Age: 60.0
Sex: F
Vaccine: HEP, HEPA, HEP, HEPA
Symptoms: Balance disorder, Electromyogram normal, Gait disturbance, Hypoaesthesia, Induration
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of numbness in a 60-year-old female patient who received HAVRIX adult (batch number MB3Y2, expiry date 10th June 2018). Co-suspect products included ENGERIX B adult (batch number C7EP5, expiry date 11th November 2018). The patient's past medical history included numbness (15 years ago after chiropractor adjusted her neck). In July 2016, the patient received the 1st dose of HAVRIX adult and the 1st dose of ENGERIX B adult. In July 2016, less than an hour after receiving HAVRIX adult and ENGERIX B adult, the patient experienced numbness, swelling of feet, stiff joint and skin warm. On an unknown date, the patient experienced walking difficulty, balance difficulty, limbs stiffness and tingling. ENGERIX B adult was discontinued (Dechallenge was negative). On an unknown date, the outcome of the numbness, swelling of feet, stiff joint, walking difficulty, balance difficulty, limbs stiffness and tingling were not recovered/not resolved and the outcome of the skin warm was recovering/resolving. The reporter considered the numbness, swelling of feet, stiff joint, skin warm, walking difficulty, balance difficulty, limbs stiffness and tingling to be related to HAVRIX adult and ENGERIX B adult. Additional details were provided as follows: This case was previously reported to a doctor. The patient reported that she received separate injections of Hepatitis A and Hepatitis B in the same location of the left upper arm. She stated it might have even been in the same site but it was different injections. She did not have the lot and expiration dates of the vaccines or the amounts but stated she was told by the practice it was GSK vaccines. She stated within in an hour of receiving the vaccines her head was completely numb including her ears. She also stated that in 2 to 3 days she was experiencing right foot numbness, like a block of wood. She also had swelling on the top of her foot then the swelling was on the ball of the bottom of her foot and her first three toes became stiff. She stated the bottom of her foot was also warm to touch and it was like a blister full of fluid but it was hard. She stated her middle toe on that foot was bent. The patient stated that the issues had affected her walking now, that her balance was off. When she had an electromyogram and a nuclear magnetic resonance imaging in the last two weeks the toe on the right foot actually improved. The electromyogram and nuclear magnetic resonance imaging was negative. Two weeks ago she also began experiencing right leg stiffness and left head slight numbness. She stated her foot was worse. She also noted that she was told not to travel and stated she had to cancel a vacation. They did not want her to travel until this was figured out. She saw a podiatrist for her foot, who found nothing. She had an appointment with a neurologist later this week and stated that she had medical friends encouraging a Doppler study to be done to rule out a clot in her right leg or foot. She also stated at times her right foot had no feeling but it was improving. The reporter preferred to be contact via email and to be sent the authorization for release and she would mail it back.