Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cataract, Chills, Drug ineffective, Fatigue, Headache
Clinical narrative: Cataracts; Scratchy throat; Runny nose; Fever; Trigger finger; Joint range of motion decreased; Fatigue; Lack of drug effect; Hands weakness of; Runny nose; psoriasis has gotten worse; Chills; Ache; Headache; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-4206916-00.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Batch/Lot number: unknown), on 04Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 14Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Lot number: 1154253) at citrate free and second regimen (Lot number: 1159670) at citrate free, all subcutaneous for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Ache"; CATARACT (medically significant) with onset 2021, outcome "not recovered", described as "Cataracts"; CHILLS (non-serious) with onset 2021, outcome "recovered" (2021); FATIGUE (medically significant) with onset 2021, outcome "unknown"; PYREXIA (medically significant) with onset 2021, outcome "recovered" (2021), described as "Fever"; MUSCULAR WEAKNESS (medically significant) with onset 2021, outcome "recovered" (2021), described as "Hands weakness of"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021); JOINT RANGE OF MOTION DECREASED (medically significant) with onset 2021, outcome "recovered" (2021); DRUG INEFFECTIVE (medically significant) with onset 2021, outcome "recovered" (2021), described as "Lack of drug effect"; RHINORRHOEA (medically significant), RHINORRHOEA (non-serious) all with onset 2021, outcome "not recovered" and all described as "Runny nose"; THROAT IRRITATION (medically significant) with onset 2021, outcome "not recovered", described as "Scratchy throat"; TRIGGER FINGER (medically significant) with onset 2021, outcome "recovered" (2021); PSORIASIS (non-serious) with onset 2021, outcome "not recovered", described as "psoriasis has gotten worse". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of trigger finger.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of Trigger Finger, Unable To Close Right Hand, Psoriasis Has Gotten Worse, No Improvement With Humira And Lost Strength In Hand with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of Cataracts, Scratchy Throat and Runny Nose was not provided. The reporter's causality for the event(s) of Fatigue and Fever with Humira (Adalimumab) was no reasonable possibility. Agency opinion is that there is no reasonable possibility that the events of Trigger Finger, Cataracts, Unable To Close Right Hand, Fatigue, Psoriasis Has Gotten Worse, Fever, No Improvement With Humira and Lost Strength In Hand are related to Humira (Adalimumab). Agency opinion is that the events of Scratchy Throat and Runny Nose are not assessable.   Causality as per reporter for PFIZER BIONTECH COVID-19 with events Scratchy throat, runny nose and Psoriasis aggravated was Not Reported and for Chills, Fever and ache , Headache was Possible.  Clinical course: Additional information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Solicited report by a consumer of an adult female with events of Trigger Finger and Cataracts and non-serious Scratchy Throat, Runny Nose, Unable To Close Right Hand, Fatigue, Psoriasis Has Gotten Worse, Fever, No Improvement With Humira and Lost Strength In Hand with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced Trigger Finger, Cataracts, Scratchy Throat, Runny Nose, Unable To Close Right Hand, Fatigue, Psoriasis Has Gotten Worse, Fever, No Improvement With Humira and Lost Strength In Hand. On unknown dates, Trigger Finger, Unable To Close Right Hand, Fever, No Improvement With Humira and Lost Strength In Hand resolved. Pfizer Biontech Covid-19 Vaccine (Tozinameran) was also considered suspect. The patient was unable to close right hand and had lost strength but was improved since Mar2022. she was regained strength. She had surgery on the two middle fingers for trigger finger. She experienced initially no improvement with psoriasis until Jan2022 but in May2022 was much better. she was fatigued after first Pfizer covid vaccination. After the second Pfizer covid vaccination, she experienced headaches, fatigue, aches, chills and a fever. After the Pfizer covid booster, she experienced headaches, aches and chills. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (24May2022): This is a solicited follow-up report based on the information received by Pfizer from Agency. (Manufacturer Control No: 21K-163-4206916-00). A contactable consumer (patient) reported that: Updated information included: New events added, Dosage regimen of Humira updated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events, Cataract, Fatigue, Rhinorrhea, Psoriasis, pain, Headache, Chills, Muscular weakness, Pyrexia, Drug Ineffective, Trigger finger, Joint range of motion decreased, Throat irritation cannot be completely ruled out. 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.