Age: 23.0
Sex: F
Vaccine: ANTH, JEV1, SMALL
Symptoms: Dermatitis, Erythema multiforme, Injection site reaction, Local reaction, Malaise
Clinical narrative: The following narrative was retrieved from VAERS 19Feb2019. Patient is a 23yo female with no significant past medical history who presents to the Health Agency-Immunization Healthcare Branch-by referral from the ED for further evaluation and management of an adverse event following immunizations. Patient received 3 vaccines (AVA, JE-VC, and SPV) on 25 Oct 2018. She describes a rash that began day 05 NOV (day 11) and covered her torso (front and back), BUE to fingers (but not hands), and BLE to calves. The lesions were severely pruritic, fixed, erythematous macules, patches and plaques. The SPV site was the most affected area. She denies vesicles, papules, pustules or scale. She initially self treated with Claritin, later benadryl OTC & Tylenol without benefit. She presented to ER on day 12 as symptoms continued to progress. DHA-IHB was contacted and reviewed photos. She had no oral lesions, eye symptoms, and UA was normal. She was treated with IV steroid, IV Benadryl, hydroxyzine & ranitidine. She states pruritus subsided in about four hours. She otherwise felt well. She did experience fever, malaise, myalgia's on day 10. She had no immediate reaction to inoculation. She denies other illness symptoms such as cough or diarrhea A/P: 1. Adverse effect of other drugs, medicaments and biological substances, initial encounter T50.995A: Patient is a 23yo healthy female who received 3 vaccines (AVA, JE-VC, and SPV) on 25 Oct 2018 and subsequently developed a generalized dermatitis on day 11 to her torso(front and back), BUE to fingers (but not hands), and BLE to calves. The lesions were severely pruritic, fixed, erythematous macules, patches and plaques. She was diagnosed with EM. She had no oral lesions, eye symptoms, and UA was normal. She was treated with IV steroid, IV BENADRYL, hydroxyzine & ranitidine. She otherwise felt well. The lesions are mostly resolved. EM is typically an acute self limiting immune mediated reaction with characteristic targetoid lesion which may include palms and soles. It is most often occurring secondary to an infectious trigger, typically HSV. Per study (cutaneous reactions to vaccines, 2015) it is difficult to know if live virus vaccine vs. a coincident infection is the triggering event. EM has been reported associated with SPV & anthrax in addition to rabies, Influenza, pneumococcal, TWINRIX, DTP, MMR, meningococcal & HPV. The SPV, being the live virus vaccine, is the most likely agent, however inactivated vaccines have also been identified as EM triggers. A review of PubMed did not identify any case reports associated with JEV. Anthrax was associated in several case reports, but generally not as solitary vaccines. SPV has been associated with EM and is live virus vaccine. EM is no longer considered on the spectrum of SJS, and there was no evidence of mucosal involvement, however due to the seriousness of SJS, it is worthy of considering on the differential as this could be an atypical case which could recur on re-exposure. (Cont:) 2. Other specified counseling Z71.89: The pt's lesions did not include palms & soles and lesions were not distinctly targetoid, (although a few in the photos of her chest are suggestive), but did have the erythematous macular coalescing appearance of EM, particularly to her left arm near the SPV site. It is also possible this was immune mediated dermatoses, which is more nonspecific immune response than EM, and generally supports continued immunization as indicated. Per review of photos from day 11 it appears there is a local site reaction which may have also been present at the inoculation site compounding the appearance. Additional information retrieved from ALLERGIES box: None Information received from lot investigation completed by Emergent Quality Assurance on 01MAY2019: Lot number FAV5558 was reported from VAERS, however this is an invalid lot number.  In the event that the correct lot was likely to be FAV555 or FAV558, both lots were evaluated.  The evaluation consisted of manufacturing review (review of batch records), deviation review, retention sample inspection and product complaint review.  The investigation noted no issues or deviating events that had impact to critical process parameters of critical quality attributes.  All requirements for lot release were met and the lots were released for distribution by Quality Assurance.  Monthly signal detection has not found any increase in the number of reports for erythema multiforme, nor have any safety issues been identified for lots FAV555 or FAV558.  As such there is no impact to BioThrax lots FAV555 or FAV558.