Age: 70.0
Sex: M
Vaccine: COVID19, UNK, UNK
Symptoms: Arthralgia, Back pain, Cyst, Incorrect dose administered, Magnetic resonance imaging
Clinical narrative: Cyst; Covid-19 vaccination; Back pain aggravated; Arthralgia aggravated; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4205066-00 (Agency).  A 71 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 19Jan2022 (Batch/Lot number: unknown) at the age of 70 years as dose 4 (booster), single, intramuscular, administration date 19Aug2021 (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular, administration date 14Feb2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 24Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous since Dec2021 (ongoing) (Batch/Lot number: unknown) at 0.4 mL (citrate free (40 mg,1 in 2 wk)) and second regimen subcutaneous from May2021 (Batch/Lot number: unknown) to Aug2021 at 0.4 mL (citrate free (40 mg,1 in 2 wk)) for psoriatic arthropathy; secukinumab (COSENTYX), from 2021 (Batch/Lot number: unknown) to 2021 for psoriatic arthropathy. Relevant medical history included: "shoulder surgery", start date: 29Apr2021 (unspecified if ongoing), notes: Shoulder Surgery (Started 29Apr2021); "Back Stimulator Implant", start date: 2011, stop date: 2018, notes: Back Stimulator Implant (2011 - 2018); "Bone Spurs" (unspecified if ongoing), notes: Bone Spurs; "Abstains from Alcohol" (unspecified if ongoing), notes: Abstains from Alcohol; "Non tobacco user" (unspecified if ongoing), notes: Non tobacco user; "Psoriatic Arthritis" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "Pain" (unspecified if ongoing); "Reflux" (unspecified if ongoing); "Erectile Dysfunction" (unspecified if ongoing); "Allergy" (unspecified if ongoing); "Short of Breath" (unspecified if ongoing); "For Prostate" (unspecified if ongoing); "Supplement" (unspecified if ongoing). Concomitant medication(s) included: MEDROL [METHYLPREDNISOLONE] taken for psoriatic arthropathy; MELOXICAM; ROSUVASTATIN; VALSARTAN taken for hypertension; BACLOFEN taken for pain; PANTOPRAZOLE taken for gastrooesophageal reflux disease; CIALIS taken for erectile dysfunction; GABAPENTIN taken for pain; ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for hypersensitivity; ALBUTEROL HFA taken for dyspnoea; ALFUZOSIN HCL taken for prostate cancer; VITAMIN D [ERGOCALCIFEROL] taken for supplementation therapy; VITAMIN B12 [CYANOCOBALAMIN] taken for supplementation therapy; NICOTINAMIDE taken for supplementation therapy; PYRIDOXINE HYDROCHLORIDE taken for supplementation therapy; RETINOL taken for supplementation therapy; RIBOFLAVIN taken for supplementation therapy; SODIUM ASCORBATE taken for supplementation therapy; THIAMINE MONONITRATE taken for supplementation therapy. Past drug history included: Lisinopril for Lisinopril Allergy, reaction(s): "Coughing", notes: Lisinopril Allergy Manifested by Coughing. The following information was reported: CYST (medically significant) with onset Feb2022, outcome "not recovered", described as "Cyst"; BACK PAIN (medically significant) with onset Jan2022, outcome "not recovered", described as "Back pain aggravated"; ARTHRALGIA (medically significant) with onset Nov2021, outcome "recovering", described as "Arthralgia aggravated"; INCORRECT DOSE ADMINISTERED (non-serious) with onset 19Jan2022, outcome "unknown", described as "Covid-19 vaccination". The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: (16Feb2022) cyst, notes: Relevant Laboratory & Other Diagnostic Tests: 16Feb2022 Magnetic Resonance Imaging on Back: Cyst. The action taken for adalimumab was dosage not changed. Clinical course: The patient was doing well with Humira, the doctor shifted him to Cosentyx for a better response. His joint pain worsened and so the doctor shifted him back to Humira. He had worsening back pain and the doctor suspected it was other than his arthritis. It was not clear if the patient was out of Humira or any other medication for months. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for Humira (Adalimumab) The reporter's causality for the event(s) of cyst in back, worsening back pain and worsened joint pains with Humira 40MG/0.4ML(Adalimumab) was no reasonable possibility Agency's opinion is that the event of cyst in back is not assessable. Agency's opinion is that there is no reasonable possibility that the events of worsening back pain and worsened joint pains are related to Humira 40MG/0.4ML(Adalimumab).  Causality for Cosentyx (Secukinumab): Causality as per reporter for Cyst, Back pain aggravated, Arthralgia aggravated was not related.  Causality for Pfizer BioNTech Covid-19 Vaccine: The reporter's assessment of the causal relationship of the events with the suspect product 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on strong temporal relationship, a possible causal association between the events  and the suspect drug BNT162B2 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.