Received Jan 8, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
sore arm; achy; low grade fever; hives; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN (achy), PYREXIA (low grade fever) and URTICARIA (hives) in an adult female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Evolocumab (Repatha) injection for High cholesterol. Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 2) in April 2021 and PFIZER BIONTECH COVID-19 VACCINE (Dose 1) in April 2021. Past adverse reactions to the above products included No adverse effect with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Drug allergy (Repatha) and High cholesterol (injectable cholesterol-lowering). In April 2023, the patient started Evolocumab (Repatha) (unknown route) at an unspecified dose. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In April 2023, the patient experienced URTICARIA (hives). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), PAIN (achy) and PYREXIA (low grade fever). At the time of the report, PAIN IN EXTREMITY (sore arm) and PYREXIA (low grade fever) had resolved and PAIN (achy) and URTICARIA (hives) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: High. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Concomitant medication was not reported. It was reported that patient had some lot numbers at home, and the rest were at pharmacy. It was stated that the base of Repatha was some sort of hamster stem cell ovary something, and it was the same base as the non-Moderna RSV vaccines, so the pharmacist would not administer a non-Moderna RSV vaccine to the patient because of the potential of a reaction. She had gotten multiple Moderna Covid vaccines with just the normal minor side effects, so she knew the mRNA vaccines were okay for her since she had multiple. Patient reaction to Repatha was completely independent of the Covid-19 vaccines. She got hives when she started Repatha. It was not at the same time of any other vaccines. Patient experienced achy, low-grade fever, and sore arm with previous Moderna Covid-19 vaccines. The first 2 Covid-19 vaccines she got were Pfizer, everything after that was once a year, usually around August or September of each year, 2022-2025, she had gotten an annual Moderna Covid-19 vaccine. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.
Drug allergy (Repatha); High cholesterol (injectable cholesterol-lowering)
Repatha
Test Name: cholesterol; Result Unstructured Data: High