Received Mar 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM / LA |
| FLU3 | INFLUENZA (SEASONAL) (FLUARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | IM / LA |
| FLU3 | INFLUENZA (SEASONAL) (FLULAVAL) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | IM / LA |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | — | IM / LA |
| FLU3 | INFLUENZA (SEASONAL) (AFLURIA) | SEQIRUS, INC. | UNK | — | IM / LA |
Patient Information ? Name: ? Age: 53 ? Sex: Male ? Address: ? Phone: ? Email: Vaccine Information ? Date of vaccination: February 19, 2025 (4:15 PM) ? Vaccines received: o Influenza Vaccine PF Trivalent 6+ MO (AFLURIA, FLUARIX, FLULAVAL, FLUZONE) o Moderna 12+Y (Blue Label Border 50 mcg/0.5 mL) COVID-19 Vaccine ? Location: Flu Clinic Adverse Event Description I went to Flu Clinic on February 19, 2025, specifically for an influenza vaccination due to the influenza A outbreak. The clinic staff informed me I was "behind" on my COVID-19 vaccination. As an essential worker, I felt compelled to receive both vaccines. When I asked if it was appropriate to receive both vaccines simultaneously in the same arm, the nurse assured me it was safe to do so. I clearly communicated my Factor V Leiden condition and history of blood clots, which is documented in my medical record, and clinic staff acknowledged this information prior to vaccination. I received both COVID-19 and influenza vaccines in my left arm on February 19, 2025. The following day I experienced expected symptoms similar to having both COVID and flu, requiring me to stay home from work. After returning to work, within 1-2 days, I began experiencing severe right leg pain. The pain is primarily and most consistently in my lower leg, with intermittent pain along my IT band and occasional, inconsistent pain in the gluteal region. The lower leg pain is the most severe. I have not experienced lower back pain at all, which makes the sciatica diagnosis questionable. The pain became so severe that it felt as though my leg had "seized up" and was almost broken. I attempted to relieve the pain through multiple stretching exercises without success. The pain has persisted for several weeks despite multiple medical visits and treatments. Now, nearly a month later (as of March 17, 2025), I still have severe pain that makes it very difficult to walk for more than a few minutes before I need to sit down. Medical Care Received 1. February 24, 2025: First Urgent Care visit o Treated with Flexeril for leg cramps o Symptoms were present for approximately 2 days at this point 2. February 28, 2025: First Emergency Department visit at Medical Center o Diagnosed with likely sciatica o Treated with Norco and Medrol (steroids) o D-dimer test performed (result 0.30, normal) o Complete blood count and basic metabolic panel performed o Physical exam showed normal leg exam, good DP and PT pulses, no swelling/edema o Instructions to take ibuprofen and Norco as needed for pain, and follow Medrol dose pack exactly as prescribed o Noted the temporal relationship between vaccines and symptom onset 3. March 7, 2025: Second Urgent Care visit with Dr. o Doctor strongly urged me to go to Medical Center immediately o Recommended additional testing including ultrasound, time test, and possibly MRI due to my Factor V Leiden history 4. March 7, 2025: Second Emergency Department visit at Medical Center (same day as Urgent Care) o Evaluated with physical exam and ultrasound for blood clot o Ultrasound showed no emergent abnormalities o Diagnosed with arthralgia of right lower leg o Multiple lab tests completed including CBC with Differential, Creatine Kinase, D-Dimer, Metabolic Panel, PTT and Prothrombin Time o ECG and Ultrasound of lower extremity veins performed o Prescribed Tylenol, Motrin, and voltaren gel o Recommended follow-up with primary care doctor within 3 days I have requested my complete medical records from all healthcare facilities involved, under the Health Insurance Portability and Accountability Act (HIPAA), specifically 45 CFR § 164.524. I have requested detailed records including vaccination information, lot numbers, all test results, provider notes, and documentation of my pre-existing Factor V Leiden condition disclosure. Current Status and Treatment ? Pain returned after initial improvement following steroid treatment ? Currently prescribed: o Cyclobenzaprine (Flexeril) 10mg for muscle spasm o Hydrocodone/acetaminophen (Norco) 5mg/325mg for pain o Methylprednisolone (Medrol) 4mg o Tylenol (acetaminophen) 1000mg every 6 hours o Motrin (ibuprofen) 600mg every 6 hours o Voltaren gel as needed ? Pain continues to interfere with walking and daily activities Relevant Medical History ? Factor V Leiden mutation ? History of deep venous thrombosis (DVT) 10 years ago ? Was on blood thinners for a long time Reason for Reporting I am reporting this event because: 1. The timing of my symptoms directly followed vaccination (physician notes document "received Covid and flu shots in L deltoid 3 days prior to symptom onset") 2. I have no history of sciatica or similar leg pain 3. I had no injury or event that would typically trigger these symptoms (medical records confirm "no direct trauma or unusual activity") 4. The symptoms have been severe and persistent despite multiple treatments 5. Multiple doctors have been unable to provide a clear explanation for my symptoms 6. Physical examinations and lab tests have been largely normal, with no physical findings that would explain the severe pain 7. The pain has not followed a typical sciatica pattern, as it's primarily in my lower leg and I have not experienced lower back pain 8. Some healthcare providers have acknowledged that vaccines can potentially cause inflammatory reactions in some individuals 9. Given my Factor V Leiden condition, I may have higher risk for unusual reactions involving inflammation or vascular issues I believe there may be a connection between receiving both vaccines simultaneously and the development of my symptoms, possibly due to an inflammatory response or other mechanism. I have had no other injuries, have done little to no exercise, and there is nothing else in my life that could explain these symptoms.
None
None
Omnaprazole and Bupropion
Pencillin
Please see Item 18.
The pain became so severe that it felt as though my leg had "seized up" and was almost broken. I attempted to relieve the pain t