Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Hypersensitivity, Limb discomfort, Myalgia
Clinical narrative: Hypersensitivity reaction; Redness/erythema; Rash that is not itchy/rash broke out week later; Nausea; Vomiting; Chills; Lite fever; Arm was kinda heavy/Arm became heavier; Sharp pain in the muscle that comes and goes; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm was kinda heavy/Arm became heavier), HYPERSENSITIVITY (Hypersensitivity reaction), ERYTHEMA (Redness/erythema), RASH (Rash that is not itchy/rash broke out week later) and MYALGIA (Sharp pain in the muscle that comes and goes) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu (high fever for several days, throwing up and body aches) in 2014. Past adverse reactions to the above products included Fever with Flu. Concurrent medical conditions included Hashimoto's disease since 2018, Autoimmune hypothyroidism since 2018, Chronic sinusitis since 2008, Fatigue (Using energy med from doctor (started in last few weeks)) since 2020, Drug allergy (Cough syrup, Aspirin), Skin rash (poison ivy spread and blistered over a month over both arms) since 04-Jun-2021 and Skin rash (tick bite caused rash for up to 6 inches for about a week) since 28-May-2021. Concomitant products included ETHINYLESTRADIOL, NORETHISTERONE (ORTHO [ETHINYLESTRADIOL;NORETHISTERONE]) for Birth control, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for Thyroid disorder NOS.    On 29-Apr-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced MYALGIA (Sharp pain in the muscle that comes and goes). On 05-May-2021, the patient experienced LIMB DISCOMFORT (Arm was kind a heavy/Arm became heavier). On an unknown date, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction), ERYTHEMA (Redness/erythema), RASH (Rash that is not itchy/rash broke out week later), NAUSEA (Nausea), VOMITING (Vomiting), CHILLS (Chills) and PYREXIA (Lite fever). The patient was treated with IBUPROFEN at a dose of 1 dosage form and CALAMINE at a dose of 1 dosage form. At the time of the report, LIMB DISCOMFORT (Arm was kind a heavy/Arm became heavier), HYPERSENSITIVITY (Hypersensitivity reaction), ERYTHEMA (Redness/erythema), RASH (Rash that is not itchy/rash broke out week later), MYALGIA (Sharp pain in the muscle that comes and goes), NAUSEA (Nausea), VOMITING (Vomiting), CHILLS (Chills) and PYREXIA (Lite fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered LIMB DISCOMFORT (Arm was kind a heavy/Arm became heavier), ERYTHEMA (Redness/erythema), RASH (Rash that is not itchy/rash broke out week later), MYALGIA (Sharp pain in the muscle that comes and goes), NAUSEA (Nausea), VOMITING (Vomiting), CHILLS (Chills) and PYREXIA (Lite fever) to be possibly related. No further causality assessment was provided for HYPERSENSITIVITY (Hypersensitivity reaction).    Treatment included ibuprofen, ice pack and cream for rash/ itching (though no itching).   This case was linked to MOD-2021-219969 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Patient's demographic details, Patient's allergy history and past medical history, Dose 2 details, Concomitant's details, New events and outcome of all events were added. On 14-Jun-2021: Non-significant Follow up Appended - NNI Received.