Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: Every subsequent COVID injection thereafter, has gotten worse in intensity; Patient noted the site to become reddened, firm, and itchy around the injection site; Patient noted the site to become reddened, firm, and itchy around the injection site; Patient noted the site to become reddened, firm, and itchy around the injection site; This spontaneous case was reported by a nurse and describes the occurrence of CONDITION AGGRAVATED (Every subsequent COVID injection thereafter, has gotten worse in intensity), VACCINATION SITE PRURITUS (Patient noted the site to become reddened, firm, and itchy around the injection site), VACCINATION SITE ERYTHEMA (Patient noted the site to become reddened, firm, and itchy around the injection site) and VACCINATION SITE INDURATION (Patient noted the site to become reddened, firm, and itchy around the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054A22A, 039D21A, 031A21A and 002A21A) for COVID-19 prophylaxis.     It was unknown if patient had acute illnesses at the time of vaccination and up to one month before.  It was unknown  if patient had ever been diagnosed with/ tested positive for COVID-19.  It was unknown if patient had chronic or long-standing health conditions.  Concurrent medical conditions included Allergy to chemicals (Thiomersal allergy). Concomitant products included INFLUENZA VACCINE INACT SPLIT 4V (QUADRIVALENT INFLUENZA VACCINE) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 15-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION SITE PRURITUS (Patient noted the site to become reddened, firm, and itchy around the injection site), VACCINATION SITE ERYTHEMA (Patient noted the site to become reddened, firm, and itchy around the injection site) and VACCINATION SITE INDURATION (Patient noted the site to become reddened, firm, and itchy around the injection site). On an unknown date, the patient experienced CONDITION AGGRAVATED (Every subsequent COVID injection thereafter, has gotten worse in intensity). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, CONDITION AGGRAVATED (Every subsequent COVID injection thereafter, has gotten worse in intensity) outcome was unknown and VACCINATION SITE PRURITUS (Patient noted the site to become reddened, firm, and itchy around the injection site), VACCINATION SITE ERYTHEMA (Patient noted the site to become reddened, firm, and itchy around the injection site) and VACCINATION SITE INDURATION (Patient noted the site to become reddened, firm, and itchy around the injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered CONDITION AGGRAVATED (Every subsequent COVID injection thereafter, has gotten worse in intensity), VACCINATION SITE PRURITUS (Patient noted the site to become reddened, firm, and itchy around the injection site), VACCINATION SITE ERYTHEMA (Patient noted the site to become reddened, firm, and itchy around the injection site) and VACCINATION SITE INDURATION (Patient noted the site to become reddened, firm, and itchy around the injection site) to have an unknown relationship.    It was reported that with the first COVID injection she noted the site to become reddened, firm, and itchy around the injection site and with every subsequent COVID injection thereafter, had gotten worse in intensity.   This case was linked to US-MODERNATX, INC.-MOD-2023-712561 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2023: Follow up received contains significant information: Updated patient demographics, medical history, allergy, suspect product dose details, route of administration, treatment medication, events, reporter causality and case narrative. Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712561:(Bivalent Dose Case)