Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Neuropathy peripheral, Post-acute COVID-19 syndrome, SARS-CoV-2 test
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4275392-00. A 66-year-old male patient received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Batch/Lot number: unknown), on 10Mar2021 as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years, all intramuscular for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Dec2021 as dose 4 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen from Dec2021 (Batch/Lot number: unknown) to Jan2022 at 40 mg (40 mg (citrate free (40mg, 1 in 2 wk.))) and second regimen since 2022 (ongoing) (Batch/Lot number: unknown) at 40 mg (40 mg (40mg, 1 in 2 wk.)), all subcutaneous for rheumatoid arthritis. The patient's relevant medical history included: "Covid 19 Positive" (unspecified if ongoing), notes: Covid 19 Positive (Started Oct2021); "Thyroid Problem" (unspecified if ongoing); "Cholesterol Problem" (unspecified if ongoing); "Seasonal Allergies Manifested by Tiredness" (unspecified if ongoing); "Non-Tobacco User" (unspecified if ongoing); "Non-Alcohol User" (unspecified if ongoing); "Seasonal Allergies Manifested by Tiredness" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ASTHMA (non-serious) with onset Jan2022, outcome "unknown";  CONFUSIONAL STATE (non-serious) with onset Jan2022, outcome "recovering", described as "Confused"; GLYCOSYLATED HAEMOGLOBIN INCREASED (non-serious) with onset Feb2022, outcome "unknown", described as "High Level Of Hemoglobin A1c"; DIABETES MELLITUS (medically significant), outcome "unknown", described as "Diabetes"; GLAUCOMA (medically significant), outcome "unknown"; NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "Neuropathy"; POST-ACUTE COVID-19 SYNDROME (hospitalization), outcome "unknown", described as "Long COVID"; DEPRESSION (non-serious), outcome "unknown", described as "long term depression"; ARTHRITIS (non-serious), outcome "unknown"; HYPERTENSION (non-serious), outcome "unknown", described as "Blood pressure high"; FATIGUE (non-serious), outcome "unknown", described as "felt tired". The patient was hospitalized for post-acute covid-19 syndrome (start date: 04Jan2022). The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) HIGH; (unspecified date) unknown; Glycosylated haemoglobin: (Feb2022) High Hemoglobin A1C; SARS-CoV-2 test: (Oct2021) Positive; (Jan2022) Positive, notes: Jan2022 Covid-19 Test: Positive. The action taken for adalimumab was dosage not changed. Clinical course: The patient was hospitalized due to COVID 19 on 04Jan2022 and felt tired. He forgot to take a dose of HUMIRA when he was hospitalized. He had used unknown medication for arthritis, asthma, thyroid, diabetes, neuropathy, long term depression, glaucoma, high blood pressure, and cholesterol. He suffered with long Covid. He did not agree to have physician contacted. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira 40mg/0.4ml (Adalimumab): The reporter's causality for the event(s) of covid-19, high level of hemoglobin a1c, confused and long Covid with Humira 40mg/0.4ml (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of glaucoma, long term depression, diabetes, arthritis, neuropathy, asthma and high blood pressure was not provided. Regulatory Authority opinion is that there is no reasonable possibility that the events of covid-19, high level of hemoglobin A1C, glaucoma, long term depression, diabetes, neuropathy, asthma, confused, high blood pressure and long Covid are related to Humira 40mg/0.4ml(adalimumab). Regulatory Authority opinion is that the event of arthritis is not assessable. The reporter's assessment of the causal relationship of "diabetes", "glaucoma", "neuropathy", "confused", "high level of hemoglobin a1c", "long term depression", "arthritis", "asthma", "blood pressure high" and "felt tired" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "long Covid" related to BNT162b2. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events diabetes", "glaucoma", "neuropathy", long Covid, "confused", "high level of hemoglobin a1c", "long term depression", "arthritis", "asthma", "blood pressure high" and "felt tired Cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product 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.