Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Tardive dyskinesia
Clinical narrative: dizziness; increased dizziness; falling; dyskinesia; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 70 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 12Feb2021 08:30 (Lot number: EL3247) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Parkinson's disease", start date: 2017 (ongoing), notes: Verbatim: Parkinson's disease. Concomitant medication(s) included: REGLAN [METOCLOPRAMIDE HYDROCHLORIDE] taken for parkinson's disease, start date: 2017. Vaccination history included: Bnt162b2 (Dose: 1, lot: EL3248, expiry date Apr2021), administration date: 22Jan2021, when the patient was 70 years old, for Covid-19 Immunization. The following information was reported: CONDITION AGGRAVATED (disability) with onset 2021, outcome "recovered" (2021), described as "increased dizziness"; FALL (disability) with onset 2021, outcome "recovered" (2021), described as "falling";TARDIVE DYSKINESIA (disability) with onset 2021, outcome "recovered" (2021), described as "dyskinesia"; DIZZINESS (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "dizziness". The events "increased dizziness", "falling", "tardive dyskinesia" and "dizziness" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood iron decreased: very low; blood pressure measurement: very very low; investigation: normal, notes: More information available (Y/N): No; fine. Therapeutic measures were taken as a result of condition aggravated, fall, dyskinesia, dizziness.  Clinical course: Prior Vaccinations (within 4 weeks): None. Relevant Tests: cardiac workup normal. States 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 is ongoing and now is the same; despite further attempts at clarification, information captured as stated by the caller. Caller states for seriousness criteria, she would say it is 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. Caller states 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 and that is why she herself is not getting the vaccine; states the patient had the booster and then all this started up all over again. Caller states for the patient's medications that were adjusted, it was his Rytary dose and the patient puts his medicine in and the dosage is 36.25mg /145mg which he takes every 3-4 hours and he began taking it for a while prior to the vaccine and takes it for Parkinsons; states the Rytary is carviopa and levodopa and the lot is 30000054, expiry date Mar2024, states she is looking for the manufacturer and does not see the manufacturer and it is a white bottle and label and states it does not have the NDC but has the GTIN; states the Rytary label has his name and Rx number and there is nothing underneath when she peels the label away; instructed not to peel the label and states the manufacturer is (withheld) and the patient takes Rytary up to five times per day; states the Rytary is the only medication that was adjusted. Caller states the patient also takes 1mg once per day of Razaglan and has been taking that for a long time since he was diagnosed with Parkinson's disease in 2017.  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 is not really ongoing and his pressure came up.  Caller states she has no name, dosage or lot number to provide for the patient's Iron infusion. Reporter assesses all the events related to vaccine.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: There is not a reasonable possibility that reported event of Tardive dyskinesia is  related to BNT162B2, this events are most likely intercurrent medical conditions of and concomitant medication  for this elderly patient with underlying Parkinsonism. However  a possible contributory role of the suspect vaccine to the reported events of Fall, dizziness and condition aggravated   a possible contributory role of the suspect vaccine.  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.