Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Haemorrhage, Menometrorrhagia, Palpitations, Ventricular tachycardia
Clinical narrative: heavy bleeding; Palpitations; SR to ST PVC, VTACH; Arthralgias; Menometrorrhagia; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 41-year-old patient received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: EJ1685) intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia", start date: 2010 (ongoing), notes: Pertinent details: was on lovastatin- switched to ezetimibe; "Cervix issues in neuropathy in hand", start date: 2016 (ongoing); "OCD", start date: 2000 (ongoing); "Childhood Asthma Mild", start date: 1996 (unspecified if ongoing), notes: Pertinent details: rare inhaler use usually with illness/PNA on excuse once every few months; "Lyme Disease", start date: 2021 (unspecified if ongoing), notes: Pertinent details: On different antibiotics over several years until blood work normal, Zed. The patient's family history included: "Migraines", start date: 2018 (ongoing); "Hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included:AIMOVIG subcutaneous taken for migraine, start date: 2018 (ongoing); EZETIMIBE oral taken for hyperlipidaemia, start date: 2019 (ongoing); NEURONTIN oral taken for cervix disorder, start date: 2016 (ongoing); ORTHO TRI-CYCLEN oral taken for migraine, obsessive-compulsive disorder, start date: 2000 (ongoing). The following information was reported: ARTHRALGIA (disability, medically significant) with onset Dec2020, outcome "not recovered", described as "Arthralgias"; MENOMETRORRHAGIA (caused and prolonged hospitalization, medically significant) with onset Dec2020, outcome "recovered" (04May2022); VENTRICULAR TACHYCARDIA (medically significant) with onset 25Dec2020, outcome "not recovered", described as "SR to ST PVC, VTACH"; HAEMORRHAGE (medically significant), outcome "unknown", described as "heavy bleeding"; PALPITATIONS (non-serious), outcome "unknown". The events "menometrorrhagia", "sr to st pvc, vtach" and "arthralgias" required physician office visit. The patient underwent the following laboratory tests and procedures: Ventricular tachycardia: (29Dec2020) 11 beats, notes: Liopath 48-144 rate: rare isolated NCS, rare ventricular artery non sustained VTach, 11 beats, non-morphine; (11Jan2021) 11 beats, notes: Liopath 48-144 rate: rare isolated NCS, rare ventricular artery non sustained VTach, 11 beats, non-morphine. Therapeutic measures were taken as a result of menometrorrhagia (Hysteroscopy, Hospitalization + Surgery); ventricular tachycardia, haemorrhage, palpitations (Metoprolol 25 mg Daily Iron supplements); and arthralgia (Dec2020- Present PRP injections steroid injection stem cell injection etodolac BID (500 mg) Tylenol PRN).; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine to the reported events can not be excluded due to temporal relationship and current known drug safety profile.  Case will be re-assessed upon the additional information provided. 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-PV202300053404 Same patient and product; different dose and event;US-PFIZER INC-PV202300021617 same patient, vaccine, different dose and event;