Age: 79.0
Sex: F
Vaccine: DTP, PNC13
Symptoms: Fatigue, Feeling abnormal, Hypersomnia, Lung infection, Psychomotor hyperactivity
Clinical narrative: This is a spontaneous report from a contactable female consumer reporting for herself. A 79-year-old female patient received PREVNAR 13, via an unspecified route of administration at 0.5ml, single probably left arm on 04May2016 10:30. Medical history included Myasthenia Gravis from 2006 and ongoing started out primarily ocular, with double vision, osteonecrosis from 2015 (she believes this has healed, state she just needs to check with her dentist to make sure), dermatomyositis from May2004 and ongoing, bronchiectasis from 2007 and ongoing, organising pneumonia from 2007 to 2008, BOOP from 2007-2008: they thought it returned in 2013, but there was no way to prove it without a lung biopsy, she has had chronic lung problems since, lung and sinus infection, bone loss, sleep disorder, fatigue, port-surgery and lung infection. Concomitant medication included DTP, prednisone taken up to 60mg a day (dose changes when she every gets a flare up, pneumonia like), as taken 4mg for the past year decreased down to 2mg three years before, from May2004 and ongoing for Dermatomyositis and Myasthenia Gravis, CELLCEPT from Feb2006 and ongoing for Dermatomyositis and Myasthenia Gravis, lorazepam from May2004 and ongoing for sleep and counteract the prednisone, MESTINON from 2008 and ongoing, FORTEO 600 mcg/2.4 mg injection in the stomach once a day from 01Apr2015 and ongoing, FLONASE from Aug2014 and ongoing for bronchiectasis and chronic lung infections, PULMICORT from 2014 and ongoing for bronchiectasis and chronic lung infections, PERIDEX from Jan2015 to Jun2016. Concerning PERIDEX, she states she had to pat the spot because it has healed and as soon the bottle runs out she will check with the dentist to see if she needs to continue. Other vaccines given within 4 weeks prior to 04May2016: Flu shot injection in Sep2015. Other vaccines given on 04May2016 with suspect vaccine: DTP Injection 1 DF single at the right arm. The patient previously used FOSAMAX to be used only for five years, so they switched her to PROLIA injections in the hospital in 2012 for a year and a half, which caused her osteonecrosis, PREVNAR 13 probably left arm on 06Oct2015 and experienced drug ineffective, influenza vaccine. The patient complained sleep too much and have increased fatigue after having been inoculated with PREVNAR 13 In May2016, 6 months apart and a second PREVNAR 13 vaccine given in error with outcome of unknown. Course of events: Two different doctor's prescribed the PREVNAR 13 vaccines, a rheumatologist and an immunologist. She received both vaccines at the same facility. She received the first PREVNAR 13 vaccine on 06Oct2015. Following the vaccine, the physician did a Pneumococcal antibody, 23 types, test and she did not respond to the vaccine. On 04May2016, she was supposed to receive the PNEUMOVAX and the physician accidentally gave a second PREVNAR 13 vaccine. The second PREVNAR 13 injection was mistakenly given instead of PNEUMOVAX as part of the immunological testing for Hypergammaglobulinemia. No hospital admission was required nor any treatment received. She was unsure of the manufacturer for either vaccine, states she though Pfizer is the only one who makes it. She thought she received both vaccines in the left arm but was unsure. Bronchiectasis and chronic lung and sinus infection appeared to increase on an unknown date after the second injection. Within days after the 04May2016 PREVNAR 13 vaccine, her fatigue quite increased and she is sleeping too much. The events fatigue and sleeping more did not require admission to hospital or any treatment received and are not recovered. Due to taking prednisone for so long, she has bone loss. She also stated that she has felt antsy, hyper, and like she is crawling on the walls while taking the prednisone. She knew she felt this way at the 60mg dose, but it has been so long since she felt this way that she is not sure of the other doses. She would feel like she was going out of her mind for the first years of taking Prednisone and then later when the doctor would raise the dose. On 30Nov2015, her doctor did a Pneumococcal antibody, 23 types, test. She was told she did not do well on it, but he wanted to do to it again for coverage for insurance. She did not respond to the vaccine. On 03Jun2016 they did another Pneumococcal antibody, 23 types, test. She responded to the second vaccine, which means she has a little bit of an immune system. They also drew blood for 13 other categories. Her doctor was trying to determine if she has an immune system and that is why she had the PREVNAR 13 vaccines. States the first one was also for pneumonia prevention. They are trying to her intravenous immunoglobulin infusions. She has been in isolation for 3 months. She had a fatigue issue before the vaccines due to her Myasthenia Gravis and fatigue was part of her life, so she was surprised with how progressively fatigued she has been. She was curious over why she was so tired. When she learned PREVNAR 13 had been substitute for PNEUMOVAX, she looked online and noted PREVNAR 13 can cause fatigue and excessive sleepiness. She only called to see if 2 doses seven months apart could cause these issues. Her response to second inoculation was better than first. Follow-up (15Aug2016): New information reported from a contactable consumer included: Bronchiectasis, chronic lung infections and sinusitis added as new event; PREVNAR 13 indication detail; chlorhexidine gluconate stop date; fatigue and sleeping more outcome; course of events.