Age: 78.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Body temperature, Chills, Erythema, Hyperhidrosis, Pyrexia
Clinical narrative: She had a bruise in the site of injection (left arm); Her neck and the top of her chest was red; Her neck and the top of her chest was red and blotchy; She woke up sweating; Fever of 100 degree F; Chills; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE BRUISING (She had a bruise in the site of injection (left arm)), ERYTHEMA (Her neck and the top of her chest was red), HYPERHIDROSIS (She woke up sweating), PYREXIA (Fever of 100 degree F) and CHILLS (Chills) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Concurrent medical conditions included Drug allergy (Morphine), Drug allergy (Estrace), Ragweed allergy and Borderline diabetes (Several years, status: controlled). Concomitant products included VITAMINS NOS, FAMOTIDINE, MONTELUKAST, FENOFIBRATE, LISINOPRIL and ESCITALOPRAM for an unknown indication.   On 21-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 21-Sep-2022, the patient experienced HYPERHIDROSIS (She woke up sweating), PYREXIA (Fever of 100 degree F) and CHILLS (Chills). On 23-Sep-2022, the patient experienced VACCINATION SITE BRUISING (She had a bruise in the site of injection (left arm)), ERYTHEMA (Her neck and the top of her chest was red) and RASH MACULAR (Her neck and the top of her chest was red and blotchy). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Chills, at an unspecified dose and frequency. On 22-Sep-2022, HYPERHIDROSIS (She woke up sweating), PYREXIA (Fever of 100 degree F) and CHILLS (Chills) had resolved. At the time of the report, VACCINATION SITE BRUISING (She had a bruise in the site of injection (left arm)), ERYTHEMA (Her neck and the top of her chest was red) and RASH MACULAR (Her neck and the top of her chest was red and blotchy) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Sep-2022, Body temperature: 100 degree Fahrenheit.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Patient received first dose of moderna vaccine on 02-Feb-2021 with lot number 011M20A Patient received second dose of moderna vaccine on 02-Mar-2021 with lot number 029A21A. Patient received first booster dose of moderna vaccine on 27-Oct-2021 with lot number 091D21A and expiration date of 12-Feb-2022 Patient received second booster dose of moderna vaccine on 07-Apr-2022.  After previous shots everything was fine and patient did not experience any symptoms, but after bivalent booster patient experience symptoms. On 21-Sep-2022, during the night patient experienced fever of 100 degree F, chills and took Tylenol and went to bed but after a while patient woke up sweating. Next morning patient felt fine  On 23-Sep-2022, the patient noticed that neck and the top of her chest was red and blotchy and had a bruise in the site of injection (left arm), these symptoms were still ongoing.