Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Lipase, Lipase increased, SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: COVID 19 antibody test result was less than 1.00 units index/ negative antibody test; His Lipase level also has gone up to 231; extreme fatigue; not being able to sleep; his blood sugar dropping to the 50s when he's diabetic; This is a spontaneous report from a contactable nurse (patient). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration in left arm on 07Jan2021 at 10:00 (at the age of 69-years-old) at 2nd dose, single dose for COVID-19 immunization. Medical history included diabetes mellitus type 2; kidney stones from 7-8 years ago, the most recent kidney stone had to be surgically removed a year ago (2020); hypothyroidism, depression, and prostatic hypertrophy. Concomitant medications included levothyroxine sodium from 2001 for hypothyroidism, venlafaxine hydrochloride (EFFEXOR) from 2006 for depression, tamsulosin from 2017 for prostatic hypertrophy; metformin from 2015 for diabetes mellitus type 2, which were all ongoing; and other unspecified medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in left arm on 17Dec2020 at 08:00 (at the age of 69-years-old) at 1st dose, single dose for COVID-19 immunization. He also previously received flu vaccine on an unspecified date in 2020 for immunization and experienced body aches. On May2021, 2 weeks ago, the patient noticed extreme fatigue, which was not enough for him to be immobile, but he felt like a wet noodle. He was able to function and see patients, but it takes it out of him. There was no correlation to time of day or activity. The fatigue just comes and goes. He was also unable to sleep on May2021. He had a lab test on 19May2021, where his COVID-19 antibody resulted in less than 1.00 unit index. The doctor said he never saw an antibody response this low and had no idea how to interpret it. The patient did some study himself and was still unsure what that means. He was asking for information about the antibody results. He then added that as a first responder nurse, he sees oncology patients and was very concerned about having no antibodies to COVID 19. His main concern was the negative antibody test. The patient also reported a new increase in lipase to a dangerous level, it has gone up to 231 (reference level: 60-70) on 19May2021. His last lipase level was in Dec2020, but he was unable to locate the results at this time. He was now scheduled for an MRI of his pancreas on 16Jun2021. The patient also noticed his blood sugars dropped down all of a sudden when he's diabetic on an unspecified date in 2021. They were 50 to 70 or 75 (2021) and this was asymptomatically. He collected his blood sugar result and checks it a dozen times a day. It has no relation to food. His two-hour postprandial can be 80 (2021) and then it drops back down. His A1C was good (2021) and there seems to be no explanation from the labs. The patient went to his doctor on 27May2021 in response to the events. The outcome of the events "extreme fatigue" and "not being able to sleep" was not recovered and unknown for all other events. The events "extreme fatigue", "not being able to sleep", "COVID 19 antibody test result was less than 1.00 units index/ negative antibody test", and "His Lipase level also has gone up to 231" were reported as serious, medically significant. Relatedness of the events "COVID 19 antibody test result was less than 1.00 units index/ negative antibody test" and "His Lipase level also has gone up to 231" to the drug was stated as related and unknown for all other events.   Information on lot/batch number has been requested.; Sender's Comments: The events "extreme fatigue", "not being able to sleep", "COVID 19 antibody test result was less than 1.00 units index/ negative antibody test", "His Lipase level also has gone up to 231", and "blood sugar decreased" are likely due to underlying medical condition and are unrelated to suspect product 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 Committees, and Investigators, as appropriate.