Sex: F
Vaccine: MENB
Symptoms: Musculoskeletal disorder, Pyrexia, Rotator cuff repair, Shoulder operation, Sluggishness
Clinical narrative: welt on her arm; fever; shoulder operation, rotator cuff surgery; Tore three sections of her bicep; This is a solicited report received from non-contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): A202203202 (AstraZeneca).  A 61-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), on 06Aug2022 as unk, single (Batch/Lot number: unknown) for immunisation; eculizumab (SOLIRIS), as 300 mg (Batch/Lot number: unknown) for myasthenia gravis.  The patient was enrolled in Patient Support Program. Medical history/concurrent conditions included leg involvement was way worse, autoimmune diseases, lupus, aseptic meningitic, and port a cath. Historical drugs included intravenous immunoglobulin (IVIG) and Mestinon. Concomitant medications and vaccination history were not reported. On an unspecified date, the patient-initialed treatment with eculizumab (Soliris) (unknown dose, route, and frequency) for the treatment of generalized myasthenia gravis (gMG). The most recent dose administered prior to the onset of the events was not reported. The batch/lot number and expiry date were not reported but requested upon follow-up. On an unspecified date, after the infusion, she was a little slow (sluggishness). She stated thats she usually receives her eculizumab infusions over two hours, but prior to yesterday as of 09Mar2022}, the Infusion went over an hour and one half rather then two hours. On an unspecified date, she felt weak (asthenia) and not good for (feeling abnormal) for three days. On an unspecified date, her infusion seemed to go quicker than two hours (it was finished in an hour and ten minutes) even when the pump was set correctly. On an unspecified date, she was dam weak. She notified the nurse and believed she would need a new pump and had requested. She believed they would bring the pump for a new infusion. She lost so much in the very beginning of this whole MG reality. She lost muscle in her shoulders and hands (muscle atrophy), and her leg involvement worsened than before she was put on eculizumab. She believed that eculizumab was helping in the prevention of worsening. The patient mentioned her abilities were slowly changing still and that her forearms were minus 4 (musculoskeletal disorder) in the context of relaying her status on eculizumab. The patient mentioned her health history which she believed was all pre-ecuhzumab.  The following information was reported: MUSCLE RUPTURE (non-serious) with onset 06Aug2022, outcome "unknown", described as "Tore three sections of her bicep"; ROTATOR CUFF REPAIR (medically significant) with onset 06Aug2022, outcome "unknown", described as "shoulder operation, rotator cuff surgery"; VACCINATION SITE URTICARIA (non-serious), outcome "recovering", described as "welt on her arm"; PYREXIA (non-serious), outcome "recovering", described as "fever". The patient reported she had shoulder surgery specified as rotator cuff surgery (rotator cuff repair) on an unspecified date in Aug2022. In the context of asking permission for follow-up/ PV, the patient relayed that she had had so many surgeries in the last three years. The patient reported she was ten days late for her infusion due to site of care change and funding prior authorization reason for the delay. She mentioned that she received her meningococcal vaccine b rfhbpa/fhbpb on 08Aug2022 and had a fever (pyrexia) two hours later and later developed a welt on her arm (administration site urticaria) and issue was improved. The patient also reported that she had familiarity with meningitis, stating she had it three times and believed it was related to IVIG pre-eculizumab. The patient believed her reaction to a vaccine (an opposite arm of recent shoulder surgery) might have been felt more by her due to the recent surgery. She was scheduled for her infusion on 19Aug2022. As of 31Aug2022, the patient reported that she also tore three sections of her bicep (muscle rupture). The patient mentioned her most recent infusion was on 19Aug2022 and was 10-11 days late (previously reported). After this infusion, i was a little tough. She reported that the next infusion was scheduled for today (31Aug2022). The event of muscle rupture was considered medically significant by (withheld) as this event is included in the Important Medical Events list. The action taken with eculizumab in response to the events was not reported. The action taken with meningococcal vaccine b rfhbpa/fhbpb in response to vents was not reported. Corrective treatment for the events of muscle rupture, feeling abnormal, muscle atrophy, sluggishness musculoskeletal disorder, administration site urticaria, pyrexia, and asthenia was not reported. The outcome of the events of fever and administration site urticaria was resolving and was not reported for other events.  The reporter causality between the events, eculizumab, and meningococcal vaccine B RFHBPA/FHBPB was not reported.  The reporter's assessment of the causal relationship of the events with the suspect product meningococcal group b Rlp2086 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Company (AstraZeneca) comment: Upon follow-up, this case is a serious, not medically confirmed, solicited report of event muscle rupture (MS); non-serious, not medically confirmed events of feeling abnormal, sluggishness, musculoskeletal disorder, asthenia. rotator cuff repair, muscle atrophy. pyrexia, and administration site urticaria. The events asthenia and pyrexia are listed while the rest of the events are unlisted in the CCDS. The company considers the events of sluggishness and asthenia as related to eculizumab based on a temporal relationship between event onset and eculizumab administration. The events of muscle atrophy, musculoskeletal disorder, and feeling abnormal are likely due to the underlying g MG given its clinical manifestations and complications and there is a lack of information on precise clinical context, details, SUR ortive investigations, and diagnosis. Given the absence of information on the indication of surgery, the company considers the event of rotator cuff repair as not related to eculizumab. The events of pyrexia and administration site urticaria were due to the meningococcal vaccine, hence the company considers the events as not related to eculizumab. The event muscle rupture could be due to mechanical reasons and not related to eculizumab.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The association between the reported events with TRUMENBA can not be fully excluded.