Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Immunodeficiency, Intra-abdominal haemorrhage
Clinical narrative: abdominal bleeding; Abdominal pain; Immune system depleted; Duodenal ulcer; arm soreness; Headache; Fatigue after COVID-19 vaccine; non-serious covid symptoms after each vaccination; Fever; mild cough; loss of taste; loss of smell; Shortness of breath; Fatigue; Recurring headache; This is a solicited report from a Non-Interventional Study based on information received by Pfizer, manufacturer control number: 21K-163-4116653-00.  Solicited report by a consumer of a 47-year-old female with events of abdominal bleeding, duodenal ulcer and abdominal pain and non-serious covid symptoms after each vaccination, positive for covid-19, immune system depleted, fatigue after covid-19 vaccine, arm soreness, headache from covid-19 vaccine, recurring headache, fever, fatigue, mild cough, loss of taste, loss of smell and shortness of breath with SKYRIZI (RISANKIZUMAB). On an unknown date, the patient experienced immune system depleted. In 2020, the patient experienced recurring headache. In Dec2020, the patient experienced positive for covid-19, fever, fatigue, mild cough, loss of taste, loss of smell and shortness of breath. In Dec2020, the positive for covid-19, fever, fatigue, mild cough, loss of taste, loss of smell and shortness of breath resolved. In 2021, the patient experienced covid symptoms after each vaccination. In Mar2021, the patient experienced fatigue after covid-19 vaccine, arm soreness and headache from covid-19 vaccine. in Mar2021, the fatigue after covid-19 vaccine, arm soreness and headache from covid-19 vaccine resolved. In oct2021, the patient experienced abdominal bleeding, duodenal ulcer and abdominal pain. Outcome of the event suspected COVID-19 was unknown, for immune system depleted and recurring headache was not recovered, for events abdominal bleeding, duodenal ulcer, and abdominal pain was recovering. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The patient's first and second dose of Skyrizi were four weeks apart before proceeding to her maintenance dose. Whenever she had her Skyrizi shot, she usually experienced headache that lasted for seven to ten days but there was no treatment nor hospitalization, dermatologist was aware of the headache. When she was tested positive for Covid-19 in early Dec2020, she was not admitted and had a home quarantine for a month. She had Covid-19 in Dec2020. There was no treatment, no medication and was only managed with liquid diet and rest. Fever lasted for 10 days, she gained back her taste and smell after the month-long quarantine, shortness of breath lasted for 10 days, mild cough resolved before the quarantine ended, fatigue lasted for a month. There were no complications from Covid-19 and not on any current product for Covid-19. Follow up nasal swab test was done at the end of Dec2020 which confirmed that she was already negative for Covid-19. Patient stated that after she had her first dose of Covid-19 vaccine, she experienced fatigue and arm soreness for three days and headache for a day. No treatment and no consultation were done. Patient went to the emergency room on 02Oct2021 or 03Oct2021 due to abdominal bleeding and pain and was admitted for three days. She was diagnosed with Duodenal ulcer, she was treated with Protonix IV to stop the bleeding. She had tests done but did not have any information about what the tests were and the results. The alternative etiology for positive for covid 19 was immune system depleted and for fever, fatigue, mild cough, loss of taste, loss of smell and shortness of breath was covid-19. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 19Mar2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech, lot number EL9265. On 09Apr2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech, lot number EM9810. Primary reporter did not have the lot number information, because the packaging was discarded. The patient was treated with PROTONIX.   The reporter's causality for the events of abdominal bleeding, duodenal ulcer, abdominal pain, covid symptoms after each vaccination, positive for COVID-19 and immune system depleted was not provided. the reporter's causality for the event of fatigue after covid-19 vaccine, arm soreness, headache from covid-19 vaccine, fever, fatigue, mild cough, loss of taste, loss of smell and shortness of breath with SKYRIZI(RISANKIZUMAB) was no reasonable possibility. The reporter's causality for the event(s) of recurring headache with SKYRIZI(RISANKIZUMAB) was a reasonable possibility. AbbVie's opinion is that there is no reasonable possibility that the events of abdominal bleeding, duodenal ulcer, abdominal pain, covid symptoms after each vaccination, positive for covid-19, fatigue after covid-19 vaccine, arm soreness, headache from covid-19 vaccine, fever, fatigue, mild cough, loss of taste, loss of smell and shortness of breath are related to SKYRIZI(RISANKIZUMAB). AbbVie's opinion is that there is a reasonable possibility that the events of immune system depleted and recurring headache are related to SKYRIZI(RISANKIZUMAB).; Sender's Comments: Based on the current available limited information and the plausible drug-event association, a possible contributory role of the suspect product BNT162B2 to the development of the events Suspected COVID-19, Immunodeficiency, Intra-abdominal haemorrhage , Duodenal ulcer , Abdominal pain, Fatigue , Pain in extremity , Headache , Pyrexia, Cough, Ageusia , Anosmia, Dyspnoea, Fatigue, Headache  cannot be fully 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 and on the conduct of the study 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.