Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hyporesponsive to stimuli, Lumbar puncture normal, Magnetic resonance imaging head normal, Malaise, Musculoskeletal stiffness
Clinical narrative: Guillain Barre syndrome; Doesn't feel from his waist down on left side; Doesn't feel from his waist down on right side; Weakness on right side; Weakness on left side; Passed out; High blood pressure; Lost hearing on right side; Headache; Fever; Pain in back; Pain in neck that went up to his head; This is a spontaneous report from a contactable consumer. A 47-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 16Mar2021 at 15:00 or 15:10 (at the age of 47-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history was reported as none. It was reported that the patient had no pre-existing conditions and was "100% healthy and normally ran every day for 2-3 miles." Concomitant medications were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. The patient did not have a history of adverse events that followed prior vaccinations. The patient previously received the flu shot in Sep2020 (at the age of 47-years-old) for immunization and experienced no side effects. It was reported that the patient received a flu shot every year and experienced no side effects. On 16Mar2021 the patient experienced fever, pain in back and pain in neck that went up to his head; on 17Mar2021 the patient experienced headache; on 18Mar2021 the patient experienced does not feel from his waist down on left side, does not feel from his waist down on right side, weakness on right side, weakness on left side, passed out and on unspecified dates the patient experienced Guillain Barre syndrome, lost hearing on right side and high blood pressure. The events does not feel from his waist down on left side, does not feel from his waist down on right side, weakness on right side, weakness of left side and passed out (911 was called) required an emergency room visit; does not feel from his waist down on left side, does not feel from his waist down on right side, weakness on right side, weakness on left side and Guillain Barre syndrome also required a physician office visit. The patient was hospitalized for the events passed out, does not feel from his waist down on left side, does not feel from his waist down on right side, Guillain Barre syndrome, weakness of right side and weakness of left side from 18Mar2021 to 08Apr2021 (also reported as "for 22 days"). The reporter (friend of the patient) called to file a report for his friend, who did not speak any English. The reporter wanted to make Pfizer aware of the adverse event that the patient experienced. The reporter stated that the hospital staff stated that they reported the patient's adverse event to Pfizer, the local health department and the CDC, but the patient's family and friends were not sure if the report was filed, thus the reporter was calling. The clinical course was reported as follows: "6-7 hours after getting home from getting the vaccine on 16Mar2021, the patient started to feel fever, pain in his back, and pain in his neck that went up to his head. The hospital had given the patient Tylenol and the hospital staff informed the patient that if he felt a fever or pain after the COVID-19 vaccine, he should take the Tylenol. The hospital staff also informed the patient that if his symptoms got worse to call 911 and go to the emergency room. The patient took the Tylenol and his fever came down a bit and the patient went to sleep. On the next day, 17Mar2021, the patient's neck pain started going up more like a headache. On the morning of Thursday, 18Mar2021, the patient got weak. The patient could barely move his hand or neck or leg. After the weakness began, "it was like 1-2-3" and the patient was passed out. After the patient passed out, 911 was called and when emergency personnel arrived, the emergency personnel thought that the patient had had a stroke. When the patient woke up on 18Mar2021, the patient was unable to feel from the waist to all the way down. The medical staff at the hospital did a lot of testing on the patient, MRIs and all that stuff, and all of the test results were coming back negative. The medical staff took some fluid from the patient's back after the patient was in the hospital for 2-3 days. The results came back negative until 2 weeks later when the patient's friends and family were informed that the patient had Guillain-Barre Syndrome. The patient's left side got a little improvement with medicine, but the patient's right side did not get any improvement." The patient's fever was treated for the first few days while hospitalized, the patient no longer had a fever. The patient was also treated for high blood pressure for the first few days that he was hospitalized. The reporter was informed of the patient's hearing loss "after the patient started speaking good, about 3-4 days after the patient had the first dose of the COVID-19 vaccine on 16Mar2021. The patient was losing hearing before that, but the patient was not able to talk to the caller or family a lot." (as reported). The reporter did not provide details on medications administered during the patient's hospital stay. The reporter stated that the patient was just discharged from the hospital and sent home. The reported believed that the patient needed more care and more medicine and that he was not finished with treatment. The reporter stated that the patient should have been back to normal health before having been discharged from the hospital. He did not know why the patient was discharged. The reporter stated that the patient was sent home without any medicine and was still experiencing daily headaches. The patient took Advil Migraine for his headaches which did not work, or only worked for 10 minutes and then the pain would come back. The hospital referred the patient to a different facility. The reporter stated that the patient could not get an appointment with this facility for up to 2 months from now. The patient could not wait 2 months for relief. He could not be like that with a headache and no feeling on his right side for 2 months. According to a different doctor the patient needed "more IVIG, immunoglobulin and needed to get attention from a neurologist to watch him until he got better." The patient had an appointment scheduled with a neurologist for Monday 26Apr2021 at 08:00. The clinical outcome of the event fever was recovered/resolved on an unspecified date; does not feel from his waist down on left side and weakness on left side were recovering/resolving; does not feel from his waist down on right side, weakness on right side, lost hearing on right side, pain in back, pain in neck that went up to his head and headache were not recovered/not resolved and passed out, Guillain Barre syndrome and high blood pressure were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up