Sex: F
Vaccine: COVID19, UNK
Symptoms: Colitis ulcerative, Illness, SARS-CoV-2 test
Clinical narrative: Sickness; Colitis ulcerative aggravated; This is a solicited report based on the information received by Pfizer. A consumer a 39-year-old female patient reported for herself that:  Solicited report by a consumer of a 39 year old female with events of skin graft was cut open, drained and was still having heavy bleeding so was changing the bandages, wrist surgery then it was sore, trying to do things with that side was very hard and hidradenitis suppurativa flare up under both underarms and in the groin area and non-serious feels like a marble under the skin, incision infected from wrist surgery because it kept festering up and oozing, skin graft was cut open, drained and was still having heavy bleeding so was changing the bandages, fatigue, mucus and sinus drainage/made voice hoarse, incision site on very wrist end was not healing right, thought there might be a stitch left inside because it was flaring up and sore, upset stomach/belly also, sick with head cold caused by rhinovirus, sinus infection, covid-19 vaccine made sick and ulcerative colitis flare with Humira (adalimumab). there was no reported medical history. On unknown dates, the patient experienced skin graft was cut open, drained and was still having heavy bleeding so was changing the bandages, feels like a marble under the skin, incision infected from wrist surgery because it kept festering up and oozing, fatigue, upset stomach/belly also, sinus infection and covid-19 vaccine made sick. in 2010, the patient experienced hidradenitis suppurativa flare up under both underarms and in the groin area. in 2020, the patient experienced wrist surgery then it was sore, trying to do things with that side was very hard and incision site on very wrist end was not healing right, thought there might be a stitch left inside because it was flaring up and sore. in 2021, the patient experienced mucus and sinus drainage/made voice hoarse and sick with head cold caused by rhinovirus. in April 2021, the patient experienced ulcerative colitis flare. covid-19 vaccine was also considered suspect. The patient had Hidradenitis Supurartiva flare up from 2010 that she had skin graft and was over. It had the size of a ping pong ball in the groin area really close to where she had skin graft down. On 25 Dec 2020, it started to go down but she had to go to urgent care and get it cut open and drained. She was still having bleeding with it pretty heavy, so she was changing the bandages. She also had a Hidradenitis Suppurativa flare up under both of her under arms, they have not erupted, they felt like a marble under the skin and it was red and swollen. she just had wrist surgery in 2020 went well. but it was still really sore, trying to do things with that side was very hard. her incision site on the very end was not healing right and she thought there might be a stitch left inside because it was flaring up and sore. her incision was festering up and oozing. but it had settled down since she got sick and was not acting like it was infected anymore. she had an upset belly also. so she was taking some Imodium. she thought all of the issues and her flare ups she had because she had been on and off Humira in 2020 for her wrist surgery. in 2021, she was sick with head cold. she was tested for corona but it came back negative and it was actually rhinovirus. she still had really bad cough leftover from the rhinovirus. the cough was really frequent and deep in her chest. she skipped her last dose of Humira in 2021 to try to give her body a chance to fight off the virus. she experienced a lot of fatigue whenever she was off of Humira for long time and then went back on Humira. As of 24Mar2021, patient was still sick but not bad as before. it was just a lot mucus and sinus drainage that made her cough and made her voice horse. she felt a lot better and could breathe better. the hidradenitis Supprativa flare up was clearing up a lot. all her arm pits, stomach and down in her groin were finally started clearing up to forty percent less. due to the patient having surgery and then getting a sinus infection she had to go off of her Humira, but she had been back on for about a month and said her hidradenitis Supprativa flair ups were getting better and that her ulcerative colitis only flared up once this month (Apr2021). it was unknown if patient was enrolled in a covid-19 vaccine trial. in 2021, patient received 1st dose covid-19 vaccine manufactured by Pfizer. the first one really made her sick and knocked her out for a few days. On 29Apr2021, patient received 2nd dose covid-19 vaccine manufactured by Pfizer. The action taken in response to the event for adalimumab was unknown. The patient was treated with IMODIUM. The outcome of events procedural bleeding, wrist surgery, marbled skin, fatigue, hoarse voice, mucus discharge, nasal sinus discharge, delayed healing of wound, incision site pain, upset stomach, head cold and sickness was not recovered. The outcome of events hidradenitis suppurativa, incision site discharge and incision site infection was recovering, the outcome of events postoperative discharge, sinus infection and colitis ulcerative aggravated was unknown.  Causality for HUMIRA(ADALIMUMAB): the reporter's causality for the event(s) of skin graft was cut open, drained and was still having heavy bleeding so was changing the bandages unknown onset, feels like a marble under the skin, skin graft was cut open, drained and was still having heavy bleeding so was changing the bandages unknown onset, sinus infection and ulcerative colitis flare was not provided. The reporter's causality for the event(s) of wrist surgery then it was sore, trying to do things with that side was very hard, hidradenitis suppurativa flare up under both underarms and in the groin area, incision infected from wrist surgery because it kept festering up and oozing unknown onset, fatigue, mucus and sinus drainage/made voice hoarse onset in 2021, mucus and sinus drainage/made voice hoarse onset in 2021, mucus and sinus drainage/made voice hoarse onset in 2021, incision site on very wrist end was not healing right, thought there might be a stitch left inside because it was flaring up and sore onset in 2020, incision site on very wrist end was not healing right, thought there might be a stitch left Inside because it was flaring up and sore onset in 2020, upset stomach/belly also, sick with head cold caused by rhinovirus, incision infected from wrist surgery because it kept festering up and oozing unknown onset and covid-19 vaccine made sick with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's assessment of the causal relationship of the events 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 on the company causality assessment.  there is no reasonable possibility that the events of skin graft was cut open, drained and was still having heavy bleeding so was changing the bandages unknown onset, wrist surgery then it was sore, trying to do things with that side was very hard, hidradenitis suppurativa flare up under both underarms and in the groin area, feels like a marble under the skin, skin graft was cut open, drained and was still having heavy bleeding so was changing the bandages unknown onset, fatigue, upset stomach/belly also, covid-19 vaccine made sick and ulcerative colitis flare are related to Humira(Adalimumab). there is a reasonable possibility that the events of incision infected from wrist surgery because it kept festering up and oozing unknown onset, mucus and sinus drainage/made voice hoarse onset in 2021, mucus and sinus drainage/made voice hoarse onset in 2021, mucus and sinus drainage/made voice hoarse onset in 2021, incision site on very wrist end was not healing right, thought there might be a stitch left inside because it was flaring up and sore onset in 2020, incision site on very wrist end was not healing right, thought there might be a stitch left inside because it was flaring up and sore onset in 2020, sick with head cold caused by rhinovirus, incision infected from wrist surgery because it kept festering up and oozing unknown onset and sinus infection are related to HUMIRA(ADALIMUMAB).  Information about lot/batch number cannot be obtained. No further information expected.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Ulcerative colitis. The case will be reassessed once new information is 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