Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral thrombosis, Computerised tomogram, Eye disorder, Eye pain, Headache
Clinical narrative: thrombotic attack in brain or optic nerve; hypersensitivity behind the eyes; when the the Patient opens their eyes they have difficulty; lethargy; inner ear infection; thrombotic attack in brain or optic nerve; Nausea; Vomiting; sea sickness; Vertigo; Pain in the eyes; Blurred vision; Intense headache; This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200439474.  A 47 year-old male patient received bnt162b2 (BNT162B2), administration date Jan2018 (Batch/Lot number: unknown) at the age of 47 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes" (ongoing), notes: recently diagnosed in the last year, controlled; "Atrial fibrillation" (ongoing), notes: a few years back, patient is not taking medication, hasn't had a recurrence in a year. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: VERTIGO (medically significant) with onset 16Mar2022, outcome "recovering", described as "Vertigo"; EYE PAIN (medically significant) with onset 16Mar2022, outcome "not recovered", described as "Pain in the eyes"; VISION BLURRED (medically significant) with onset 16Mar2022, outcome "recovering", described as "Blurred vision"; HEADACHE (medically significant) with onset 16Mar2022, outcome "recovering", described as "Intense headache"; CEREBRAL THROMBOSIS (medically significant), RETINAL VASCULAR THROMBOSIS (non-serious), outcome "unknown" and all described as "thrombotic attack in brain or optic nerve"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "hypersensitivity behind the eyes"; EYE DISORDER (non-serious), outcome "unknown", described as "when the the Patient opens their eyes they have difficulty"; NAUSEA (non-serious) with onset 16Mar2022, outcome "recovered" (17Mar2022), described as "Nausea"; VOMITING (non-serious) with onset 16Mar2022, outcome "recovered" (17Mar2022), described as "Vomiting"; MOTION SICKNESS (non-serious) with onset 16Mar2022, outcome "unknown", described as "sea sickness"; LETHARGY (non-serious), outcome "unknown", described as "lethargy"; LABYRINTHITIS (non-serious), outcome "unknown", described as "inner ear infection". The events "vertigo", "pain in the eyes", "blurred vision", "intense headache", "hypersensitivity behind the eyes", "when the the patient opens their eyes they have difficulty", "nausea", "vomiting" and "sea sickness" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: (16Mar2022) negative; magnetic resonance imaging head: (16Mar2022) negative. The patient had taken the booster dose of the Pfizer Covid vaccine 2 months ago and now experiencing vertigo. The patient also had hypersensitivity behind the eyes, when the patient opens their eyes, they have difficulty. Patient had onset of vertigo, nausea, vomiting- similar to a severe sea sickness, blurred vision, pain in eyes, and intense headache. Patient went to emergency room and underwent MRI and CAT scans, which were negative. Patient states this episode feels like a super intense version of the side effects he experienced post-booster vaccine, including lethargy. Patient had very mild symptoms about 8 weeks ago right after the booster, now more intense. For the event nausea, the patient now has mild symptoms. Vomiting was resolved. Pain in eyes was less severe. Blurred vision and intense headache affected the patient's activities of daily living and work. The patient saw an ear, nose, and throat doctor on 17Mar2022, for a possible inner ear issue, and as of yet, he was negative. The patient will follow up with a neurologist. Physician would like to rule out thrombotic attack in brain or optic nerve associated with 60 days post vaccination. Reporter seriousness for vertigo, pain in the eyes, blurred vision, intense headache was medically significant. Reporter seriousness for nausea, vomiting was not serious.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported events cannot be completely ruled out given the known suspect drug profile and/or implied temporal association. 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 Regul atory Authorities, Ethics Committees and Investigators, as appropriate.