Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vertigo, Vision blurred
Clinical narrative: stomach pains; Severe Vertigo; Severe Migraine; Severe fatigue; blurred vision; unable to stay awake; joint pain; Severe Nausea; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient. A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2022 at 16:30 as dose 2, sin gle (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID; PERCOCET [OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE; PARACETAMOL]; HYDROXYZINE; BACLOFEN; VIIBRYD. Vaccination history included: coviD-19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Laocation of injection: Arm Left, Vaccine Administration Time: 04:30 PM), administration date: 09Mar2022, when the patient was 40-year-old, for Covid-19 immunization.  The following information was reported: MIGRAINE (medically significant) with onset 31Mar2022 at 02:00, outcome "not recovered", described as "Severe Migraine"; NAUSEA (medically significant) with onset 31Mar2022 at 02:00, outcome "not recovered", described as "Severe Nausea"; VERTIGO (medically significant) with onset 31Mar2022 at 02:00, outcome "not recovered", described as "Severe Vertigo"; FATIGUE (medically significant) with onset 31Mar2022 at 02:00, outcome "not recovered", described as "Severe fatigue"; VISION BLURRED (medically significant) with onset 31Mar2022 at 02:00, outcome "not recovered", described as "blurred vision"; ARTHRALGIA (medically significant) with onset 31Mar2022 at 02:00, outcome "not recovered", described as "joint pain"; ABDOMINAL PAIN UPPER (medically significant) with onset 31Mar2022 at 02:00, outcome "not recovered", described as "stomach pains"; SOMNOLENCE (medically significant) with onset 31Mar2022 at 02:00, outcome "not recovered", described as "unable to stay awake". The events "severe nausea", "stomach pains", "severe vertigo", "severe migraine", "severe fatigue", "blurred vision", "unable to stay awake" and "joint pain" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of nausea, abdominal pain upper, vertigo, migraine, fatigue, vision blurred, somnolence, arthralgia.   Clinical information Severe Nausea stomach pains Severe Vertigo Severe Migraine Severe fatigue blurred vision -unable to stay awake joint pain- All unchanged by Medications! Ubrelvy Imitrex Zofran Percocet Baclofen and Tordal injection. Ae resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. Ae treatment: Tordal inj today- now on patient way to the ER. Patient did not had covid prior vaccination. Patient did not tested covid post vaccination. No Known allergies. Patients received Other medical history. Other medications in two weeks: Synthroid, Percocet, Hydroxyzine, Baclofen, Viibry. Patient did not received other vaccine in four weeks.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2 , a causal relation between the events nausea, abdominal pain upper, vertigo, migraine, fatigue, vision blurred, somnolence, arthralgia and the administration of the vaccine 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.