Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, SARS-CoV-2 test
Clinical narrative: Difficulty breathing 24 hours post vaccination, severe right-sided chest pain that persisted for 48 hours before seeking care at the emergency department.; Difficulty breathing 24 hours post vaccination, severe right-sided chest pain that persisted for 48 hours before seeking care at the emergency department.; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Oct2023 at 11:15 as dose 1, single (Lot number: HG9498) at the age of 28 years, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history included: "known allergies: mammal meat" (unspecified if ongoing), notes: known allergies: mammal meat; "COVID" (unspecified if ongoing), notes: if COVID prior vaccination: Yes. Concomitant medication(s) included: FLUMIST nasal taken for immunisation, on 23Oct2023 as dose 1, single. Vaccination history included: moderna bivalent (Dose Number: 4, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 14Sep2022, when the patient was 27-year-old, for COVID-19 immunization; bnt162b2 (Dose Number: 3, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 17Nov2021, when the patient was 26-year-old, for COVID-19 immunization; moderna (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 03Mar2021, when the patient was 25-year-old, for COVID-19 immunization; moderna (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 29Jan2021, when the patient was 25-year-old, for COVID-19 immunization. The following information was reported: DYSPNOEA (medically significant), CHEST PAIN (medically significant) all with onset 27Oct2023 at 23:00, outcome "not recovered" and all described as "Difficulty breathing 24 hours post vaccination, severe right-sided chest pain that persisted for 48 hours before seeking care at the emergency department.". The event "difficulty breathing 24 hours post vaccination, severe right-sided chest pain that persisted for 48 hours before seeking care at the emergency department." required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Oct2023) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of dyspnoea, chest pain. Clinical courses is as follows: Difficulty breathing 24 hours post vaccination, severe right-sided chest pain that persisted for 48 hours before seeking care at the emergency department. Treatment included extensive diagnostics, and pain management.  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be 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.