Sex: M
Vaccine: UNK
Symptoms: Muscle strength abnormal, Muscular weakness, Nerve conduction studies abnormal, Paraesthesia, Peripheral sensorimotor neuropathy
Clinical narrative: GBS following the 13-valent pneumococcal conjugate vaccine (PCV13); This is a literature report  INTRODUCTION: Guillian Barre syndrome (GBS) is an acute immune mediated polyneuropathy which presents as monophasic paralyzing illness typically provoked by a preceding infection. The overall incidence of GBS is 1-2 cases a year per 100,000. An increased risk of GBS has been associated with the influenza vaccination. Despite the association of GBS with the influenza vaccine, there are limited cases of GBS documented with the pneumococcal vaccination. Authors present a case of GBS following the 13-valent pneumococcal conjugate vaccine (PCV13). CASE PRESENTATION: 61-year-old male with a past medical history of a stroke, coronary artery disease, and hypertension presented with lower extremity weakness and decreased sensation. He reported tingling in his feet which had been progressing up to his knees, with associated weakness. He had received PCV13 2 weeks prior to admission. He denied upper respiratory infections, or diarrhea. Lab were significant for leukocytosis 13.0 cells/microL. Muscle strength was 1/5 in the left lower extremity and 3/5 in the right lower extremity. Sensory motor deficits were noted up to the level of the mid shin bilaterally. Lumbar puncture demonstrated 0 RBCs, glucose 65 mg/dL, and protein elevated 79 mg/dL. CSF culture was negative. Nerve conduction study revealed evidence of severe sensorimotor demyelinating peripheral neuropathy. Work-up including a viral respiratory panel and influenza nasal swab were negative. The patient was started on intravenous immune globulin (IVIG) infusion at 1 g/kg once daily for a total of 5 days. DISCUSSION: Guillain-Barre Syndrome (GBS) is a rare acute flaccid paralysis syndrome commonly preceded by symptoms of upper respiratory tract infection or diarrhea within the prior 3 months. The underlying etiology of GBS remains unclear, but the pathophysiology in most cases of GBS is due to stimulation of autoimmunity that produces auto-immune antibodies that attack the myelin sheath of the nerves in the peripheral nervous system. In the case of this patient, he appropriately received PPSV23 prior to 65 years of age because of his chronic lung disease but he did not have a compelling indication to receive PCV13. There is inconclusive data that the greater immunogenicity of PCV13 leads to a higher incidence of immune reactions potentially leading to GBS. CONCLUSIONS: Pneumococcal vaccination is generally safe and effective with a very low chance for serious adverse events. Carefully administering PCV13 when truly indicated can further minimize the potential for harm. The development of injection site reactions should be carefully monitored as higher IgG-specific antibody titers could increase risk of GBS. Despite some of the recent reports of GBS associated with the pneumococcal vaccine, the overall benefit of preventing life-threatening infections largely outweighs the potential risks for adverse drug events.  Pfizer is a marketing authorization holder of pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) the country of incidence. This may be a duplicate report if another marketing authorization holder of pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities.; Sender's Comments: Based on the information currently available, there is a plausible time association as Guillian Barre syndrome occurred 2 weeks following the 13-valent pneumococcal conjugate vaccine.  As an individual case report there is no evidence to establish a causal relationship with the study product.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.