Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Arthralgia, COVID-19 immunisation, Chills, Fatigue, Headache
Clinical narrative: immune system is compromised; I felt terribly sick, just as if I was having Covid-19 all over again; fatigue; headache; muscle pain; joint pain; chills; nausea and vomiting; nausea and vomiting; fever; rash; revaccination with different COVID-19 vaccine; interchange of vaccine products; This spontaneous case was reported by a patient and describes the occurrence of IMMUNODEFICIENCY (immune system is compromised) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 prophylaxis.    The patient's past medical history included COVID-19.   On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form On an unknown date, received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. and fifth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNODEFICIENCY (immune system is compromised) (seriousness criterion medically significant), ILLNESS (I felt terribly sick, just as if I was having Covid-19 all over again), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), VOMITING (nausea and vomiting), NAUSEA (nausea and vomiting), PYREXIA (fever), RASH (rash), COVID-19 IMMUNISATION (revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products). At the time of the report, IMMUNODEFICIENCY (immune system is compromised), ILLNESS (I felt terribly sick, just as if I was having Covid-19 all over again), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), VOMITING (nausea and vomiting), NAUSEA (nausea and vomiting), PYREXIA (fever), RASH (rash), COVID-19 IMMUNISATION (revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered IMMUNODEFICIENCY (immune system is compromised), ILLNESS (I felt terribly sick, just as if I was having Covid-19 all over again), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), VOMITING (nausea and vomiting), NAUSEA (nausea and vomiting), PYREXIA (fever) and RASH (rash) to be related. No further causality assessments were provided for COVID-19 IMMUNISATION (revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products).    No concomitant medication was reported. The patient had Covid-19 about 2 and a half years ago and then had to start receiving the vaccines. While the patient was recovering very nicely from Covid until, started getting the vaccines. The patient received 2 original shots + 2 booster doses from Moderna. Then another booster from Pfizer. The patient had to receive nursing care. The doctors know nothing about this, they said it just happens and that´s it. The patient felt terribly sick, just as if the patient was having Covid-19 all over again. The patient feel very sick every time, the patient got a shot. The patient was homebound and sick. The patient's immune system was compromised. Nurses were taking care of the patient at home. No treatment medication was reported. Company comment- This spontaneous case concerns a female patient of unknown age with no relevant medical history reported, who experienced the unexpected serious (medically significant) event immunodeficiency along with several non-serious events. A dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine was administered. Latency unknown as the onset date of the event and vaccination date were not specified. It was reported patient received 2 original shots and 2 booster doses from Moderna, then another booster from PFIZER (revaccination with different COVID-19 vaccine and interchange of vaccine products). She reported she had to receive nursing care, she felt terribly sick, just as if she was having COVID-19 all over again. She said her immune system is compromised. Fatigue, headache, muscle pain, joint pain, chills, nausea and vomiting, fever, rash were the kind of side effects she experienced. The benefit-risk relationship mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-736245 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-736245:Bivalent Case