Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chapped lips, Cheilitis, Feeding disorder, Oral mucosal eruption, Rash erythematous
Clinical narrative: could not eat or drink; lips were all cuts and sores; body had skin peeling/arms, legs, and lower back peeled 3 times/upper arms and back peeled twice; lips were all cuts and sores; rash affected mouth; bright red legs, rash started out behind my knees/skin looked like sunburn; This spontaneous case was reported by a patient and describes the occurrence of RASH ERYTHEMATOUS (bright red legs, rash started out behind my knees/skin looked like sunburn), FEEDING DISORDER (could not eat or drink), CHAPPED LIPS (lips were all cuts and sores), SKIN EXFOLIATION (body had skin peeling/arms, legs, and lower back peeled 3 times/upper arms and back peeled twice), CHEILITIS (lips were all cuts and sores) and ORAL MUCOSAL ERUPTION (rash affected mouth) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 011M20A and 002B21A) for COVID-19 vaccination.     Concomitant products included DILTIAZEM, METOPROLOL SUCCINATE and MESALAMINE for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH ERYTHEMATOUS (bright red legs, rash started out behind my knees/skin looked like sunburn) (seriousness criterion hospitalization). On an unknown date, the patient experienced FEEDING DISORDER (could not eat or drink) (seriousness criterion hospitalization), CHAPPED LIPS (lips were all cuts and sores) (seriousness criterion hospitalization), SKIN EXFOLIATION (body had skin peeling/arms, legs, and lower back peeled 3 times/upper arms and back peeled twice) (seriousness criterion hospitalization), CHEILITIS (lips were all cuts and sores) (seriousness criterion hospitalization) and ORAL MUCOSAL ERUPTION (rash affected mouth) (seriousness criterion hospitalization). The patient was hospitalized for 6 days due to CHAPPED LIPS, CHEILITIS, FEEDING DISORDER, ORAL MUCOSAL ERUPTION, RASH ERYTHEMATOUS and SKIN EXFOLIATION. The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (bright red legs, rash started out behind my knees/skin looked like sunburn), FEEDING DISORDER (could not eat or drink), CHAPPED LIPS (lips were all cuts and sores), SKIN EXFOLIATION (body had skin peeling/arms, legs, and lower back peeled 3 times/upper arms and back peeled twice), CHEILITIS (lips were all cuts and sores) and ORAL MUCOSAL ERUPTION (rash affected mouth) outcome was unknown.            The patient received her first and second Moderna Covid-19 vaccine in her left arm shoulder deltoid muscle. She experienced no adverse reactions with the first and second Moderna Covid-19 vaccine. She experienced a rash two weeks after receiving the booster dose. On 03 Dec 2021, she woke up with bright red legs. The rash started out behind her knees on 03 Dec 2021. She went to urgent care on 07 Dec 2021 and the physician placed patient on PREDNISONE. The rash started spreading throughout her body on 08 Dec 2021. Some of her skin looked like a sunburn. The patient followed up with her physician and the physician had the patient admitted to the hospital. The patient was in the hospital for six days. The rash affected her mouth in such a way that she could not eat or drink. Her lips were all cuts and sores. Most of her body had skin peeling. Her arms, legs, and lower back peeled a lot. Her arms, legs, and lower back peeled three times. Her upper arms and back peeled twice. Concomitant medications also included antibiotics and steroid cream.  Company Comment:  This spontaneous case concerns a 79-year-old female patient with no medical history reported, who experienced serious unexpected events of rash erythematous, chapped lips, cheilitis, exfoliation and feeding disorder. The events started occurring approximately 2 weeks after the booster dose of the mRNA-1273.  Reportedly, the patient woke up with bright red legs, rash that started behind the knees, looked like sunburn and spread throughout the whole body. The patient went to the emergency room, received prednisone and was subsequently hospitalized for 6 days. Additionally, the patient had rash in mouth that made him unable to ear or drink, lips were full of cuts and sores and there were multiple skin peelings. The rechallenge was not applicable due to occurrence after the booster dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 79-year-old female patient with no medical history reported, who experienced serious unexpected events of rash erythematous, chapped lips, cheilitis, exfoliation and feeding disorder. The events started occurring approximately 2 weeks after the booster dose of the mRNA-1273.  Reportedly, the patient woke up with bright red legs, rash that started behind the knees, looked like sunburn and spread throughout the whole body. The patient went to the emergency room, received prednisone and was subsequently hospitalized for 6 days. Additionally, the patient had rash in mouth that made him unable to ear or drink, lips were full of cuts and sores and there were multiple skin peelings. The rechallenge was not applicable due to occurrence after the booster dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.