Age: 43.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Injection site irritation, Injection site pain, Injection site pruritus, Injection site swelling, Lymph node pain
Clinical narrative: This case was received on 21 July 2011 via a third party query tool search on the VAERS database, under reference number 422450. A 43 year-old female patient had received on 08 April 2011 a left deltoid injection of ACAM2000 (lot number VV04003A). The patient also received on 04 April 2011, a left deltoid injection of AVA #2 (manufacturer, lot number, route and site of administration not reported) and a left deltoid injection of HepB #2 (manufacturer, lot number, route and site of administration not reported). The patient denied any adverse events other than site tenderness after receiving the small pox vaccine on 08 April 2011. Approximately 4 to 5 days later, the patient experienced a dull frontal and occipital headache which she reported to be 5/10. She treated herself with OTC MOTRIN with relief. The patient reported that she attributed the headache to the onset of her menses as the headache was similar to her past menstrual headaches. Approximately day 6 to 7, her SPV site began to redden, swell and itch with skin tenderness. On day 8 (reported as 16 April 2011), the patient experienced left axillary node swelling and tenderness. On day 11 (reported as 19 April 2011), she experienced scattered red macular spots on left and right forearms, right shoulder, neck and hairline. She had a mild headache and neck ache which was treated with MOTRIN and neck rubbing. The pruritic red spots were self treated with Triamcinolone. On day 12 (reported as 20 April 2011) the patient presented to the medical clinic with a mild fever of 99.2 F and "skin lesions". She was transferred to another clinic for further evaluation. The patient reported that she had kept her SPV site covered with large Band-Aids that resulted in skin irritation around the site from the "adhesive". On day 13 (reported as 22 April 2011) the tender, macule, lesions expanded to her arms, forearms; hands (including hypothenar regions) and two papules were noted on the left anterior thigh. The patient reported tender "pinpoint" red macules on the anterior hairline and behind her left ear. The patient was hospitalized (dates were not reported). Laboratory data included a skin biopsy on 20 April 2011 which showed a "mild papillary dermal edema with vacuolar interface change and a perivascular and interstitial neutrophilic infiltrate with nuclear dust. No vasculitis was identified". According to the reporter, no viral cytopathic effect suggestive of generalized vaccinia was identified and the features were not felt to be typical of allergic contact dermatitis. Concomitant medications included BCP TRISPRINTEC and acne medication Minocycline. On 25 April 2011, the patient reported the skin lesions were almost resolved with "dark patch skin discoloration at the sites and continued tenderness on the hypothenar region of the right hand. The patient denied any new symptoms, headache, fevers, or myalgia. She reported treatment of Clodetasol cream to sites. Current illnesses and history were reported as none. Vaccine history included on 03 March 2011, a dose of Typhoid (manufacturer, lot number, route and site of administration not reported), AVA #1 (manufacturer, lot number, route and site of administration not reported) and HepB #1 (manufacturer, lot number, route and site of administration not reported) with no systemic events; however she did report a nodule formation to her left deltoid lasting about one month. No further information was available at the time of the report. The patient's outcome was reported as recovered with full resolution of rash on 05 May 2011 with some scaring. Note: There may be a discrepancy between the event date field (recorded as captured in VAERS database) and the onset date information in the free text narrative field in the data reported (as per information retrieved from VAERS database). Documents held by sender: none.