Age: 77.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Endoscopy, Fall, Feeling abnormal, Feeling cold, Gait disturbance
Clinical narrative: had some issues with her Parkinson's; much more weak; feeling off balance, balance issues, unstable; feeling off balance, balance issues, unstable; blurred vision; falls; freezing; anxiety attack; speech worsened after the vaccine; teeth were falling out; teeth were breaking off, broken teeth; teeth were breaking off, broken teeth; Gait was worse than it had been before the Covid vaccine; chills,; sensitive teeth; Feeling weaker, almost not able to stand; This is a spontaneous report from a contactable consumer or other non hcp. A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on 16Feb2021 (at the age of 77-years-old) as 2nddose, single for covid-19 immunisation; amantadine hydrochloride (GOCOVRI), oral from an unspecified date (Batch/Lot Number: 17JM-029; Expiration Date: 31Mar2022) and ongoing, at 205.5 mg, oral from 2019 (Batch/Lot Number: 1641624; Expiration Date: 28Feb2021) to an unspecified date, at 205.5 mg, oral from an unspecified date (Batch/Lot Number: 1624718A; Expiration Date: 31Jan2021) and ongoing, at 205.5 mg, oral from an unspecified date (Batch/Lot Number: 1641626; Expiration Date: 28Feb2021) to an unspecified date, at 205.5 mg, oral from an unspecified date (Batch/Lot Number: 1671657; Expiration Date: 30Sep2020) and ongoing, at 137 mg, 1x/day at bedtime, oral from an unspecified date (Batch/Lot Number: 17JM167; Expiration Date: 31Aug2020) to an unspecified date, at 205.5 mg, oral from an unspecified date (Batch/Lot Number: 17JM147; Expiration Date: 31Aug2020) and ongoing, at 137 mg, 1x/day at bedtime, oral from an unspecified date (Batch/Lot Number: 17JM127; Expiration Date: 31Jul2020) and ongoing, at 137 mg, 1x/day at bedtime, oral from 07Nov2018 (Batch/Lot Number: 17JM111; Expiration Date: 30Jun2020) to an unspecified date, at 137 mg, 1x/day at bedtime, via an unspecified route of administration from 22Jun2018 (Batch/Lot Number: 17JM030; Expiration Date: 31Mar2018) to 06Nov2018, at 274 mg,1x/day at bedtime for dyskinesia.  It was reported that, on 14Jul2018, a solicited report was received from a consumer via a company representative regarding a 74-year-old female who was being treated with GOCOVRI 137 MG (amantadine). On 19Sep2019, 18Oct2019, additional information was received from a consumer via a company representative and Gocovri (amantadine) extended release 68.5 MG capsules were added as a suspect product. On 22Oct2019, 04Nov2019, 05Dec2019, 03Mar2020, 15Jun2020, 02Oct2020,26Oct2020 and 30Apr2021, additional information was received from a consumer via a company representative. On 30Apr2021, an unspecified COVID-19 vaccine was made as a co-suspect. On 07may2021, additional information was received from a consumer, and clarification was received that the patient had received Pfizer's COVID-19 vaccine.  Medical history included vision blurred, hysterectomy, dystonia, constipation, asthenia, Parkinson's disease and dyskinesia (in patients with Parkinson's disease receiving levodopa-based therapy) from an unknown date and unknown if ongoing. Other products included: Azilect (rasagiline), carbidopa/levodopa, Lasix (furosemide), potassium chloride microencapsulated, pravastatin, Rytary (carbidopa/levodopa), and vitamin D. On 08Jun2018, the patient started treatment with GOCOVRI 137 MG at 274 mg, once daily orally at bedtime for dyskinesia. On an unreported date, after starting GOCOVRI, the patient started seeing red, white, and blue. As of 14Jul2018, treatment with GOCOVRI was ongoing, as was the event. On 17Jul2018, follow up information was obtained from a consumer. Additional medical history included: 100-pound weight loss since starting Rytary in 2017 (decreased from 230 pounds to 130 pounds), historical treatment with amantadine immediate-release 11 years ago (relative to 17Jul2018) with an event of "sky-high" LFTs (liver function tests), historical treatment with liquid amantadine for dystonia at 1/2 teaspoon, twice daily (started in 2017, no adverse event reported), and blurry vision during "off time." Other medication included: Comtan (entacapone). The event of seeing red, white, and blue was further described as seeing colors that "made everything look strange." The event usually happened in the morning, but not all the time. The patient's physician was not made aware of the event. In addition to the vision color changes, the patient experienced feeling tired, a decreased appetite, and a 13-pound weight loss since starting GOCOVRI. The patient's physician wanted her to wean down the Comtan, but she was unable to do so due to feeling sleepy and nervous (similar symptoms of her "off time"). As of 17Jul2018, treatment with GOCOVRI was ongoing, as were all the events. On 08Aug2018, additional information was received from a consumer. On unreported dates, in addition to seeing colors that was also reported previously, the patient started experiencing blurred vision and shakiness. It was not specified if the blurred vision was worse than baseline. As of 08Aug2018, treatment with GOCOVRI was ongoing, as were the events. On 31Aug2018, additional information was received from a consumer via a company representative. On unreported dates, after starting GOCOVRI, the patient's physician thought she had cataracts. She also had other unspecified side effects, but the physician did not think they were from GOCOVRI. On 13Sep2018, follow up information was obtained from a consumer. Additional medical history included: past events of angina and being "dragged down" by heart medications, including Systolic (nebivolol), so all heart medications were stopped; hysterectomy; thrombophlebitis; and a bladder infection "here and there." It was also clarified that the patient was treated with the liquid amantadine Symmetrel after experiencing liver function failure with immediate release amantadine, but she was still having too many movements, so that is when she was switched to GOCOVRI. It was confirmed the patient started GOCOVRI on 08Jun2018, but at a dose of 137 mg, once daily at bedtime. After 14 days, the dose was increased to 274 mg, once daily at bedtime. After increasing to the 274 mg dose, the patient started seeing colors and "maybe a tiny bit of thinking there was a person there or not." This would occur sometimes throughout the day and sometimes just in the morning. In Jul2018 (reported as the last two months relative to 13Sep2018), the patient experienced blurry vision (assumed worsened from baseline, as she could no longer read the signs on the road). The patient saw her doctor and she was diagnosed with cataracts at the end of Aug2018. The doctor said her eyes were ok except for cataracts and had never heard of anyone seeing colors from the medication. On unspecified dates, the patient started experiencing constipation, trouble speaking due to mucous in her mouth, and a return of swelling in the ankles. On an unspecified date, the patient's Lasix had been cut back to three times weekly and the patient noticed her ankles/legs seemed to be swelling again. About two weeks ago (relative to 13-SEP-2018), the patient experienced shakiness, like a rocking, in the morning. The patient did not know if some of the events were her Parkinson's disease advancing or what, it was hard to know. As of 13Sep2018, treatment with GOCOVRI was ongoing, as were the events of seeing colors, weight loss, nervousness, blurry vision, cataracts, mucous in the mouth, constipation, and swelling in the ankles/legs. Due to the weight loss, the patient was planned to have a colonoscopy. As treatment for the constipation, she was taking Peri-Colace (docusate sodium; sennosides). The events reported as improved included: shakiness, tiredness, decreased appetite, and sleepiness. On 25Sep2018, additional information was received from a consumer via a company representative. In addition to events of constipation and weight loss (previously reported), the patient experienced seeing spots on an unreported date. As of 25Sep2018, treatment with GOCOVRI was ongoing and the outcomes of these events were unknown. On 19Oct2018, additional information was received from a consumer via a company representative. In addition to events of constipation and weight loss, which were previously reported, the patient also experienced hallucinations, a raspy voice, trouble swallowing GOCOVRI, and her Parkinson's disease had gotten worse since starting GOCOVRI. As of 19Oct2018, treatment with GOCOVRI was ongoing and the outcomes of the events were unknown. On 26Oct2018, follow up information was received from a consumer. Additional medical history included: dystonia, incontinence, and constipation. It was also noted that in addition to her LFTs going "sky high" during treatment with amantadine in the past, she also started to lose weight (previously only contributed to Rytary). The patient confirmed that the historical conditions of weight loss and constipation worsened after starting GOCOVRI. She was treating the constipation with Colace (docusate), Miralax (polyethylene glycol), prunes, and a high fiber diet. The patient's current weight as of 26-OCT-2018 was 126 pounds (down from 220 pounds, most of which occurred prior to starting GOCOVRI). Due to the weight loss, the patient had an endoscopy performed on an unreported date. Before the endoscopy, the patient was having issues with a hoarse voice (previously reported as a "raspy voice") and garbled speech. After the endoscopy, she was unable to talk at all for two days. The results of the endoscopy were not reported. With reference to the hallucinations, the dose at onset could not be confirmed. It was initially reported that the hallucinations "started pretty fast," but later reported that the hallucinations started "a couple months ago" relative to 26Oct2018. The patient's hallucinations were moderate in severity and mixed in nature. She would get the feeling that someone was in the house, or hear dogs in the house, or see things in the room that looked like bugs. Once she saw her father sitting in a chair. At first, the patient was not aware that she was hallucinating and was scared about her eyes (worried she was going blind), but then realized she was hallucinating. The hallucinations lasted a couple hours depending on what she ate or what time she took the GOCOVRI. It was also noted that the patient had a bladder infection, but the exact date of this was unknown. An attempt to clarify the previous report of seeing spots was queried, but clarification was not obtained. The patient went to an eye doctor on an unreported date, who said she had a little bit of cataracts, but her eyes were fine. No diagnosis was made for seeing spots or seeing colors and the events continued. The events of weight loss, raspy/hoarse voice, and garbled speech were also ongoing as of 26Oct2018; the events of constipation and hallucinations were improved. Treatment with GOCOVRI was unchanged, as the patient's doctor told her she would have energy and it would take away her dystonia, which it did. On 12Nov2018, additional information was received from a consumer via a company representative. It was learned the patient's constipation was "kind of severe" (previously reported as improved). She also continued to experience seeing white and blue stripes and having hallucinations of people and shadows. About a month ago (relative to 12Nov2018), while on two capsules (274 mg) of GOCOVRI daily, the patient experienced a fall and subsequently started experiencing bad speech and vision. It was previously reported that the patient experienced events of garbled and raspy voice and blurred vision, seeing spots, and cataracts, but it was not clarified if the bad speech and vision after the fall were different. The patient's doctor was aware of the events experienced and on 07Nov2018, had the patient start taking one capsule (137 mg) at bedtime. With the dose decrease, the patient experienced it was harder to get up in the morning and was having jerky movements in her head and neck. As of 12Nov2018, treatment with GOCOVRI was ongoing at the 137 mg dose and the outcomes of severe constipation, seeing stripes, hallucinations, fall, bad speech and vision, "harder to get up in the morning," and jerky movements were unknown. On 17Jan2019, additional information was received from a consumer via a company representative It was again reported that the patient had reduced the dose of GOCOVRI due to "seeing things" and falling. The patient's doctor was aware of the dose decrease. As of 17Jan2019, treatment with GOCOVRI was ongoing at 137 mg daily and the outcomes of seeing things and falling were unknown. On 06feb2019, additional information was received from a consumer via a company representative. The patient continued to experience hallucinations and weight loss. As of 06Feb2019, treatment with GOCOVRI was ongoing. On 18Mar2019, additional information was received from a consumer via a company representative. On unreported dates, the patient experienced feeling sluggish and her liver level dropped. As of 18Mar2019, treatment with Gocovri was ongoing, as were the events. On 25Mar2019, additional information was received from the prescriber. The prescriber was "not concerned" about the event of "liver level drop" and that it could have come from anything. The prescriber declined to provide any further information. On 25Apr2019, additional information was received from a consumer via a company representative. On an unreported date, the patient started experiencing knots in her body. As of 25Apr2019, treatment with Gocovri was ongoing and the events of knots in her body, as well as constipation, seeing red, white, and blue dots and stripes, and weight loss were also ongoing. The patient had lost over 100 pounds. On 22May2019, additional information was received from a consumer via a company representative. It was reported that in addition to experiencing hallucinations when taking two 137 mg capsules, the patient also experienced dizziness. On an unreported date(s), both events resolved. On an unreported date, the patient missed one dose of Gocovri. As of 22Mayt2019, treatment with Gocovri was ongoing at 137 mg at bedtime. On 12Jul2019, additional information was received from a consumer via a company representative. It was reported the patient continued to experience some hallucinations, severe constipation, and some weight loss. As of 12Jul2019, treatment with Gocovri was ongoing at 137 mg at bedtime. On 19Sep2019, the patient continued to report hallucinations, weight loss and constipation. As of 19Sep2019, the treatment with the product remained decreased and ongoing. The hallucinations, weight loss and constipation were not resolved. On 18Oct2019, additional information was received from a consumer. On an unspecified date in 2019, the patient started treatment with Gocovri 68.5 MG at 68.5 mg, taken orally, once daily at bedtime. On unspecified dates, the patient continued to experience drowsiness (feeling tired). On an unspecified date in 2019, the patient's dose was increased to 205.5 mg (one 137 mg capsule and one 68.5 mg capsule nightly. On 17Oct2019, the patient missed one dose of Gocovri because she forgot. On unspecified dates in 2019, after increasing her dose of Gocovri, the previously reported events of hallucinations, weight loss, and constipation resolved. As of 18Oct2019, the patient continued to take Gocovri at 205.5 mg nightly and experience drowsiness (feeling tired). On 22Oct2019, additional information was received from a company representative. The patient's pharmacy dispensed the 68.5 mg capsule on 22Oct2019 (the start date of the 205.5 mg dose was not reported). On 04Nov2019, the reported dose of Gocovri was 68.5 mg once daily at bedtime. On an unspecified date, the patient missed one dose due to falling asleep. On 05Dec2019, the reported dose of Gocovri 137 MG was at 137 mg once daily at bedtime (the change of dose date was not reported). On 22Nov2019, the patient was "feeling weird." As of 05Dec2019, the Gocovri dose was increased and ongoing. The "feeling weird" was not resolved. On 03Mar2020, the dose of Gocovri was reported as one 68.5 mg capsule and one 137 mg capsule 1x/day at bedtime. It was also reported that the patient experienced weight loss, hoarseness and alertness. As of 03Mar2020, treatment with Gocovri, weight loss, hoarseness and alertness were ongoing. On 15Jun2020, it was reported that within the past month (JUN-2020), the patient felt off balance and continued to have falls. Additionally, her weight loss was ongoing. As of 15Jun2020, treatment with Gocovri was ongoing, as were the events of off balance, falls, and weight loss. On 02Oct2020, it was reported the patient continued to experience balance issues. As of 02Oct2020, treatment with Gocovri was ongoing at 205.5 mg daily. The current status of the balance issues was unknown. On 26Oct2020, it was reported that the patient experienced another bladder infection (date not specified). As of 26Oct2020, treatment with Gocovri and the bladder infection were ongoing. Date of prior events was reported as 2018, however the events were not specified. The patient previously experienced Chromatopsia (seeing red, white, and blue; seeing colors; red, white, blue stripes), tremor (shakiness, rocking), speech has been affected because of mucous in my mouth (salivary hypersecretion), seeing spots (vitreous floaters), voice was garbled, couldn't talk at all for 2 days (Aphonia), raspy voice, voice is hoarse (dysphonia), 13 pound weight loss since starting Gocovri, weight loss much worse after starting Gocovri; losing over 100 lbs (weight decreased), Parkinson's disease has gotten worse, vision was getting bad (visual impairment), jerky movement in head/neck (dyskinesia), liver level drop (Liver function test decreased), knots in her body (myofascial spasm), was feeling weird (feeling abnormal), Sleepy, sluggish, drowsiness (somnolence), nervousness, freezes when she doesn't take her pills on time and bladder infection (cystitis) and little tired. Concomitant medications included furosemide (LASIX [FUROSEMIDE]) from 2018 to an unspecified stop date; carbidopa, levodopa (RYTARY) from 2017 to an unspecified stop date; potassium chloride (POTASSIUM CHLORIDE); pravastatin (PRAVASTATIN); vitamin d (VITAMIN D [VITAMIN D NOS]); entacapone (COMTAN); clopidogrel bisulfate (PLAVIX); rasagiline mesylate (AZILECT) start and stop date were not reported, taken for an unspecified indication; carbidopa, levodopa (CARBIDOPA/LEVODOPA DAVUR) taken for parkinson's disease, start and stop date were not reported. The patient previously took BNT162B2 on 26Jan2021 (at the age of 77-years-old) for covid-19 immunisation. The patient previously took amantadine for dyskinesia and experienced liver function test increased, amantadine for dyskinesia and experienced weight decreased, symmetrel for dystonia and dyskinesia.  After receiving the second dose of BNT162B2, the patient experienced some issues with her, much weaker, feeling off balance, balance issues, unstable, blurred vision, falls, freezing, anxiety attack, speech worsened after the vaccine, teeth were falling out, teeth were breaking off, broken teeth, gait was worse than it had been before the covid vaccine, chills, sensitive teeth, feeling weaker, almost not able to stand on an unspecified date.   On 30Apr2021, additional medical history included that the patient was weak. On an unspecified date (presumably in 2021), the patient received 2 doses of an unspecified COVID -19 vaccine. Following her second dose, she had some issues with her Parkinson's. She was much weaker and, unstable. In general, she has had more problems with blurred vision and has had some falls due to feeling weaker. She also reported having sensitive teeth for a few days at one point as well. As of 30Apr unstable blurred vision freezing 2021, the treatment with Gocovri, feeling weaker, sensitive teeth, Parkinsons disease, falls, being unstable and the blurred vision were all ongoing. On 07May2021, it was learned that concomitant products included both oral and sublingual carbidopa/levodopa and Plavix (clopidogrel) was added as a concomitant product. It was clarified that the patient had received Pfizer's COVID-19 vaccine on 26Jan2021 and 16Feb2021 at an unreported dose and route, for an unreported indication. It was reported that the patient experienced freezing if she didn't take her pills on time beginning on an unreported date, and she got something like anxiety but not so consistently. Previously reported "feeling weaker" was reported to have begun on an unknown date in Feb2021, about a week after the second dose of the vaccine. She was not able to stand and had to sit right down. She was very anxious, and sometimes the doctor would say it was an anxiety attack, but the patient didn't think it was. Additionally, after receiving the vaccine, she was experiencing anxiety and freezing more consistently, she kept getting chills, her gait was worse than it had been before the vaccine, and she had gone to speech therapy because her speech worsened after the vaccine. She also went to physical therapy because of a fall from being weaker. She thought she had COVID-19 because of the aforementioned symptoms after receiving the vaccine, but she was not seen or tested for COVID-19. The previously reported sensitive teeth were further reported as her teeth were falling out (further described as she had been taking pieces of teeth out of her mouth). It was clarified that her teeth falling out and most of the teeth were breaking off began on an unknown date prior to receiving the COVID-19 vaccine. However, the patient told her dentist that this was all happening after the vaccine, and onset was also reported as about a week after she received her second dose of the COVID-19 vaccine. In addition to going to her dentist for the broken teeth, the patient was referred to an oral surgeon. As of 07May2021, the patient continued treatment with Gocovri. The anxiety, freezing, chills, and feeling weaker had improved compared to their onset. The worsening gait had not improved. The outcome of her worsening speech was not reported. The broken and sensitive teeth were ongoing; she had not seen the oral surgeon yet and they needed to do an x-ray of her jaw to figure out what caused the broken teeth. She anticipated seeing her neurologist "this coming week" (relative to 07may2021) and she felt that he would laugh at her and tell her that it was not due to the vaccine or maybe he wouldn't. She also planned to see her family physician soon. Patient was little tired. The patient underwent lab tests and procedures which included endoscopy on unspecified date in 2018 for weight loss and result was not reported. The action taken in response to the events for amantadine hydrochloride was not applicable. Therapeutic measures were taken as a result of blurred vision (vision blurred). Upon follow-up on 30Jul2021 is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.The outcome of the events some issues with her parkinson's, feeling off balance, balance issues, unstable, blurred vision, falls, speech worsened after the vaccine, feeling weaker, almost not able to stand was unknown, outcome of much weaker, freezing, anxiety attack, chills was recovering and others events outcome was not recovered.  Follow-up (30Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  No additional information was provided. Follow up was requested.