Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, Interchange of vaccine products, Pain, Therapeutic product effect decreased
Clinical narrative: FELT PAIN OF ACHING; COVID-19; FEELING OF THE EFFETENESS WAS DIMINISHING; Interchange of vaccine products; Revaccination with different COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (FELT PAIN OF ACHING), COVID-19 (COVID-19), THERAPEUTIC PRODUCT EFFECT DECREASED (FEELING OF THE EFFETENESS WAS DIMINISHING), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form, ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. and third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (FELT PAIN OF ACHING), COVID-19 (COVID-19), THERAPEUTIC PRODUCT EFFECT DECREASED (FEELING OF THE EFFETENESS WAS DIMINISHING), 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 (FELT PAIN OF ACHING) had not resolved, COVID-19 (COVID-19) had resolved and THERAPEUTIC PRODUCT EFFECT DECREASED (FEELING OF THE EFFETENESS WAS DIMINISHING), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome 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.  No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported. Company comment-This spontaneous case concerns an elderly female patient of unspecified age with no relevant medical history reported, who experienced the unexpected non serious AESI event of COVID-19 on unknown date in the context of mRNA-1273 vaccination.  Patient had received 1st and 2nd dose of same vaccine on unknown dates and booster dose with TOZINAMERAN, Interchange of vaccine products was noted. Latency cannot be assessed since vaccination date nor event onset date were provided. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event was resolved at the time of report. Current pandemic situation of COVID 19 may remain as confounders to the event Covid -19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2022: Live Significant FU: received updates to reporter opinion of causality, suspect drug information and narrativedescription. New event added; Sender's Comments: This spontaneous case concerns an elderly female patient of unspecified age with no relevant medical history reported, who experienced the unexpected non serious AESI event of COVID-19 on unknown date in the context of mRNA-1273 vaccination.  Patient had received 1st and 2nd dose of same vaccine on unknown dates and booster dose with TOZINAMERAN, Interchange of vaccine products was noted. Latency cannot be assessed since vaccination date nor event onset date were provided. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event was resolved at the time of report. Current pandemic situation of COVID 19 may remain as confounders to the event Covid -19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement