Sex: M
Vaccine: COVID19
Symptoms: Back pain, Blood test abnormal, Cardiomegaly, Drug ineffective
Clinical narrative: LACK OF EFFECT; ENLARGED HEART; BACK PAIN; BLOOD TEST NUMBERS WILL GO UP; This spontaneous report received from a 65 year old male patient. The patient's height, and weight were not reported. The patient's concurrent conditions included: multiple myeloma. The patient received covid-19 vaccine ad26.cov2.s (dose in series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. The patient also received daratumumab (concentrate for solution for infusion, route of admin, and batch number were not reported) dose, frequency, for one or two months around MAY or JUN-2021 for multiple myeloma. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced lack of effect (dose in series 1), enlarged heart  (dose in series 1), back pain (dose in series 1), and blood test numbers will go up (dose series 1). It was reported that darzalex was reducing pain, he had back pain for 15 years and it did not go away. The patient also had multiple myeloma, when he got darzalex his back pain decreased. He trade out darzalex due to loss of effectiveness. When he switched to the other chemotherapy, his back pain returned. The patient initially was on darzalex on MAY or JUN-2021. He had taken off darzalex after having significant reaction. The patient reported that he got an enlarged heart, but it went away. He determined the reaction occurred due to JnJ Covid shot and not due to darzalex. The patient resumed darzalex in the summer of 2021, but his condition nor his numbers improved. It was also reported that he had been on a cycle of chemotherapies not working and then switching to another one. The patient stated he just did CAR-T and it did the job. The patient was still experiencing back pain. The patient commented that darzalex was the only thing that reduced his back pain.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable ; treatment with daratumumab was withdrawn with regards to back pain, enlarged heart, lack of effect and blood test numbers will go up. The patient had recovered from enlarged heart, and had not recovered from back pain, and the outcome of lack of effect, and blood test numbers will go up, was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: Covid-19 vaccine ad26.cov2.s -Drug ineffective. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: CONMEDS-OTHER SUSPECT DRUGS (daratumumab). Therefore, this event is considered inconsistent with vaccine administration.  Daratumumab -Drug ineffective -Considering the fact that the reported event is a special situation and owing to its very nature, it is not possible to attribute this occurrence to the suspect drug, hence causality is considered not related to the reported event.