Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: a swollen lymph node under her left ear after the first dose; she has a bad back; barely able to get out of bed because the pain was so severe.; her joints, her bones hurt; Has lumbar pain, which is really bad anyway; She hurts all the time anyway because she has degenerative joint disease and had a lumbar fusion but has never been in so much pain in her life; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 70-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6201, Expiry date: Unknown) dose 1 via an unspecified route of administration in Arm Left on 08Feb2021 11:00 as single dose for COVID-19 IMMUNISATION. The patient also received ethinylestradiol, norelgestromin (XULANE, Lot Number: 1391558; Expiration Date: May2022), via an unspecified route of administration from an unspecified dateand ongoing (Lidocaine patches 5% apply as needed) for pain; paracetamol (TYLENOL ARTHRITIS, Lot Number: PAA062; Expiration Date: Sep2021), oral from an unspecified date and ongoing (Extended release, extra strength 8hours), 650mg, tablets by mouth as needed for pain; insulin degludec (TRESIBA, Lot Number: KZFN101; Expiration Date: Dec2022), via an unspecified route of administration from 27Feb2020 and ongoing (100ml/3mg, administer 14 units every day at night in stomach area) for diabetes mellitus. Medical history included ongoing chronic obstructive pulmonary disease, ongoing diabetes mellitus, ongoing polycythaemia vera secondary, ongoing osteoarthritis, ongoing spinal fusion surgery, scoliosis, spasmodic dysphonia, pain, obesity she is obese and has a lot of weight to carry. Concomitant medication(s) included umeclidinium bromide, vilanterol trifenatate (ANORO ELLIPTA) taken for chronic obstructive pulmonary disease from an unspecified start date and ongoing; insulin (INSULIN) taken for an unspecified indication, start and stop date were not reported. The patient previously took influenza and experienced pain in extremity, metformin hcl (Metformin HCL ER 500mg for 2 years and was having issues), jardiance and jardian and experienced drug ineffective and Glimepiride which put her in the hospital.On an unspecified date, the patient experienced a swollen lymph node under her left ear after the first dose, she has a bad back, her joints, her bones hurt, has lumbar pain, which is really bad anyway. The patient states she had a stupid question. Had her first Covid-19 vaccine since she was a senior on 08Feb2021. She was a diabetic. She didn't feel a thing when the lady gave her the Covid-19 vaccine she was really good and the facility was really good. Started then having every day after the shot a little bit of symptoms but was just trying to prepare herself for her 01Mar2021 symptoms because she has a bad back. One of her symptoms, it seemed like every one of her joints, her bones hurt. She hurts all the time anyway because she has degenerative joint disease and had a lumbar fusion but has never been in so much pain in her life that lasted about 4 days and was really intense. The patient mentions that she had other health issues, and not sure if her insulin and other things may interfere. Doesn't know if she has arthritis or she may get it in the future. Had lumbar pain, which was really bad anyway, but this pain was sunk down in the joints of her fingers, neck, feet, legs, just about all joints and she is obese and has a lot of weight to carry. It was really intense. Lymph nodes below her ears were swollen. Does feel a little better, but she always just has the pain.  Again, mentions she was trying to prepare for the second shot and from what she read the second shot was a huge shot. The first shot was like a primer and the second shot will be the one to help her really well. The patient enquired that would second shot make her side effects worse. Wants to be sure so she can buy groceries before because she was barely able to get out of bed because the pain was so severe. Normally uses Xulane patches (Lidocaine patch 5%) on her butt or take Tylenol. Puts those patches on her butt since it's big enough. If she can use things like that would that interact with the shot. The patient mentioned she lost a couple of inches due to history of scoliosis and has history of spasmodic dysphonia. Clarifies conditions before receiving Covid-19 vaccine. Again, mentions she always has the back, lumbar pains but they got worse than normal pains, it was elevated. It was worse 2 days after the vaccine and then hit a plateau and today she feels almost herself. Again, mentions the joint pains and she has Polycythemia vera secondary, which was a blood cell condition and has COPD. Mentions those conditions also before receiving the Covid-19 vaccine. No other vaccines received that day and none 4 weeks prior. States she only has had soreness in the arm with the flu shot she received back in Nov2020. Unable to provide NDC, Lot, or expiry for flu shot. One of her friends was a retired nurse and told her the line for the vaccine wasn't long that day and they were taking people age 70 an dover and she was finally cleared from the Pulmonologist and Endocrinologist. They didn't see any reason she shouldn't get it and left that decision up to her. The patient had an appointment next week for fasting blood work with the Endocrinologist. The patient was contacted to collect product details for Xulane patches and Tylenol after initial call. When providing product details for Xulane and Tylenol caller mentions print on Xulane is hard to see with her bifocals. The patient mentions has appointment next month for fasting bloodwork on 01Mar2021 and she has to see the endocrinologist next week on the 8th so she does not know if the units of her insulin will change. Then mentioned she was on Metformin HCL ER 500mg for 2 years and was having issues with that and they started her on samples of different kinds of things. Has been on Jardiance and Jardian. None of those samples worked. Was worse on the Jardiance and when on Glimepiride, which put her in the hospital, that should be outlawed. Unable to provide NDC, Lot, or expiry for samples, Metformin HCL ER, Glimepiride, Jardiance and Jardian. Caller provides spellings of product names. When providing insulin, Tresiba, details stated she used to give it in the thigh but it made her fat hurt. The Tresiba has been working the best. No further details provided. Also mentions she also has an emergency inhaler but does not provide any further details. The outcome of the event a swollen lymph node under her left ear after the first dose, her joints, her bones hurt, has lumbar pain, which is really bad anyway was not recovered. The outcome of event she has a bad back was unknown.