Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Pain, Polymerase chain reaction, SARS-CoV-2 test
Clinical narrative: felt like my legs were burning; so much physical pain; severe muscle spasms; twitches; Anxiety; depression; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Jan2021 08:30 (Lot number: EJ1686) at the age of 29 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "chronic pain" (unspecified if ongoing). Concomitant medication(s) included: METHOCARBAMOL; GABAPENTIN; VENLAFAXINE; BUTALBITAL. Past drug history included: Zofran, reaction(s): "Zofran: Drug Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Pfizer EH9899, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 08:30 AM), for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The following information was reported: BURNING SENSATION (disability) with onset 12Feb2021 19:00, outcome "not recovered", described as "felt like my legs were burning"; PAIN (disability) with onset 12Feb2021 19:00, outcome "not recovered", described as "so much physical pain"; described as "needed a walker to walk or a wheelchair at stores/prolonged events"; MUSCLE SPASMS (disability) with onset 12Feb2021 19:00, outcome "not recovered", described as "severe muscle spasms"; MUSCLE TWITCHING (disability) with onset 12Feb2021 19:00, outcome "not recovered", described as "twitches"; ANXIETY (disability) with onset 12Feb2021 19:00, outcome "not recovered", described as "Anxiety"; DEPRESSION (disability) with onset 12Feb2021 19:00, outcome "not recovered", described as "depression". Reported that she had severe muscle spasms, constant pain, twitches/spasm that are visibly seen. Anxiety, depression from the result of the constant pain and spasms. They have not figured out something that helps them. The events "felt like my legs were burning", "so much physical pain", "needed a walker to walk or a wheelchair at stores/prolonged events", "severe muscle spasms", "twitches", "anxiety" and "depression" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: antibodies: (04Jan2022) positive, notes: Blood test; PCR: (04Jan2022) negative, notes: Other; Nasal Swab: (04Jan2022) negative. Therapeutic measures (pain medicines, muscle relaxants, nausea medicine) were taken as a result of burning sensation, pain, muscle spasms, muscle twitching, anxiety, depression.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the events -  Depression, anxiety, muscle twitching, muscle spasms, pain, burning sensation, and the suspect drug "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.