Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: vaccination site pain; Gland in neck; Neck mass; Ileitis; Gastrointestinal inflammation; Anxiety aggravated; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  A 17 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date May2021 (Batch/Lot number: unknown) as dose 1, single and intramuscular, administration date Jun2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) for colitis ulcerative, crohn's disease, juvenile idiopathic arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (hospitalization) with onset Jun2021, outcome "unknown", described as "vaccination site pain"; LYMPHADENOPATHY (non-serious) with onset Jun2021, outcome "unknown", described as "Gland in neck"; NECK MASS (non-serious) with onset Jun2021, outcome "unknown", described as "Neck mass"; ENTERITIS (non-serious) with onset Jun2021, outcome "unknown", described as "Ileitis"; GASTROINTESTINAL INFLAMMATION (non-serious) with onset Jun2021, outcome "unknown", described as "Gastrointestinal inflammation"; ANXIETY (non-serious) with onset Jun2021, outcome "unknown", described as "Anxiety aggravated". The patient was hospitalized for vaccination site pain (start date: 25Jun2021). The action taken for adalimumab was unknown.  Clinical information: Solicited report by a consumer of a 17 year old female with an event of  Pain from covid vaccine and non-serious lymph nodes that was swelling at back of neck/four lumps on side of neck , four lumps on side of neck, ileus and inflammation in gastrointestinal tract that spread and increased anxiety with humira (adalimumab). There was no reported medical history. On an unknown date, the patient experienced lymph nodes that was swelling at back. Of four lumps on side of neck, ileus and inflammation in gastrointestinal tract that spread and increased anxiety in Jun2021 the patient experienced pain from covid vaccine pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. On 25Jun2021 the patient was hospitalized for pain from covid vaccine. She had ileus and inflammation in the gastrointestinal tract that spread and she had four lumpe on the side her neck which she was concerned about she had lymph node that was swelling at the back of her neck and there was more than the original one physician keep telling her it was due to nit having autoimmune disorder and her conditions causing her body to fight her disorders. Her mom said increase anxiety and though she had lymphoma from taking humira that was not diagnosed. It was unknown if patient was enrolled in a covid-19 vaccine trial. On May2021, patient received 1st dose covid-19 vaccine manufactured by Pfizer/biontech, on Jun2021 , patient received 2nd dose covid-19 vaccine manufactured by Pfizer/ biontech.  The reporter's causality for the events of Pain from covid vaccine, four lumps on side of neck, ileus and inflammation in gastrointestinal tract that spread unknown onset and ileus and inflammation in gastrointestinal tract that spread unknown onset was not provide. The reporter causality for event of lymph nodes that was swelling at back of neck, four lumps on side of neck increased anxiety with humira (adalimumab) was not reasonable possibility. Causality as per reporter for the events gland in neck, neck mass, ileitis, gastrointestinal inflammation, anxiety aggravated with bnt162b2 was not reported, for event vaccination site pain was possible.  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 and a possible contributory role of suspect product BNT162B2 to the development of events vaccination site pian, lymphadenopathy, neck mass, enteritis, gastrointestinal inflammation, anxiety cannot be totally excluded. 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 RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : 21K-163-4177934-00