Age: 16.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Muscular weakness, Pain, Polyneuropathy
Clinical narrative: Initial information received on 29Sep05. A 16 yr old female pt, developed bilateral leg pain and weakness less than 12 hrs after she received an IM, left arm injection of Adacel, lot number C2151AC on 22Sept05. She was unable to weight bear. At the time of vaccination, she had a viral illness with slight fever, st, and congestion. On 23Sep05, she was seen by a doctor and sent to the ER for further evaluation with emergentologists and a neurologist who felt the symptoms were likely a poly neuropathy, possibly related to the vaccine. The pt also received Menactra vaccine on 07Jun05. The hospital records for the pt were received. 23Sept05 at 1909: As per the attending Emergency resident, the pt has a chief c/o bilateral lower extremity weakness and pain. The pt was laying down last night and when tried to arise she was unable to get up. The pt stated her leg muscles, as well as joints have pain and that she was able to move her legs, but they feel stiff and achy. Her thighs felt as though they're being squeezed. The onset of weakness was the same in all parts of her legs (ie.no ascending weakness). No fevers. No dyspnea. The pt stated her feet were getting cold and she had a small amount of tingling. No burning sensation. The pt was unable to sit up last night, but now can sit up. Her arm had more weakness last night, but have improved today. No rash. The pt states her symptoms are RL in lower extremities. ROS: +ST x 1.5weeks, +sinus pressure, HA, RN. Cough, worse at night. Saw PCP yesterday. RST negative and cx negative. The pt received Adacel and returned home. Sick contacts: MOC with sore throat, multiple family members with URI's. PMH: The pt takes Midrin as needed for migraines. She has tendinitis in the right shoulder and was on Naproxen in the past. In addition to the medications listed in the medication history, she is taking OCP's. Social history: She traveled several months ago. She had multiple mosquito bites at that time. She currently noticed a small bug bite on arm yesterday, no surrounding rash. Neuro: The pt appeared alert and interactive. She had grossly nonfocal, cranial nerves: cranial nerves II XII grossly intact and symmetric, deep tendon reflexes: patellar 2+ and brachial 1+, muscle strength: Bilateral 5/5 in upper and lower extremities, but effort limited by pain. Unable to assess gain. TTP over thigh muscles, gastrocnemius muscles, knee joints, and ankle joints bilaterally. Sensation intact to light touch. Labs: Electrolytes, CBC WNL. CPK55, ESR 11. ED Course: Findings consistent with a possible neuropathy. Guillain Barre appears less likely given PE findings. The case was discussed with Neurology. GBS unlikely per neurology consult and symptoms likely consistent with neuropathic pain possibly secondary to Adacel immunization. Recommend OTC pain control (NSAIDS, Tylenol) over weekend and if symptoms fail to improve, to return to ER. The pt will follow up with PCP in 2 days. Diagnosis: Polyneuropathy. The complete set of pt records received are available in the case file. Follow-up information received on 17-Oct-2005 from the patient's mother and on 18-Oct-2005 from the initial reporter and the consulting neurologist. The patient's mother reported that on the evening of the vaccination the patient was "stricken with pain in both of her legs. Since then, she is unable to walk without the aid of crutches for a short amount of time or (she has to) use a wheelchair. She is unable to sit with her legs down for more than 15 minutes without become in terrible pain (and) she has been missing school". The patient was referred to a neurologist and has had blood work, MRI and an EMG, with all tests coming back normal. The patient's mother stated that there have been no explanations as to why the patient is still having pain. Contact information was provided for the consulting neurologist and the patient's mother and she granted permission for the company to contact this physician. The initial reporter of thsi case was contacted on 18-Oct-2005 to verify the lot number for the menactra product administered on 07-Jun-2005. The lot number provided was U1493AC. The consulting neurologist was also contacted on 18-Oct-2005 for the purpose of requesting medical records for the patient. As per the neurologist, the patient's primary issue at this point is leg pain. She has intact strength and has not yet had an EMG, although one is planned. Guillain-Barre Syndrome has been ruled out. A spinal tap has not been performed. The patient has had normal CK levels and and ANA, sed rate and CRP have been negative. Lumbar/spinal imaging has also been negative. She has not been tested for Lyme disease. The patient was treated initially with Neurontin 100 mg three times a day, but this was increased to 200mg three times a day since the lower dose was not alleviating the symptoms. The patient has not recovered and is still undergoing medical evaluation. Follow-up received on 02/Nov/2005 from a health care professional. It was reported that the pediatric MRI of the spine showed a bulging disc in the patient's lumbar-sacral area. This abnormality caused the resulting myelopathy and the symptoms the patient experienced. He felt it was unlikely to have any relationship to the vaccines the patient had received. Follow-up information received on 30/Nov/2005 from the Centers for Disease Control and Prevention. The patient was examined by the neurologist on 07/Oct/2005. Follow-up information received on 29/Dec/2005 from the neurologist. The patient was initially seen by the neurologist on 03/Oct/2005 and for a follow-up office visit on 12/Oct/2005. At the time of the follow-up visit, the patient had been experiencing increasing pain involving her thighs and calves. She experienced some paresthesias in the lower extremities, particularly when they were cold. She was not doing well with crutches and had some falls related to not being able to bear weight because of the pain. The pain was made worse by hot water, such as in a bath, or by sitting for prolonged periods or when her legs were out straight. The patient attempted treatment with Vicodin, which she felt made things worse, and with ibuprofen, which did not help. She had not undergone physical therapy or modalities at the time of the neurology consult. A complete review of systems was performed. She had no bowel or bladder symptoms. She felt generally weak, although the pain was her major complaint, he had some mild coryza about two weeks before her symptoms began but she had no major medical complaints, including no major intercurrent illness. The physical examination was largely unremarkable, although it was noted that the patient had some discomfort with percussion of the lower spine, nonspecific. Straight leg raising was significant only for some tightness in the right leg, but there was no evidence of meningismus. A neurologic examination was normal. It was felt that the patient's motor limitations were related to the pain she was experiencing. She did not have any evidence of either myositis or of a neuropahty given her intact reflexes and essentially normal muscle strength throughout. The patient never followed up with the neurologist after her office visit on 12/Oct/2005. It is unknown whether the patient recovered from these events.