Age: 28.0
Sex: M
Vaccine: FLU(H1N1), FLUN3, HEPAB, MNQ, TDAP, FLUN3, FLUX(H1N1), HEPAB, MNQ, TDAP
Symptoms: Full blood count, Guillain-Barre syndrome, Headache, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: This case was reported in a literature article and described the occurrence of Miller Fisher syndrome in a 28-year-old male subject who received Hepatitis A and Hepatitis B vaccine. Co-suspect products included H1N1 vaccine, MENACTRA, ADACEL and influenza vaccine. On 7th January 2010, 2 days after receiving Hepatitis A and Hepatitis B vaccine, the subject developed upper respiratory tract infection. Serious criteria included hospitalization. Additional event(s) included fever on 7th January 2010 with serious criteria of hospitalization, chills on 7th January 2010 with serious criteria of hospitalization, sore throat on 7th January 2010 with serious criteria of hospitalization, rhinorrhea on 7th January 2010 with serious criteria of hospitalization, cough on 7th January 2010 with serious criteria of hospitalization, general body pain on 7th January 2010 with serious criteria of hospitalization, fever on 12th February 2010 with serious criteria of hospitalization, chills on 12th February 2010 with serious criteria of hospitalization, diaphoresis on 12th February 2010 with serious criteria of hospitalization, sore throat on 12th February 2010 with serious criteria of hospitalization, cough on 12th February 2010 with serious criteria of hospitalization, general body pain on 12th February 2010 with serious criteria of hospitalization, Miller Fisher Syndrome in February 2010 with serious criteria of hospitalization and GSK medically significant, numbness of extremities on 20th February 2010 with serious criteria of hospitalization, numbness oral on 21st February 2010 with serious criteria of hospitalization, burred vision on 21st February 2010 with serious criteria of hospitalization, sinus infection on 22nd February 2010 with serious criteria of hospitalization, headache on 23rd February 2010 with serious criteria of hospitalization, loss of sensation on 23rd February 2010 with serious criteria of hospitalization, areflexia on 23rd February 2010 with serious criteria of hospitalization, walking difficulty on 24th February 2010 with serious criteria of hospitalization, urinary hesitancy on 24th February 2010 with serious criteria of hospitalization, ataxic gait on 24th February 2010 with serious criteria of hospitalization, low back pain on 26th February 2010 with serious criteria of hospitalization, myalgia on 26th February 2010 with serious criteria of hospitalization, salivary hypersecretion on 26th February 2010 with serious criteria of hospitalization, dysarthria on 26th February 2010 with serious criteria of hospitalization, swallowing difficult with serious criteria of hospitalization, facial paresis with serious criteria of hospitalization, hemophilus infection with serious criteria of hospitalization and GSK medically significant, paresthesia with serious criteria of hospitalization, paresthesia oral with serious criteria of hospitalization, productive cough with serious criteria of hospitalization, speech disorder with serious criteria of hospitalization and walking aid user with serious criteria of hospitalization. The subject was treated with immunoglobulin human normal (IVIG) and IMITREX. The outcome of upper respiratory tract infection was recovered/resolved. The outcome(s) of the additional event(s) included Miller Fisher Syndrome (unknown), fever (recovered/resolved), chills (recovered/resolved), sore throat (recovered/resolved), rhinorrhea (recovered/resolved), cough (recovered/resolved), general body pain (recovered/resolved), fever (unknown), chills (unknown), diaphoresis (unknown), sore throat (unknown), general body pain (unknown), numbness of extremities (unknown), numbness oral (unknown), blurred vision (unknown), sinus infection (unknown), headache (unknown), loss of sensation (unknown), areflexia (unknown), walking difficulty (unknown), urinary hesitancy (unknown), ataxic gait (unknown), low back pain (unknown), myalgia (unknown), salivary hypersecretion (unknown), swallowing difficult (unknown), dysarthria (unknown), facial paresis (unknown), hemophilus infection (unknown), paresthesia (unknown), paresthesia oral (unknown), productive cough (unknown), speech disorder (unknown) and walking aid user (unknown). It was unknown if the investigator considered the upper respiratory tract infection, fever, chills, sore throat, rhinorrhea, cough, general body pain, fever, chills, diaphoresis, sore throat, cough, general body pain, Miller Fisher Syndrome, numbness of extremities, numbness oral, blurred vision, sinus infection, headache, loss of sensation, areflexia, walking difficulty, urinary hesitancy, ataxic gait, low back pain, myalgia, salivary hypersecretion, dysarthria, swallowing difficult, facial paresis, hemophilus infection, paresthesia, paresthesia oral, productive cough, speech disorder and walking aid user to be related to Hepatitis A and Hepatitis B vaccine. Relevant Tests: on 23 February 2010, neurological evaluation revealed "stocking loss of sensation in association with areflexia in the legs; subtle breakdown in smooth pursuits coinciding with blurred vision. On 24 February 2010, physical exam revealed distal areflexia, ataxic gait, instability with Romberg testing, muscle strength and tone was 5/5 and symmetric in BLE/BUE. On 26 February 2010, patient evaluation revealed normal BLE/BUE muscle strength and tone, weakness of facial muscles, diminished corneal reflexes, mild dysarthria. Diagnostic results (unless otherwise stated, normal values were not provided): In February 2010, Anti-GAD antibody positive result was positive unknown, Bacterial test negative result was negative unknown, Barium swallow normal result was normal unknown, Blood albumin decreased result was decreased unknown, Blood calcium decreased result was decreased unknown, Blood creatine phosphokinase increased result was increased unknown, Blood creatinine normal result was normal unknown, Blood glucose increased result was increased unknown, Blood urea increased result was increased unknown, Chest X-ray result was normal unknown, Corneal reflex decreased result was decreased unknown, Full blood count result was not provided unknown, Haematocrit decreased result was decreased unknown, Metabolic function test result was not provided unknown, Platelet count increased result was increased unknown. Romberg test positive result was positive unknown, Sputum culture positive result was positive unknown and White blood cell count increased result was increased unknown. On 23rd February 2010, Nerve conduction studies result was GBS symptoms unknown and Neurological examination result was see text unknown. On 24th February 2010, Physical examination result was see text unknown. Additional information was provided: This case was reported in a literature article and described the occurrence of Guillain Barre syndrome (GBS) in a 28-year-old male who was vaccinated with TWINRIX (GlaxoSmithKline), H1N1 (Novartis), FLUMIST (MedImmune vaccine), MENACTRA (Sanofi Pasteur) and ADACEL (Sanofi Pasteur). The patient was part of the retrospective review of military and civilian vaccine adverse events reporting system (VAERS) reports to investigate possible differences in adverse events reporting rates for both the 2009 pandemic H1N1 and 2009-2010 seasonal influenza vaccines. In this study, All VAERS reports were reviewed by a CDC medical officer who classified the AEs based on information in the text of the report and in medical records (when available) according to one of the following body system categories: hypersensitivity (e.g., anaphylaxis, angioedema, dyspnea, urticaria, wheezing), cardiovascular (e.g., arrhythmia, hypertension, hypotension, myocarditis), ENT (ears, nose, throat), gastrointestinal (e.g., vomiting, diarrhea), local reaction (e.g., pain, tenderness, erythema), musculoskeletal (e.g., arthralgia, arthritis), neurologic (e.g., paresthesia, peripheral neuropathy, Bell's palsy, Guillain-Barre syndrome, convulsion), pregnancy-specific outcomes (e.g., spontaneous abortion, fetal death), psychiatric, respiratory (e.g., influenza-like illness, rhinorrhea, sore throat, cough), other infectious, other non-infectious conditions (e.g., diabetes, thrombocytopenia, multiple symptoms) and death. No information on patient's medical or family history or concurrent condition or concomitant medication was provided. On 5th January 2010, the patient received TWINRIX, H1N1, FLUMIST, MENACTRA and ADACEL. He had no adverse reactions after vaccination, multiple vaccination (In this study, vaccine was administered in a military clinic and/or was purchased with military funds and included active personnel in the military branches. Military vaccination coverage among personnel was determined by using data from an active surveillance system administered by the Department to integrate data from medical treatment facilities, vaccination centres, and military personnel offices worldwide). On 7th January 2010 date, the patient felt feverish, chilled, had a sore throat, rhinorrhea, slight cough and body aches which lasted about 4 days. There were other people around him who were also sick. On 12th February 2010, the patient experienced fever, chills, diaphoresis, severe sore throat, cough and generalised body aches. The patient had not recalled that other was also sick. On 20th February 2010, the patient noted the numbness on the bottom of feet and fingertips. On 21st February 2010, the patient also noted the numbness of lips, tongue and blurry vision. On 22nd February 2010 the patient was treated in the emergency room for a sinus infection and was instructed to follow-up in the AM for his neurological symptoms. On 23rd February 2010, the patient was seen in the medical for a headache, blurry vision and numbness/tingling of the bottom of his feet, mouth, and fingertips. The patient was evaluated by a neurologist. Patient evaluation revealed "a stocking loss of sensation in association with areflexia in the legs; subtle breakdown in smooth pursuits coinciding with blurred vision." A nerve conduction study was performed. it was felt that the patient most likely had Guillain-Barre syndrome but his symptoms were so mild that treatment was not warranted so the patient was returned and went back to work with instructions to follow up in 2 days. On 24th February 2010, the patient returned to medical with complaints of headache, difficulty walking, numbness in his calves, anus, scrotum and worsening of his blurry vision. He denied bowel or bladder incontinence but he did have urinary hesitancy. The patient was reevaluated by the neurologist and released due to "no progression in his parethesias". The patient was admitted to the hospital for observation. The physical exam revealed distal areflexia, ataxic gait, instability with Romberg testing, muscle strength and tone was 5/5 and symmetric in BLE/BUE. Over the next 48 the patient's symptoms progressed to include onset of low back pain (LBP), generalized myalgias, perioral and facial numbness, difficulty managing his oral secretions and coughing with intake of liquids. On 26th February 2010, patient evaluation revealed normal BLE/BUE muscle strength and tone, weakness of facial muscles, diminished corneal reflexes, mild dysarthria. The patient was transferred to another hospital with complaints of numbness of his fingertips, feet, legs, hips, pelvis, abdomen up to the rib cage, and difficulty swallowing and talking due to numbness of his mouth and lips, and blurry vision. Subsequently the patient was diagnosed with Miller-Fisher variant of Guillain-Barre syndrome. The patient laboratory tests included complete blood count and comprehensive metabolic panel (results not provided). This case has been considered serious due to hospitalisation. The patient was treated with IVIG 0.8mg/kg daily for 3 days. As of 3/8/10 the patient's headaches were being treated with IMITREX, there was improvement of the facial paresis and patient was ambulating with a cane. The outcome of the event was not reported. The authors did not comment on the relationship between GBS and TWINRIX. The authors concluded that "We found higher reporting of GBS following MIV among male service personnel compared with civilian men, even though the rate of serious AEs following MIV by the military personnel was about half that reported by the civilian population. The reason for the differences in GBS reporting is not clear but it may be related to differences in reporting practices between the military and civilian sectors, preceding infections and other potential environmental exposures. Of note, during the 2009-2010 influenza season, the CDC and the Food and Drug Administration actively solicited reports of serious events such as GBS which may have been linked with the H1N1 2009 monovalent vaccine and the seasonal 2009-2010 influenza vaccine. This is 1 of the 5 valid cases of the same literature article.