Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site inflammation, Vaccination site irritation, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ORAL DISCOMFORT (Left side of mouth, jaw, neck, and left shoulder felt weird), MUSCULOSKELETAL DISCOMFORT (Left side of mouth, jaw, neck, and left shoulder felt weird), TENDERNESS (Arm tender shot sight became itchy, inflamed, and irritated), VACCINATION SITE IRRITATION (Arm tender shot sight became itchy, inflamed, and irritated.\) and DIARRHOEA (Severe vomiting and diarrhea) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced DIARRHOEA (Severe vomiting and diarrhea) and VOMITING (Severe vomiting and diarrhea). On 03-Jan-2022, the patient experienced ORAL DISCOMFORT (Left side of mouth, jaw, neck, and left shoulder felt weird), MUSCULOSKELETAL DISCOMFORT (Left side of mouth, jaw, neck, and left shoulder felt weird), ARTHRALGIA (Left side of mouth, jaw, neck, and left shoulder felt weird) and HEADACHE (Headaches). On 07-Jan-2022, the patient experienced TENDERNESS (Arm tender shot sight became itchy, inflamed, and irritated), VACCINATION SITE IRRITATION (Arm tender shot sight became itchy, inflamed, and irritated), VACCINATION SITE INFLAMMATION (Arm tender shot sight became itchy, inflamed, and irritated), VACCINATION SITE PRURITUS (Arm tender shot sight became itchy, inflamed, and irritated) and VACCINATION SITE SWELLING (Shot site was raised and the size of a half dollar). On 05-Jan-2022, DIARRHOEA (Severe vomiting and diarrhea) and VOMITING (Severe vomiting and diarrhea) had resolved. At the time of the report, ORAL DISCOMFORT (Left side of mouth, jaw, neck, and left shoulder felt weird), MUSCULOSKELETAL DISCOMFORT (Left side of mouth, jaw, neck, and left shoulder felt weird), TENDERNESS (Arm tender shot sight became itchy, inflamed, and irritated), VACCINATION SITE IRRITATION (Arm tender shot sight became itchy, inflamed, and irritated), VACCINATION SITE INFLAMMATION (Arm tender shot sight became itchy, inflamed, and irritated), ARTHRALGIA (Left side of mouth, jaw, neck, and left shoulder felt weird), VACCINATION SITE PRURITUS (Arm tender shot sight became itchy, inflamed, and irritated), VACCINATION SITE SWELLING (Shot site was raised and the size of a half dollar) and HEADACHE (Headaches) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DIARRHOEA (Severe vomiting and diarrhea) and VOMITING (Severe vomiting and diarrhea) to be related. No further causality assessments were provided for ORAL DISCOMFORT (Left side of mouth, jaw, neck, and left shoulder felt weird), MUSCULOSKELETAL DISCOMFORT (Left side of mouth, jaw, neck, and left shoulder felt weird), TENDERNESS (Arm tender shot sight became itchy, inflamed, and irritated), VACCINATION SITE IRRITATION (Arm tender shot sight became itchy, inflamed, and irritated), VACCINATION SITE INFLAMMATION (Arm tender shot sight became itchy, inflamed, and irritated), ARTHRALGIA (Left side of mouth, jaw, neck, and left shoulder felt weird), VACCINATION SITE PRURITUS (Arm tender shot sight became itchy, inflamed, and irritated), VACCINATION SITE SWELLING (Shot site was raised and the size of a half dollar) and HEADACHE (Headaches). No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter. This case was linked to MOD-2022-467332 (Patient Link).