Sex: U
Vaccine: COVID19, COVID19
Symptoms: Anal incontinence, Arthralgia, Blood creatinine, Bone densitometry, Dialysis
Clinical narrative: Myasthenia Gravis; Dialysis; Bowel Incontinence; Right arm pain; Bilateral kneee pain; This is a solicited report received from contactable reporter(s) (Physician). Other Case identifier(s): A202211026 (Agency).  An elderly patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; eculizumab (SOLIRIS), since Jul2019 (Batch/Lot number: unknown) at 300 mg for myasthenia gravis. The patient's relevant medical history included: "Parathyroidectomy", start date: Oct2016 (unspecified if ongoing); "Hypercalcemia", start date: Oct2016 (unspecified if ongoing), notes: secondary hypercalcemia; "Bulbar palsy" (unspecified if ongoing), notes: bulbar weakness; "Ptosis" (unspecified if ongoing); "Weakness generalised (Asthenia)" (ongoing); "Difficulty in standing (Dysstasia)" (ongoing), notes: could not stand without assistance; "Osteoporosis (Osteoporosis)" (unspecified if ongoing); "Cyst (Cyst)" (unspecified if ongoing); "Myasthenia gravis (Myasthenia gravis)" (ongoing), notes: Unknown to ongoing; "Myasthenia gravis aggravated", start date: 18Nov2016, stop date: 09Dec2016, notes: Myasthenia gravis aggravated(Myasthenia gravis). Concomitant medication(s) included: IMURAN [AZATHIOPRINE], start date: 27Nov2019; MESTINON; DELTASONE [DEXAMETHASONE], start date: 14Dec2021, stop date: 29Aug2022; NORVASC, start date: 27Nov2019; ASPIRIN (E.C.); LIPITOR, start date: 27Nov2019; CALCIUM CARBONATE AND VITAMIN D; CHOLECALCIFEROL; LEXAPRO, start date: 27Nov2019; COZAAR, start date: 27Nov2019. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization; Flu shot (influenza vaccine), for Immunization (Immunisation), reaction(s): "No adverse event ( No adverse event)". The following information was reported: MYASTHENIA GRAVIS (medically significant), outcome "unknown"; DIALYSIS (medically significant), outcome "unknown"; ANAL INCONTINENCE (non-serious), outcome "unknown", described as "Bowel Incontinence"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Right arm pain"; ARTHRALGIA (non-serious), outcome "unknown", described as "Bilateral kneee pain". The patient underwent the following laboratory tests and procedures: Blood creatinine: stable at 2.00; Bone densitometry: consistent with osteoporosis, notes: was consistent with osteoporosis she had a significantly higher risk of fracture; Magnetic resonance imaging: showed a large lobulated cystic structure, notes: the right parietal lobe extending to the right occipital lobe suggestive of a benign cyst such as neuro-glial cyst. The action taken for eculizumab was unknown. Therapeutic measures were taken as a result of myasthenia gravis.  Clinical course: On an unspecified date in Jul2019, the patient initiated treatment with eculizumab (Soliris), (dose. route, and frequency were not reported) for the treatment of generalized myasthenia gravis (gMG). The most recent dose administered prior to the onset of the event was not reported. The batch/lot number and expiration date were not reported. Co-suspect drugs included the COVID-19 vaccine (Moderna and Pfizer booster). The patient received immunoglobulin human normal treatment and also received plasmapheresis with a total of seven exchanges for myasthenia gravis exacerbation which occurred from 18Nov2016 to 09Dec2021. On 28May2019, the patient had myasthenia gravis exacerbation (Myasthenia gravis). On an unspecified date, the patient had right arm pain (Pain in extremity), bilateral knee pain (Arthralgia), dialysis Monday-Wednesday-Friday (MWF) (Dialysis), and bowel incontinence (Anal incontinence). The MRI showed a-large lobulated cystic structure in the right parietal lobe extending to the right occipital lobe suggestive of a benign cyst such as a neuro-glial cyst. The bone density test was consistent with osteoporosis and she had a significantly higher risk of fracture. The creatinine was stable at 2.00 (units and reference ranges were not provided). The event Of myasthenia gravis was assessed as medically significant by Agency as this event is included in the Important Medical Events list. Action taken with eculizumab in response to the events was not reported. Action taken with the COVID-19 in response to the events was not reported. The plasma exchange was carried out seven times (or myasthenia gravis and was transferred to rehabilitation where she improved over three weeks. Corrective treatment for the Other events was not reported. The outcome of the event myasthenia gravis was resolving and the outcome of the Other events was not reported. The reporter causality between the events and eculizumab therapy was not reported. The reporter causality between the events and the COVID-19 vaccine was not reported.  The reporter's assessment of the causal relationship of "myasthenia gravis", "dialysis", "bowel incontinence", "right arm pain" and "bilateral kneee pain" with the suspect product(s) BNT162b2, BNT162b2 omi ba.4-5 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided, a causal relationship between BNT162B2  and the reported events "myasthenia gravis", "dialysis", "bowel incontinence", "right arm pain" and "bilateral kneee pain"  cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.