Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Off label use, Poor quality product administered, Product administration error
Clinical narrative: getting 4th dose because of immune status; Caller mentioned that he "noticed the expiration of the lot was okay." Caller also stated that it was stored in a refrigerator since 13Jan2022 or 83 days; and was given to one individual today.; Caller mentioned that he "noticed the expiration of the lot was okay." Caller also stated that it was stored in a refrigerator since 13Jan2022 or 83 days; and was given to one individual today.; getting 4th dose because of immune status; This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 07Apr2022 as dose 4 (booster), 0.3 ml single (Lot number: FJ6369, Expiration Date: 31May2022) at the age of 61 years intramuscular, in left deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (3rd Dose, NDC number: 59267100001, Lot number: FF2587, Expiration date: 31Dec2021), administration date: 15Oct2021, when the patient was 61-year-old, for Covid-19 Immunization; BNT162b2 (2nd Dose, NDC number: unknown, Lot number: ER8735, Expiration date: 31Jul2021), administration date: 18Apr2021, when the patient was 61-year-old, for Covid-19 Immunization; BNT162b2 (1st Dose, NDC number: unknown, Lot number: ER8734, Expiration date: 31Jul2021), administration date: 28Mar2021, when the patient was 61-year-old, for Covid-19 Immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 07Apr2022 and all described as "Caller mentioned that he "noticed the expiration of the lot was okay." Caller also stated that it was stored in a refrigerator since 13Jan2022 or 83 days; and was given to one individual today."; OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 07Apr2022 and all described as "getting 4th dose because of immune status".  Additional information : Caller stated that they have the adult formulation of the Pfizer COVID Vaccine. Caller verified it to be the gray cap formulation. Caller mentioned that he "noticed the expiration of the lot was okay." Caller also stated that it was stored in a refrigerator since "13Jan2022" or "83 days"; and was given to one individual today." Caller wants to know if the dose was still effective or needs to be repeated and if the vaccines can still be used. You reported a temperature excursion for gray cap vials that cannot be supported by stability information currently available to Pfizer Medical Information. As per our policy, we will send a form for you to complete and submit to Pfizer's team. Please be sure to follow the instructions carefully as the details, including specific temperatures, exposure times, and lot number, will be needed for a more thorough evaluation. A member of that team will subsequently respond to you to let you know if Pfizer has any additional stability information. Once the form is received, they will contact you as soon as possible but I am not able to provide a specific turnaround time to you. Please be sure to quarantine the affected supply pending this response. Please also note that if Pfizer is unable to provide stability information on your excursion and the vaccine was administered to individuals, it would be out of Pfizer's remit to recommend the need or timing of revaccination." Sent the form via email. as requested by the caller. Offered survey. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  No follow-up attempts are possible. No further information is expected.  Follow-up (07Apr2022): This is a follow-up spontaneous report received from a same contactable consumer. This consumer reported for a 61-year-old female patient that: Updated Information: Added same reporter another address added in slider#02, patient details, suspect product details, new events (Off label use and Booster).