Received Feb 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
all of a sudden, my legs gave out and I collapsed; COVID-19; usual soreness and all that stuff; I'm not gonna remember everything you said; feel the weakness in the back of my legs; maybe I fainted because my pressure must have went down; This spontaneous case was reported by a patient and describes the occurrence of CIRCULATORY COLLAPSE (all of a sudden, my legs gave out and I collapsed) and COVID-19 (COVID-19) in a 77-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication. The patient's past medical history included Mobility decreased (bad mobility with my legs) and Pacemaker insertion (cardiac) (Cardiac pacemaker insertion) on 15-Apr-2024. Concurrent medical conditions included Diabetic and Blood pressure high. On 13-Nov-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and Influenza vaccine (Flu) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CIRCULATORY COLLAPSE (all of a sudden, my legs gave out and I collapsed) (seriousness criteria medically significant and life threatening), COVID-19 (COVID-19) (seriousness criterion life threatening), PAIN (usual soreness and all that stuff), MEMORY IMPAIRMENT (I'm not gonna remember everything you said), MUSCULAR WEAKNESS (feel the weakness in the back of my legs) and HYPOTENSION (maybe I fainted because my pressure must have went down). The patient was treated with Amlodipine besilate, Benazepril hydrochloride (Amlodipine and benazepril hydrochloride) at an unspecified dose and frequency and Metoprolol tartrate at a dose of 25 milligram twice a day. At the time of the report, CIRCULATORY COLLAPSE (all of a sudden, my legs gave out and I collapsed), COVID-19 (COVID-19), PAIN (usual soreness and all that stuff), MEMORY IMPAIRMENT (I'm not gonna remember everything you said), MUSCULAR WEAKNESS (feel the weakness in the back of my legs) and HYPOTENSION (maybe I fainted because my pressure must have went down) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 89 (units not specified). The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medications were reported. The patient was on cardiac medication. The patient used shopping cart as walker. The patient walked up one of the blocks, all of a sudden, the back of her legs felt very weak. She got home, when she got up 3 blocks up, it's an up block and it's a sloping block and it was and pushed herself and determined to get home. The patient was collapsed, got up right away. It wasn't that knocked out or unconscious, got up from the floor on her own, sat down and rested, but was awake and waited and felt little better. Most recent FOLLOW-UP information incorporated above includes: On 07-Feb-2025: Significant live follow up received included. Additional event of COVID-19 was added. On 10-Feb-2025: Non-significant follow up received included: Reference number was added.; Reporter's Comments: Co-suspect product Influenza vaccine and Covid-19 disease are confounders for all events; past medical history of Pacemaker insertion, Concurrent medical conditions included Diabetic and Blood pressure high are confounders for events hypotension and circulatory collapse; past medical history of Mobility decreased and age are confounders for muscular weakness event. The benefit -risk relationship of product is not affected by this report.
Blood pressure high; Diabetic
Medical History/Concurrent Conditions: Mobility decreased (bad mobility with my legs); Pacemaker insertion (cardiac) (Cardiac pacemaker insertion)
Test Name: Heart rate; Result Unstructured Data: 89 (units not specified)