Received Nov 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
lymph node that was about ready to cut off the blood supply to his right leg; Patient received lower dose due to pharmacist who didn't even understand the difference (of the two vaccines); This spontaneous case was reported by a consumer and describes the occurrence of FOLLICULAR LYMPHOMA RECURRENT (lymph node that was about ready to cut off the blood supply to his right leg) in a 69-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. The non-company product included Influenza vaccine for an unknown indication. The patient's past medical history included Follicular lymphoma from 2019 to 2022 and CAR T-cell therapy (diagnosed 6 years ago). Previously administered products included for COVID-19 prophylaxis: moderna covid-19 vaccine (dose 1) in March 2021 and moderna covid-19 vaccine (dose 2) in March 2021; for Product used for unknown indication: Pneumonia (Pneumonia vaccine). Past adverse reactions to the above products included No adverse effect with Pneumonia, moderna covid-19 vaccine and moderna covid-19 vaccine. Concurrent medical conditions included Immunodeficiency (did not have any immune system). In November 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose and dose of Influenza vaccine (unknown route) 1 dosage form. In November 2024, the patient experienced UNDERDOSE (Patient received lower dose due to pharmacist who didn't even understand the difference (of the two vaccines)). In December 2024, the patient experienced FOLLICULAR LYMPHOMA RECURRENT (lymph node that was about ready to cut off the blood supply to his right leg) (seriousness criterion medically significant). At the time of the report, FOLLICULAR LYMPHOMA RECURRENT (lymph node that was about ready to cut off the blood supply to his right leg) had resolved and UNDERDOSE (Patient received lower dose due to pharmacist who didn't even understand the difference (of the two vaccines)) outcome was unknown. The patient got a few vaccines that older people get, like pneumonia and a couple of other ones, but within 4 weeks, no vaccines were received by the patient. The only vaccines he had been getting besides those were the flu vaccine and COVID vaccines. It would not have been 4 weeks before because he always gets the flu vaccine in October or November. No relevant medical conditions. Before all the cancer, cell therapy, he was fine. Patient got all the COVID-19 vaccines in the past. He was on CAR-T therapy. He needed a completely different vaccine than everybody else and that, because of it, it changed him completely relative to everybody else. No concomitant medication was reported. He did not know how many doses he got. He got the initial 2 doses; it would have been Mar-2021; first of March and the last of March. It was reported that the patient might receive the first vaccination on 1-Mar-2021 and 2nd vaccination on 28-Mar-2021. According to his doctor, he needed 4 vaccines this season because he had CAR-T therapy. Because of this therapy, he was much more susceptible to COVID than most people because he did not have an immune system, and he was old. He got the lower dose last time because the pharmacist did not even understand the difference between the two vaccines. The patient did not have any immune system. Patient had been diagnosed with cancer many times, but his original diagnosis was 6 years ago. He started getting COVID vaccines as soon as they became available. Then in 2022, he got treatment and that got rid of it for 18 months. After that, it came back, got really bad, and then they got rid of it again; that was the main diagnosis in the meantime. Last December, he had a lymph node that was about ready to cut off the blood supply to his right leg. He got it taken care of quickly and, in the meantime, he got rid of all the cancer. He started CAR-T therapy in Apr-2025. He got 4 doses before that and since then he had 2 doses and had been due for another one. It was unknown if the patient experienced any additional symptoms/events. This case was linked to MOD-2025-789227 (Patient Link).; Reporter's Comments: Company comment: Causality for follicular lymphoma recurrent is assessed as not related considering underlying history of follicular lymphoma also with prior recurrences. The benefit-risk relationship of product is not affected by this report.
Immunodeficiency (did not have any immune system)
Medical History/Concurrent Conditions: CAR T-cell therapy (diagnosed 6 years ago); Follicular lymphoma