Sex: F
Vaccine: COVID19
Symptoms: Cerebral venous sinus thrombosis, Computerised tomogram, Extradural haematoma, Facial bones fracture, Fall
Clinical narrative: pneumocephalus; head injury; left transverse sinus venous thrombosis; fall; Altered Mental Status; epidural hematoma; left occipital bone fracture/Calvarias Fracture; left supraorbital frontal/ Orbital Wall Fracture; Subdural Hematoma; Benign Paroxysmal Positional Vertigo; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 63-year-old female patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose number unknown (booster), 30 ug single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension", start date: 17Sep2021 (ongoing); "Osteoarthritis", start date: Jun2021 (ongoing); "Tracheal Resection", start date: 2008 (not ongoing); "Anxiety", start date: 2011 (ongoing); "Hyperlipidemia", start date: 2008 (ongoing); "Attention Deficit Hyperactivity Disorder", start date: 2005 (ongoing); "Bladder Spasms", start date: Jan2020 (ongoing); "Lumbar Fusion L4-S1", start date: 1999 (not ongoing); "Depression", start date: 1994 (ongoing); "Insomnia", start date: 2006 (ongoing). Concomitant medication(s) included: PROZAC oral taken for depression, start date: Jun2021 (ongoing); MAXZIDE oral taken for hypertension, start date: 17Sep2021 (ongoing); MOBIC oral taken for arthritis, start date: Jun2021 (ongoing); DITROPAN XL oral taken for bladder spasm, start date: Jan2020 (ongoing); VYVANSE oral taken for attention deficit hyperactivity disorder, start date: 2005 (ongoing); DESYREL oral taken for insomnia, start date: 2006; MACRODANTIN oral taken for urinary tract infection, prophylaxis, start date: Jan2021 (ongoing); XANAX oral taken for anxiety, start date: 2011; AMBIEN oral taken for insomnia, start date: 2006 (ongoing); CRESTOR oral taken for hyperlipidaemia, start date: 2008 (ongoing). Vaccination history included: Covid-19 vaccine (Primary series completed with unknown manufacturer), for Covid-19 Immunization. The following information was reported: VERTIGO POSITIONAL (non-serious) with onset 16May2022, outcome "not recovered", described as "Benign Paroxysmal Positional Vertigo"; MENTAL STATUS CHANGES (hospitalization) with onset 04Jun2022, outcome "recovered" (18Jun2022), described as "Altered Mental Status"; EXTRADURAL HAEMATOMA (hospitalization, medically significant) with onset 04Jun2022, outcome "recovered" (08Jun2022), described as "epidural hematoma"; FALL (hospitalization) with onset 04Jun2022, outcome "unknown"; SKULL FRACTURE (hospitalization, medically significant) with onset 04Jun2022, outcome "recovered" (08Jun2022), described as "left occipital bone fracture/Calvarias Fracture"; FACIAL BONES FRACTURE (hospitalization, medically significant) with onset 04Jun2022, outcome "recovered" (08Jun2022), described as "left supraorbital frontal/ Orbital Wall Fracture"; CEREBRAL VENOUS SINUS THROMBOSIS (hospitalization, medically significant) with onset 04Jun2022, outcome "recovered" (18Jun2022), described as "left transverse sinus venous thrombosis"; HEAD INJURY (hospitalization) with onset 04Jul2022, outcome "unknown"; PNEUMOCEPHALUS (hospitalization, medically significant) with onset 04Jul2022, outcome "unknown"; SUBDURAL HAEMATOMA (hospitalization, medically significant) with onset 11Jul2022, outcome "recovered with sequelae", described as "Subdural Hematoma". The patient was hospitalized for subdural haematoma (start date: 15Jul2022, hospitalization duration: 3 day(s)). The events "subdural hematoma", "epidural hematoma", "left occipital bone fracture/calvarias fracture", "left supraorbital frontal/ orbital wall fracture", "pneumocephalus" and "head injury" required emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: (unspecified date) abnormal, notes: acute subdural hematoma along the left aspect of the anterior falx, new compared to 16Jun2022; (May2022) No acute bleeding was found; (05Jun2022) Epidural Hematoma and left transverse and sigmoid, notes: thromboses, hematoma to now be 7mm at the widest point; (05Jun2022) showed the hematoma to now be 7mm at the widest, notes: point second CT; (12Jul2022) enlarging Left Parafalcine Subdural Hematoma, notes: of 5mm; X-ray: (05Jun2022) Calvarial and Orbital Wall fractures. Therapeutic measures were taken as a result of subdural haematoma, cerebral venous sinus thrombosis, extradural haematoma, skull fracture, facial bones fracture, pneumocephalus, head injury. Clinical course: On 11Jul2022, around 9 pm, the participant, a 63-year-old female again presented to an emergency department after experiencing another vertigo occurrence which resulted in a fall. She received a study vaccine or placebo on 01Nov2021. Subject also received a covid booster vaccine, Pfizer 30mcg, on 01Apr2022. She recently was admitted after a fall on 04Jun2022 at which time she suffered epidural hematoma with extra-axial hemorrhages and pneumocephalus, as well as a non-displaced left occipital bone fracture and a left supraorbital frontal bone fracture. During the current fall (11Jul2022) she states she hit her head on the nightstand, got up, and then fell again in the bathroom with no loss of consciousness. The patient has an established history of benign paroxysmal positional vertigo starting in May2022. No acute bleeding was found on CT at this time and the patient was subsequently discharged from the emergency department on 12Jul22. An enlarging parafalcine subdural hematoma of 5mm was later found on CT. The patient was transported back to hospital on 12Jul22. The patient had a second CT that showed the hematoma to now be 7mm at the widest point. The patient was admitted to ICU on 12Jul2022. The Eliquis prescribed from her previous admission 14Jun22 discontinued on 12Jul2022 and KCentra 2560 units via IV were administered due to the current bleed. Keppra 500mg PO BID for 7 days was ordered on 14Jul22 as well as Aspirin 81mg PO Daily. The patient was discharged on 15Jul2022 to home with PT/OT. The patient has since recovered with minimal neurological impairment per subject during study visit. Diagnosed with a benign vestibular disorder in May2022. She was later found to have a left transverse sinus venous thrombosis and treated with Eliquis ongoing. SAE1. A 63-year-old female with a head injury resulting in a skull fracture in June 2022. Presented this visit with a second fall resulting in an abnormal CT scan. CT determined that there was an acute subdural hematoma along the left aspect of the anterior falx, new compared to 16Jun2022. The patient fell in the evening getting out of bed and hit the right facial area on furniture. The patient was admitted to hospital from 12Jul to 15Jul.  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 available information in the case, the causal association between the events subdural hematoma, cerebral venous sinus thrombosis, extradural hematoma, skull fracture, facial bones fracture, pneumocephalus, head injury and the suspect drug BNT162B2  cannot be 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.