Age: 12.0
Sex: M
Vaccine: MEN, TD, MEN, TD
Symptoms: Injection site inflammation, Muscular weakness, Myalgia, Myositis, Neck pain
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report receive from a healthcare professional on 10/13/2005. A 12 year old male patient received a dose of Decavac, lot number U1215DA, and a dose of Menomune A/C/Y/W 135, lot number UE431AA, on 7/29/2005. Both vaccines were administered in the left deltoid and the route of administration was not reported. The patient was playing football and received an injury to his ribs and began to have chest pain two days later on 10/1/2005. He was seen in the physicians office on 10/3/2005 for complaints of chest pain with deep breathing. The pain radiated to his neck and could be aggravated with exercise. It was reported that the pain feels like chest is tight, not real pain. The patient also reported that his legs felt very weak bilaterally. The leg weakness started on 10/1/2005. The patient had no loss of reflexes. Physical examination showed chest wall tenderness at the costovertebral angle, left greater than right, with no ecchymosis or deformity. No abnormality was noted in the strength of the patients legs. The patient was diagnosed with costochondritis and muscle weakness and was treated with Naprosyn EC 375 every 12 hours for three days, then as needed. The patient was seen by the physician for a follow up on 10/6/2005. At that time he still felt weak and had pain in his upper extremities, which was very atypical for him. He reported a nasty headache the previous day and his leg weakness had reoccurred. At the time of examination he reported that his neck and back ached. A review of systems was unremarkable with the exception of his chief complaints. His muscle strength was 5/5 for all groups tested and his muscle tone was normal. Testing of the cranial nerves revealed no deficits and his coordination was noted to be good. His deep tendon reflexes were normal. He was diagnosed with myalgia and myositis and started on Doxycycline 100 mg. every 12 hours for ten days. A Lyme panel and chemistry panel were negative. It was also planned to check the patients CPD, as well as Ehrlichiosis and Babesiosis titers. On 10/13/2005 the patient was again seen by the physician for follow up. At that time he reported feeling much better and felt that the Doxycycline really helped. A review of systems was normal. Cranial nerves II - XII were noted to be intact and his deep tendon reflexes were 2+/4+ bilaterally and symmetrical. A follow up Lyme panel, CBC and sed rate were drawn. The patient did not have an EMG or lumbar puncture. He was to continue on Doxycycline. It was reported that the patient recovered from the events. It was noted during internal review of this case that the medical records forwarded by the physicians office on 10/17/2005 noted that the patient received Menactra, however the lot number provided UE431AA matched that of Menomune A C Y W 135 single dose vial. The physician confirmed that she administered lot number UE431AA to both the patient and her sister and stated that she has only ever ordered Menactra. The physicians order history was verified with Medical information services. The physicians office received Menactra, lot number U1677AA on 7/15/2005 and Menactra, lot number U1783AA on 9/14/2005. Both lot numbers were for multi dose packages. The physician reported to medical information services that she did not reconstitute any vaccine, however, Menomune A C Y W 135 is powder and is reconstituted with accompanying diluent. It was reported that the facility received vaccine from the company, as well as through the state VFC program, but it was not determined whether Menomune A C Y W 135 is available through VFC. Medical information services is completing an investigation. Follow up information received from a physician on 11/8/2005. The patient was re examined for symptoms of bilateral pain and weakness of the upper and lower extremities. Deep tendon reflexes were normal. It was the opinion of the physician that this did not represent Guillain Barre syndrome. The patient was referred to a neurologist. At the time of this report, the patient had not recovered. Follow up information received from the neurologist on 12/21/2005. MRI of the cervical spine showed syringomyelia of C3-C7. The patient was referred to a neurosurgeon.