Received Mar 30, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 6 | — | IM |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
lower lumbar stenosis; cervical stenosis in his neck and back; This spontaneous case was reported by a consumer and describes the occurrence of LUMBAR SPINAL STENOSIS (lower lumbar stenosis) and CERVICAL SPINAL STENOSIS (cervical stenosis in his neck and back) in an 83-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication. The patient's past medical history included Pacemaker insertion (cardiac) (Medtronic micro-pacemaker inserted right inside the heart because of the total heart block he suffered in 2021) in 2021 and Aortic valve replacement (bovine aortic valve (Edward's valve)) in August 2018. Previously administered products included for COVID-19 immunization: Moderna COVID-19 Vaccine (Dose:1, Lot/Batch Number: 029L20A) on 21-Jan-2021, Moderna COVID-19 Vaccine (Dose:2, Lot/Batch Number: 024M20A) on 18-Feb-2021, Moderna COVID-19 Vaccine (Dose:3, Lot/Batch Number: 012F21A) on 29-Oct-2021, Spikevax (Dose:4, Lot/Batch Number: 002M21A) on 12-May-2022, Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) (Dose:5 and Lot/Batch Number: HS714513) on 23-Sep-2022; for Product used for unknown indication: Flu. Past adverse reactions to the above products included No adverse effect with Flu, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) and Spikevax. Concurrent medical conditions included COPD, Carotid artery stenosis (carotid artery stenosis of both arteries), Type 2 diabetes mellitus and Heart block (Medtronic micro-pacemaker implanted in 2021) since 2021. On 31-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On an unknown date, the patient received dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On an unknown date, the patient experienced LUMBAR SPINAL STENOSIS (lower lumbar stenosis) (seriousness criteria hospitalization and medically significant) and CERVICAL SPINAL STENOSIS (cervical stenosis in his neck and back) (seriousness criteria hospitalization and medically significant). At the time of the report, LUMBAR SPINAL STENOSIS (lower lumbar stenosis) and CERVICAL SPINAL STENOSIS (cervical stenosis in his neck and back) outcome was unknown. No concomitant medications were reported. Patient had received a total of six Moderna COVID 19 vaccinations between 2021 and 2023. In 2024, he developed lower lumbar spinal stenosis and cervical spinal stenosis and subsequently received steroid injections in his back and neck, which were administered several weeks apart due to scheduling. Because he was receiving high dose steroid injections, vaccination was delayed, also it was reported that the steroids would have reduced the effectiveness of the vaccine. As a result, patient did not receive vaccination during the typical respiratory illness season, and the next vaccination was not administered until February 2025, after completion of the steroid injections. It was reported that spinal stenosis and steroid treatments occurred after 2021. Reporter stated that patient has multiple chronic medical conditions that existed for several years prior to receiving any Moderna COVID 19 vaccine. These include advanced chronic obstructive pulmonary disease (COPD), bilateral carotid artery stenosis, and a Medtronic micro pacemaker placed due to a total heart block that occurred in 2021. This case was linked to US-MODERNATX, INC.-MOD-2021-066816 (E2B Linked Report). This case was linked to MOD-2026-794506 (Patient Link).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-066816:Wife Case (Patient K-K)
Carotid artery stenosis (carotid artery stenosis of both arteries); COPD; Heart block (Medtronic micro-pacemaker implanted in 2021); Type 2 diabetes mellitus
Medical History/Concurrent Conditions: Aortic valve replacement (bovine aortic valve (Edward's valve)); Pacemaker insertion (cardiac) (Medtronic micro-pacemaker inserted right inside the heart because of the total heart block he suffered in 2021)