Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Myalgia, Pain, Pain in extremity
Clinical narrative: Intense pain in upper thigh, both legs; sometimes unable to walk/ could barely walk/ could hardly walk; muscle weakness; Cannot sleep at night; Had pain pretty much all day, This was intense pain and it kind of changed a little bit during the day; muscle pain in arms; 'BUN' test was outside of the parameters; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 01Mar2021 (Batch/Lot Number: EN6205) (at the age of 81 years) as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation. Patient was not pregnant at time of vaccination. Medical history included low back pain, overactive bladder urgency, allergies: dye in CT scan, type 2 diabetes mellitus, flu, been achy, hip replaced about 2 years ago in 2019. Concomitant medications included metformin taken for an unspecified indication, start and stop date were not reported; atorvastatin taken for an unspecified indication, start and stop date were not reported; glimepiride (GLIMIPRIME) taken for an unspecified indication, start and stop date were not reported; omeprazole taken for an unspecified indication, start and stop date were not reported. Patient previously took modafinil (PROVIGIL). Patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 08Feb2021 14:30 (Batch/Lot Number: EL9264) (at the age of 81 years) as single dose for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. It was reported that patient experienced intense pain in upper thigh, both legs, sometimes unable to walk, general muscle weakness, began 48 hrs post-2nd vaccine (also reported as occurring on 10Mar2021 22:00). Became less in 24 hrs, became intense again in another 24 hrs, and has continued ever since. Patient cannot sleep at night. Patient clarified she had it ever since 48 hours after second dose on 01Mar2021 and it's very unpleasant and does not know what to do about it and wanted to report it. These did not happen immediately and after second vaccine, patient did not have any problem till 48 hours, 10 o'clock, she had it on Monday at 12:00 and at 10 o'clock in the evening on Wednesday, she started to get intense pain on right side, she could barely walk and she have never had pain there before and she tried to walk and she was 81, she goes to the bathroom frequently with bladder issues and that was hard and it went on all night. In the morning, she had it not only in right leg but upper side like above the knees but in the front not in the back of the leg and then the next day, when she woke up and then, she had it in the upper side in left leg and closer to the groin and more like around and didn't know what to do and she wasn't going to go to an emergency ward as she was 81 and she doesn't go around that easily. Patient called her doctor, and patient had pain pretty much all day and he said how was it now and told him that it was slightly better. He said more than likely it will go away but he kept saying these are the kind of side effects that they were reporting though flu like achiness was nothing like what she had, she have had the flu (history) and been achy (history) but this wasn't like that. This was intense pain and it kind of changed a little bit during the day but it was still there. Her doctor said, if it doesn't go away by tomorrow morning which was Friday, then make an appointment and come in to see her, she will do blood work or whatever. So, she got an appointment for 2:30, by noon, it was just gone totally gone like if it never had been there. She cancelled the appointment then yesterday she got it back again and she could hardly walk but it wasn't as intense, it was really painful and hard for her to walk and it was around both legs and she doesn't know what to make of that, she went to rheumatologist because she thought she might be having muscle pain in arms from something else, he did some blood work (unknown results), he couldn't make anything out of it and he said he will look at the blood work and he gave her kind of a steroid cream to rub on arm (treatment) which she thought she had a problem but months ago (consumer was not sure). Now she couldn't sleep last night, it was so uncomfortable, and she had to go to the bathroom several times and again it really hurts to walk. So, that was what happened to her and she would not call that achiness of the flu at all. Regarding treatment, patient took Tylenol, do take other medications but nothing unusual and take the same that she always have and by the way the intense pain was only in one leg for twelve to twenty hours and then all of a sudden it began in the left leg as well and slightly with different pace but still on. The one in the right leg was most intense, she could barely stand. For laboratory test, the 'BUN' test was outside of the parameters and after getting several tests he did, she wanted to see if she had some sort of rheumatoid thing and they are all in her record. This was not one of the typically adverse reactions that people reported at least according to what she read and according to aspects of it. The outcome of events pain, muscle pain in arms, and BUN abnormal was unknown while for other events was not recovered.   No follow-up attempts are needed. No further information is expected.