Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Right wrist swelling; Noticed decrease in gross motor function; Severe neck pain; Numbness, tingling, pins and needles in right arm and severe pain 10/10 in hand/same symptoms in left hand; Numbness, tingling, pins and needles in right arm and severe pain 10/10 in hand/same symptoms in left hand; Numbness, tingling, pins and needles in right arm and severe pain 10/10 in hand/same symptoms in left hand; Severe lower back pain 8 to 10/10; Disrupted sleep; Unable to bend over and tie shoes and to stand up straight / Unable to sleep sidelying on either side with neck turned since that resulted in pins and needles in arm and hand; This is a spontaneous report received from a contactable consumer other healthcare professional (The consumer reported for self)  A 41-years-old (non pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: ER8733, Expiration date: UNKNOWN), via an unspecified route of administration in Right arm on 03Apr2021 03:45 PM as single for COVID-19 immunisation. Medical history included anaemia, Extremely low ferritin levels, Arthritis of the cervical vertebrae. Known allergies to Kiwi, Tomatoes, nightshades from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19.  On April 5th to April 11th the patient experienced Severe lower backpain 8 to 10/10 which disrupted sleep and caused me to be unable to bend over and tie shoes and to stand up straight. Resolved with ATC Tylenol and Motrin after 6 days. On April 19th the patient Began noticing severe neck pain with concomitant numbness, tingling, pins and needles in right arm and severe pain 10/10 in hand. Adverse event start date: 19Apr2021. On April 20th the patient noticed the same symptoms in left hand. Unable to sleep side lying on either side with neck turned since that resulted in pins and needles in arm and hand. Pain 8 to 10/10 unrelieved by Tylenol and Motrin. Patient was only able to sleep on back with head in midline position. Patient noticed decrease in gross motor function, was unable to open doors with right hand, unable to make a fist with right hand. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events. Patient received Treatment for the adverse events which includes, 6 day course of steroid (Steroid taper 6days and started Neurontin 100mg TI) ordered by PMD resolved neck pain but still have numbness, tingling in both hands with daily continuous pain of 7 to 10 at any time. On April 28th: Right wrist swelling noted after steroid completion. Pain still persisting. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included Sars-cov-2 test (COVID test name: PCR Test; Test type: Nasal Swab): Negative on 24Apr2021. Outcome of the event Severe lower back pain 8 to 10/10, Disrupted sleep, unable to bend over and tie shoes and to stand up straight, Severe neck pain had recovered on 11Apr2021; the remaining events were reported as not recovered. ; Sender's Comments: Considering a plausible temporal relationship , a possible contributory role of suspect product BNT162B2 to the reported events 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.