Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Ejection fraction, Fibrin D dimer, Heart rate, Immune reconstitution inflammatory syndrome
Clinical narrative: sought care for 3 days of a diffuse body rash/ multisystem inflammatory syndrome (MIS) after immunization; She had no known coronavirus disease (COVID-19) exposure but was SARSCoV- 2 PCR and nucleocapsid IgG positive; She had no known coronavirus disease (COVID-19) exposure but was SARSCoV- 2 PCR and nucleocapsid IgG positive; This is a literature report.  Patient 1 was a 20-year-old woman who sought care for 3 days of a diffuse body rash, tactile fever, sore throat, mild neck discomfort, and fatigue. There was no cough, congestion, headache, or abdominal pain. She had vomiting and diarrhea, which had subsided 8 days before admission. She received her first dose of SARS-CoV-2 vaccine 15 days before admission. She had no known coronavirus disease (COVID-19) exposure but was SARSCoV- 2 PCR and nucleocapsid IgG positive. She was hypotensive at arrival to the emergency department, requiring inotropic support. She had elevated troponin and brain natriuretic peptide (BNP) with a left ventricular ejection fraction initially mildly reduced at 45% but 30%-35% the following day. She responded well to therapy with intravenous immunoglobulin (IVIG) and methylprednisolone. Conclusions At the time of our study, our medical group was only vaccinating healthcare workers and patients >75 years of age. The 3 patients that were immunized qualified for early vaccination because they either worked or volunteered in a healthcare setting. These cases occurred approximately equal to 1 month after the peak surge of COVID-19 cases in the local area. At the time these patients sought care, only approximately equal to 7% of the adult (>18 years of age) population who were members of the healthcare facility patient group (approximately equal to 3,776,000 members) had received >1 SARS-CoV-2 vaccine, whereas 3 of the 6 patients in this study who had MIS were vaccinated. These 6 patients were hospitalized at 5 of the 15 medical centers in the area. We believe the temporal association after SARS-CoV-2 immunization is worth noting, given the theoretical concern of MIS-C/A after vaccination (3). We did not identify any patients with MIS after vaccination who did not have recent SARS-CoV-2 infection. It is possible that other case-patients in our member population were hospitalized outside of our 15 medical centers and thus were not captured for this case series. Overall, MIS is rare in adults. In comparison we treated >50 children with MIS-C during January 2021-February 2021 and >100 since May 2020 among a pediatric population of 960,000. The Centers for Disease Control and Prevention (CDC) allows for vaccination after a SARS-CoV-2 infection after recovery from the acute illness and after the isolation period, with no recommended minimal interval between infection and vaccination. Most cases of MIS-C/A occur 2-6 weeks after an exposure or infection (1-3), although we have seen several children brought for care as late as 8-10 weeks after a confirmed infection or exposure. We need to continue to monitor for MIS-C/A after SARS-CoV-2 infection and immunization as more of the population are vaccinated, especially as vaccines are administered to children who are at higher risk for MIS. CDC and the US Food and Drug Administration co-manage VAERS (the Vaccine Adverse Event Reporting System), which is being used to monitor for adverse events after COVID-19 vaccines. MIS-C/A is listed as a postvaccination adverse event of special interest and should be reported to VAERS.  Timeline displaying intervals between coronavirus (COVID-19) vaccine, acute COVID-19 symptom onset, and MIS symptom onset in patients in the region. MIS, multisystem inflammatory syndrome Demographic, laboratory, and clinical characteristics of 3 patients who had multisystem inflammatory syndrome after SARSCoV- 2 immunization, Demographic, laboratory, and clinical characteristics of patients who had multisystem inflammatory syndrome without SARSCoV- 2 immunization; Sender's Comments: Based on known drug safety profile and temporal relationship, there is reasonable possibility of causal association between the reported events Immune reconstitution inflammatory syndrome, Covid-19, Drug ineffective and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.