Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Erythema, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: redness in approximately 50 % of left arm; hot injection site; sore injection site; injection site is still a little swollen ,hot and red; injection site is still a little swollen ,hot and red; fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness in approximately 50 % of left arm), VACCINATION SITE WARMTH (hot injection site), VACCINATION SITE PAIN (sore injection site), VACCINATION SITE ERYTHEMA (injection site is still a little swollen ,hot and red) and VACCINATION SITE SWELLING (injection site is still a little swollen ,hot and red) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included High cholesterol on 06-Jan-2011 and Basal cell carcinoma on 06-Feb-2001. Concurrent medical conditions included Penicillin allergy and Seasonal allergy (pollen). Concomitant products included CETIRIZINE HYDROCHLORIDE from 03-Jan-2011 to an unknown date for Allergy, ATORVASTATIN and FISH OIL from 03-Jan-2011 to an unknown date for Cholesterol, MULTIVITAMIN [VITAMINS NOS] from 01-Jan-1980 to an unknown date for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced PYREXIA (fever) and CHILLS (Chills). On 28-Mar-2021, the patient experienced VACCINATION SITE WARMTH (hot injection site), VACCINATION SITE PAIN (sore injection site) and VACCINATION SITE ERYTHEMA (injection site is still a little swollen ,hot and red). 28-Mar-2021, the patient experienced VACCINATION SITE SWELLING (injection site is still a little swollen ,hot and red). On 31-Mar-2021, the patient experienced ERYTHEMA (redness in approximately 50 % of left arm). On 05-Apr-2021, ERYTHEMA (redness in approximately 50 % of left arm) had resolved. At the time of the report, VACCINATION SITE WARMTH (hot injection site), VACCINATION SITE PAIN (sore injection site), VACCINATION SITE ERYTHEMA (injection site is still a little swollen ,hot and red) and VACCINATION SITE SWELLING (injection site is still a little swollen ,hot and red) outcome was unknown and PYREXIA (fever) and CHILLS (Chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   treatment included Tylenol. Action taken with  mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-062360 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: Follow up information received on 15-May-2021: patient demographics added, concomitant medications added, medical history added, event outcome updated for fever, chills and redness.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-062360: