Age: 74.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Device dislocation, Stoma site discharge, Stoma site erythema, Stoma site irritation
Clinical narrative: Device dislodgement; Stoma site discharge; Stoma site irritation; Stoma site redness; This is a Solicited report from a non-contactable consumer (patient) based on the information received by Pfizer (Manufacturer Control No: 21K-163-3983675-00). A contactable 74-year-old female consumer reported that:  Solicited report by a consumer of a 74 year old female with events of J-TUBE COMPLETELY DISLODGED/ and HOSPITALIZATION and non-serious STOMA SITE DISCHARGE, STOMA SITE IRRITATION and STOMA SITE REDNESS with DUOPA (LEVODOPA/CARBIDOPA). In 2021, the patient experienced HOSPITALIZATION, STOMA SITE DISCHARGE, STOMA SITE IRRITATION and STOMA SITE REDNESS. In May2021, the patient experienced J-TUBE COMPLETELY DISLODGED/. In May2021, the J-TUBE COMPLETELY DISLODGED/ resolved.  Patient advised her PEG J tube came out. Nurse case manager inquired if the entire tube came out, no tube in the stoma. Patient verbalized yes, entire tube out. There was some yellow drainage/seepage that was irritating her stoma and made it slightly red, but no bleeding or pain. Nurse case manager advised since no bleeding or pain, the emergency room was not necessary, but if she felt like she needs emergency care, should go to the emergency room. She stated she does not felt like its an emergency. She reported on May2021 the J tube completely dislodged. The j tube was replaced. She confirmed there were no product quality issues with the peg tube. Duopa tubing was replaced with tubing. Tubing had a balloon. After the procedure, the patient was kept in the hospital overnight. Previous tubing was discarded. No other details reported. She had since resided in an assisted living facility since Jun2021. Patient was not enrolled in a COVID-19 Vaccine Trial. On Mar2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer, lot number unknown, expiration date unknown. On 02Apr2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer, lot number unknown, expiration date unknown. Primary reporter did not have the lot number information, because the packaging was discarded.   Causality for DUOPA(LEVODOPA/CARBIDOPA) The reporter's causality for the event(s) of J-TUBE COMPLETELY DISLODGED/, HOSPITALIZATION, STOMA SITE DISCHARGE, STOMA SITE IRRITATION and STOMA SITE REDNESS was not provided. AbbVie's opinion is that there is no reasonable possibility that the events of J-TUBE COMPLETELY DISLODGED/, HOSPITALIZATION, STOMA SITE DISCHARGE, STOMA SITE IRRITATION and STOMA SITE REDNESS are related to DUOPA(LEVODOPA/CARBIDOPA).  DUOPA (Gastroenteral suspension) (LEVODOPA/CARBIDOPA) Route of Administration was percutaneous J-tube. Actions taken inresponse to the events device dislodgement, Stoma site discharge, Stoma site irritation, Stoma site redness was dose not changed; Causality as per reporter was not assessable; Causality as per Mfr: No reasonable possibility.  The reporter's assessment of the causal relationship of the events STOMA SITE DISCHARGE, STOMA SITE IRRITATION and STOMA SITE REDNESS 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 been obtained.; Sender's Comments: Based on the available information, there was no reasonable possibility that the events device dislodgement, Stoma site discharge, Stoma site irritation, Stoma site redness were  related to the suspect product BNT162B2.