Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Paraesthesia, Product dose omission issue, Sensory disturbance
Clinical narrative: Did not get the 2nd dose; Lost 7 pounds; Vibration sensation in the center of her body/different sensations all over her body; Hand are asleep every morning/ feet asleep every morning/  numbness in her toes; Bottom of skull is aching/Neck feel like it was going to cave in; Headache; Nausea; Chills; Diarrhea; Tingling in her toes and feet; Burning sensation on the backs of both legs/ kind of a burning feeling/ burning sensation in different part of her body (face, arms, hips,feet, and thighs); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (Tingling in her toes and feet), BURNING SENSATION (Burning sensation on the backs of both legs/ kind of a burning feeling/ burning sensation in different part of her body (face, arms, hips,feet, and thighs)), PRODUCT DOSE OMISSION ISSUE (Did not get the 2nd dose), WEIGHT DECREASED (Lost 7 pounds) and SENSORY DISTURBANCE (Vibration sensation in the center of her body/different sensations all over her body) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No relevant concomitant medications reported. No relevant medical history was reported.     On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PARAESTHESIA (Tingling in her toes and feet), BURNING SENSATION (Burning sensation on the backs of both legs/ kind of a burning feeling/ burning sensation in different part of her body (face, arms, hips,feet, and thighs)) and DIARRHOEA (Diarrhea). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not get the 2nd dose), WEIGHT DECREASED (Lost 7 pounds), SENSORY DISTURBANCE (Vibration sensation in the center of her body/different sensations all over her body), HYPOAESTHESIA (Hand are asleep every morning/ feet asleep every morning/  numbness in her toes), PAIN (Bottom of skull is aching/Neck feel like it was going to cave in), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Tingling in her toes and feet), BURNING SENSATION (Burning sensation on the backs of both legs/ kind of a burning feeling/ burning sensation in different part of her body (face, arms, hips,feet, and thighs)), PAIN (Bottom of skull is aching/Neck feel like it was going to cave in), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills) had not resolved, PRODUCT DOSE OMISSION ISSUE (Did not get the 2nd dose), DIARRHOEA (Diarrhea) and HYPOAESTHESIA (Hand are asleep every morning/ feet asleep every morning/  numbness in her toes) had resolved and WEIGHT DECREASED (Lost 7 pounds) and SENSORY DISTURBANCE (Vibration sensation in the center of her body/different sensations all over her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The allergist recommended to not take the second dose of the vaccine.She had seen her primary physician, allergist/immune doctor and neurologist. On an unspecified date, a blood work-up was normal.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Updated lab data, events and treatment taken. On 07-May-2021: Updated vaccine route of administration, events and outcome of events.