Received Mar 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
unfortunately he is worse than before. It's really sad, it doesn't work to take pills, so he doesn't do it/when he had the last shot, he had a bit of neuropathy so, he started to have like this tangling sensations on the bottom of his foot; unfortunately he is worse than before. It's really sad, it doesn't work to take pills, so he doesn't do it; Moderna caused inflammation that irritated his issues with his nerves in his spines; This spontaneous case was reported by a patient family member or friend and describes the occurrence of LUMBAR RADICULOPATHY (unfortunately he is worse than before. It's really sad, it doesn't work to take pills, so he doesn't do it/when he had the last shot, he had a bit of neuropathy so, he started to have like this tangling sensations on the bottom of his foot), CONDITION AGGRAVATED (unfortunately he is worse than before. It's really sad, it doesn't work to take pills, so he doesn't do it) and INFLAMMATION (Moderna caused inflammation that irritated his issues with his nerves in his spines) in a male patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The patient's past medical history included Spinal operation (Patient had 3 failed spine surgeries.). Previously administered products included for Product used for unknown indication: Pfizer; for COVID-19 prophylaxis: Moderna. Past adverse reactions to the above products included No adverse effect with Moderna and Pfizer. Concurrent medical conditions included Lumbar radiculopathy. On 04-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced LUMBAR RADICULOPATHY (unfortunately he is worse than before. It's really sad, it doesn't work to take pills, so he doesn't do it/when he had the last shot, he had a bit of neuropathy so, he started to have like this tangling sensations on the bottom of his foot), CONDITION AGGRAVATED (unfortunately he is worse than before. It's really sad, it doesn't work to take pills, so he doesn't do it) and INFLAMMATION (Moderna caused inflammation that irritated his issues with his nerves in his spines). At the time of the report, LUMBAR RADICULOPATHY (unfortunately he is worse than before. It's really sad, it doesn't work to take pills, so he doesn't do it/when he had the last shot, he had a bit of neuropathy so, he started to have like this tangling sensations on the bottom of his foot) and CONDITION AGGRAVATED (unfortunately he is worse than before. It's really sad, it doesn't work to take pills, so he doesn't do it) had not resolved and INFLAMMATION (Moderna caused inflammation that irritated his issues with his nerves in his spines) outcome was unknown. No concomitant medication was reported. Patient's wife mentioned that her husband had not a bad reaction to the Moderna. he had Moderna and Pfizer before, but he has an underlying issue with Lumbar Radiculopathy, he had 3 failed spine surgeries and the last time he had a Moderna vaccine on 04-Oct-2024. Patient always has pain running down from his back all the way to his foot, it was part of his problem, why patient had the surgeries and unfortunately, he was worse than before. It was really sad, it did not work to take pills, so he did not do it. When patient had the last shot, he had a bit of neuropathy, so he started to have like these tangling sensations on the bottom of his foot, which was kind of unusual for him. So, he had Moderna before, all the shots ever had, he was very careful, since he has underlying medical conditions, still wearing masks and never had COVID. But his wife asked doctor, he said like it sounds like maybe the Moderna caused inflammation that irritated his issues with his nerves in his spine and so he agreed with her for switch to Novavax next time. Patient has some medical procedures coming up where he has to be unmasked on 31-Mar and then he has another one at the end of April. No treatment medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2025-783234, US-MODERNATX, INC.-MOD-2025-783235 (E2B Linked Report).; Reporter's Comments: The patient's underlying lumbar radiculopathy remains a major confounder as it was stated that the patient had three failed spine surgeries in his medical history. However, the patent's physician suspected that vaccine caused "inflammation" which further caused aggravation of lumbar radiculopathy. The benefit-risk relationship of the product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-783234:Patient 2 of 3 (Reporter's son) US-MODERNATX, INC.-MOD-2025-783235:Invalid case for multiple patient's
Lumbar radiculopathy
Medical History/Concurrent Conditions: Spinal operation (Patient had 3 failed spine surgeries.)