Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: delayed injection site reaction that continue for a week still, although now it is fainting; reaction consisted of inflammation in the arm of the injection, it was red, hot, painful, itchy ,and burnt. It got worse by Tuesday, spread, became diffuse, but better around Wednesday. Now there is a faint ring around area affected; injection site that was red; injection site that was hot; injection site that was painful; injection site that was itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (delayed injection site reaction that continue for a week still, although now it is fainting), VACCINATION SITE INFLAMMATION (reaction consisted of inflammation in the arm of the injection, it was red, hot, painful, itchy ,and burnt. It got worse by Tuesday, spread, became diffuse, but better around Wednesday. Now there is a faint ring around area affected), VACCINATION SITE ERYTHEMA (injection site that was red), VACCINATION SITE WARMTH (injection site that was hot) and VACCINATION SITE PAIN (injection site that was painful) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Primary biliary cholangitis (Began ursodiol therapy when condition was diagnosed in 2020, but chronically elevated liver enzymes suggest that the condition.) on 06-Jan-2020. Concurrent medical conditions included Hypertension (Mild.Improvement since diagnosis; no change in valsartan dosage) since 01-May-2009 and Penicillin allergy. Concomitant products included VALSARTAN from 05-May-2009 to an unknown date for Hypertension, AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLLINE) from 15-Aug-2018 to an unknown date for Irritable bowel syndrome, MULTIVITAMINS & MINERALS PLUS LUTEIN for Nutritional supplement, URSODEOXYCHOLIC ACID (URSODIL) from 06-Jan-2020 to an unknown date for Primary biliary cholangitis.   On 07-Feb-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE REACTION (delayed injection site reaction that continue for a week still, although now it is fainting), VACCINATION SITE WARMTH (injection site that was hot), VACCINATION SITE PAIN (injection site that was painful) and VACCINATION SITE PRURITUS (injection site that was itchy). 15-Feb-2021, the patient experienced VACCINATION SITE INFLAMMATION (reaction consisted of inflammation in the arm of the injection, it was red, hot, painful, itchy ,and burnt. It got worse by Tuesday, spread, became diffuse, but better around Wednesday. Now there is a faint ring around area affected) and VACCINATION SITE ERYTHEMA (injection site that was red). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Adverse reaction, at an unspecified dose and frequency and HYDROCORTISONE (HYDROCORTISONE 1% IN ABSORBASE) for Adverse reaction to product, at an unspecified dose and frequency. On 22-Feb-2021, VACCINATION SITE REACTION (delayed injection site reaction that continue for a week still, although now it is fainting) and VACCINATION SITE INFLAMMATION (reaction consisted of inflammation in the arm of the injection, it was red, hot, painful, itchy ,and burnt. It got worse by Tuesday, spread, became diffuse, but better around Wednesday. Now there is a faint ring around area affected) had resolved and VACCINATION SITE ERYTHEMA (injection site that was red), VACCINATION SITE WARMTH (injection site that was hot), VACCINATION SITE PAIN (injection site that was painful) and VACCINATION SITE PRURITUS (injection site that was itchy) outcome was unknown.            This case was linked to MOD-2021-022333, MOD-2021-117565 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received Included second dose information, allergy, historical conditions, concomitant drugs, events. On 11-May-2021: NNI