Age: 18.0
Sex: F
Vaccine: HEP, MMR, TD
Symptoms: CSF test abnormal, Hypoaesthesia, Inflammation, Laboratory test abnormal, Musculoskeletal stiffness
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received from the patients father, who is a physician, on 8/29/2005. An 18 year old female patient received an injection of Decavac, lot number U1565DA, in the right deltoid on 8/2/2005. Ten days later, she developed. numbness in her right arm, right chest and right foot. At the time of this report, she had not recovered. Follow up information was received on 10/13/2005 from the patients father and also from the responsible physician. Based upon the new information provided, it was decided to upgrade to serious as per medical judgement. Follow up information was also received from the consulting neurologist and is being included in this version. It was reported that the patient received a dose of MMR, lot number unknown, on 8/2/2005 in addition to the aforementioned Decavac. The responsible physician reported that the patient had previously received a first dose of Menactra, lot number U1657AA, administered intramuscularly in the right deltoid and a first dose of hepatitis B vaccine, lot number AHBVB074BA, intra muscularly in the left arm on 7/7/2005. 19 days after receiving Decavac and MMR previously reported as ten days later and 45 days after receiving Menactra and Hepatitis B vaccine, the patient experienced numbness in her hands and arms. Five weeks later, she experienced numbness in her legs and feet. An MRI revealed a second lesion, more posterior than the first, at level C3. The second lesion was quite distinct and was not a continuation of the first. The patient was referred to a hospital for consultation, but was not hospitalized for the events. After the second lesion was discovered, the patient was treated with intravenous Solumedrol tapered doses over five days. Her definitive diagnosis was transverse myelitis. At the time of this report the patient had not recovered from the events. The symptoms in her hands and arms are abating and the symptoms in her feet have shown a slight improvement. It was reported that the patient had no significant past medical history and recent sick contacts prior to the onset of the symptoms. The patients father reported that the product received on 8/2/2005 was Adacel rather than Decavac, but no lot number was provided. The number previously provided for Decavac, U1565DA, was verified as a valid lot number for this product. The physicians office was contacted on 10/14/2005 to verify which product the patient had received, but they were unable to confirm it at this time. A request for medical records was sent to the responsible physician on 10/13/2005. Information was received on 10/18/2005 from the consulting neurologist. He stated that the patients outside medical records confirm the diagnosis of transverse myelitis. Her symptoms began around the last week of August 2005, approximately two weeks after Diphtheria and tetanus and six weeks after the meningococcal vaccine. MRI imaging on 9/22/2005 confirmed an active inflammatory lesions at C2-3, while MIR of the C spine on 10/6/2005 showed resolution of that lesion and the appearance of a new active inflammatory lesion at C3-4. MRIs of the brain on two occasions were normal. CSF examination on 9/9/2005 showed only four WBCs, but a markedly elevated IgG index 1.45, (normal less than 0.7) and the presence of oligoclonal bands. It was determined, as based upon both the CSF and the imaging, that the patient met the criteria for transverse myelitis. As per the neurologist, it is unclear whether this is a case of isolated transverse myelitis or part of a wider disease, such as multiple sclerosis. The presence of oligoclonal bands is suggestive that she has an increased risk of this ultimately being MS, but the patient dose not meet the criteria for MS at present (need two radiologic and or clinical attacks separated by three or greater months. Follow up information received on 1/6/2006. The patient received a second dose injection of hepatitis B vaccine, manufacturer not reported, lot number not reported, on 8/2/2005. Per the report, as of 10/5/2005, the patient continues to have numbness, tingling and a stiffness in the legs and a band like squeezing sensation. A Lyme titer on an unspecified date was non reactive. CSF culture were negative. Western Equine Enceph, St Louis Enceph, La Crosse Virus Enceph, IGG and WNV were done, but results were not provided. The patient had a total of three MRIs completed. The first showed a lesion in the patients spinal column at level C2 or C3. The second MRI revealed a second lesion, more posterior than the first, at level C3. The patient also has a spinal tap, CBC and Chem 7, but no results were provided. From follow up information received on 10/18/2005, it was reported that the 1st MRI confirmed an active inflammatory lesion at C2-3, second MRI of C spine showed resolution of that lesion and the appearance of a new active inflammatory lesion at C3-4. 2 MRIs of the brain were normal. CSF showed 4 WBC and elevated IgG index and oligoclonal bands.