Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Discomfort, Gait disturbance, Headache, Insomnia
Clinical narrative: Arm became to itch incessantly; Injection site becoming red and puffy; Injection site soreness; Has considerable amount of discomfort; Headache; Difficulty sleeping; Problem with left leg; Pain started from hip down to thigh in the back side of leg; Painful to walk; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIMB DISCOMFORT (Problem with left leg), PAIN (Pain started from hip down to thigh in the back side of leg), GAIT DISTURBANCE (Painful to walk), PRURITUS (Arm became to itch incessantly) and INSOMNIA (Difficulty sleeping) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes since 2017, Arthritis (Early onset of arthritis) since August 2020, Pollen allergy (Experienced headache), Allergy NOS and Drug allergy (Sulfur based medicine). Concomitant products included OMEPRAZOLE for Acid reflux (esophageal).   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced LIMB DISCOMFORT (Problem with left leg), PAIN (Pain started from hip down to thigh in the back side of leg), GAIT DISTURBANCE (Painful to walk) and INSOMNIA (Difficulty sleeping). On 05-Mar-2021, the patient experienced DISCOMFORT (Has considerable amount of discomfort) and HEADACHE (Headache). On an unknown date, the patient experienced PRURITUS (Arm became to itch incessantly), VACCINATION SITE ERYTHEMA (Injection site becoming red and puffy) and VACCINATION SITE PAIN (Injection site soreness). The patient was treated with NAPROXEN at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency; AVENA SATIVA FLUID EXTRACT (AVEENO) for Itch, at an unspecified dose and frequency; ISOPROPANOL (RUBBING ALCOHOL) for Itching, at an unspecified dose and frequency and MENTHOL (ABSORBINE JR) for Itching, at an unspecified dose and frequency. On 05-Mar-2021, HEADACHE (Headache) had resolved. On 06-Mar-2021, PAIN (Pain started from hip down to thigh in the back side of leg) had resolved. At the time of the report, LIMB DISCOMFORT (Problem with left leg), GAIT DISTURBANCE (Painful to walk), PRURITUS (Arm became to itch incessantly), INSOMNIA (Difficulty sleeping), DISCOMFORT (Has considerable amount of discomfort), VACCINATION SITE ERYTHEMA (Injection site becoming red and puffy) and VACCINATION SITE PAIN (Injection site soreness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2020, X-ray: unknown (Inconclusive) Thought it was torn meniscus. On an unknown date, Body temperature: elevated (High) Elevated.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow-up information received on 03-JUN-2021 contains significant information: Added patient demographics, medical history (allergy: Sulfa based medicine, current condition: Diabetes), 2nd dose of vaccine information, concomitant medications, treatment medications, new events "Injection site becoming red and puffy", "Injection site soreness", "Arm began to itch". The outcome of the events "Pain radiating from hip to upper thigh" and "Headache" changed from unknown to resolved.