Age: 40.0
Sex: F
Vaccine: HEPAB
Symptoms: X-ray normal
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling arm in a 40-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medical conditions included allergy to ceclor, allergy to Lortab and sulfa allergy. On 28 March 2013 at 10:00 the subject received 1st dose of TWINRIX (unknown, right arm) that expired on 22 June 2012. On 28 March 2013, during vaccination with TWINRIX, the subject experienced burning during injection and expired vaccine used. Immediately after vaccination with TWINRIX the subject experienced swelling, pain down to elbow [elbow pain radiating to arm], and numbness of pinky and ring fingers. The healthcare professional reported the adverse events started immediately after injection was administered. At that point the subject was referred to the emergency room (ER). The healthcare professional stated the adverse events were more than local as its affecting fingers and they will be reluctant of giving her another dose, but were unsure at this time. The outcome of the ER visit was unknown. At the time of reporting the outcome of the swelling arm, burning during injection, elbow pain radiating to arm and numbness in pinky and ring finger of hand were unspecified. The healthcare professional reported another subject who received a dose from the same batch complained of burning as it went in and was planning to return this lot as she suspected the symptoms may be related to this particular lot [pharmaceutical product complaint]. Please see case A1018366A for this report. Follow up was received from nurse on 6 May 2013. The nurse documented that the case was not serious. The practice notes document that, "after injection" the subject experienced a "weakness of hand grip and strength" (weakness of hand grip and decrease hand strength) of the right hand. "When induction was being done, pull back showed no blood." The subject had "no rash, no sign of local infection/reaction. She had no shortness of breath." The subject was treated with ice on the affected area. The subject was transferred to the emergency room. The emergency department physician documented that concurrent medical conditions included allergy to ceclor, allergy to Lortab, fatty liver, non-tobacco user, non-drinker, obesity and sulfa allergy. The emergency department physician also documented that the subject experienced a localized reaction to immunization. On 28 March 2013, during vaccination with TWINRIX, the subject experienced burning at injection site during injection (also described as "lateral deltoid which is tender" and previously described as "pain down to the elbow"), numbness at the injection site (described as "numbness of pinky and ring fingers"), and hematoma injection site. On the same day as the vaccination with TWINRIX, the emergency department physician evaluated the right upper extremity and observed "a small hematoma on the lateral deltoid which is tender. There is no crepitus. There is no swelling. She has full strength in the hand. When I go to specifically ask her to move those fingers, she says that she cannot, but when I have her crossed her fingers in front of her and asked her to  move those fingers, she moves them without difficulty and sensation is intact at that time." Previously, the reporting nurse stated that the subject experienced arm swelling, weakness in grip and numbness in pinky and ring fingers; however the emergency department physician did not observe these events. The emergency department physician ordered "films so as to be  sure there was no foreign body or other side effect, those were negative per the radiologist." The subject was treated with ice at the physician office. She was treated in the emergency department with oxycodone/acetaminophen (Percocet) and ondansetron (Zofran). The subject was discharged from the emergency department with tramadol (Ultram) and ibuprofen. At the time of reporting the outcome of the events were unspecified.