Sex: F
Vaccine: SMALL
Symptoms: Adverse event, Biopsy skin abnormal, Exposure to vaccinated person, Orthopox virus infection, Orthopoxvirus test positive
Clinical narrative: Skin lesion on right upper extremity; Possible contact transmission of smallpox; This case was obtained on 22APR2021 from the review of scientific literature.    A 27-year-old female presented to health clinic with a 7-day lesion on her right upper extremity. She disclosed that her boyfriend was a marine and was vaccinated against smallpox two weeks prior to her developing the skin lesion. The specific smallpox vaccine that he received is unknown and her boyfriend did not cover the vaccine site as instructed. The patient's skin lesion was non-itchy, approximately 5 millimeter (mm) blister like rash that ulcerated with a grayish, white center and had a surrounding red border. She denied any fever, chills, pets at home, insect bites or trauma to the area. While at the health clinic, the patient's skin lesion was unroofed, and a sample was sent to Laboratory of Public Health for identification. The sample returned positive for Orthopoxvirus DNA by polymerase chain reaction (PCR). The patient was instructed to cover the area while at work, keep the lesion open to air at home, and to avoid skin-to-skin contact. The clinic also reported the event to Department of Health for possible contact transmission of smallpox. The outcomes of the events of possible contact transmission of smallpox and lesion on her right upper extremity was not reported.  The patient's medical history includes asthma. Concomitant medications include unspecified nebulizers for asthma.  Author's Comment: Recipients of smallpox vaccine have a potential for autoinoculation and inoculation of close contacts. Hence, the vaccine recipients should be well educated about proper care of the vaccination site for preventing possible contact transmission of the virus. These include covering the vaccination site, proper hand washing after bandage changes, and avoiding skin-to-skin contact.  Company Comment: The suspected drug as described, was possible ACAM2000. ACAM2000 is a live vaccinia virus that can be transmitted to persons who have close contact with the vaccinee. In this case, the female presented a lesion that was confirmed to be Orthopoxvirus. The lesion is consistent with a contamination due to a secondary transmission from the male who was recently vaccinated; therefore, the lesions are considered related to ACAM2000.  The case is an adverse event of special interest (AESI) and considered medically important for the purpose of submission to the FDA as required commitment.; Sender's Comments: The suspected drug as described, was possible ACAM2000. ACAM2000 is a live vaccinia virus that can be transmitted to persons who have close contact with the vaccinee. In this case, the female presented a lesion that was confirmed to be Orthopoxvirus. The lesion is consistent with a contamination due to a secondary transmission from the male who was recently vaccinated; therefore, the lesions are considered related to ACAM2000.  The case is an adverse event of special interest (AESI) and considered medically important for the purpose of submission to the FDA as required commitment.