Sex: F
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal discomfort, Vision blurred
Clinical narrative: her BP was 220/140 mmHg; headache; blurry vision; unsteady gait; some joint discomfort; loss of appetite; at one point the sphincter tone of her rectum had gone away; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 52 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "mitochondrial disorder" (ongoing); "fatigue" (unspecified if ongoing), notes: Per her description it is a rare form of a mitochondrial disorder and one of her symptoms with that is fatigue. Diagnosed probably at least a decade or maybe two decades ago. There was no family history relevant to the adverse events.  There were no concomitant medications. There were no adverse events following prior vaccinations. There were no other vaccination received within 4 weeks prior to BNT162B2. Patient received her first Pfizer COVID vaccine dose sometime in Oct2021. The reporter doesn't have the specific date that the patient received the vaccine but she said to him that "her world changed on 09Oct2021" so it was around that particular point in time. Approximately 4 days later, within about 4 days she started to experience a headache that worsened over time with a little bit of blurring of her vision and she had unsteadiness of her gait. She saw her primary care provider and her blood pressure was 220/140 mmHg. She has no prior history of hypertension. He stated her BP was controlled at rest but rises dramatically when she stands. She first presented with this when she was seen in the emergency department and hospitalized. She was admitted to the hospital for blood pressure control and was put on several agents. One thing that they noticed was that her blood pressure was controlled at rest but as soon as she would get up and walk, even for a short distance, her blood pressure would rise dramatically, even when she was on medications. Subsequent to that she had some joint discomfort and someone, not at the reporter's institution, gave her a trial of corticosteroids, dexamethasone 4 mg, several months ago and her blood pressure had stabilized. She also had some gastrointestinal complaints such as loss of appetite and at one point the sphincter tone of her rectum had gone away but her weight has been stable.  The following information was reported: BLOOD PRESSURE INCREASED (hospitalization, medically significant) with onset Oct2021, outcome "not recovered", described as "her BP was 220/140 mmHg"; HEADACHE (hospitalization, medically significant) with onset Oct2021, outcome "unknown", described as "headache"; VISION BLURRED (hospitalization, medically significant) with onset Oct2021, outcome "unknown", described as "blurry vision"; GAIT DISTURBANCE (medically significant) with onset Oct2021, outcome "unknown", described as "unsteady gait"; MUSCULOSKELETAL DISCOMFORT (medically significant) with onset Oct2021, outcome "unknown", described as "some joint discomfort"; DECREASED APPETITE (medically significant) with onset Oct2021, outcome "unknown", described as "loss of appetite"; ANAL SPHINCTER ATONY (medically significant) with onset Oct2021, outcome "unknown", described as "at one point the sphincter tone of her rectum had gone away". The events "her bp was 220/140 mmhg", "headache", "blurry vision", "unsteady gait", "some joint discomfort", "loss of appetite" and "at one point the sphincter tone of her rectum had gone away" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (Oct2021) 220/140 mmhg. Therapeutic measures were taken as a result of blood pressure increased. She was originally put on clonidine and an angiotensin receptor blocker but was switched to dexamethasone which helped decreased her elevated BP. They are unable to successfully wean her off the dexamethasone because it is keeping her BP controlled. She has also started taking methotrexate as a steroid sparing therapy. She had came to see him because every time they try to wean her off of the dexamethasone her blood pressure goes back up into the 220 range. She is now on methotrexate for blood pressure control and the reporter "has no idea what is happening." The reporter commented that the only event that seemed to stand out temporarily was that she received the vaccine. He is looking for a little bit of guidance for prior reports. Her kind of natural history was that her initial event was in Oct2021 and now we are in Jan2022, and she is still on the immunosuppressive agents for blood pressure control and the reporter was not used to a patient telling him that. This all began then and she was having the recurring symptoms just as the presenting symptoms were, with the attempt to wean her off of the corticosteroids. She was seen at three different institutions. Regarding her symptoms still occurring, the reporter stated only when she has the elevated blood pressure.   The reporter assessed the events as medically significant and Related to BNT162B2. The reporter commented that at the very least, there is a possible association. He couldn't say that it is definite or probable but he can say that it is very possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on temporal relationship the possibility of causal association between the reported events Blood pressure increased, headache, vision blurred, gait disturbance, musculoskeletal discomfort, decreased appetite, anal sphincter atony and the 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.