Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Immobile, Laboratory test, Muscle abscess, Sepsis
Clinical narrative: Abscess in my spine and both sides muscles/I had severe back pain; I was diagnosed with Sepsis of unknown origin; septic shock; abscess in my spine and both sides muscles; This spontaneous case was reported by a patient and describes the occurrence of SPINAL CORD ABSCESS (Abscess in my spine and both sides muscles/I had severe back pain), SEPSIS (I was diagnosed with Sepsis of unknown origin), SEPTIC SHOCK (septic shock) and MUSCLE ABSCESS (abscess in my spine and both sides muscles) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A22B, 042L20A, 023M20A and 939904 or 939G04) for COVID-19 prophylaxis.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2022, the patient experienced SPINAL CORD ABSCESS (Abscess in my spine and both sides muscles/I had severe back pain) (seriousness criteria hospitalization and medically significant), SEPSIS (I was diagnosed with Sepsis of unknown origin) (seriousness criteria hospitalization and medically significant), SEPTIC SHOCK (septic shock) (seriousness criteria hospitalization and medically significant) and MUSCLE ABSCESS (abscess in my spine and both sides muscles) (seriousness criteria hospitalization and medically significant). The patient was treated with Rehabilitation therapy (Rehab therapy for 3 weeks) for Spinal cord abscess; Rehabilitation therapy (Rehab therapy for 3 weeks) for Sepsis; Rehabilitation therapy (Rehab therapy for 3 weeks) for Septic shock and Rehabilitation therapy (Rehab therapy for 3 weeks) for Muscle abscess. At the time of the report, SPINAL CORD ABSCESS (Abscess in my spine and both sides muscles/I had severe back pain), SEPSIS (I was diagnosed with Sepsis of unknown origin), SEPTIC SHOCK (septic shock) and MUSCLE ABSCESS (abscess in my spine and both sides muscles) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. It was reported that on June 4th, patient was admitted to the emergency room with an abscess in her spine and both sides muscles. She had severe back pain and it turned out she was septic. She had sepsis, septic shock. She was in the hospital for two weeks and then the rehab for three weeks. It was it was a big deal, and it never even occurred to her that it might be related to vaccination. She pretty much lost the summer 2022 there. She was diagnosed with sepsis of unknown origin. They did all kinds of studies on every organ. She didn't have anything. She didn't have any injuries. She did not have any illnesses. She had to swallow a camera to see if she had vegetation's on her heart because they could not find any source for this infection. She was fine and totally recovered and back to doing her regular life. She stated, at the time nobody thought it might have anything to do with the vaccine. It was reported that on DEC-2023 she read an article about possible contamination of Moderna vaccines. She was wondering if the lot she received was part of the contaminated batch. She stated that she was still traumatized not knowing what happened to her a why she got so sick.  It was also reported that patient received Dose 5 Moderna COVID-19 vaccine on 14-SEP-2022 (Lot AS71910 & Exp. Date: unknown), Dose 6 Moderna COVID-19 Bivalent Booster dose on 21-APR-2023 (Lot 062F22A & Exp. Date: unknown). Dose 7 Spikevax on 09-OCT-2023 (Lot RA06087 & Exp. Date: unknown).  Company Comment: This is a spontaneous case concerning a 72-year-old female patient with no reported medical history, who experienced the serious (due to medically significant and hospitalization) unexpected events of Septic shock, Sepsis, Spinal cord abscess and Muscle abscess. The events occurred on an unknown date in Jun 2022, approximately 15 days a dose of mRNA-1273 vaccine received as the fourth dose of COVID-19 vaccination schedule. It was reported that the patient was admitted to the emergency room with an abscess in her spine and both sides muscles. She had severe back pain and it turned out she was septic. She had sepsis, septic shock. She was in the hospital for two weeks and then the rehab for three weeks. She was diagnosed with sepsis of unknown origin. Supportive diagnostic procedures and treatment were not provided. The outcome of the events was reported as recovered. The events was considered unrelated to the vaccine as etiopathogenesis of the events is not consistent with the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: Company Comment: This is a spontaneous case concerning a 72-year-old female patient with no reported medical history, who experienced the serious (due to medically significant and hospitalization) unexpected events of Septic shock, Sepsis, Spinal cord abscess and Muscle abscess. The events occurred on an unknown date in Jun 2022, approximately 15 days a dose of mRNA-1273 vaccine received as the fourth dose of COVID-19 vaccination schedule. It was reported that the patient was admitted to the emergency room with an abscess in her spine and both sides muscles. She had severe back pain and it turned out she was septic. She had sepsis, septic shock. She was in the hospital for two weeks and then the rehab for three weeks. She was diagnosed with sepsis of unknown origin. Supportive diagnostic procedures and treatment were not provided. The outcome of the events was reported as recovered. The events was considered unrelated to the vaccine as etiopathogenesis of the events is not consistent with the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.