Age: 72.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: Got COVID; Got COVID; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 72-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 11:00 as dose 6 (booster), 0.3 ml single (Lot number: GH9693) at the age of 72 years intramuscular, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 29Jan2021 at 17:30 as dose 1, 0.3 ml single (Lot number: EL9261), in left arm, on 18Feb2021 at 17:30 as dose 2, 0.3 ml single (Lot number: EM9809), in left arm, on 16Aug2021 at 15:00 as dose 3 (booster), 0.3 ml single (Lot number: FC3181), in left arm, on 22Jan2022 at 12:00 as dose 4 (booster), 0.3 ml single (Lot number: FH8020), in left arm and on 04Jun2022 at 15:00 as dose 5 (booster), 0.3 ml single (Lot number: FM7553), in arm, all intramuscular for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 01Oct2021 as dose number unknown, 0.5 ml single (Lot number: UJ749AA) and on 19Sep2022 as dose number unknown, 0.7 ml single (Lot number: UJ904AD), in arm, all intramuscular for influenza immunisation; cilgavimab, tixagevimab (EVUSHELD), on 21Jun2022 at 13:30 as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history included: "ESRD", start date: 05Dec1974 (ongoing), notes: ESRD; "ESRD", start date: 10Feb1996, stop date: 20Sep1998, notes: Pertinent details: CAPD; "Renal Tx", start date: 20Sep1998 (not ongoing), notes: Pertinent details: Still working; "HFPEF" (ongoing), notes: Pertinent details: aortic valve replacement 2011; "aortic valve replacement 2011", start date: 2011 (not ongoing); "CKD", start date: 05Dec1974 (ongoing), notes: Pertinent details: Tx renal 20Sep1998; "Aortic stenosis", start date: 2006 (ongoing), notes: Pertinent Details: Bovine replacement 2011 current one is wearing out; "Aortic valve stenosis", start date: 2008 (ongoing), notes: Pertinent details: Valve replacement 2011, need new one; "Congestive heart failure", start date: 2017 (ongoing); "Hysterectomy" (not ongoing); "Booster dose due to a weakened immune system" (unspecified if ongoing); "Urinary tract bleeding" (unspecified if ongoing); "CRD", start date: May1969 (ongoing), notes: Pertinent Details: Peritoneal Dialysis Tc 20Sep1998; "Skin cancer basal cell squamous cell carcinoma", start date: 2002 (ongoing), notes: Pertinent Details: Removal too many to list; "PERITONEAL DIALYSIS/CAPD", start date: 20Sep1998 (not ongoing); "Skin neoplasm excision" (not ongoing). Concomitant medication(s) included: AMOXICILLIN oral taken for dental disorder prophylaxis, start date: 19Jan2021 (ongoing). The patient also took other concomitant therapy. Past drug history included: Metoprolol succinate for Cardiac disorder, notes: Metoprololsuccinate ER 100 mg QD 25 mg PRN, LabetalolHCl 100 mg BID, Aspirin325 mg K-Lor20 meq SR QD; Labetalol hcl for Cardiac disorder; Aspirin for Cardiac disorder; Amlodipine for Hypertension, notes: Hypertension: Amlodipine 5 mg QD; L-thyroxine 100 for Thyroid Replacement, notes: Thyroid Replacement: L-Thyroxine 100 mcg QD 5x/Week; Calcium for Osteoporosis, notes: 4000 IU Vit D Calcium 600 mg Multivitamin; Vitamin d for Osteoporosis; Multivitamin for Osteoporosis; Furosemide for Edema, notes: Edema: Furosemide 40 mg QD; Noritate for Rosacea, notes: Rosacea: Noritate (topical) QD, Tazorac .05 PC (topical) QD; Tazorac for Rosacea; Sevelamer carbonate for Hyperparathyroid, notes: Hyperparathyroid: Sevelamer carbonate 800 mg TID w/meals; Pravastin for Blood cholesterol abnormal, notes: Cholesterol: Pravastin Sodium 80 mg QD, Ezetimibe 10 mg QD; Ezetimibe for Blood cholesterol abnormal; Allopurinol for Gout, notes: Allopurinol 100 mg QD; Triamcinolone acetonide for Scale, notes: Triamcinolone Acetonide 0.1%; Amoxicillin for Tooth disorder, notes: Amoxicillin 500 mg Take 2000 mg 30-60 minutes before procedure; Prednisone for Antirejection, notes: Prednisone 5 mg QD, Mycophenolate Mofetil 500 mg BID, Cyclosporine modified 50 mg AM/25 mg PM; Mycophenolate mofetil for Antirejection; Cyclosporine for Antirejection. Vaccination history included: tdap (DOSE 3 (BOOSTER), SINGLE, Anatomical Route: Intramuscular, Anatomical site of injection: Arm), administration date: 14Jan2021, when the patient was 71-year-old, for Immunization; flu-aiiv4 (DOSE NUMBER UNKNOWN, 0.5ML SINGLE , Batch/Lot number: 279790, Route: Intramuscular, Vaccine Manufacturer: Seqirus), administration date: 08Sep2020, when the patient was 70-year-old, for Influenza immunisation; Tdap (DOSE 1, SINGLE), for Immunization; Tdap (DOSE 2, SINGLE), for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Oct2022, outcome "recovering" and all described as "Got COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Oct2022) Positive, notes: tested positive for COVID. Comments: Treated with monoclonal antibodies; (12Oct2022) Positive, notes: Comments: No addition treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had 3 Pfizer vaccines as part of initial treatment, 2 Pfizer Boosters, and the current bivalent Booster along with cilgavimab, tixagevimab. When patient got COVID this fall patient was able to be treated with monoclonal antibodies and stayed home. Patient had a very compromised immune system. Booster dose due to weekend immune system. Use of medication that suppress the immune system (e.g. high-dose of corticosteroids, cyclosporine, methotrexate, azathioprine, and biologic therapies like rituximab and etanercept). Vaccination facility type: Hospital; Pharmacy or drug store; Public Health Clinic/Administration Facility, Vaccine was not administered at this facility.Monoclonal antibody 04Oct2022 08:15 COVID treatment 2 Days, The patient received On 07Nov2022, Shingrix1 Vaccine of Glaxo Smith Kline with Batch/Lot number: YA29D. On 05Apr2023, Shingrix 2 Vaccine Dose: 0.5 of Glaxo Smith Kline with Batch/Lot number: 4LS95 (Illegible). No Family medical history relevant to adverse events (AES). No Specific relevant test for thromboembolic events with thrombocytopenia.The also patient received Influenza FLU-AIIV4 vaccine dose 0.5mL via Intramuscular route Anatomical Site of Injection: arm on 11Sep2023 batch/lot number: 370267 Manufacturer: Seqirus, RSV adjuvanted Monovalent Pref Subunit Vaccine dose 0.5mL via Intramuscular route on 11Oct2023 batch/lot number: KY322 Manufacturer: GlaxoSmithKline, Vaccine: Zoster Unspecified 0.5mL on 01Nov2022 batch/lot number: YA29D, Comirnaty Pfizer Covid-19 Vaccine dose 8 (booster), 0.3 ml single (Lot number: HG4628) via Intramuscular route on 22Sep2023 for covid-19 Immunisation. Patient got Covid 02Oct2022, was treated with monoclonal antibodies via infusion. In addition to the shots patient had Evershed, infusion. The shot on 22Sep2023 was the only one patnet didn't have a bloody nose after. All other shorts were given in the arm. Usually the left. Not one of patient doctors have all the information. Everything they have was provided by patient. When she got a vaccine she asked for the information to pass onto them.  On 29Mar2023, investigation results for lot numbers GH9693, EL9261, EM9809, FC3181, FH8020 and FM7553 were reported as follows: 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 was 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.  The complaint for Pfizer Biontech COVID-19 Vaccine was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GH9693. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. Withheld concluded that the reported defect was not representative of the quality of the batch and the batch remained acceptable. The investigative process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.   The complaint for lack of effect of the Pfizer BioNTech COVID-19 Vaccine lot EM9809 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 EM9809, fill lot EM9807, and the formulated drug product lot EM9805. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There was 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 complaint for lack of effect of the Pfizer Biontech COVID-19 Vaccine lot FC3181 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 FC3181, fill lot EY0567, and the formulated drug product lot FE3195. A complaint sample was not returned. No related quality issues were identified during the investigation. There was 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 complaint for lack of effect of the Pfizer Biontech COVID-19 Vaccine Injectable lot FH8020 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FH8020, fill lot FG3521, and the bulk formulated drug product lot FH0137. A complaint sample was not returned. No related quality issues were identified during the investigation. There was 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.  The complaint for Pfizer BioNTech COVID-19 Vaccine was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FM7553. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. Withheld concluded that the reported defect was not representative of the quality of the batch and the batch remained acceptable. The investigative process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.  The complaint for "Treatment of COVID-19" of PFIZERBIONTECH COVID-19 VACCINE INJECTABLE" was investigated. The investigation Included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot "GL1990". A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. RA (site name withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The investigative process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.  Follow-up (22Nov2022): This is a spontaneous follow-up report received from the contactable consumer. Updated information: relevant medical history, lab data result, Vaccination facility details added; vaccination details (1st, 2nd and 3rd vaccination date, vaccination time, lot number, route of administration and anatomical location); event details (verbatim, onset date).   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  Amendment: This follow-up report is being submitted to amend previous information: To update case closure comment in narrative.  Follow-up attempts are completed. No further information is expected.  Follow-up (28Nov2022): This is a spontaneous follow up report from a contactable consumer. This consumer (patient) reported in response to consumer letter sent via follow-up letter which included that: Updated information: Reporter and patient's middle name added. Event outcome updated for event Got COVID" to recovering  Follow-up attempts are completed. No further information is expected.  Follow-up (27Mar2023): This is a spontaneous follow-up report from a contactable consumer. This consumer reported in response to Non HCP letter sent in cross reference case that included: Updated information included: email address added. Zip code updated. Other medical history added. Suspect product (Vaccination date, Lot number, Anatomical location) added. Co-suspect product (Vaccination dates, Lot numbers, Anatomical locations) added.   Follow-up attempts are completed. No further information is expected.  Follow-up (29Mar2023): This is a follow-up report from product quality group providing investigation results.  Follow-up attempts are completed. No further information is expected.  Follow-up (24Apr2023): This is a follow-up report from product quality group providing investigation results: Updated information included: Suspect (Lot number EM9509 updated to EM9809) and narrative updated.  Follow-up (27Jun2023): This is a spontaneous follow-up report from a contactable consumer. This consumer (patient) reported in response to Non-HCP letter sent in the cross-referenced case, which included that: Updated information includes: Patient information (Alternate email id added in patient tab); RMH details (ESRD notes field only added. CKD added with start date and stop date added. Aortic valve stenosis added with start date and ongoing were checked as per SD. Congestive heart failure added with start date as 2017 and ongoing were checked as per SD. For TDAP notes field added as No. of previous dose: 2. Colonoscopy and Hysterectomy/Urinary tract bleeding added ) Lab data (For test COVID-19 test only notes updated with Comments and PCR test was added). Co-suspect details (Evusheld time added as per SD). Concomitant drug details (Amoxicillin added); Vaccine facility information captured and clinical course added.  Follow-up attempts are completed. No further information is expected.  Follow-up (05Dec2023): This is a spontaneous follow up report received from a contactable Consumer. This consumer (patient) reported in response to Non-HCP letter. Updated Information included: Reporter information, and suspect product details.  Follow-up (29Dec2023): Follow-up attempts are completed.  Follow-up (25Jan2024): This is a follow-up report from Product Quality Group providing investigation results: Updated information: Investigation results added.  Follow-up attempts are completed.  Amendment: This follow-up report is being submitted to amend previously reported information: [Patient gender updated]  Follow-up (12Feb2024): This is a spontaneous follow-up report received from a same consumer.  Updated information included: Relevant medical history, historical vaccine, Suspect vaccines, Co-suspect Influenza vaccine details and clinical course updated. Patient date of birth and age at vaccination added.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200110208 same patient, same drug, different dose/events(6th dose);US-PFIZER INC-PV202200112909 same patient, same drug, different dose/events(1st dose);US-PFIZER INC-202201337655 same patient, same drug, different dose/events(2nd dose);US-PFIZER INC-202201337656 same patient, same drug, different dose/events(3rd dose);US-PFIZER INC-PV202300057499 same patient, same drug, different dose/events(4th dose);US-PFIZER INC-202300134163 same patient, same drug, different dose/events(5th dose);US-PFIZER INC-PV202300198790 same patient, same drug, different dose/events(7th dose);