Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Inappropriate schedule of product administration, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: Patient got the vaccine on 27Apr2021; her arm started to get swollen; The rash came back, but worse; her arm started to get swollen and was very painful; body was sore to the touch; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got the vaccine on 27Apr2021), PERIPHERAL SWELLING (her arm started to get swollen), CONDITION AGGRAVATED (The rash came back, but worse), PAIN IN EXTREMITY (her arm started to get swollen and was very painful) and MYALGIA (body was sore to the touch) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Lot# C007C21A and 042L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CRATAEGUS LAEVIGATA, MAGNESIUM CITRATE, PLECTRANTHUS HADIENSIS, THEANINE, THEOBROMA CACAO (HIGH BLOOD PRESSURURE), ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) and BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS, LACTOBACILLUS RHAMNOSUS (PROBIOTICS [BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced PERIPHERAL SWELLING (her arm started to get swollen), CONDITION AGGRAVATED (The rash came back, but worse), PAIN IN EXTREMITY (her arm started to get swollen and was very painful) and MYALGIA (body was sore to the touch). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got the vaccine on 27Apr2021). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF) ongoing since an unknown date at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) ongoing since an unknown date at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) ongoing since an unknown date at an unspecified dose and frequency. On 10-May-2021, PERIPHERAL SWELLING (her arm started to get swollen), CONDITION AGGRAVATED (The rash came back, but worse), PAIN IN EXTREMITY (her arm started to get swollen and was very painful) and MYALGIA (body was sore to the touch) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got the vaccine on 27Apr2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   steroid shot used for treatment, delayed reaction was observed both time   This case was linked to MOD-2021-029157 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Non-Significant follow up updated on 06-Jul-2021