Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Inappropriate schedule of product administration, Memory impairment, Paraesthesia
Clinical narrative: Blood pressure had risen it got really high around 150/70 or 150/80; Felt electric shocks in the head area; She forgets often; Only had first dose of vaccine from the vaccination series; Watched for a stroke; Tingling first on her chin, then her lips, all over head, and went into left arm; Numbness first on her chin, then her lips, all over head, and went into left arm; Speech was slurred; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Watched for a stroke) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D [VITAMIN D NOS] for Vitamin D supplementation.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Watched for a stroke) (seriousness criterion medically significant), PARAESTHESIA (Tingling first on her chin, then her lips, all over head, and went into left arm), HYPOAESTHESIA (Numbness first on her chin, then her lips, all over head, and went into left arm) and DYSARTHRIA (Speech was slurred). On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure had risen it got really high around 150/70 or 150/80), ELECTRIC SHOCK SENSATION (Felt electric shocks in the head area), MEMORY IMPAIRMENT (She forgets often) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Only had first dose of vaccine from the vaccination series). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, CEREBROVASCULAR ACCIDENT (Watched for a stroke) outcome was unknown and PARAESTHESIA (Tingling first on her chin, then her lips, all over head, and went into left arm), HYPOAESTHESIA (Numbness first on her chin, then her lips, all over head, and went into left arm), DYSARTHRIA (Speech was slurred), BLOOD PRESSURE INCREASED (Blood pressure had risen it got really high around 150/70 or 150/80), ELECTRIC SHOCK SENSATION (Felt electric shocks in the head area), MEMORY IMPAIRMENT (She forgets often) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Only had first dose of vaccine from the vaccination series) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: elevated (High) The blood pressure had risen during this time- "It got really high- around 150/70 or 150/80, don't remember exactly.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. The Company believes the event of Cerebrovascular accident is not supported in the source documents, is invalid and should be deleted and the case downgrade to non-serious.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. The Company believes the event of Cerebrovascular accident is not supported in the source documents, is invalid and should be deleted and the case downgrade to non-serious.