Received Sep 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 1 | — | IM |
The Gazyva infusion neutralized the effect of the Covid vaccine(s)/ was not responding to the vaccine/The Covid-19 vaccines were not effective; The Gazyva infusion neutralized the effect of the Covid vaccine(s)/ was not responding to the vaccine; sore arm; got tired the next day; This spontaneous case was reported by a consumer and describes the occurrence of 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), VACCINE INTERACTION (The Gazyva infusion neutralized the effect of the Covid vaccine(s)/ was not responding to the vaccine), PAIN IN EXTREMITY (sore arm) and FATIGUE (got tired the next day) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Co-suspect products included non-company products Obinutuzumab (Gazyva) for Chronic lymphocytic leukemia and Cilgavimab, Tixagevimab (Evusheld) for COVID-19 vaccination. Concurrent medical conditions included Chronic lymphocytic leukemia (was immunocompromised). In 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Obinutuzumab (Gazyva) (unknown route) at an unspecified dose and dose of Cilgavimab, Tixagevimab (Evusheld) (unknown route) 1 dosage form. On an unknown date, the patient experienced 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), VACCINE INTERACTION (The Gazyva infusion neutralized the effect of the Covid vaccine(s)/ was not responding to the vaccine), PAIN IN EXTREMITY (sore arm) and FATIGUE (got tired the next day). At the time of the report, 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), VACCINE INTERACTION (The Gazyva infusion neutralized the effect of the Covid vaccine(s)/ was not responding to the vaccine), PAIN IN EXTREMITY (sore arm) 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 mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. No concomitant medication was reported. 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. The patient experiences the sore arm with every vaccine, but she got tired the next day with a couple of vaccine doses, the patient could not recall exact numbers. 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. The patient required treatment with Gazyva for chronic lymphocytic leukemia (CLL). The COVID-19 vaccines were not effective for the patient. During that time, the patient was receiving Evusheld in lieu of COVID-19 vaccines. Evusheld was eventually discontinued due to not being as effective. They stopped using it because they found that it was not as effective as they thought it was going to be for people. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to MOD-2025-788943 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2025: Significant live follow-up received: Co-suspects were added, additional events of vaccination failure and vaccine-drug interaction were added, and narrative was updated.; 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 (was immunocompromised)
GAZYA; 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