Age: 27.0
Sex: F
Vaccine: SMALL
Symptoms: Hypersensitivity, Immunology test, Injection site pain, Injection site reaction, Injection site vesicles
Clinical narrative: This case was received on 27 September 2011 via a third party query tool search on the VAERS database, under reference number 427541. A 27 year-old female patient had received on 05 May 2011 a first dose left arm injection of ACAM2000 (lot number VV04003A), and 5 days later on 10 May 2011, she experienced throbbing and tingling at the vaccine site with LUE (left upper extremity) pain. On 12 May 2011, PVD (post vaccination day) seven, she developed edema of the right leg. On 13 May 2011, "the site had blistered with a few hours of severe pain (7/10) in her whole left arm and in the lymph nodes of the left axilla". The same date she also developed edema of the left leg, abdominal pain, severe back and neck pain, headache, fatigue and fever/chills 100.2. On 14 May 2011, edema of the right arm occurred. The patient began to feel better on 17 May 2011 with "some decrease in the severity of the edema, headache and upper back/neck ache". According to the report, the edema was impressive, non-pitting and in the abdomen, both LE's (lower extremities) and RUE (right upper extremity). Leg elevation and ice did not relieve the edema. The patient's weight increased by five pounds from "4/11 to 4/16" (note this is an inconsistency with previously reported dates for the events). The patient's abdominal pain was diffuse with more in RUQ (right upper quadrant), LUQ (left upper quadrant) and "perumbilical" area with intensity of 4-5/10 at rest and 7/10 with palpation, lying on her stomach or with activity. The patient was found to have a distended abdomen, poor appetite and loss of sense of satiety. She had no change in BM's (bowel movements) or N/V (nausea/vomiting). According to the patient, lying on her back increased her back pain. On 14 May 2011, the patient was evaluated in the ED (emergency department) a DVT (deep vein thrombosis) was ruled out in the RLE (right lower extremity) and cellulitis was suspected. The patient was evaluated again in the ED on 15 May 2011 and DVT's were ruled out in both the RLE (right lower extremity) and RUE. She as diagnosed with lymphedema. The patient was found to have a tender and enlarged liver with edema which raised a concern for cardiac involvement, but was ruled out. On 19 May 2011, the patient had a significant decrease in the edema with ecchymosis on the dorsum of the feet and "erythema reticular patter on all extremities." Laboratory tests on 19 May 2011 revealed a "C4 of 6". On 20 May 2011, the patient developed a rash that was consistent with a hypersensitivity reaction to the smallpox vaccine sometimes described as non-viral pustolosis. On 24 May 2011, the patient was evaluated by DERM (dermatology) and PCM. The patient continued to complain of mild burning and swelling of the LE's. The patient's mild fatigue, headache, abdominal pain, fevers and most of the edema had resolved. On PE (physical exam), the patient was found to have mild edema and pustules on her back but "no other rash". According to the report, the patient's back rash was likely head rash/miliaria. Additional laboratory findings included: a punch biopsy for the right calf and right dorsal foot with "neg Immunoflorescence testing"; neg testing with anti-IgG, IgM, IgA, C3 and fibrin; C4, 6-10; CH50, 33; CBC, wnl; U/A, wnl; CRP, 2.6 then decr to wnl; Fibrin D dimer, 2.26; cardiac enzymes, wnl; basic metabolic profile, wnl; Parvovirus B 19 IgG, 4.1 and IgM, 0.2. No further information was available at the time of the report. The patient's recovery status was reported as unknown. Documents held by send.