Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: International normalised ratio, Irritability, Joint swelling, Lethargy, Malaise
Clinical narrative: tired and exhausted; Panic/anxiety; Panic/anxiety; feels like her ribs are killing her; Back hurts; Arms hurt the front of her breasts; Her feet, ankles, calves and back hurt; Bones feel hurt; injection site is just sore; Lethargic; When I get up it actually hurt to walk all my ankles on my feet now; the site is very red and very sore and swollen; I had all kind of things going on but did not feel as weak as I felt the next couple of days; I still was not feeling right/I just did not feel well; Joint pain/Joint were bothering; Chills/extreme chills to my bones; body and muscle aches/Pain in my muscle; the site is very red and very sore and swollen; body and muscle aches; Slept the entire week/she just wanted to sleep; Touching of my skin it hurts; Everything was irritating her/it's irritating, wearing cloths irritated, the sheet irritate it, my thigh, joint, hip, knees, shoulder, the back of my arm, elbows, forearm; This is a spontaneous report from a contactable consumer or other non hcp. A 61-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6206), via an unspecified route of administration on 12Mar2021(at 61-years-old) as single dose for covid-19 immunization. Medical history included , thoracic outlet syndrome She had a pectoral flap moved up to her chest , thyroid disorder, autoimmune thyroiditis, renal stone removal from 08Feb2021 to an unknown date She had a kidney stone removed and had complications with that and he called the other day and said she has a UTI, which is a reoccurring , ongoing urinary tract infection , heart valve replacement from an unknown date and unknown if ongoing , coronary artery bypass from an unknown date and unknown if ongoing , coronary artery disease from an unknown date and unknown if ongoing. Concomitant medication(s) included ranolazine (RANEXA) taken for an unspecified indication, start and stop date were not reported; semaglutide (OZEMPIC) taken for an unspecified indication, start and stop date were not reported; metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (EUTHYROX) taken for an unspecified indication, start and stop date were not reported; empagliflozin (JARDIANCE) taken for an unspecified indication, start and stop date were not reported. The patient previously took Percocet [oxycodone hydrochloride; oxycodone terephthalate; paracetamol] for cardiac operation, warfarin. The patient reported that she had the first dose of the vaccine on 12Mar2021. It started about 3 o'clock in the morning (13Mar2021). She was experiencing something she had never experienced before. Later that night and more towards the morning she had joint pain. She noticed this first in her ankles and feet, she only noticed that because she had to go to let her dog out. Then the next day, she had pain in her muscle she had chills to the bone, and she just started with body and muscle aches and that was all last week and she slept the entire week. She had the chills really bad. The site was very red and very sore and swollen. She was like that Saturday, joint pain and chills and then she called a friend of her who got first shot but she got Moderna and she said she had symptoms similar to that (hence submitted as split case), said that was not big deal, that means it working so she was like okay. Then on Sunday she still was not feeling right. She got up and took Xanax. She took her normal medication. She took Xanax for anxiety (Intent: Treatment) and took 5 mg percocet (Oxycodone) for joint pain in order to function, get up and get around and do stuff with her husband who was only home on the weekend. So anyhow she did that on Sunday. She ended up coming to bed early and she fell asleep and the entire week last week she did not do anything she just stayed in bed and she just felt very lethargic. The patient actually fell asleep trying to talk to her husband on the phone, she means on video chat because we video chat every night while we he was awake. So, she thought she was just tired, so she stopped video chat with him and just started talking to him every night and this was last week, and I was really tired. She was in her bed. She had one of the beds where pop comes up and legs come up because she had underlying condition. A big deal underlying condition and all last week she stayed in bed all week and she just slept and when she gets up it actually hurt to walk all her ankles on her feet now. It feels like just touching of her skin, this was been going on since yesterday maybe Friday, just touching of my skin it hurts, it was irritating, wearing cloths irritated, the feet irritate it, her thigh, joint, hip, knees, shoulder, the back of her arm, elbows, forearm, and just tried to massage them and just tried to get through it yesterday. The patient took yet again an anxiety medication within addition to my other medication. She took anxiety medication and an Oxycodone. So that she can go to viewing her husband's friend passed and people were like what's wrong with you, you look like you could fall asleep. They did not stay long, came back home and climbed back in bed and that was where she was all day yesterday. She had not taken anything thus far and literally the sheets she got up last night and as she tried to slide out of bed, it literally hurts rubbing the sheet back of my leg and then getting up out of her bed going in into the bathroom because she had other issues, bladder issues. So, this morning she still had some issues and her husband said could it be the result of the covid, the vaccine you got, and she said you know what I never even thought of that, so she started reading some paperwork and it was like joint pain. She was like well she got more than joint pain or muscle pain that she got joint muscle and chills. She was still feeling the same way. Her back hurts just lying on the bed and hurts. When she gets up to move it feels like her ribs are killing her, her arms hurt the front of her breasts. This was something new and prolonged. Walking to the kitchen her feet, ankles, calves and back hurt and her nightgown is hurting her skin. Her bones feel hurt, and her calves hurt. The injection site was just sore. The patient did not have chill at the time of report but jacked up the heat in her house. The patient normally keeps it at 68 all year around whether a heat or cold she turned up the heat and stayed in bed and at the time of report she was under sheet blanket and heavy comfort. The patient asked could any of this related to the shot. It was reported that she tests her own INR and it went down to 2.2, it was up to 2.8 and for some reason it dropped down to 2.2 in middle of the week and I am due to test tomorrow and for some reason the doctor called but that his test was done before she got the shot. The patient stated that she supposed to figure out the drug interaction, possible drug interaction maybe as she takes other drugs. The patient reported that she still experiencing symptoms and it could be due to the Pfizer vaccination. The patient asked that how long can she expect these symptoms to last. She asked if the symptoms reported in the clinical trials with people with underlying conditions. The patient underwent lab tests and procedures which included international normalized ratio: 2.2 it was up to 2.8 and for some reason it dropped down to 2.2 in middle of the week. The patient received treatment. The clinical outcome of the events tired and exhausted, panic/anxiety, back hurts, calves and back hurt, bones feel hurt, lethargic, when i get up it actually hurt to walk all my ankles on my feet now, touching of my skin it hurts, irritability, the site is very red and very sore and swollen was unknown whereas the remaining events was not recovered. No follow-up attempts are possible. No further information is expected