Sex: F
Vaccine: UNK
Symptoms: Death, Respiratory failure, Stevens-Johnson syndrome, Toxic epidermal necrolysis
Clinical narrative: respiratory failure; stevens johnson syndrome; toxic epidermal necrolysis; Initial information received on 31-DEC-2019 regarding an unsolicited valid serious literature case.   This case is linked to cases 2020SA001262, 2020SA001225, 2020SA001235 and 2020SA001250 (Same reporter).  The following is verbatim from the article:  Background: 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 43 years old female patient who experienced Stevens-Johnson syndrome (Stevens-Johnson syndrome), respiratory failure (respiratory failure) and toxic epidermal necrolysis (toxic epidermal necrolysis) while she received vaccine INFLUENZA VACCINE.  Medical history included Post herpetic neuralgia. Medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included AMOXICILLIN SODIUM (AMOXICILLIN [AMOXICILLIN SODIUM]).  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE TRIVALENT produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed serious Stevens-Johnson syndrome (Stevens-Johnson syndrome) and toxic epidermal necrolysis (toxic epidermal necrolysis) 3 days following the administration of INFLUENZA VACCINE. The patient was died due to respiratory failure (respiratory failure) on an unspecified date. All events was assessed as medically significant.  It is unknown if an autopsy was done.  Details of laboratory data not reported.  Final diagnosis was toxic epidermal necrolysis, Stevens Johnson syndrome and respiratory failure  It was not reported if the patient received a corrective treatment.  The outcome of the events toxic epidermal necrolysis, Stevens Johnson syndrome was unknown at the time of reporting.   There will be no information available on the batch number for this case.; Sender's Comments: This case involves a 43 years old female patient who experienced toxic epidermal necrolysis, respiratory failure, Stevens Johnson syndrome and reported (fatal) death after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is compatible with the role of vaccine. Medical history included Post herpetic neuralgia. 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 vaccine cannot be assessed.; Reported Cause(s) of Death: respiratory failure