Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyschezia, Injection site pain, Pelvic pain, Proctalgia, Surgery
Clinical narrative: suspected pelvic mass/lower pelvic pain that progressed into severe pain over the next day/Pelvic mass/pain with bowel movements/difficulty to sit/ weight loss/ internal pelvic pulling sensation; This is a spontaneous report received from a contactable physician (reporting on herself). A 43-years-old Non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EL1284 and Expiration date was not reported), via an unspecified route of administration in Arm Left on 07Jan2021 12:00 (at the age of 43 years), as SINGLE DOSE for covid-19 immunization. Medical history included Latex_contact, laparoscopic surgery and Prior to vaccination, the patient was diagnosed with COVID-19 other medical history was none. Concomitant medication(s) included (within 2 weeks of vaccination) multivitamins (MULTIVITAMINS) daily. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not pregnant at the time of vaccination. It was reported that the evening after 1st pfizer covid 19 vaccine injection on 07Jan2021, Patient developed lower pelvic pain that progressed into severe pain over the next day requiring medical attention first at urgent care. Patient was then referred to the emergency department and found to have a suspected pelvic mass. Pain controlled with medication, improved but continued to have dull pelvic pain, pain with bowel movements, difficulty to sit, weight loss, internal pelvic pulling sensation. Follow up involved referral to specialist with imaging confirmed pelvic mass with plan for surgery. Patient received 2nd pfizer covid 19 vaccine given on 28Jan2021, 4 hours after injection developed again the severe pain experienced after the first injection require pain management. Underwent laparoscopic surgery for removal of pelvic mass and lysis of adhesions of intestines. Prior to the 1st vaccine on 07Jan2021 she had no pelvic pain or intestinal issues, no prior surgery and had maintained a very active lifestyle. Since the vaccination, patient was not tested for COVID-19. The outcome of the event was recovering.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Considering a plausible temporal relationship and known product safety profile, a possible contributory role of suspect product  bnt162b2 to the reported event 'Pelvic Mass" cannot be excluded. However, more information is needed regarding the Pelvic mass. The case will be reassessed once new information such as biopsy reports, tumor markers , Complete blood picture are 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.