Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, COVID-19, Gastrointestinal infection, Interchange of vaccine products, Pain in extremity
Clinical narrative: Painful knees; Hand pain; COVID-19; Gastrointestinal infection; Interchange of vaccine products; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL INFECTION (Gastrointestinal infection), ARTHRALGIA (Painful knees), PAIN IN EXTREMITY (Hand pain) and COVID-19 (COVID-19) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination and ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE (It was unknown if patient experienced any adverse reactions following administration of covid-19 vaccine ad26.cov2.s. (suspension for injection and intramuscular and dose number in series was 1) .) on 20-Mar-2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE. Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis).   In 2021, the patient received second dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 04-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In December 2021, the patient experienced GASTROINTESTINAL INFECTION (Gastrointestinal infection) (seriousness criterion hospitalization). On an unknown date, the patient experienced ARTHRALGIA (Painful knees) (seriousness criterion hospitalization), PAIN IN EXTREMITY (Hand pain) (seriousness criterion hospitalization), COVID-19 (COVID-19) (seriousness criterion hospitalization) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). The patient was hospitalized for 5 days due to ARTHRALGIA, COVID-19, GASTROINTESTINAL INFECTION and PAIN IN EXTREMITY. At the time of the report, GASTROINTESTINAL INFECTION (Gastrointestinal infection), ARTHRALGIA (Painful knees) and COVID-19 (COVID-19) was resolving and PAIN IN EXTREMITY (Hand pain) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown. Not Provided          No concomitant medications were reported.  No treatment medications were reported.  It was reported that the patient received Other Manufacturer covid-19 vaccine ad26. cov2.s (dose number in series was 2) (suspension for injection, intramuscular, batch number unknown, expiry: unknown) dose was not reported, 1 total, administered on 2021 for prophylactic vaccination which reported for off label use and inappropriate schedule of vaccine administered.  On an unspecified date, the patient had covid-19, patient got covid after left hospital. Missed doses of Humira while in hospital and during covid and had painful knee and hand pain. The patient was hospitalized on an unknown date for five days.   On an unspecified date therapy with Co-suspect Humira was discontinued.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Company Comment: This spontaneous case of Interchange of vaccine products, concerns a 56-year-old female patient, with relevant medical history of previous vaccination of JANSSEN COVID-19 VACCINE for Prophylactic vaccination and ADALIMUMAB (HUMIRA) for Rheumatoid arthritis, who experienced the unexpected serious events of Gastrointestinal infection, Arthralgia, Pain in extremity and COVID-19 (AESI). The events occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine and resulted in hospitalization. At the time of the report the outcome of the events was unknown. The patient's medical history of previous vaccination of JANSSEN COVID-19 VACCINE for Prophylactic vaccination and ADALIMUMAB (HUMIRA) for Rheumatoid arthritis, remain as confounders for the occurrence of the events. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case of Interchange of vaccine products, concerns a 56-year-old female patient, with relevant medical history of previous vaccination of JANSSEN COVID-19 VACCINE for Prophylactic vaccination and ADALIMUMAB (HUMIRA) for Rheumatoid arthritis, who experienced the unexpected serious events of Gastrointestinal infection, Arthralgia, Pain in extremity and COVID-19 (AESI). The events occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine and resulted in hospitalization. At the time of the report the outcome of the events was unknown. The patient's medical history of previous vaccination of JANSSEN COVID-19 VACCINE for Prophylactic vaccination and ADALIMUMAB (HUMIRA) for Rheumatoid arthritis, remain as confounders for the occurrence of the events. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.