Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Brain compression, Cerebellar haemorrhage, Cerebral haemorrhage, Cerebrovascular accident
Clinical narrative: Cerebellar Intracerebral Hemorrhage; Intraventricular hemorrhage with hydrocephalus; Brain stem compression/ cerebellar intracerebral hemorrhage with brain stem compression/Unresponsive to stimuli; Stroke; Bleeding in the cerebellum; Clots; Intraventricular hemorrhage with hydrocephalus; Fell on the floor,could not get up/dropped flat on the living room floor; Very high blood pressure; Cannot stand,are disable.; Confused; Cannot walk/cannot walk yet and cannot stand; Altered mental status; Lost weight; Through up,vomited; Headache/ headaches off and on; Stomach aches/ stomach ached off and on; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE (Cerebellar Intracerebral Hemorrhage), HYDROCEPHALUS (Intraventricular hemorrhage with hydrocephalus), BRAIN COMPRESSION (Brain stem compression/ cerebellar intracerebral hemorrhage with brain stem compression/Unresponsive to stimuli), CEREBROVASCULAR ACCIDENT (Stroke), CEREBELLAR HAEMORRHAGE (Bleeding in the cerebellum), THROMBOSIS (Clots), FALL (Fell on the floor,could not get up/dropped flat on the living room floor) and INTRAVENTRICULAR HAEMORRHAGE (Intraventricular hemorrhage with hydrocephalus) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0241420A, 040A71A and 014F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bone spur. Concurrent medical conditions included Blood pressure high.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced FALL (Fell on the floor,could not get up/dropped flat on the living room floor) (seriousness criterion hospitalization). On 03-Nov-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach aches/ stomach ached off and on) and HEADACHE (Headache/ headaches off and on). On an unknown date, the patient experienced CEREBRAL HAEMORRHAGE (Cerebellar Intracerebral Hemorrhage) (seriousness criteria hospitalization and medically significant), HYDROCEPHALUS (Intraventricular hemorrhage with hydrocephalus) (seriousness criteria hospitalization and medically significant), BRAIN COMPRESSION (Brain stem compression/ cerebellar intracerebral hemorrhage with brain stem compression/Unresponsive to stimuli) (seriousness criteria hospitalization and medically significant), CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant), CEREBELLAR HAEMORRHAGE (Bleeding in the cerebellum) (seriousness criteria hospitalization and medically significant), THROMBOSIS (Clots) (seriousness criteria hospitalization and medically significant), INTRAVENTRICULAR HAEMORRHAGE (Intraventricular hemorrhage with hydrocephalus) (seriousness criteria hospitalization and medically significant), HYPERTENSION (Very high blood pressure), MOBILITY DECREASED (Cannot stand,are disable.), CONFUSIONAL STATE (Confused), GAIT INABILITY (Cannot walk/cannot walk yet and cannot stand), MENTAL STATUS CHANGES (Altered mental status), WEIGHT DECREASED (Lost weight) and VOMITING (Through up,vomited). At the time of the report, CEREBRAL HAEMORRHAGE (Cerebellar Intracerebral Hemorrhage), HYDROCEPHALUS (Intraventricular hemorrhage with hydrocephalus), BRAIN COMPRESSION (Brain stem compression/ cerebellar intracerebral hemorrhage with brain stem compression/Unresponsive to stimuli), CEREBROVASCULAR ACCIDENT (Stroke), CEREBELLAR HAEMORRHAGE (Bleeding in the cerebellum), THROMBOSIS (Clots), FALL (Fell on the floor,could not get up/dropped flat on the living room floor), INTRAVENTRICULAR HAEMORRHAGE (Intraventricular hemorrhage with hydrocephalus), HYPERTENSION (Very high blood pressure), MOBILITY DECREASED (Cannot stand,are disable.), CONFUSIONAL STATE (Confused), GAIT INABILITY (Cannot walk/cannot walk yet and cannot stand), MENTAL STATUS CHANGES (Altered mental status), ABDOMINAL PAIN UPPER (Stomach aches/ stomach ached off and on), WEIGHT DECREASED (Lost weight), HEADACHE (Headache/ headaches off and on) and VOMITING (Through up,vomited) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: showed a stroke.         Reporter stated that patient had stomach and headaches on and off after receiving the booster dose, patient also dropped flat on the living room floor. The caller reported after her husband received the booster dose, his stomach ached off and on and he experienced headaches off and on. Approximately 5 weeks after receiving the booster the caller stated her husband dropped flat on the living room floor. Patient was placed in the ICU for few weeks and then in the neurology section of the hospital. Patient used to have allergies and no longer had them. It was reported that patient had to have surgery to stop the bleeding. Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company comment: This is a spontaneous case concerning a 69-year-old male patient with concurrent condition of Blood pressure high, who experienced the serious (hospitalization and medically significant) unexpected events of Cerebral haemorrhage, Hydrocephalus, Brain compression, Cerebrovascular accident, Cerebellar haemorrhage, Thrombosis, Fall and Intraventricular haemorrhage, among other non-serious events. The events occurred on an unknown date, 5 weeks after the third and booster dose of mRNA-1273 (Moderna COVID-19 Vaccine). The patient´s wife stated her husband dropped flat on the living room floor.  The patient was hospitalized in ICU. A CT scan showed a stroke. It was reported that patient had to have surgery to stop the bleeding. Clinical course, other supportive diagnostic procedures, and treatment were not provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2022: Follow up received on 5-JAN-2022 included patient updated information, historical condition, additional event. On 05-Jan-2022: Upon internal review on 03-Aug-2023, Significant amendment was performed to Subsume event Unresponsive to stimuli under Event Brain stem compression/ cerebellar intracerebral hemorrhage with brain stem compression.