Sex: M
Vaccine: COVID19
Symptoms: Malaise, Nausea, Physical examination, Presyncope, Pyrexia
Clinical narrative: sudden onset of weakness/just weak.; fatigue/tired; general malaise; Light headed/dizziness; with increased LFTs; low-grade temperature; nausea; vomiting; no appetite; speech is a little slow; already lost 5-6 lbs; looked like he was going to pass out; anemic; This is a spontaneous report from a contactable nurse (patient's mother). A 38-year-old male patient (COMIRNATY, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on May2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included (COMIRNATY, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on Apr2021 as dose 1, single for covid-19 immunisation and experienced low grade temperature and chills. The patient did not receive any vaccines within four weeks prior to the vaccination. Approximately 2 weekends ago patient started to experience sudden onset of weakness, looked like he was going to pass out, low-grade temperature, nausea and vomiting, no appetite, general malaise, speech was a little slow, just weak. Caller also reported dizziness, lightheadedness, and fatigue. The caller stated the patient had already lost 5-6 lbs. He had a physical back in March, and everything was fine. He had bloodwork done and everything was out of whack, all of a sudden with increased LFTs (liver function tests), low hemoglobin, low hematocrit, and low iron. He had occult blood in the urine, which was a bright orange color and warranted a urology consult. The patient had been to the ER 3 times, seen his PCP twice, had a urology consult, seen an endocrinologist, seen one hematologist and was seeing another tomorrow. CT (computerized tomography) scan of abdomen was clear, and no findings from the endocrinologist (who checked his thyroid). According to the caller the doctors was baffled. Caller did report that the patient was starting to feel better. The most concerning lab finding for the caller was the increase in LFTs and his hematocrit, hemoglobin and iron out of whack all of a sudden and delayed onset of symptoms (weeks after receiving the second dose of vaccine). Weak started two Saturdays ago. He was still weak, easily fatigued, just general malaise. It was medically significant, and it had improved a little. He was just taking supplements, vitamins, and trying to eat more properly. He was drinking a lot of fluids, electrolyte replacement, Pedialyte, Gatorade. She was just so tired. She had been to the emergency room with him three times, he's seen doctors and specialist and went to hematologist because of his liver. It went away she doesn't have a date. Seriousness criteria for dizziness now it was not serious because it had subsided. He had lasting effects he was still weak. No dizziness noted. They have been running back and forth to primary care provider. She had referred him to multiple to specialists. Light headed started about two Saturdays ago. Todays the 22JUN2021. It went away, she did not have the date. In the beginning it was medically significant with lasting effects. Whatever was going on had affected the integrity of his blood they had blood work done and his liver enzymes are totally abnormal. Nauseous, all the symptoms are gone, vomiting was gone. The weakness fatigue and lost of appetite persists. Prior to the vaccine he was fine and his bloodwork was normal and no complaints and in good condition and now he was anemic in one month. Caller was not sure if it was related directly to the vaccine but she think it was worth mentioning. Reporter seriousness for event was unspecified. Causality was unknown but prior to the vaccine he was fine. Adverse events required a visit to emergency room 3 times and physician office. Patient was not hospitalized. Outcome of events nausea and vomiting recovered on 2021 and for all other events was unknown.  Follow up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information currently available,  the reported events of asthenia, Malaise and Fatigue of the suspected vaccine BNT162B2 cannot be completely 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.