Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Nasopharyngitis
Clinical narrative: hungry all the time; ate a salad and had an episode of diarrhea; steroids made unable to sleep; headache; head cold; full blown ulcerative colitis flare; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-4178974-00.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 02Jul2021 as dose 1, single (Batch/Lot number: unknown) and on 05Aug2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COLITIS ULCERATIVE (medically significant) with onset 13Aug2021, outcome "unknown", described as "full blown ulcerative colitis flare"; HUNGER (non-serious), outcome "unknown", described as "hungry all the time"; ADVERSE FOOD REACTION (non-serious), outcome "unknown", described as "ate a salad and had an episode of diarrhea"; INSOMNIA (non-serious), outcome "unknown", described as "steroids made unable to sleep"; HEADACHE (non-serious), outcome "unknown"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "head cold". The patient underwent the following laboratory tests and procedures: Blood test: (2021) colitis was 7300; (Jun2021) Colitis was 41; (Aug2021) Colitis was 4500. The action taken for adalimumab was dosage not changed.  The reporter considered "full blown ulcerative colitis flare" not related to BNT162b2. The reporter's assessment of the causal relationship of "hungry all the time", "ate a salad and had an episode of diarrhea", "steroids made unable to sleep", "headache" and "head cold" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Causality for Humira(Adalimumab): The reporter's causality for the event(s) of hungry all the time, steroids made unable to sleep, headache and head cold with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of ate a salad and had an episode of diarrhea and full blown ulcerative colitis flare was not provided.   Causality for Pfizer BioNteh Covid-19 Vaccine (Tozinameran): Causality as per reporter for events Hunger, Adverse food reaction, Sleeplessness, Headache, Head cold is Not Reported and for event full blown ulcerative colitis flare was Not Related.  Clinical course: Patient was hungry all the time, ate a salad and had an episode of diarrhea,  steroids made unable to sleep, full blown ulcerative colitis flare, headache and  head cold with Humira (Adalimumab). There was no reported medical history.  On unknown dates, the patient experienced hungry all the time, ate a salad and  had an episode of diarrhea, steroids made unable to sleep, headache and head cold. On 13Aug2021, the patient experienced full blown ulcerative colitis flare. Pfizer BioNtech covid-19 vaccine(Tozinameran) was also considered suspect. Upon Change History On 07Jul2022, received updates to patient demographics, event information, reporter opinion of causality, Suspect drug information and narrative description. The event of "full blown colitis" was amended to "full blown colitis flare". On 08Sep2022, received updates to event information, reporter opinion of causality, suspect drug information, concomitant drug information and narrative description. The event of "ate a salad and had an episode of diarrhea" was added. The event of "full blown colitis flare" was amended to "full blown ulcerative colitis flare". It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. Concomitant Drugs is Not Reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the eventS", "hunger ", "adverse food reaction", "insomnia ", "headache and the suspect drug BNT162B2 cannot be excluded, and the event ulcerative colitis aggravated unrelated to suspect drug BNT162B2.