Age: 85.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Hypoacusis, Malaise, Vomiting
Clinical narrative: My sugar have been crazy/my blood sugar is continually 195 to 240, well the worst was 294; vomited twice/threw-up; exhausted; shivering; malaise/I didn't feel well; I threw-up; I did not need eat the rest of the day; Hard of hearing; This is a spontaneous report received from a contactable nurse (patient herself). An 85-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: EL1283) via an unspecified route of administration in the right arm on 04Feb2021 at 18:30 (at the age of 85-year-old) as single dose for COVID-19 immunization and Insulin via an unspecified route of administration on an unspecified date at an unspecified dose for an unspecified indication. Medical history included Diabetic, Cardiac, unstable gait, hypothyroid and Known allergies: PCN (penicillin). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN) and furosemide. Patient historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318), via an unspecified route of administration in the left arm on 14Jan2021 at 18:45 for COVID-19 immunization. On 05Feb2021 at 9:30, the patient experienced shivering, malaise, vomited twice and exhausted. On 06Feb2021 patient was reported that her sugar has been crazy, she has hardly even eating because she doesn't feel well; her blood sugar is continually 195 to 240, well the worst was 294, that's not me usually my high at night is 166 or 157, she threw-up; she did not need eat the rest of the day, she doesn't feel comfortable this way; yesterday she didn't feel well the day before she didn't feel well and hard of hearing. Patient stated that "on the 5th the next day she did not feel well, she ate almost a soft-boiled egg in the morning with a slice of toast and she threw that up and she did not need eat the rest of the day and her blood sugar went up to 294 which she never had that high." Patient reported as "that night (07Feb2021), when she went to the bed 3 or 4 hours after she ate it was 294. She took 15 units of insulin and in the morning, it was 137 which is unusually high for her. That night it was 230 before she went to bed the next morning after 15 units of insulin it was 195 in the morning 7:53 in the morning and then at 9:50 last night she went to bed early it was 240 this morning after 17 units of went insulin it was 198. She checked it contour and it was 211. The patient did not receive any treatment for the events. Action taken for the insulin with respect to the events was unknown. The clinical outcome of the events shivering, exhausted was recovering, malaise, vomited twice, blood sugar abnormal, did not need eat the rest of the day was not recovered and hard of hearing was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the Blood glucose abnormal and other reported events  due to temporal relationship. However, the reported events may possibly represent intercurrent medical condition in this patient.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including fasting plasma glucose at baseline, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  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.