Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Blood thyroid stimulating hormone decreased, Body temperature decreased, Gait disturbance, Headache, Joint stiffness
Clinical narrative: This is a spontaneous report from a contactable Registered Medical Assistant calling on behalf of physician. A 66-year-old female patient received PREVNAR 13 (lot/batch number M35763, expiry date 31May2017, NDC number: 545696-61300) intramuscularly on the left deltoid on 09Jun2016 at 12:17 at 0.5 ml single. Relevant medical history included adrenal insufficiency due to corticosteroid withdrawal, cholestyramine POWD, Erythromycin TABS and PREVNAR 13 allergy, nasal septum deviation, acute stress reaction, allergic rhinitis, anosmia, anxiety disorder, cellulitis, chronic laryngitis, cough, Crohn's disease, diarrhoea, fatigue, hyperventilation, hypoalbuminemia, hypoglycaemia, hypokalaemia, insufficiency pituitary, lethargy, lumbar radiculitis, osteopenia, palpitation, pancreatic cyst, sepsis, shortness of breath, genitourinary symptom, vision loss, left eye, sleep difficult, osteoporosis, postmenopausal, renal insufficiency, smoker, family history of Crohn's Disease: Brother, history of total Abdominal Hysterectomy, history of Laparoscopy, total Colectomy, history of Colonoscopy (Fiber optic), history of Breast Surgery Enlargement Procedure Elective, hypothyroidism and hypertension. Concomitant medications included KLOR-CON oral from 22Dec2008 and ongoing at 10 mEq daily for hypertension, levothyroxine oral from 09Jun2016 and ongoing at 75 ug daily for hypothyroidism, METAMUCIL 1.7 gm wafer, take 2 wafer before meals since 29Jul2010 and ongoing, Vitamin D3 Oral Tablet, 1000 units daily since 04Feb2008, Prednisone 5 mg oral tablet daily since Feb2016 for cough, MOBIC and hydrocortisone. No other vaccines were given on same date and within four weeks prior to the suspect vaccine. The patient experienced balance issues, myalgia/muscle ache, severe pain all throughout her body, headache, pain down her legs, weakness, back pain, joint pain, joint swelling, joint stiffness, difficulty walking and tremor on unknown date. The patient was treated with unspecified treatment due to the events. The patient was hospitalized from 17Jun2016 to 19Jun2016. On 15Jun2016 vital signs were taken: temperature taken was a tympanic temperature of 98.9 degrees Fahrenheit, heart rate was 66 and blood pressure 138/74. On 21Jun2016 blood pressure 122/88, temperature taken was a tympanic temperature of 96.7 degrees Fahrenheit, heart rate was 68, O2 saturation was 96; on 23Jun2016 blood pressure 118/60, Blood thyroid stimulating hormone lower cortisone, temperature taken was a tympanic temperature of 96.6 degrees Fahrenheit, heart rate was 70, O2 saturation 97; on 29Jun2016 blood pressure 104/70, temperature taken was a tympanic temperature of 97.7 degrees Fahrenheit , heart rate was 78, O2 saturation was 97. The outcome of the event myalgia/muscle ache was reported as recovering, the outcome of the event asthenia was reported as not recovered and the outcome of the other events was unknown. The patient's myalgia was related to the vaccine. The reporter stated she could not say for certain if all the symptoms were caused by the vaccine. Follow-up (12Jul2016) additional information received from the Medical Assistant includes information on lab data and outcome. New events added. Case upgraded to serious.