Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: COVID-19, Chills, Inappropriate schedule of product administration, Interchange of vaccine products, Pain
Clinical narrative: Achiness/Ache; COVID-19; Chills; Fever; Interchange of vaccine products; Received 1st dose on : 03-MAR-2021 and 2nd dose on : 28-APR-2021; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achiness/Ache), COVID-19 (COVID-19), CHILLS (Chills), PYREXIA (Fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 1st dose on : 03-MAR-2021 and 2nd dose on : 28-APR-2021) in a 58-year-old 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) injection for Crohn's disease.    No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 28-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 1st dose on : 03-MAR-2021 and 2nd dose on : 28-APR-2021). On an unknown date, the patient experienced PAIN (Achiness/Ache), COVID-19 (COVID-19), CHILLS (Chills), PYREXIA (Fever) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, PAIN (Achiness/Ache), CHILLS (Chills) and PYREXIA (Fever) had resolved and COVID-19 (COVID-19), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 1st dose on : 03-MAR-2021 and 2nd dose on : 28-APR-2021) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.            It was unknown whether patient was enrolled in a clinical trial.  No concomitant medication was reported by reporter.  Patient took suspect Humira injection in pre-filled pen. Pfizer vaccine was taken as booster.  No treatment medication was reported by reporter.  Reporter causality for Humira with respect to the events was not provided and causality for Pfizer vaccine for event chills, fever, ache was possible and for COOVID-19 not reported.  Company comment: This spontaneous case concerns a 58 year old male patient with relevant medical history of Crohns disease on adalimumab, who experienced the unexpected non serious of COVID-19, unknown days after receiving the second dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the first dose of the same vaccine about 56 days ago. Inappropriate schedule of product administration was noted. He received the third dose with Pfizer vaccine. Interchange of vaccine products was noted. No further information on risk factors, co morbidities, clinical course and management of the event was available in the report. The outcome of the event was unknown. Co-suspect adalimumab and the ongoing COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 58 year old male patient with relevant medical history of Crohns disease on adalimumab, who experienced the unexpected non serious of COVID-19, unknown days after receiving the second dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the first dose of the same vaccine about 56 days ago. Inappropriate schedule of product administration was noted. He received the third dose with Pfizer vaccine. Interchange of vaccine products was noted. No further information on risk factors, co morbidities, clinical course and management of the event was available in the report. The outcome of the event was unknown. Co-suspect adalimumab and the ongoing COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.