Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity, Ultrasound Doppler
Clinical narrative: Whole Leg Pain after first dose of Covid Vaccine/hurt in her thighs, knees, calves, and down into her ankles; Lower back sore intermittently/The back pain fluctuates from a pressure and mild ache to soreness; This is a spontaneous report from a contactable other nurse (patient). A 65-year-old female patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine), via an unspecified route of administration, administered in Deltoid Left on 29Mar2021 10:30 (Batch/Lot Number: ER8727) as First Dose; Left Deltoid for covid-19 immunization. Vaccination facility type was in pharmacy. No vaccines administered on same date of the Pfizer suspect. None prior vaccinations within 4 weeks. Family medical history relevant to AE was none. Medical history included ongoing high cholesterol diagnosed about 30 years ago (it was hereditary), ongoing Hashimoto's thyroiditis diagnosed about 20 years ago. Concomitant medications included rosuvastatin taken for blood cholesterol from about 3 years ago in 2018 to Apr2021 (a few weeks after the first dose of the vaccine); levothyroxine sodium (UNITHROID) taken for Hashimotos thyroiditis and ongoing. Patient was not on any other cholesterol medication currently. About 2 weeks after the first vaccine she started having leg pain. It was whole leg pain. It hurt in her thighs, knees, calves, and down into her ankles. She went to her doctor who did doppler studies and found no blood clots in Apr2021. Thought maybe it was the cholesterol medications that she had been on for years; so she stopped taking it. The pain in legs subsided a few days later and ended a few days before she got the second vaccine. She was a hiker and was in amazing shape. She had not done anything different, nothing that would have exacerbated this. She believed her symptoms are medically significant as she did not know for sure what was causing them. She was uncertain if her symptoms have been caused by the Covid Vaccine. The event whole leg pain after first dose of Covid Vaccine required a visit to physician office. No emergency room visited. She had issues with her back.  She noticed something new. Her lower back was sometimes sore. It came and went intermittently; unlike the leg pain that was constant. The back pain fluctuates from a pressure and mild ache to soreness. This also occurred after both vaccines. The outcome of back pain was not recovered, of other event was recovered in Apr2021. The reporter (patient) was uncertain if her symptoms have been caused by the Covid Vaccine.; Sender's Comments: Based on the information currently available,The casual association between the reported event "Pain in extremity","Back pain" and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021467940 same patient/drug, different vaccine dose/AE