Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, SARS-CoV-2 test negative
Clinical narrative: encephalitis-like symptoms; Hearing loss; memory loss; parathesias; visual disturbances; taste disturbances; dizziness; Lsided chest pain; staggering; elevated SBP 190-200; severe L-sided chest tightness; pre-syncope; elevated BP; DDimer was elevated; fell; intermittent memory lapses; nausea episodes; cant smell  that last 1-2 hrs; L neck /head pain; L neck /head pain; Left axilla lymphadenopathy; rhinitis; lightheaded/lightheadedness; had an episode of  pain all over; SOB; This is a spontaneous report from a contactable physician (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were unknown), via an unspecified route of administration from on 19Dec2020 at a single dose for COVID-19 immunization. Medical history included ovarian cancer at age 29, food allergy to clams and escargot, and allergy to sulfa. The patient's concomitant medications were not reported. The patient previously took bactrim and experienced allergies. On 19Dec2020, immediately after vaccine had rhinitis, lightheaded, given Zyrtec and water and observed for a duration of 30 min. Three hours postvaccination on 19Dec2020, at home had an episode of pain all over and SOB (shortness of breath). 3 days later (22Dec2020), patient had L (left) neck /head pain and left axilla lymphadenopathy. On 23Dec2020, she fell in the shower. On the same day (23Dec2020) the patient had intermittent memory lapses, lightheadedness, nausea episodes, can't smell that last 1-2 hours a few times a day. Symptoms worsened on 03Jan2021, with severe L-sided chest tightness, pre-syncope, was seen in the ER with elevated BP. DDimer was elevated, CT Scan of Chest/Abdomen showed L axilla lymphadenopathy, negative for PE. CBC, Electrolytes WNL (within normal limits), still on 03Jan2021. Observed in ER for 7 hrs. and then discharged home. Intermittent symptoms continued. On 08Jan2021, patient had another severe episode while at work. She was noted to be staggering, and again was complaining of left-sided chest pain. She was taken to the ER by her colleagues on 08Jan2021 and noted to have elevated SBP 190-200. On 08Jan2021, patient underwent CT head negative, MRI negative, w/u (workup) for pheochromocytoma negative and COVID negative. She was started on prednisone and Norvasc and discharged home. She continues to have intermittent episodes however they have decreased in intensity and last for about 1 hour. She described her symptoms as encephalitis-like symptoms. These include memory loss, paresthesia, visual disturbances, hearing loss, taste disturbances, and dizziness. These symptoms when severe have been incapacitating. She had been hospitalized for a neurological and infectious work up (including Brain MRI and multiple COVID tests) but no diagnosis has been yet identified. This symptom kcomplex (unspecified) has persisted to now. She has not received the second dose of vaccine. She is asking how long mRNA, the lipid nanoparticles and the protein spike lasts in the body. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the limited information currently available, a possible contributory role of the suspect drug in the reported events cannot be completely excluded given the implied temporal association. However, underlying medical conditions may provide the alternate explanations.  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.