Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Magnetic resonance imaging, Off label use, Product use issue, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 35 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administration date 28Sep2021 12:30 (Batch/Lot number: unknown) at the age of 35 years as dose number unknown, single for Covid-19 immunisation. Relevant medical history included: "Pregnant hypothyroidism" (unspecified if ongoing), notes: Other medical history: Pregnant hypothyroidism. Date of last menstrual period: 05May2021. The patient was 20 weeks pregnant at the time of exposure to bnt162b2. The patient was 21 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 28Feb2022. Concomitant medication(s) included: LEVOTHYROXINE [LEVOTHYROXINE SODIUM]. Vaccination history included: Bnt162b2 (Dose Number: Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 12:30 AM), administration date: 31Aug2021, when the patient was 35 years old, for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 01Oct2021 11:00, outcome "recovered" (2021) and all described as "Pregnancy Due Date 28-FEB-2022"; VISION BLURRED (non-serious) with onset 01Oct2021 11:00, outcome "recovered" (2021), described as "Blurry vision in left eye"; HEADACHE (non-serious) with onset 01Oct2021 11:00, outcome "recovered" (2021), described as "Lasted 30 mins followed by headache". The events "pregnancy due date 28-Feb-2022", "pregnancy due date 28-Feb-2022", "blurry vision in left eye" and "lasted 30 mins followed by headache" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of off label use, product use issue, vision blurred, headache. Additional information: Most recent COVID-19 vaccine was administered at hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Levothyroxine within 2 weeks of vaccination. All vitals were normal including blood sugar. Lasted 30 mins followed by headache. MRI normal. Adverse event resulted in emergency room/department or urgent care. MRI fluids were treatment received for the adverse event. Prior to vaccination, patient was not diagnosed with COVID-19. Adverse event resulted in emergency room/department or urgent care. MRI fluids were treatment received for the adverse event. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient was tested for COVID-19. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Follow-up (17Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.