Age: 22.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Erythema, Immunology test, Inflammation, Pain of skin, Polymerase chain reaction
Clinical narrative: This case was received on 11 January 2009 via a search of the VAERS database, under reference number 327213. A 22-year-old female patient received the following vaccination on 29 July 2008: smallpox (manufacturer unknown, lot number not reported), and BIOTHRAX (manufacturer and lot number not reported). Sixteen days after vaccination, on 15 August 2008, the patient was seen for evaluation of a painful, itchy rash on her face, elbows, hands, knees, feet, and palms. Steroids were prescribed. On 23 September 2008, the patient reported she had stopped taking the steroids 10 days previously (13 September 2008,) and had experienced a "few outbreaks of the lesions" which were "not as bad as they were initially". Wound cultures, including viral cultures for vaccinia, PCR, varicella, and HSV were negative. Results of a punch skin biopsy showed superficial perivascular inflammation with interstitial eosinophils and epidermal spondylosis. Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. Follow-up information was received from a health care professional on 14 July 2010 via a search of the scientific literature. In addition to this case, the article mentioned 7 other patients who experienced similar events; these events are captured in case numbers 2009-03775, 2010-03865, -03866, 03867, -03868, -03869, and 03870. The patient, who was on active duty and a primary vaccinee, had not reported any acute illness, any contact with sick persons, or any previous adverse events following prior immunizations. She had a past history of human papilloma virus cervicitis, but was otherwise healthy at the time of vaccination. On post-vaccination day 16, the patient developed a skin eruption without any systemic symptoms which was described on 18 August 2008 (post-vaccination day 20) as the following: 15 to 20 vesicles, 1 to 4 mm in size, over both knee extensors, 30 to 40 vesicles on the palmar and dorsal surfaces of the hands, especially on the fingers, 15 to 20 vesicles along the right arm and over the elbow extensor, and 7 to 10 vesicles on the dorsolateral surfaces of each foot, sparing the soles. The patient also had a few lesions on her lips, ear and scalp. A 10 x 6 mm erosion with crust was noted on the left lateral proximal arm at the site of the ACAM2000. On post-vaccination day 20, a punch biopsy specimen of a vesicle on the right forearm showed a vesicular/spongiotic dermatitis with eosinophils. Further diagnosis included negative viral and bacterial cultures as well as a nonreactive vaccinia PCR and negative direct immunofluorescent studies for VZV and HSV. Initial treatment consisted of diphenhydramine and acetaminophen-oxycodone, ibuprofen, valacyclovir hydrochloride and fluocinonide topical cream, 0.05%. On post-vaccination day 23, the patient developed worsening erythema at the vesicles bases; but no new lesions. She was started on a four day burst of prednisone 60 mg/d. After completing the burst, her lesions were shrinking, drying up, and healing, and she further denied pruritus or pain. Despite continues resolution of her lesions, she experienced a recurrence of her symptoms and noted the eruption of two new vesicles on post vaccination day 34 that subsequently resolved following a 3-week steroid taper (length of eruption until clearance also reported as 44 days). The patient had been deployed and was not available for follow-up. According to the authors, a casual relationship could not be definitively proven; however, they felt the papulovesicular eruptions were due in part, if not wholly, to the ACAM2000. They further stated that co-vaccination with anthrax may have played a contributory role, but believe the reaction was more likely related to the ACAM2000 because similar yet less dramatic cutaneous reactions have been previously reported with other (DRYVAX). List of documents held by Sender: None.