Sex: F
Vaccine: VARZOS
Symptoms: Drug eruption, Eosinophil count, Epidermal necrosis, Erythema, Herpes simplex test negative
Clinical narrative: bullous rash on her left arm, axilla and lateral chest wall; epidermal necrosis; contact dermatitis; bullous drug eruption; Fever; intermittent loose stools; diffuse erythema; swelling extended from the mid-chest to axilla and down the upper arm; blisters, some of which had a central dusky appearance/bullae formation; interstitial inflammation with numerous eosinophils and scattered neutrophils; Rash; Tenderness; This case was reported in a literature article and described the occurrence of bullous rash in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included infliximab. Concurrent medical conditions included crohn's disease.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced bullous rash (serious criteria GSK medically significant), skin necrosis (serious criteria GSK medically significant), contact dermatitis, drug eruption vesicular, fever, loose stools, erythema diffuse, swelling, blister, inflammation, rash and tenderness. The patient was treated with valaciclovir hydrochloride (Valacyclovir), prednisone, triamcinolone, corticosteroid nos (Corticosteroids (Drug Name Unknown)) and corticosteroid nos (Corticosteroids (Drug Name Unknown)). On an unknown date, the outcome of the bullous rash, skin necrosis, contact dermatitis, drug eruption vesicular, fever, loose stools, erythema diffuse, swelling, blister, inflammation, rash and tenderness were unknown.   The reporter considered the bullous rash, skin necrosis, contact dermatitis, drug eruption vesicular, fever, loose stools, erythema diffuse, swelling, blister, inflammation, rash and tenderness to be related to Shingrix.  Additional details were reported as follows: This case was reported in a literature article and described the occurrence of Bullous fixed drug eruption in a 51 years old female patient who was vaccinated with Recombinant adjuvant Shingrix vaccine (GlaxoSmithKline) for prophylaxis. The patient's current condition included Crohn's disease. The patient was taking infliximab for Crohn's disease for 1 year and was due for next dose the following week from date of reporting. The patient was not taking any new medications at the time, had not used any new topical products and did not have a similar rash in the past. No information on patient's family history was provided. On an unspecified date, the patient received 2nd dose of Shingrix vaccine (administration route and site unspecified; batch number not provided). The age at vaccination was not provided. On an unspecified date, two days after the vaccination, the patient presented to primary care provider with a bullous rash on her left arm, axilla and lateral chest wall with associated subjective fever. The patient was experiencing intermittent loose stools at the time of examination, which was her normal baseline with the disease. On physical examination, the patient had diffuse erythema and swelling extending from the mid chest to axilla and down the upper arm with associated bullae, some of which had a central dusky appearance. There was no evidence of mucosal involvement on examination. The patient was referred to dermatology, and a biopsy was performed. PCR from one of the bullae for herpes simplex virus (HSV) 1, HSV 2 and (Varicella Zoster virus) VZV was negative. Punch biopsy revealed epidermal necrosis leading to bullae formation along with a superficial and deep interstitial inflammation with numerous eosinophils and scattered neutrophils. The clinical and histological changes were consistent with a bullous fixed drug eruption in response to the vaccine. Differential diagnosis at the time of patient presentation included VZV infection, HSV infection, bullous fixed drug eruption and contact dermatitis. Bullous pemphigoid was considered less likely due to the patient's age at presentation and localized involvement; therefore, direct immunofluorescence was not performed. Aetiologies such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) were considered less likely due to the lack of mucosal involvement and severe systemic symptoms. With negative HSV and VZV PCR in conjunction with the biopsy findings, bullous fixed drug eruption was diagnosed. The patient was prescribed prednisone 40 mg daily for 5 days with subsequent taper and triamcinolone 0.1 % (percent) cream applied two times per day for 2 weeks. Because results of the viral PCR were not available at the time, the patient was also given a prescription for valacyclovir 1000 mg three times a day for 7 days. The patient's rash was successfully treated with oral and topical corticosteroids after 1 week of onset. The patient had not experienced a subsequent similar bullous reaction but had some tenderness in the area. The authors commented, "Dermatological reactions have been reported immediately following vaccine administration in previous cases, but this is the first known case of a reaction to the recombinant Shingrix vaccine. This case provides evidence that immunologically mediate reactions can occur with Shingrix vaccine administration despite its improved safety profile compared with the live vaccination. As in this case, patients with autoimmune disease may be at increased risk given the immune dysregulation associated with their underlying condition. Development of a bullous fixed drug eruption to medications and vaccinations is a rare complication that can appear similar to bullous pemphigoid, SJS and TEN. The development of a bullous rash is likely due to a delayed-type hypersensitivity reaction, marked by T-cell hyperactivation. The reaction is generally self-limited and treated with discontinuation of the offending agent and corticosteroids. Bullous reactions can rarely occur with inflammatory bowel disease; however, the reaction in this case is more likely due to vaccination because the reaction occurred immediately following vaccination and has not recurred. The Naranjo Score, a tool used to determine the likelihood of adverse drug reaction, in this case was 6, which indicates that the bullous reaction was likely an adverse reaction to vaccination. This case highlights the possibility of an acute bullous reaction to the recombinant adjuvant Shingrix vaccine. The vaccine has been shown to be very effective at preventing VZV reactivation and postherpetic neuralgia and is well tolerated in most patients, so the benefits of receiving the vaccination outweigh the risks. Nonetheless, recognition of acute reactions associated with the vaccine such as the delayed-type immune dysregulation seen in this patient should be recognised and treated early." This article corresponding to this case is not available for regulatory submission due to copyright restriction.