Age: 72.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Arthralgia, Biopsy stomach abnormal, Blood glucose increased, Diarrhoea, Electrocardiogram QT prolonged
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This 72-year-old female patient received the first dose of PREVNAR 13 at 0.5 ml single and a single dose of influenza vaccine (manufacturer unknown) injection, both via intramuscular route in the right arm on 06Oct2014 at 5 PM. She had had a pneumonia shot because she did not have a spleen so she had to get it every 5 years. The patient previously took a pneumococcal vaccine in Sep2010 but she was hospitalized with pneumonia from 18Dec2012 to 26Dec2012. Relevant medical history also included splenectomy in 1988, gastrectomy in 1988, gallbladder removal in 1974, ongoing high blood pressure (blood pressure was erratic and sometimes it was normal, it was 178/93 in Nov2014, 148/80 in Jan2015), ongoing high cholesterol, fibromyalgia, ongoing depression, ongoing sleep disorder, ongoing muscle spasms, ongoing macular degeneration, ongoing pain, gall stones in 1978, non-healing ulcer since 1988, compromised immune status since 1988, ongoing psoriasis, ongoing osteoporosis, allergies to sulfa, penicillin, most of the rarely mycins (such as streptomycin, terramycin, etc), CIPRO and tetanus. Concomitant medications included pravastatin (manufacturer unknown) tablet orally at 40 mg once a day from 1997 to 16Dec2014 for high cholesterol; lisinopril (manufacturer unknown) tablet orally at 20 mg once a day from 2010 to 16Dec2014 for high blood pressure; hydrochlorothiazide (HCTZ, manufacturer unknown) capsule orally at 12.5 mg once a day from 2000 and ongoing for high blood pressure; sertraline (manufacturer unknown) capsule orally at 100 mg twice a day from 2011 and ongoing for depression; zolpidem (manufacturer unknown) capsule orally at 1.25 mg once a day from 2011 and ongoing for sleep; carisoprodol (manufacturer unknown) tablet orally at 350 mg four times a day from 1985 and ongoing for muscle spasms; oxycodone (manufacturer unknown) tablet orally at 5 mg four times a day as needed from 2000 and ongoing for pain; HUMIRA injection at 40 mg by once every two weeks from 2013 and ongoing for psoriasis; vitamin D (manufacturer unknown) tablet orally at 50000 unit twice weekly from 2005 and ongoing for vitamin supplementation; calcium (manufacturer unknown) tablet orally at 600 mg two times a day from 2005 and ongoing for osteoporosis; PRESERVISION SOFTGELS WITH LUTEIN tablets orally at 1 DF twice daily from an unknown date and ongoing for macular degeneration; and multivitamins tablet orally 1DF once a day as recommended from an unknown date and ongoing. The patient had been taking influenza vaccines yearly since 1988, and she did not receive any other vaccination within eight weeks prior to 06Oct2014. In the morning of 07Oct2014, the patient experienced excruciating pain since every joint that bend was frozen. That meant fingers, wrists, elbows, shoulders, hips, knees, ankles, and toes. The pain was bilateral on both sides of body. The patient also broke out in a rash and itch on 07Oct2014. At the time of reporting, she was still suffering and she could barely hold the phone up to her ear. She reported some improvement in hips and knees and ankles, but it came back and it was just as bad as it was on the 07Oct2014. Arms had not improved. She could not pick up an 8 ounce bottle of water nor pick up groceries out of the car on 07Oct2014. The patient did not receive any treatment in response to these events. By Dec2014, the patient could barely walk and she just shuffled. The patient also had an intermittent low grade fever since 06Oct2014. The patient visited her physician and laboratory work has been done every month since these events occurred. The dermatologist saw the patient on 08Jan2015 and said that the rash was an allergic reaction. On unknown date and the patient experienced diarrhea, vomiting, hypocalcemia, hypokalemia, pain, and all her electrolytes were out-of-balance. The patient complained that it had been 4 months that she was experiencing the reported adverse events. This had been a very painful experience and she would never have taken this vaccine again. The patient underwent laboratory tests and procedures which included blood glucose increased at 200 on 15Jan2015, endoscopy with biopsy showed evidence of severe gastritis on 22Jan2015, kidney level at 40 on 15Jan2015. A rheumatologist saw the patient in Jan2015. By the middle of Feb2015, the rash and the pain began to fade. She still had pain in both elbows, wrists and fingers although not as bad as it was. Her physician closed the practice on 30Apr2015. It was also reported that on 29May2015, intractable nausea occurred and gastroenteritis and extended QT interval was observed which required patient's hospitalization. The patient recovered from itch and shoulder pain in Feb2015. She was recovering from rash and from allergic reaction. The patient did not recover from excruciating pain every joint that bend was frozen; fingers, toes, on both sides and from weakness of arms. The outcome of all the other events was unknown. The patient was discharged from the hospital on an unspecified date in Jun2015. Follow-up (11May2015): New information received from the same contactable consumer includes: concomitant medication details, past drug event, medical history details, clinical course, events 'frozen joints', 'intermittent low grade fever' and 'barely walk/just shuffled' added, outcome of the events 'excruciating shoulders pain on both sides', 'rash' and 'itch' changed to recovered. Follow-up attempts completed. No further information expected. Follow-up (09Jun2015): New information from the same contactable consumer includes: new events, outcome, seriousness criterion (hospitalization).