Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, referring to an unspecified number of patients of unknown ages and genders. No information was provided regarding the patient's medical history, concurrent conditions and concomitant medications. On unknown dates, unspecified number of patients were vaccinated with improperly stored ROTATEQ, orally, lot # N022015 (expiration date: 10-MAR-2019) or lot # N029870 (expiration date: 02-MAR-2019) and VAQTA, lot # R009953 (expiration date: 12-JUN-2019) for prophylaxis (strength, dose, frequency and route of administration were not reported). Temperature excursion was 32.21 degree Fahrenheit (degrees F) (32F to 35 F) and time frame was approximately 3.5 hours. Previous excursion was 50.37 degrees F for 4.5 hours as recorded by a data logger. No adverse effects were reported. No product quality complaint was involved. This is a non-valid report due to lack of patient identifiers. Follow-up information has been received from certified medical assistant on 20-FEB-2019. On 20-FEB-2019, a call was placed to the reporter. The call went directly to voicemail. A voice mail was left requesting a return call. Additionally, a request was made for patient identifiers, lot and vaccine received and on what date. Follow-up information has been received from medical assistant on 20-FEB-2019. On 20-FEB-2019, a call was received from reporter. The reporter was unable to locate the patient information, at the time of the call, but the reporter would conduct research of the patients who was administered the vaccines. Upon receipt of follow-up information it was determined that this case is now valid because the patient identifiers were received. Follow up information has been received from medical assistant on 20-FEB-2019 refers to a 12 month old patient of unknown gender. On 30-OCT-2018, the patient was vaccinated with improperly stored dose of VAQTA, lot # R009953 (expiration date: 12-JUN-2019) for prophylaxis (strength, dose, frequency and route of administration were not reported). This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA009323: Original Case : 1809USA002868; US-009507513-1902USA009324; US-009507513-1902USA009326; US-009507513-1902USA009326; US-009507513-1902USA009436; US-009507513-1902USA009437; US-009507513-1902USA009438; US-009507513-1902USA009439; US-009507513-1902USA009440; US-009507513-1902USA009441; US-009507513-1902USA009442; US-009507513-1902USA009443; US-009507513-1902USA009444; US-009507513-1902USA009445; US-009507513-1902USA009446; US-009507513-1902USA009447; US-009507513-1902USA009448; US-009507513-1902USA009449; US-009507513-1902USA009450; US-009507513-1902USA009451; US-009507513-1902USA009452; US-009507513-1902USA009453; US-009507513-1902USA009454; US-009507513-1902USA009455; US-009507513-1902USA009456; US-009507513-1902USA009457; US-009507513-1902USA009458; US-009507513-1902USA009459; US-009507513-1902USA009460; US-009507513-1902USA009461; US-009507513-1902USA009462; US-009507513-1902USA009463; US-009507513-1902USA009495; US-009507513-1902USA009496; US-009507513-1902USA009497; US-009507513-1902USA009498; US-009507513-1902USA009499; US-009507513-1902USA009500; US-009507513-1902USA009501; US-009507513-1902USA009502; US-009507513-1902USA009503; US-009507513-1902USA009504; US-009507513-1902USA009505; US-009507513-1902USA009506; US-009507513-1902USA009507; US-009507513-1902USA009508; US-009507513-1902USA009509; US-009507513-1902USA009510; US-009507513-1902USA009511; US-009507513-1902USA009512; US-009507513-1902USA009513; US-009507513-1902USA010264; US-009507513-1902USA010265; US-009507513-1902USA010266; US-009507513-1902USA010267; US-009507513-1902USA010268; US-009507513-1902USA010269; US-009507513-1902USA010270; US-009507513-1902USA010271; US-009507513-1902USA010272; US-009507513-1902USA010273; US-009507513-1902USA010274; US-009507513-1902USA010275; US-009507513-1902USA010276; US-009507513-1902USA010277; US-009507513-1902USA010278; US-009507513-1902USA010279; US-009507513-1902USA010280; US-009507513-1902USA010281; US-009507513-1902USA010282; US-009507513-1902USA010284; US-009507513-1902USA010285; US-009507513-1902USA010283.