Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood pressure measurement, Dizziness, Fatigue, Hypotension, Loss of consciousness
Clinical narrative: Kidney stones/two kidney stones; Blackout; Fainting; Low blood pressure; Urinary tract infection; Tiredness; Vaccination adverse reaction/She had a slight reaction to the Pfizer COVID vaccine; Dizziness; Pinched nerve; Vomiting; This is a solicited report from a non-Pfizer sponsored program, received from a non-contactable consumer (patient). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE for COVID-19 immunisation and adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot number was not reported) at unknown dose for moderate to severe chronic plaque psoriasis. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced kidney stones, blackout, fainting, low blood pressure, urinary tract infection, tiredness, vaccination adverse reaction, dizziness, pinched nerve, and vomiting. It was further reported that patient had two kidney stone, blackouts, low blood pressure, fainting, urinary tract infection, took adalimumab week early and was little tired, small reaction to COVID vaccine, dizziness and pinched nerve in neck. The patient stated that she made a mistake and took her adalimumab a week early and she was a little tired, but she felt fine after a day or so and now she feels better like she has more energy. She had been having fainting spells, physician thought it might be due to a pinched nerve in her neck. She had a bad urinary tract infection and in Mar2021 she had to have two kidney stones removed. She also had vomiting and low blood pressure. She had a slight reaction to the Pfizer COVID vaccine. It was unknown if she was enrolled in a COVID-19 Vaccine Trial. The reporter considered the event kidney stone as serious. The action taken in response to the events for adalimumab was not applicable. Therapeutic measures were taken as a result of kidney stones which included removal of two kidney stones in Mar2021. On an unspecified date, the patient recovered from urinary tract infection and vaccination adverse reaction and was recovering from tiredness. The patient had not yet recovered from kidney stones, blackout, fainting, and dizziness. The outcome of low blood pressure, pinched nerve, and vomiting was unknown. The reporter's causality for the events of blackouts, fainting, urinary tract infection, took adalimumab week early and was little tired unknown onset, small reaction to COVID vaccine and dizziness with Humira (adalimumab) was no reasonable possibility. AbbVie's opinion was that there was no reasonable possibility that the events of two kidney stone, blackouts, low blood pressure, fainting, urinary tract infection, took adalimumab week early and was little tired unknown onset, small reaction to COVID vaccine, dizziness and pinched nerve in neck are related to Humira (adalimumab). AbbVie's opinion was that there was a reasonable possibility that the event of took adalimumab week early and was little tired unknown onset was related to humira (adalimumab).  The reporter's assessment of the causal relationship of the events kidney stones, low blood pressure, tiredness, dizziness, pinched nerve, and vomiting 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.  Information about the lot/batch number has been requested.; Sender's Comments: Based on available information and currently known drug safety profile, a possible contributory role of bnt162b2 can not be excluded for the reported events blackout, fainting, low blood pressure, tiredness, vaccination adverse reaction, dizziness, pinched nerve and vomiting. The other reported events kidney stones and urinary tract infection more likely represented intercurrent illnesses, but not related to bnt162b2. Case will be reassessed when additional 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 RAs, Ethics Committees, and investigators, as appropriate.