Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Erythema, Herpes zoster, Impaired healing, Insomnia
Clinical narrative: Could not swallow and eat; Scleroderma; Shingles; Red skin turned into wound; Wound not healing; Not able to really sleep; Red skin turned into wound; This spontaneous case was reported by a consumer and describes the occurrence of SCLERODERMA (Scleroderma) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In 2021, the patient experienced IMPAIRED HEALING (Wound not healing), SKIN WOUND (Red skin turned into wound), INSOMNIA (Not able to really sleep) and ERYTHEMA (Red skin turned into wound). In November 2021, the patient experienced SCLERODERMA (Scleroderma) (seriousness criterion medically significant) and HERPES ZOSTER (Shingles). On 17-Nov-2021, the patient experienced DYSPHAGIA (Could not swallow and eat). At the time of the report, SCLERODERMA (Scleroderma), IMPAIRED HEALING (Wound not healing) and HERPES ZOSTER (Shingles) had not resolved and SKIN WOUND (Red skin turned into wound), DYSPHAGIA (Could not swallow and eat), INSOMNIA (Not able to really sleep) and ERYTHEMA (Red skin turned into wound) outcome was unknown.            No concomitant medication was reported.  The co-suspect Humira formulation was reported as solution for injection in pre-filled pen.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was reported.  The reporter causality for the events scleroderma, red skin turned into wound onset in 2021, could not swallow and eat, not able to really sleep, wound not healing, shingles and red skin turned into wound onset in 2021 co-suspect Humira was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a spontaneous case concerning a 67-year-old female patient with medical history of plaque psoriasis, who experienced the unexpected, serious (medically significant) event of Scleroderma, approximately 1 month after receiving the third dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The event had not resolved at the time of the report. Medical history of plaque psoriasis remains a risk factor for the event. Inappropriate schedule of vaccine administered was also reported as an additional event. The benefit-risk relationship of mRNA-1273 is not affected by this report.    Sender's Comments: This is a spontaneous case concerning a 67-year-old female patient with medical history of plaque psoriasis, who experienced the unexpected, serious (medically significant) event of Scleroderma, approximately 1 month after receiving the third dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The event had not resolved at the time of the report. Medical history of plaque psoriasis remains a risk factor for the event. Inappropriate schedule of vaccine administered was also reported as an additional event. The benefit-risk relationship of mRNA-1273 is not affected by this report.