right leg paresthesia;   This is a report from an interventional study managed and reported by Pfizer on the sponsors behalf.   A 53-year-old female subject received the first dose of blinded vaccine therapy (BNT162;PLACEBO) on 14Aug2020 at 11:33 and the second dose on 04Sep2020 at 13:13, both via intramuscular (IM) in the left deltoid as single doses for immunization. The subject's medical history includes ongoing chronic migraines (from 2008); neck pain since 2008 with temporary relief from chiropractic manipulation; osteopenia; vitamin D deficiency (2013 to 2014) controlled with Vit D supplements until now; Vit B12 deficiency. In 2014, the subject was diagnosed with occipital neuralgia, right greater than left. She got a steroid injection and did a one-month oral steroid taper, both without relief. She declined to try gabapentin, pregabalin (LYRICA) or other neuropathic pain medications. In addition, the  chronic migraines occur 1-2 times per month requiring multiple therapeutic interventions (including B2/Mg, doxepin, zolmitriptan (ZOMIG) as needed (PRN)) and had an episode of intractable chronic migraines without aura and status migrainosus treated with botulinum toxin type A (BOTOX) in 2016. She had experienced relief with botulinum toxin type A and zolmitriptan. Per neurology visit on 01Mar2016, the subject did not feel a typical aura for the migraines, she may have some scalp tenderness or neuralgia-like feeling. She had never had a complicated migraine. Subject's family medical history relevant to adverse event was none. The subject had no concomitant vaccines or prior vaccines (within 4 weeks). Concomitant medication included zolmitriptan for migraines from 2008, vitamin D from 2013 as supplement, both ongoing. On 20Oct2020, the subject started experiencing right leg paresthesia, which required a visit to the physician's office and was considered as an important medical event. On 28Oct2020  the subject underwent a nasal/sinus surgery after which she was given codeine phosphate/paracetamol for three days. On 02Nov2020, she had lower back pain and bilateral lower extremities pain including a shooting "patchy" pain, worse on the right side. Her legs and parietal scalp were sensitive to touch with an associated burning pain. She also reported tenderness in bilateral inguinal area. Symptoms had a gradual onset approximately 3 weeks before. Subject had a magnetic resonance imaging (MRI) of her back which appeared "ok" but she had not seen her primary care physician (PCP) or a neurologist. She denied a history of neurologic or lower back problems. Investigator had a follow-up on 10Nov2020. The paresthesia and skin sensitivity on head had improved but not resolved. Subject still required use of analgesic daily. At its worst, her pain was 6-7/10 in severity. When symptoms started, pain severity was 8-9/10 for a couple of weeks. Without use of analgesic, she had significantly decreased level of activity. But the pain did not prevent activity. With analgesics, she was able to function adequately despite persistence of a mild constant pain of lower back and legs which rates as 1-2/10 in severity. She had required use of some form of analgesic since pain started on approximately 20Oct2020. She had used paracetamol (TYLENOL), ibuprofen (ADVIL), codeine phosphate/paracetamol (TYLENOL#3), and most recently celecoxib (CELEBREX). She said the pain started on approximately 20Oct2020 but then said it started closer to 5 weeks after vaccination 2. She had not noticed any exacerbating factors. Subject denied any recent injury, travel, infection, or change in diet. She went for a walk on 10Nov2020 and walked approximately one mile without a problem. She stopped walking by choice not due to pain. Initially, adverse event was not reported since there was no official diagnosis and symptoms were believed to have occurred approximately six weeks after second vaccination. Despite still not having an official diagnosis, investigator had opted to report this as an important medical event since symptoms had persisted and the subject believed they started closer to five weeks after vaccination which was close to the four week post-vaccination observation period. Medical records from the neurologist were obtained. Per the note from 06Nov2020, MRI of cervical spine done several years before showed mild degenerative changes and spondylosis. MRI of lumbar spine recently done by subject showed: "degenerative discopathy, small left central disc protrusion at T5-T6 with minimal indentation thecal sac; No spinal cord compression, spinal canal stenosis or neural foramina narrowing; Multilevel hypertrophic changes of the facets within the lumbar spine with no neural foramina stenosis; Incidental finding multilevel small hemangiomas in cervical and thoracic vertebral bodies." Neurologic exam on 06Nov2020 was normal Including gait and tandem walk. Tenderness was noted in lower extremities musculature bilaterally throughout and large mobile inguinal lymph nodes palpable bilaterally. Lab ordered by neurologist were normal including Vit B12 635 (200-960PG/ML), Folate 19.6 (equal and more than 6.0UG/L), Vit D 25-Hydroxy 33 (30-100NG/ML), Total creatine phosphokinase (CK) 45 (28-176U/L), erythrocyte sedimentation rate (ESR) 15 (0-20MM/HR), C-Reactive Protein 0.3 (less than 0.5MG/DL), serum aldolase 3.9 (1.5-7.2U/L), thyroid stimulating hormone (TSH) 1.130 (0.400-4.100UIU/ML), FREE T4 1.42 (0.80-1.90 NG/DL), lyme antibody 0.25 (Negative less than 0.9), antinuclear antibody (ANA) negative; serum protein electrophoresis normal, no monoclonal protein seen. Neurologist impression included possible post-viral syndrome or an autoimmune process. There was no mention of concern for myelitis or plan for further work-up. Neurologist's recommendation was to continue celecoxib, PRN and follow-up with primary care physician if labs were unrevealing. Plan to have subject return to clinic to obtain more in-depth history and possibly some labs as well as request reports of MRIs. On 01Mar2021, the subject was seen for visit4, it was confirmed that the event was ongoing but continuing to improve. The action taken for blinded vaccine therapy in response to the event was not applicable. The outcome of the event was recovering.  The investigator considered there was a reasonable possibility that the event "right leg paresthesia" was related to blinded vaccine therapy (temporal relationship only, possible due to no other obvious potential etiologies), but unrelated to concomitant drugs or clinical trial procedure.  On 18Nov2020, the blinded code was broken due to serious, related, unexpected event.  Follow-up (10Dec2020): This is a follow-up report based on the receipt of the publication: No new information provided.  Follow-up (23Mar2021): New reported information included: clinical course (on visit4, confirmed that the event was ongoing but continuing to improve).; Sender's Comments: The event Paresthesia Lower Limb is unlisted in the Single Reference Safety Document (SRSD) of the Investigational Product blinded therapy vaccine (BNT162;PLACEBO).   There is not a reasonable possibility for the event paresthesia lower limb to be related with the blinded therapy vaccine (BNT162; PLACEBO). As an individual case report, there is not enough evidence to establish a causal relationship with the study vaccine apart from a chronological association at this time of the report. Based on the information currently available, it is more likely that the event is associated with the subject's underlying known neurological conditions.  The impacts of this report on the benefit/risk profile of the Pfizer product and on the conduct of the study 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 Committee and Investigators, as appropriate.