Reporte zur Charge N020502

Symptomtext

pneumoccocal polysaccharide PPV23 on 26-OCT-2017 and pneumoccocal conjugate PCV 13 on 10-OCT-2018; This spontaneous report was received from an adult female patient, concerning to herself via medical record from a case in litigation for zoster vaccine live (ZOSTAVAX) (Marrs# 2103USA001618). The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported. On 26-OCT-2017, the patient was vaccinated with pneumococcal polysaccharide PPV23 (manufacturer unknown) for prophylaxis with a dose of 0.5 mL, administered in the right deltoid , lot number N020502, expiration date 08-FEB-2019 (strength and route of administration was not provide) .It was reported that another doses of pneumococcal conjugate PCV13 pneumococcal vaccine, polyvalent for prophylaxis, with a dose of 0.5 mL, administered in the left deltoid, intramuscular, lot number W33491 (strength and expiration date was not provided) was administered on 10-OCT-2018 (inappropriate schedule of product administration). This is one of two reports received from the same patient. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: N020502; expirationdate: 08-FEB-2019; deviceage and unit: 0 ; operatorofdevice: Licensed Practical Nurse; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments: US-009507513-2103USA001618: