Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Magnetic resonance imaging head, Muscle contractions involuntary, Muscle spasms, Pain
Clinical narrative: Fasciculation lower left leg; spasms in left leg and left thumb/muscle spasm (chronic pain) fasciculations lower left leg; Numbness in foot/Left hand and foot numbness; feeling of pins and needles in lower left leg and 3 middle fingers in left hand/tingling/extreme pains needles pain; pain in lower left leg, below the knee; Leg swollen from knee to toes/Lower left leg and foot swelling; Pain/left fingers left arm pain; This is a spontaneous report from a contactable consumer (patient) and a contactable consumer.  A 23-year-old female patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EW0167), at the age of 23 years old, via intramuscular upper muscle in left arm on 02May2021 at 14:19 at single dose for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Medical history included ongoing hypoparathyroidism from 2009, anxiety, depression, allergies, scoliosis from 2013 to 21Oct2014, spinal fusion surgery on 21Oct2014. Patient was not diagnosed with COVID-19 prior vaccination. Prior vaccination: None. Family medical history relevant to events: None. The patient did not receive other vaccine in four weeks. Concomitant medications in two weeks included montelukast sodium (SINGULAIR) at 10 mg orally taken for allergies from 2007 and ongoing; sertraline hydrochloride (ZOLOFT) at 100 mg orally taken for depression, anxiety from 2009 and ongoing; calcitriol at 100 mg orally taken for hypoparathyroidism from Dec2019 and ongoing; calcium carbonate at 600 mg orally taken for hypoparathyroidism from 2009 and ongoing; vitamin D3 (10 ug) at 400 iU orally taken for hypoparathyroidism from 2009 and ongoing; calcium carbonate (TUMS) at 1000 mg orally taken for hypoparathyroidism from 2009 and ongoing, undecipherable and ethyl esteadiol 0.1/0.02 mg orally taken for birth control from 2013 and ongoing. The patient previously took clarithromycin and experienced known allrgies. The patient previously received the first dose of BNT162B2 (lot number: EW0153), at the age of 23 years old, via intramuscular upper muscle in left arm on 11Apr2021 at 14:06 at single dose for COVID-19 immunisation. Patient woke up on 13May2021 with pain in lower left leg, below the knee. Experiencing numbness in foot. Leg swollen from knee to toes. Continued to have pain to this day and feeling of pins and needles in lower left leg and 3 middle fingers in left hand. Had spasms in left leg and left thumb. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with hydrocodone bitartrate (NORCO), gabapentin and muscle relaxants. Patient experienced lower left leg and foot swelling and extreme pains needles pain on 15May2021. Events resulted in physician office visit. Seriousness criteria was persistent. Treatment included nabumetone (RELAFEN), norethisterone (NORCA), prednisone ultrasound. Patient experienced left hand and foot numbness tingling also left fingers left arm pain on 22Jul2021. Events resulted in physician office visit. Seriousness criteria was persistent, important medical event. Treatment included EMG, CT scan, X-ray, labwork, 4 mri's. Patient experienced muscle spasm (chronic pain) fasciculations lower left leg on 29Aug2021 (also 29Sep2021). Events resulted in emergency room visit. Seriousness criteria was significant disability, important medical event. Treatment included ultrasound gabapentin or cynobenzaprine undecipherable. Patient had not been tested for COVID-19 post vaccination. The patient underwent lab tests and procedures which included CT scan low extrem LT WO contrast: mild soft tissue swelling on 01Jul2021, electromyogram (EMG): mild soft tissue swelling on 19Aug2021, endocrinology labwork: normal on 13Jul2021 (Rule out complications of hypoparathyroidism), left hand rulled out labwork: normal on 23Sep2021 (Labwork ruled out autoimmune disease), magnetic resonance imaging (MRI) left tibia/fibula: soft tissue muscle, mild bone edema on 19Jul2021 (Labwork ruled out autoimmune disease), MRI brain, cervical lumbar spine: normal on 13Aug2021 (Labwork ruled out autoimmune disease), left leg tibia fibula x-ray/ left leg x-ray: soft tissue swelling on 18May2021, swelling normal lab on 16Jun2021, left leg vascular ultrasound: normal on 25May2021. Outcome of events was not recovered.  Follow-up (21Oct2021): New information received from a contactable consumer (patient) in response to consumer letter sent via follow-up letter which includes seriousness criteria updated from non-serious to serious.  No follow-up attempts are possible. No further information is expected.