Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Pyrexia, Seizure, Tardive dyskinesia
Clinical narrative: that night, she experienced a lot of side effects related to Tardive Dyskinesia/That are kind of some of these are a lot higher intensity, than they normally are for her Tardive Dyskinesi; She had the booster shot from Pfizer and that night, she experienced a lot of side effects related to Tardive Dyskinesia; she thought she was having a seizure; She also had fever and chills; She also had fever and chills; This is a spontaneous report received from a Pharmacist.  A 62-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; deutetrabenazine (AUSTEDO), (Lot number: 100034330, Expiration Date: 13Sep2024) for tardive dyskinesia. The patient's relevant medical history included: "Tardive Dyskinesia" (unspecified if ongoing). Concomitant medication(s) included: ABILIFY; FLUDROCORTISONE; GABAPENTIN; PROLIA; PROPRANOLOL; PROZAC; QULIPTA; SYNTHROID; TOPAMAX; VENLAFAXINE. The following information was reported: CONDITION AGGRAVATED (medically significant), outcome "unknown", described as "that night, she experienced a lot of side effects related to Tardive Dyskinesia/That are kind of some of these are a lot higher intensity, than they normally are for her Tardive Dyskinesi"; TARDIVE DYSKINESIA (medically significant), outcome "unknown", described as "She had the booster shot from Pfizer and that night, she experienced a lot of side effects related to Tardive Dyskinesia"; SEIZURE (medically significant), outcome "unknown", described as "she thought she was having a seizure"; PYREXIA (non-serious), outcome "unknown", described as "She also had fever and chills". The action taken for deutetrabenazine was unknown. The clinical course of events was as follows: Reporter (pharmacist) was counselling a patient on a medication for Tardive Dyskinesia and she mentioned that, she had apparently this happened a little while ago, it happened back at the end of September but she had the booster shot from Pfizer for the Pfizer COVID booster shot (new Pfizer COVID Booster shot) and that night, she experienced a lot of side effects related to Tardive Dyskinesia which is being controlled for an extended period of time on this medication and then they all went back to how she had been over the span of the night. So, the only thing that seem to have change and she is claimed that here was this shot. Patient had the shot and that evening she had very strong side effects/potential reaction and she wanted to report it to reporter who's the one that's dispensing a different medication that is controlling like suppressing those side effects that happen in her naturally and so she told reporter about it like you know 4 months later when I was talking to her about this medication Austedo. When clarified if patient using Austedo as a treatment, reporter stated, "No. So, Austedo is the medication used in what she's using it for is to treat Tardive Dyskinesia which is a set of involuntary movements that come on usually it from sometimes from a side effects of a typical antipsychotic medications. So, this medication is essentially suppressing a lot of different ticks and movements disorders that she would naturally have such as." (Incomplete sentence). When probed for the clarification for the side effects, reporter stated, "It was experiencing but on the night that she had the shot so, she had her COVID-19 Booster shot and that night, in the middle of a night, she woke up with her body reacting to everything, she had her jaw was chattering, her hips were thursting, she had restless legs, she thought she was having a seizure because is all of these ticks that had are normally suppressed by her medication (Austedo) that are kind of some of these are a lot higher intensity, than they normally are for her Tardive Dyskinesia, were back and she could not stop them. It happened for a couple of hours. She also had fever and chills and then they slowly petered off and then since she went back, she went to sleep and since then she is been back to her normal controlled status, does not having those extrapyramidal side effects and those extra movements and everything." Causality: Reporter stated, "I believe its possible."  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: The events condition aggravated, tardive dyskinesia, and seizure are conservatively assessed as related to the suspect drug BNT162B2 OMI XBB.1.5 based on close temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. 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.