Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Bacterial infection, COVID-19, Dysphonia, Fatigue, Nasopharyngitis
Clinical narrative: vaccination failure; COVID-19; Mucus discharge; Fatigue aggravated; Common cold; Voice disturbance; Bacterial infection; FACILITATED COLLECT  This is a solicited report received from non-contactable reporter(s) (Consumer or other non HCP) from product quality group for a Pfizer sponsored program (NOT PROVIDED). The reporter is the patient. Other Case identifier(s): 21K-163-4216546-00.  A 62 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 27Dec2021 (Lot number: FL3197) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous from Aug2021 (Batch/Lot number: unknown) to Dec2021 at 40mg/0.4ml/ citrate free (40 mg,1 in 2 wk), second regimen subcutaneous from 15Dec2021 (Batch/Lot number: unknown) to 05Jan2022 at 40mg/0.4ml/ citrate free (40 mg,1 in 1 wk) and third regimen subcutaneous since 12Jan2022 (ongoing) (Batch/Lot number: unknown) at 40mg/0.4ml/ citrate free (40 mg,1 in 1 wk) for rheumatoid arthritis. Relevant medical history included: "TOBACCO USE", stop date: 2010, notes: TOBACCO USE (Stopped 2010); "FIBROMYALGIA", start date: 2020 (unspecified if ongoing), notes: Fibromyalgia (Started 2020); "MEMORY ISSUES" (unspecified if ongoing); "PENICILLIN ALLERGY" (unspecified if ongoing); "CODEINE ALLERGY" (unspecified if ongoing), notes: Codeine allergy manifestation by hives and itching.; "TETRACYCLINE ALLERGY" (unspecified if ongoing); "ALCOHOL USE WINE" (unspecified if ongoing), notes: occasionally. Concomitant medication(s) included: CELEBREX taken for rheumatoid arthritis; PRILOSEC [OMEPRAZOLE MAGNESIUM] taken for gastritis; PREDNISONE taken for rheumatoid arthritis; MELATONIN taken for somnolence; CLONAZEPAM taken for sleep disorder; VITAMIN D [COLECALCIFEROL] taken for supplementation therapy; FOLATE taken for rheumatoid arthritis; BACLOFEN taken for rheumatoid arthritis; ZYRTEC ALLERGY taken for hypersensitivity; METHOTREXATE SODIUM taken for rheumatoid arthritis; MAGNESIUM SULFATE taken for supplementation therapy; ZINC CHLORIDE taken for immune enhancement therapy; CALCIUM taken for supplementation therapy; VITAMIN C [ASCORBIC ACID;ROSA CANINA] taken for immune enhancement therapy. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number EL9263), administration date: 17Mar2021, for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Lot number EN6204), administration date: 06Apr2021, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant) with onset 31Dec2021, outcome "unknown", described as "vaccination failure"; COVID-19 (medically significant) with onset 31Dec2021, outcome "unknown", described as "COVID-19"; SECRETION DISCHARGE (non-serious) with onset 31Dec2021, outcome "recovering", described as "Mucus discharge"; FATIGUE (non-serious) with onset 31Dec2021, outcome "recovering", described as "Fatigue aggravated"; NASOPHARYNGITIS (non-serious) with onset 31Dec2021, outcome "recovered" (Jan2022), described as "Common cold"; DYSPHONIA (non-serious) with onset 31Dec2021, outcome "not recovered", described as "Voice disturbance"; BACTERIAL INFECTION (non-serious) with onset 31Dec2021, outcome "recovering", described as "Bacterial infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) positive, notes: Positive for Covid-19. The action taken for adalimumab was unknown.  Clinical information: The patient was treated with Tylenol. Causality as per reporter for Humira was Not Related. Causality as per reporter for bnt162b2 was Not Reported. As part of the simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according.  Investigation result: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EL9263 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EL9263, fill lot EL9254, and the formulated drug product lot EL9245. 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. When more than one investigation is found in the family, the Conclusion field could result in repeating rows for the CR in the table. If the Conclusion is blank in the table above, then the investigation record is likely an Offline Contractor Investigation and the conclusion must be obtained directly from the child investigation record(s) of the linked Complaint Record.  No follow-up attempts are possible. No further information is expected.  Follow-Up (28Jan2022): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided and known drug safety profile the lack of efficacy of the vaccine and the events fatigue, secretion discharge and nasopharyngitis with the suspect drug BBNT162B2 cannot be excluded. The events dysphonia and bacterial infection were considered as an intercurrent illness and hence were assessed as unrelated to the suspect vaccine BNT162B2. Case will be reassessed if any new information is available.