Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Condition aggravated, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Disease aggravation; COVID-19; COVID-19; This is a solicited report from the marketing program per Regulatory Authority based on information received by Pfizer from the Regulatory Authority. (MFR Control No. # 21K-163-4089689-00).   A contactable consumer (patient) reported that a 47-year-old female received bnt162b2 (BNT162B2 also reported as COVID-19 Vaccine manufactured by Pfizer/BioNTech, lot unknown), intramuscular on 12Feb2021 as dose 2, single; bnt162b2 (BNT162B2 also reported as COVID-19 Vaccine manufactured by Pfizer/BioNTech, lot unknown), intramuscular on 21Jan2021 as dose 1, single for Covid-19 immunisation (age at vaccination: 46-year-old); adalimumab (HUMIRA, lot unknown), subcutaneous from an unspecified date to Aug2021, at unspecified dose for an unspecified indication. Medical history included Penicillin allergy, contrast dye allergy, had Covid-19 on 02Feb2020 was in the hospital for about a month, had influenza on 2020. The patient's concomitant medications were not reported. The patient previously took Remicade and gabapentin and had reaction of drug allergy; Humira for unspecified date to Aug2018 and had an unknown disease flare up. The patient experienced Covid-19 on 29Jul2021 and disease aggravation on an unspecified date. The patient underwent laboratory test which included Sars-cov-2 test: positive on 29Jul2021. The action taken in response to the events for adalimumab was not applicable. The outcome of events was unknown.   Causality for Humira (ADALIMUMAB): The reporter's causality for the event(s) of Covid-19 onset 02Feb2020, Flu, Unknown disease flare up and Covid 19 onset 29Jul2021 was not provided. (withheld) opinion is that there is no reasonable possibility that the events of COVID-19 onset 02Feb2020, Flu, Unknown disease flare up and Covid 19 onset 29Jul2021 are related to Humira (ADALIMUMAB).  Causality (Humira and events):  1)  Covid-19 (Covid-19): Causality as per reporter (Drug/Vaccine) : Not Reported , Causality as per Mfr.(Drug/Vaccine):No reasonable possibility 2)  Flu: Causality as per reporter (Drug/Vaccine): Not Reported, Causality as per Mfr.(Drug/Vaccine): No reasonable possibility   3)  Disease aggravation: Causality as per reporter (Drug/Vaccine): Not Reported, Causality as per Mfr.(Drug/Vaccine): No reasonable possibility   4)  Covid-19: Causality as per reporter (Drug/Vaccine): Not Reported, Causality as per Mfr.(Drug/Vaccine): No reasonable possibility    Causality (PfizerBioNtech covid-19 vaccine and events):  1)  Covid-19 (Covid-19): Causality as per reporter (Drug/Vaccine) : Not Reported   2)  Flu: Causality as per reporter (Drug/Vaccine): Not Reported   3)  Disease aggravation: Causality as per reporter (Drug/Vaccine): Not Reported   4)  Covid-19: Causality as per reporter (Drug/Vaccine): Possible  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events vaccination failure, COVID-19, condition aggravated and suspect drug BNT162B2 cannot be excluded.