Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Heart rate, Insomnia, Loss of personal independence in daily activities
Clinical narrative: affecting mental health; cannot function normally; cannot sleep; It is debilitating; tingling in both legs when goes to bed; legs twitching; Legs hurt from the knees downwards; incredibly exhausted; Legs are hurting from the knee down; legs are swelling; rash on full body/travel throughout body; some swelling in throat; throat tight when tried to swallow.; very bad reaction to vaccine; Itchiness on chest/was very itchy; Itchiness on scalp/was very itchy; hives on full body/travel throughout body; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (affecting mental health) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced VACCINATION COMPLICATION (very bad reaction to vaccine), PRURITUS (Itchiness on chest/was very itchy), PRURITUS (Itchiness on scalp/was very itchy), URTICARIA (hives on full body/travel throughout body), PHARYNGEAL SWELLING (some swelling in throat), THROAT TIGHTNESS (throat tight when tried to swallow.) and RASH (rash on full body/travel throughout body). On 04-Jan-2022, the patient experienced PAIN IN EXTREMITY (Legs are hurting from the knee down) and PERIPHERAL SWELLING (legs are swelling). On an unknown date, the patient experienced MENTAL IMPAIRMENT (affecting mental health) (seriousness criterion medically significant), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (cannot function normally), INSOMNIA (cannot sleep), ASTHENIA (It is debilitating), PAIN IN EXTREMITY (Legs hurt from the knees downwards), PARAESTHESIA (tingling in both legs when goes to bed), MUSCLE TWITCHING (legs twitching) and FATIGUE (incredibly exhausted). The patient was treated with FAMOTIDINE (PEPCID [FAMOTIDINE]) for Throat swelling and Throat tightness, at an unspecified dose and frequency; LORATADINE (CLARITIN [LORATADINE]) for Adverse event, at an unspecified dose and frequency; HYDROXYZINE for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MENTAL IMPAIRMENT (affecting mental health), VACCINATION COMPLICATION (very bad reaction to vaccine), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (cannot function normally), INSOMNIA (cannot sleep), ASTHENIA (It is debilitating), PHARYNGEAL SWELLING (some swelling in throat), THROAT TIGHTNESS (throat tight when tried to swallow.), PAIN IN EXTREMITY (Legs hurt from the knees downwards), PAIN IN EXTREMITY (Legs are hurting from the knee down), PARAESTHESIA (tingling in both legs when goes to bed), MUSCLE TWITCHING (legs twitching), PERIPHERAL SWELLING (legs are swelling) and FATIGUE (incredibly exhausted) outcome was unknown and PRURITUS (Itchiness on chest/was very itchy), PRURITUS (Itchiness on scalp/was very itchy), URTICARIA (hives on full body/travel throughout body) and RASH (rash on full body/travel throughout body) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: rapid heart beat (High) Rapid heart beat.         Patient reported to not have any concomitant  medication.  Treatment medication also included antihistamines.  Company comment:This is a spontaneous case concerning a 50-year-old female patient with no medical history reported, who experienced the serious unexpected event of Mental impairment(seriousness criterion medically significant). On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine), with the event of Mental impairment occurring on an unknown date. The rechallenge was unknown since there's no information about the first two doses. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2022: Follow up received, events of pain in extremity (onset date -04-Jan-2022) and peripheral swelling were added.; Sender's Comments: This is a spontaneous case concerning a 50-year-old female patient with no medical history reported, who experienced the serious unexpected event of Mental impairment(seriousness criterion medically significant). On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine), with the event of Mental impairment occurring on an unknown date. The rechallenge was unknown since there's no information about the first two doses. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.