Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Constipation, Electrocardiogram, Feeling hot, Hallucination
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 2021ADA03145 (Regulatory Authority). A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 17Dec2021 (Batch/Lot number: unknown) at the age of 63 years as dose 3 (booster), single for Covid-19 immunisation; amantadine hydrochloride (GOCOVRI), first regimen oral from 23Nov2021 (Batch/Lot number: unknown) to 29Nov2021 at 137 mg 1x/day (137 mg, 1x/day at bedtime) and second regimen oral since 30Nov2021 (ongoing) (Batch/Lot number: unknown) at 274 mg 1x/day (274 mg, 1x/day at bedtime) for dyskinesia. Relevant medical history included: "Back pain", start date: 2021 (unspecified if ongoing); "Parkinson's disease" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Respiratory disorder" (unspecified if ongoing); "Dysphagia/trouble swallowing" (unspecified if ongoing), notes: trouble swallowing pills; "Urinary hesitation" (unspecified if ongoing), notes: Intermittent, difficulty going pee/starting urinary flow (intermittent); "Constipation" (unspecified if ongoing), notes: trouble going poop/constipation; "Fluid intake reduced" (unspecified if ongoing), notes: not drinking enough water; "Nausea" (unspecified if ongoing); "Postmenopause" (unspecified if ongoing); "Sciatica" (unspecified if ongoing), notes: onset: when she went to the ER [emergency room] a year ago for sciatica); "Rectal polyp" (unspecified if ongoing); "Gallbladder polyp" (unspecified if ongoing); "Dyskinesia" (unspecified if ongoing), notes: In patients with Parkinson's disease receiving levodopa-based therapy. Concomitant medication(s) included: CYCLOBENZAPRINE; ONDANSETRON; CARBIDOPA/LEVODOPA; MULTIVITAMIN (dietary supplement) tablet and FIBER GUMMIES (dietary supplement). Past drug history included: Cortisone shots, start date: 2021, stop date: 2021, for Back pain, reaction(s): "Drug ineffective", notes: Cortisone shots; Drug; Tetracyclines for Drug therapy, reaction(s): "Drug hypersensitivity", notes: Tetracyclines and related; Carbidopa/levodopa for Drug therapy, reaction(s): "Constipation"; Symbicort (budesonide/formoterol fumarate dihydrate); for Drug therapy, reaction(s): "No adverse event". Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "No adverse event"; Bnt162b2 (Dose 2), for COVID-19 immunization, reaction(s): "No adverse event". The following information was reported: HALLUCINATION (medically significant), outcome "not recovered", described as "Hallucinations"; NIGHT SWEATS (non-serious) with onset Dec2021, outcome "not recovered", described as "Sweating a lot; occurs at night; wake up in a sweat"; CHEST DISCOMFORT (non-serious) with onset 31Dec2021, outcome "not recovered", described as "Chest between her boobs really hurt with pressure"; CONSTIPATION (non-serious) with onset Dec2021, outcome "not recovered", described as "Trouble going poop/constipation got worse"; FEELING HOT (non-serious), outcome "not recovered", described as "Feeling hot". The event "chest between her boobs really hurt with pressure" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: electrocardiogram: unknown results. On 23Nov2021, the patient started treatment with Gocovri at 274 mg orally 1x/day at bedtime for dyskinesia. On an unspecified date in Nov2021 or Dec2021, after starting Gocovri, the patient experienced sweating a lot. As of 15Dec2021, treatment with Gocovri and sweating a lot were ongoing. On 15Dec2021, the current preferred terms (PTs) included: Hyperhidrosis. On 11Jan2022, it was learned that the patient had trouble going pee and poop among other issues (unspecified). As of 11Jan2021, treatment with Gocovri, trouble going pee and poop, and other issues were ongoing. On 11Jan2022, the current preferred terms (PTs) included: Hyperhidrosis, Dysuria, Constipation, Unevaluable event. On 17Jan2022, it was learned that additional medical history included trouble swallowing pills, difficulty going pee/starting urinary flow (intermittent), trouble going poop/constipation, nausea, post-menopausal, rectal polyp, gallbladder polyp, sciatica, back pain (onset: when she went to the ER [emergency room] a year ago for sciatica), cortisone shots for back pain which didn't work, "problems" (clarified as constipation) with carbidopa/levodopa, not drinking enough water, prior use of Symbicort (budesonide/formoterol fumarate dihydrate), and administration of COVID vaccine (Pfizer; vaccine numbers 1 and 2; dates not reported). Additional concomitant products included: carbidopa/levodopa, cyclobenzaprine, ondansetron, and fiber gummies. The start date of Gocovri was reported, but it was clarified that the patient started at 137 mg 1x/day at bedtime for the first 7 days before increasing to 274 mg 1x/day at bedtime on 30Nov2021. COVID vaccine (Pfizer) was added as a co-suspect and the patient received vaccine number 3 on 17Dec2021. It was clarified that the difficulty going pee/starting urinary flow started prior to Gocovri start and did not worsen after starting Gocovri (event removed). On an unspecified date in Dec2021, after starting Gocovri and receiving the third COVID vaccination, the patient began sweating a lot (event originally reported on 15Dec2021). She began sleeping in underwear and a t-shirt and was still sweating, and it was "like when she went through menopause". It was noted that they thought it was a side effect of the Pfizer COVID vaccine as some post-menopausal women experience menopause symptoms again. On an unspecified date in Dec2021, the trouble going poop/constipation got worse. On 31Dec2021 and 07Jan2022 or 08Jan2022, the patient went to the ER because she "couldn't go and it backed up on her". The patient "thought she was having a heart attack" because her chest between her boobs really hurt with pressure, but it was determined to be from the constipation. During one of the ER visits, they did an EKG (electrocardiogram; results not reported). The patient was not admitted to the hospital for either ER visit and she was told to drink more water and increase the fiber in her diet. It was clarified the patient didn't have "other issues" (previously reported; event removed). On an unspecified date, the patient went back to see the doctor and she was prescribed prednisone for the back pain (did not worsen after starting Gocovri). She couldn't take the prednisone because it was too close to having received the COVID vaccine, so she had to wait, and began taking the prednisone on 14Jan2022 (5 day course). As of 17Jan2022, treatment with Gocovri, sweating and constipation were ongoing, and the status of the chest pressure was not reported. On 17Jan2022, the current preferred terms (PTs) included: Hyperhidrosis, Chest discomfort, Constipation. On 09Mar2022, it was again reported that the patient experienced sweating. On unreported dates, the patient also experienced hallucinations and feeling hot. As of 09Mar2022, treatment with Gocovri, the hallucinations, feeling hot, and sweating were all ongoing. No additional information was provided. Follow-up information was requested. On 09Mar2022, the current preferred terms (PTs) included: Hyperhidrosis, Chest discomfort, Feeling hot, Constipation, Hallucination. On 21Mar2022, it was learned that the feeling hot started a few months back and was associated with the sweating. The feeling hot and sweating occurred at night time, every night, and nothing made it better or worse. She would be sleeping and would wake up in a sweat and the sweating was in the chest area. It felt like she was going through "change in life" (clarified as menopause), but she already did that. As of 21Mar2022, treatment with Gocovri, feeling hot and sweating at night time were ongoing. The patient planned to see her doctor (scheduled appointment not reported). On 21Mar2022, the current preferred terms (PTs) included: Night sweats, Chest discomfort, Feeling hot, Constipation, Hallucination. The reporter's assessment of the causal relationship of the event with the suspect products 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 possible; information about lot/batch number cannot be obtained. No further information is expected. Follow-up (10Mar2022): 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 completed. No further information is expected. Follow up (23Mar2022): New information received from a Non-Interventional Study (Program ID not available) based on the information received by Pfizer from "PRIVATE" manufacture number (2021ADA03145) via contactable consumer (patient) reported for herself included: Added new events (Feeling hot and Hallucinations), event "Sweating a lot; occurs at night; wake up in a sweat" was recoded to "Night sweats" and updated clinical information. Sender's Comments: Based on the information available and a close temporal association a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. 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