Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Skin burning sensation, Skin ulcer
Clinical narrative: sore hip; ulcer on her hip and an ulcer on her upper, posterior thigh close to the size of a quarter; Burning skin; This case was initially received via an unknown source (no reference has been entered for a license partner) on 08-Jan-2021. The most recent information was received on 30-Mar-2021 and was forwarded to Moderna on 30-Mar-2021.    This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (sore hip), SKIN ULCER (ulcer on her hip and an ulcer on her upper, posterior thigh close to the size of a quarter) and SKIN BURNING SENSATION (Burning skin) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 030L20A) for COVID-19 vaccination.   Concurrent medical conditions included Penicillin allergy and Iodine allergy. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for LDH, PARACETAMOL (TYLENOL) for Pain, MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.  On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Dec-2020, the patient experienced MUSCULOSKELETAL DISCOMFORT (sore hip), SKIN ULCER (ulcer on her hip and an ulcer on her upper, posterior thigh close to the size of a quarter) and SKIN BURNING SENSATION (Burning skin). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. On 05-Feb-2021, MUSCULOSKELETAL DISCOMFORT (sore hip) was resolving and SKIN ULCER (ulcer on her hip and an ulcer on her upper, posterior thigh close to the size of a quarter) and SKIN BURNING SENSATION (Burning skin) had resolved.  mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Treatment over the counter bacitracin, Vitamin C 1000mg twice a day. treatment as dr said to use hydrocortisone cream on wound.  It was reported that the patient had checked in mirror and found left posterior thigh with open sore. Left hip size of quarter deep and red with pus. Healed inside to outside about six weeks later. The thigh ulcer not bad as hip ulcer.  Company Comment: This case concerns a 57-year-old female who experienced nonserious unexpected events of pain and skin ulcer.  Event onset occurred 3 days after the first dose of mRNA-1273. Treatment with Bacitracin. Events resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Follow-up information received on 30-Mar-2021 contains patient's demographics, allergic reactions, additional dosing regimen, concomitant drugs, outcome of the events, and treatment medications.; Sender's Comments: This case concerns a 57-year-old female who experienced nonserious unexpected events of pain and skin ulcer.  Event onset occurred 3 days after the first dose of mRNA-1273. Treatment with Bacitracin. Events resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded