Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Incorrect dose administered, Rhinorrhoea
Clinical narrative: 4th DOSE: 10Feb2022; Rhinorrhoea; Fatigue; Cough; 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): 22K-163-4277236-00.  A 57 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 10Feb2022 (Batch/Lot number: unknown) at the age of 57 years as dose 4, single for covid-19 immunisation; etanercept (ENBREL) (Batch/Lot number: unknown); adalimumab (HUMIRA), subcutaneous from 2021 (Batch/Lot number: unknown) to 29Oct2021 at citrate free for psoriatic arthropathy. Relevant medical history included: "OCULAR MIGRAINES" (unspecified if ongoing), notes: ocular migraines. Concomitant medication(s) included: CELEBREX taken for product used for unknown indication; NABUMETONE taken for product used for unknown indication; PREMARIN taken for product used for unknown indication. Vaccination history included: Bnt162b2 (Dose:3, Route of Admin: Intra-muscular), administration date: 10Sep2021, when the patient was 56 years old, for Covid-19 Vaccination, reaction(s): "Off label use"; Bnt162b2 (Dose:2, Route of Admin: Intra-muscular), administration date: 14May2021, when the patient was 56 years old, for Covid-19 Vaccination; Bnt162b2 (Dose:1, Route of Admin: Intra-muscular), administration date: 23Apr2021, when the patient was 56 years old, for Covid-19 Vaccination, reaction(s): "Hormone replacement therapy", "Ear disorder", "Ophthalmic migraine", "Unwell", "Bruising", "Joint pain", "Pain in extremity", "Drug effect decreased". The following information was reported: RHINORRHOEA (medically significant) with onset Feb2022, outcome "recovering", described as "Rhinorrhoea"; FATIGUE (medically significant) with onset Feb2022, outcome "recovering", described as "Fatigue"; COUGH (medically significant) with onset Feb2022, outcome "recovering", described as "Cough"; INCORRECT DOSE ADMINISTERED (non-serious) with onset 10Feb2022, outcome "unknown", described as "4th DOSE: 10Feb2022". The action taken for adalimumab was dosage permanently withdrawn on 29Oct2021.  Causality for Humira (ADALIMUMAB) The reporter's causality for the event(s) of hormone replacement and ocular migraines with Humira (ADA-LIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of ears were crusty, body was not well, sniffly/running nose, still fatigue, cough, hands/arms and joint pain became awful onset in 2021, hands/arms and joint pain became awful onset in 2021 and Humira did not last longer was not provided. The re-porter's causality for the event(s) of bruising with Enbrel with Humira (ADALIMUMAB) was a reasonable possibility.   Agency's opinion is that there is no reasonable possibility that the events of hormone replacement, ears were crusty, ocular migraines, sniffly/running nose, still fatigue, bruising with Enbrel, cough, hands/arms and joint pain became awful onset in 2021, hands/arms and joint pain became awful onset in 2021 and Humira did not last longer are related to Humira (ADALIMUMAB). Agency's opinion is that the event of body was not well is not assessable.  The reporter's assessment of the causal relationship of the events with the suspect product (BNT162B2) was not reported at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Clinical course:Solicited report by a consumer of a 57-year-old female with events of hormone replacement and non-serious ears were crusty, ocular migraines, body was not well, sniffly/running nose, still fatigue, bruising with Enbrel, cough, hands/arms and joint pain became awful and Humira did not last longer with Humira (ADA-LIMUMAB). The patient had a relevant medical history of ocular migraines.  On unknown dates, the patient experienced hormone replacement and ocular migraines. In 2021, the patient experienced ears were crusty, body was not well, bruising with Enbrel, hands/arms and joint pain became awful and Humira did not last longer. In Feb2022, the patient experienced sniffly/running nose, still fatigue and cough. Enbrel (ETANERCEPT) and PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) were also considered suspect. Patient experienced some ocular migraines before starting Humira and after but did not last more than 20 to 30 minutes and felt fine. She was on hormone replacement and Premarin was started in 2017. Her skin was clear in one month or less when began Humira and scalp was almost complete clear, ears were crusty and hands, arms and joint pain became awful. Body was not well after six months on Humira. She was on Celebrex and Nabumetone. Her Humira was discontinued on 29Oct2021 and switched to Enbrel after two weeks. Her Humira device was pain-less.She had bruising with Enbrel since stopping Humira and was very pleased with Citrate Free Humira pen device but it did not last longer. First two doses of Covid vaccine were started before Humira and fourth vaccine on 10Feb2022, which caused cough and sniffly, running nose and fatigue. 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.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events rhinorrhoea,  fatigue, cough, incorrect dose administered, and the suspect drugs BNT162B2 and Enbrel.  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.