Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Feeling abnormal, Illness, Impaired quality of life, Major depression, Myalgia
Clinical narrative: Impaired quality of life; Brain fog; He has lost some weight/losing weight; Had a very severe adverse effect to the booster vaccine that caused a major horrific automobile incident/Motor vehicle accident; From fully functional to very disoriented/ was severely disoriented; Confused / The rest is a blur of confusion; Called out sick due to the substantial pain n body ache / Body hurt so bad; Called out sick due to th substantial pain and body ache; Called out sick due to th substantial pain and body ache /  could not even touch my skin due to the pain; Body aches were so bad; He feels that his life will be negatively impacted for the rest of his life because of the accident. I am living a "nightmare" right now / Brain Fog; Depression/severe depression; Right arm itching, and scratching; Major depression/ depression / Mild Depression; Short term memory loss; This spontaneous case was reported by a patient and describes the occurrence of MAJOR DEPRESSION (Major depression/ depression / Mild Depression) in a 68-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 016H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Patient reports that he has diabetes type I.  The patient's past medical history included Blood sugar level fluctuation (But never to the degree of having paramedics on site. Snickers, glucose gell). Concurrent medical conditions included Type I diabetes mellitus since 21-Apr-1991 and Hypertension. Concomitant products included INSULIN for Type 1 diabetes mellitus, LISINOPRIL from 20-Feb-2020 to an unknown date, INSULIN HUMAN (NOVOLIN R) and INSULIN GLARGINE (GLARGINE BIOCON) for an unknown indication.    On 13-Dec-2022 at 2:45 PM, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Dec-2022, the patient experienced MAJOR DEPRESSION (Major depression/ depression / Mild Depression) (seriousness criterion medically significant). 13-Dec-2022, the patient experienced AMNESIA (Short term memory loss). 13-Dec-2022, the patient experienced PAIN (Body aches were so bad), FEELING ABNORMAL (He feels that his life will be negatively impacted for the rest of his life because of the accident. I am living a "nightmare" right now / Brain Fog), DEPRESSION (Depression/severe depression) and VACCINATION SITE PRURITUS (Right arm itching, and scratching). On 14-Dec-2022, the patient experienced ILLNESS (Called out sick due to th substantial pain and body ache), PAIN (Called out sick due to th substantial pain and body ache /  could not even touch my skin due to the pain) and MYALGIA (Called out sick due to the substantial pain n body ache / Body hurt so bad). On 21-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced DISORIENTATION (From fully functional to very disoriented/ was severely disoriented). 21-Dec-2022, the patient experienced CONFUSIONAL STATE (Confused / The rest is a blur of confusion). On 21-Dec-2022 at 6:10 PM, the patient experienced ROAD TRAFFIC ACCIDENT (Had a very severe adverse effect to the booster vaccine that caused a major horrific automobile incident/Motor vehicle accident). On an unknown date, the patient experienced IMPAIRED QUALITY OF LIFE (Impaired quality of life) and WEIGHT DECREASED (He has lost some weight/losing weight). an unknown date, the patient experienced FEELING ABNORMAL (Brain fog). At the time of the report, MAJOR DEPRESSION (Major depression/ depression / Mild Depression), PAIN (Body aches were so bad), FEELING ABNORMAL (He feels that his life will be negatively impacted for the rest of his life because of the accident. I am living a "nightmare" right now / Brain Fog), DEPRESSION (Depression/severe depression) and VACCINATION SITE PRURITUS (Right arm itching, and scratching) was resolving, AMNESIA (Short term memory loss) had not resolved and ROAD TRAFFIC ACCIDENT (Had a very severe adverse effect to the booster vaccine that caused a major horrific automobile incident/Motor vehicle accident), DISORIENTATION (From fully functional to very disoriented/ was severely disoriented), ILLNESS (Called out sick due to th substantial pain and body ache), PAIN (Called out sick due to th substantial pain and body ache /  could not even touch my skin due to the pain), CONFUSIONAL STATE (Confused / The rest is a blur of confusion), IMPAIRED QUALITY OF LIFE (Impaired quality of life), FEELING ABNORMAL (Brain fog), WEIGHT DECREASED (He has lost some weight/losing weight) and MYALGIA (Called out sick due to the substantial pain n body ache / Body hurt so bad) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Blood glucose: Sometimes it goes from 300 to 45 unbeknownst to the patient and it goes from a very high reading to a very low reading in seconds to minutes and had the data from patient's sugar readings. There were notable tragic differences that patient experienced.. On 16-Dec-2022, Blood glucose: Constant extreme highs in the 390 to 400 range. Some days did not eat dinner due to the extreme excessive highs. Past 3 months my Diabetes was in better than tight control.. On 17-Dec-2022, Blood glucose: low blood sugar. On 21-Dec-2022, Blood glucose: high sugar readings. On an unknown date, Blood glucose: Blood glucose abnormal.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered MAJOR DEPRESSION (Major depression/ depression / Mild Depression), AMNESIA (Short term memory loss), ROAD TRAFFIC ACCIDENT (Had a very severe adverse effect to the booster vaccine that caused a major horrific automobile incident/Motor vehicle accident), ILLNESS (Called out sick due to th substantial pain and body ache), PAIN (Called out sick due to th substantial pain and body ache /  could not even touch my skin due to the pain), FEELING ABNORMAL (Brain fog) and MYALGIA (Called out sick due to the substantial pain n body ache / Body hurt so bad) to be related. No further causality assessments were provided for DISORIENTATION (From fully functional to very disoriented/ was severely disoriented), CONFUSIONAL STATE (Confused / The rest is a blur of confusion), IMPAIRED QUALITY OF LIFE (Impaired quality of life), WEIGHT DECREASED (He has lost some weight/losing weight), PAIN (Body aches were so bad), FEELING ABNORMAL (He feels that his life will be negatively impacted for the rest of his life because of the accident. I am living a "nightmare" right now / Brain Fog), DEPRESSION (Depression/severe depression) and VACCINATION SITE PRURITUS (Right arm itching, and scratching).    The patient reported that he received his primary series vaccine with no monovalent booster dose. The patients first booster dose was with the bivalent booster dose.  On 13-Dec-2022 at 2:45 PM, the patient received third dose of MODERNA COVID-19 VACCINE, BIVALENT on right shoulder.  Since 13-Dec-2022, when he received his Moderna Bivalent Booster Dose that he was in a tremendous depression. However, the patient felt that he was pulling out of the depression and was losing weight.  Previously administered products included for Product used for unknown indication: MODERNA COVID-19 VACCINE on 14-Jul-2021 and MODERNA COVID-19 VACCINE on 12-Aug-2021. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE and MODERNA COVID-19 VACCINE.  Other concomitant medications included Novilin-R, 15 units 3 times daily via hip, Glargine 20 units 1 daily via hip, Dexcom G6 sensors, 1 sensor for 10 days via side of navel, Dexcom Transmitter, 1 every 3 months via side of navel. Both were started on 24-Jul-2020. Patient didn't received any other vaccine 4 weeks prior to COVID-19 vaccine.  On 14-Jul-2021 at 2 pm patient received first dose of Modena monovalent vaccine and on 12-Aug-2021 at 1.30 pm patient received second dose of Moderna monovalent vaccine. On 17-Dec-2022, patient had an event at the place of employment called paramedics that patient had a severe low blood sugar. Things were bottoming out and higher than normal and was gave a candy bar. Patient totaled car on 21-Dec-2022. Patient had blood glucose fluctuation.  Patient body wasn't reacting to the insulin that patient was taking and was not able to bring the sugars down. It was very problematic and life changing.  Treatment medication was not provided.   This case was linked to MOD-2022-694138 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2023: Follow-up information received included Event added, Medical history and Narrative updated. On 23-Jan-2023: Live follow-up information received included Event added and Narrative updated. On 23-Jan-2023: Live significant follow up: Case (MOD-2022-694138) was identified as duplicate of case (MOD-2022-692832), hence all source documents are copied from MOD-2022-694138  (deletion case) and appended into case MOD-2022-692832 (retained case). Case MOD-2022-692832 (retained case) will retain for further follow up and case ID- MOD-2022-694138  needs to be deleted. On 27-Jan-2023: Live follow-up information received included Event outcome and narrative updated.  Company comment: This case concerns a 68-year- old male patient with Concurrent medical conditions of Type I diabetes mellitus and Hypertension, who experienced serious unexpected serious (medically significant) event of Major depression among other non-serious events that occurred on same day after the third dose of mRNA 1273 bivalent BA 4-5 vaccine. The primary series of vaccination was received in regular interval. It was reported that after receiving his Moderna Bivalent Booster Dose that he was in a tremendous depression and had a very severe adverse effect to the booster vaccine that caused a major horrific automobile incident/Motor vehicle accident, called out sick substantial pain and body ache, However, the patient felt that he was pulling out of the depression and was losing weight. Patient body wasn't reacting to the insulin that patient was taking and was not able to bring the sugars down. It was very problematic and life changing. Patient had blood glucose fluctuation. The outcome of event was reported as resolving. No further information on risk factors, clinical course, relevant medical history, diagnostic investigations, and treatment received were available for review. Patient's Concurrent medical conditions of Type I diabetes mellitus and Hypertension could be the risk factor events. The benefit-risk relationship of mRNA-1273 Bivalent BA.4-5 vaccine is not affected by this report.; Sender's Comments: This case concerns a 68-year- old male patient with Concurrent medical conditions of Type I diabetes mellitus and Hypertension, who experienced serious unexpected serious (medically significant) event of Major depression among other non-serious events that occurred on same day after the third dose of mRNA 1273 bivalent BA 4-5 vaccine. The primary series of vaccination was received in regular interval. It was reported that after receiving his Moderna Bivalent Booster Dose that he was in a tremendous depression and had a very severe adverse effect to the booster vaccine that caused a major horrific automobile incident/Motor vehicle accident, called out sick substantial pain and body ache, However, the patient felt that he was pulling out of the depression and was losing weight. Patient body wasn't reacting to the insulin that patient was taking and was not able to bring the sugars down. It was very problematic and life changing. Patient had blood glucose fluctuation. The outcome of event was reported as resolving. No further information on risk factors, clinical course, relevant medical history, diagnostic investigations, and treatment received were available for review. Patient's Concurrent medical conditions of Type I diabetes mellitus and Hypertension could be the risk factor events. The benefit-risk relationship of mRNA-1273 Bivalent BA.4-5 vaccine is not affected by this report.