take it again more consistently, she has noticed an improvement in fatigue at this time. No other symptoms reported. On 08-JUL-2025, the patient experienced Vaccination site pain, Vaccination site swelling, Vaccination site warmth and recurrent Fatigue. The patient reported that she received Trumenba vaccine the day prior. Today, 08-JUL-2025, her arm where she received the vaccine was tender, swollen and warm. She also stated that she was noticing some fatigue today. The events Vaccination site pain, Vaccination site swelling, Vaccination site warmth and recurrent Fatigue reported for product Empaveli had a Not applicable dechallenge and Not applicable rechallenge. Company Comments: The reporter assessed Fatigue (1st occurrence and recurrence) to have an unknown relationship to Empaveli (pegcetacoplan). The reporter assessed Vaccination site pain, Vaccination site swelling, and Vaccination site warmth to be not related to Empaveli (pegcetacoplan). The reporter assessed Fatigue (1st occurrence and recurrent) to have an unknown relationship to Trumenba. The reporter assessed Vaccination site pain, Vaccination site swelling, and Vaccination site warmth to be related to Trumenba. The company assessed Fatigue as not related to Empaveli (1st occurrence and recurrence), and can be plausibly explained by the underlying paroxysmal nocturnal hemoglobinuria. The company assessed Vaccination site pain, Vaccination site swelling, Vaccination site warmth as not related to Empaveli and are due to the co-suspect drug Trumenba. The company assessed Fatigue (1st occurrence and recurrence) as not related Trumenba since it can be explained by the underlying disease. The company assessed Vaccination site pain, Vaccination site swelling and Vaccination site warmth as related to Trumenba due to close temporal relationship between onset of events and administration of Trumenba. Batch/lot number is not provided, and it cannot be obtained.
Medical History/Concurrent Conditions: Fatigue
SOLIRIS; PENICILLIN NOS; FOLIC ACID; PEGCETACOPLAN