Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Irritability
Clinical narrative: Pfizer vaccine caused fatigue and irritability/Onset date for fatigue and irritability: 2021; Pfizer vaccine caused fatigue and irritability/Onset date for fatigue and irritability: 2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): ABBVIE-22K-163-4506816-00.  An 86-year-old female patient received BNT162b2 (BNT162B2), on 15Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 85 years for covid-19 immunisation; adalimumab (HUMIRA), first regimen since 10Apr2021 (Lot number: 1164825) at 40 mg (40 mg (citrate free, every 2 weeks)), second regimen since Feb2022 (Lot number: 1164825) at 40 mg (40 mg (citrate free, every 2 weeks)), third regimen (Lot number: 1164825) at 160 mg 1x/day (160 mg, 1x/day (citrate free)) and fourth regimen (Lot number: 1164825) at 80 mg 1x/day (80 mg, 1x/day (citrate free)), all subcutaneous for crohn's disease. The patient's relevant medical history included: "Non-tobacco user" (unspecified if ongoing), notes: Other Relevant History (e.g.diagnostics, allergies,pregnancy with last month of period, etc; "No alcohol use [Abstains from alcohol]" (unspecified if ongoing); "Crohns Disease" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE: 2, Route(s) of Administration: Intramuscular), administration date: 04Mar2021, when the patient was 85-year-old, for COVID-19 immunization; BNT162b2 (DOSE: 1, Route(s) of Administration: Intramuscular), administration date: 10Feb2021, when the patient was 85-year-old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), IRRITABILITY (non-serious) all with onset 2021, outcome "unknown" and all described as "Pfizer vaccine caused fatigue and irritability/Onset date for fatigue and irritability: 2021". The action taken for adalimumab was unknown.  Additional information: Pfizer vaccine caused fatigue and irritability. Primary reporter contact for lot number information was unsuccessful. Primary reporter did not have the lot number information, because the packaging was discarded. The patient's daughter denied any additional medical history and did not have any known allergies.   The reporter's causality for the event(s) of Pfizer vaccine caused fatigue and irritability with Adalimumab Solution for Injection was No Reasonable Possibility. The reporter's causality for the event(s) of Pfizer vaccine caused fatigue and irritability with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility. The reporter's causality for the event(s) of Pfizer vaccine caused fatigue and irritability with Adalimumab Solution for Injection was Not Provided. AbbVie's opinion was that the causality for the event(s) of Pfizer vaccine caused fatigue and irritability with Adalimumab Solution for Injection was Not Provided. AbbVie's opinion was that the causality for the event(s) of Pfizer vaccine caused fatigue and irritability with Adalimumab Solution for Injection was Not Provided. AbbVie's opinion was that the causality for the event(s) Pfizer vaccine caused fatigue and irritability with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided.  Assessment Results: Pfizer BioNTech COVID-19 vaccine Fatigue, Non-Health Care Professional, Global Introspection, Probable. Pfizer BioNTech COVID-19 vaccine Fatigue, Market Authorization Holder (MAH). HUMIRA 80MG/0.8ML Fatigue, Non-Health Care Professional, Global Introspection, Not Reported. HUMIRA 80MG/0.8ML Fatigue, Market Authorization Holder (MAH). Pfizer BioNTech COVID-19 vaccine Irritability, Non-Health Care Professional, Global Introspection, Probable. Pfizer BioNTech COVID-19 vaccine Irritability, Market Authorization Holder (MAH). HUMIRA 80MG/0.8ML Vaccination adverse reaction, Market Authorization Holder (MAH). HUMIRA 80MG/0.8ML Vaccination adverse reaction, Non-Health Care Professional, Global Introspection, Not Reported. HUMIRA 80MG/0.8ML Irritability, Non-Health Care Professional, Global Introspection, Not Reported. HUMIRA 80MG/0.8ML Irritability, Market Authorization Holder (MAH). HUMIRA 40MG/0.4ML Fatigue, Non-Health Care Professional, Global Introspection, Not Related. HUMIRA 40MG/0.4ML Fatigue, Market Authorization Holder (MAH). HUMIRA 40MG/0.4ML Irritability, Non-Health Care Professional, Global Introspection, Not Related. HUMIRA 40MG/0.4ML  Irritability, Market Authorization Holder (MAH)  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.