Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 5 | 3043160 | IM |
More swollen than from previous Pfizer vac injections; About 2 weeks later, dark red at injection site which then spread, coned, crusted, left white mark when healed; About 2 weeks later, dark red at injection site which then spread, coned, crusted, left white mark when healed; Much sorer than previous 4 Pfizer COVID vac for 4 days; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Much sorer than previous 4 Pfizer COVID vac for 4 days), VACCINATION SITE SWELLING (More swollen than from previous Pfizer vac injections), VACCINATION SITE ERYTHEMA (About 2 weeks later, dark red at injection site which then spread, coned, crusted, left white mark when healed) and VACCINATION SITE DISCOLOURATION (About 2 weeks later, dark red at injection site which then spread, coned, crusted, left white mark when healed) in an 81-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043160) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 1), Pfizer vaccine (Dose 1), Pfizer vaccine (Dose 2), Pfizer vaccine (Dose 4), Pfizer vaccine (Dose 3), Pfizer vaccine (Dose 3), Pfizer vaccine (Dose 4) and Pfizer vaccine (Dose 2). Past adverse reactions to the above products included Pain with Pfizer vaccine, Pfizer vaccine, Pfizer vaccine and Pfizer vaccine; and Swelling with Pfizer vaccine, Pfizer vaccine, Pfizer vaccine and Pfizer vaccine. On 22-Aug-2024, the patient received fifth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. In 2024, the patient experienced VACCINATION SITE DISCOLOURATION (About 2 weeks later, dark red at injection site which then spread, coned, crusted, left white mark when healed). On 05-Sep-2024, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced VACCINATION SITE SWELLING (More swollen than from previous Pfizer vac injections). In September 2024, the patient experienced VACCINATION SITE ERYTHEMA (About 2 weeks later, dark red at injection site which then spread, coned, crusted, left white mark when healed). On an unknown date, the patient experienced PAIN (Much sorer than previous 4 Pfizer COVID vac for 4 days). At the time of the report, PAIN (Much sorer than previous 4 Pfizer COVID vac for 4 days), VACCINATION SITE SWELLING (More swollen than from previous Pfizer vac injections) and VACCINATION SITE ERYTHEMA (About 2 weeks later, dark red at injection site which then spread, coned, crusted, left white mark when healed) had resolved and VACCINATION SITE DISCOLOURATION (About 2 weeks later, dark red at injection site which then spread, coned, crusted, left white mark when healed) outcome was unknown. The concomitant medication was not reported. It was unknown if the patient experienced any additional symptoms/events. The treatment drug information was not reported. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2025: Live follow up received: Significant information received in which dose updated from 1 mL to 0.5mL, event of vaccine overdose was deleted, event verbatim updated for Vaccination site swelling and Pain and reference number was added.