Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Heat/hot to the touch; Hard knot at the injection site; Red; Achy arm,tenderness at the injection site; Swollen; Muscle aches; Was also experiencing mild body aches; Headache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Heat/hot to the touch), VACCINATION SITE MASS (Hard knot at the injection site), PAIN IN EXTREMITY (Sore arm), PAIN (Was also experiencing mild body aches) and VACCINATION SITE PAIN (Achy arm,tenderness at the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 010M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy, Drug allergy (Cefdinir), Blood pressure high and Acid reflux (esophageal). Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for Acid reflux (esophageal), LISINOPRIL for Blood pressure high, CALCIUM, COLECALCIFEROL (CALCIUM & VITAMIN D [CALCIUM;COLECALCIFEROL]) and VITAMINS NOS for an unknown indication.   On 14-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2011, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache). On 04-Nov-2021, the patient experienced PAIN (Was also experiencing mild body aches) and MYALGIA (Muscle aches). 04-Nov-2021, the patient experienced VACCINATION SITE SWELLING (Swollen). On 05-Nov-2021, the patient experienced VACCINATION SITE PAIN (Achy arm,tenderness at the injection site). On 06-Nov-2021, the patient experienced VACCINATION SITE WARMTH (Heat/hot to the touch), VACCINATION SITE MASS (Hard knot at the injection site) and VACCINATION SITE ERYTHEMA (Red). The patient was treated with IBUPROFEN for Vaccination site warmth, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Injection site reaction, at an unspecified dose and frequency. On 10-Nov-2021, PAIN (Was also experiencing mild body aches) and MYALGIA (Muscle aches) had resolved. On 10-Nov-2021 at 3:00 AM, VACCINATION SITE ERYTHEMA (Red) had resolved. On 11-Nov-2021 at 3:00 AM, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE SWELLING (Swollen) and HEADACHE (Headache) had resolved. On 11-Nov-2021 at 3:30 AM, VACCINATION SITE WARMTH (Heat/hot to the touch) had resolved. At the time of the report, VACCINATION SITE MASS (Hard knot at the injection site) had resolved and VACCINATION SITE PAIN (Achy arm,tenderness at the injection site) had not resolved.      Patient applied ice to the area. Within two days the symptoms were improved.  Patient reported that adverse events most likely caused by Moderna COVID-19 vaccine.   This case was linked to MOD-2021-378122, MOD-2021-378123 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Nov-2021: Follow up received and added concurrent conditions, allergies, added concomitant medications, Events sore arm, pain added, Events redness, swelling at injection site, Injection site are hot to touch onset date updated. Event vaccination site pain outcome updated from recovered to not recovered. Event vaccination site mass outcome updated from unknown to recovered.