Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Immunodeficiency
Clinical narrative: NO IMMUNE RESPONSE TO MODERNA COVID VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (NO IMMUNE RESPONSE TO MODERNA COVID VACCINE) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product VENETOCLAX (VENCLEXTA) for Chronic lymphocytic leukemia.    The patient's past medical history included Chronic lymphocytic leukemia and Post polio syndrome. Concomitant products included LEVOTHYROXINE, RIVAROXABAN (XARELTO), ACYCLOVIR SODIUM, ONDANSETRON HYDROCHLORIDE DIHYDRATE (ZOFRAN [ONDANSETRON HYDROCHLORIDE DIHYDRATE]), PREDNISOLONE SODIUM PHOSPHATE (PRELONE [PREDNISOLONE SODIUM PHOSPHATE]), PROCHLORPERAZINE EDISYLATE (COMPAZINE [PROCHLORPERAZINE EDISYLATE]) and TIMOLOL MALEATE for an unknown indication.   On 30-Jan-2021, the patient started VENETOCLAX (VENCLEXTA) (Oral) 20 milligram once a day. In 2021, VENETOCLAX (VENCLEXTA) (Oral) dosage was changed to 400 milligram once a day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced IMMUNODEFICIENCY (NO IMMUNE RESPONSE TO MODERNA COVID VACCINE) (seriousness criterion medically significant). At the time of the report, IMMUNODEFICIENCY (NO IMMUNE RESPONSE TO MODERNA COVID VACCINE) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: she had not made any Coronavirus antibodies.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was provided.  Company comment-This spontaneous case concerns an elderly female patient of unspecified age with relevant medical history of CHRONIC LYMPHOCYTIC LEUKEMIA reported, who experienced the unexpected serious (medically significant) event of Immunodeficiency (reported as NO IMMUNE RESPONSE TO MODERNA COVID VACCINE) that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. Patient had an antibody test done on an unknown date, which showed no coronavirus antibodies. No further information on clinical course and treatment received was available in the report. Outcome of the event was not resolved at the time of report. Relevant medical history remains a confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement Case notes--Due to limited information, Events seriousness was assessed as per medical judgement and available information.; Sender's Comments: This spontaneous case concerns an elderly female patient of unspecified age with relevant medical history of CHRONIC LYMPHOCYTIC LEUKEMIA reported, who experienced the unexpected serious (medically significant) event of Immunodeficiency (reported as NO IMMUNE RESPONSE TO MODERNA COVID VACCINE) that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. Patient had an antibody test done on an unknown date, which showed no coronavirus antibodies. No further information on clinical course and treatment received was available in the report. Outcome of the event was not resolved at the time of report. Relevant medical history remains a confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement Case notes--Due to limited information, Events seriousness was assessed as per medical judgement and available information.