Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Myalgia, Poor quality product administered, Product administration error
Clinical narrative: Slight shortness of breath; Middle muscle aches; Headache; Vaccine was diluted for 188 hours and 30 minutes and was stored in the vials and was administered to a patient; Vaccine was diluted for 188 hours and 30 minutes and was stored in the vials and was administered to a patient; This is a spontaneous report received from a contactable healthcare professional from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 29Jun2021 at 09:30 as dose 1, single (Lot number: EW0178) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 29Jun2021 at 09:30, outcome "unknown" and all described as "Vaccine was diluted for 188 hours and 30 minutes and was stored in the vials and was administered to a patient"; HEADACHE (non-serious) with onset 30Jun2021, outcome "unknown"; MYALGIA (non-serious) with onset 30Jun2021, outcome "unknown", described as "Middle muscle aches"; DYSPNOEA (non-serious) with onset 30Jun2021, outcome "unknown", described as "Slight shortness of breath".  Additional Information: For a patient, after being given a diluted vial for a magnitude of days. The vaccine was diluted for 188 hours and 30 minutes and was stored in the vials and was administered to a patient. He was asking if the vaccine is non-viable. As of 02Jul2021, the product was delivered to one of the healthcare professional's enrolled providers on 21Jun2021. A COVID-19 Pfizer vaccine vial was opened or diluted at 1 PM on 21Jun2021. That vial should have been discarded at 7 PM (after 6 hours) that day if it was not used. Instead, it was stored in a refrigerator which maintained proper temps (between 2 to 8 degree C). A first dose was given from that same vial at 09:30 AM on 29Jun2021. This was an administration error and should not have happened. Time elapsed was 188.5 hours (182.5 hours past the 6 hours allowable). The patient had mild symptoms on 30Jun2021 including slight shortness of breath, middle muscle aches, and headache. Their team needs to know three things to move forward: How do they count that dose in their immunization registry? What is the guidance for the patient regarding re-vaccination of the dose? What is the guidance for the patient regarding the second dose?   Follow-up (12Jul2021): New information received from the same contactable other HCP included: new verbatim, the vaccine was diluted for 188 hours and 30 minutes and was stored in the vials and was administered to a patient. He is asking if the vaccine is non-viable.  Follow-up (25Aug2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  Follow-up (02Jul2021): This is a spontaneous follow-up report from a contactable healthcare professional. Updated Information: new events (added "Slight shortness of breath", "Middle muscle aches", and "Headache"), reaction data (Product preparation error was recoded to Product administration error), suspect product information, and course of events.