Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: redness in the injection site in the right arm; arm swollen; extremely itchy; pain; nausea; fever; aches; chills; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (extremely itchy), PAIN (pain), VACCINATION SITE ERYTHEMA (redness in the injection site in the right arm), VACCINATION SITE SWELLING (arm swollen) and NAUSEA (nausea) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7163B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient did not received other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient never had COVID positive test or diagnosis.  Concurrent medical conditions included Dust allergy, Hypothyroidism (20 years ago) and Acid reflux (esophageal). Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, ROSUVASTATIN CALCIUM (CRESTOR), VITAMIN D NOS, AMLODIPINE and PARACETAMOL (TYLENOL) for an unknown indication.    On 05-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Oct-2022, the patient experienced PAIN (pain), NAUSEA (nausea), PYREXIA (fever), MYALGIA (aches) and CHILLS (chills). On 07-Oct-2022, the patient experienced VACCINATION SITE PRURITUS (extremely itchy), VACCINATION SITE ERYTHEMA (redness in the injection site in the right arm) and VACCINATION SITE SWELLING (arm swollen). The patient was treated with CORTISONE at a dose of 3 times a day. On 07-Oct-2022, PAIN (pain), NAUSEA (nausea), PYREXIA (fever), MYALGIA (aches) and CHILLS (chills) had resolved. On 10-Oct-2022, VACCINATION SITE SWELLING (arm swollen) had resolved. At the time of the report, VACCINATION SITE PRURITUS (extremely itchy) and VACCINATION SITE ERYTHEMA (redness in the injection site in the right arm) was resolving.            Patient height was reported as 5 feet and 2 inches.  It was reported that on 10 Feb 2021 patient received first dose of Moderna COVID-19 Vaccine with LOT number 015M20A and expiration date as unknown. On 12 Mar 2021 patient received second dose of Moderna COVID-19 Vaccine with LOT number 048A21A and expiration date as unknown. On 26 Nov 2021 patient received  first booster of Moderna COVID-19 Vaccine with LOT number 031H21A and expiration date as unknown.   After receiving bivalent booster patient experienced nausea, fever, aches, pain and chills during 2 days on 07 Oct 2022 and experienced redness in the injection site in the right arm, was swollen and extremely itch used Cortisone 3 times a day. On 10 Oct 2022 patient called to the pharmacy and asked for medical advise, treatment given was Claritin. Currently redness was almost resolved but itchiness was still ongoing but improving. Patient did not experienced a similar event in the past.  Treatment medication also included Claritin.   This case was linked to MOD-2022-657160 (Patient Link).