Sex: F
Vaccine: COVID19
Symptoms: Colitis ulcerative, Diabetes mellitus, Fatigue
Clinical narrative: Fatigue; Colitis ulcerative aggravated; Diabetes mellitus; This is a solicited report from the marketing program facilitated collect from a contactable consumer (patient) based on information received by Pfizer from Regulatory Authority (Mfr. Control No.: 20K-163-3250113-00).   A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at citrate free for moderate to severe ulcerative colitis.  The patient medical history and concomitant medications were not reported.  The patient experienced colitis ulcerative aggravated (medically significant); fatigue (medically significant); diabetes mellitus (medically significant) in Feb2021. Serious criteria: Other Medically Important Condition. Clinical course: Solicited report from the RA by a consumer of a female with events of flare up of ulcerative colitis symptoms which appear few days prior to injections and non-serious (as reported) fatigue after Covid Vaccination, Postherpetic Neuralgic Pain From Bout Of Shingles/Contracted Shingles Because Immune system was low due to HUMIRA, diabetic, neuropathy and flare up of ulcerative colitis symptoms which appear few days prior to injections with HUMIRA (ADALIMUMAB). There was no reported medical history. On unknown dates, the patient experienced flare up of ulcerative colitis symptoms which appear few days prior to injections, fatigue after covid vaccination and postherpetic neuralgic pain from bout of shingles/contracted shingles because immune system was low due to humira. in 2018, the patient experienced neuropathy and postherpetic neuralgic pain from bout of shingles/contracted shingles because immune system was low due to HUMIRA. In Feb2021, the patient experienced DIABETIC. On an unknown date, fatigue after COVID VACCINATION resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. In 2018, the patient had post neuralgic hepatic pain from bout of shingles and it still continued. She believed she contracted shingles because her immune system was low due to Humira. She used two boxes of Lidocaine patches in every month to kept the pain under control. She was also on high dose of steroids, the pain was subsided but returned after stopping medication. She had flare up of ulcerative colitis symptoms such as bleeding appear a few days prior to Humira injections. In Feb2021, she was diagnosed as diabetes. She was experiencing fatigue after taking the Pfizer covid vaccination. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient received COVID-19 Vaccine manufactured by Pfizer. The patient was treated with LIDOCAINE. Causality for HUMIRA (ADALIMUMAB) The reporter's causality for the event(s) of flare up of ulcerative colitis symptoms which appear few days prior to injections unknown onset, postherpetic neuralgic pain from bout of shingles/contracted shingles because immune system was low due to HUMIRA unknown onset, diabetic and postherpetic neuralgic pain from bout of shingles/contracted shingles because immune system was low due to HUMIRA onset in 2018 with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of FATIGUE AFTER COVID VACCINATION and NEUROPATHY with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of postherpetic neuralgic pain from bout of shingles/contracted shingles because immune system was low due to HUMIRA onset in 2018 and flare up of ulcerative colitis symptoms which appear few days prior to injections unknown onset was not provided. Regulatory Authority opinion is that there is no reasonable possibility that the events of flare up of ulcerative colitis symptoms which appear few days prior to injections unknown onset, fatigue after covid vaccination, diabetic, neuropathy, postherpetic neuralgic pain from bout of shingles/contracted shingles because immune system was low due to HUMIRA onset in 2018 and flare up of ulcerative colitis symptoms which appear few days prior to injections unknown onset are related to HUMIRA(ADALIMUMAB). Regulatory Authority opinion is that the events of postherpetic neuralgic pain from bout of shingles/contracted shingles because immune system was low due to Humira unknown onset and postherpetic neuralgic pain from bout of shingles/contracted shingles because immune system was low due to HUMIRA onset in 2018 are not assessable. The action taken in response to the events for adalimumab was unknown. The outcome of colitis ulcerative aggravated and diabetic was not recovered, fatigue was recovered on unknown date. The reporter assessed causality between fatigue and bnt162b2 was probable.  The reporter's assessment of the causal relationship of the events (except fatigue) with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based the company causality assessment.  No follow up attempts are possible. Information on Lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events Fa-tigue, Colitis ulcerative  and suspect drug BNT162B2 cannot be excluded.The reported event Diabetes mellitus  the causal role of vaccine is unlikely due elderly age case will be reassess once additional information becomes available specially medical history. 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.