Age: 53.0
Sex: F
Vaccine: TD
Symptoms: Muscular weakness, Nervous system disorder, Ocular hyperaemia, Oedema, Pain
Clinical narrative: (OMIC) From initial information received on 06/08/05 from a physician regarding an adverse event occurring. It was reported that a female pt of unspecified age (no specific information provided) was accidentally splashed in the eye with TET TOX ADS USP, lot number not reported, on an unspecified date. An unspecified amount of time later, the pt developed eye irritation and was therefore sent to an ophthalmologist. It was not reported whether the pt recovered from this event. Follow up information received on 11/23/05. Upon internal review, the case has been upgraded to serious status due to clinical significance and persistent disability. It was reported that on 06/08/05, the pt (a nurse who works in a doctor's office) with a medical history of hypertension and hypercholesterolemia, accidentally sprayed 0.5mL of Decavac (lot U1212AB, exp 07/07/06) into her eyes during preparation. The nurse was removing the stopper from the prefilled syringe requiring a pulling motion, when the stopper released, it caused a recoil of the left hand (holding syringe) downward, the plunger hit the desk and expelled the contents to spray it upwards into the face and burned the nurse's eyes. From the doctor's summary on 08/18/05, the pt suffered a severe injury to her eye on 06/08/05. The eyes were initially irrigated with normal saline and then 15 mins in each eye with room temp tap water. The pt immediately went to an ophthalmologist, was started initially on Artificial tears beginning every hr tapering down to every 2-3 and then four times a day. The pt, however, had severe symptoms and was seen again by the ophthalmologist on June 13 and started on Lotemax at the time qid for three days. The pt resumed the tears on June 17. The pt persisted in having dry eyes, in spite of frequent administration of artificial tears. She was seen by the ophthalmologist on Jun 24. Visual fields were accomplished at that time. It was interesting to note that the pt's initial visual acuity. She saw another ophthalmologist (her own) on Jun 11. A Shirmer test at that time revealed  no tear production and the pt was started on Soothe with the recommendation for possible Restasis in the future. The pt did have new glasses prescribed at that time. On Jun 17, at the office, the pt developed a sudden feeling of paresthesias of both her face and left arm. Because of the sudden onset of focal neurological symptoms, the pt was sent on an emergency basis to the ER and seen by a physician. Tests at that time included an MRA of the brain, an MRI as well as a CAT scan. The pt's initial blood pressure was 200/100 although the blood pressure had been 130/90 in the office. The pt had been maintained on HCTZ 25mg and K tab 30mEq with stable blood pressure for a significant period of time. The pt over the intervening next who months had persistent left facial and left arm numbness occurring on an intermittent basis. At times the numbness of the arm was accompanied by weakness of the arm as well. The pt has had intermittent episodes when this was proceeded by a lack of mental clarity. One particular severe episode occurred with lack of being able to articulate clearly, developing into not only facial numbness and left arm weakness but pain in both her face and left arm weakness and diaphoresis. The pt's further evaluation during this time included lab testing for vascular coagulation. Although minor variations were noted it was not felt by the hematologist to represent any significant factor. The pt underwent an echocardiogram of her heart and underwent a carotid artery artery, however MRA of the carotid arteries showed a plaque but no significant stenosis and no evidence of friability for the plaque and no ulceration. The pt's additional evaluation has included an EEG, based on the face that many of these episodes but not all were proceeded by a sense of weakness and lack of mental clarity and profound fatigue after the event. The EEG along with photic stimulation has been negative. The pt had a repeat MRI with gad, showing UBO's but not in a pattern suggestive of MS. The pt has not had a spinal tap for evaluation of possible MS.  The pt has suffered what appears to be permanent eye damage in terms of lack of tear production and difficulty with vision and eye pain. The pt was left with intermittent neurological symptoms involving her left arm and left face for which no clear etiology has been established. The pt although hypertensive had never shown an association between hypertension and the occurrence of these neurological events. Initially, the hypertensive medication during this period of time had been changed from her HCTZ and potassium to an ARB plus HCTZ which resulted in hypotension and ARB alone resulted in lability of blood pressure. IT was elected then to put her on calcium channel blockers followed  in a period of time with smaller amounts of diuretic and potassium. The pt in the past has been intolerant of ACE inhibitors because of the cough. The changes in medication did not appear to correlate in any way with symptomatology. Attempts at controlling hypercholesterolemia in the past have resulted previously in hair loss and muscle weakness with Lipitor which resolved on discontinuation of this medication. This was in her past history and not related to the current episode. From the doctor's summary on 11/10/05, it was reported that the pt was currently on Restasis with persistent diminuation of tears, along with unremitting pain and discomfort in her eyes that have not recovered to any significant extent. She was maintained on Neurontin 300 mg tid for the paresthesias of her left face and arm. Further details are available in the case file. Follow up information received on 03/01/06 from a physician. The pt had received Diphtheria Tetanus injection (route, site, manf and lot number not reported) in Jan93 without any ill effect. The pt has a past history of cervical radiculitis with numbness of the first three fingers of the left hand that was associated with pain. Per the reporter, the pt's both eyes were sprayed with the Decavac. Her eyes became very erythematous and were burning. She had severe persistent eye discomfort, and on 06/11/05, her eyes became very irritated and swollen. On 06/13/05, she had swelling of the bulbar conjunctiva. On 06/17/05 the pt began having a midline headache and her blood pressure went up to 200. Her blood pressure continued to be labile. She also felt a pulling sensation and a drawing sensation on the left side of her face. Because these symptoms (paraesthesia, numbness, weakness) wee associated with focal neurological symptoms an MRI, MRA and CAT scan of the head were completed. The results were negative. She continued with intermittent left facial  and left arm numbness. Lab tests on 06/29/05 showed her B2 glycoprotein IgM antibodies slightly elevated at 14 but IgA and IgG were negative. Repeat lab work showed an MRHFR DNA mutation that was positive for one copy, each of the C677 TNA 129 8C mutations with no increase in homocysteine levels. She has been maintained on folic acid for some time. On 07/06/05 the pt was started on Aggrenox. On 07/08/05 she felt very unsteady and had feelings of dizziness. On 08/10/05 the pt experienced epigastric discomfort, jaw pain, suspect irregular heart beat that was not documented, and she broke into a full sweat. An EKG was completed that was negative, and she was started on Cardizem CD 180 because of the possibility that the large dose of HCTZ may have contributed to her symptoms. The pt continues with intermittent feelings of facial numbness and left arm weakness and numbness. The events were updated per this report. The pt had not recovered at the time of this report.