Sex: F
Vaccine: FLU3
Symptoms: Tremor, Urine analysis normal, Vision blurred, Vitamin D deficiency
Clinical narrative: This case was reported in a literature article and described the occurrence of bronchitis in a 52-year-old female subject who received Flu seasonal TIV Dresden. Co-suspect products included carbamazepine for an unknown indication, NUVIGIL for an unknown indication and KLONOPIN for an unknown indication. Concurrent medication conditions included obstructive sleep apnea syndrome, hypersomnia and Epstein-Barr virus infection. Concomitant products included Multivitamin, fish oil and Vitamin. On 23rd September 2010, 3 days after receiving Flu Seasonal TIV Dresden, the subject developed bronchitis. Serious criteria included GSK medically significant. Additional event(s) included fatigue on 23rd September 2010 with serious criteria of hospitalization, sneezing on 23rd September 2010, cough on 23rd September 2010, headache on 23rd September 2010, eye dryness on 4th October 2010, eye discharge on 4th October 2010, abnormal eye movements nos on 7th October 2010, blurred vision on 22nd October 2010 with serious criteria of hospitalization, tremor on 22nd October 2010 with serious criteria of hospitalization, photophobia on 22nd October 2010, neurological symptom on 22nd October 2010, sensorimotor disorder on 22nd October 2010, facial paralysis on 28th October 2010 with serious criteria of GSK medically significant, hemiparesis on 28th October 2010 with serious criteria of GSK medically significant, motor dysfunction on 28th October 2010, walking difficulty on 28th October 2010, demyelination on 2nd November 2010 with serious criteria of GSK medically significant, short-term memory impairment on 4th November 2010 with serious criteria of hospitalization, activities of daily living impaired on 4th November 2010, impaired driving ability on 4th November 2010, expressive aphasia on 4th November 2010, gaze palsy on 9th November 2010 with serious criteria of GSK medically significant, optic neuritis on 10th November 2010 with serious criteria GSK medically significant, skin red on 15th November 2010, weakness on 18th November 2010 with serious criteria of hospitalization, fever on 18th November 2010, vitamin D deficiency on 27th December 2010 and drug interaction The subject was treated with Z-PAK, Lubricating Eye Drops (Nos), MEDROL, ARTANE and BOTOX. The outcome of bronchitis was unknown. The outcome(s) of the additional event(s) included blurred vision (unknown), fatigue (unknown), tremor (unknown), facial paralysis (unknown), demyelination (unknown), short-term memory impairment (unknown), gaze palsy (unknown), optic neuritis (unknown), weakness (unknown), hemiparesis (unknown), activities of daily living impaired (unknown), sneezing (unknown), cough (unknown), headache (unknown), eye dryness (unknown), drug interaction (unknown), eye discharge (unknown), abnormal eye movements nos (unknown), photophobia (unknown), motor dysfunction (unknown), walking difficulty (unknown), impaired driving ability (unknown), expressive aphasia (unknown), skin red (unknown), fever (unknown), neurological symptom (unknown), sensorimotor disorder (unknown) and vitamin D deficiency (unknown). It was unknown if the investigator considered the bronchitis, fatigue, sneezing, cough, headache, eye dryness, eye discharge, abnormal eye movements nos, blurred vision, tremor, photophobia, neurological symptom, sensorimotor disorder, facial paralysis, hemiparesis, motor dysfunction, walking difficulty, demyelination, short-term memory impairment, activities of daily living impaired, impaired driving ability, expressive aphasia, gaze palsy, optic neuritis, skin red, weakness, fever and vitamin D deficiency to be related to Flu seasonal TIV Dresden. Relevant Tests: Between 18 and 21 November 2010, the patient was admitted to medical center. Laboratory tests, MRI of spine and brain, lumbar puncture, 24 hour urine collection was done. Undetermined MRI results, subtle foci periventricular raised concern for demyelinating plaques in 2 areas. Follow up MRI 6 to 12 months as per doctor was advised. Diagnostic results (unless otherwise stated, normal values were not provided): On 2nd October 2010, Nuclear magnetic resonance imaging brain result was demyelination areas unknown. On 18th November 2010, Body temperature result was 100.9, 100.6 unknown. On 10th December 2010, Urine analysis result was negative for MS unknown. On an unknown date, Epstein-Barr virus test result was positive unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of bronchitis, activities of daily living impaired in a 52-year-old female who was vaccinated with FLULAVAL (GlaxoSmithKline). The corresponding Vaccine Adverse Event Reporting System (VAERS) ID is 413966. The patient was part of the study in which authors collected Adverse Event Following Immunization (AEFI) reports submitted to VAERS from July 1990 to April, 2016 and database from December 2009 to August 2016 for individuals receiving all available types of vaccines against the influenza virus recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and stains (i.e. haemorrhages, overdosage and rhabdomyolysis, respectively). The authors applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. The patient's pre-existing and concurrent condition included: Obstructive sleep apnoea and hypersomnia. The patient's co-suspect included Carbamazepine. The patient's medication included: NUVIGIL 250 mg daily; Multivitamin; Fish oil; KLONOPIN 0.5 mg; Vitamin. The medications: NUVIGIL and KLONOPIN were considered under pharmacokinetic drug interactions. No information on patient's family history was provided. On 20 September 2010, the patient received 1 dose of FLULAVAL intramuscularly in left arm with lot number AFLLA603AA. The age of vaccination was not provided. On 23 September 2010, 3 days after vaccination, the patient developed cough, headache, sneezing, and fatigue. On 27 September 2010, the patient had visited doctor's office. The patient was diagnosed with bronchitis and was treated with Z PACK. On 4 October 2010, the patient developed dry irritated left eye with some discharge and was treated with ABX eye drops. On 7 October 2010, left eye tremors began. The patient visited neurologist and fatigue was considered as possible cause of eye tremors. On 22 October 2010, the patient developed left sided facial tremors along with left eye tremors, blurred vision, and photophobia of left eye. The patient visited the eye institute office. The patient was diagnosed with chronic dry eye, eye tremor caused by fatigue. For facial tremors, the patient was advised to see neurologist. The patient was treated with lubricating eye drops as needed and eye gel at bedtime. On 28 October 2010, the patient had left sided facial paralysis for approximately 30 - 45 minutes. Motor deficits of left side, difficulty in walking and controlling left arm and left arm tremors began. On 29 October 2010, the patient had visited neurologist office and was prescribed for KLONOPIN 0.5 mg at bedtime and in morning as needed for tremors. The patient was scheduled for magnetic resonance imaging (MRI) brain at medical center. On 2 November 2010, the patient had visited neurologist office. Possible diagnosis of adverse reaction to vaccination was made. EVP was scheduled to demyelination areas seen on MRI of brain to rule out Multiple Sclerosis. On 4 November 2010 - the patient had visited the primary physician office. The symptoms were discussed and Laboratory tests were ordered. The patient had difficulty with short term memory, unable to drive due to facial tremors, had blurred vision and expressive aphasia. On 9 November 2010, the patient had visited the office visit. All symptoms worsened, eyes rolled back with tremors and tried to focus. The patient was advised to see neurologist. The patient was advised to be off work. On 10, 11 and 12 November 2010, the patient was diagnosed with possible optic neuritis. The patient was scheduled for office visit with DO at eye center. Still was unable to drive with worsening photophobia wearing sunglasses nearly all the time. On 10 November 2010, the patient was evaluated by DO for optic neuritis. On 12 November 2010, the patient had office visit. MEDROL dose pack was prescribed. On 13 November 2010, the patient started MEDROL dose pack and resumed NUVIGIL, ARTANE, KLONOPIN as prescribed and advised by doctor. The patient developed uncontrolled shaking over entire body. On 14 November 2010, MEDROL dose pack was continued and NUVIGIL was discontinued. The patient still had all over body shaking. On 15 November 2010, the patient was advised by doctor to discontinue MEDROL dose pack and to continue to take NUVIGIAL, ARTANE and KLONOPIN. Between 13 November and 16 November 2010, the patient had uncontrollable all over shaking trembling. Skin on face and chest reddened. Between 15 and 16 November 2010, the patient had redness all over body. On 18 November 2010, tremors continued and the patient was febrile. The patient was driven to the doctor office. Oral temp in office was 100.9, 100.6 (units and normal range not provided). The doctor contacted neurologist and scheduled an appointment for 23 November 2010. Z PACK prescription was written and was advised that if the patient did not feel any better to immediately report to medical center emergency room for further treatment. The patient had extreme weakness and was still unable to drive. Between 18 and 21 November 2010, the patient was admitted to medical center. Laboratory tests, MRI of spine and brain, lumbar puncture, 24 hour urine collection was done. Carbamazepine 100 mg by mouth 3 times daily was prescribed at discharge. The patient was hospitalised for 3 days. On 22 November 2010, the patient had doctor visit. The patient was advised to be off work until 3 December 2010. On 1 December 2010, the patient had office visit. The patient was advised to be off work until 3 January 2011 due to severe fatigue, blurred vision, left sided weakness and facial tremors, short term memory deficits. On 10 December 2010, the patient had visited neurologist and discussed labs, MRI results. The patient's medications were adjusted. 24 hour urine testing for MS was negative. It was unable to identify the cause of the neurological symptoms. The patient was found an active Epstein Barr Virus. The patient treatment of tremors with BOTOX injection was discussed by physician. On 20 December 2010, tremors decreased substantially. Doctor was contacted and discussed returning to work. On 27 December 2010, the patient returned to work. The paperwork was faxed to Employee Health Office. Diagnoses at this time were idiopathic neurological symptoms, active Epstein Barr Virus infection, and Vitamin D deficiency. Undetermined MRI results, subtle foci periventricular raised concern for demyelinating plaques in 2 areas. Follow up MRI 6 to 12 months as per doctor was advised. The patient continued to have facial tremors when fatigued and had difficulty with short term memory. The patient continued to restrict strenuous activity to avoid these symptoms. On 14 January and 23 February 2011, the patient had scheduled office visit with doctor. On unspecified date, the patient had activities of daily living impaired, asthenia, decreased activity, erythema, irritation, gaze palsy, hemiparesis, memory impairment and pyrexia. This case has been considered serious due to hospitalisation/as per author. The reporter considered the causality assessment as Indeterminate. [In this study, 'Cases without adequate information were classified as unclassifiable; cases with adequate information were categorized as 'consistent with a causal relationship' when the available evidence supported a causal relationship between the vaccine and the AEFI in the individual but it did not rule out the possibility that the AEFI may have been caused by a factor other than the vaccine, 'inconsistent with a causal association' when the available evidence did not support a causal relationship between vaccine administration and the reported AEFI in the individual, 'indeterminate' when the temporal relationship was consistent but the available evidence insufficient to support or rule out a causal relationship in the individual]. The author considered the drug-vaccine interaction as probable. [In this study, to assess the likelihood of interaction, we used a published and validated algorithm to assess drug-drug interactions (DDIs), known as Drug Interaction Probability Scale (DIPS), a 10-item tool specifically developed to assess the likelihood of DDIs. Higher total scores correspond to higher likelihood of drug-vaccine interaction (i.e. more than 8 equal to Highly Probably; 5-8 equal to Probable; 2-4 equal to Possible; less than 2 equal to doubtful). The authors concluded, "The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which is thus to be recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful". This is 1 of the 11 valid cases reported in the same literature article.