Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Device connection issue, Device dislocation, Dysphagia, Dyspnoea
Clinical narrative: This is a solicited report based on information received by Pfizer.  A 59-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on Jul2021 (at the age of 59-years-old) as dose 2, single for COVID-19 immunisation; and carbidopa, levodopa (DUOPA), via an unspecified route of administration from 2018, at unspecified dose, via an unspecified route of administration from 11Feb2020 to an unspecified date, at unspecified dose for an unspecified indication. Previously the patient received the first dose of bnt162b2 on an unspecified date in Jul2021 for COVID-19 immunisation. Medical history included naso Jejunal Tube Placement, Non Smoker, Abstains From Alcohol and hospitalisation from Jan2021 (palliative care). The patient's concomitant medications were not reported. The patient experienced multiple falls on an unspecified date, parkinson's disease on an unspecified date, difficulty breathing on an unspecified date, feeling unwell on an unspecified date, unable to swallow on an unspecified date, unable to walk on an unspecified date, weakness on an unspecified date, device dislocation on 21Jul2021, device connection issue on 21Jul2021 with outcome of not recovered. The patient's wife reported that from Jan2021 the patient was in the hospital and spent three months in hospital. He was in palliative care. GIMD changed the tubing both times he was in the hospital. On 21Jul2021, connector was coming off the inner tube and wanted to order a new connector. The registered nurse who came two times week told wife she could change the tubing for him. NCM encouraged wife to rule out to gimd. Wife reported something happened with the pump. She told the nurse could do it. NCM encouraged to rule out to morning dose. Offered with to mdo. Wife did not have time to speak to him. He had oral carbidopa and levodopa on hand. He was still used Duopa. NCM asked if tube was coming out of connector. Wife said yes. NCM offered to discontinue Duopa. He had a J tube replacement. Replaced the J tube only with all connectors. New Tube lot number was 32463288 for the J tube placed 12Aug2021. He was hospitalized with a psychotic episode on an unknown date and that's when he removed the J tube and the Y connector was broken. He was in restraints. On 10Aug2021, patient was hospitalized and was currently still in the hospital with the possible plan of care of being discharge to a rehab center. He was not feeling well because of the dislocation of the J tube and he was not getting the Duopa medication. His psychotic episode was the hallucinations. His Duopa dose was increased by approximately eight months ago from daily to 24-hour use (off label use). His wife suspects that the second dose of the Covid- 19 vaccination resulted in the he becoming weaker. The patient was hospitalized for multiple falls. The outcome of events Device connection issue and Device dislocation was Unknown, the other events were not resolved.   The reporter assessed the event weakness as possible related to bnt162b2, the causality assessment for events Device connection issue and Device dislocation was not provided, and the other events were assessed as not related to bnt162b2.  The reporter's assessment of the causal relationship of the reported events Device connection issue and Device dislocation 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  Causality for DUOPA (LEVODOPA/CARBIDOPA)The reporter's causality for the event(s) of unspecified hospitalization, connector issue/connector was came off the inner tube and J TUBE DISLOCATION was not provided. The reporter's causality for the event(s) of multiple falls, advanced Parkinson's disease, not feeling well, difficulty breathing, inability to move/walk, inability to swallow, off label use/patient used duopa for 24 hours and weak with duopa(levodopa/carbidopa) was no reasonable possibility. AbbVie's opinion is that there is no reasonable possibility that the events of unspecified hospitalization, multiple falls, connector issue/connector was came off the inner tube, j tube dislocation, advanced Parkinson'sdisease, not feeling well, difficulty breathing, inability to move/walk, inability to swallow, off label use/patient used duopa for 24 hours and weak are related to duopa(levodopa/carbidopa).   The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events (falls, Parkinson's disease) and the administration of the vaccine cannot be 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.