Received Sep 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
strong backache; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (strong backache), CHILLS (chills) and NAUSEA (nausea) in a 62-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The patient's past medical history included COVID-19 (Bad case) in January 2023. Previously administered products included for Product used for unknown indication: Pfizer (Dose 1, upper arm, EW0164) on 16-Apr-2021, Pfizer (Dose 2, upper arm, EW0165) on 07-May-2021, Pfizer (Dose 3, upper arm and FH8030) on 26-Nov-2021. Past adverse reactions to the above products included Vaccination adverse reaction with Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Menopause (Strong menopause symptoms). Concomitant products included Estradiol and Progesterone for Menopause. In 2023, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (strong backache), CHILLS (chills) and NAUSEA (nausea). At the time of the report, BACK PAIN (strong backache), CHILLS (chills) and NAUSEA (nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: 160. The patient had bad adverse reactions to the Moderna vaccine received in 2023. The patient had strong negative reactions- causing backache/ nausea/ chills to the COVID vaccine received since getting actual COVID- bad case but not hospitalized in early 2023. On an unknown date, patient received Comirnaty (2024-2025 Formula) intramuscularly in arm. The patient did not receive any other vaccines on the same date as the Pfizer vaccine nor received any other vaccines within 4 weeks prior to the first administration of the vaccine. Following Comirnaty, the patient had severe back aches and pain, chills and stomach nausea. The symptoms were like those when the patient had COVID, back aches were very painful. The patient also had a cough. The adverse event did not require an emergency room visit nor visit to the physician's office. The patient recovered from these symptoms. It was unknown if the patient was allergic to any previous vaccination, medications, food or other products. No treatment medication was reported.
Menopause (Strong menopause symptoms)
Medical History/Concurrent Conditions: COVID-19 (Bad case)
Estradiol; Progesterone
Test Name: Weight; Result Unstructured Data: 160