Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood thyroid stimulating hormone, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Lot of pressure in their head; Uncomfortable to rest the head in a hard surface; Lost the ability to work; Traumatizing experience psychologically; Not strong enough to walk/had to used a wheelchair; Strong weakness started; Head felt lightheaded, constantly feeling they may faint; Excessive hunger; tremors that extended over time and up their spine, to the back of their head; Lower extremities begun to have tremors; Weakness in the legs; Body aches; Tiredness/fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEAD TITUBATION (tremors that extended over time and up their spine, to the back of their head), TREMOR (Lower extremities begun to have tremors), HEAD DISCOMFORT (Lot of pressure in their head), DIZZINESS (Head felt lightheaded, constantly feeling they may faint), INCREASED APPETITE (Excessive hunger), FEELING ABNORMAL (Uncomfortable to rest the head in a hard surface), ASTHENIA (Strong weakness started), IMPAIRED WORK ABILITY (Lost the ability to work), GAIT DISTURBANCE (Not strong enough to walk/had to used a wheelchair), PSYCHOLOGICAL TRAUMA (Traumatizing experience psychologically), MUSCULAR WEAKNESS (Weakness in the legs), MYALGIA (Body aches) and FATIGUE (Tiredness/fatigue) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 018B21A) for COVID-19 vaccination.     The patient's past medical history included Fatigue (only 2 episodes of debilitating fatigue were their TSH levels were out of range). Concurrent medical conditions included Hashimoto's disease (Patient stated she had Hashimoto's disease for 23 years and is been well controlled). Concomitant products included LEVOTHYROXINE for an unknown indication.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced MUSCULAR WEAKNESS (Weakness in the legs) (seriousness criterion disability), MYALGIA (Body aches) (seriousness criterion disability) and FATIGUE (Tiredness/fatigue) (seriousness criterion disability). On 27-Apr-2021, the patient experienced HEAD TITUBATION (tremors that extended over time and up their spine, to the back of their head) (seriousness criterion disability), TREMOR (Lower extremities begun to have tremors) (seriousness criterion disability), DIZZINESS (Head felt lightheaded, constantly feeling they may faint) (seriousness criterion disability), INCREASED APPETITE (Excessive hunger) (seriousness criterion disability) and ASTHENIA (Strong weakness started) (seriousness criterion disability). On 29-Apr-2021, the patient experienced GAIT DISTURBANCE (Not strong enough to walk/had to used a wheelchair) (seriousness criterion disability). On an unknown date, the patient experienced HEAD DISCOMFORT (Lot of pressure in their head) (seriousness criterion disability), FEELING ABNORMAL (Uncomfortable to rest the head in a hard surface) (seriousness criterion disability), IMPAIRED WORK ABILITY (Lost the ability to work) (seriousness criterion disability) and PSYCHOLOGICAL TRAUMA (Traumatizing experience psychologically) (seriousness criterion disability). On 27-Apr-2021, MUSCULAR WEAKNESS (Weakness in the legs), MYALGIA (Body aches) and FATIGUE (Tiredness/fatigue) had resolved. At the time of the report, HEAD TITUBATION (tremors that extended over time and up their spine, to the back of their head), TREMOR (Lower extremities begun to have tremors), HEAD DISCOMFORT (Lot of pressure in their head), DIZZINESS (Head felt lightheaded, constantly feeling they may faint), INCREASED APPETITE (Excessive hunger), FEELING ABNORMAL (Uncomfortable to rest the head in a hard surface), ASTHENIA (Strong weakness started), IMPAIRED WORK ABILITY (Lost the ability to work), GAIT DISTURBANCE (Not strong enough to walk/had to used a wheelchair) and PSYCHOLOGICAL TRAUMA (Traumatizing experience psychologically) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Blood thyroid stimulating hormone: abnormal (abnormal) thyroid level outside normal range.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient advised TSH levels were out of normal range.  Patient advised on 13-APR-2021 she went to routine check-up and climbed 6 level stairs without any problem and after second shot of vaccine on 29-APR-2021 she had used wheelchair.  Patient stated it was traumatizing experience both physically and psychologically.  No treatment information was provided.  Company Comment - This is a 43-year-old female patient with history of Hashimoto's disease, who experienced HEAD TITUBATION among multiple events after second dose of m-RNA1273. Very limited information regarding this event has been provided at this time. Details including the results of tests/ diagnostics, HCP notes/diagnosis, outcome is required for further assessment. Even seriousness assessed as per reporter, however there was no information in the source document supporting the events resulted in a persistent or permanent incapacity.   This case was linked to MOD-2021-309940 (Patient Link).; Sender's Comments: This is a 43-year-old female patient with history of Hashimoto's disease, who experienced HEAD TITUBATION among multiple events after second dose of m-RNA1273. Very limited information regarding this event has been provided at this time. Details including the results of tests/ diagnostics, HCP notes/diagnosis, outcome is required for further assessment. Even seriousness assessed as per reporter, however there was no information in the source document supporting the events resulted in a persistent or permanent incapacity.