Age: 15.0
Sex: F
Vaccine: MNQ, TD
Symptoms: Benign intracranial hypertension, CSF test abnormal, Headache, Optic discs blurred, Papilloedema
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received from a nurse on 8/18/2005. A 14 year old female patient was diagnosed with papilledema 69 days after receiving the intramuscular injection of Menactra, lot number U1575AA on 6/9/2005. Site of administration not reported. The patient received in concomitant the intramuscular injection of TD Decavac lot number U1370BA. Site of administration not reported. On 8/17/2005 the patient was seen by her optometrist for a routine visit and was found to have papilledema of unknown origin. The patient is asymptomatic. The patient denies any illness at the time of vaccination and was on no medication. Follow up information received on 9/6/2005 from a physician. The patient was referred to a neurologist on 8/31/2005 for papilledema of one months duration. It was noted that the patient had been taking minocycline since March 2005. Upon examination, it was noted the patients visual acuity was 20/20 in the left and 20/25 in the right eye. The neurologist's impression was pseudotumor cerebri, possibly secondary to minocycline. The minocycline was discontinued. It was not reported whether the patient has recovered from these events. Based upon the new medical information provided, this case has been upgraded to serious. Follow up information received on 9/22/2005 from a neurologist. It was reported that the patient had experienced headaches on 8/2/2005. The headache was frontal in nature and there was no associated vomiting. Excedrin helped the headache to some extent. She was seen on 8/4/2005 for a routine eye checkup by an optician. During examination it was noted that the patient had blurring of the optic disc and she was referred to an ophthalmologist, who confirmed the papilledema. A CT with contrast was obtained and was normal. As previously reported, the patient had been taking minocycline 1500 mg twice a day for acne since March 2005. She was also taking Zyrtec. The patient was seen by a neurologist on 8/31/2005 for her symptoms. Her past medical history was noted to be unremarkable. Physical examination showed the patients pupils to be equal, round and reactive to light. The extraocular muscles were intact. Fundi were benign with flat sharp discs and normal vasculature. Mental status was appropriate for age. Cranial nerves II through XII were examined in detail and found to be normal with noted exception II eg fundi benign, pupils equal, round and reactive to light, no afferent papillary defect, visual fields intact to confrontation). III, IV and VI (eg no ptosis, extraocular muscles intact, saccates full). V (eg facial sensation to light touch and corneals intact). VII (eg facial symmetry intact). VII (eg hearing is grossly intact). IX, X (eg palate movement intact and uvula midline). XI (eg normal shoulder strength). XII (eg normal tongue movement). Sensation (eg to touch, pinprick, vibration, proprioception, double simultaneous movement, and heat and cold) was intact and tested as appropriate for age and state of the patient. The patients visual acuity was noted to be 20/20 in the left eye and 20/25 in the right eye. She does wear contact lenses. The neurologist found no evidence of an increase in the ceco scotoma, however, the optic fundi were blurred and were quite compatible with papilledema. The visual fields were full. The remainder of the neurological examination was unremarkable. The final finding was bilateral papilledema, associated with normal visual acuity and no visual field changes. It was felt that in all likelihood the patient did have pseudotumor cerebri and that the etiologic agent causing the pseudotumor was the minocycline. The minocycline was discontinued and the patient was placed on Diamox 250 mg twice a day. The patient was seen by the neurologist two weeks later for follow up. It was noted that an MRI MRV were negative. A lumbar puncture was completed on 9/16/2005 and the patients ocular pressure was noted to be 280 and her cranial pressure 200. It was not reported whether the patient recovered from the events. Follow up information received from a health care provided on 10/21/2005. Correction were made to ocular pressure of 280 and her cranial pressure of 200 noted in narrative above. This should read CSF pressure was 280. This was reduced to 200 after fluid was removed. The statement fundi were benign with flat sharp discs and normal vasculature was removed from the narrative. Per the reporter, Fundi continue to be abnormal. Visual acuity is normal. Patient is taking Diamox 250 BID. Additional information with corrections received 10/21/2005. Ocular pressure noted above under 9/16/2005 should read CSF pressure was 280. This was reduced to 200 after fluid was removed.