Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Pain
Clinical narrative: felt very dizzy; severe fatigue/she was so fatigued that she couldn't lift arms; aches all over her body; couldn't get out of bed; had been sick ever since; received a shot of Orencia; This is a spontaneous report from a contactable consumer (patient). An 82-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, Batch/Lot number: EN6201), dose 1 via an unspecified route of administration, administered in left arm on 26Feb2021 at 12:30 hours as DOSE 1, SINGLE (at the age of 82-years-old) for COVID-19 immunization. The patient's medical history included ongoing rheumatoid arthritis, had rheumatoid arthritis for 5-6 years, and hypothyroidism, has been hypothyroid for years. The patient's concomitant medications included abatacept (ORENCIA) taken for rheumatoid arthritis on 26Feb2021 at 10:30 hours, 125 mg/mL autoinjector dose, takes every Friday once a week; levothyroxine sodium (SYNTHYROID) taken for hypothyroidism from 1997; denosumab (PROLIA) shot taken for an unspecified indication on 23Feb2021. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines were administered on same date of the Pfizer Suspect. The patient had no prior vaccinations (with in 4 weeks). Family medical history relevant to events was not provided. The patient received the first dose of the Pfizer-BioNtech COVID-19 vaccine on Friday 26Feb2021 at 12:30 hours and that day at 10:30 hours, received a shot of Orencia that she takes every Friday for rheumatoid arthritis. The patient did not realize until after the vaccine was administered and got the paperwork that the patient should not take medicines that affect the immune system before the vaccine. On 26Feb2021 at 16:30 hours, late in the afternoon (4 hours after vaccine administration), the patient felt very dizzy, also had a severe fatigue/she was so fatigued that she couldn't lift arms and aches all over body (after dinner), for 2 days the patient couldn't get out of bed. The patient would like to know whether to receive the second dose of the vaccine on 19Mar2021. The patient further reported that after COVID-19 vaccination, the patient had been sick ever since and clarified of not getting out of bed for 2 days, saying ached, and was very fatigued. The patient was almost 83 years old. The patient did not get the COVID-19 Vaccine literature until after the shot. The patient read in the COVID-19 Vaccine literature about autoimmune diseases and did not realize that the patient had to be concerned with autoimmune diseases if she got the COVID-19 Vaccine. The patient has rheumatoid arthritis and was concerned whether she should get the second COVID-19 Vaccine shot, since the patient has rheumatoid arthritis, and had a reaction after the first COVID-19 Vaccine dose. The patient further reported of taking a rheumatoid arthritis shot once a week and clarified about self-administering an Orencia 125mg/mL auto injector dose once a week. The patient took an Orencia shot 2 hours before receiving her first COVID-19 Vaccine. The patient was unable to find the Orencia 125mg/ml autoinjector NDC Number on the product packaging providing number: 1369574A1, Lot Number: ABS1930, and Expiration Date: May2022. The patient informed endocrinologist about going to get the COVID-19 Vaccine but was not able to reach rheumatoid arthritis doctor. The patient clarified stating that she received her first COVID-19 Vaccine on Friday, 26Feb2021, at 12:30 hours and was fine. The side effects hit after dinner on 26Feb2021. The patient was so fatigued that she could not lift arms, experienced dizziness, and had all over achiness, as well. The symptoms continued all day Saturday (27Feb2021) and Sunday (28Feb2021). The patient was starting to feel better on the day of reporting, and the fatigue and achiness were gone on the morning of reporting. The patient still had a little dizziness (01Mar2021) and felt like someone punched her. The patient declined any treatment. The patient was scheduled to receive her second COVID-19 Vaccine shot on 19Mar2021. The endocrinologist performed blood work on Tuesday, 23Feb2021, and said everything looked fine. No further details provided. The patient further reported of having a Prolia shot when she saw her endocrinologist on 23Feb2021 and did not have the Prolia NDC, Lot, and Expiration Date. The Prolia shot was administered in her left arm on 23Feb2021. The adverse events did not require a visit to emergency room/physician office. No relevant tests were reported. The outcome for the events couldn't get out of bed was recovered on 28Feb2021; outcome for severe fatigue/she was so fatigued that she couldn't lift arms, and aches all over her body was recovered on 01Mar2021; outcome for the events had been sick ever since and received a shot of Orencia was unknown; and the patient had not recovered from the event felt very dizzy.  No follow-up attempts are possible. No further information is expected.