Age: 75.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Hallucination, visual, Malaise, Sluggishness
Clinical narrative: Crumb on the floor will start to look like a bug that moves; Did not feel good; like she was full; did not feel top notch; Sluggish; This is a solicited report based on information received by Pfizer. A contactable consumer (patient) reported that a 75-year-old female patient received bnt162b2 (Batch/Lot number was not reported), via an unspecified route of administration on 22May2021 at the age of 75-year-old as dose number unknown, single for covid-19 immunization; amantadine hydrochloride (GOCOVRI, Extended-Release Capsule, 68.5 mg), via an unspecified route of administration from 20Apr2021 (Batch/Lot Number: 17JM-029; Expiration Date: 31Mar2022) to 26Apr2021, at 68.5, 1x/day, orally from 27Apr2021 (Batch/Lot Number: 17JM-029; Expiration Date: 31Mar2022) and ongoing, at 137 mg, 1x/day (every night at bedtime) for dyskinesia. Medical history included dyskinesia, freezing phenomenon (Freezing of her feet), muscle twitching, twitching in lower legs and toes, nephrolithiasis (kidney stones), parkinson's disease (levodopa-based therapy), Acid Reflux; seizure all from an unknown date and unknown if ongoing. Concomitant medications included propranolol (PROPANOLOL) taken for an unspecified indication, start and stop date were not reported. The patient previously took amantadine and experienced visual impairment. The patient experienced did not feel good; like she was full; did not feel top notch in May2021, sluggish in May2021, crumb on the floor will start to look like a bug that moves in May2021. On 21May2021, a solicited report was received from a consumer, via a company representative, regarding a 75-year-old female who was being treated with Gocovri (amantadine) extended release 68.5 MG capsules. On 28May2021, additional information was received from a consumer and COVID shot (Pfizer) was added as co-suspect. Medical history included dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy and Parkinson's disease. Concomitant products included an unspecified levodopa-based therapy. On 20Apr2021, the patient started treatment with Gocovri 68.5 MG at 68.5 mg orally 1x/day at bedtime for 7 days, before increasing to 137 mg orally 1x/day at bedtime for dyskinesia. On an unspecified date in 2021, after starting the product, the patient experienced that she still had dyskinesia in her toes, so her Gocovri dose was increased (no further details were reported). On 19May2021 (reported as the last 2 days, relative to 21May2021), the patient missed doses of Gocovri because she ran out. As of 21May2021, treatment with Gocovri was ongoing. Dyskinesia in her toes and missed doses were ongoing. No additional information was provided but follow up was requested. On 21May2021, the current preferred terms (PTs) included: Dyskinesia, Product availability issue. On 28May2021, it was learned that medical history also included: kidney stones, freezing of her feet, dyskinesia was further described as it would come and go and she felt like she had twitching in lower legs and toes, and use of regular amantadine (it bothered her eyes; she would see like an etch a sketch pattern on the wall while she was taking 2 pills of it. So she went to 1 pill of it and then it was like pepper on the wall). Additional concomitant products included: an unspecified seizure medication (for Parkinson), propanolol, an unspecified acid reflux medication, an unspecified medication for her brain (to stop freezing of her feet). Specific names of concomitant products could not be clarified. It was clarified the dyskinesia in toes had not worsened since starting Gocovri, and the patient was not sure it was related to Gocovri. She had hoped Gocovri would take care of it. It was clarified the Gocovri dose was not increased as previously reported; her doctor wanted her to take 3 (capsules; 205.5 mg) at bedtime. However, on 22May2021 (last Saturday, relative to 28May2021), the patient received a COVID shot (Pfizer) at an unreported dose, route and frequency, for an unreported indication. After the COVID shot, she did not feel good, like she was full and was sluggish. She just did not feel top notch. She did not want to increase her dose of Gocovri until she felt better. Additionally, on an unspecified date in May2021 (this past week, relative to 28May2021), the patient would see a crumb on the floor and it would start to look like a bug that moved. As of 28May2021, treatment with Gocovri was ongoing, and she was going to try to increase the dose of Gocovri this next week. It was not reported if the patient anticipated receiving another COVID shot. The statuses of not feeling good, sluggishness, and seeing a crumb on the floor would start to look like a bug that moved were not reported. No additional information was provided or requested. On 28May2021, the current preferred terms (PTs) included: Product availability issue, Malaise, Sluggishness, Hallucination. The action taken in response to the events for amantadine hydrochloride was dose increased. The outcome of events was unknown.  The reporter's assessment of the causal relationship of all events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided and known product safety profile, the events malaise and sluggishness are assessed as related to bnt162b2. The event "a crumb on the floor and it would start to look like a bug that moved" is assessed as unrelated to bnt162b2. The diagnosis of the event needs to be further confirmed. Of note, the patient previously took amantadine and experienced visual impairment.