Sex: U
Vaccine: COVID19
Symptoms: Osteolysis, Plasma cell myeloma
Clinical narrative: multiple myeloma; lytic lesion; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height and weight were not reported. Age at time of vaccination was unknown.  No past medical history, concurrent conditions or pre-existing medical conditions were reported.  The patient received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose and frequency not reported, administered on 13-Mar-2021, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 25-Jan-2023, the patient experienced lytic lesion. On Mar-2023, the patient experienced multiple myeloma and was hospitalized on an unspecified date. (dose series 1).  The development of the disease has caused extreme physical, emotional, and financial suffering. Since the symptoms began, the patient's quality of life has diminished immensely.  The vaccine was simultaneously impacting M-Spike protein levels, until the patient reached a point where chronic and worsening back pain forced to cease regular activities of dancing, roller skating, and playing tennis.  The patient's exhaustion levels became increasingly concerning, becoming particularly notable over the holidays in December 2022 and finally coming to an unmistakable head when the patient was forced to take a leave of absence from work on February 28, 2023 when the patient no longer possessed the energy required to complete duties as a high school teacher. Once the diagnosis was finalized and a treatment plan was agreed upon, the patient was admitted to the hospital for what was supposed to be an overnight stay to observe physical reactions to the initial dose of chemotherapy.  What resulted was a two-week hospital stay, during which the patient had to undergo multiple kyphoplasty's in an attempt to repair the irreversible damage caused by the lytic lesions from 2021 to present. Since this date, the physical effects have included a Curvature of backbone due to the compression on weakened spine due to the lytic lesions. Continuous pain in my right sternum and right upper shoulder, which has persisted and become more severe since March 2023, subsequently resulting in a shift in sternum's position within chest. Damage to heart resulting from multiple myeloma treatment, which cause severe mitral valve regurgitation and required the insertion of two mitral valve clips on April 18, 2024. The attempt to correct extreme shortness of breath was only partially successful, and to this day the patient continue to experience shortness of breath through even simple activities. Impacted lung function and an increased frequency of phlegm buildup.   The action taken with janssen covid-19 vaccine was not applicable.  The outcome of lytic lesion and multiple myeloma was not reported.  This report was associated with a product quality complaint: Product Complaint 90000348998.  Investigation Results: 90000348998-Voided- This record was reported as "There was a letter that came into the J&J Global Benefits Department via mail related to an adverse effect", which does not meet the definition of a product quality complaint or explicitly allege a potency issue.  This record will be voided as no PQC. Forwarding this record to PQV Management review to void approval. This report describes medical adverse events for the patient. There is no allegation regarding a product quality issue or product efficacy in the information reported. Approval to void due to no PQC identified..  This report was serious (caused/prolonged hospitalization).; Sender's Comments: V0; Plasma cell myeloma; The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.