Age: 77.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Computerised tomogram head abnormal, Eye pain, Facial paresis, Ocular hyperaemia, Pain
Clinical narrative: This is a spontaneous report from a contactable Registered Nurse Office Manager at Dr. office, from patient sister and from a contactable physician. A 77-year-old female patient received PREVNAR 13 (lot # 104915, exp date 01Jul2016 NDC# 0005-1971-02) intramuscular 0.5 ml, single dose on right deltoid muscle on 07Apr2015 14:18. No vaccine was given on the same day. Medical history included blood cholesterol increased, osteoporosis, dementia, intracranial aneurysm, brain surgery, hip surgery, right; left arm surgery; allergy to ampicillin; no latex allergy; former smoker of tobacco, all from an unknown date and unknown if ongoing. No illness were present at time of vaccination. Concomitant medication included Meclizine HCl as needed from 05Jul2012 ongoing, Vitamin D orally from 16Jun2010 and from 07Apr2015, Vitamin B12 from 16Jun2010 ongoing, Multivitamins from 07Apr2015, simvastatin from 08Mar2013 ongoing and from 07Apr2015 10 mg oral tab 1 tab once daily in the evening for cholesterol, FOSAMAX 70 mg oral tab 1 tab once weekly, calcium daily, magnesium daily. The nurse mentioned that no other vaccines were given four weeks prior to the day of PREVNAR 13. The patient experienced Bell's Palsy on 11Apr2015. On 11Apr2015 21:06 the consumer presented to emergency room (ER) via walk in with complaints of severe weakness of the right side of the face, associated signs and symptoms: reported as pertinent positives: seizure and right eye pain and redness. The symptoms began on the same day and were continuing. Symptoms were mild. The patient had not experienced similar symptoms in the past. Patient's baseline: Neuro: alert and fully oriented, Motor: no deficits, ambulation: walks without assistance, Speech: normal. At 21:09, at the ER: Constitutional: negative for fever, chills, and weight loss. Neck: negative for injury, pain, and swelling, cardiovascular: negative for chest pain, palpitations, and edema, Respiratory: negative for shortness of breath, cough, wheezing, and pleuritic chest pain, abdomen/GI: negative for abdominal pain, nausea, vomiting, diarrhea, and constipation. Back: negative for injury and pain. All systems are negative except Eyes: Positive for redness. Neuro: positive for weakness. At discharge: no septal abnormalities noted. Tympanic membranes are normal and external auditory canals are clear. Oropharynx with no redness, swelling or masses, excludes, or evidence of obstruction, uvula midline. Mucous membrane. Neck: trachea midline, no thyromegaly or masses palpated, and no cervical lymphadenopathy. Full range of motion without nuchal rigidity, or vertebral point tenderness. No Meningismus. Cardiovascular: regular rate and rhythm with a normal S1 and S2. No gallops, murmurs, or rubs. Normal PMI, no JVD. No pulse deficits. Respiratory: Lungs have equal breath sounds bilaterally, clear to auscultation and percussion. No rales, rhonchi or wheezes noted. No increased work of breathing, no retractions or nasal flaring. Abdomen/GI: no evidence of tenderness. Eyes: Periorbital structures: appear normal, Pupils: no acute changes, extraocular movements: no acute changes, Conjunctiva: injected. Neuro: Orientation: no acute changes, Cranial nerves: normal except facial, facial droop noted on right, with forehead spared. Motor: is normal, sensation: is normal. Examination performed at 21:10: ENT: Nares patent. Visual activity: at 20:12 Right Eye with Lenses, 20/50, Left Eye with Lenses, 20/50, Both Eyes with Lenses, 20/40 mol. At 20:37 head CT w/o contrast: Abnormal: reported read, stable. Vital Signs: 20:06  BP 138/80; pulse 88; Resp 18; Temp 97.3 (TE); Pulse Ox 96% on R/A; weight 60.78 kg/mol 134 lbs (R); Pain 7/10; 20:06 Body Mass Index 24.51 mol. She did follow up with the doctor on the 13Apr2015. The patient was put on Prednisone 40mg 3 tablets oral once daily for 10 days and they also ordered an eye lubricant that was REFRESH LACRI-LUBE 5.25 inch as needed for eye, both from 11Apr2015 to 16Apr2015. On 13Apr2015 she went to see the doctor and the doctor was continuing the prednisone as she was not improved. The patient was not hospitalized but just went to ER. Symptoms of Bell's Palsy have improved but not recovered. The outcome of the events seizure, eye redness, eye pain was unknown. The patient have not experienced the same adverse event before. The reporter physician was provided with the information regarding the adverse events by the patient and provide the causality relationship as unknown. The reporter already reported this adverse event to Health department (VAERS). The reporter was willing to be contacted again by Pfizer on the reporter adverse events. Follow-up (04May2015): New information received from a contactable physician includes: suspect data; not hospitalization; medical history; concomitant medications data; new events (seizure, eye redness, eye pain); lab tests; course of events; reporter informed regarding the adverse events; reporter causality; reporter further contactability.