Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: had red spots on the body that doesnot consider related because they went away with a cream; Swelling(little bump) at injection site; Swelling at injection site; Itching at the injection site; Redness at injection site/ some little red spots here and there; Bruising at the injection site; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), VACCINATION SITE BRUISING (Bruising at the injection site), ERYTHEMA (had red spots on the body that doesnot consider related because they went away with a cream), VACCINATION SITE INDURATION (Swelling(little bump) at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy. Concomitant products included SITAGLIPTIN PHOSPHATE (JANUVIA), MONTELUKAST, GLIMEPIRIDE, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), SIMVASTATIN and LISINOPRIL for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE BRUISING (Bruising at the injection site), VACCINATION SITE INDURATION (Swelling(little bump) at injection site), VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site/ some little red spots here and there). 06-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at injection site). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm) and ERYTHEMA (had red spots on the body that doesnot consider related because they went away with a cream). At the time of the report, PAIN IN EXTREMITY (Pain in arm), VACCINATION SITE BRUISING (Bruising at the injection site) and ERYTHEMA (had red spots on the body that doesnot consider related because they went away with a cream) had resolved, VACCINATION SITE INDURATION (Swelling(little bump) at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PRURITUS (Itching at the injection site) outcome was unknown and VACCINATION SITE ERYTHEMA (Redness at injection site/ some little red spots here and there) had not resolved.            No treatment medications were reported. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to, INC.-MOD-2021-103056 (E2B Linked Report). This case was linked to MOD-2021-102790 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up received on 04-MAY-2021 Contains age was changed, updated other relevant history (penicillin allergy), added 1st dose vaccine information and concomitant medications, event was added(pain), updated duration and outcome of the event. On 07-Jun-2021: Non-significant follow up Received on 07-JUN-2021 Contains no new information.; Sender's Comments: INC.-MOD-2021-103056: