Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Eyelid ptosis, Fatigue, Gastric disorder, Hypnagogic hallucination
Clinical narrative: Her stomach bothers her with infusions, her abdominal muscles are coming apart; Her stomach bothers her with infusions, her abdominal muscles are coming apart; she felt as though her legs were going to sleep; she felt as though her legs were going to sleep/ Numbness in her left hip; The muscles were giving away more in her throat; The muscles were giving away more in her throat; unable to sing anymore; When she tries to swallow, if she has scrambled eggs sometimes they get in the wrong place; Starts coughing, coughing all the time, especially at night, dry cough; She feels her legs have gotten worse since provider last saw her; Patient had some stress in her life; Light headed; Eyelids would not stay up and she were very heavy and took a nap; sensitive to medication; Urinary tract infection (UTI); Throat dry; Flu-like; Weak; Pelvis hurt sometimes when she walked, described it as a knife; left leg and hip pain; left leg and hip pain; Patient felt like she was hallucinated in her sleep; Very tired; Not feeling well about three weeks ago; This is a solicited report received from contactable reporter (consumer or other non-HCP). The Other Case identifier is A202211611. The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), as DOSE 1, SINGLE (batch/lot number: unknown) and as DOSE 2, SINGLE (batch/lot number: unknown) for COVID-19 immunization; eculizumab (SOLIRIS), (ongoing) (batch/lot number: unknown) at 300 mg (300 mg, every 2 weeks (q2w)) for myasthenia gravis. The patient's relevant medical history included: "Myasthenia gravis" (ongoing); "stroke on her left side" (unspecified if ongoing); "Positive airway pressure therapy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: CPAP; Intravenous immune globulin; Pre-eculizumab. Case Description was reported as follows: This solicited case from the United States was reported by a consumer (patient) on 21Sep2022 via a company representative and follow-up received on 22Sep2022 concerns an elderly female patient. On an unspecified date, the patient initiated treatment with eculizumab (Soliris) (dose and route were not reported) for the treatment of myasthenia gravis (gMG). The most recent dose of eculizumab administered prior to the onset of the events was not reported. The batch/lot number and expiration date were not reported but requested upon follow-up. The patient received the COVID-19 vaccine on and unspecified date for COVID-19 immunization (dose, route, and frequency we are not reported). The patient reported that she was not feeling well (Malaise) for about three weeks ago (on an unspecified date in 2022) after her second COVID vaccine flu-like (Influenza like illness) ,and was weak (Asthenia). The patient mentioned her pelvis hurt sometimes when she walked, describe it as a knife (Pelvic pain), and mentioned left leg (Pain in extremity) and hip pain (Arthralgia) the patient mentioned this had been for quite a while and was not new. The patient mentioned she continued every two weeks of eculizumab infusions and the next infusion was tomorrow 22Sep2022. The patient reported that a day or two before her infusion she was tired (refer to case #), also mention her stomach bothers her with infusions and that her abdominal muscles were coming apart (Abdominal discomfort). The patient mention she had a blood test (not sure of what it was for or the results), post a recent eculizumab infusion (values, units, and reference range was not reported). She stated she was not sure if she was getting worse, she felt as though her legs were going to sleep (Limb discomfort) and that the muscles were giving away more in her throat (Oropharyngeal discomfort). She was unable to sing anymore (refer to case #), and mentioned in the mornings when she tried to swallow the scrambled eggs, sometimes they went in the wrong place (Dysphagia) and she started coughing (Cough) and stated she was coughing all the time, especially at night, dry cough. The patient mentioned she had a cardiologist follow-up in a couple of weeks. Staff redirected the patient back to a neurologist to report on the current status, as the patient reported her legs had gotten worse since the provider last saw her (Condition aggravated). The patient had some stress in her life (Stress) (mentions her spouse had a stroke and has some memory loss) and she was dealing with this and mentioned intent to follow up with provider and reported that she received her eculizumab infusion today (as of 22Sep2022) and got light headed (Dizziness), very tired (Fatigue) and her eyelids would not stay up and she were very heavy and took a nap (Eyelid ptosis) and felt like she was hallucinated in her sleep (Hallucination). She was sensitive to medication and had a UTI (Urinary tract infection) in the past and no further details obtained (this was mentioned in the context of discussion about potential switch to ravulizumab and UTI as a side effect). She was still in the morning and had some numbness in her left hip (Hypoaesthesia) and she mentioned on the phone when staff called throat dry (Dry throat) post eculizumab infusion.   The event of hallucination was assessed as medically significant by Alexion on as this event is included in the important medical events list. No action was taken with eculizumab in response to the events. Action taken with the COVID-19 vaccine in response to the events was not reported. Corrective treatment of the events was not reported. The outcome of the events was not reported. This case is cross-referenced to the following case. Additional information has been requested. The reporter's causality between the events, eculizumab therapy and COVID-19 vaccine was not reported.  Company comment: This is a serious, not medically confirmed, solicited report of event hallucinations (MS). Non-serious events malaise, pelvic pain, abdominal discomfort, limb discomfort, condition aggravated, oropharyngeal discomfort, dysphagia, cough, influenza like illness, asthenia, pain in extremity, stress, fatigue, dizziness, hypoaesthesia, dry throat, urinary tract infection, eyelid ptosis, and arthralgia. The events cough, influenza like illness, asthenia, pain in extremity, fatigue, dizziness, urinary tract infection and arthralgia are listed while the rest of the events are unlisted in the eculizumab CCDS. Listedness is unknown for COVID-19 vaccine. The event influenza like illness, asthenia and malaise could be due to COVID-19 vaccine; hence considered as related to COVID-19 vaccine and not related to eculizumab. The company considers the events abdominal discomfort, fatigue, dizziness, and eyelid ptosis as related to eculizumab due to likely temporality; hence considered as not related to COVID-19 vaccine. Relevant medical information is limited, and the report does not include the cause and/or circumstances that led to the events pelvic pain, limb discomfort, condition aggravated, oropharyngeal discomfort, dysphagia, cough, pain in extremity, hypoaesthesia and arthralgia, underlying condition myasthenia gravis is a confounding factor for the events. The event stress is due to the stroke the patient's spouse has. The event of hallucination is likely due to the event of stress. There is a lack of relevant information including past medical history, diagnosis, and supportive investigations for the events urinary tract infection and dry throat. Hence the company considered these events as not related to eculizumab and COVID-19 vaccine.  No follow-up attempts are needed; information about the batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of  subject product, BNT162B2 vaccine, cannot be excluded for the hallucination and the other reported events, based on temporal relationship. There is  limited information provided in this report. This consumer report lacks confirmation from a healthcare professional. Confirmation from the patient's treating physician would be helpful.   This case will be reassessed upon receipt of follow-up information.   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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.