Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Eye operation; Respiratory tract congestion; Psoriasis flare-up; Vaccination adverse reaction; SORENESS IN ARM WITH COVID BOOSTER with HUMIRA; 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-163-4256978-00 (AbbVie).  A 66-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Sep2021 (Batch/Lot number: unknown) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Route of Admin : Intramuscular, had first covid vaccine was tender at the injection site), administration date: 20Feb2021, when the patient was 66 years old, for COVID-19 immunization, reaction(s): "Vaccination site tenderness"; Bnt162b2 (Dose 2, Route of Admin : Intramuscular, soreness in arm with second covid vaccine), administration date: 20Mar2021, when the patient was 66 years old, for COVID-19 immunization, reaction(s): "Vaccination site pain". The following information was reported: VACCINATION SITE PAIN (medically significant) with onset 20Mar2021, outcome "recovered" (22Mar2021), described as "SORENESS IN ARM WITH COVID BOOSTER with HUMIRA"; VACCINATION COMPLICATION (medically significant) with onset 01Sep2021, outcome "recovered" (03Sep2021), described as "Vaccination adverse reaction"; EYE OPERATION (medically significant), outcome "recovering", described as "Eye operation"; RESPIRATORY TRACT CONGESTION (medically significant), outcome "recovering", described as "Respiratory tract congestion"; PSORIASIS (medically significant), outcome "recovering", described as "Psoriasis flare-up". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The action taken for adalimumab was temporarily withdrawn. Therapeutic measures were taken as a result of eye operation. REACTION ONSET: 15Feb2021. DESCRIBE REACTION(S) (include relevant test/lab data). COVID-19 virus test positive (SARS-CoV-2 test positive) - Recovering/resolving. Vaccination site tenderness (Vaccination site pain) - Recovered/resolved. Vaccination site pain (Vaccination site pain) - Recovered/resolved. Respiratory tract congestion (Respiratory tract congestion) - Recovering/resolving. Seq. No.1. Reaction: COVID-19 virus test positive (SARS-CoV-2 test positive). Seq. No: 2. Reaction: Vaccination site tenderness (Vaccination site pain). Start Date: 15Feb2021. Stop Date: 17Feb2021. Duration: 2 D. Seq. No: 3 Reaction: Vaccination site pain (Vaccination site pain) Start Date: 15Mar2021. Stop Date: 17Mar2021. Duration: 2 D. Seq. No: 4. Reaction: Respiratory tract congestion (Respiratory tract congestion). had first covid vaccine was tender at the injection site and soreness in arm with Covid booster with Humira (Adalimumab). There was no reported medical history. On an unknown date, the patient experienced Covid test it came back positive/congestion. On 15Feb2021, the patient experienced had first covid vaccine was tender at the injection site. On 17Feb2021, the had first covid vaccine was tender at the injection site resolved. On 15Mar2021, the patient experienced soreness in arm with covid booster. On 17Mar2021, the soreness in arm with Covid Booster resolved. Pfizer Biontech Covid-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Relevant Laboratory & Other Diagnostic Tests: Unknown date COVID-19 TEST: Positive. Suspect Drugs. Product-Reaction level. Seq.No: 1. Drug: HUMIRA (Solution for injection in pre-filled pen) (ADALIMUMAB). Route of Admin: 1) Subcutaneous. Therapy Dates/Duration: UNK. Indications for use: moderate to severe chronic plaque psoriasis Seq.No: 2 Drug: PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN)(TOZINAMERAN), UNKNOWN, UNKNOWN, UNKNOWN. Daily Dose: 1) First dose. (1 in 1 Once). 2)Second dose. (1 in 1 Once). 3)Booster dose. (1 in 1 Once). Route of Admin: 1) Intramuscular 2) Intramuscular 3) Intramuscular. Therapy Dates/Duration: 1) 15Feb2021 - 15Feb2021 2) 15Mar2021 - 15Mar2021 3) 01Sep2021 - 01Sep2021. Indications for use: COVID-19 VACCINATION. Concomitant drugs and dates of administration (Exclude those used to treat event). Concomitant Drugs Not Reported. Other relevant history: Not reported. Additional information: Lab Result: Test name: COVID-19 TEST. Test date: Unk, On unknown dates, the patient experienced eye surgery, covid test it came back positive/congestion and plaque psoriasis flare up. On 20Feb2021, On 22Feb2021, the had first covid vaccine was tender at the injection site resolved. On 20Mar2021, the patient experienced soreness in arm with second covid vaccine. On 22Mar2021, the soreness in arm with second covid vaccine resolved. On 01Sep2021, the patient experienced booster covid vaccine caused adverse events. On 03Sep2021, the booster covid vaccine caused adverse events resolved. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was also considered suspect. She had eye surgery and had to be off Humira for a couple of weeks so been having a Plaque Psoriasis flare up but since starting back Humira she was feeling better. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial.  The reporter's causality of Humira (Adalimumab) for the event(s) of eye surgery, had first covid vaccine was tender at the injection site, soreness in arm with second covid vaccine, booster covid vaccine caused adverse events, covid test it came back positive/congestion unknown onset while for plaque psoriasis flare up was not provided.  Company's causality (AbbVie's opinion) for events of eye surgery, covid test it came back positive/congestion unknown onset, had first covid vaccine was tender at the injection site, soreness in arm with second covid vaccine, booster covid vaccine caused adverse events, and plaque psoriasis flare up are unrelated related to Humira (Adalimumab).  Reporter's and company causality for events eye surgery, covid test it came back positive/congestion unknown onset, had first covid vaccine was tender at the injection site, soreness in arm with second covid vaccine, booster covid vaccine caused adverse events, and plaque psoriasis flare to up to Pfizer-BioNTech Covid-19 Vaccine are not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (04Mar2022): New information reported based on information received by Pfizer from AbbVie (Manufacturer Control Number#: 22K-163-4256978-00). A 66-year-old female contactable consumer (patient) included: Updated Information included: Historical vaccine date. Formulation. Action Taken. Include in VAERS Block. New event "Vaccination adverse reaction, Eye operation, Respiratory tract congestion and Psoriasis flare-up" was added. Causality for Humira (Adalimumab) was added.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information 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.