Sex: F
Vaccine: COVID19
Symptoms: Blood creatine, Computerised tomogram, Haematocrit, Haemoglobin, Traumatic intracranial haemorrhage
Clinical narrative: Traumatic Intracranial Hemorrhage; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 66-year-old female patient received BNT162b2 (BNT162B2), on 08Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pure Hypercholesterolemia", start date: 14Jan2019 (ongoing); "Obesity", start date: 16Aug2015 (ongoing); "Migraine", start date: 05May2015 (ongoing); "major depressive disorder" (unspecified if ongoing). Concomitant medication(s) included: ABILIFY oral taken for major depression, start date: 17Sep2015 (ongoing); WELLBUTRIN oral taken for major depression, start date: 05May2015 (ongoing); PRAVACHOL oral taken for type iia hyperlipidaemia, start date: 14Jan2019 (ongoing); TOPAMAX taken for migraine, start date: 12Mar2014 (ongoing); EFFEXOR oral taken for major depression, start date: 13Aug2015 (ongoing). Vaccination history included: PF-06928316 (respiratory syncytial virus) prefusion f subunit vaccine (Investigational Vaccine(s):, Regimen Dose Number: 01, Generic Name: PF-06928316 (Respiratory Syncytial Virus) prefusion F Subunit Vaccine, Trade Name: PFIZER, Indication: prophylactic, Lot Number: 749694261, Expiration Date: 09Sep2021, Route: Intramuscular, Anatomical Location (L or R) Anatomical Location: Left arm, Vaccination Date: 09Sep2021, Age: 66, Hour Vaccination: 14, Minutes Vaccination: 46, Last Action Taken: Dose not changed), administration date: 09Sep2021, when the patient was 66-year-old, for prophylactic; BNT162b2 (First dose, Vaccine Name: covid , Manufacturer: Pfizer , Route: IM, Anatomical Location (Left or Right): Left, Anatomical Location: Arm , Day: 13 , Month: Feb, Year: 2021), administration date: 13Feb2021, for COVID-19 immunization; BNT162b2 (Second dose, Vaccine Name: covid , Manufacturer: Pfizer , Route: IM, Anatomical Location (Left or Right): Left, Anatomical Location: Arm , Day: 06 , Month: Mar, Year:2021), administration date: 06Mar2021, for COVID-19 immunization. The following information was reported: TRAUMATIC INTRACRANIAL HAEMORRHAGE (hospitalization, medically significant) with onset 01Jan2022, outcome "recovered" (02Jan2022), described as "Traumatic Intracranial Hemorrhage". The patient was hospitalized for traumatic intracranial haemorrhage (hospitalization duration: 1 day(s)). The event "traumatic intracranial hemorrhage" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood creatine (0.2-1.3): (01Jan2022) 0.9 mg/dl; Computerised tomogram: (01Jan2022) Parenchyma: There is subarachnoid hemorrhage, notes: Parenchyma: There is subarachnoid hemorrhage seen at the base of the left temporal lobe and some hemorrhage in the left sylvian fissure. There is hemorrhage along the left 10 Tory him and slightly along the right medial tentorium. There is a small amount of blood tracking along the falx. Sinuses and Orbits: Imaged paranasal sinuses, orbits, and mastoids show no significant abnormality; (01Jan2022) Normal, notes: Parenchyma: No parenchymal hemorrhage. No evidence of mass, midline shift, or CT findings of acute infarction. Gray-white differentiation is distinct. Extraaxial Spaces: Small volume subarachnoid hemorrhage and left sylvian fissure as before. Small volume interhemispheric hemorrhage measuring up to 4 mm in width, unchanged. Thin band of left tentorial hemorrhage. No subdural or epidural collections identified. Ventricles: Normal in size and position. Sinuses and Orbits: Imaged paranasal sinuses, orbits, and mastoids show no significant abnormality. Bones: No evidence of fracture or calvarial defect. Other: There is a left parietal/occipital scalp hematoma; (01Jan2022) Normal, notes: Alignment: Normal. No scoliosis or spondylolisthesis. Bones: There are no acute fractures or subluxations. Interspace Levels/Facets: Cervical spondylosis with degeneration of the disks C3-T1. There are degenerative changes at the uncovertebral joints. Musculature: Normal. No fatty atrophy. Other: The paravertebral and prevertebral soft tissues are normal. The lung apices are clear; Haematocrit (32.8-45.5): (02Jan2022) 37.7 %; Haemoglobin (11-15.4): (01Jan2022) 14.7 g/dl; (02Jan2022) 12.9 g/dl.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the event cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.