Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis, Unresponsive to stimuli, Vomiting, Weight decreased
Clinical narrative: Intraventricular hemorrhage with hydrocephalus; Cerebellar Intracerebral Hemorrhage; Intraventricular hemorrhage with hydrocephalus; Brain stem compression/ cerebellar intracerebral hemorrhage with brain stem compression; Stroke; Bleeding in the cerebellum; Clots; Fell on the floor,could not get up/dropped flat on the living room floor; Lost weight; Through up,vomited; Unresponsive,mute; Very high blood pressure; Cannot stand,are disable.; Confused; Cannot walk/cannot walk yet and cannot stand; Altered mental status; Stomach aches/ stomach ached off and on; Headache/ headaches 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), 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) (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), UNRESPONSIVE TO STIMULI (Unresponsive,mute), 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), 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), UNRESPONSIVE TO STIMULI (Unresponsive,mute), 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 (abnormal) 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 medical history of bone spur and concurrent condition of Blood pressure high, who experienced the serious unexpected events of Cerebellar Intracerebral Hemorrhage, Stroke,Bleeding in the cerebellum, Thrombosis, Intraventricular hemorrhage(seriousness criteria hospitalization and medically significant). On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine). Approximately 5 weeks after receiving the booster the caller stated her husband dropped flat on the living room floor. Was later placed in ICU. 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.; Sender's Comments: This is a spontaneous case concerning a  69-year-old male patient with medical history of bone spur and concurrent condition of Blood pressure high, who experienced the serious unexpected events of Cerebellar Intracerebral Hemorrhage, Stroke,Bleeding in the cerebellum, Thrombosis, Intraventricular hemorrhage(seriousness criteria hospitalization and medically significant). On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine). Approximately 5 weeks after receiving the booster the caller stated her husband dropped flat on the living room floor. Was later placed in ICU. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.