Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain, Vaccination site swelling
Clinical narrative: tested positive for COVID on 29-Jun-2022/ again on 9-Jul-2022/sleepy/ diarrhea/ sick as a dog/ high fever; she couldn't sit up because of the back pain/ had a stabbing pain like someone was killing her with a trident about where her backbone connects to her butt; has an inability to walk correctly since soon after her 2nd booster/still is hobbling on her right leg & having trouble walking; she was in bed for two to three to four days/ had to stay in the bed because she couldn't sit up because of the back pain; She still is hobbling on her right leg & having trouble walking but the pain & ability to walk has improved.; within a couple of days after her 2nd booster dose she had a sore injection site that hurt a lot & had swelling; The arm was "giant painful"; That all moved to her elbow & there were sores on the elbow; within a couple of days after her 2nd booster dose she had a sore injection site that hurt a lot & had swelling; pass out; was feeling horrible; caused her to fall forward on her bed & pass out.; was in a deep sleep & was confused; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (pass out) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A22A, 067F21A, 047A21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced LOSS OF CONSCIOUSNESS (pass out) (seriousness criterion medically significant), FEELING ABNORMAL (was feeling horrible), FALL (caused her to fall forward on her bed & pass out.) and CONFUSIONAL STATE (was in a deep sleep & was confused). 2022, the patient experienced GAIT DISTURBANCE (has an inability to walk correctly since soon after her 2nd booster/still is hobbling on her right leg & having trouble walking). 2022, the patient experienced BED REST (she was in bed for two to three to four days/ had to stay in the bed because she couldn't sit up because of the back pain), PAIN IN EXTREMITY (She still is hobbling on her right leg & having trouble walking but the pain & ability to walk has improved.), VACCINATION SITE PAIN (within a couple of days after her 2nd booster dose she had a sore injection site that hurt a lot & had swelling), PAIN IN EXTREMITY (The arm was "giant painful"), ARTHRALGIA (That all moved to her elbow & there were sores on the elbow) and VACCINATION SITE SWELLING (within a couple of days after her 2nd booster dose she had a sore injection site that hurt a lot & had swelling). In June 2022, the patient experienced BACK PAIN (she couldn't sit up because of the back pain/ had a stabbing pain like someone was killing her with a trident about where her backbone connects to her butt). In 2022, the patient experienced LOSS OF CONSCIOUSNESS (pass out) (seriousness criterion medically significant), FEELING ABNORMAL (was feeling horrible), FALL (caused her to fall forward on her bed & pass out.) and CONFUSIONAL STATE (was in a deep sleep & was confused). 2022, the patient experienced GAIT DISTURBANCE (has an inability to walk correctly since soon after her 2nd booster/still is hobbling on her right leg & having trouble walking). 2022, the patient experienced BED REST (she was in bed for two to three to four days/ had to stay in the bed because she couldn't sit up because of the back pain), PAIN IN EXTREMITY (She still is hobbling on her right leg & having trouble walking but the pain & ability to walk has improved.), VACCINATION SITE PAIN (within a couple of days after her 2nd booster dose she had a sore injection site that hurt a lot & had swelling), PAIN IN EXTREMITY (The arm was "giant painful"), ARTHRALGIA (That all moved to her elbow & there were sores on the elbow) and VACCINATION SITE SWELLING (within a couple of days after her 2nd booster dose she had a sore injection site that hurt a lot & had swelling). On 29-Jun-2022, the patient experienced COVID-19 (tested positive for COVID on 29-Jun-2022/ again on 9-Jul-2022/sleepy/ diarrhea/ sick as a dog/ high fever). In June 2022, BED REST (she was in bed for two to three to four days/ had to stay in the bed because she couldn't sit up because of the back pain) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (pass out), FEELING ABNORMAL (was feeling horrible), FALL (caused her to fall forward on her bed & pass out.), CONFUSIONAL STATE (was in a deep sleep & was confused), BACK PAIN (she couldn't sit up because of the back pain/ had a stabbing pain like someone was killing her with a trident about where her backbone connects to her butt), VACCINATION SITE PAIN (within a couple of days after her 2nd booster dose she had a sore injection site that hurt a lot & had swelling), PAIN IN EXTREMITY (The arm was "giant painful"), ARTHRALGIA (That all moved to her elbow & there were sores on the elbow), VACCINATION SITE SWELLING (within a couple of days after her 2nd booster dose she had a sore injection site that hurt a lot & had swelling) and COVID-19 (tested positive for COVID on 29-Jun-2022/ again on 9-Jul-2022/sleepy/ diarrhea/ sick as a dog/ high fever) outcome was unknown and GAIT DISTURBANCE (has an inability to walk correctly since soon after her 2nd booster/still is hobbling on her right leg & having trouble walking) and PAIN IN EXTREMITY (She still is hobbling on her right leg & having trouble walking but the pain & ability to walk has improved.) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jun-2022, SARS-CoV-2 test: (Positive) Positive. On 09-Jul-2022, SARS-CoV-2 test: (Positive) Positive.         Concomitant product use was not provided by the reporter.   Reported that within a couple of days after 2nd booster dose patient had a sore injection site that hurt a lot and had swelling. That all moved to her elbow and there were sores on the elbow. The arm was  painful. About 6 days later patient was feeling horrible, had a stabbing pain like someone was killing her with a trident about where her backbone connects to her butt. This caused patient to fall forward on her bed & pass out. Patient was not sure how long she was there but she was in a deep sleep and was confused.  Also reported that patient went to the ER because of the back pain on 8 Jun 2022. On 16Jun2022 she went to an urgent care for the back pain. She still had hobbling on her right leg and having trouble walking but the pain and ability to walk has improved.  On 08 Jun 2022, the patient underwent x-rays and blood tests but didn't find any reason for the pain. Patient tested positive for COVID-19 on 29-Jun-2022 and again on 9-Jul-2022 with outcome unknown.  Company comment: This is a spontaneous case concerning a 76-year-old, female patient with no reported medical history. Patient has vaccination history of receiving 2 primary doses of mRNA-1273 vaccine with appropriate dosage interval of 28 days and 1 booster dose. Patient experienced the unexpected serious (medically significant) event of loss of consciousness (pass out), the unexpected non-serious AESI event of Covid-19, the unexpected non-serious events of feeling abnormal, fall, confusional state, back pain, gait disturbance, bed rest and pain in extremity, and the non-serious expected events of pain in extremity (the arm was "giant painful), arthralgia, vaccination site swelling and vaccination site pain. The events loss of consciousness, feeling abnormal, fall, confusional state and back pain occurred approximately 6 days after the second booster dose of mRNA-1273 vaccine administration. The event Covid-19 occurred approximately 35 days after the second booster dose of mRNA-1273 vaccine administration with positive Covid-19 test results. The rest of the events exact occurrence unknown but stated that the events occurred after the second booster dose of mRNA-1273 vaccine administration. It was reported that the went to the urgent care for back pain. Patient underwent x-ray and blood testes with no explanation for back pain, and received opiates and muscle relaxants. The outcome of the event bed rest was resolved, gait disturbance and pain in extremity the outcome was reported as resolving. The rest of the events the outcome was unknown. The current Covid-19 pandemic remain confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 76-year-old, female patient with no reported medical history. Patient has vaccination history of receiving 2 primary doses of mRNA-1273 vaccine with appropriate dosage interval of 28 days and 1 booster dose. Patient experienced the unexpected serious (medically significant) event of loss of consciousness (pass out), the unexpected non-serious AESI event of Covid-19, the unexpected non-serious events of feeling abnormal, fall, confusional state, back pain, gait disturbance, bed rest and pain in extremity, and the non-serious expected events of pain in extremity (the arm was "giant painful), arthralgia, vaccination site swelling and vaccination site pain. The events loss of consciousness, feeling abnormal, fall, confusional state and back pain occurred approximately 6 days after the second booster dose of mRNA-1273 vaccine administration. The event Covid-19 occurred approximately 35 days after the second booster dose of mRNA-1273 vaccine administration with positive Covid-19 test results. The rest of the events exact occurrence unknown but stated that the events occurred after the second booster dose of mRNA-1273 vaccine administration. It was reported that the went to the urgent care for back pain. Patient underwent x-ray and blood testes with no explanation for back pain, and received opiates and muscle relaxants. The outcome of the event bed rest was resolved, gait disturbance and pain in extremity the outcome was reported as resolving. The rest of the events the outcome was unknown. The current Covid-19 pandemic remain confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.