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 ENERGIX 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 physician. The patient reported that she received separate injections of Hepatitis A and Hepatitis B in the same location of the left upper arm. The patient stated it might have even been in the same site but it was different injections. The patient 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. The patient stated within an hour of receiving the vaccines her head was completely numb including her ears. The patient also stated that in 2 to 3 days she was experiencing right foot numbness, like a block of wood. The patient also had swelling on the top her foot then the swelling was on the ball of the bottom of her foot and her first three toes became stiff. The patient 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 contacted via email and to be sent the authorization for release and she would mail it back. Follow up information received from consumer and nurse via call center representative on 9th December 2016, 13th December 2016 and 14th December 2016: The reporter's details were updated. The reporter was the nurse for physician and the events were reported to physician. On 22 July 2016, the patient HAVRIX adult and ENGERIX B adult 0.5 ml intramuscularly. The VAERS details were updated. Less than a year after receiving HAVRIX adult and ENGERIX B adult, the patient experienced worsening breakage of fingernails that were not growing the way they used to (serious criteria disability), worsening sagging of skin on thighs and upper arms (serious criteria disability), limp, thinning hair, bulging veins in both feet and hands (serious criteria disability), and constipation while using product, awareness of her right foot (serious criteria GSK medically significant), right foot stiffness (serious criteria disability), constant fatigue (serious criteria disability), stringy hair (serious criteria disability), body freezing including shivering (serious criteria disability), headaches (serious criteria disability), head numbness including her ears and face (serious criteria disability), right hand numbness (serious criteria disability), bowel movement changes (serious criteria disability), some loss of appetite (serious criteria disability), slightly elevated blood pressure (serious criteria disability) and elevated white blood cell counts (serious criteria disability), and a low grade fever lasting for one week in October in 2016. These symptoms continued to get worse. On 18th October 2016 and 7th December 2016, the patient was seen in the physician's office regarding these symptoms. The reporter called before requesting to be contacted regarding the patient's experience and had not received any correspondence. The outcome of the hair thinning was not resolved. The outcome of the events constipation, awareness of her right foot, right foot stiffness, worsening breakage of fingernails that were not growing, worsening sagging of skin on thighs and upper arms, constant fatigue, stringy hair, body freezing, shivering, headaches, head numbness including her ears and face, right hand numbness, bulging veins in feet and hands, bowl movement changes, some loss of appetite, slightly elevated blood pressure and elevated white blood cell counts was unknown. The reporter considered the worsening breakage of fingernails that were not growing, worsening sagging of skin on thighs and upper arms, limp, hair thinning, bulging veins in feet and hands, constipation, awareness of her right foot, constant fatigue, stringy hair, body freezing, shivering, headaches, head numbness including her ears and face, right hand numbness, bowel movement changes, some loss of appetite, slightly elevated blood pressure and elevated white blood cell counts to be related to HAVRIX adult and ENGERIX B adult. The patient wanted further investigation. The reporter preferred to be contacted using the provided telephone number.