Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site discomfort, Vaccination site rash
Clinical narrative: Hypersensitivity reaction; Rash on her left arm below the injection site. Since that time the rash has spread downward and outward around her arm. The muscles underneath the rash are very very tender and the rash is hot to the touch; Chills; Fever; Nausea; Body aches; Shoulder aches; Flu like symptoms; With the first injection I could feel the liquid enter my body; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE DISCOMFORT (With the first injection I could feel the liquid enter my body), HYPERSENSITIVITY (Hypersensitivity reaction), VACCINATION SITE RASH (Rash on her left arm below the injection site. Since that time the rash has spread downward and outward around her arm. The muscles underneath the rash are very very tender and the rash is hot to the touch) and CHILLS (Chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypersensitivity, Hives, GERD (Now Fructore Malabsorption) since 01-Jan-2015, Allergy to metals (red bumps) since 01-Jan-1970, Drug allergy (dermatitis) since 01-Jan-1951, Plant skin sensitivity (resh/dermatitis) since 20-Jul-2018 and Allergy to metals (rash dermatitis) since 20-Jul-2018.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE DISCOMFORT (With the first injection I could feel the liquid enter my body). On 21-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nausea), MYALGIA (Body aches) and ARTHRALGIA (Shoulder aches). On 22-Feb-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction) and VACCINATION SITE RASH (Rash on her left arm below the injection site. Since that time the rash has spread downward and outward around her arm. The muscles underneath the rash are very very tender and the rash is hot to the touch). The patient was treated with ANTIHISTAMINES (oral) on 20-Feb-2021 for Hypersensitivity reaction, at a dose of 1 dosage form. On 22-Feb-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nausea), MYALGIA (Body aches) and ARTHRALGIA (Shoulder aches) had resolved. On 01-Mar-2021, HYPERSENSITIVITY (Hypersensitivity reaction) and VACCINATION SITE RASH (Rash on her left arm below the injection site. Since that time the rash has spread downward and outward around her arm. The muscles underneath the rash are very very tender and the rash is hot to the touch) had resolved. At the time of the report, VACCINATION SITE DISCOMFORT (With the first injection I could feel the liquid enter my body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HYPERSENSITIVITY (Hypersensitivity reaction) to be possibly related. No further causality assessments were provided for INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE DISCOMFORT (With the first injection I could feel the liquid enter my body), VACCINATION SITE RASH (Rash on her left arm below the injection site. Since that time the rash has spread downward and outward around her arm. The muscles underneath the rash are very very tender and the rash is hot to the touch), CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nausea), MYALGIA (Body aches) and ARTHRALGIA (Shoulder aches).    Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-246703 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Significant Follow up Appended - New events added and medical history updated. On 29-Jul-2021: Additional information added include no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.