Age: 87.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Syncope
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of NEAR DEATH EXPERIENCE (almost died), SYNCOPE (next thing I know, I was on the ground must have fainted), PELVIC FRACTURE (Cracked the bone with 2 balls, Cracked Pelvis in 1 spot per CAT Scan or MRI, Broke the other ball clean through), HYPERHIDROSIS (Sweats, woke up wringing wet), PELVIC PAIN (Broke my pelvis because of this shot, Knocked me for a loop, a lot of pain), FEELING HOT (Body was on fire), DIZZINESS (felt really, terribly dizzy) and CHILLS (Chills so bad teeth chattered) in an 87-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in September 2021. Previously administered products included for Drug use for unknown indication: JANSSEN COVID-19 VACCINE (Dose 1). Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE. Concurrent medical conditions included Blood pressure management and Allergy (Allergies: long time ago but can't recall). Concomitant products included LOSARTAN for Blood pressure high. On 08-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In September 2022, the patient experienced NEAR DEATH EXPERIENCE (almost died) (seriousness criteria hospitalization and medically significant), SYNCOPE (next thing I know, I was on the ground must have fainted) (seriousness criteria hospitalization and medically significant), PELVIC FRACTURE (Cracked the bone with 2 balls, Cracked Pelvis in 1 spot per CAT Scan or MRI, Broke the other ball clean through.) (seriousness criteria hospitalization and medically significant), HYPERHIDROSIS (Sweats, woke up wringing wet) (seriousness criterion hospitalization), PELVIC PAIN (Broke my pelvis because of this shot , Knocked me for a loop, a lot of pain) (seriousness criterion hospitalization), FEELING HOT (Body was on fire) (seriousness criterion hospitalization), DIZZINESS (felt really, terribly dizzy) (seriousness criterion hospitalization) and CHILLS (Chills so bad teeth chattered) (seriousness criterion hospitalization). On an unknown date, the patient experienced COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). The patient was hospitalized from 12-Sep-2022 to 14-Sep-2022 due to CHILLS, DIZZINESS, FEELING HOT, HYPERHIDROSIS, NEAR DEATH EXPERIENCE, PELVIC FRACTURE and PELVIC PAIN. The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NEAR DEATH EXPERIENCE (almost died), SYNCOPE (next thing I know, I was on the ground must have fainted), PELVIC FRACTURE (Cracked the bone with 2 balls, Cracked Pelvis in 1 spot per CAT Scan or MRI, Broke the other ball clean through.), HYPERHIDROSIS (Sweats, woke up wringing wet), PELVIC PAIN (Broke my pelvis because of this shot , Knocked me for a loop, a lot of pain), FEELING HOT (Body was on fire), DIZZINESS (felt really, terribly dizzy) and CHILLS (Chills so bad teeth chattered) had not resolved and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, SARS-CoV-2 test: (Positive) had symptoms but no hospitalization. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments. Patient had chills so bad her teeth chattered, sweats, broke her pelvis because of this shot, knocked for a loop, patient went to bed that night woke up wringing wet, her body was on fire, got water and turned, she felt terribly dizzy, next thing she know she was on ground, must have fainted. Patient was hospitalized from 12-Sep-2022 through Wednesday afternoon, 14-Sep-2022. She was crippled, cracked the bone with 2 balls, cracked pelvis in one spot per CAT scan or MRI, broke the other ball clean through. Patient suffered until Monday. Doctors said it will take 6 weeks to 2 months to heal. Doctor's can not do surgery now. Company comment: This spontaneous case concerns an 87-year-old female patient, with relevant medical history of allergy and had symptomatic COVID-19 with positive SARS-CoV-2 test (same month of vaccination), who experienced the unexpected serious (hospitalization and medically significant) events of Near death experienced (reported as almost died) and Pelvic fracture, and unexpected serious (hospitalization) Hyperhidrosis, Pelvic pain, Feeling hot, Dizziness, and Chills, and expected serious (medically significant and hospitalization) event of Syncope (reported as I was on the ground, must have fainted) after receiving a dose of mRNA-1273 bivalent BA.4/BA.5. The events occurred within the same month of vaccination. Patient reported that she was almost died, felt dizzy and must had fainted and broke her pelvis because of the shot and got crippled. Took Paracetamol and Ibuprofen. Patient was hospitalized 4th day post vaccination and was discharged after two days. Computerized tomography or magnetic resonance imaging showed pelvic fracture. The outcome of events was reported as not resolved. On an unknown date, patient received COVID-19 VACCINE NRVV AD26 (JNJ 78436735) as 1st dose prior to mRNA-1273 bivalent BA.4/BA.5 (Revaccination with different COVID-19 vaccine and Interchange of vaccine products). It was reported that patient was in good health prior to vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2022-647572, US-MODERNATX, INC.-MOD-2022-647578 (E2B Linked Report). Sender's Comments: This spontaneous case concerns an 87-year-old female patient, with relevant medical history of allergy and had symptomatic COVID-19 with positive SARS-CoV-2 test (same month of vaccination), who experienced the unexpected serious (hospitalization and medically significant) events of Near death experienced (reported as almost died) and Pelvic fracture, and unexpected serious (hospitalization) Hyperhidrosis, Pelvic pain, Feeling hot, Dizziness, and Chills, and expected serious (medically significant and hospitalization) event of Syncope (reported as I was on the ground, must have fainted) after receiving a dose of mRNA-1273 bivalent BA.4/BA.5. The events occurred within the same month of vaccination. Patient reported that she was almost died, felt dizzy and must had fainted and broke her pelvis because of the shot and got crippled. Took Paracetamol and Ibuprofen. Patient was hospitalized 4th day post vaccination and was discharged after two days. Computerized tomography or magnetic resonance imaging showed pelvic fracture. The outcome of events was reported as not resolved. On an unknown date, patient received COVID-19 VACCINE NRVV AD26 (JNJ 78436735) as 1st dose prior to mRNA-1273 bivalent BA.4/BA.5 (Revaccination with different COVID-19 vaccine and Interchange of vaccine products). It was reported that patient was in good health prior to vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-647572:Patient No 1 case; US-MODERNATX, INC.-MOD-2022-647578: Patient No 2 case.