Age: 68.0
Sex: F
Vaccine: TD
Symptoms: Laryngeal oedema, Pulmonary granuloma, Salivary hypersecretion, Vocal cord paralysis
Clinical narrative: Seriousness criteria: Other - Medically significant. No seriousness criteria was reported. Based on medical judgment this case is considered serious: medically significant event. From initial information received on 27/Jul/2004 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 68-year-old female patient received a booster dose of TD ADS ADULT, lot number U1185AA, administered intra-muscularly in the left deltoid on 17/jun/2004. Three days later, on 20/Jun/2004, the patient complained of hoarseness and was subsequently diagnosed with vocal cord paralysis. A CT scan of her larynx showed swelling. She is to have an endoscopy procedure in the future. The patient has not recovered from these events. From additional information received on 13/Sep/2004 from a health care professional, it was reported that the patient had a parathyroidectomy in February 2000, patient was diagnosed with hypercalcemia. She was referred to another physician who ordered a computed tomography scan of the larynx and neck and scheduled a biopsy. Cardiac and pulmonary work up was within normal limits. The patient was admitted to the hospital on 30/Jun/2004 and discharged on 02/Jul/2004. A 2-dimensional echocardiogram was within normal limits except a trivial pericardial effusion. Pulmonary Function Tests (PFT's) and computed tomography of the chest were within normal limits. From additional information received on 14/Oct/2004 from office visit notes of the surgical consultant from 19/Jul/2004, it was reported that the patient had a sudden onset of loss of voice and shortness of breath since 20/Jun/2004. She was seen in the emergency room on 30/Jun/2004 and had a CT scan of her lungs which showed a small pulmonary nodule probably not related to her voice loss. The patient was placed on prednisone, but the prednisone caused her increased shortness of breath and anxiety so she stopped taking it. A fiberoptic laryngoscopy was performed, which shows she has generalized laryngeal edema and heavy secretions. She had significant anxiety with the procedure and the physician was unable to get a good look at her vocal cords. On 23/Jul/2004 the patient had a CT scan of her neck which showed the thyroid was mildly enlarged and there was evidence of previous parathyroid surgery. The aryepiglottic folds are thickened and there was thickening and irregularity of the right false cord. Reportedly the patient still remains hoarse. On 29/Jul/2004 a biopsy was taken from an area of granulation tissue just above the left false vocal cord. Sections of the vocal cord biopsy sowed benign lymphoepithelial tissue with overlying squamous epithelium. Some features raise the possibility of a tonsillar cyst, however a discrete cyst is not present. There is no evidence of a malignant process. Slides were reviewed by one other pathologist in the department who concurs with the diagnosis. From physician notes dated 09/Aug/2004 the patient is still having severe shortness of breath, exhaustion and no voice. Cranial nerves tests no deficits. It was not reported if the patient has recovered from these events. From additional information received on 22/Nov/2004 from the initial reporter, it was reported that it is unknown if the swelling in the larynx was unilateral or bilateral. The patient recovered from these events. No further information is anticipated, this case is considered closed. Medical Assessment: This represents the first case of vocal cord paralysis reported after administration of Td vaccine. In the current case, it is unknown if vocal cord paralysis is unilateral or bilateral. Due to limited information follow-up will be requested regarding the laboratory and diagnostics that support this diagnosis and that of another etiology. Follow-up (13/Sep/2004): It is still unknown if vocal cord paralysis was unilateral or bilateral. the results of endoscopy procedure, CT of larynx and neck, and biopsy have not been provided. The event was reported in a patient with a history of parathyroidectomy. Parathyroidectomy may cause damage to the recurrent laryngeal nerve that can weaken or paralyze the vocal cord. Follow-up 14 Oct 2004: Based upon the follow up information the patient's laryngeal edema, granulation tissue above the false vocal cord and the history of parathyroidectomy may have contributed to the occurrence of the event. No further information is expected.(OMIC)