Age: 54.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pain, Pyrexia
Clinical narrative: cramping increased; shingles; General body pain; Headache; Fever; chills; ulcerative colitis flare; 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): 21K-163-3982406-00 (Agency).  A 54 year-old male patient received bnt162b2 (BNT162B2, Solution for injection), intramuscular, administration date Apr2021 (Batch/Lot number: unknown) at the age of 54 years as dose 2, single and intramuscular, administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), first regimen subcutaneous (Batch/Lot number: unknown) at unk (citrate free) and second regimen subcutaneous since 2020 (Batch/Lot number: unknown) at weekly (unk, weekly (citrate free)) 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 2021, outcome "unknown", described as "ulcerative colitis flare"; MUSCLE SPASMS (non-serious) with onset 21Jun2021, outcome "unknown", described as "cramping increased"; HERPES ZOSTER (non-serious) with onset 2021, outcome "unknown", described as "shingles"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "General body pain"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills". The action taken for adalimumab was unknown.  The reporter considered "general body pain", "headache", "fever" and "chills" related to bnt162b2.  Clinical source: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On Feb2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. On Apr2021 patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer. Causality for BNT162B2: The reporter's causality for the event(s) of cramping increased, ulcerative colitis flare, shingles was Not Reported; for the events of general body pain, headache, fever and chills was Possible. Causality for Humira (Adalimumab): The reporter's causality for the event(s) of cramping increased, ulcerative colitis flare, shingles, body pain, headache, fever and chills was Not Reported.   The reporter's assessment of the causal relationship of the events (cramping increased, ulcerative colitis flare, shingles) with the suspect product 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.  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, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.  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.