Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Balance disorder, Cognitive disorder, Gait inability, Haemorrhage
Clinical narrative: she was given a drain for her bleeding; brain aneurysm/lost consciousness/ She continued to be in a coma upon arrival to the emergency room/ headaches which progressively got worse for a week; cognitive deficits; short term memory loss; She cannot walk any more; lacks balance; She cannot use the restroom or bathe on her own; her vision has been effected described as "she sees lots of different things in her view; This spontaneous case was reported by a consumer and describes the occurrence of INTRACRANIAL ANEURYSM (brain aneurysm/lost consciousness/ She continued to be in a coma upon arrival to the emergency room/ headaches which progressively got worse for a week) and HAEMORRHAGE (she was given a drain for her bleeding) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No relevant medical history/conditions, allergy, concomitant diseases and risk factor.  Previously administered products included for Drug use for unknown indication: COVID-19 VACCINE (lot number 012M20A) on 29-Jan-2021 and COVID-19 VACCINE (lot number 014M20A) on 27-Feb-2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE and COVID-19 VACCINE.    On 22-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INTRACRANIAL ANEURYSM (brain aneurysm/lost consciousness/ She continued to be in a coma upon arrival to the emergency room/ headaches which progressively got worse for a week) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced HAEMORRHAGE (she was given a drain for her bleeding) (seriousness criteria hospitalization and medically significant), COGNITIVE DISORDER (cognitive deficits), AMNESIA (short term memory loss), GAIT INABILITY (She cannot walk any more), BALANCE DISORDER (lacks balance), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (She cannot use the restroom or bathe on her own) and VISUAL IMPAIRMENT (her vision has been effected described as "she sees lots of different things in her view). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency and IBUPROFEN (ADVIL 12H) for Headache, at an unspecified dose and frequency. At the time of the report, INTRACRANIAL ANEURYSM (brain aneurysm/lost consciousness/ She continued to be in a coma upon arrival to the emergency room/ headaches which progressively got worse for a week), HAEMORRHAGE (she was given a drain for her bleeding), COGNITIVE DISORDER (cognitive deficits) and AMNESIA (short term memory loss) had not resolved and GAIT INABILITY (She cannot walk any more), BALANCE DISORDER (lacks balance), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (She cannot use the restroom or bathe on her own) and VISUAL IMPAIRMENT (her vision has been effected described as "she sees lots of different things in her view) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter.  It was reported that, she came home after the booster with headaches which progressively got worse for a week. Her daughter encouraged her to take Advil, and Tylenol. 1 week later she called her daughter and stated she couldn't take the headaches anymore; she dropped the phone and lost consciousness. An ambulance was called where they resuscitated the individual on site before taking her to the emergency room. She continued to be in a coma upon arrival to the emergency room. From the local emergency department, she was transported to a trauma unit. She had suffered a severe brain aneurysm. Over the course of the next month, she had multiple procedures and treatments she was given a drain for her bleeding, she had a coil placed for the aneurysm, and she also then had a shunt placed. She woke up from the coma 1 week after the shunt procedure. She has continued to have deficits from this including the following: She cannot walk any more, has cognitive deficits, has short term memory loss, lacks balance, and her vision has been affected described as "she sees lots of different things in her view." She now has a full-time aid. She cannot use the restroom or bathe on her own.  Company Comment: This spontaneous case concerns 68-year-old female patient, with no medical history, allergy, concomitant diseases, or risk factor, who experienced the serious (medically significant and hospitalization) unexpected events of INTRACRANIAL ANEURYSM (reported as brain aneurysm) and HAEMORRHAGE after the booster dose of mRNA-1273 vaccine (previously she received the first and the second dose of the vaccine schedule with an unknown product). She experienced headaches after vaccination that progressively got worse and took ibuprofen and paracetamol. She lost her consciousness a week later and was transferred to the emergency room where a brain aneurysm was diagnosed. Multiple procedures and treatments were given for the next month: drain for her bleeding, coil placed for the aneurysm, and a shunt was placed. She woke up from the coma a week after the shunt procedure and had the following deficits: cannot walk, cognitive deficits, short term memory loss, lacks balance, and visual impairment. She has a full-time aid for her daily activities. No further clinical information was available for medical review. Patient´s age could be a risk factor for intracranial aneurysm. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns 68-year-old female patient, with no medical history, allergy, concomitant diseases, or risk factor, who experienced the serious (medically significant and hospitalization) unexpected events of INTRACRANIAL ANEURYSM (reported as brain aneurysm) and HAEMORRHAGE after the booster dose of mRNA-1273 vaccine (previously she received the first and the second dose of the vaccine schedule with an unknown product). She experienced headaches after vaccination that progressively got worse and took ibuprofen and paracetamol. She lost her consciousness a week later and was transferred to the emergency room where a brain aneurysm was diagnosed. Multiple procedures and treatments were given for the next month: drain for her bleeding, coil placed for the aneurysm, and a shunt was placed. She woke up from the coma a week after the shunt procedure and had the following deficits: cannot walk, cognitive deficits, short term memory loss, lacks balance, and visual impairment. She has a full-time aid for her daily activities. No further clinical information was available for medical review. Patient´s age could be a risk factor for intracranial aneurysm. The benefit-risk relationship of mRNA-1273 is not affected by this report.