Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Bacterial infection, COVID-19, Drug ineffective, Dysphonia, Fatigue
Clinical narrative: Unevaluable event; Fatigue aggravated; Voice disturbance; Mucus discharge; COVID-19; COVID-19; Common cold; Bacterial infection; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) from product quality group for a sponsored program. The reporter is the patient.  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 40 mg (citrate free (40 mg,1 in 2 wk)), second regimen subcutaneous from 15Dec2021 (Batch/Lot number: unknown) to 05Jan2022 at 40 mg (citrate free (40 mg,1 in 1 wk)), third regimen subcutaneous since 12Jan2022 (ongoing) (Batch/Lot number: unknown) at 40 mg (citrate free (40 mg,1 in 1 wk)) and fourth regimen subcutaneous (Batch/Lot number: unknown) at 0.4 mL for rheumatoid arthritis. Relevant medical history included: "Tobacco use", stop date: 2010; "Fibromyalgia", start date: 2020 (unspecified if ongoing); "Memory issues" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "Alcohol use wine occasionally" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "for sleep" (unspecified if ongoing); "Stomach issues" (unspecified if ongoing). Concomitant medication(s) included: CELECOXIB taken for rheumatoid arthritis; PRILOSEC [OMEPRAZOLE] taken for abdominal discomfort; METHOTREXATE taken for rheumatoid arthritis; PREDNISONE taken for rheumatoid arthritis; MELATONIN taken for sleep disorder; CLONAZEPAM taken for sleep disorder; VITAMIN D [COLECALCIFEROL] taken for supplementation therapy; FOLATE taken for rheumatoid arthritis; VITAMIN C [ASCORBIC ACID;ROSA CANINA] taken for immune complex level increased; ZINC taken for immune complex level increased; CALCIUM taken for supplementation therapy; MAGNESIUM taken for supplementation therapy; BACLOFEN taken for rheumatoid arthritis; ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for hypersensitivity. Past drug history included: Codeine, reaction(s): "Codeine allergy Manifestation by hives and itching"; Codeine, reaction(s): "Codeine allergy Manifestation by hives and itching"; Tetracycline, reaction(s): "Tetracycline allergy". Vaccination history included: Bnt162b2 (On 06Apr2021, she received 2nd dose covid-19 Vaccine manufactured by Pfizer/Biontech, lot number EN6204), administration date: 06Apr2021, when the patient was 62 years old, for covid-19 immunization; Bnt162b2 (On 17Mar2021, she received 1st dose covid-19 Vaccine manufactured by Pfizer/Biontech, lot number EL9263), administration date: 17Mar2021, when the patient was 62 years old, for covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31Dec2021, outcome "unknown" and all described as "COVID-19"; NASOPHARYNGITIS (non-serious) with onset 31Dec2021, outcome "recovered" (Jan2022), described as "Common cold"; BACTERIAL INFECTION (non-serious) with onset 31Dec2021, outcome "recovering", described as "Bacterial infection"; UNEVALUABLE EVENT (non-serious), outcome "unknown", described as "Unevaluable event"; FATIGUE (non-serious) with onset 31Dec2021, outcome "recovering", described as "Fatigue aggravated"; DYSPHONIA (non-serious) with onset 31Dec2021, outcome "not recovered", described as "Voice disturbance"; SECRETION DISCHARGE (non-serious) with onset 31Dec2021, outcome "recovered", described as "Mucus discharge". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) positive. The action taken for adalimumab was unknown. Investigation results for lot EN6204 (Dose 2) and Dose 3 (FL3197). The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EN6204 and  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 EN6204, fill lot EN5335, and the formulated drug product lot EN5325. 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 complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE INJECTABLE lot FL3197 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 FL3197, fill lot FJ8803, and the formulated drug product lot FL3180. 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. Clinical Course: It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. The patient was treated with Tylenol. The Reporter Causality for the all the events for suspect Bnt162b2 was not reported and for another suspect, ADALIMUMAB for the events (Mucus discharge, Fatigue aggravated, Covid-19, Nasopharyngitis and Bacterial infection it was reported as unrelated. It was not reported for the event unevaluable event.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.