Sex: F
Vaccine: FLUX
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme; Initial information received on 31-Dec-2019 regarding an unsolicited valid serious case from other healthcare professional issued from a literature article.   This case is linked to cases 2020SA001262, 2020SA001250, 2020SA001235 and 2020SA001256 (same reporter).  Abstract:  Since the last review of vaccine safety surveillance data for erythema multiforme (EM), Stevens Johnson syndrome (SJS), SJS/TEN, and toxic epidermal necrolysis (TEN) (EM/SJS/TEN), over 37 new vaccines have been introduced. We sought to describe reported EM/SJS/TEN after vaccines during 1999-2017. Methods: We identified reports of EM/SJS/TEN received by the Vaccine Adverse Event Reporting System (VAERS) during 1999-2017. We stratified analysis by condition (EM, SJS, or TEN), and analyzed reports by serious or non-serious status, sex, age group, time from vaccination to symptom onset, exposure to known causes of EM/SJS/TEN, and vaccines administered. We used data mining to detect vaccine-AE pairs reported more frequently than expected. Results: Of 466,027 reports to VAERS during 1999-017, we identified 984 reports of EM, 89 reports of SJS, 6 reports of SJS/TEN, and 7 reports of TEN. Few reports of EM (9%), and most reports of SJS (52%), SJS/TEN (100%), and TEN (100%) were serious. Overall, 55% of reports described males, 48% described children aged 4 years; 58% of EM/SJS/TEN occurred 7 days after vaccination. Few reports (5%) described exposure to known causes of EM/SJS/TEN. Overall, childhood vaccines (e.g., combined measles, mumps, and rubella vaccine) were most commonly reported. We identified 6 deaths; 4 were exposed to medications associated with EM/SJS/TEN. EM after smallpox vaccine was reported disproportionately among people aged 19 - 49 years. Conclusions: EM/SJS/TEN were rarely reported after vaccination; data mining identified a known association between EM and smallpox vaccine.  This case involves a 2 years old female patient who experienced erythema multiforme (erythema multiforme), while she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site.  On an unknown date, the patient developed a serious erythema multiforme (erythema multiforme) (Unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Laboratory details were not reported.  Final diagnosis was erythema multiforme.   It was not reported if the patient received a corrective treatment.  The outcome of the event was not reported.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns a two years old female patient who presented with erythema multiforme (EM) following the vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. The patient's past medical history, concomitant medication, lab data ruling out alternate etiologies would be needed for complete assessment. Based upon the reported information, the role the vaccine cannot be assessed.