Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Furuncle, Gastrointestinal disorder, Glycosylated haemoglobin, Nausea, White blood cell count
Clinical narrative: Gastrointestinal surgery; Dizzy on standing/feeling faint when stood up; Tiredness; Fibromyalgia; Blood sugar increased; Nausea; White blood cell count low; Boil on leg; This is a solicited report from a marketing program 'Facilitated Collect' based on information received by Pfizer, (Mfr. Control No.: Mfr. Control No.: 21K-163-4129954-00). A contactable consumer (patient) reported that a 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular on 09Aug2021 (Batch/Lot number was not reported) (at the age of 49-year-old) as dose 1, single, and intramuscular on 30Aug2021 (Batch/Lot number was not reported) (at the age of 49-year-old) as dose 2, single for COVID-19 immunization (reported as covid-19 vaccination); adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at an unknown dose (Citrate free) for moderate to severe Hidradenitis suppurativa.  The patient's medical history was not reported. Concomitant medications included dulaglutide (TRULICITY), insulin degludec (TRESIBA), and ertugliflozin pidolate (STEGLATRO); all taken for unspecified indications, start and stop dates were not reported. On an unspecified date, the patient experienced gastrointestinal surgery (reported as serious - Other medically important condition), dizzy on standing/feeling faint when stood up, tiredness, fibromyalgia, blood sugar increased, nausea, white blood cell count low. On an unspecified date in 2021, the patient experienced boil on leg. The patient underwent lab tests and procedures which included blood glucose: 400, A1C: 9.6, and white blood count: 46 (white blood count had a low of 46 before); all on an unspecified date. Therapeutic measures were taken as a result of gastrointestinal surgery, fibromyalgia, and boil on leg (furuncle). The action taken in response to the events for adalimumab was unknown. The outcome boil on leg was recovered on an unspecified date in 2021. The outcome of events gastrointestinal surgery, dizzy on standing/feeling faint when stood up, and fibromyalgia was not recovered. The outcome of the remaining events was unknown. Solicited report from the Regulatory Authority by a consumer of a 49 year old female with events of gastrointestinal surgery and non-serious feeling faint when stood up/dizzy tired, fibromyalgia, blood sugar getting up to four hundred, boil between legs, nausea and white blood count low with HUMIRA (ADALIMUMAB). There was no reported medical history. On unknown dates, the patient experienced gastrointestinal surgery, feeling faint when stood up/dizzy, tired, fibromyalgia, blood sugar getting up to four hundred, nausea and white blood count low. In 2021, the patient experienced boil between legs. On an unknown date in 2021, boil between legs resolved. Pfizer BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The patient was feeling faint when stood up. She was tired, dizzy and had nausea. She took off Trulicity 1.5 mg, Tresiba daily 90 units and Steglatro 15 mg all 3 weeks ago. She had A1c 9.6 (no unit). Her blood sugar was getting up to 400 (no unit). Her white blood count had a low of 46 (no unit) before. She had gastrointestinal surgery and got her blood sugar down. She had steroids shots on back. Doctor told her she had fibromyalgia. Had new boil between legs over a month ago which broke the next day and put on triple antibiotics on it. It was unknown if she was enrolled in a COVID-19 Vaccine Trial. On 09Aug2021, she received 1st dose COVID-19 Vaccine manufactured by Pfizer BioNTech. On 30Aug2021, she received 2nd dose COVID-19 Vaccine manufactured by Pfizer BioNTech. Primary reporter did not have the lot number information, because the packaging was discarded.  AbbVie's opinion is that there is no reasonable possibility that the events of gastrointestinal surgery, fibromyalgia, blood sugar getting up to four hundred and boil between legs are related to HUMIRA (ADALIMUMAB). AbbVie's opinion is that the events of feeling faint when stood up/dizzy, tired, nausea and white blood count low are not assessable.   The reporter's causality for the events of gastrointestinal surgery, tired, blood sugar getting up to four hundred, boil between legs, nausea and white blood count low with HUMIRA (ADALIMUMAB) was not provided. The reporter's causality for the events of feeling faint when stood up/dizzy and fibromyalgia with HUMIRA (ADALIMUMAB) was no reasonable possibility. The reporter's causality for the events of gastrointestinal surgery, dizzy on standing, tiredness (fatigue), fibromyalgia, blood sugar increased, boil on leg, nausea, and white blood cell count low with BNT162B2 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 information provided in the narrative, a causal association between the suspect drug and the events cannot be completely 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.