Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Restless legs syndrome
Clinical narrative: very grumpy; crying at nothing; fatigue and tiredness; arm soreness; pain throughout body; caller already has restless leg syndrome but this is making it worse; caller already has restless leg syndrome but this is making it worse; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8732 and Expiration Date: 13Jul2021, NDC number: 59267-1000-1) via an unspecified route of administration, administered in upper right arm on 10Apr2021 at 08:40 (at the age of 67-year-old) as a single dose for COVID-19 immunization at hospital. The patient medical history included ongoing anxiety, to help her sleep (sleep disorder), blood pressure abnormal, for heart (heart disorder), restless legs syndrome (ongoing for a couple of years) and she had a hard time seeing due to getting old (last 6 months she has not been able to see but she cannot go in for another year for new glasses). The concomitant medication included lorazepam at a dose of 2 mg twice a day for anxiety from an unspecified start date, trazodone at a dose of 50 mg, 2 tablets at bedtime for sleep disorder, has been on for 6-8 months, simvastatin at a dose of 40 mg (been on for a good 15 years) for blood pressure abnormal from on an unspecified date in 2006, candesartan at a dose of 16 mg (been on for 2 years) from on an unspecified date in 2019 and metoprolol at a dose of 25 mg (been on for about 2 years, started at the same time as candesartan) for cardiac disorder and still ongoing. The patient did not receive other vaccinations within four weeks prior to the first administration date of the vaccine. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6199 and Expiration Date: 30Jun2021, NDC number 59267-1000-2) via an unspecified route of administration, administered in upper right arm on 20Mar2021 at 08:40 as a single dose for COVID-19 immunization and did not experienced any adverse event. The patient previously received regular flu shot last year for immunization. The patient had no adverse event following prior vaccinations and no family medical history relevant to adverse event. The patient stated that, she seems to have side effects from the COVID-19 Vaccine. On 10Apr2021, the patient got the shot and went home, her arm was so sore she could not lift it above her arm, it was just a little bit there but not bad at all and she had pain throughout body that started right after the vaccine and gotten a little better. The next day (11Apr2021), patient had tiredness and stayed in bed all day. She was still feeling tired, and the fatigue was hanging on. The patient heard that fatigue can be a side effect. On 12Apr2021, the patient was grumpy, and she cried at nothing that gone along with grumpiness. She does not know if she has depression or something. She was not too grumpy today (as per the report) and was still ongoing. It was reported that she had to run upstairs to get the information on the vaccine she received but she cannot really run and stated that she had restless leg syndrome, but this was making it worse and some of the veins glued because of this and was being in pain and all of this, it does not help, and restless legs have been going on for a couple of years, it just is not getting any better and the pain does not help. She stated that her little vein doctor was trying (as reported). Patient received Tylenol as a treatment for the events arm soreness and pain throughout body, the first night after getting the shot, that is the only time because she does not know how often to take aspirin or anything. The events did not result in physician office and emergency room. Patient stated that she will consult her physician. The outcome of the events arm soreness, pain throughout body was recovering, restless leg syndrome was unknown, and the rest of the events was not recovered.  No follow-up attempts are needed. No further information is expected.