Sex: F
Vaccine: FLUX, FLUX
Symptoms: Erythema multiforme, Rash papular, Vaccine positive rechallenge
Clinical narrative: Erythema multiforme; Erythema multiforme; papular lesions; papular lesions; This case was reported in a literature article and described the occurrence of erythema multiforme in a 2-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine at an unknown dose and Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine and not applicable after receiving Flu vaccine, the patient experienced erythema multiforme (serious criteria GSK medically significant), erythema multiforme (serious criteria GSK medically significant), papular rash and papular rash. Rechallenge with Flu vaccine was positive. On an unknown date, the outcome of the erythema multiforme and papular rash were recovered/resolved and the outcome of the erythema multiforme and papular rash were unknown.   The reporter considered the erythema multiforme and papular rash to be related to Flu vaccine. The reporter considered the erythema multiforme and papular rash to be related to Flu vaccine.  Additional details were reported as follows: This case was reported in a literature article and described the occurrence of erythema multiforme (EM) in a female patient aged 2-year-old who was vaccinated with unspecified influenza vaccine (manufacturer unknown) for prophylaxis. This case corresponds to result section reported in this literature article. The patient was a part of study that aimed to describe reported Erythema multiforme, Stevens Johnson syndrome, and toxic epidermal necrolysis (EM/SJS/TEN) after vaccines during 1st October 1999 through 31st December 2017 (among reports received by CDC and FDA through April 27, 2018). Country reports of EM/SJS/TEN received by the Vaccine Adverse Event Reporting System (VAERS) were identified and compared the relative frequency of EM/SJS/TEN reported to VAERS by vaccine, to better understand if there were any concerning patterns of reported EM/SJS/TEN (e.g., after a specific vaccine, or among a particular age group) or other emerging safety concerns. [In this study, it was reported AEs occurring after vaccination can be reported to VAERS, a national spontaneous reporting system established in 1990 to monitor AEs that is jointly administered by the Centers for Disease Control (CDC) and Prevention and the Food and Drug Administration (FDA)]. No information on patient's medical or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified influenza vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided.  On an unspecified date, an unknown period after vaccination, the patient was noted with EM. On an unspecified date between 1st October 1999 through 31st December 2017 (among reports received by CDC and FDA through 27th April 2018), the patient received unspecified influenza vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date between 1st October 1999 through 31st December 2017 (received as of 27th April 2018), an unknown period after vaccination, the patient was again noted with EM. [In this study, the resulting reports for reports of EM/SJS/TEN that were diagnosed by physicians (reported by a physician, or a physician's diagnosis was documented in available medical records) were received. For reports of symptoms consistent with EM/SJS/TEN, but without a physician's diagnosis, we defined EM as papular lesions, classically with a ringed (targetoid") appearance, usually beginning peripherally and then spreading to the torso, that could involve the palms of the hands and/or soles of the feet, without mucosal lesions. Most reports of EM/SJS/TEN described onset of symptoms within 14 days of vaccination] Treatment was unknown. Outcome of the event was not reported. The authors commented, "Of the 4 persons we describe who previously experienced EM or SJS after vaccination, two experienced another episode of EM or SJS after the same vaccine (positive rechallenge). Our estimated reporting rates of EM/SJS/TEN after varicella and influenza vaccines were well below this figure (i.e., the highest estimate was 1.0 report of EM per million doses of varicella vaccine distributed), a notable observation considering that varicella vaccine was one of the most commonly reported vaccines after which EM/SJS/TEN occurred. Despite potentially underestimating rates, our data suggest that EM/SJS/TEN is reported no more frequently after vaccination than after known causes of these conditions. Importantly, while EM/SJS/TEN can occur after vaccination, previous post-marketing analyses and case-control studies demonstrate that vaccination itself does not increase the likelihood of these conditions". The authors concluded "EM/SJS/TEN were rarely reported after vaccination; data mining identified a known association between EM and smallpox vaccine". This is 1 of the 6 valid cases reported in the same literature article.