Sex: F
Vaccine: COVID19
Symptoms: Gynaecological examination, Haemorrhage, Investigation, Laboratory test, Palpitations
Clinical narrative: Epiploic appendages; epiploic appendicitis; severe abdominal pain; ANA positive (10.65 mg/l); Candida IgG positive (13%); Cervical polyp 0.8 x 0.6 x 0.5; benign result polyp; chromic, inflammatory reactive epithelial change; Low ferritin (9 ng/ml); Ultrasound pelvis showed 2 fibroids minimum 1.5x1.1x1.4; Bleeding; continuous to bleed heavy; Palpitations; Increased vaginal discharge; This is a spontaneous report received from a contactable nurse. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 12Jan2021 as dose 2, single (Lot number: EJ1686) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "OCD" (unspecified if ongoing); "Migraines" (ongoing); "Mild childhood asthma", start date: 1996 (unspecified if ongoing); "Cervix issues" (ongoing); "Neuropathy in hands" (ongoing); "Lyme disease", start date: 2021 (unspecified if ongoing), notes: On different antibiotics over several years until blood work normal; "Hyperlipidemia", start date: 2010 (ongoing), notes: Family history: Mother. The patient's family history included MI (father, 2018). Concomitant medication(s) included: ZETIA oral taken for hyperlipidaemia, start date: 2019 (ongoing); NEURONTIN oral taken for cervix disorder, neuropathy peripheral, start date: 2016 (ongoing); ORTHO TRI-CYCLEN oral taken for migraine, obsessive-compulsive disorder, start date: 2000 (ongoing); AIMOVIG subcutaneous taken for migraine, start date: 2018 (ongoing). Vaccination history included: BNT162b2 (DOSE 1; Lot Number: EJ1685; intramuscular in left deltoid), administration date: 23Dec2020, for COVID-19 immunization, reaction(s): "Arthralgias", "Menometrorrhagia", "SR to ST PVC, VTACH", "SR to ST PVC, VTACH", "Heavy bleeding", "Palpitations". The following information was reported: SERUM FERRITIN DECREASED (non-serious) with onset 29Mar2021, outcome "unknown", described as "Low ferritin (9 ng/ml)"; HAEMORRHAGE (medically significant) with onset 2021, outcome "not recovered", described as "Bleeding; continuous to bleed heavy"; VAGINAL DISCHARGE (non-serious) with onset 2021, outcome "unknown", described as "Increased vaginal discharge"; PALPITATIONS (non-serious) with onset 2021, outcome "unknown"; UTERINE LEIOMYOMA (non-serious) with onset 2021, outcome "unknown", described as "Ultrasound pelvis showed 2 fibroids minimum 1.5x1.1x1.4"; CERVICAL POLYP (non-serious) with onset 15Jul2021, outcome "unknown", described as "Cervical polyp 0.8 x 0.6 x 0.5; benign result polyp; chromic, inflammatory reactive epithelial change"; ANTINUCLEAR ANTIBODY POSITIVE (non-serious) with onset 14Sep2021, outcome "unknown", described as "ANA positive (10.65 mg/l)"; CANDIDA TEST POSITIVE (non-serious) with onset 14Sep2021, outcome "unknown", described as "Candida IgG positive (13%)"; EPIPLOIC APPENDAGITIS (medically significant) with onset 20Oct2021, outcome "recovered" (Jan2022), described as "Epiploic appendages; epiploic appendicitis; severe abdominal pain". The patient underwent second vaccination on 12Jan2021 and experienced continuous heavy bleeding. Laboratory tests checked on 24Mar2021. On and off palpitation and bleeding, doctors continued to monitor laboratory tests and rule out other issues experienced - other symptoms like increased vaginal discharge and (illegible) blood checked DVC (unspecified) to heavy bleeding. This was positive. Antifungals started. Bleeding continued and abdominal pain extreme prompting ultrasound pelvis and CT abdomen (Sep2021 to Oct2021); pelvis which showed 2 fibroids minimum 1.5x1.1x1.4 and show 2x1.8x2 and epiploic appendages. They continued to monitor ferritin/CRPs and multiple follow-up appointments. The patient underwent other laboratory tests and procedures: Antinuclear antibody (0-3): (14Sep2021) 10.65 mg/l; Blood test: (24Mar2021) DVC to heavy bleeding; Candida test (15-55): (14Sep2021) 13 %; Computerised tomogram abdomen: (24Oct2021) Hybrids x 2 intramuscular submucosal, notes: Spreading of that exposed appendicitis; C-reactive protein (0-3): (15Jul2021) 8.68 mg/l, notes: High; C-reactive protein (0-10): (29Mar2021) 5 mg/l; Full blood count: (29Mar2021) Normal; Gynaecological examination: (15Jul2021) Cervical polyp 0.8 x 0.6 x 0.5, notes: Benign result polyp; chromic, inflammatory reactive epithelial change; Hammer strainer (0-14.5): (29Mar2021) 6.5 v/mol/L; Serum ferritin (15-150): (29Mar2021) 9 ng/ml, notes: Low; (29Dec2021) 12 ng/ml; Ultrasound pelvis: (24Oct2021) Hybrids x 2 intramuscular submucosal, notes: Spreading of that exposed appendicitis. The event "epiploic appendages; epiploic appendicitis; severe abdominal pain" required emergency room visit. All events required physician office visit. Therapeutic measures were not taken as a result of epiploic appendagitis. Therapeutic measures were taken as a result of haemorrhage, palpitations, vaginal discharge.; Sender's Comments: The causal relationship between BNT162b2 and the events epiploic appendagitis and haemorrhage cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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.,Linked Report(s) : US-PFIZER INC-PV202300021617 Same patient and product; different dose and event;US-PFIZER INC-202300123226 Same patient and product; different dose and event;