Age: 74.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Asthenia, Fatigue, Fear, Hypersomnia, Illness
Clinical narrative: sick; Miss 3-4; missed a dose/missed 3-4 doses of Gocovri; pneumonia; general malaise; super fatigued; sleeping a lot; Didn't gain back her general energy; Might have been her allergies; Nausea; she was congested; rib pain; fear of throwing up; she had lost 40 pounds; This is a solicited report based on the information received by Pfizer from another Manufacturer.  A contactable consumer (patient) reported that a 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in Apr2021 (Batch/Lot number was not reported) (at the age of 74-year-old) as DOSE 2, SINGLE for covid-19 immunisation; and amantadine hydrochloride (GOCOVRI, capsule), oral from 16Jul2020 (Batch/Lot number was not reported) and ongoing at 137 mg, once daily at night for dyskinesia. Medical history included ongoing dyskinesia, parkinson's disease, diarrhoea, respiratory disorder (other respiratory disorders), mixed incontinence, non-hodgkin's lymphoma from an unknown date to 1995 (Got rid of it by 1995), daydreaming, multiple allergies, chemotherapy, Penicillin allergy, Sulfonamide derivatives/antibiotics allergy, disease of the upper respiratory tract, allergies, and absent mindedness. Concomitant medications included cyanocobalamin (B12); carbidopa, levodopa; carbidopa; tolterodine l-tartrate (DETROL); bismuth subsalicylate (PEPTO-BISMOL); probiotics; paracetamol (TYLENOL); oxycodone; rotigotine (NEUPRO) from 2021 to Jul2021; and CBD-KINGS WITH LIDOCAINE (LIDOCAINE; MENTHOL; METHYL SALICYLATE; CAMPHOR; CAPSICUM). The patient previously took macrolides and ketolide, both as drug therapy and experienced drug hypersensitivity. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on unspecified date in 2021 as DOSE 1, SINGLE for covid-19 immunization. On unspecified date in 2021, the patient experienced pneumonia, general malaise, super fatigued, sleeping a lot, didn't gain back her general energy, might have been her allergies, nausea, she was congested, rib pain, fear of throwing up, and she had lost 40 pounds. On 20Jul2021, the patient experienced sick; and miss 3-4; missed a dose in May2021. It was further reported that on an unspecified (presumably in 2021), after starting Gocovri, the patient missed 3-4 doses of Gocovri due to being sick. On an unspecified date in Jul2021, being sick was resolved. As of 30Jul2021, treatment with Gocovri was ongoing. On 06Aug2021, it was learned that additional medical history included allergies, absent mindedness, and non-Hodgkin's lymphoma for which she went through chemotherapy and completely got rid of it by 1995. Carbidopa/levodopa ER was removed from concomitant products as the patient had never taken it. Additional concomitant products included oxycodone and Neupro (rogitogine; tried "recently" and stopped 1.5 weeks ago, relative to 06Aug2021). The starting date and dose of Gocovri were confirmed. On an unspecified date, the patient received a first dose of COVID vaccine (Pfizer) at an unreported dose, route and frequency, for an unreported indication. On an unspecified date in Apr2021, the patient received her second dose of COVID vaccine (Pfizer). Subsequently, presumably in Apr2021, the patient missed a dose of Gocovri because she experienced general malaise and was super fatigued and sleeping a lot after her second COVID vaccine. On an unspecified date in 2021, the general malaise, fatigue and sleeping a lot improved, but she did not gain back her general energy she used to have. On an unspecified date in May2021, the patient missed a dose of Gocovri due to absent mindedness/forgetting. On or around 20Jul2021, the patient became sick. She thought she was coming down with pneumonia. She experienced nausea, she was congested and had rib pain and fatigue, and just wanted to sleep. She thought it might have been her allergies as that was her normal reaction to allergies. She missed a few doses of Gocovri for fear of throwing up. On an unspecified date in Jul2021 or Aug2021, she went to the doctor and it was determined that she did not have pneumonia. No specific diagnosis was given, but she was prescribed an unspecified antibiotic. When they weighed the patient at the doctor's office, she found out she had lost 40 pounds. She didn't know when the weight loss began, but she had always been around 150 pounds and she was 111 pounds at the doctor's office. The patient felt the weight loss was unusual for her because she has a good appetite. She was placed on a high protein diet and added carbohydrates. On an unspecified date, the patient also saw a neurologist and they talked but no treatment or diagnosis was provided. On an unspecified date, after taking the antibiotic, the symptoms of nausea, congestion, rib pain, fatigue, and wanting to sleep, which may have been her allergies, resolved. As of 06Aug2021, treatment with Gocovri was ongoing. They were still working on figuring out what was causing the weight loss, but the patient had gained "a couple of pounds" and was up to around 112 pounds. The action taken in response to the events for amantadine hydrochloride was dose not changed. Therapeutic measures were taken as a result of super fatigued, sleeping a lot, nausea, she was congested, and rib pain. On unspecified date in 2021, the patient recovered from general malaise, super fatigued, sleeping a lot, nausea, she was congested, and rib pain; recovered from sick on unspecified date in Jul2021; was recovering from she had lost 40 pounds; had not yet recovered from didn't gain back her general energy while outcome of the other events was unknown.  The reporter's assessment of the causal relationship of the 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 possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. 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.