Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: interchange of vaccine products; Caller stats she just tested on Tuesday the 5th and it was positive; Caller stats she just tested on Tuesday the 5th and it was positive; This is a spontaneous report received from a Nurse from product quality group.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Batch/Lot number: unknown), on 17Mar2021 as dose 2, single (Lot number: EP6955), on 21Aug2021 as dose 3 (booster), single (Lot number: EW0187) and on 19Apr2022 as dose 4 (booster), single (Lot number: FJ8762) at the age of 70 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Oct2022 as dose 5 (booster), single (Lot number: GJ3277) and on 23Sep2023 as dose 6 (booster), single (Lot number: 202F23A) for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing); "Chronic Lymphocytic Leukemia" (unspecified if ongoing); "Non Hodgkin's Lymphoma" (unspecified if ongoing); "surgeries on her neck for cancer", stop date: 2022, notes: had 7 surgeries on her neck for cancer, surgeries were before Paxlovid, the last one in 2020.; "allergic to a lot of medications" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Dec2023, outcome "unknown" and all described as "Caller stats she just tested on Tuesday the 5th and it was positive"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Dec2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had Cancer Chronic Lymphocytic Leukemia and Non Hodgkin's Lymphoma but she felt fine normally. Patient took Paxlovid on 05Dec2023. Patient stated she wasn't feeling well on Monday but she didn't test for Covid until Tuesday, because a lot of times it did not show up in the first 24 hours does show. She stated she just tested on Tuesday the 5th and it was positive, she even called PRIVACY about the little line thing. Patient stated it was positive, so she called her primary care physician (PCP) immediately and they ordered her Paxlovid. Patient stated she tends to be allergic to a lot of medications. Patient stated she has had 7 surgeries on her neck for cancer. She stated she has had 6-7 Covid vaccines plus she had cancer, so she took 2 vaccines that put the actual antibodies in her body. Patient first dose: Pfizer 24Feb2021, Lot: EV6198 or EU6198. States the writing is bad. She stated she also had an experimental use vaccine that was more for patients with Chronic Lymphocytic Leukemia because they don't make the antibodies when they were injected with the proteins for the vaccine. She explained their body did not make the antibodies like it should so that was why her Oncologist suggested she take a vaccine called Evusheld. She stated she asked them to write down the information but they stated they were not required to. she stated she had one dose on 11May2022 and another dose on 21Nov2022. She stated the variant now Evusheld was ineffective for and variants since then.  Based on investigation result conclusion: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EP6955 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EP6955 (fill lot EP6954, and the formulated drug product lot EP6953); lot EW0187 (fill lot EP8737, and the bulk formulated drug product lot EP8618); lot FJ8762 (fill lot FJ8797, and formulated drug product lot FJ8509). A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications..  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event based on the known safety profile and temporal association.