Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Glycosylated haemoglobin, Glycosylated haemoglobin increased, Headache, Malaise, Pain
Clinical narrative: Malaise; Body ache; Headache; I had some chills; My arm was sore at the site of administration which is a right deltoid; The expiry dating on that was December 2069 and I just called the pharmacy and they said they got that from a scan of the vial; glycosylated hemoglobin test which came out to be 5.1; blood pressure and the blood pressure was a bit high it was 137 over 60 something; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 72 year-old patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 14Feb2022 19:30 (Lot number: FM0698, Expiration Date: Dec2069) at the age of 72 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1, single, Manufacturer: Unspecified), for COVID-19 immunization; Bnt162b2 (DOSE: 2, single, Manufacturer: Unspecified), for COVID-19 immunization. The following information was reported: MALAISE (non-serious), outcome "recovered", described as "Malaise"; PAIN (non-serious), outcome "recovered", described as "Body ache"; HEADACHE (non-serious), outcome "recovered", described as "Headache"; CHILLS (non-serious), outcome "recovered", described as "I had some chills"; ADMINISTRATION SITE PAIN (non-serious), outcome "unknown", described as "My arm was sore at the site of administration which is a right deltoid"; SUSPECTED PRODUCT QUALITY ISSUE (non-serious), outcome "unknown", described as "The expiry dating on that was December 2069 and I just called the pharmacy and they said they got that from a scan of the vial"; GLYCOSYLATED HAEMOGLOBIN INCREASED (non-serious), outcome "unknown", described as "glycosylated hemoglobin test which came out to be 5.1"; BLOOD PRESSURE INCREASED (non-serious), outcome "unknown", described as "blood pressure and the blood pressure was a bit high it was 137 over 60 something". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: On unspecified date Patient arm was sore at the site of administration, which was a right deltoid, on unspecified date expiry date on that was Dec2069 and patient just called the pharmacy and they said they got that from a scan of the vial, events was occurred on unspecified dates. The expiry dating on that was Dec2069 and I just called the pharmacy and they said they got that from a scan of the vial. Patient stated that just called because have question about the expiry dating on your recent Pfizer vaccine gray cap, which is 12 and up the formulation, and had a booster administered on the 14th of this month which is this past Monday and it was administered at (Pharmacy name withheld) in (place name withheld), (place name withheld). The report that was given to me regarding the vaccine was sent to my email, patient read through it and got down to the LOT# and the expiry date and, on the expiry, date have a question with. The LOT number that was administered to me was FM0698, the expiry dating on that was Dec2069 and just called the pharmacy and they said they got that from a scan of the vial. So, my question is, right now patient not really, that have been in pharmacy (Further not clarified), a pharmaceutical business for a while, retired from that, do not know very much about the expiry dating for your vaccines but 47 years seems to being an excessive amount of expiry date, patient not know what you have information to back that up but just want to alert you that is what is being listed at this particular store." Patient added, "It was a Gray Cap with the latest formulation for 12 and up." And stated vaccine was administered to patient on Monday, Monday evening followed up with the store, and felt that the expiration date seems to be a bit excessive so followed up with the store, the store told me they got it from a scan of the vial, Which you know if it is correct then and it is supported by expiry and more stability information then that is fine but 47 years for actually probably rounded up for like 50 years, that type of expiry dating seems to me to be a bit excessive for something for the biologic in it even if you lyophilizing it, holding it at extremely low temperature." Consumer was informed about Pfizer drug safety role. Consent to Follow up includes Consumer stated, "Yes, I am not disputing the date I am just saying that to me in my experience it seems do not know even with solid dose just have never seen a 47 year or 50-year expiry dating under any circumstances." Any Adverse event experienced like Consumer stated, "No, none aside from the generalized effects. So, the Malaise, body ache, headache and I had some chills. But aside from that most of that been resolved as of this morning. My arm was sore at the site of administration which is a right deltoid and aside from that no real adverse effects as such just a normal stuff (Further not clarified) you except from that viral vaccine administration according to what you guys have described. Consumer stated, there was no events or anything like that, patient did have a in house visit from the representative wherein they did blood glucose, glycosylated hemoglobin test which came out to be 5.1, blood pressure and the blood pressure was a bit high it was 137 over 60 something. Aside from that nothing out of the ordinary. Yes, something like that (Not sure, hence not captured in tab)."Patient do not know if there is an NDC and think there was NDC on it and have a medication number from Pfizer 1860536. Patient stated there was no other prior vaccinations.  Product quality complaints: Question raised for the product quality complaints Pfizer Product Quality Complaints is in receipt of the subject complaint reporting an invalid expiration date of Dec2069 is provided when the barcode is scanned. Would it be possible to supply a photo of the incorrect expiration date upon scanning the barcode? This information will assist in expediting the investigation. Pfizer Product Quality Complaints will be shipping prepaid mailing materials to you to collect samples of the barcode. If you have any questions or concerns regarding this issue, please call Product Quality Complaints at #, prompt 6. When calling please reference the subject complaint number. Response from the  includes patient not the vendor, vaccine recipient of a booster from (Facility name and address), and noticed the error on my records from the store where I received the vaccine on 14Feb2022 at 7:30 PM. Please contact the store for clarification.  No follow-up attempts are possible. No further information is expected.