Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Nausea, Vaccination site pain
Clinical narrative: 01Oct2022 but had a expiration date of 30Sep2022; local soreness at the injection site; mild nausea; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team, Program ID.  A 23-year-old female patient received BNT162b2 (BNT162B2), on 01Oct2022 as dose 1, 30 ug single (Lot number: FM7553, Expiration Date: 30Sep2022) at the age of 23 years, in arm for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 01Oct2022, outcome "unknown", described as "01Oct2022 but had a expiration date of 30Sep2022"; VACCINATION SITE PAIN (non-serious) with onset 01Oct2022, outcome "unknown", described as "local soreness at the injection site"; NAUSEA (non-serious) with onset 01Oct2022, outcome "unknown", described as "mild nausea".  Additional details: Monovalent 1st dose primary dose was administered (Dosage text: 30mcg, 0.3ml in her arm) (unsure of cap color) on 01Oct2022 but had an expiration date of 30Sep2022. Indication as Reported by the Primary Source: requested to have it for school requirement. Unknown if any other condition, other products, and any investigations performed. A physician's assistant on the line that has a question regarding 11 hour expired Pfizer Covid 19 vaccine for 12 years old and older. Relays it was already expired. Caller was asking if they need to repeat the dose or if the vaccine still valid since it just recently expired. Caller was asking if would reach out to the patient and how long does a report take. Caller asking to have the clinic phone number removed as he would like to be contacted directly. Primary / Prescribing Healthcare Professional Info: declines. States it was through XRT as a nurse visit. States the vaccine was given on Saturday, 01Oct2022. It was the 1st dose of the primary series, monovalent. Caller states the vaccine had just expired. States he doesn't do this process, they usually do. They use an online data base to check the expiry date and he was tried to do it for a couple of hours, it took about 2-3 hours to do and finally got the official expiration date. Stated they did a good job of getting rid of expired vaccines but didn't want the patient to wait. Stated that he called the patient and informed her right away and she has no risk factors to think of myocarditis or other adverse reactions to past like vaccines like thrombocytopenia. She had local soreness at the injection site and mild nausea. Caller does not have time frame to provide. He called her around 5pm, she got the injection around 11 to 11:30 am and about 2 to 3 hours later was when they found out it was expired. Stated the CDC recommends if it was expired the patient can get updated without waiting but to contact the manufacturer. Stated that it's not even a day past the expiry. Before they repeat the dose, he wanted to reach out for data or recommendation. Looking at her chart the nurse got a good history, and it doesn't show any history or medications at all. There was no history of previous immunization with the Pfizer vaccine, additional vaccines administered on same date of the Pfizer suspect. No AE required to visit to emergency room and physician office. It was unknown if any prior vaccinations within 4 weeks. Unknown if any AE following prior vaccinations and as per chart no history or anaphylaxis. Unknown if medical history (including any illness at time of vaccination), family medical history relevant to ae and any relevant test.