Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Pyrexia
Clinical narrative: Was hospitalized for 4 days RIT urinating blood; Loss of hair; Cramp in her rib; Had fever; musculoskeletal chest pain; Had Covid infection twice during the pandemic; Had Covid infection twice during the pandemic;   This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): A202302080 (Company).  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; ravulizumab (ULTOMIRIS [RAVULIZUMAB]), since 2016 (Batch/Lot number: unknown) at 300 mg for paroxysmal nocturnal haemoglobinuria. The patient's relevant medical history included: "leukemia" (ongoing); "Paroxysmal nocturnal haemaglobinuria" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Had Covid infection twice during the pandemic"; HAEMATURIA (hospitalization, medically significant), outcome "unknown", described as "Was hospitalized for 4 days RIT urinating blood"; ALOPECIA (non-serious), outcome "unknown", described as "Loss of hair"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "Cramp in her rib"; PYREXIA (non-serious), outcome "unknown", described as "Had fever"; MUSCULOSKELETAL CHEST PAIN (non-serious), outcome "unknown". The patient was hospitalized for haematuria (hospitalization duration: 4 day(s)). Therapeutic measures were taken as a result of haematuria.  The reporter's assessment of the causal relationship of "had covid infection twice during the pandemic", "was hospitalized for 4 days rit urinating blood", "loss of hair", "cramp in her rib" and "had fever" with the suspect product(s) BNT162b2 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. The reporter considered "musculoskeletal chest pain" related to BNT162b2.  Clinical course: The patient was enrolled  in study for Ultomiris. allergies were not reported. On an unspecified date in 2016, the patient initiated treatment with Ultomiris (ravulizumab) 300mg (frequency was not reported) (Off label use) for the treatment of paroxysmal nocturnal haemoglobinuria (PNH). The most recent dose administered before the onset of the event was not reported. The batch/lot number was unknown, and the expiry date was not reported. In 2016, the patient thought that the MD was treating her for leukemia and not for PNH and only had her on 300 mg and was hospitalized, On 11Feb2023, the patient had a blood transfusion this week (Transfusion). On an unspecified date, the patient had covid infection twice during the pandemic (Suspected Covid-19), had fever (Pyrexia) and loss of hair (Alopecia) was prescribed Paxiovid, due to which the patient had a bad reaction that brought systems back and she could barely breath (Dyspnoea) and walk (Gait Disturbance). In 2020, the patient had a death in family and lost insurance due to which she gave up and went off the treatment. The patient was hospitalized for four days for urinating blood (Haematuria). The patient reported that she cannot have Covid vaccinations as it caused her to have a blood transfusion and a cramp in her rib (Muscle Spasms). The event blood transfusion was assessed as serious (medically significant) by (Name withheld). Action taken with ravulizumab, Covid-19 vaccine and Paxlovid in response to the event was not reported. Corrective treatment for the event suspected COVID-19 included Paxlovid and not reported for the remaining events. The outcome of the events was not reported.  The reporter causality between the events and ravulizumab therapy was not reported. The causality between the events musculoskeletal chest pain and transfusion was related to Covid-19 vaccine and causality between Covid-19 vaccine and remaining events was not reported. The causality between the events dyspnoea was related to Paxlovid and not reported for remaining events.  Company comment: This is a serious, solicited, not medically confirmed report of event hematuria (H) and transfusion (MS);  non-serious, not medically confirmed events of suspected Covid-19, alopecia, dyspnoea, gait disturbance, muscle cramps, off label  use and pyrexia. The events of muscle cramps and pyrexia are listed while the rest of the events are unlisted. The listedness of the events with Covid-19 vaccine is unknown.  The company considers all the events as not related to ravulizumab. Heamturia occurred following drug interruption and event was due to underlying PNH. The events transfusion and muscle cramps occurred following Covid-19 vaccination, hence related to Covid-19 vaccine and not related to ravulizumab; the rest of the events are not related to Covid-19 vaccine given the lack of temporality. There is a lack of relevant details of events alopecia, dyspnoea, gait disturbance and pyrexia including precise therapy details and duration, concurrent conditions, confirmation of diagnosis. PNH could be a confounder for dyspnoea. The event of suspected Covid-19 is attributed to the ongoing viral pandemic. The event off label use is non-clinical event  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report, a possible causal relationship between the events haematuria, drug ineffective, COVID-19, alopecia, muscle spasms, pyrexia and musculoskeletal chest pain and suspect product bnt162b2 cannot be completely 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.