Reporte zur Charge 025J202A/039K20

Symptomtext

Site reaction at injection site was red; Site reaction at injection site was swollen; Site reaction at injection site was hot; Bumpy rash on her neck; Skin on her face had a sandpaper feeling, chapped; Lower eye puffy; Lower eye reddish; Red face; Swollen face and cheeks; Hive on face; A spontaneous report was received from a nurse concerning a 48-year-old female patient, who was the patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced eye swelling, eye redness, neck rash, dry skin face, injection site warmth, hive on face, face and cheek swelling, injection site redness, and injection site swelling. The patient's medical history, as provided by the reported, included hives. No relevant concomitant medications were reported. On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Batch/Lot Number: 025J202A/039K20A) in her right deltoid for prophylaxis of COVID-19 infection. On 29 Dec 2020, the patient had a dime-sized raised hive on her face. Treatment included cetirizine. On 30 Dec 2020, the patient's lower eye was puffy and red; it looked like she was punched in the face. She took cetirizine and famotidine. Her face got redder and more swollen, so she took more famotidine. The patient's eyes, nose, and cheeks were swollen. On 31 Dec 2020, the patient went to urgent care and was prescribed prednisone. She also took diphenhydramine. She developed a bumpy rash on her neck which cleared up. The patient's skin was dry and chapped. On 06 Jan 2020, the patient's symptoms were back to normal after tapering off the steroids. The patient was still experiencing a hot, red, and swollen injection site reaction. She didn't have facial fillers. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, eye swelling, eye redness, neck rash, dry skin face, hive on face, face and cheek swelling, was considered recovered/resolved on 06 Jan 2021. The outcome of the events, injection site redness, injection site warmth, and injection site swelling, was considered not recovered/resolved.; Reporter's Comments: This case concerns a 48-year-old female patient with medical history of hives, who received their first of two planned doses of mRNA-1273 (Lot 025J202A/039K20A), and who experienced the non-serious listed events of injection site redness and injection site swelling, and experienced the non-serious unlisted events of eye swelling, eye redness, neck rash, dry skin, injection site warmth, hive on face, face and cheek swelling, and erythema (face). Based on the current available information and temporal association between the use of the product and the onset of events starting on the day of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine. The patient's medical history of hives remains a confounder for the events.