Age: 71.0
Sex: M
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Viral infection
Clinical narrative: This case was retrieved via a search of scientific literature on 08 April 2014. Verbatim from the article: "The purpose of this analysis is to describe cranial nerve palsies, other than VII, that have been reported to the Vaccine Adverse Event Reporting System (VAERS) after routine vaccination. Because motor deficits may be more concerning to patients and clinicians than purely sensory neuropathies, and because sensory changes are highly subjective and difficult to document, this analysis focuses on palsies. Therefore disturbances of cranial nerve VIII and the sensory branches of V are not included. Materials and Methods: VAERS. Established in 1990, VAERS is jointly managed by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention. These spontaneous reports of suspected vaccine side effects are submitted by health care providers, vaccine recipients, vaccine manufacturers, and other interested parties. Federal regulations require manufacturers to report all adverse events occurring within the country, and all serious and unexpected adverse events occurring outside the country. Healthcare professionals and consumers are encouraged to report adverse events; individuals may report an adverse event even if they are not certain that the vaccine caused it. FDA medical officers review all serious adverse events, which for regulatory purposes are defined as those reported as fatal, disabling, life threatening, requiring hospital admission, prolonging a hospital stay, resulting in a congenital anomaly, or requiring medical intervention to prevent such an outcome. VAERS data may be used to detect new or rare adverse events, monitor known reactions, perform vaccine lot surveillance, identify risk factors, and evaluate the safety of newly licensed vaccines. Report identification and review we selected all VAERS reports (July 1, 1990 - January 30, 2012) with any of the following Medical Dictionary for Regulatory Activities (MedDRA Version 13.1) Preferred Terms (PTs): IIIrd nerve disorder, IIIrd nerve paralysis, IIIrd nerve paresis, IVth nerve disorder, IVth nerve paralysis, IVth nerve paresis, trigeminal nerve disorder, trigeminal palsy, trigeminal nerve paresis, VIth nerve disorder, VIth nerve paralysis, glossopharyngeal nerve disorder, glossopharyngeal nerve paralysis, vagus nerve disorder, vagus nerve paralysis, accessory nerve disorder, XIth nerve paralysis, hypoglossal nerve disorder, hypoglossal nerve paralysis, hypoglossal nerve paresis, cranial nerve disorder, cranial nerve injury, cranial nerve palsies multiple, cranial nerve paralysis, cranial neuropathy, or paresis cranial nerve. We reviewed the reports to identify the involved cranial nerve (s) and verify that the adverse event included paresis or paralysis. We summarized the results with descriptive statistics. Disproportionality analysis Data mining methods can identify adverse events that are reported more commonly for one vaccine than others. Disproportionally high reporting of a given event after a specific vaccine does not imply a causal relationship, but may indicate that further investigation is warranted. We applied Empirical Bayesian methods to identify disproportionality in reporting of the aforementioned MedDRA PTs, covering the same time period, in order to identify vaccine-event pairs that deserved further review. A 71-year-old man with pre-existing symptoms of an upper respiratory infection developed fever, malaise, and anorexia two days after influenza H1N1 vaccination. He was hospitalized twice and received supportive care. Discharge diagnoses included elevated liver function tests, possibly secondary to a viral infection; mesenteric panniculitis; elevated hemoglobin A1C; and fatty infiltration of the liver. Twenty-four days after vaccination, he developed diplopia. He was evaluated as an outpatient and was diagnosed with diabetic third nerve palsy, which reportedly resolved." Documents held by sender: none.