Age: 69.0
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Asthenia, Confusional state, Constipation, Dizziness, Injection site pain
Clinical narrative: This spontaneous report was received from a male patient of unknown age. Information on his concurrent conditions, medical history and drug allergies were not reported. On 16-MAR-2016, the patient was vaccinated with PNEUMOVAX 23 (lot, expiry date, dose number and units were not specified), intramuscular or subcutaneously. Concomitant medication were not reported. On 16-MAR-2016 (later that evening), the patient felt lightheaded, weak, dizziness, nauseous, and off balance. The patient stated that although, he felt a little better, the systems kept reappearing, and each time got a little worse. The patient had not been able to reach his primary provider for care. The patient would attempt contact with emergency room in his area. Patient had sought medical attention for the events by an attempt to call physician. The outcome of balance disorder, asthenia, nausea and dizziness were reported as not recovered/not resolved at the time of reporting. There was no Product Quality Concern (PQC) involved. Relatedness of the events with PNEUMOVAX 23 were not reported. Follow up information that has been received from the physician on 01-JUN-2016, via medical records concerning a 69 year old patient with diabetes mellitus, hypertension and chronic back pain. The patient's historical drug include: Allopurinol and lisinopril (manufacturer unknown) (from 06-AUG-2013 to 19-SEP-2015). Additionally, NORCO, once on 19-SEP-2015. It was reported that he had not illness at the time of vaccination or pre-existing allergies or birth defects. On 16-MAR-2016 at 11:10 hours, the patient was vaccinated with a first dose of PNEUMOVAX 23 (lot# L012521, expiration date was not reported), intramuscular on his left deltoid. Concomitant therapies included aspirin, simvastatin (manufacturer unknown), ascorbic acid and betamethasone dipropionate. Since the time of vaccination, on 16-MAR-2016, the patient had some spinning dizziness, poor balance, mild nausea but no vomiting (conflicting information also reported as 21-MAR-2016). On 21-MAR-2016, at 10:00 am, the patient experienced "loss of balance" and dizziness; then, the patient went to emergency room and he denied rash, itching or shortness of breath. Additionally, it was reported that dizziness got worse if he shaked his head, the severity of his symptoms were reported as moderate, constant and the patient reported that his symptoms worst with the movement. During the review of systems the patient denied problems related to constitutional, cardiovascular, respiratory, gastrointestinal, genitourinary, musculoskeletal, abdominal tenderness, integumentary, psychist, ear, nose, regular rate and rhythm, per pulses. It was reported that the patient had mild horizontal nystagmus on lateral gaze. The patient had a normal neurological examination except for vertiginous symptoms as not focal findings and lymphadenopathy. The laboratory evaluation was non-diagnostic. On the same date, the following laboratories were performed: Blood chloride (Cl): 107 mmol/lm, total Carbon Dioxide (TCO2): 21 mmol/lm, blood urea (BUN): 17 mg/dl, blood creatinine (Crea): 1.0 mg/dL, haematocrit (Hct): 43% PCV, blood sodium (NA): 140 mmol/l, blood potassium (K): 4.4 mmol/lm, hemoglobin: 14.6 g/dL and the blood glucose value was increased: 109 mg/dL. Based on the history, physical examination and diagnostic evaluation the physician believed the patient's symptoms were related to acute vertigo. Following therapy with ZOFRAN and ANTIVERT, the patient was  able to ambulate in the emergency department without difficulty. The discharge of diagnosis from the emergency room was vertigo, on 21-MAR-2016 and he was discharged on the following medications: ANTIVERT and ZOFRAN. On re-evaluation the patient was recovering reported as he was feeling much better of his symptoms. At the reporting time the outcome of blood glucose increased was unknown. The medications were discontinued. The condition of the patient was stable. They would be discharged to follow up with their primary care physician one to 2 days. The instructions was reported as general department discharge instructions, Vertigo, Vertigo was considered disabling by the physician. All available medical records will be provided upon request. Additional information has been requested.