Age: 47.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pyrexia, Somnolence, Vaginal fistula
Clinical narrative: Crohns disease aggravated; Vaginal fistula leakage flare up; Vaginal fistula leakage flare up; Occasional fatigue after HUMIRA injection; Healing impaired; Low fever; Fatigue; Sleepiness; General body pain; This is a solicited report (a non-interventional study report from the marketing program with marketing program name not available) based on information received contactable consumer (patient) by Pfizer (MFR Control No#: 21K-163-4061513-00). A 47-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported, Sequence number: 2), dose 2 intramuscular on 18Mar2021 (at the age of 47years old) as DOSE 2, SINGLE for covid-19 immunisation (COVID-19 Vaccination); and received adalimumab (HUMIRA (Citrate Free); Solution for injection in pre-filled pen, Seq.no. 1; Batch/Lot number was not reported; dosage: unknown), subcutaneous from an unspecified date and ongoing for moderate to severe adult Crohn's Disease. Medical history included colectomy in 2011 (recovered/resolved on an unknown date; the patient had colon removed in 2011). The patient's concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Previously, on 18Feb2021 (reported also as 15Feb2021, for clarification) (at the age of 47years old), patient received 1st dose of PFIZER BIONTECH COVID-19 VACCINE (COVID-19 Vaccine manufactured by Pfizer; Batch/Lot number and expiration date was not reported) as DOSE 1, SINGLE for covid-19 immunisation. On unknown dates, the patient experienced occasional fatigue after HUMIRA injection, vaginal fistula leakage flare up, and on unknown date in 2021, had fatigue, low fever, and general body pain. Clinical course was as follow: She had occasional fatigue after injection and vaginal fistula leakage flare up. She had second injection of Pfizer brand Covid-19 vaccine on 18Mar2021 and had reaction of low fever, fatigue, and body aches and pains. No adverse event Information provided by patient related to Covid vaccine. On 02Nov2021, it was reported that patient experienced reaction of fatigue, low fever, body aches and pains and sleepiness and Crohn's disease flare up and that was not healing with Humira (Adalimumab). On unknown dates, the patient experienced occasional fatigue after Humira injection and Crohn's disease flare up and that was not healing. In march 2021, the patient experienced had Pfizer second vaccine and caused reaction of fatigue, low fever, body aches and pains and sleepiness, all duration of 24hours. She had occasional fatigue after injection. She had Crohn's disease flare up and vaginal fistula leakage which was not healing. It was unknown if patient was enrolled in a covid-19 vaccine trial. The events were assessed as non-serious by the reporter. Outcome for occasional fatigue after HUMIRA injection,Crohns disease aggravated and vaginal fistula leakage flare up was not recovered/not resolved; and for Healing impaired was unknown, events general body pain,Low fever,Fatigue,Sleepiness recovered on Mar2021. Action taken with HUMIRA was dose not changed. Causality for HUMIRA (adalimumab): The reporter's causality for the event(s) of Colon removed; occasional fatigue after injection and vaginal fistula leakage flare up with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of fatigue, low fever, and body aches/pain with HUMIRA (adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of colon removed, occasional fatigue after Humira injection and Crohn's disease flare up and that was not healing unknown onset with Humira(Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of had pfizer second vaccine and caused reaction of fatigue, low fever, body aches and pains and sleepiness onset in march 2021 with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of Crohn's disease flare up and that was not healing unknown onset was not provided. Abbvie's opinion is that there is no reasonable possibility that the events of colon removed, had Pfizer second vaccine and caused reaction of fatigue, low fever, body aches and pains and sleepiness onset in Mar2021, Crohn's disease flare up and that was not healing unknown onset and Crohn's disease flare up and that was not healing unknown onset are related to Humira(Adalimumab). RA's opinion is that there is a reasonable possibility that the event of occasional fatigue after Humira injection is related to Humira (Adalimumab). Causality for PFIZER BIONTECH COVID-19 VACCINE Causality as per reporter (Drug/Vaccine): Not reported for Colectomy, Fatigue, Crohns disease aggravated, Healing impaired. Causality as per reporter (Drug/Vaccine): Possible for events Fatigue, Sleepiness, Low grade fever. Causality as per reporter (Drug/Vaccine): Not related for generalized body pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (02Nov2021): This is a follow-up solicited report based on information received by Pfizer (Mfr. Control No. :21K-163-4061513-00) from a contactable consumer includes: event details, causality assessment. Case is upgraded to serious.  No follow up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The events Crohns disease, fatigue, low grade fever, fatigue, somnolence ,impaired healing was considered related to suspect BNT162b2 vaccine based on temporal association General body pain, fistula discharge, vaginal fistula was considered unrelated.