Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Constipation, Food intolerance, Gastrointestinal scarring, Headache
Clinical narrative: Generalized aching / body aches / lot of pain; Intestinal obstruction; Intestinal scarring / obstruction was from possible scar tissue; going to restroom more; Constipation; Food intolerance / could not eat most foods; Eight months pregnant with her first child; low grade fever; nausea; headaches; dental surgery; This is a solicited report from a marketing program based on information received by Pfizer, Manufacturer control number: 21K-163-3923614-00 via a non-contactable consumer (patient).     A 30-year-old pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on an unspecified date (Batch/Lot number was not reported) (at the age of 30 years old) as single dose for Covid-19 immunisation; and co-suspect adalimumab (HUMIRA), via an unspecified route of administration from 01Apr2020 (Batch/Lot number was not reported) to Apr2021, at 40 mg(40 mg,1 in 3 - 2), then subcutaneous from 25May2021 (Batch/Lot number was not reported) and ongoing, at 40 mg,1 in 3 wk) for Crohn's disease. The patient's medical history was not reported. Concomitant medication included unspecified oral immunosuppressant medication. The mother was eight months pregnant with her first child when she received the vaccine. In Mar2021, the patient experienced generalized aching / body aches / lot of pain, intestinal obstruction, intestinal scarring / obstruction was from possible scar tissue. In Apr2021, the patient had low grade fever, nausea, headaches, and dental surgery; then going to restroom more, constipation, food intolerance / could not eat most foods on an unspecified date. The clinical course was reported as follows: After starting therapy and after each dose, the patient experienced one to four days of low grade fever, nausea, body aches and headaches. She was eight months pregnant with her first child and was followed by a specialist. She noticed that the side effects worsened since being pregnant. The fetus was exposed to maternal use of Humira in utero. She had a lot of pain due to intestinal obstruction and required hospitalization for four days in Mar2021 however, scans could not be done while inpatient due to pregnancy but it was felt that the obstruction was from possible scar tissue. Second gastroenterologist opinion in Mar2021 was taken who advised to stop oral immunosuppressant medication which was causing nausea. She had a delay in two doses of Humira in Apr2021, one due to shipment and another due to required emergency dental surgery and physician advised to hold dose for one week after surgery. Three weeks in between doses were confirmed instead of every fourteen days as prescribed, physician was aware. As of 25May2021, maternal use of Humira was ongoing. She was going to restroom more and constipated. She could not eat most foods. It was unknown if she was enrolled in a Covid 19 vaccine trial. The action taken in response to the events for adalimumab was dose not changed. Therapeutic measures were taken as a result of dental surgery (tooth disorder). Outcome of the events Intestinal obstruction, Intestinal scarring, dental surgery was unknown. Outcome of the other events was not recovered.   The reporter's assessment of the causal relationship of the events 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.; Sender's Comments: Based on the current available information, the reported events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available.