Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Headache
Clinical narrative: headaches; received the first booster dose on 30Sep2021. On the label on our vaccine card the expiration date is listed as 31Mar2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 30Sep2021 as dose 3 (booster), single (Lot number: FF2589, Expiration Date: 31Mar2021) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (ongoing), notes: 20 Years; "GERD" (ongoing), notes: Over last 25 years; "Right hip replacement", start date: 2014, stop date: 2014, notes: Right hip replacement; "Reduced Hysterectomy", start date: 2006, stop date: 2008, notes: Reduced Hysterectomy. Concomitant medication(s) included: CRESTOR taken for blood cholesterol increased; DEXILANT taken for gastrooesophageal reflux disease; BREO ELLIPTA taken for dyspnoea. Vaccination history included: BNT162b2 (First dose, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot Number: FL6142 or FL0142, Unable to locate or read the details Not sure of 1st number 6 or a ones), administration date: 12Jan2021, when the patient was 73-year-old, for Covid-19 Immunization; BNT162b2 (Second dose, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/ Lot Number: EL9265), administration date: 01Feb2021, when the patient was 73-year-old, for Covid-19 Immunization.  The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 30Sep2021, outcome "unknown", described as "received the first booster dose on 30Sep2021. On the label on our vaccine card the expiration date is listed as 31Mar2021"; HEADACHE (non-serious) with onset Jan2022, outcome "not recovered", described as "headaches".  Additional Information: Consumer stated, "We received our booster Pfizer dose and we received it at the end of September, we were looking at our immunization card over the weekend and realized that the sticker that they put on the card said that, that particular drug lot that we receive had expired 31Mar2021, we received it 30Sep, six months later, so our concern is that we received expired medication. I went to the facility that gave it to us, this morning and they said that they have received permission form Pfizer to use it for six more months, I want to know if that's true or not?" Consumer was informed about the role of Pfizer Drug Safety and Pfizer Medical Information. Consumer stated, "Well my husband has been sick since this happened, so I called CDC, she's the one gave me your phone#, she said that there is a vaccine adverse event reporting system and all that kind of information ten she gave me your number because I don't know if it's from an expired vaccine for his problems or something else is happened. So, I want to speak to someone who could look up this LOT# and say yes, we told them make it use it six months later and send me that information in writing, that's what I am looking for." Consumer was informed about Pfizer Medical Information and provided with the number as # withheld, Option 3 with timing 8 AM- 9 PM from Monday to Friday, EST. When asked for further probing consumer stated, "Well I do but I want to find out Pfizer to verify that, Yes the date was expired but they gave, the person who gave the permission to give it for six more months so, until I don't know the answer to that I don't know if it was the cause of the vaccine or not." LOT#: Consumer stated, "FF2589. You know what I will give you the information now so what do your questions?" Prior vaccination: Consumer stated, "No, we haven't had any vaccines since the booster." Medical history: Consumer stated, "I don't have that right now, but I have like High Cholesterol and I'm taking Crestor for that, and I also have GERD and I take a medicine called Dexilant. My husband now, he didn't have this before the shot but now he has GERD and he's on Nexium, he did have prior to this. He also has cholesterol, and he is on the same Crestor. He is on Breo Ellipta inhaler for breathing and he is on a heart tablet twice a day for Metoprolol tartrate. And forgot one for me which is the same Breo Ellipta inhaler, I'm on that also."  Treatment: Consumer stated, "For me I did not take anything new after the booster shot. For him, he did, this is that's why I was calling. He had mini stroke and he had quadruple bypass all of which he did not had before the shot." Expiration date: Consumer stated, "The expiration date on the card says 31Mar2021. That's the expiration date they put on our cards 31Mar2021, but we received the dose on 31Mar2021, six months later, I mean six months after the expiration date." Customer service at Pfizer said expiration date 31Mar2022. Pfizer drug safety medical division said FF2589  lot was manufactured Jun2021 expired 31Mar2022.  Upon follow up reporter stated that the, patient had headaches since Jan2022, Booster given after it expired so concern are did it harm me, am I concerned Lime green sticks say expiration date was 31Mar2021. Booster given 30Sep2021 (care name withheld) printed such a form that said expiration date was 30Sep2021. Customer service at Pfizer said expiration date 31Mar2022. Pfizer drug safety medical division said above lot was manufactured Jun2021 expired 31Mar2022. I would like waiting from Pfizer actual correct dates.  No follow-up attempts are needed. No further information is expected.  Follow-Up (18May2022):Follow-up attempts are completed. No further information is expected.  Follow up(31May2022): This is a spontaneous follow up report from a contactable consumer. This female consumer (patient) reported in response to consumer letter sent via follow-up letter which included that: In historical vaccine 1st and 2nd dose added as BNT162B2 with date and age field and in notes section added as Anatomical site of injection, route and lot number, RMH (Right HIP replacement and Reduced Hysterectomy) added, In RMH for GERD and high cholesterol ongoing checked, For suspect product dose number and dose description added, Vaccination facility type and phone no. added, New event Headache added with outcome and event onset date.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200690106 as same reporter/drug/event, different patient.