Age: 70.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Vaccination failure; In November 2021, the patient experienced COVID; FACILITATED COLLECT 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-163-4240000-00 (Agency).  A 70 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Sep2021 (Batch/Lot number: unknown) at the age of 70 years as dose 3 (booster), single, intramuscular, administration date 20Mar2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 20Feb2021 (Batch/Lot number: unknown) as dose 1, 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. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Nov2021, outcome "recovered", described as "Vaccination failure"; SUSPECTED COVID-19 (medically significant) with onset Nov2021, outcome "recovered", described as "In November 2021, the patient experienced COVID". The action taken for adalimumab was unknown. Solicited report from the USA by a consumer of a 70 year old female with events of non-serious RASH AT INJECTION SITE and COVID with HUMIRA (ADALIMUMAB). There was no reported medical history. On an unspecified date, the patient experienced rash at injection site and COVID-19. In Nov2021, the patient experienced COVID-19. On an unspecified date, COVID-19 resolved. PFIZER BIONTECH COVID-19 mRNA VACCINE (TOZINAMERAN) was also considered suspect.It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 20Feb2021, patient received first dose of COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 20Mar2021, patient received second dose of COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 20Sep2021, patient received third dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. Causality for HUMIRA (ADALIMUMAB): The reporter causality for the events of rash at injection site with HUMIRA (ADALIMUMAB) was a reasonable possibility. The reporter causality for the events of COVID-19 onset in Nov2021 with HUMIRA (ADALIMUMAB) was no reasonable possibility. The reporter causality for the events of COVID-19 unknown onset was not provided. SUSPECT DRUGS (include generic name) included HUMIRA (ADALIMUMAB) and PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) (TOZINAMERAN, UNKNOWN, UNKNOWN, UNKNOWN). Route of administration was reported as intramuscular. Indications for use for Humira as moderate to severe chronic plaque psoriasis COVID-19 vaccination. Therapy date for COVID-19 was 20Feb2021. Did event abate after stopping drug was reported as NA. Concomitant drugs and dates of administration was (Exclude those used to treat event) as the concomitant drugs were not reported. HUMIRA (ADALIMUMAB): Causality assessment for the event Injection site rash. Action taken with drug as unknown. Causality as per reporter (Drug/Vaccine) was reasonable possibility. Dechallenge was NA. Causality assessment for the event COVID-19 included action taken with drug was Unknown. Causality as per reporter (Drug/Vaccine) was no reasonable possibility. Dechallenge was NA. Causality assessment for the event COVID-19 included action taken with drug was Unknown. Causality as per reporter (Drug/Vaccine) was not reported. Dechallenge was NA. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) (TOZINAMERAN, UNKNOWN, UNKNOWN, UNKNOWN): Route of Admininistration was Intramuscular for all three doses of vaccination. The therapy dates were 20Feb2021, 20Mar2021 and 20Sep2021. Causality assessment for the event injection site rash included action taken with drug as Unknown. Causality as per reporter (Drug/Vaccine) was possible. Dechallenge was NA. Causality assessment for the event Covid-19 included action taken with drug was not applicable. Causality as per reporter (Drug/Vaccine) was Possibile. Dechallenge was NA. Causality assessment for the event Covid-19 included causality as per reporter (Drug/Vaccine) was Possible and dechallenge was NA. The reporter considered "vaccination failure" and "in november 2021, the patient experienced covid" related to BNT162b2. The outcome for Injection site rash was recovering, for COVID-19 was resolved.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded.