Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Endotracheal intubation, Headache, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative
Clinical narrative: BRAIN DEATH; RIGHT PARIETAL INTRAPARENCHYMAL HEMATOMA; MUCOSAL THICKENING OF RIGHT SINUS; HEADACHE; This spontaneous report received from a health care professional concerned a 45 year old  female The patient's height, and weight were not reported. The patient's concurrent conditions included nuts allergy, type 2 diabetes, dysphagia, thrombocytosis, hypertension, vertigo, migraine, and iron deficiency. The patient was not pregnant at the time of vaccination. The patient had no any adverse event following any previous vaccine. The patient was previously treated with diphtheria vaccine toxoid/pertussis vaccine acellular/tetanus vaccine toxoid for prophylactic vaccination, measles vaccine/mumps vaccine/rubella vaccine for prophylactic vaccination, varicella zoster vaccine for prophylactic vaccination, and influenza vaccine for prophylactic vaccination. It was unknown if patient had an adverse event following any previous vaccine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.Concomitant medications included butalbital/caffeine/paracetamol, fluticasone propionate, loratadine, mannitol, metformin, and propranolol. On 21-MAR-2021, the patient experienced headache. On 22-MAR-2021 patient awakened at home with headache. 23-MAR-2021 physician ordered computerized tomogram (CT) of head which was normal. On 24-MAR-2021 physician repeated CT of head in which mucosal thickening of right sinus appeared and she arrived to emergency department (ED) with intractable headache and nausea. On 25-MAR-2021 CT of head showed right parietal intraparenchymal hematoma, 5 cc of Mannitol infused. Loss of pupil reflexes noted. Right decompressive craniectomy by done physician. Following surgery intracranial pressure (ICP) was more than 60. Remained intubated. laboratory data showed fibrinogen (NR: not provided) 195, Influenza (NR: not provided) negative, Platelet count (NR: not provided) 34, SARS-CoV-2 test (NR: not provided) negative, and white blood cell count (NR: not provided) 12.7.  On 26-MAR-2021 ICP remains high. No reflexes noted. On 27-MAR-2021 the patient announced brain dead. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of brain death. The patient had not recovered from mucosal thickening of right sinus, headache, and right parietal intraparenchymal hematoma. This report was serious (Death and Hospitalization Caused / Prolonged).; Sender's Comments: V0: This report was obtained and concerned a 45 year old female patient,  who was noted to have mucosal thickening of the right sinus and right parietal intraparenchymal hematoma 11 days and 12 days, respectively, after receiving the Janssen COVID-19 vaccine. The patient's height, and weight were not reported. The patient's concurrent conditions included Type 2 diabetes, dysphagia, thrombocytosis, hypertension, vertigo, migraine, and iron deficiency. Concomitant medications included butalbital/caffeine/paracetamol, fluticasone propionate, loratadine, mannitol, metformin, and propranolol. The patient has allergy to nuts. The patient was not pregnant at the time of vaccination and did not have adverse event following any previous vaccine. Eight (8) days post vaccine, patient experienced headache that was persistent and progressing. Physician ordered for computerized tomogram (CT) of the head, which was normal. Eleven (11) days post vaccine, repeat of the CT Scan of the head showed mucosal thickening of the right sinus. Twelve (12) days post vaccine, patient had intractable headache and nausea; repeat of the CT Scan of the head showed right parietal intraparenchymal hematoma. The tests taken: Fibrinogen  195 (NR: not provided), Influenza  negative, Platelets 34 (NR: not provided), SARS-CoV-2 test NEGATIVE, and Whole body scan 12.7 (NR: not provided). Loss of pupil reflexes was noted. Right decompressive craniectomy was done. Intracranial pressure (ICP) was increased, more than 60, and remained high. Patient was noted not have reflexes. Fourteen (14) days post vaccine, brain death was pronounced by physician. It was unknown if an autopsy was performed. Based on the available information, the relationship with Janssen Covid-19 vaccine is considered indeterminate causality classification of adverse events following immunization. More information will be sought when contact information becomes available.; Reported Cause(s) of Death: BRAIN DEATH