Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: pretty strong reaction which includes injection is quite warm, red, and itchy; soreness; sore throat; pretty strong reaction which includes injection is quite warm, red, and itchy; pretty strong reaction which includes injection is quite warm, red, and itchy; fatigue; headache; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE WARMTH (pretty strong reaction which includes injection is quite warm, red, and itchy), PAIN (soreness), OROPHARYNGEAL PAIN (sore throat), INJECTION SITE PRURITUS (pretty strong reaction which includes injection is quite warm, red, and itchy) and INJECTION SITE ERYTHEMA (pretty strong reaction which includes injection is quite warm, red, and itchy) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A57644C) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Patient had no relevant medical history, allergy, concomitant diseases and risk factor. It was reported that patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (1st dose , Lot 037K20A) on 17-Jan-2021, MODERNA COVID-19 VACCINE (2nd dose , Lot 041L20A) on 13-Feb-2021, Moderna COVID-19 Vaccine (3rd dose , Lot 046C21A) on 22-Oct-2021, Moderna COVID-19 Vaccine (4th dose , Lot 058A22A) on 02-Jun-2022, Moderna COVID-19 Vaccine (5th dose  and A57148B) on 09-Sep-2022. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 01-Aug-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Aug-2023, the patient experienced INJECTION SITE WARMTH (pretty strong reaction which includes injection is quite warm, red, and itchy), PAIN (soreness), OROPHARYNGEAL PAIN (sore throat), INJECTION SITE PRURITUS (pretty strong reaction which includes injection is quite warm, red, and itchy), INJECTION SITE ERYTHEMA (pretty strong reaction which includes injection is quite warm, red, and itchy), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, INJECTION SITE WARMTH (pretty strong reaction which includes injection is quite warm, red, and itchy), PAIN (soreness), OROPHARYNGEAL PAIN (sore throat), INJECTION SITE PRURITUS (pretty strong reaction which includes injection is quite warm, red, and itchy), INJECTION SITE ERYTHEMA (pretty strong reaction which includes injection is quite warm, red, and itchy), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Suspect product dosage text was reported as unknown. No treatment medication was reported.