Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Dyspnoea, Headache, Hypertension
Clinical narrative: flashes and floaters ("oily" spot in the visual field) in the right eye; flashes and floaters ("oily" spot in the visual field) in the right eye; 3 episodes of abrupt and transient hypertension (max 218/113); fever (38.1 C); headache; dyspnea; This is a spontaneous report received from a contactable healthcare professional (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8994), via an unspecified route of administration, administered in the left arm on 20Jan2021 18:15 (at the age of 55 years old) as dose 2, single for COVID-19 immunization. Medical history included Hashimoto disease, history of melanoma, allergies: many medicines (delayed hypersensitivity to many medicines), allergies: antibiotics, all from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included levothyroxine sodium (TIROSINT SOL) taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), via an unspecified route of administration, administered in the left arm on 30Dec2020 17:30 (at the age of 55 years old) as dose 1, single for COVID-19 immunization; and Flu vaccine on 2017 for immunization and experienced allergies: became allergic to eggs/chicken after adverse reaction to flu vaccine in 2017. Egg-free-flu vaccine is OK. The patient experienced 3 episodes of abrupt and transient hypertension (max 218/113), fever (38.1 C), headache, dyspnea on 03Mar2021 15:15, flashes and floaters ("oily" spot in the visual field) in the right eye 05Mar2021. It was reported that the patient experienced 3 episodes of abrupt and transient hypertension (max 218/113), with fever (38.1 C), headache and dyspnea on March 3, 4 and 7, requiring visits at Emergency Department (ED) on March 4 and 7. Episodes on March 3 and 4 lasted few hours and self-resolved (2 liters iv saline on 3/4 at ED).  Episode on March 7 required use of i.v. Atenolol at ED and oral Atenolol for the next 5 days. Starting March 5, flashes and floaters (oily spot in the visual field) in the right eye. All symptoms disappeared/recovered with lasting effects after March 12, except for the floater in the right eye. The adverse events resulted in a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for 3 episodes of abrupt and transient hypertension (max 218/113) included intravenous saline solution and atenolol. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included blood pressure: 218/113 and body temperature: 38.1 centigrade on 03Mar2021. The outcome of the event vitreous floaters was not recovered while the outcome of all other events was recovered with sequel on an unspecified date.; Sender's Comments: Based on current information available, the event hypertension mostly represented intercurrent condition in this patient with advanced age and with concurrent disease, unrelated to Bnt162b2.  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 RAs, Ethics Committees, and Investigators, as appropriate