Received Nov 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
breast cancer; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER FEMALE (breast cancer) in a 79-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Moderna Covid-19 vaccine (had COVID-19 in 2022) in 2020. Past adverse reactions to the above products included COVID-19 with Moderna Covid-19 vaccine. Concurrent medical conditions included Arthritis (From 20 years ago), Migraine (patient had migraines before), Vascular disorder and Allergy to antibiotic (Severe allergies to antibiotics, From: as a child, so in distant past). On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2024, the patient experienced BREAST CANCER FEMALE (breast cancer) (seriousness criterion medically significant). The patient was treated with Acetylsalicylic acid (Aspirin) for Vascular disorder, at a dose of 325 milligram once a day; Paracetamol (Tylenol) at a dose of 2 doses of extra strength and Surgery (Mastectomy and chemotherapy) for Breast cancer female. At the time of the report, BREAST CANCER FEMALE (breast cancer) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cancer screening: Breast cancer was found through routine screening, patient never felt a lump.. No concomitant medications were taken by patient. The patient had undergone mastectomy and chemotherapy, aside from childhood crap that people get. The patient received two Tylenol doses of extra strength and was able to go back to sleep with an ice pack. On 03-Oct-2025, the patient received a dose of Fluzone High-Dose (Sanofi Pasteur) for unknown indication. On 18-Oct-2025, the patient received 0.3 ml dose of Comirnaty (Pfizer) vaccine (expiry date: 09-Jul-2026, batch no.: NA4452) in upper left arm for an unknown indication. Patient had really bad reaction to Comirnaty vaccine within 12 hours of administration, and it made the caller woke up. Patient woke up with severe chest pressure, chills, migraine, body aches, joint pain, nausea, dizziness, and fatigue. Fatigue continued. Patient did take Aspirin, and normally took Aspirin at a dose of 325 mg at night for vascular issues. The patient did get up and took two Tylenol doses of extra strength and was able to go back to sleep with an ice pack. Patient has had COVID vaccine since it first came out, but this was patient's first time having Pfizer dose, and the patient usually got Moderna vaccine. Prior doses were all of Moderna COVID-19 vaccine. Patient got Comirnaty vaccine injection on 18-Oct-2025, and had severe chest pressure, chills, body aches, joint pain, nausea, and dizziness in overnight of 19-Oct-2025. All resolved by next morning, 19-Oct-2025. Patient just stayed tired for the day, that was it, and everything else went away, and patient confirmed that the symptoms of severe chest pressure, chills, body aches, joint pain, nausea, and dizziness all resolved. Patient was just enough to wake up and got scared. Patient had migraines for a little bit, not as migraine, but as a little headache. Patient has had migraines before. This case was linked to MOD-2025-790445 (Patient Link).; Reporter's Comments: Regulatory Authority causality for Breast cancer female was assessed as not related, due to lack of biological plausibility. The benefit-risk relationship of product is not affected by this report.
Allergy to antibiotic (Severe allergies to antibiotics, From: as a child, so in distant past); Arthritis (From 20 years ago); Migraine (patient had migraines before); Vascular disorder
Test Name: Routine screening; Result Unstructured Data: Breast cancer was found through routine screening, patient never felt a lump.