Reporte zur Charge 029L20A029L20A

Symptomtext

rash; itching; swollen; sore; tired; warmth; red rash at site of injection; redness; swelling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (red rash at site of injection), INJECTION SITE WARMTH (warmth), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE RASH (rash) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A029L20A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy (water blisters on hands) since 1960, Allergy to antibiotic (cipro, sore muscles, tingling) since 2004, Allergy to antibiotic (tetracycline) since 1997 and Allergy to antibiotic (sulfa, red itching rash, head to toe) since 1963. Concomitant products included SIMVASTATIN (ZOCOR) for Hypercholesteremia, ZOLPIDEM TARTRATE (AMBIEN) for Sleep problem, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), MULTIVITAMINS & MINERALS PLUS LUTEIN, ZINC, VITAMIN D3, CYANOCOBALAMIN (VITAMINE B12), VITAMIN C [ASCORBIC ACID] and PANTOPRAZOLE for an unknown indication. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling). On 01-Feb-2021, the patient experienced HYPERSENSITIVITY (red rash at site of injection). On 03-Feb-2021, the patient experienced INJECTION SITE WARMTH (warmth), VACCINATION SITE RASH (rash), VACCINATION SITE PRURITUS (itching), INJECTION SITE SWELLING (swollen), MYALGIA (sore) and FATIGUE (tired). The patient was treated with CORTISONE ongoing since an unknown date at an unspecified dose and frequency. On 27-Jan-2021, VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling) had resolved. On 08-Feb-2021, HYPERSENSITIVITY (red rash at site of injection) had resolved. At the time of the report, INJECTION SITE WARMTH (warmth), VACCINATION SITE RASH (rash), VACCINATION SITE PRURITUS (itching), INJECTION SITE SWELLING (swollen), MYALGIA (sore) and FATIGUE (tired) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the events were Not Applicable. No treatment drugs are not provided by reporter. Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Patient medical history was updated, New adverse event - hypersensitivity reaction was updated,Second dose information was updated.