Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Gastrooesophageal reflux disease, Haemoglobin normal, Insomnia, Liver function test normal
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for her mother-in-law and from a contactable physician. A 90 year-old female patient received a single dose of PREVNAR 13 (Lot J67643, expiry date Mar2016) at 0.5 ml single via an unspecified route of administration in the right deltoid on 03Dec2014. Medical history included ongoing body height decreased from an unknown date, ongoing blood pressure disorder from an unknown date for which she was taking a blood pressure medication, severe chronic obstructive pulmonary disease (COPD), hypertension, arthritis, stable osteoporosis, bronchiectasis, rib fracture, pulmonary hypertension, neuropathy, bronchogenic cyst, methicillin resistant staphylococcus infection pneumonia, stenotrophomonas maltophilia in sputum from Aug2013. Past surgical history included left hip replacement in 2000, right hip open reduction of fracture with internal fixation (ORIF) in 20013. Patient concomitant medications included: PROVENTIL 1.25 mg via inhalation every four hours, CARDIZEM CD 180 mg daily orally, COZAAR 100 mg daily orally, PROTONIX 40 mg orally. By the day following the vaccination, on 04Dec2014, the patient started to experience shaking, chills, swelling in both her arms, she could not move her neck, she was not able to sleep, she was fatigued, she could not get out of bed. At that time the patient had called her doctor that had advised her to take ADVIL. The patient presented to emergency room on 07Dec2014, with complaint of generalized myalgias or aching in multiple joints, swelling and body aches which the patient related to having developed on 04Dec2014 after receiving the vaccine. At admission, the patient was alert, oriented, had no acute distress, was well nourished, normal hydrated and was cooperative. The patient denied the following: malaise, fever, chills, generalized weakness, shortness of breath, headache, nausea, vomiting, abdominal pain and chest pain. Myalgia was present. Neck examination revealed no meningismus, no tenderness, full range of motion. Respiratory/chest examination revealed only occasional rhonchi. Cardiovascular examination revealed murmur, otherwise normal. Abdominal examination was normal. Examination of the vaccine site revealed intact skin, no hematoma, no evidence of infection. Extremities were normal at inspection, no tenderness, no swelling, full range of motion, no compartment syndrome, distal pulses intact, no active synovitis, no active erythema, no soft tissue infection. Back examination was normal: no trauma, full range of motion with no pain, no midline vertebral tenderness, no muscle spasm, negative costovertebral angle tenderness. Neurological examination revealed no anomalies; gait was stable with walker. Laboratory data performed on 07Dec2014 included: white blood cells (WBC) at 9900/ul, hemoglobin at 13.3 g/dl, sodium at 132 mmol/l, potassium at 3.6 mmol/l, blood urea (BUN) at 17 mg/dl, creatinine at 0.87 mg/dl, glucose at 101 mg/dl, platelets at 295000/mm3, albumin at 3.6 g/dl. CK-MB was at 0.95 ng/ml, creatine kinase was at 45 IU/l, Troponin I was >0.015 ng, prothrombin time (PT) was at 9.4 seconds and activated partial thromboplastin time (PTT) at 24 seconds. Liver functions were normal, total bilirubin was at 0.4 mg/dl, alanine aminotransferase (ALT) was at 10 IU/l, aspartate aminotransferase (AST) at 18 IU/l, urinalysis revealed negative nitrites and leukocyte esterase. The same complaints that had led the patient to visit the emergency room on 07Dec2014 persisted and worsened leading to a new emergency room visit on 11Dec2014 for a 23 hours hospitalization. At admission the patient was alert, oriented, normal hydrated, afebrile. Respiratory/chest examination revealed no distress, no tenderness, no wheezing few scattered rhonchi. Cardiovascular revealed regular rate and rhythm, normal heart sounds, normal capillary refill. Examination of the extremities revealed no edema, mild tenderness in the knees, ankles and hand, full range of motion, no calf tenderness. Neurological examination revealed no motor deficits, no sensory deficits, Chest x-ray revealed cardiomegaly, stable mass overlying the medial left lung base. EKG revealed normal sinus rhythm, left anterior hemiblock. Esophagram revealed spontaneous gastroesophageal reflux. Myalgias and joint swelling were noted: these symptoms improved after treatment with SOLUMEDROL 20 mg intravenous. The patient was also treated with TYLENOL. Laboratory data on 11Dec2014 revealed: WBC at 11400/mm3, hemoglobin at 13.0 g/dl, platelet count at 399000/mm3, sodium at 132 mmol/l, potassium at 4.3 mmol/l, BUN at 19 mg/dl, creatinine at 0.9 mg/dl and glucose at 112 mg/dl. Albumin was at 3.3 g/dl. Cardiac isoenzymes were negative (creatine kinase at 33 IU/l, CK-MB at 1.24 ng/ml; Troponin I <0.015 ng). PT was 9.4 seconds, PTT 26 seconds. Liver functions were normal (total bilirubin at 0.3 mg/dl, ALT at 8 IU/l, AST at 16 IU/l). B-Natriuretic Peptide  was at 1.054 ng/ml. Urinalysis revealed negative nitrites and leukocytes esterase. The patient improved and was discharged on 12Dec2014 with the following treatments recommended: methylprednisolone sodium succinate 20 mg IV-1 more dose, and then prednisone 10 mg po daily, nebulizer treatments with albuterol, diltiazem 180 mg daily, losartan 100 mg daily and pantoprazole 40 mg a day. The patient was recovering from generalized myalgias or aching in multiple joints, swelling and body aches and swelling in both arms, she recovered from chills and fatigue on an unspecified date in Dec2014, outcome of events shaking, she could not move her neck, she was not able to sleep, she could not get out of bed was unknown. The reporting consumer had spoken to a doctor who told her that Guillain-Barre had been reported with some vaccines and she inquired whether Guillain-Barre or having difficulty moving the neck or arms had been reported with PREVNAR 13. The physician considered the PREVENAR 13 had a causal effect to the adverse events. Follow-up (11Dec2014): New information reported from the same contactable consumer includes: past drug history, therapeutic measures (ibuprofen), reaction data (added events: difficulty moving her arms and neck and she was in a lot of pain). Follow-up (09Jan2015): New information reported from the same contactable physician includes: physician assessment. Follow-up (26Jan2015): New information reported from the same contactable physician includes: suspect product details (lot, expiry date, anatomical location of vaccination), additional details on medical history, concomitant medications, reaction data (new events generalized myalgias or aching in multiple joints, swelling, body aches, serious per hospitalization, were added, events feels awful and she was in a lot of pain were removed), relevant tests and laboratory data, updated events outcome, treatments given.