Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Disease recurrence, Insomnia, Pain in extremity, Ultrasound Doppler
Clinical narrative: Whole Leg Pain after second dose of Covid Vaccine; Lower back sore intermittently; This also occurred after both vaccines.; Leg pain making it hard to sleep; This is a spontaneous report from  PPDi. A contactable nurse reported herself that a 65-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Deltoid Right on 20Apr2021 10:15 (Batch/Lot Number: ER8731) as 2ND DOSE, SINGLE for covid-19 immunization, with Age at Time of Vaccination at 65 years old.  Medical history included ongoing blood cholesterol increased (Verbatim: High cholesterol. Stated she was diagnosed about 30 years ago. Said it was hereditary), ongoing autoimmune thyroiditis (Verbatim: Hashimoto's thyroiditis. Stated she was diagnosed about 20 years ago). Historical vaccine included first dose of Covid Vaccine (Batch/lot number: ER8727) on 29Mar2021 given at 1030, at Left Deltoid and experienced whole leg pain (about 2 weeks after the first vaccine she started having leg pain). Concomitant medications included rosuvastatin taken for blood cholesterol from an unspecified start date to Apr2021 (reported as Started medication about 3 years ago.  Stopped a few weeks after the first dose of the vaccine, was not on any cholesterol medication at this time); levothyroxine sodium (UNITHROID) taken for autoimmune thyroiditis from an unspecified start date and ongoing. The patient experienced whole leg pain after second dose of covid vaccine (medically significant) on Apr2021 with outcome of not recovered, lower back sore intermittently (non-serious) on Apr2021 with outcome of not recovered, leg pain making it hard to sleep (non-serious) on Apr2021 with outcome of unknown.  The patient underwent lab tests which included ultrasound doppler: no blood clots on Apr2021. Reported she went for her second vaccine and about 5 days later the leg pain came back. Said she took Tylenol and Motrin, nothing helps the pain.  Said her legs have been hurting for about 4 days now. Stated that her pain seems unusual because it goes all the way down into her ankles and travels back and forth. Caller stated that she was a hiker and was in amazing shape.  She had not done anything different, nothing that would have exacerbated this. Caller states she retired after being a Licensed Practical Nurse for 30 years in 2019. Caller stated that the leg pain after her first vaccine started about 2 weeks after the vaccine and lasted for about a week.  Said it ended a few days before she got the second vaccine. Caller stated that her leg pain after the second vaccine was ongoing.  Said that she got the vaccine on a Tuesday and her legs started to hurt again around Friday. Said that was effecting her life.  Her legs hurt in every position.  It was making it hard for her to sleep. Stated she believed her symptoms were medically significant as she did not know for sure what was causing them. Later in the call the caller mentioned that she had issues with her back.  Said she noticed something new.  Her lower back was sometimes sore.  It comes and goes intermittently; unlike the leg pain that was constant.  Stated the back pain fluctuates from a pressure and mild ache to soreness.  This also occurred after both vaccines. Treatment received included: Tylenol and Motrin that did not offer any relief for her leg pains: Tylenol Extra Strength 500mg; P121876; Expiration Date:  Sep 2023.  Stated she took 2 tablets at a time. Motrin 200mg; 0GE2545A; Expiration Date: Mar 2022.  Stated she took 2 tablets at a time. Causality: Stated she was uncertain if her symptoms have been caused by the Covid Vaccine.  Follow-up attempts have been completed.; Sender's Comments: Based on the temporal association, there is a reasonable possibility that the administration of vaccination BNT162B2 played a contributory role in triggering the onset of the event pain in extremity. 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  Committees and Investigators, as appropriate.,Linked Report(s) : 2021467913 same patient/drug, different vaccine dose/AE