Received Jun 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
serious adverse effects; I usually take it on the weekend because I know I'm going to be sick afterwards, like a fever and body aches, etc; I usually take it on the weekend because I know I'm going to be sick afterwards, like a fever and body aches, etc; This subject of an unknown age and gender was involved in an other study and received COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) for COVID-19 prophylaxis. The report describes a case of IMMUNISATION REACTION (serious adverse effects). The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication. No Medical History information was reported. On an unknown date, the subject received dose of COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) (unknown route) 1 dosage form at an unspecified frequency and dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form at an unspecified frequency. On an unknown date, the subject experienced IMMUNISATION REACTION (serious adverse effects) (seriousness criterion medically significant), PAIN (I usually take it on the weekend because I know I'm going to be sick afterwards, like a fever and body aches, etc) and PYREXIA (I usually take it on the weekend because I know I'm going to be sick afterwards, like a fever and body aches, etc). At the time of the report, IMMUNISATION REACTION (serious adverse effects), PAIN (I usually take it on the weekend because I know I'm going to be sick afterwards, like a fever and body aches, etc) and PYREXIA (I usually take it on the weekend because I know I'm going to be sick afterwards, like a fever and body aches, etc) outcome was unknown. The action taken with COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) (Unknown) and Tozinameran (Pfizer BioNTech COVID-19 vaccine) (Unknown) was unknown. For COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) (Unknown), the reporter did not provide any causality assessments. DCP-ID: DCP-0420-25 DCP name: mRNA-1083 Life Cycle Management Concept Evaluation No concomitant medications provided by the reporter. It was reported that subject did have serious adverse effects. No treatment medications provided by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2025-786904, US-MODERNATX, INC.-MOD-2025-786905, US-MODERNATX, INC.-MOD-2025-786906, US-MODERNATX, INC.-MOD-2025-786907, US-MODERNATX, INC.-MOD-2025-787115, US-MODERNATX, INC.-MOD-2025-787116, US-MODERNATX, INC.-MOD-2025-787117 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 22-May-2025: Live non-significant information follow-up received in which new reporter details were added. On 26-May-2025: Live follow-up received in which follow-up information included no new information. On 27-May-2025: Live follow up received that contains significant information includes added DCP number and narrative was updated.; Reporter's Comments: The causality of the event Immunisation reaction, Pain and Pyrexia was assessed conservatively as related, due to the unknown temporal association and limited information provided. Further information is requested. The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-786904:Unspecified number of peoples US-MODERNATX, INC.-MOD-2025-786906:Female patient US-MODERNATX, INC.-MOD-2025-786905:Female patient US-MODERNATX, INC.-MOD-2025-786907:Male patient US-MODERNATX, INC.-MOD-2025-787116:Female patient US-MODERNATX, INC.-MOD-2025-787117:Unknown patient US-MODERNATX, INC.-MOD-2025-787115:Unknown patient