Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Positive airway pressure therapy, Product use in unapproved indication, Respiratory arrest, Respiratory distress, Resuscitation
Clinical narrative: Guillain Barre Syndrome/weakness, numbness in extremities/upperbody weakness & numbness/Increased work of breathing, required intubation & had tracheostomy/Respiratory distress/decline in-flight, condition listed as severe; decompensated during the flight, her respirations were supported with a face mask and manually compressible source of air/oxygen; Once again, ended up in the hospital and was intubated.; Cardiac arrest/CPR performed and pt was revived; Respiratory arrest; received the Pneumococcal Polysaccharide Vaccine (PPSV23) for symptoms of pneumonia; Information has been received from a lawyer regarding a case in litigation which referred to a 61-year-old female patient (pt). Information regarding concomitant medications and medical history was not provided. On 14-FEB-2019, she was hospitalized due to worsening of bilateral pneumonia of "unspecified organism". On 15-FEB-2019, pt was given a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for symptoms of pneumonia (product use in unapproved indication), prior to discharge (exact dose, route of administration, anatomical site of vaccination, lot number and expiration date were not provided). On 02-MAR-2019, she returned to the hospital with complaints of weakness and numbness in extremities getting worse. Further testing was needed (reported as magnetic resonance imaging (MRI)), and she was transferred via air to a second hospital for that purpose. Before she was transferred to the new hospital, she began to decline in-flight, with her condition listed as "severe". Thereafter, pt decompensated during the flight and ended up being "bagged", which means her respirations were supported with a face mask and a manually compressible source of air or oxygen (acute respiratory failure). Thereafter, she complained of upper body weakness and numbness. When she arrived at the hospital, she could only respond by blinking. Upon arrival, she was intubated and admitted to intensive care unit (ICU) for monitoring and testing. She underwent plasmapheresis while there, and the working diagnosis was "high suspicion" for Guillain Barre Syndrome (GBS). Afterwards, on an unspecified date in 2019, she was discharged (no details provided). On 22-MAR-2019, she was again admitted for "increased work of breathing" (considered as a symptom of GBS). On 31-MAR-2019, pt required intubation again and had a tracheostomy, plasmapheresis was ordered. Thereafter, on an unspecified date in 2019, she was discharged to a third hospital where she was later admitted (no new admission details were provided). On 04-MAY-2019, she was discharged to a skilled nursing. On 19-MAY-2019, she once again ended up in the emergency room (ER) for respiratory distress. She did not want to be intubated again so bilevel positive airway pressure (BiPAP) was tried and her oxygen (O2) stats. increased. Within a few hours she went into respiratory arrest and was intubated again, which led to cardiac arrest; cardiopulmonary resuscitation (CPR) was performed for approximately 8-10 minutes and pt was revived. On 23-MAY-2019, she was discharged to a long-term acute care (LTAC) facility. Once again, pt ended up in the hospital (adverse event) in June 2019 and was intubated. She was sent to LTAC again and was not discharged until 16-NOV-2020- a period of over a year, and had incurred repeated re-admissions to LTAC thereafter. As a direct and proximate result of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. In addition, the pt sustained severe and permanent personal injuries. Further, the pt had suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Finally, as direct and proximate result of pneumococcal vaccine, polyvalent (23-valent (PNEUMOVAX23), the pt sustained and continued to suffer severe physical pain, limitation and mental suffering. The outcome of the event GBS was considered as not recovered, the event cardiac arrest was considered as resolved, and the outcome of the remaining events was unknown. The causal relationship between the events (except product use in unapproved indication) and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was assessed as related.  Acute respiratory failure, respiratory arrest, cardiac arrest, adverse event, and Guillain-Barre syndrome were considered as disabling events by the reporter.   Upon internal review, the events acute respiratory failure, respiratory arrest, cardiac arrest, and Guillain-Barre syndrome were determined to be medically significant. Upon medical assessment, the event coded as adverse event was determined to be medically significant due to the treatment provided (intubation). The event cardiac arrest was considered as life-threatening.