Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Magnetic resonance imaging, Red blood cell count, Spinal cord infection, White blood cell count
Clinical narrative: Staph infection in her spinal canal; excruciating pain in her lower back area; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL CORD INFECTION (Staph infection in her spinal canal) and BACK PAIN (excruciating pain in her lower back area) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Nov-2021, the patient experienced BACK PAIN (excruciating pain in her lower back area) (seriousness criterion hospitalization). On 12-Nov-2021, the patient experienced SPINAL CORD INFECTION (Staph infection in her spinal canal) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 09-Nov-2021 to 16-Nov-2021 due to BACK PAIN and SPINAL CORD INFECTION. The patient was treated with CEFAZOLIN ongoing since an unknown date for Antibiotic therapy, at a dose of UNK, q8h for the next 12 weeks and Surgery (An Emergency surgery to remove staph from her spinal.) for Spinal cord infection. At the time of the report, SPINAL CORD INFECTION (Staph infection in her spinal canal) and BACK PAIN (excruciating pain in her lower back area) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Nov-2021, Magnetic resonance imaging: abnormal (abnormal) Staph infection in spinal canal and abnormal (abnormal) Staph infection in spinal canal. On an unknown date, Red blood cell count: 8 (Low) 8. On an unknown date, White blood cell count: 1800 (High) 1800.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Patient called to report that she received her Moderna booster on 02NOV2021.  On 09NOV2021 patient reported that she was rushed to the hospital with excruciating pain in her lower back area.  After two MRI's on 12NOV2021, it was discovered that patient had a Staph infection in her spinal canal.  They did an Emergency surgery to remove staph from her spinal canal.  She also stated that her white blood count was through the roof (1800) and her red blood cells were low (8) but are coming up. Patient further reported that she is taking antibiotic home infusion therapy called Cefazolin.  She has to take infusions every 8 hours for the next 12 weeks.   Patient also stated the antibiotic therapy was helping.   She reported she was admitted to the hospital on 09NOV2021 and discharged 16NOV2021.  Patient plans to see a Hematologist on 30NOV2021.  Lot Number #: 033F21A, Expiration date: Unknown  Company Comment: This case concerns a 63-year-old female patient with no relevant medical history, who experienced the serious unexpected events of Back Pain and Spinal Cord Infection. The events, which caused hospitalization to the patient, occurred approximately 7-10 days after receiving the third dose of mRNA-1273 Vaccine. During hospitalization, the patient's white blood cell count was elevated, and red blood cell count decreased. MRI revealed Staph infection her spinal canal and then underwent emergency surgery to treat the spinal canal infection. Patient was hospitalized for 5 days then discharged with home medications. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 63-year-old female patient with no relevant medical history, who experienced the serious unexpected events of Back Pain and Spinal Cord Infection. The events, which caused hospitalization to the patient, occurred approximately 7-10 days after receiving the third dose of mRNA-1273 Vaccine. During hospitalization, the patient's white blood cell count was elevated, and red blood cell count decreased. MRI revealed Staph infection her spinal canal and then underwent emergency surgery to treat the spinal canal infection. Patient was hospitalized for 5 days then discharged with home medications. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.