Received Sep 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
sore arm; The Gazyva infusion neutralized the effect of the Covid vaccine(s)/ was not responding to the vaccine; The Gazyva infusion neutralized the effect of the Covid vaccine(s)/ was not responding to the vaccine/The Covid-19 vaccines were not effective; got tired the next day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), VACCINE INTERACTION (The Gazyva infusion neutralized the effect of the Covid vaccine(s)/ was not responding to the vaccine), VACCINATION FAILURE (The Gazyva infusion neutralized the effect of the Covid vaccine(s)/ was not responding to the vaccine/The Covid-19 vaccines were not effective) and FATIGUE (got tired the next day) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect products included non-company products Obinutuzumab (Gazyva) infusion for CLL and Cilgavimab, Tixagevimab (Evusheld) for an unknown indication. Concurrent medical conditions included Chronic lymphocytic leukemia (diagnosed prior to receiving any Moderna COVID vaccine and was immunocompromised). On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form, Obinutuzumab (Gazyva) (unknown route) at an unspecified dose and Cilgavimab, Tixagevimab (Evusheld) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), VACCINE INTERACTION (The Gazyva infusion neutralized the effect of the Covid vaccine(s)/ was not responding to the vaccine), VACCINATION FAILURE (The Gazyva infusion neutralized the effect of the Covid vaccine(s)/ was not responding to the vaccine/The Covid-19 vaccines were not effective) and FATIGUE (got tired the next day). At the time of the report, PAIN IN EXTREMITY (sore arm), VACCINE INTERACTION (The Gazyva infusion neutralized the effect of the Covid vaccine(s)/ was not responding to the vaccine), VACCINATION FAILURE (The Gazyva infusion neutralized the effect of the Covid vaccine(s)/ was not responding to the vaccine/The Covid-19 vaccines were not effective) and FATIGUE (got tired the next day) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: at the time of COVID her blood levels got to the point where she started needing treatment for her chronic lymphocytic leukemia diagnosis. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medications were reported. It was reported that, the patient had no side effects from the Moderna COVID vaccine, other than a sore arm and being a little bit tired the next day. She experienced the sore arm with every vaccine but got tired the next day with a couple of vaccine doses, she could not recall exact numbers. She was immunocompromised and had always gotten the Moderna COVID vaccine. She received at least one Moderna Covid-19 vaccine, had already been vaccinated, but she could not remember if once or twice. She required treatment with Gazyva for CLL. The Gazyva infusion neutralized the effect of the Covid vaccine(s), she was not responding to the vaccine. The Covid-19 vaccines were not effective for her. During that time, she was receiving Evusheld in lieu of Covid-19 vaccines. Evusheld was eventually discontinued due to not being as effective, but that had been discontinued. They stopped using it because they found that it was not as effective as they thought it was going to be for people. The treatment she was getting nullified the vaccine, so for two years, she did not respond to the vaccine at all. At the beginning of COVID, she was pretty much housebound for 2 years and did use an unintelligible but was then not considered viable. After about two years, they started testing her again after every vaccine, and she began responding to it, so now she received a Moderna COVID vaccine every 6 months. No other details were provided. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. This case was linked to MOD-2025-788941 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2025: Live follow-up received included significant information included co-suspects added, new events (vaccine-drug interaction and vaccination failure) added, narrative updated, and reference numbers were added.; Reporter's Comments: Patients' Chronic lymphocytic leukemia under Obinutuzumab is strong confounder for the events. The benefit-risk relationship of product is not affected by this report.
Chronic lymphocytic leukemia (diagnosed prior to receiving any Moderna COVID vaccine and was immunocompromised)
GAZYVA; EVUSHELD
Test Name: Blood levels; Result Unstructured Data: at the time of COVID her blood levels got to the point where she started needing treatment for her chronic lymphocytic leukemia diagnosis