Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram thorax, Dyspnoea exertional, Fatigue, Feeling abnormal, Fibrin D dimer
Clinical narrative: shortness of air with minimal exertion; delayed memory/memory gap is exaggerated; fainted; had no energy; nauseated and she could not eat; lost her taste and smell; lost her taste and smell; tested positive for Covid 19; fever; extreme fatigue; feels foggy; This is a spontaneous report from a contactable Nurse (patient). A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL0142), intramuscularly administered in the Left Arm on 06Jan2021 afternoon, around lunchtime (at the age of 64-years-old) as dose 1, single for covid-19 immunisation. The patient's medical history included that the patient was a former smoker. She stopped about 20 years ago. She smoked when she was an emergency room nurse. She had a flu vaccine in Oct2020 and prior vaccinations within 4 weeks was TDAP on 10Dec2020. Concomitant medications were not reported. The patient was not taking any medications routinely prior to the event being reported. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) were none. Additional all vaccines administered on same date with the Pfizer vaccine considered as suspect was none. Events following prior vaccinations was none. Antipyretic Use (around the dates of Vaccination) was none. She did not have pre-existing diseases worsened during the SARS-CoV2 infection. Patient was not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. On an unspecified date the patient experienced shortness of air with minimal exertion and delayed memory/memory gap is exaggerated on an unspecified date. On 06Jan2021, she had fever, extreme fatigue and feels foggy. On 07Jan2021, she tested positive for covid 19, nauseated and she could not eat, and lost her taste and smell. Event required a visit to Emergency Room but no Physician Office. Patient reported that very night after she received the Covid 19 vaccine on 06Jan2021 she started having a fever and fatigue. She reported the night of the 06Jan2021 she had a low-grade fever, maybe 101.6F. Patient reported on 07Jan2021 she went to get tested for the Covid 19 virus at the urgent care under Hospital and had her first Covid 19 virus test. She had not received the results from the first Covid 19 test done on 07Jan2021 at this time. She got up that morning on the 09Jan2021 and walked into the kitchen to get her morning drink, a nutrient drink. She felt like she was going to faint, she knew she was going to faint. She remembers leaning up against the counter and then she was out. The next thing she knew there were paramedics around her. She had no energy; she could hardly get her voice up enough to talk to the paramedics and answer their questions. When the paramedics came in the ambulance to take her to the hospital after she fainted, they started an IV and gave her IV fluids. She was given no other medications in the emergency room. On Saturday 09Jan2021 she was tested again because she fainted at home and went to the emergency room after. she thought they may have called it the rapid test and then on Sunday, 10Jan2021 they tried to schedule and reschedule the Bamlanivimab infusion about 5 times and finally got it scheduled for 11Jan2021. On 11Jan2021 she received the infusion Bamlanivimab. The doctor in the emergency department thought that she needed the Bamlanivimab infusion because she was 64. She did not even require oxygen with a nasal cannula. She reported the nausea was more related to her taste being gone and trying to eat and needing to eat and she could not eat because there was no taste. She could not chew it and swallow it; she could not stand to eat because she could not taste it. She was able to drink a lot, so she was using the bathroom and peeing very well. She reported she was very healthy, never sick, she did not take any medicine or anything. The doctor thought because of her age she needed to take the Bamlanivimab. She reported she did not move for a solid week. She was still running a fever and it got up to 102.6F. She continued to run a low-grade fever up until 19Jan2021, more like 99F. She did not think that her symptoms were serious enough to go back to the emergency department. Her symptoms were something she could manage at home. The fatigue lasted a week. She believed she got Covid 19 at the hospital where she worked, and she shared the Covid 19 virus with her son. Her son did better because he was 30 something years younger than her. She was like a zombie. She had extreme fatigue, she was nauseated, and she could not eat. She lost her taste and smell, and she could only take 3-4 bites of anything she put in her mouth. She went to bed at night and got up in the morning and slept in her recliner during the day. She felt short of air, but she had a pulse ox at home and her O2 level did not go below 92%. She had literally just started her nursing contract and worked for one week, got Covid 19, and was out for 3 weeks. She reports the first week was really bad. The second week she was moving around a lot more. Then she developed shortness of air with minimal exertion. She got an inhaler and steroids and that helped quite a bit. She felt better overall around the end of the 3rd or 4th week after testing positive for the Covid 19 virus. She felt comfortable enough to go back to work. The shortness of air was better. She was ready to go back to work but was anxious about it, like would she be able to perform the way she was supposed to. She doubted that her testing positive for the Covid 19 virus was related to the Covid 19 vaccine. She thought the positive test was related to getting the Covid 19 virus. She did think the Covid 19 vaccine lessened her viral symptoms. The doctor at the emergency room told her not to get the second dose of the Covid 19 vaccine for 3 months. She wants to ask when she can receive the second Covid 19 vaccine as it is been 3 months or does she have to start over and get the first Covid 19 vaccine again. She was on a crisis contract for a nursing job. She was back home. She got to get the second Covid 19 dose and she was a little over 3 months after having the first Covid 19 vaccine. She was wondering if she needs to start over or can she just get the second Covid 19 vaccine. She reported she was not admitted to the hospital with the Covid 19 virus. She was discharged from the emergency department. In the emergency department they checked her CBC, Chemistry, her D-dimer was elevated so she had to get a CT scan of her lungs which was negative. She has had a positive D-dimer in the past when she had upper respiratory problems. She also had a chest X-ray and EKG and both of those were normal. She was floated to the emergency department, she was not supposed to have any patients, she was only supposed to be tasking and she was given a patient assignment. Throughout the day she ended up having 4 positive Covid 19 patients and they were very sick. Her son did not get the Covid 19 vaccine. He said let someone else have it. She went to an urgent care on 22Jan2021 because she was short of air. The urgent care prescribed Prednisone, 20mg 2 tablets by mouth once daily for 5 days and an inhaler, Albuterol Sulfate HFA 18gm 2 puffs every 4 hours as needed. These were prescribed a couple weeks after her diagnosis. She did not have the NDC/Lot/Expiry for Prednisone. Inhaler albuterol sulfate expiration Apr2022. She putted her glasses on to see the print on the inhaler. She had been working in the yard, spreading grass seed and fertilizing. She was old and she feels like she was having delayed memory. She was talking to an anesthesiologist who had the Covid 19 virus, and he was describing his symptoms to her. She describes it as walking into the kitchen and thinking what she came in here for and having to retrace her steps. Now she had that times 10. She had intended to go directly to another nursing contract, but she decided not to do that because she still feels foggy. She was functioning fine, but it was that little memory gap is exaggerated. She decided to come back home in her own environment and get back to 100% before she took another nursing contract. She felt like all of her symptoms are directly related to the Covid 19 virus. She had been hearing other people who have had the Covid 19 virus that there are problems with delayed memory. She thinks it was a common thing. She had been reading about the delayed memory and she feels more comfortable knowing that it will pass. Physically she was fine. The shortness of air had gone. She went to donate plasma and they said she was not a candidate because she had the Bamlanivimab infusion. The lady at the plasma facility told her she could try to donate again later. She thought she tried to donate plasma around the first part of Mar2021. She does not recall the exact date. she believed it was an inflammatory thing. predisposing factors was, she was floated to the emergency department, she was not supposed to have any patients, she was only supposed to be tasking and she was given a patient assignment. Throughout the day she ended up having 4 positive Covid 19 patients and they were very sick. She was foggy that day, real drowsy she did not recall the emergency room saying they were going to culture this or that, she never received information of a positive culture. Patient display clinical signs at rest indicative of severe systemic illness, Fever 102.6F. Patient did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. New or worsened symptoms/signs during the COVID-19 illness experienced (including date of onset/worsening) was Respiratory: dyspnea. The patient received any additional therapies for COVID, Bamlanivimab infusion. It was unknown, from how many days the SARS-CoV2 diagnosis did it take before the SARS-CoV2 antigen test became negative and if patient had SARS-CoV2 antibodies at diagnosis. The patient was not hospitalized. The patient was not admitted to an Intensive Care Unit. She put her glasses on to see the print on the inhaler. Product strength and count size dispensed and Packaging sealed and intact were unspecified. The patient underwent lab tests and procedures on 07Jan2021 Covid 19 test, which was positive and on 09Jan2021, which included chest x-ray, which was negative, Chest CT scan which was negative, fibrin d dimer which was elevated and Covid 19 test which was positive. Therapeutic measures were taken as a result of shortness of air with minimal exertion (dyspnoea exertional). Method of assessment for events were reported as Global Introspection and Drug results were Unrelated. Outcome of the shortness of air with minimal exertion, fainted, had no energy, extreme fatigue, nauseated and she could not eat, lost her taste and smell were unknown, outcome of tested positive for covid 19 was recovering, fever was recovered on 19Jan2021 and delayed memory/memory gap is exaggerated and feels foggy on 06Jan2021 were not recovered.  No follow-up attempts are possible. No Further information is expected.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of exertional dyspnea,covid19. The case will be reassessed once new 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