Age: 66.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Exfoliative rash
Clinical narrative: peeling scaly rash; This spontaneous case was reported by an other health care professional and describes the occurrence of EXFOLIATIVE RASH (peeling scaly rash) in a 66-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 207H23A) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (INFLUENZA) for an unknown indication.    Previously administered products included for Product used for unknown indication: covid-19 vaccine (dose 2) in 2021 and covid-19 vaccine (dose 1) in 2021. Past adverse reactions to the above products included No adverse effect with covid-19 vaccine and covid-19 vaccine. Concurrent medical conditions included Drug allergy (allergies: hydrocodone, oxycodone and prednisone) and Penicillin allergy.   On 06-Sep-2024, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter and dose of INFLUENZA VACCINE (INFLUENZA) (unknown route) 1 dosage form. On 07-Sep-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced EXFOLIATIVE RASH (peeling scaly rash). The patient was treated with PARAFFIN (VASELINE [PARAFFIN]) in September 2024 at an unspecified dose and frequency; FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) in September 2024 at an unspecified dose and frequency and SALICYLIC ACID (EUCERIN [SALICYLIC ACID]) in September 2024 at an unspecified dose and frequency. At the time of the report, EXFOLIATIVE RASH (peeling scaly rash) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported. The day after the vaccine, she began to have blisters on her face, from her eyelids down to her chin. HCP described it as a peeling scaly rash and states that she was certain it was from the Moderna booster. She never had any reactions before and had the two initial doses in 2021. The dried blisters surrounded her eyes and she had peeled some of the skin off. It was just area from her eyelids down to her chin, not on her forehead. The current state of her face was that it was super dry, hard and scaly, like a blister would feel. She applied vaseline on her face and the HCP prescribed her Allegra and Eucerin cream. Reporter causality was not reported.  Company comment: This spontaneous case concerns a 66-year-old female patient, with medical history of drug allergies to hydrocodone, oxycodone, prednisone and penicillin, who experienced the unexpected and non-serious AESI of exfoliative rash, on the following day of one dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) vaccine, received as the third dose of the COVID-19 vaccine schedule. No brand of the previous doses was provided. She began to have blisters on her face, from her eyelids down to her chin. She was treated with vaseline paraffin, fexofenadine hydrochloride and salicylic acid but the event had not resolved. No further clinical information was available for medical review. Patient´s medical history of drug allergy and the co-suspect INFLUENZA VACCINE, received on the same day of mRNA-1273.815 remain as confounders for the event. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) vaccine is not affected by this report.