Sex: U
Vaccine: COVID19
Symptoms: Chillblains
Clinical narrative: Vaccine-triggered Pernio; This literature-non-study case was reported in a literature article and describes the occurrence of CHILLBLAINS (Vaccine-triggered Pernio) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.        No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLBLAINS (Vaccine-triggered Pernio) (seriousness criterion medically significant). At the time of the report, CHILLBLAINS (Vaccine-triggered Pernio) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered CHILLBLAINS (Vaccine-triggered Pernio) to be related.    No concomitant and treatment medication were reported.  Patients diagnosed with pernio (onset in or after March 2020) were considered for inclusion in this prospective cohort study. Exclusion criteria included previous diagnosis of systemic lupus erythematosus or chilblain lupus.  Vaccine-triggered phenomenon occurred after secondary vaccine dose in the patient.  Although pernio is a hallmark manifestation of the interferonopathies, systemic treatment with IFN-I is insufficient for its development. In the cohort, enrichment with IFN-mediated autoimmune disorders supports the role of IFNs in pandemic-associated pernio. Close alignment with cold and propensity for relapses suggest a durable immune memory response. Ongoing translational investigation in the cohort would help to precisely elucidate the role of IFN-I, along with the genetic and immunological mechanisms that underlie pandemic-associated pernio.  Company comment- This literature-non-study case concerns a patient of unknown age and gender with no medical history reported, who experienced the unexpected serious (medically significant) AESI of Chillblains (reported as Vaccine-triggered Pernio) after second dose of mRNA-1273 vaccine. Latency cannot be assessed since vaccination date nor event onset date was disclosed. No information on risk factors, co morbidities, detailed clinical course, management of the event, vaccination details and the outcome was available in the report. Author concludes that, enrichment with IFN-mediated autoimmune disorders supports the role of IFNs in pandemic-associated pernio. Close alignment with cold and propensity for relapses suggest a durable immune memory response. Ongoing translational investigation in this cohort will help to precisely elucidate the role of IFN-I, along with the genetic and immunological mechanisms that underlie pandemic-associated pernio. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2022: Live follow up received by safety on 13-Oct-2022 has email with full text article and contains significant information, author details and citation details (additional author, year, and page number) updated.; Sender's Comments: This literature-non-study case concerns a patient of unknown age and gender with no medical history reported, who experienced the unexpected serious (medically significant) AESI of Chillblains (reported as Vaccine-triggered Pernio) after second dose of mRNA-1273 vaccine. Latency cannot be assessed since vaccination date nor event onset date was disclosed. No information on risk factors, co morbidities, detailed clinical course, management of the event, vaccination details and the outcome was available in the report. Author concludes that, enrichment with IFN-mediated autoimmune disorders supports the role of IFNs in pandemic-associated pernio. Close alignment with cold and propensity for relapses suggest a durable immune memory response. Ongoing translational investigation in this cohort will help to precisely elucidate the role of IFN-I, along with the genetic and immunological mechanisms that underlie pandemic-associated pernio. The benefit-risk relationship of mRNA-1273 is not affected by this report.