Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, COVID-19 immunisation, Diarrhoea, Fatigue, Interchange of vaccine products
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ache), THERAPEUTIC RESPONSE SHORTENED (Humira not lasting entire cycle/ Wearing off effect), DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and VACCINATION SITE RASH (Vaccination site rash) in an elderly male 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 TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) for an unknown indication. No Medical History information was reported. On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. In 2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced PAIN (Ache), THERAPEUTIC RESPONSE SHORTENED (Humira not lasting entire cycle/ Wearing off effect), DIARRHOEA (Diarrhea), FATIGUE (Fatigue), VACCINATION SITE RASH (Vaccination site rash), VACCINATION SITE PAIN (Vaccination site pain), ARTHRALGIA (Joint pain), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). At the time of the report, PAIN (Ache), THERAPEUTIC RESPONSE SHORTENED (Humira not lasting entire cycle/ Wearing off effect), DIARRHOEA (Diarrhea), FATIGUE (Fatigue), VACCINATION SITE RASH (Vaccination site rash), VACCINATION SITE PAIN (Vaccination site pain), ARTHRALGIA (Joint pain), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown. No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Company Comment: This spontaneous case concerns an elderly male patient (age not specified) with no relevant medical history reported, who experienced the non-serious event Therapeutic response shortened, that occurred in the context of mRNA-1273 vaccination. Patient also had non serious events of Pain, Diarrhoea, Fatigue, Vaccination site rash, Vaccination site pain and Arthralgia. Patient also had received two doses covid-19 vaccine Tozinameran on an unknown date (interchange of vaccine products). No further information on clinical course, investigations and treatment received was available in the report. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement. Sender's Comments: This spontaneous case concerns an elderly male patient (age not specified) with no relevant medical history reported, who experienced the non-serious event Therapeutic response shortened, that occurred in the context of mRNA-1273 vaccination. Patient also had non serious events of Pain, Diarrhoea, Fatigue, Vaccination site rash, Vaccination site pain and Arthralgia. Patient also had received two doses covid-19 vaccine Tozinameran on an unknown date (interchange of vaccine products). No further information on clinical course, investigations and treatment received was available in the report. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.