Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dyskinesia, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: severe involuntary body movements returned worse than ever; severe involuntary body movements returned worse than ever; Relevant past drug history, Patient Drug Start date 21Dec2021/Date of start of drug 04Feb2022; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Feb2022 15:15 (Lot number: 33036VD) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypotension" (unspecified if ongoing); "Intracranial hypertension" (unspecified if ongoing); "Insomnia" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "Anorexia-bulimia" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "Epilepsy" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Known allergies: strawberry/ cherries/ coconut" (unspecified if ongoing); "Peanut" (unspecified if ongoing); "Tree nut" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Covid-19", start date: 29Dec2021, stop date: 29Dec2021. Concomitant medication(s) included: ACETAZOLAMIDE; ALBUTEROL [SALBUTAMOL SULFATE]; ASMANEX; MELATONIN; VITAMIN D [VITAMIN D NOS]; TIZANIDINE; TOPIRAMATE; CYMBALTA; EPINEPHRINE; LEVOCETIRIZINE; LYRICA; TRAMADOL; ZOFRAN [ONDANSETRON HYDROCHLORIDE DIHYDRATE]; PANTOPRAZOLE; MIRALAX; FIBER SUPPLEMENT; SEROQUEL; SILODOSIN. Past drug history included: Sudafed, reaction(s): "known_allergies:Sudafed"; Reglan, reaction(s): "Known allergies:Reglan"; Keflex, reaction(s): "Known allergies: Keflex"; Amoxicillin, reaction(s): "Known allergies: amoxicillin"; Depakote, reaction(s): "Known allergies: Depakote". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: SJ1620, Vaccine Administration Time: 03:15 PM, Route of Administration: Intramuscular), administration date: 21Dec2021, for COVID-19 immunization. The following information was reported: DYSKINESIA (medically significant), CONDITION AGGRAVATED (medically significant), outcome "not recovered" and all described as "severe involuntary body movements returned worse than ever"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 04Feb2022 15:15, outcome "not recovered", described as "Relevant past drug history, Patient Drug Start date 21Dec2021/Date of start of drug 04Feb2022". The events "severe involuntary body movements returned worse than ever", "severe involuntary body movements returned worse than ever" and "relevant past drug history, patient drug start date 21dec2021/date of start of drug 04feb2022" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of dyskinesia, condition aggravated.  Clinical course: She was smacking herself in the face with items she was holding. The involuntary movements occur over and over again at rest or at movement. She almost fell again. Neurologist wasn't sure how to treat. She never had a tic prior. the patient provide information to you regarding the reported adverse event(s) with the use of the product. the Pfizer product do not had a causal effect to the adverse event. I am her neurologist. I am not/ was not is not involved in her vaccine. Please contact her PCP.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be 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