Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head, Dizziness, Feeling abnormal, Head discomfort, Headache
Clinical narrative: extreme pressure in brain / cranial area; felt like a rush to her brain like something liquid was sitting up there / brain feels swollen; pounding headache; felt lightheaded / dizzy spell; felt off; spinning comes and goes; migraine; The initial safety information received was reporting only non-serious adverse drug reaction(s). Upon receipt of follow-up information on 13Dec2021, this case contains serious adverse reaction(s) and all safety information is processed together.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 27Sep2021 12:00 (Lot number: FF2587) at the age of 51 years as dose 1, single for COVID-19 immunization at a hospital, non-military facility. The patient had no relevant medical history.  There were no concomitant medications. The patient did not received any other vaccination 4 weeks prior to COVID 19 Vaccine. Vaccination history included: Flu shot, administration date: 2020, for influenza immunization. The following information was reported: INTRACRANIAL PRESSURE INCREASED (medically significant) with onset 27Sep2021 12:05, outcome "not recovered", described as "extreme pressure in brain / cranial area"; HEAD DISCOMFORT (non-serious) with onset 27Sep2021 12:05, outcome "not recovered", described as "felt like a rush to her brain like something liquid was sitting up there / brain feels swollen"; MIGRAINE (non-serious) with onset 2021, outcome "not recovered", described as "migraine"; HEADACHE (non-serious) with onset 27Sep2021 12:05, outcome "not recovered", described as "pounding headache"; DIZZINESS (non-serious) with onset 27Sep2021 12:05, outcome "not recovered", described as "felt lightheaded / dizzy spell"; VERTIGO (non-serious) with onset Sep2021, outcome "not recovered", described as "spinning comes and goes"; FEELING ABNORMAL (non-serious) with onset 27Sep2021 12:05, outcome "not recovered", described as "felt off". The events "extreme pressure in brain / cranial area", "felt like a rush to her brain like something liquid was sitting up there / brain feels swollen" and "pounding headache" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram head: (20Oct2021) no acute intracranial hemorrhage, notes: no mass or mass affect, no midline shift or basal cistern. Therapeutic measures were taken as a result of intracranial pressure increased, headache, dizziness, vertigo, feeling abnormal. Clinical Course: The patient received the first dose on 27Sept2021 and within about 5 minutes, she felt lightheaded and dizzy spell. She felt like it rushed to her brain and dispersed. It felt like the liquid was just sitting there and it hasn't gone away. The rush to her head sat there giving her extreme pressure in the brain/cranial area along with an explosive headache. She had a pounding headache ever since the first dose and it has not subsided. She drank water and took Tylenol and she had to take the next day off. She "felt off" the whole week. The spinning comes and goes but the headache doesn't go away. She took Tylenol for 2 or 3 days but the Tylenol was not working for her headache. It's like if the liquid was just sitting in her brain and it does not go away. She just doesn't know what's happening in her head. She had persistent headache, migraine and pressure in the brain. She went to urgent care but they could do nothing so they referred her to the emergency room. Then she went home hoping it would pass but it did not. She was still experiencing pressure and headache. She received the second vaccine on 18Oct2021. The second shot had a moment of lightheadedness but she did not feel the rush to her head as she did with the first shot. The pressure and extreme headache she experienced since the first dose had never recovered. She went to the emergency room on 20Oct2021 where a CAT scan was done and found nothing. They prescribed a headache medication Benzonatate which does nothing. She took Aleve which elevated the pressure mildly for two seconds on 29Nov2021. She was still suffering from the cranial pressure and headache. The pressure swells sometimes more than others and was unbearable with her tears swelling. Her brain feels swollen. She was prescribed butalbital, acetaminophen, caffeine.  She was trying to schedule an appointment with a neurologist. There were no specific relevant test for thromboembolic events with thrombocytopenia.   Follow-up attempts are completed. No further information is expected.  Follow-up (17Dec2021): Follow-up attempts are completed. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101787733 Same patient, different dose/AEs.