Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Dizziness, Fatigue, Feeling abnormal, Fibrin D dimer increased
Clinical narrative: Dose 1 and Dose 2: BNT162B2, Dose 3: Moderna; Treatment of COVID-19; Treatment of COVID-19; 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 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL9261, Expiration Date: 31May2021), in left arm and on 26Feb2021 as dose 2, single (Lot number: EN6198, Expiration Date: 30Jun2021) at the age of 56 years, in left arm, all intramuscular for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 30Dec2021 as dose 3 (booster), single (Lot number: 032h21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "BMI 26" (unspecified if ongoing); "prediabetes" (unspecified if ongoing); "Menopause 5X" (ongoing). Concomitant medication(s) included: ESTRACE oral taken for menopause, start date: 2017 (ongoing); PROVERA [MEDROXYPROGESTERONE] oral taken for menopause, start date: 2017 (ongoing). The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose 1 and Dose 2: BNT162B2, Dose 3: Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid. The patient had no drug allergy. The patient reported that she received only one booster shot and that it was from Moderna and that she received the booster shot at the facility (name withheld). She stated that her booster shot was for other company Moderna and so did not provide any additional details about her booster shot. Investigation results were reported. Conclusion of Previously Completed Investigation for lot EN6198: "The complaint for lack of effect of the Pfizer-Biontech Covid-19 Vaccine lot EN6198 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 EN6198, fill lot EN5330, and the formulated drug product lot EN5319. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective and 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." Conclusion of Previously Completed Investigation for lot EL9261: The complaint for lack of effect of the Pfizer BioNTech Covid-19 Vaccine Injectable lot EL9261 was investigated. The investigation included reviewing manufacturing and packaging batch records, release test results, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EL9261, fill lot EL9252, and the bulk formulated drug product EL9243. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Follow-up (05Oct2022): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201021316 same patient/event, different drug;