Sex: U
Vaccine: COVID19, UNK
Symptoms: Abdominal pain, Sensory loss, Thrombosis, Transient ischaemic attack
Clinical narrative: Abdominal pain; In the hospital they felt the patient had clotting/ a lot of clots in the abdomen; Transient ischaemic attack; Lost sensation on his left side; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Transient ischaemic attack), SENSORY LOSS (Lost sensation on his left side), ABDOMINAL PAIN (Abdominal pain) and THROMBOSIS (In the hospital they felt the patient had clotting/ a lot of clots in the abdomen) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.    Co-suspect product included non-company product RAVULIZUMAB (ULTOMIRIS [RAVULIZUMAB]) solution for infusion for Paroxysmal nocturnal haemoglobinuria.    Previously administered products included for Paroxysmal nocturnal haemoglobinuria: Soliris from July 2011 to May 2019 and Soliris from July 2011 to May 2019. Past adverse reactions to the above products included Abdominal pain with Soliris; and Clot blood with Soliris. Concurrent medical conditions included Paroxysmal nocturnal haemoglobinuria (hospitalized in 2019) since 2019.   On 13-May-2019, the patient started RAVULIZUMAB (ULTOMIRIS [RAVULIZUMAB]) (unknown route) at an unspecified dose. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Transient ischaemic attack) (seriousness criteria hospitalization and medically significant) and SENSORY LOSS (Lost sensation on his left side) (seriousness criterion hospitalization). In August 2022, the patient experienced ABDOMINAL PAIN (Abdominal pain) (seriousness criterion hospitalization) and THROMBOSIS (In the hospital they felt the patient had clotting/ a lot of clots in the abdomen) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 15-Aug-2022 due to ABDOMINAL PAIN and THROMBOSIS. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (Transient ischaemic attack), SENSORY LOSS (Lost sensation on his left side), ABDOMINAL PAIN (Abdominal pain) and THROMBOSIS (In the hospital they felt the patient had clotting/ a lot of clots in the abdomen) outcome was unknown.            It was reported that sensory loss was a symptom of transient ischemic attack. For the event transient ischemic attack, there was a lack of relevant event details including diagnostic tests, past medical history and concomitant medications. The events of abdominal pain and thrombosis are more likely due to underlying paroxysmal nocturnal haemoglobinuria.  No treatment drug was provided by reporter.  Company Comment: This spontaneous case concerns a patient (age and gender not specified) with a medical history of paroxysmal nocturnal haemoglobinuria with Abdominal pain and blood clots while on Soliris, who experienced the unexpected serious (hospitalization and medically significant) AESI of Transient ischaemic attack and Thrombosis and unexpected serious (hospitalization) events of Sensory loss and Abdominal pain which occurred unspecified days after the second dose of mRNA-1273 vaccine. On an unspecified date in Apr-2021 after receiving the second dose of the vaccine and patient experienced a transient ischaemic attack and was hospitalized under stroke protocol. The patient lost sensation on his left side. On an unspecified date in Aug-2022, the patient experienced abdominal pain and went to the hospital on 15-Aug-2022. In the hospital, they felt the patient had clotting. No further information on clinical course, investigations and treatment received was available in the report. The outcome of the events was reported as unknown. Patients mentioned medical history could be confounding for the events Thrombosis and Abdominal pain. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient (age and gender not specified) with a medical history of paroxysmal nocturnal haemoglobinuria with Abdominal pain and blood clots while on Soliris, who experienced the unexpected serious (hospitalization and medically significant) AESI of Transient ischaemic attack and Thrombosis and unexpected serious (hospitalization) events of Sensory loss and Abdominal pain which occurred unspecified days after the second dose of mRNA-1273 vaccine. On an unspecified date in Apr-2021 after receiving the second dose of the vaccine and patient experienced a transient ischaemic attack and was hospitalized under stroke protocol. The patient lost sensation on his left side. On an unspecified date in Aug-2022, the patient experienced abdominal pain and went to the hospital on 15-Aug-2022. In the hospital, they felt the patient had clotting. No further information on clinical course, investigations and treatment received was available in the report. The outcome of the events was reported as unknown. Patients mentioned medical history could be confounding for the events Thrombosis and Abdominal pain. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.