Age: 66.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Pain in extremity, Parkinson's disease, Product use issue
Clinical narrative: I have had my old episodes/I had a hard time/got worst; I had always soreness on my arm; the blood work for diabetes was high; I had the Pfizer vaccine and the flu shot on the same time; I had the Pfizer vaccine and the flu shot on the same time; possible for Parkinson's/Parkinson in tremors/exacerbates previous condition of Parkinson/shaking pretty badly and abrupt/jaw, left and right hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Oct2022 as dose 4 (booster), single (Lot number: GH9703) at the age of 66 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 09Oct2022 as single dose (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: 5 years ago; "Covid" (unspecified if ongoing), notes: Covid back in Jun. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; TRULICITY taken for diabetes mellitus. Vaccination history included: moderna (covid vaccine) (DOSE 3; Lot number: 017F21A), administration date: 30Oct2021, when the patient was 65-year-old, for Covid-19 immunization; Moderna (covid vaccine) (DOSE 1), for Covid-19 immunization; Moderna (covid vaccine) (DOSE 2), for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 09Oct2022, outcome "unknown" and all described as "I had the Pfizer vaccine and the flu shot on the same time"; PARKINSON'S DISEASE (medically significant) with onset Oct2022, outcome "unknown", described as "possible for Parkinson's/Parkinson in tremors/exacerbates previous condition of Parkinson/shaking pretty badly and abrupt/jaw, left and right hand"; BLOOD TEST ABNORMAL (non-serious) with onset Nov2022, outcome "unknown", described as "the blood work for diabetes was high"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "I have had my old episodes/I had a hard time/got worst"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I had always soreness on my arm". The events "possible for parkinson's/parkinson in tremors/exacerbates previous condition of parkinson/shaking pretty badly and abrupt/jaw, left and right hand", "the blood work for diabetes was high", "i have had my old episodes/i had a hard time/got worst", "i had always soreness on my arm" and "i had the pfizer vaccine and the flu shot on the same time" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: (Nov2022) blood work for diabetes was high but not that high; Dopamine transporter scintigraphy: (Oct2022) possible for Parkinson's, notes: a week later. Clinical course: the patient received for the first time the bivalent booster on 09Oct2022, and a week later she started shaking, like she had her old episodes, but she shook pretty badly and abrupt and since then she went to a neurologist after a week later and had a DAT-scan and it was possible for Parkinson's, and the neurologist prescribed her some medication which she cannot tell. She stated that Parkinson's was not the effect of COVID which she had back in Jun. She was concerned that she had COVID vaccine and flu shot at the same time, and her previous shots were Moderna COVID vaccine. She asked if there were anything about the COVID vaccine that anyone else might had the same effects, that started happening about 7 days afterwards.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300003592 Same patient/drug, different event/dose;