Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site pain, Vaccination site rash
Clinical narrative: the skin around the elbow is extremely sore; Hot skin; hurts to bend it; pain; stiffness in elbow; skin around the elbow is itchy; It looked like I had a bad sunburn; rash got worse; My arm swelled so badly; my right shoulder to 2 inches below the right elbow; rash right bicep right; Hives right arm and shoulder localized; Pain at injection site (right arm); Lip tingled immediately after injection; numbness in right cheek; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site (right arm)), PARAESTHESIA ORAL (Lip tingled immediately after injection), HYPOAESTHESIA (numbness in right cheek), VACCINATION SITE RASH (rash right bicep right) and URTICARIA (Hives right arm and shoulder localized) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLERGIA [FEXOFENADINE HYDROCHLORIDE]) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site (right arm)), PARAESTHESIA ORAL (Lip tingled immediately after injection) and HYPOAESTHESIA (numbness in right cheek). On 24-Mar-2021, the patient experienced VACCINATION SITE RASH (rash right bicep right) and URTICARIA (Hives right arm and shoulder localized). On 30-Mar-2021, the patient experienced RASH (rash got worse), PERIPHERAL SWELLING (My arm swelled so badly), RASH (my right shoulder to 2 inches below the right elbow) and SUNBURN (It looked like I had a bad sunburn). On 12-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness in elbow), PRURITUS (skin around the elbow is itchy), PAIN (hurts to bend it) and PAIN (pain). On an unknown date, the patient experienced FEELING HOT (Hot skin) and ARTHRALGIA (the skin around the elbow is extremely sore). Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient has administered Tylenol . nurse has prescribed chlorpheniramine maleate 4mg, Hydrocortisone 2.5% cream. Nurse practitioner gave 12 days of Prednisone (finished on 12Apr2021), Triamcinolone Acetonide ointment to put in my arm to cover it, and also advised to use cold compresses.   This case was linked to MOD21-076493 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Added email ,events. On 12-May-2021: Added address; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded. Vaccination site pain, vaccination site rash and rash are consistent with the known safety profile of the vaccine. MOD21-076493:CROSSLINKED