Age: 48.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Arthralgia, Dysstasia, Gait disturbance, Joint swelling, Muscular weakness
Clinical narrative: A cluster of four adult patients who each received FLUZONE (lot number not reported) and ENGERIX B (GSK, lot number AHBVB767AA) and within 12 to 24 hours developed muscle pains in the lower extremities. Initial report received on 06 November 2009 from a healthcare professional. According to the reporting nurse, 25 patients received flu shots on 03 November 2009. Ten of them had also received their second Hepatitis B vaccine. Four of these ten patients, who were healthy adults (aged 22 to 61 years) without underlying disease, had received a 0.5 ml injection of FLUZONE (lot number not reported) and a 1.0 ml injection of ENGERIX B (GSK, lot number AHBVB767AA) in opposite deltoids. Within 12 to 24 hrs (either during the night or in the morning following vaccination), the four patients began to have aching in the legs and calves. In Patient 1: The symptoms progressed to foot weakness and difficulty walking on 05 November 2009. He was immediately referred to his primary care physician for evaluation and he was unable to stand by the time he saw his physician at 5:00 p.m. He had knee and ankle swelling on one side and ankle weakness on the other. Corrective treatment was INDOCIN and he was sent home. On the morning of 06 November 2009, the swelling was gone and the muscle aches in general were less. He was to have a follow-up on 09 November 2009. In Patient 2: By 06 November 2009, the aches were in all her joints and muscles from head to toe and she was advised to consult her primary care physician. On 06 November 2009, the symptoms had resolved in Patient 3 and were less but still present in Patient 4. All 10 patients had received the first dose of ENGERIX B one month ago (different lot number) with no problems reported, except two of the four patients stated that they had mild symptoms (muscle aches) after the first dose of the Hepatitis B vaccine but never compared symptoms or thought any more of it until their second dose. All four of the patients were taking OTC anti-inflammatory, which were either MOTRIN, ADVIL or TYLENOL. According to the reporter, the remaining 6 of 10 patients also received the same combination of ENGERIX B and FLUZONE with no report of illness. Twenty-five other patients at the clinic had only received FLUZONE with no side effects. In the 100 dose allotment of FLUZONE, 50 doses had been given with no adverse reports. This case is for Patient 2, a healthy female adult (aged 22 - 61 yrs) without underlying disease, who received a 0.5 ml injection of FLUZONE (lot number not reported) and a second 1.0 ml injection of ENGERIX B (GSK, lot number AHBVB767AA) in opposite deltoids. Within 12 to 24 hrs she began to have aching in the legs and calves. Corrective treatment was an OTC anti-inflammatory, which was either MOTRIN, ADVIL or TYLENOL. By 06 November 2009, the aches were in all her joints and muscles, from head to toe, and she was advised to consult her primary care physician. The patient's outcome was not reported. Additional information for Patient 2 was received on 28 December 2009 from a healthcare professional. The patient was 48 years old. FLUZONE (lot number U3227AA) and Hepatitis B vaccines were administered on 04 November 2009 between 10:00 and 10:30 a.m. (previously reported as 03 November 2009). The patient experienced the events late in the evening on 04 November 2009 (previously reported as 06 November 2009). The patient's symptoms also included sluggish walking, which felt like her legs "dragged". The patient outcome was unknown. The events for Patient 1 are described in case 2009-04776.