Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Disease recurrence, Dizziness, Dyskinesia, Electrocardiogram ambulatory, Fall
Clinical narrative: dizziness; falling; dyskinesia; had again a deep increase in falling, dizziness, and dyskinesia symptoms; tardive dyskinesia; the tardive dyskinesia was diagnosed and was really increased and is terrible since the patient had the Pfizer covid vaccine 2nd and 3rd doses; iron level was very low; booster dose 30Dec2021; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 71 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 30Dec2021 11:15 (Lot number: FL3197) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Parkinson's disease", start date: 2017 (ongoing); "tardive dyskinesia" (ongoing). Concomitant medication(s) included: RYTARY taken for parkinson's disease; REGLAN [METOCLOPRAMIDE] taken for parkinson's disease, start date: 2017. Vaccination history included: Bnt162b2 (Dose 1,  lot EL3248 and expiry date Apr2021, at approximately 08:30am), administration date: 22Jan2021, when the patient was 70 years old, for COVID-19 immunization; Bnt162b2 (Dose 2, Batch/lot number: EL3247, administered upper left arm, at approximately 11:15am), administration date: 12Feb2021, when the patient was 70 years old, for COVID-19 immunization, reaction(s): "dizziness", "falling", "dyskinesia". The following information was reported: IMMUNISATION (disability, medically significant) with onset 30Dec2021 11:15, outcome "unknown", described as "booster dose 30Dec2021"; DIZZINESS (disability), outcome "not recovered", described as "dizziness"; FALL (disability), outcome "not recovered", described as "falling"; DYSKINESIA (disability), outcome "not recovered", described as "dyskinesia"; DISEASE RECURRENCE (disability), outcome "not recovered", described as "had again a deep increase in falling, dizziness, and dyskinesia symptoms"; TARDIVE DYSKINESIA (disability, medically significant), outcome "not recovered", described as "tardive dyskinesia"; CONDITION AGGRAVATED (disability), outcome "not recovered", described as "the tardive dyskinesia was diagnosed and was really increased and is terrible since the patient had the Pfizer covid vaccine 2nd and 3rd doses"; BLOOD IRON DECREASED (non-serious), outcome "unknown", described as "iron level was very low". The events "dizziness", "falling", "dyskinesia", "had again a deep increase in falling, dizziness, and dyskinesia symptoms", "tardive dyskinesia" and "the tardive dyskinesia was diagnosed and was really increased and is terrible since the patient had the pfizer covid vaccine 2nd and 3rd doses" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: iron: (2021) very low, notes: iron level was very low; blood pressure: (2021) very low, notes: low very very low blood pressure; cardiac workup: (2021) everything was normal; holter monitor: (2021) fine; other workup: (2021) fine. Therapeutic measures were taken as a result of blood iron decreased. Patient that received the Pfizer Covid vaccine primary series in January and again in February and that was followed by an increased dizziness, falling and dyskinesia and the patient is also a Parkinson's patient; events subsided after 6 months and the patient got the Pfizer Booster covid vaccine last Thursday on 30Dec2021 and he had again a deep increase in falling, dizziness, and dyskinesia symptoms. Neurologist had stated there was no link to vaccine. The patient's dyskinesia and dizziness lasted and the patient started feeling good around Aug2021 or Sep2021 and then he had been really feeling good and now he got the 2nd vaccine and it started all over again; clarified later that the symptoms began after the 2nd dose of the vaccine and then again after the 3rd or booster dose of the vaccine; stated the patient cannot tolerate physical therapy at this point without getting dizzy and she told the transferring agent the patient had tardive dyskinesia. None vaccines administered on same date of the Pfizer suspect. The dizziness began and started the week right after the 2nd vaccine that week and she never made the connection and nobody listed to her and now the patient's symptoms are ongoing and stopped and then the symptoms resumed because he had the Pfizer covid booster vaccine and the symptoms began within a couple of days after the 2nd dose and a couple of days after the 3rd dose of the vaccine. The tardive dyskinesia was diagnosed and was really increased and is terrible since the patient had the Pfizer covid vaccine 2nd and 3rd doses; states the tardive dyskinesia was ongoing and was the same. For seriousness criteria, it was disabling and the patient also went to the hospital a few times and clarified to state it was not an overnight admission to the hospital but emergency room visits. The cardiac workup and he saw the neurologists and had everything done trying to figure out why he was getting dizzy and falling and they adjusted his medications and then said he seems to have resolved and then the symptoms began again with the Pfizer booster vaccine. Caller states for the cardiac workup and everything was normal and the only thing the patient did was have his iron level was very low and he had the iron infusions and everything else was fine and the holter monitor was fine and the other workup was fine and he had low very very low blood pressure and that blood pressure was not really ongoing and his pressure came up.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug Comirnaty cannot be excluded. The case will be reassessed once new information is available. 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.