Age: 72.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fall, Full blood count, Loss of consciousness, Sleep disorder, Stoma site hypergranulation
Clinical narrative: Stoma site hypergranulation; Sleep disturbance; j tube knotted; Loss of consciousness; fall; Agitated; Elevated blood pressure; FACILITATED COLLECT   This is a solicited report from a contactable consumer (patient) based on information received by Pfizer (Mfr. Control No.:21K-163-4042042-00).  A 72-year-old male patient received BNT162B2, dose 1 intramuscular on 03Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation; dose 2 of covid-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), intramuscular on 09Mar2021, at unspecified dose for covid-19 immunisation; carbidopa, levodopa (DUOPA, Gastroenteral suspension), via Percutaneous J-tube administration from 2009 (Batch/Lot number was not reported) and ongoing, at unspecified dose for Advanced parkinson's disease. Medical history included Bladder frequency, Labile blood pressure.  Concomitant medications included quetiapine; donepezil hydrochloride (ARICEPT) for brain function; mirabegron (MYRBETRIQ); trospium; melatonin (MELATONIN GUMMIES) for sleep, gabapentin for Leg pain. The patient experienced loss of consciousness in Aug2021 with outcome of recovered in Aug2021, fall in Aug2021 with outcome of recovered in Aug2021, blood in urine in 2020 with outcome of unknown, j tube knotted on 06Aug2021 with outcome of not recovered, elevated blood pressure in 2021 with outcome of unknown, agitated in Jun2021 with outcome of not recovered, stoma site hypergranulation and sleep disturbance on an unspecified date with outcome of unknown. Clinical course: Tissue around the stoma and sleep disturbance overnight with DUOPA (LEVODOPA/CARBIDOPA). On unknown dates, the patient experienced possible hypergranulating tissue around the stoma and sleep disturbance overnight. In 2020, the patient experienced blood in urine. In 2021, the patient experienced blood pressure elevated. In Jun2021, the patient experienced agitated. In Aug2021, the patient experienced loss of consciousness, falls and fell about 20 times. On 06Aug2021, the patient experienced j tube knotted. In Aug2021, the loss of consciousness, falls and fell about 20 times resolved. COVID-19 VACCINE was also considered suspect. The spouse stated that the was falling because he would not use his walker. On an unknown date back in 2020, the patient was diagnosed with slight blood in his urine. The patient was supposed to undergo an unknown procedure for the bladder but when he presented for surgery, his blood pressure was elevated and physician postponed the surgery. Reading value was not known. The spouse stated she and the patient had been very agitated since Jun2021 due to their move and loss of personal belongings. The spouse could not assess if COVID vaccine was related to events. It was stated he began falling about 20 times in early Aug2021. One of the times, he loss consciousness. He was taken to the Emergency Room (ER) whereby two scans, blood work and an x-ray of unknown body part were normal. He lost consciousness for approximately 10-15 seconds. He was doing well on DUODOPA with nil issues flushing tubes and mobilizing tube daily. Carer described possible hyper granulating tissue around the stoma and advice given for the ongoing treatment using hypertonic solution on the area. He was advised to continue to mobilize the stoma and that the mild ooze at times was normal. Stoma education revisited regarding the possible signs of infection to look out for. He was having some sleep disturbance overnight and as advised to speak with the Treating Specialist regarding this at the next appointment. Patient had only been requiring a single extra dose through the days that she had poor sleep the night before. It was reported that the patients tube was knotted again and he had not been able to use Duopa 1 week took oral. Alternative etiology for falls and fell about 2o times was given not using walker. Gel/ Cassette lot number: 1144163, Primary reporter did not have the lot number information, because the packaging was discarded. The action taken in response to the events for carbidopa, levodopa was dose not changed. The event loss of consciousness was serious with Other medically important condition.  Causality for DUOPA (LEVODOPA/CARBIDOPA): The reporter's causality for the event(s) of loss of consciousness, blood in urine, blood pressure elevated and agitated with DUOPA (LEVODOPA/CARBIDOPA) was no reasonable possibility. The reporter's causality for the event(s) of falls, j tube knotted, fell about 20 times, possible hypergranulating tissue around the stoma and sleep disturbance overnight was not provided. Opinion is that there is no reasonable possibility that the events of loss of consciousness, falls, j tube knotted, blood in urine, blood pressure elevated, fell about 20 times, agitated, possible hypergranulating tissue around the stoma and sleep disturbance overnight are related to DUOPA(LEVODOPA/CARBIDOPA).  Drug: DUOPA (Gastroenteral suspension) (LEVODOPA/CARBIDOPA) Causality: Loss of consciousness: Causality as per reporter (Drug/Vaccine): Not Related; Causality as per Mfr. (Drug/Vaccine: No reasonable possibility; Fall (10016173): Causality as per reporter (Drug/Vaccine): Not assessable; Causality as per Mfr.(Drug/Vaccine): No reasonable possibility; Device kink: Causality as per reporter (Drug/Vaccine): Not Reported; Causality as per Mfr.(Drug/Vaccine): No reasonable possibility; Blood in urine (Blood urine present): Causality as per reporter (Drug/Vaccine): Not Related; Causality as per Mfr.(Drug/Vaccine): No reasonable possibility; Elevated BP (Blood pressure increased): Causality as per reporter (Drug/Vaccine): Not Related; Causality as per Mfr.(Drug/Vaccine): No reasonable possibility; Fall: Causality as per reporter (Drug/Vaccine): Not assessable; Causality as per Mfr.(Drug/Vaccine): No reasonable possibility; Agitated (Agitation): Causality as per reporter (Drug/Vaccine): Not Related; Causality as per Mfr.(Drug/Vaccine): No reasonable possibility; Stoma site hypergranulation: Causality as per reporter (Drug/Vaccine): Not Reported; Causality as per Mfr.(Drug/Vaccine): No reasonable possibility; Sleep disturbance (Sleep disorder): Causality as per reporter (Drug/Vaccine): Not Reported; Causality as per Mfr.(Drug/Vaccine): No reasonable possibility. Drug: COVID-19 VACCINE (COVID-19 VACCINE) Daily Dose: 2) MFR - MODERNA Loss of consciousness: Causality as per reporter (Drug/Vaccine): Not assessable; Fall (10016173): Causality as per reporter (Drug/Vaccine): Not assessable; Device kink (Device kink): Causality as per reporter (Drug/Vaccine): Not applicable; Blood in urine (Blood urine present): Causality as per reporter (Drug/Vaccine): Not assessable; Elevated BP (Blood pressure increased): Causality as per reporter (Drug/Vaccine): Not assessable; Fall: Causality as per reporter (Drug/Vaccine): Not assessable; Agitated (Agitation): Causality as per reporter (Drug/Vaccine): Not assessable; Stoma site hypergranulation: Causality as per reporter (Drug/Vaccine): Not Reported; Sleep disturbance (Sleep disorder): Causality as per reporter (Drug/Vaccine): Not Reported.  The reporter's assessment of the causal relationship of the events with the suspect product BNT162B2 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.; Sender's Comments: As there is limited information in the case provided, the causal association between the events (Loss of consciousness, Blood pressure increased, Agitation, Sleep disturbance ) and the BNT162B2 cannot be excluded. Consider also contributory role of co-suspect drug levodopa and Moderna vaccine. "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."