Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, Product complaint, Product expiration date issue, Product packaging confusion
Clinical narrative: was expired (6/30/2020) / the vaccine was administered; Lot number on box was LE79N and expiration 6/30/21/ Lot number on syringe was 2LL97 and expiration 6/30/20; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number LE79N, expiry date 30th June 2021) and (batch number 2LL97, expiry date 30th June 2020) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Fluarix Quadrivalent 2020-2021 season. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced expired vaccine used and pharmaceutical product complaint. On an unknown date, the outcome of the expired vaccine used and pharmaceutical product complaint were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The employee of health system reported Fluarix vaccine was received and lot number and expiration date on outside of box is different from lot number and expiration date on syringe inside of box. The lot number on box reported as LE79N and expiration 30th June 2021. The lot number on syringe reported as 2LL97 and expiration 30th June 2020. It was not known how many syringes or boxes were affected and had no any additional information. It was unable to provide any further contact information for the health care professional without her permission and follow up would be performed with the health care professional and call back to provide additional details needed. It was not known if there was product available to return. Replacement or credit was pending until further information is obtained. A follow up call was made to the nurse in charge to obtain additional information regarding the reported mix-up. It was reported that three unopened sealed Fluarix cartons were checked prior to use for employee vaccinations. During the evening shift 6 PFS's were used from one box. Following use of the 7th PFS it was noticed that the lot number 2LL97 did not match the carton and was expired (30th June 2020). Since the vaccine was administered a related adverse event would be filed and led to expired vaccine used. The three remaining unused syringes from the same carton were also expired. The used syringe and three unused expired syringes were held and were available for retrieval. This Hospital acquired it's Fluarix inventory from a different Hospital in the network and both lot numbers were direct shipped to that location approximately one year apart. Credit had to be provided for 4 doses. There was a similar mix up complaint from a different Hospital within the same network of 17 which was documented.   Follow up information received from QA department on 7th October 2020 and 9th October 2020: In response to follow up questions with the reporting nurse the additional information was provided. The Emergency room/ Urgent Care Center obtained a total of 35 Fluarix syringes for the 2020/2021 flu season for the sole purpose of providing annual flu vaccinations to staff (3 cartons of 10 syringes and one partial carton of 5 syringes). The partial carton of 5 syringes was reportedly used first without incident. With regards to the disposition of unused Fluarix it was stated that once vaccinations for staff are completed all remaining syringes are returned to Hospital inventory for use for the remainder of the current flu season. As a result, no expired Fluarix remained in the facility prior to obtaining vaccine for the 2020/2021 flu season. The following procedures and controls were described: The lot/ expiry for each carton was checked upon receipt from GSK. Cartons are stored in the refrigerator as sealed cartons until first use. Once a carton is opened, unused syringes remain in the carton until the carton is empty (i.e. they are not stored as loose syringes). No vaccines from prior flu seasons reside in the area for the reason described. In addition, the pharmacy reportedly conducted monthly inspections of all vaccines in the refrigerator (full cartons and individual syringes for opened partials) to ensure they are not expired. It's Fluarix vaccine exclusively from GSK. Following the end of the flu season the hospital returns unused product for GSK credit using the GSK Returned Goods Process. The information was clarified based upon additional communication with the reporting nurse. The day shift nurse opened the carton of 10 and the tamper evident seal was intact. She used 2 syringes for vaccination on the 16th September 2020. The remainder were used on the evening and midnight shift. Four more syringes were used then the last 4 in that carton were noted as expired. The nurse who administered the expired vaccine was not the one who opened the sealed carton which contained the expired syringes.   Follow up information was received from QA department on 19th November 2020: An investigation has been conducted, including review of the reported defect trends, the returned sample, the retained samples and our production records, which has demonstrated that the subject batch was produced in compliance with the applicable procedures and met all required specifications. According to the observation of the returned sample and the protocol performed with unused carton tray boxes similar design concluded that the returned sample side opening was compatible with a potential tampering of the product. The in-depth investigation performed concluded that a mix-up or a tampering under GSK control was very unlikely. However, since both batches nvolved in this reported defect were distributed to the customer at the time of the related flu season campaign, it could not be excluded that the hospitals and clinics had faced challenges to adequately control and remove all expired Flu vaccine prior to initiating vaccinations for the 2020/2021 flu season. Therefore, it was concluded that the mix-up likely occurred at the end customer place and that a voluntary tampering cannot be excluded. GSK Biologicals consider this complaint as a Tampered product.