Age: 72.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Body temperature increased, Burning sensation, Erythema, Feeling hot, Injection site pain
Clinical narrative: burning sensation in my scalp; increased warmth in an area about 5 inches below the site of vaccination; local pain/increased pain in an area about 5 inches below the vaccination site; disseminated rash/residual rash/ rash/generalized skin rash/ face also had the rash; local erythema/increased erythema in an area about 5 inches below the site of vaccination; local itching present/ itching ankles/ itching all over my body; swelling all over my body/arms and face; pitting edema/minimal edema/pitting edema more prominent in patient arms; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (local itching present/ itching ankles/ itching all over my body), SWELLING (swelling all over my body/arms and face), OEDEMA (pitting edema/minimal edema/pitting edema more prominent in patient arms), SKIN BURNING SENSATION (burning sensation in my scalp) and VACCINATION SITE WARMTH (increased warmth in an area about 5 inches below the site of vaccination) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (NSAIDs), Drug allergy (chlorthalidone) and Asthma.    On 09-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Sep-2022, the patient experienced SKIN BURNING SENSATION (burning sensation in my scalp), VACCINATION SITE WARMTH (increased warmth in an area about 5 inches below the site of vaccination), VACCINATION SITE PAIN (local pain/increased pain in an area about 5 inches below the vaccination site), RASH (disseminated rash/residual rash/ rash/generalized skin rash/ face also had the rash) and VACCINATION SITE ERYTHEMA (local erythema/increased erythema in an area about 5 inches below the site of vaccination). In September 2022, the patient experienced PRURITUS (local itching present/ itching ankles/ itching all over my body), SWELLING (swelling all over my body/arms and face) and OEDEMA (pitting edema/minimal edema/pitting edema more prominent in patient arms). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) on 11-Sep-2022 at a dose of 180 milligram. At the time of the report, PRURITUS (local itching present/ itching ankles/ itching all over my body) and RASH (disseminated rash/residual rash/ rash/generalized skin rash/ face also had the rash) had not resolved and SWELLING (swelling all over my body/arms and face), OEDEMA (pitting edema/minimal edema/pitting edema more prominent in patient arms), SKIN BURNING SENSATION (burning sensation in my scalp), VACCINATION SITE WARMTH (increased warmth in an area about 5 inches below the site of vaccination), VACCINATION SITE PAIN (local pain/increased pain in an area about 5 inches below the vaccination site) and VACCINATION SITE ERYTHEMA (local erythema/increased erythema in an area about 5 inches below the site of vaccination) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2022, Body temperature: increased temperature about 10 hrs after the vaccination that receded spontaneously.     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 drug information was provided. Patient had received dose 1 Moderna COVID-19 vaccine on 19Feb2021, lot number 024M20A, Dose 2 on 19Mar2021, lot number 006B21A, Dose 3 on 18Sep2021, lot number 048F21A and initial booster on 03Apr2022, lot number 002M21A. Patient was administered a 0.5 booster of Moderna COVID-19 vaccine. Patient had reported that the initial symptoms were mild. It was also reported that patient had a burning sensation in the face as face also had the rash. The patient was very close to going to the hospital and she was nervous about getting additional doses. It was reported that patient had experienced the similar events with chlorthalidone. On 11 Sep 2022, patient immediately took Allegra. she medicated herself because she was a doctor. Patient continued to take the Allegra, on 12 and 13 Sep2022. Patient still had rash, local itching with triple Lewis response when rubbing. Patient was going to see the doctor that afternoon. At the time of this report, patient had minimal symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2022: Follow-up received, New events added and I narrative was updated.