Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Fall, Feeling abnormal, Loss of consciousness, Oral discomfort
Clinical narrative: brain bleed from the fall, was told it was an A2 brain bleed; passed out face first onto the tile floor,When she came to there was blood everywhere. She then passed out again; felt weird; Next thing she remembers is having her lip sewn up; had a slight brain bleed from the fall; This spontaneous case was reported by a patient and describes the occurrence of CEREBRAL HAEMORRHAGE (brain bleed from the fall, was told it was an A2 brain bleed), LOSS OF CONSCIOUSNESS (passed out face first onto the tile floor,When she came to there was blood everywhere. She then passed out again), FEELING ABNORMAL (felt weird), ORAL DISCOMFORT (Next thing she remembers is having her lip sewn up) and FALL (had a slight brain bleed from the fall) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 010A21A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Lactose intolerance (allergic to lactose and she can have it if she takes something beforehand).   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, the patient experienced CEREBRAL HAEMORRHAGE (brain bleed from the fall, was told it was an A2 brain bleed) (seriousness criteria hospitalization and medically significant), LOSS OF CONSCIOUSNESS (passed out face first onto the tile floor,When she came to there was blood everywhere. She then passed out again) (seriousness criteria hospitalization and medically significant), FEELING ABNORMAL (felt weird) (seriousness criterion hospitalization), ORAL DISCOMFORT (Next thing she remembers is having her lip sewn up) (seriousness criterion hospitalization) and FALL (had a slight brain bleed from the fall) (seriousness criterion hospitalization). The patient was hospitalized from 07-Dec-2021 to 08-Dec-2021 due to CEREBRAL HAEMORRHAGE, FALL, FEELING ABNORMAL, LOSS OF CONSCIOUSNESS and ORAL DISCOMFORT. At the time of the report, CEREBRAL HAEMORRHAGE (brain bleed from the fall, was told it was an A2 brain bleed), LOSS OF CONSCIOUSNESS (passed out face first onto the tile floor,When she came to there was blood everywhere. She then passed out again), FEELING ABNORMAL (felt weird), ORAL DISCOMFORT (Next thing she remembers is having her lip sewn up) and FALL (had a slight brain bleed from the fall) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  On 07-Dec-2021 after breakfast while cleaning up in kitchen patient told her husband she felt weird, then passed out face first onto the tile floor. When patient came to there was blood everywhere. Patient then passed out again. Patients husband then called for help and & ambulance took her to the emergency room. Next thing she remembers was having her lip sewn up. She spent 2 days in the hospital and had a slight brain bleed from the fall. She was told it was an A2 brain bleed.  No treatment information was reported by the reporter.  Company Comment: This spontaneous case reported by a 79 year old female patient, with no relevant medical history reported, who experienced the unexpected, serious ( Hospitalization , Medically significant) AESI events of Loss of consciousness and Cerebral haemorrhage along with the unexpected, serious (Hospitalization) events of feeling abnormal, Fall and Oral disorder, 01 day after receiving the 3 dose of Modena mRNA1273 vaccine in the covid 19 vaccination series. Patient previously received 2 primary doses with Moderna vaccines with the last dose taken about 09 months prior to the 3 dose. It was reported that the patient, after breakfast while cleaning up in kitchen, felt weird, then passed out with face first onto the tile floor with blood everywhere. Patient then passed out again and was taken to the emergency room where she remembered that her lip was sewn up. She spent 2 days in the hospital and had a slight brain bleed from the fall. She was told it was an A2 brain bleed. Details of confirmed diagnosis, risk factors, co-morbidities, labs and diagnostics, concomitant medications and treatment were not provided. Age of the subject could be a confounder to the event of fall which could have precipitated the Cerebral haemorrhage.The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case reported by a 79 year old female patient, with no relevant medical history reported, who experienced the unexpected, serious ( Hospitalization , Medically significant) AESI events of Loss of consciousness and Cerebral haemorrhage along with the unexpected, serious (Hospitalization) events of feeling abnormal, Fall and Oral disorder, 01 day after receiving the 3 dose of Modena mRNA1273 vaccine in the covid 19 vaccination series. Patient previously received 2 primary doses with Moderna vaccines with the last dose taken about 09 months prior to the 3 dose. It was reported that the patient, after breakfast while cleaning up in kitchen, felt weird, then passed out with face first onto the tile floor with blood everywhere. Patient then passed out again and was taken to the emergency room where she remembered that her lip was sewn up. She spent 2 days in the hospital and had a slight brain bleed from the fall. She was told it was an A2 brain bleed. Details of confirmed diagnosis, risk factors, co-morbidities, labs and diagnostics, concomitant medications and treatment were not provided. Age of the subject could be a confounder to the event of fall which could have precipitated the Cerebral Haemorrhage. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.