Sex: M
Vaccine: UNK
Symptoms: Death, Skin exfoliation, Toxic epidermal necrolysis
Clinical narrative: Death NOS; toxic epidermal necrolysis; desquamation of 8090% of BSA; Initial information received on 31-DEC-2019 regarding an unsolicited valid serious literature case.    This case is linked to cases 2020SA001225, 2020SA001235, 2020SA001250, 2020SA001256 (Same reporter).  The following is verbatim from the article:  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 Empirical Bayesian 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 71 years old male patient who experienced toxic epidermal necrolysis (toxic epidermal necrolysis) and later died (death NOS), while he received vaccine INFLUENZA VACCINE TRIVALENT.  Medical treatment, vaccination and family history were not provided.  At the time of the event, the patient had ongoing Plasma cell myeloma, Rheumatic heart disease and Gout.  Concomitant medications included Allopurinol for Gout.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE TRIVALENT (produced by unknown manufacturer) (lot number and other dosing details were not reported) via unknown route in unknown administration site.  On an unknown date, the patient developed a serious toxic epidermal necrolysis (toxic epidermal necrolysis) and desquamation of 80-90% of body surface area (skin exfoliation), one day following the administration of INFLUENZA VACCINE (TRIVALENT). These events were assessed as medically significant.  On an unknown date, the patient died (death), following the administration of INFLUENZA VACCINE (TRIVALENT). This event was assessed as medically significant and was leading to death.   Details of laboratory data not reported.  Final diagnosis was severe skin exfoliation and severe toxic epidermal necrolysis and death NOS.  It was unknown if an autopsy was done. The cause of death was not reported.  The outcome of the events was Unknown for toxic epidermal necrolysis and desquamation of 80-90% of body surface area and later patient died due to unknown reason.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns a 71 years old male patient who presented with toxic epidermal necrolysis and skin exfoliation one day after vaccination with INFLUENZA VACCINE (TRIVALENT) produced by unknown manufacturer and died due to unknown reasons. The time to onset is compatible with the role of vaccine. Additional information regarding condition at the time of vaccination, lab data excluding other etiologies and detailed autopsy report would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: Death NOS