Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Factor V Leiden mutation, Haemoglobin, Heart rate, Hypertension, International normalised ratio
Clinical narrative: Cerebral haemorrhage/ left frontal lobe intracerebral hemorrhage; Cerebral venous sinus thrombosis; Mental status changes/ altered mental state; Seizure; Subarachnoid haemorrhage; Superior sagittal sinus thrombosis; Post-ictal state accompanied by tachypnea; Post-ictal state accompanied by tachypnea; Hypertensive; For the first few days, he had local adverse effects, including soreness on the site of injection and arm pain.; This literature-non-study case was reported in a literature article and describes the occurrence of CEREBRAL HAEMORRHAGE (Cerebral haemorrhage/ left frontal lobe intracerebral hemorrhage), CEREBRAL VENOUS SINUS THROMBOSIS (Cerebral venous sinus thrombosis), MENTAL STATUS CHANGES (Mental status changes/ altered mental state), SEIZURE (Seizure), SUBARACHNOID HAEMORRHAGE (Subarachnoid haemorrhage), SUPERIOR SAGITTAL SINUS THROMBOSIS (Superior sagittal sinus thrombosis), POSTICTAL STATE (Post-ictal state accompanied by tachypnea), TACHYPNOEA (Post-ictal state accompanied by tachypnea) and HYPERTENSION (Hypertensive) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE: Central venous sinus thrombosis with subarachnoid hemorrhage following an mRNA COVID-19 vaccination: are these reports merely co-incidental?    The patient's past medical history included Crush injury (open fracture to left thumb). Concurrent medical conditions included Diabetes mellitus. Concomitant products included CEFALEXIN (KEFLEXIN), DOCUSATE SODIUM (COLACE), IBUPROFEN, METFORMIN and GABAPENTIN for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced CEREBRAL HAEMORRHAGE (Cerebral haemorrhage/ left frontal lobe intracerebral hemorrhage) (seriousness criteria hospitalization, disability, medically significant and life threatening). 09-May-2021, the patient experienced CEREBRAL VENOUS SINUS THROMBOSIS (Cerebral venous sinus thrombosis) (seriousness criteria hospitalization, disability, medically significant and life threatening), MENTAL STATUS CHANGES (Mental status changes/ altered mental state) (seriousness criteria hospitalization, disability and life threatening), SEIZURE (Seizure) (seriousness criteria hospitalization, disability, medically significant and life threatening), SUBARACHNOID HAEMORRHAGE (Subarachnoid haemorrhage) (seriousness criteria hospitalization, disability, medically significant and life threatening) and SUPERIOR SAGITTAL SINUS THROMBOSIS (Superior sagittal sinus thrombosis) (seriousness criteria hospitalization, disability, medically significant and life threatening). In May 2021, the patient experienced POSTICTAL STATE (Post-ictal state accompanied by tachypnea) (seriousness criterion medically significant), TACHYPNOEA (Post-ictal state accompanied by tachypnea) (seriousness criterion medically significant) and HYPERTENSION (Hypertensive) (seriousness criterion medically significant). In 2021, the patient experienced VACCINATION SITE PAIN (For the first few days, he had local adverse effects, including soreness on the site of injection and arm pain.). The patient was treated with LORAZEPAM (intravenous) in May 2021 for Adverse event, at a dose of 4 milligram; ESMOLOL (intravenous) in May 2021 for Intracerebral hemorrhage and Subarachnoid hemorrhage, at a dose of 50 mcg/kg/min; NIMODIPINE in May 2021 for Intracerebral hemorrhage and Subarachnoid hemorrhage, at a dose of 60 milligram every four hours; LEVETIRACETAM in May 2021 for Seizure prophylaxis, at a dose of 500 milligram twice a day; HEPARIN (intravenous) from 09-May-2021 to 2021 for Cerebral venous sinus thrombosis, at an unspecified dose and frequency; WARFARIN SODIUM (COUMADIN) on 09-May-2021 for Cerebral venous sinus thrombosis, at an unspecified dose and frequency; Surgery (Extubation) for Cerebral haemorrhage and Surgery (Endotracheal intubation) for Cerebral venous sinus thrombosis. At the time of the report, CEREBRAL HAEMORRHAGE (Cerebral haemorrhage/ left frontal lobe intracerebral hemorrhage), CEREBRAL VENOUS SINUS THROMBOSIS (Cerebral venous sinus thrombosis), MENTAL STATUS CHANGES (Mental status changes/ altered mental state), SEIZURE (Seizure), SUBARACHNOID HAEMORRHAGE (Subarachnoid haemorrhage), SUPERIOR SAGITTAL SINUS THROMBOSIS (Superior sagittal sinus thrombosis), POSTICTAL STATE (Post-ictal state accompanied by tachypnea), TACHYPNOEA (Post-ictal state accompanied by tachypnea), HYPERTENSION (Hypertensive) and VACCINATION SITE PAIN (For the first few days, he had local adverse effects, including soreness on the site of injection and arm pain.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2021, Angiogram cerebral: abnormal (abnormal) revealed an absence of opacification in the anterior 1/2 of the superior sagittal sinus, consistent with acute venous sinus thrombosis with collateral drainage through the cavernous sinus. On 09-May-2021, Blood pressure measurement: 147/48 mmhg (High) 147/48 mmHg (hypertensive) and 198/98 mmhg (High) 198/98 mmHg (on arrival to the emergency department). On 09-May-2021, Magnetic resonance imaging head: abnormal (abnormal) revealed intracranial hemorrhage within the anterior left frontal lobe without a definitive underlying enhancing mass, bifrontal subarachnoid hemorrhage, and anterior superior sagittal sinus thrombosis (when the patient was in ICU).. In May 2021, Activated partial thromboplastin time: 30.5 sec 30.5 sec (23.1-34.3 sec). In May 2021, Angiotensin converting enzyme: 32 (9-67 u/l) 32 (9-67 U/L). In May 2021, Antineutrophil cytoplasmic antibody: <1: 20 (<1: 20) <1: 20 (<1: 20), 0 (0-19 au/ml) 0 (0-19 AU/mL) and 0 (0-19 au/ml) 0 (0-19 AU/mL). In May 2021, Antinuclear antibody: <1: 80 (<1: 80) <1: 80 (<1: 80) and negative (Negative) Negative. In May 2021, Blood bicarbonate: 7.1 7.1 (unit not reported). In May 2021, Blood calcium: 10.2 10.2. In May 2021, Blood chloride: 99 99. In May 2021, Blood creatinine: 134.4 umol/l (1.52 mg/dl) 134.4 umol/L (1.52 mg/dL). In May 2021, Blood gases: abnormal (abnormal) revealed a pH of 7.32, PO2 168, PCO2 34, HCO3 18, with lactic acid of 28 mmol/L (on arrival to the ED). In May 2021, Blood glucose: 237 mg/dl 237 mg/dL and 19.25 mmol/l (347 mg/dl) 19.25 mmol/L (347 mg/dL). In May 2021, Blood lactic acid: 28.3 mmol/l 28.3 mmol/L. In May 2021, Blood magnesium: 2.9 2.9 (unit not reported). In May 2021, Blood potassium: 3.9 3.9. In May 2021, Blood sodium: 142 142 (unit not reported). In May 2021, Blood urea: 8.93 mmol/l (25 mg/dl) 8.93 mmol/L (25 mg/dL). In May 2021, Cardiolipin antibody: negative (Negative) Negative. In May 2021, Chest X-ray: normal (normal) Normal (On arrival to the ED). In May 2021, Coma scale: 3 3 and 6/15 GCS on arrival to the ED had improved to 6/15.. In May 2021, Computerised tomogram: ich with sah (abnormal) revealed a left frontal lobe intracerebral hemorrhage (ICH) along with subarachnoid hemorrhage (SAH) and normal (normal) which ruled out any occult malignancies or other thrombosis.. In May 2021, Electrocardiogram: not reveal any acute st-t changes (normal) EKG on arrival did not reveal any acute ST-T changes. (On arrival to the ED) and normal (normal) showed a normal ejection fraction, no septal defects, and no intracardiac clots or valvular pathologies.. In May 2021, Factor II mutation: not detected (normal) Not detected. In May 2021, Factor V Leiden mutation: negative (Negative) Negative. In May 2021, Haemoglobin: 15.7 g/dl 15.7 g/dL. In May 2021, Heart rate: 140 bpm 140 bpm and 157 bpm 157 bpm. In May 2021, International normalised ratio: 1.2 1.2. In May 2021, Lipoprotein (a): 32 (=29 mg/dl) 32 (=29 mg/dL). In May 2021, Oxygen saturation: 86% 86% on room air and 96% improved with jaw thrust and a nasal trumpet to 96%. In May 2021, Platelet count: 255×10e3/ul 255×10E3/uL. In May 2021, Prothrombin time: 14.8 sec 14.8 sec (11.7-14.2 sec). In May 2021, Respiratory rate: 40 breaths per minute 40 breaths per minute and 42 breaths per minute 42 breaths per minute. In May 2021, Rheumatoid factor: <12 iu/ml <12 IU/mL (<14). In May 2021, SARS-CoV-2 test: negative (Negative) Negative. In May 2021, Troponin: <0.02 <0.02. In May 2021, White blood cell count: 17.9×10e3/ul 17.9×10E3/uL.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered CEREBRAL HAEMORRHAGE (Cerebral haemorrhage/ left frontal lobe intracerebral hemorrhage), CEREBRAL VENOUS SINUS THROMBOSIS (Cerebral venous sinus thrombosis), MENTAL STATUS CHANGES (Mental status changes/ altered mental state), SEIZURE (Seizure), SUBARACHNOID HAEMORRHAGE (Subarachnoid haemorrhage), SUPERIOR SAGITTAL SINUS THROMBOSIS (Superior sagittal sinus thrombosis), POSTICTAL STATE (Post-ictal state accompanied by tachypnea), TACHYPNOEA (Post-ictal state accompanied by tachypnea), HYPERTENSION (Hypertensive) and VACCINATION SITE PAIN (For the first few days, he had local adverse effects, including soreness on the site of injection and arm pain.) to be possibly related.    The patient had no prior history of a seizure disorder or head trauma.  Seven days after the day of vaccination with second dose, the patient started having headaches and neck pain that did not relieve with over-the-counter analgesics.  On the day of presentation (day 8 after receiving the vaccine), he had worsening headache, with a tonic-clonic seizure witnessed by his partner. This was followed by another episode on arrival of the emergency medical services (EMS).  The patient was then transferred to the emergency department where the patient was immediately intubated for airway protection and the lab tests there revealed left frontal lobe intracerebral hemorrhage (ICH) along with subarachnoid hemorrhage (SAH).  The patient was transferred to the Intensive Care Unit (ICU) under the care of the neurocritical care team for management of ICH with SAH where the MRI revealed intracranial hemorrhage within the anterior left frontal lobe without a definitive underlying enhancing mass, bifrontal subarachnoid hemorrhage, and anterior superior sagittal sinus thrombosis.  The patient was successfully treated and discharged with no neurological sequelae, with a follow-up in the vascular neurology clinic in 4 weeks with no recurrence.  Company Comment: This case concerns a 45-year-old male patient with no relevant medical history, who experienced the unexpected events of cerebral haemorrhage, cerebral venous sinus thrombosis, mental status changes, seizure, subarachnoid haemorrhage, superior sagittal sinus thrombosis, postictal state, tachypnoea, and hypertension. The events occurred  8 days after the receipt of the 2nd dose of Spikevax. The rechallenge was unknown since there's no information about the first dose. The benefit-risk relationship of Spikevax in not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Significant follow-up was received by safety 13-Sep-2021 included an Email. Report type, reporter information were updated. Events and lab data were added. On 15-Sep-2021: Follow up received by safety 16-Sep-2021 included an Email with FTA received from team and does not contain any new information.; Sender's Comments: This case concerns a 45-year-old male patient with no relevant medical history, who experienced the unexpected events of cerebral haemorrhage, cerebral venous sinus thrombosis, mental status changes, seizure, subarachnoid haemorrhage, superior sagittal sinus thrombosis, postictal state, tachypnoea, and hypertension. The events occurred  8 days after the receipt of the 2nd dose of Spikevax. The rechallenge was unknown since there's no information about the first dose. The benefit-risk relationship of Spikevax in not affected by this report.