Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vestibular disorder, Vibratory sense increased
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INTRACRANIAL PRESSURE INCREASED (Intracranial pressure in my head) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced TOOTH LOSS (I lost a molar tooth for no reason. It just fell out of my mouth). On 20-Jun-2021, the patient experienced INTRACRANIAL PRESSURE INCREASED (Intracranial pressure in my head) (seriousness criterion medically significant), MUSCULOSKELETAL STIFFNESS (Couldn't turn neck), VIBRATORY SENSE INCREASED (Vibration in center of my head, it was pretty severe/It [vibration] seems to be moving to my voice box & chest area) and VERTIGO (Severe vertigo). On 02-Feb-2022, the patient experienced CHEST PAIN (I have chest pain), VESTIBULAR DISORDER (Seems to affect both my vestibular areas), PALPITATIONS (Sometimes my heart starts racing), VERTIGO (I have vertigo) and HYPOAESTHESIA (Sometimes my hands go numb). At the time of the report, INTRACRANIAL PRESSURE INCREASED (Intracranial pressure in my head), TOOTH LOSS (I lost a molar tooth for no reason. It just fell out of my mouth), MUSCULOSKELETAL STIFFNESS (Couldn't turn neck), VIBRATORY SENSE INCREASED (Vibration in center of my head, it was pretty severe/It [vibration] seems to be moving to my voice box & chest area), CHEST PAIN (I have chest pain), VESTIBULAR DISORDER (Seems to affect both my vestibular areas), PALPITATIONS (Sometimes my heart starts racing), VERTIGO (I have vertigo), VERTIGO (Severe vertigo) and HYPOAESTHESIA (Sometimes my hands go numb) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, Computerised tomogram: normal (normal) normal. In July 2021, Magnetic resonance imaging: normal (normal) normal. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative twice. Concomitant product use was not provided by the reporter. Patient saw symptoms were getting worse. Patient have no medical history at all. Patient seen by 9 specialist and no one knows what's going on. Patient does not have history of myocarditis/pericarditis. Patient did not have any side effects from first dose of Moderna Covid-19 vaccine. Treatment information was not provided. No HX cardiac issues. C-19 neg x2. No SOB. Company Comment: This is an Spontaneous case concerning a 51-year-old female patient, with no medical relevant history reported in this case, who experienced the serious unexpected event of Intracranial pressure increased, also other non-serious events were reported in this case. The event occurred approximately 1 month and 10 days after the administration of the second dose of the mRNA-1273. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The case was assessed as serious due to Medically Significant.; Sender's Comments: This is a spontaneous case concerning a 51-year-old female patient, with no medical relevant history reported in this case, who experienced the serious unexpected event of Intracranial pressure increased, also other non-serious events were reported in this case. The event occurred approximately 1 month and 10 days after the administration of the second dose of the mRNA-1273. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The case was assessed as serious due to Medically Significant.