Sex: U
Vaccine: COVID19
Symptoms: Back pain, Pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 09May2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, Unknown manufacturer), for COVID-19 Immunization. The following information was reported: PAIN (non-serious), BACK PAIN (non-serious) all with onset 09May2022, outcome "unknown" and all described as "I am in so much pain; I have bad pain in my back".  Additional Information: Is COVID-19 Vaccine a Pfizer product? Yes, COVID-19 Vaccine manufacturer: unspecified, NDC number of COVID-19 Vaccine: Unknown, UPC number of COVID-19 Vaccine: Unknown, Reason for no lot number: of COVID-19 Vaccine: Complainant hung up abruptly/transfer incomplete, Expiry Date of COVID-19 Vaccine: Unknown. Consumer stated, "I had a booster two days ago and since 'that day' I have badly pain in my back." When paraphrased to clarify suspect product as Pfizer COVID-19 Vaccine: Consumer stated, "Yes."(Hence, suspect captured as COVID-19 Vaccine in the tab). When paraphrased if consumer have some question regarding the concern: Consumer stated, "I want to know about the side effect and what medicine should I take that's all." Consumer was informed about the role of Drug Safety and Medical Information as the concerned department for the queries. On request, Consumer was provided the number of  Medical Information as # option 3 and timings as 8 am to 9 pm from Monday to Friday. Further probing could not be initiated as consumer hung up abruptly. Hence, product details (LOT#, expiration date, NDC#, UPC#), purchase details and other details were unknown and limited information was available over the call. QR Comment: Reporter type could not be probed hence captured by default as Consumer or other non-health professional in tab. Query: Could you please provide an update on the next steps for our excursion investigation? I will be out of office after 11May and need to alert our CEO about the progress and any further expectations from Clinic. Response: It is my understanding that we were to send the supporting documents (listed below) and the  clinical department would determine if the vaccine was /wasn't viable when administered to the patients: Calibration Certificate, Temperature Logs, Explanation of occurrence, Excursion time frames, Shipping receipt, Completed documentation for each patient. After the clinical department offers its determination, we would know whether we need to contact the individual patients and make them aware of the administration of the expired vaccine.am I correct in this assumption? Minutes of Excursion: 227, Hours of Excursion: 3.8. It is my understanding that we were to send the supporting documents (listed below) and the  clinical department would determine if the vaccine was /wasn't viable when administered to the patients: Calibration Certificate, Temperature Logs, Explanation of occurrence, Excursion time frames, Shipping receipt, Completed documentation for each patient. After the clinical department offers its determination, we would know whether we need to contact the individual patients and make them aware of the administration of the expired vaccine. Am I correct in this assumption? Below request has been processed as follow-up in our safety database for all 59 patients, please find attached AER# for your reference. We have also made a request to the Complaint group for an investigation to be performed for the concerned COVID-19 vaccine with Lot FD0809. Additionally, we would like to confirm the detailed information such as Excursion start time/minutes of excursion for patient "(Initials Withheld) female DOB (Withheld)" that was initially reported by you on 14Apr2022 but did not present on the excel you sent last week. In the query response regarding this patient you only mentioned she is the correct patient (please see attached email), can you please provide below information just like other patients in the excel? Thank you! Response: I have added information below and updated the attached spread sheet. All of these vaccines were always diluted prior the administering. I updated the spread sheet to indicate that it was diluted. The excursion start time is when the vaccine was taken out of the ultra freezer. Ms. (Withheld) is on Leave. She is expected to be out for a couple of weeks. If additional information is needed, please let me know.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.