Sex: F
Vaccine: SMALL
Symptoms: Axillary pain, Injection site scab, Pain in extremity, Skin lesion, Urticaria
Clinical narrative: My left armpit was also sore; The lesion is scabbing over with very little drainage; My arm was very painful; Had a raised, red welt surrounding the vaccination site lesion; Spontaneous report was received on 12NOV2021.  A healthcare professional reported that "had a raised, red welt surrounding the vaccination site lesion" (PT: Urticaria), "my arm was very painful" (PT: Pain in extremity), "my left armpit was also sore" (PT: Axillary pain), and "the lesion is scabbing over with very little drainage" (PT: Injection site scab) following the administration of ACAM2000 (Smallpox (Vaccinia) Vaccine, Live). On 26OCT2021, the patient received first dose of ACAM2000. On 05NOV2021, 10 days post-vaccination, had a raised, red welt surrounding the vaccination site lesion which got to maximum size of 4 inches long by 3 inches wide. It was reported that the patient's arm was very painful and left armpit was also sore. By 07NOV2021, the red welt went down and barely noticeable. Now, as of 12NOV2021, 17 days post-vaccination, the welt was completely gone with no pain in the arm. The lesion was scabbing over with very little drainage.  The patient had recovered from the reported events "had a raised, red welt surrounding the vaccination site lesion" and "arm was very painful" whereas the outcome of the event "the lesion is scabbing over with very little drainage" was resolving and the outcome of the event "left armpit was also sore" was unknown.  Company comment: A consumer received ACAM2000 and after about 10 days developed a raised, red welt surrounding the vaccination site lesion (urticaria), reported that arm was very painful (pain in extremity), left armpit was also sore (axillary pain), and the lesion is scabbing over with very little drainage (injection site scab). Considering the case information and the expected response to vaccination, the causality of urticaria, pain in extremity, axillary pain, and injection site scab is assessed as possible with ACAM2000.  Significant follow up information received from the healthcare professional on 24NOV2021. The follow up information included description of the needle and site of administration of ACAM2000, medical history and concomitant medications of the patient, treatment, and outcome of the events.  It was updated that the patient was a female.  It was reported that she was administered with ACAM2000 via a 15 times bifurcated needle on her upper arm.   She was prescribed by her physician to take Tylenol, Claritin and Ibuprofen as a treatment medication for the events and her physician stated that the reaction might be due to the bandage.   The outcome of the events was updated as she had not recovered from the events "had a raised, red welt surrounding the vaccination site lesion", "my left armpit was also sore" and "my arm was very painful".  The patient's medical history included anxiety and depression. It was reported that she had a migraine treatment and currently she is off from the treatment.  Concomitant medications included bupropion (bupropion hydrochloride), Wellbutrin (bupropion hydrochloride; 300 mg), Cymbalta (duloxetine hydrochloride; 60 mg a day) and other over the counter (OTC) women multivitamins (ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride) included Vitamin D (colecalciferol), Vitamin B12 (cyanocobalamin), and probiotics (bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus).  Company comment: A consumer received ACAM2000 on her upper arm and after about 10 days developed a raised, red welt surrounding the vaccination site lesion (urticaria), reported that arm was very painful (pain in extremity), left armpit was also sore (axillary pain), and the lesion is scabbing over with very little drainage (injection site scab). Considering the case information and the expected response to vaccination, the causality of urticaria, pain in extremity, axillary pain, and injection site scab is assessed as possible with ACAM2000.; Sender's Comments: A consumer received ACAM2000 on her upper arm and after about 10 days developed a raised, red welt surrounding the vaccination site lesion (urticaria), reported that arm was very painful (pain in extremity), left armpit was also sore (axillary pain), and the lesion is scabbing over with very little drainage (injection site scab). Considering the case information and the expected response to vaccination, the causality of urticaria, pain in extremity, axillary pain, and injection site scab is assessed as possible with ACAM2000.