Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Ear disorder, Interchange of vaccine products, Poor quality product administered, Product administration error, SARS-CoV-2 test
Clinical narrative: Has chronic ear fluid, build up behind right ear/did have to receive Prednisone 10mg twice daily for 3 days, total of 6 tablets started 20Jan2023; The vaccine was given at 13 weeks/ if a patient (did not mention if there was one or more patients) has received the gray cap bivalent for 12 yrs and older beyond the 10 week storage; The vaccine was given at 13 weeks/ if a patient (did not mention if there was one or more patients) has received the gray cap bivalent for 12 yrs and older beyond the 10 week storage; Prior to the Pfizer Bivalent she had had 2 Moderna primary series doses and 2 Moderna COVID boosters.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 66-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Jan2023 as dose 5 (booster), 0.3 ml single (Lot number: GJ6665, Expiration Date: 30Jun2023) at the age of 66 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Chronic otitis media of right ear", start date: 23Nov2022 (ongoing); "Chronic sinusitis right side", start date: 23Nov2022 (ongoing). There were no concomitant medications. Vaccination history included: Moderna (Dose: 1), for COVID-19 Immunization; Moderna (Dose: 2), for COVID-19 Immunization; Moderna (Dose: 3), for COVID-19 Immunization; Moderna (Dose: 4), for COVID-19 Immunization.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Jan2023, outcome "unknown", described as "Prior to the Pfizer Bivalent she had had 2 Moderna primary series doses and 2 Moderna COVID boosters."; POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 20Jan2023, outcome "unknown" and all described as "The vaccine was given at 13 weeks/ if a patient (did not mention if there was one or more patients) has received the gray cap bivalent for 12 yrs and older beyond the 10 week storage"; EAR DISORDER (medically significant), outcome "unknown", described as "Has chronic ear fluid, build up behind right ear/did have to receive Prednisone 10mg twice daily for 3 days, total of 6 tablets started 20Jan2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Aug2022) Negative; (23Nov2022) Negative. Therapeutic measures were taken as a result of ear disorder.  Clinical information: Nurse practitioner wants to know what is the guidance if a patient (did not mention if there was one or more patients) has received the gray cap bivalent for 12 yrs and older beyond the 10 week storage in the refrigerator. The vaccine was given at 13 weeks. They received the shipment of the product on 16Oct2022 which is when it was placed into refrigeration, so they had 10 weeks after that until it expired. He has already gotten in contact with the patient. He was advised to contact Pfizer for any advice on what to do with regards to this event. It was reported patient has chronic ear fluid, build up behind right ear/did have to receive Prednisone 10mg twice daily for 3 days, total of 6 tablets started 20Jan2023. Vaccination facility: Clinic. Vaccine was not administered in facility.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event ear disorder and the use of suspect product BNT162b2, BNT162b2 omi ba.4-5 cannot be fully excluded.The causal association between the at-risk event interchange of vaccine products and the use of suspect product BNT162b2, BNT162b2 omi ba.4-5 cannot be fully excluded.The case will be reassessed once further information is available The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300057129 Same reporter/event, different patient;