Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Hypoaesthesia oral, Peripheral swelling, Pruritus, Vaccination site erythema
Clinical narrative: Cellulitis; Itchy; Hot to the touch around the injection site; Left arm swelling; A hard lump; 4"x3" big red area; Pain in center of injection site; Lower lip got numb; This spontaneous case was reported by a nurse and describes the occurrence of CELLULITIS (Cellulitis) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypertension since an unknown date, GERD and Bowel dysfunction. Concomitant products included FISH OIL for Cholesterol, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) from an unknown date to 20-May-2021 for GERD, LISINOPRIL for Hypertension, VITAMIN D3 for Vitamin D deficiency, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) and VITAMIN E NOS for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced HYPOAESTHESIA ORAL (Lower lip got numb). On 15-Jan-2021, the patient experienced PRURITUS (Itchy), VACCINATION SITE WARMTH (Hot to the touch around the injection site), PERIPHERAL SWELLING (Left arm swelling), VACCINATION SITE MASS (A hard lump), VACCINATION SITE ERYTHEMA (4"x3" big red area) and VACCINATION SITE PAIN (Pain in center of injection site). On an unknown date, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 08-Feb-2021, CELLULITIS (Cellulitis), PRURITUS (Itchy), VACCINATION SITE WARMTH (Hot to the touch around the injection site), PERIPHERAL SWELLING (Left arm swelling), VACCINATION SITE MASS (A hard lump), VACCINATION SITE ERYTHEMA (4"x3" big red area) and VACCINATION SITE PAIN (Pain in center of injection site) had resolved. At the time of the report, HYPOAESTHESIA ORAL (Lower lip got numb) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included 7- day course of antibiotics.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MODERNATX, INC.-MOD-2021-079616 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Patient details, medical history, dosing details and 2 events added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. MODERNATX, INC.-MOD-2021-079616:Second dose