Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Gout, Guillain-Barre syndrome, Haematocrit decreased, Haemoglobin decreased, Immunoglobulin therapy
Clinical narrative: Case number PHHY2011US49321 is an initial spontaneous report received from a consumer (patient) on 06 Jun 2011 with a follow up batch review report received from a quality assurance department (Ref: 113909) on 21 Jun 2011 with another follow-up received from the physician on 08 Jul 2011. This report refers to a 75-year-old male patient. He received flu vaccine every year for the last eight to ten years but never experienced any adverse event. His medical history included vaccination with TD vaccine less than ten years ago and vaccination against pneumonia in Oct 2008. His other medical conditions included burn on to the left lower extremity in 1983, deep vein thrombosis, hypertension and obesity, hyperlipidemia for which he took regular medication, followed low fat diet and exercised daily. He did not have any muscle ache, jaundice, chest pain or sob. He also suffered from chronic obstructive pulmonary diseases but denied any shortness of breath or wheezing. He had gastroesophageal reflux disease for which he took regular medications, he also complained about occasional burning symptoms and avoided caffeine, spicy and fried food. He had benign prostatic hypertrophy and gout which were reported to be stable, and sleep apnea. His inactive problems were melanoma of resection in the right arm in 2005. He had also undergone an internal fixation surgery for his left fractured wrist. His father had rheumatic fever as a child and his mother was positive for glaucoma. He was allergic to sulpha medications. He was vaccinated with FLUVIRIN 2010/2011 (batch number: unknown) intramuscularly on 17 Sep 2010. He was also on treatment with multiple other medications. He was diagnosed with Guillain-Barre syndrome on 27 Sep 2010. On 28 Sep 2010, he was hospitalized and underwent a five day course of intravenous human immunoglobulin G for treatment and then was transferred to medical intensive care unit for respiratory failure related to his weakness. He was placed on mechanical ventilation and then traced. After several weeks, he started to improve clinically with movements in the upper and lower extremities. His hospital course was complicated by abdominal ileus and pneumonia, which required treatment of antibiotics, but showed improvement. He was then transferred to a medical center for continued care and disposition planning. He progressed with therapies sufficiently to warrant consideration for in patient rehabilitation program. He underwent a swallow study on 28 Oct 2010 which revealed ability to tolerate full liquid diets. He was in no acute distress and had intact breath sounds and active bowel sounds. He was admitted in a rehabilitation hospital on an unspecified date in 2010 in medically stable condition. On 08 Nov 2010, he presented with decreased dysphagia, nausea, orthostatic hypotension, Guillain Barre Syndrome with tremors, weakness, and significant auto immune dysfunction. He was re examined on 18 Nov 2010, and was further diagnosed with urinary tract infection; however, his GBS condition was reported to be improving. Laboratory tests done on 22 Apr 2011 showed normal results for urea nitrogen (BUN), creatinine, glomerular filtrate rate (GFR), sodium, potassium, chloride, carbon dioxide, calcium, total protein, albumin, globulin, albumin to globulin ration, total bilirubin, alkaline phosphatase, alanine transaminase (ALT), aspartate transaminase (AST), thyroid stimulating hormone (TSH) and white blood cell count. However, his blood glucose value was reported as 105 mg/dL, his red blood cell count was 3.96 million/L, hemoglobin was 12.0 g/dL and hematocrit was 35.7%. Since the batch number was not reported, the batch review was performed but based on the Annual Product Review (APR) of northern hemisphere influenza-2010; it was concluded that the FLUVIRIN was processed at a good level of overall control and that the supporting systems were effective in supporting the compliant production, testing and supply processed for the FLUVIRIN vaccine. It was also concluded that there was no reason or explanation to account for the reported adverse event. Follow up information received on 21 Jun 2011: Batch review report summary was updated. Follow up information received on 21 Jun 2011: Batch review report summary was updated. Follow-up received from the physician on 08 Jul 2011: Updated information about patient's medical history, concomitant medications, events and outcome.