Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Minor aches and pains all over body described as "achiness"; Tenderness around the injection site; lymph nodes swelling around the injection site with hardness felt when touching the lymph nodes; Fatigue; Headache; Lymph node hardness and swelling around the injection site; Itch around the injection site; Red rash around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itch around the injection site), VACCINATION SITE RASH (Red rash around the injection site), MYALGIA (Minor aches and pains all over body described as "achiness"), VACCINATION SITE PAIN (Tenderness around the injection site) and VACCINATION SITE LYMPHADENOPATHY (lymph nodes swelling around the injection site with hardness felt when touching the lymph nodes) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Palatal disorder (Problem with the roof of her mouth (May have started before or after first dose of vaccine patient can not recall).). Concomitant products included AMOXICILLIN, CLAVULANIC ACID (AUGMENTINE [AMOXICILLIN;CLAVULANIC ACID]) from 07-Mar-2021 to an unknown date for Palatal disorder, LEVOTHYROXINE, SIMVASTATIN, CICLOSPORIN (RESTASIS MULTIDOSE), MULTIVITAMINS [VITAMINS NOS], CALCIUM and CHONDROITIN SULFATE, GLUCOSAMINE (GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE;GLUCOSAMINE]) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itch around the injection site) and VACCINATION SITE RASH (Red rash around the injection site). On 06-Mar-2021, the patient experienced MYALGIA (Minor aches and pains all over body described as "achiness"), VACCINATION SITE PAIN (Tenderness around the injection site), FATIGUE (Fatigue), HEADACHE (Headache) and VACCINATION SITE SWELLING (Lymph node hardness and swelling around the injection site). 06-Mar-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (lymph nodes swelling around the injection site with hardness felt when touching the lymph nodes). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. On 09-Mar-2021, MYALGIA (Minor aches and pains all over body described as "achiness"), FATIGUE (Fatigue) and HEADACHE (Headache) had resolved. On 10-Mar-2021, VACCINATION SITE PAIN (Tenderness around the injection site), VACCINATION SITE LYMPHADENOPATHY (lymph nodes swelling around the injection site with hardness felt when touching the lymph nodes) and VACCINATION SITE SWELLING (Lymph node hardness and swelling around the injection site) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itch around the injection site) had not resolved and VACCINATION SITE RASH (Red rash around the injection site) was resolving.            This case was linked to MOD-2021-052322 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Reporter's contact details updated, route of administration updated.