Received Sep 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 2 | 30L20A | — |
on a blood pressure medication; affect his eyesight/ problem with his peripheral vision; having problems remembering things; had a brain bleed; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE (had a brain bleed) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 30L20A and 022M20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Open heart surgery (mitral valve reconstruction) on 17-Mar-2020. Concurrent medical conditions included Diabetic. Concomitant products included Insulin porcine (Insulin) for Diabetes. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2023, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CEREBRAL HAEMORRHAGE (had a brain bleed) (seriousness criterion medically significant). On an unknown date, the patient experienced BLOOD PRESSURE ABNORMAL (on a blood pressure medication), VISUAL FIELD DEFECT (affect his eyesight/ problem with his peripheral vision) and MEMORY IMPAIRMENT (having problems remembering things). The patient was treated with Surgery for Cerebral haemorrhage. At the time of the report, CEREBRAL HAEMORRHAGE (had a brain bleed) was resolving, BLOOD PRESSURE ABNORMAL (on a blood pressure medication) outcome was unknown and VISUAL FIELD DEFECT (affect his eyesight/ problem with his peripheral vision) and MEMORY IMPAIRMENT (having problems remembering things) had not resolved. Concomitant medication also included blood pressure medication. Patient did not receive any other vaccines. On 02-Oct-2023, the patient had brain bleeding and had to do emergency surgery. The patient was saved but it did affect his eyesight. He could not drive for 6 months. His neurosurgeon said there was no reason why this should have happened. The patient did not have any high blood pressure, and he did not think the diabetes caused this either. The brain bleed had really changed his life- he was very active, played golf and all that. Ever since he went into emergency surgery on 02-Oct-2023, he was doing better. The current symptoms he had were the problem with his peripheral vision and that he was having problems remembering things. The patient can drive again as well. He was currently on blood pressure medication. The blood pressure medication was a very low dose as they did not want this to happen to him again. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-788915 (E2B Linked Report).; Reporter's Comments: Causality for Cerebral haemorrhage, Visual field defect and Memory impairment was assessed as not related, due to long latency. Underlying diabetes could be a confounding factor for the events. The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-788915:Wife's case
Diabetic
Medical History/Concurrent Conditions: Open heart surgery (mitral valve reconstruction)
Insulin