Sex: M
Vaccine: UNK
Symptoms: Globulins increased, Glomerular filtration rate normal, Glycosylated haemoglobin increased, Haemoglobin decreased, Injection site erythema
Clinical narrative: Elevated body pustules Arms and back (the final diagnosis was given as inadvertent innoculation.); A report was received on 04FEB2016 for subject who was enrolled in Clinical Study.  The subject is a 57-year old male who was vaccinated with ACAM2000 (Sanofi-Pasteur, Lot  # VV04-003-0A expiry date 04OCT2019) on 22JAN2016 ion the right arm.  He was previously vaccinated against smallpox in 1963 and has history of allergy to penicillin and pine and untreated borderline diabetes.   In the morning of 03FEB2016, the subject noticed redness and rash around the vaccination site on his upper right arm.  By the next day, numerous papules/pustules had developed on the same arm, a few on the opposite arm and neck.  After 8 hours of observation in the medical office, he was transported to the emergency room (ER) for further evaluation of suspected progressive vaccinia.  He presented to the ER with numerous fleshy papules on an erythematous base, with some approaching confluence on his right arm, one necrotic appearing papule about 1 cm in diameter in the site of vaccination and similar papules, although less in number, on the posterior neck, upper back and left upper arm/forearm.  The subject stated that he had not been scratching the rash.  He denied any fevers, chills, headache of other systemic signs of illness.  He did not take anything for the rash.  On 04FEB2016 his labs were HgB 14.8 g/dL, WBC 9.6 103/uL, Neutrophils 68%, Lymphocytes 22%, IgG 681 mg/dL (N 681-1684), IgA 357mg/dL (N 87-474), IgM 85 mg/dL (N 48-312), CD4 1084 (N 515-1800mm3); glucose 217 mg/dL.  On 05FEB2016 HgB A1C 6.3% Est Avg Glucose 134.1 mg/dL.  Capillary blood glucose before and after meals along with a low-dose NovoLog sliding scale was ordered.  While in the ER, the Department of Health (DoH) and  the Infectious Disease physician concluded that the subject did not qualify for Vaccinia Immunoglobulin, that the subject could be discharged home.  However, as the patient lives in a boarding house with 20 other residents, it was recommended that the patient be admitted to the hospital (04FEB2016).  He was cleared for discharged on 05FEB2016 with instructions on how to keep the lesions covered.  No treatment was recommended.  As of 12Feb2016, the lesions have healed, there are 3 scabs present, one on the primary inoculation site and two on the lesions from which samples were taken for testing.  The Principal Investigator re-assessed the adverse event from progressive vaccinia to auto-inoculation (inadvertent inoculation) and has considered the case as not serious, moderate in intensity and probably related.  27Apr2018: Data migration of ACAM2000 data revealed two subordinate cases of this case, both previously reported to VAERS.  Case ID 2017SA107101 (700472) and 2016SA227827(672814) - both are duplicate of one literature article published (Middaugh, 2016). VAERS was notified of duplicate reporting.    Follow up information was received from the investigator on 18JUL2019:  As per the query response received, event stop date was updated to 11MAR2016.  Company Medical Assessment:  The case was downgraded by the Investigator from serious to non-serious due to initial suspicious of generalized vaccinia. The final diagnosis was auto inoculation and need no hospitalization. However, because the case was forwarded to Sanofi, Sanofi (MAH), Sanofi submitted the case as a 15-day report as per licensing agreement with FDA.  Auto inoculation was considered definite related to ACAM2000. Information received was to include the resolution date, which according to 21 CFR 314.80 guidelines requires follow-up submission.; Sender's Comments: The case was downgraded by the Investigator from serious to non-serious due to initial suspicious of generalized vaccinia. The final diagnosis was auto inoculation and need no hospitalization. However, because the case was forwarded to Sanofi, Sanofi (MAH), Sanofi submitted the case as a 15-day report as per licensing agreement with FDA.  Auto inoculation was considered definite related to ACAM2000. Information received was to include the resolution date, which according to  21 CFR 314.80 guidelines requires follow-up submission.