Age: 73.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Syncope
Clinical narrative: Pain in the arm, slightly sore arm; Joint pain; Fatigue; Headache; Muscle pain; Chills; Nausea; Revaccination with different COVID-19 vaccine; interchange of vaccine products; His wife found him unconscious and in a puddle of urine; he got sick/it got worse and worse/He felt he was dying; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (His wife found him unconscious and in a puddle of urine) in a 73-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 055F22B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Drug use for unknown indication: Pfizer (Dose Number: 1 and Lot number: EN6201) on 10-Feb-2021, Pfizer (Dose Number: 2 and Lot number: EN6198) on 03-Mar-2021, Pfizer (Dose Number: 3 and Lot number: EW0186) on 12-Oct-2021, Pfizer (Dose Number: 4 and Lot number: FK9894) on 02-May-2022 and Flu (Received a week earlier Manufacturer: Seqirus Dose- 0.5 ml Lot number: 346338) in September 2022. Past adverse reactions to the above products included Headache with Pfizer, Pfizer, Pfizer and Pfizer; and No adverse event with Flu. Concurrent medical conditions included Blood pressure management, Cholesterol, Depression and Gastrointestinal discomfort (Digestion). Concomitant products included SERTRALINE for Antidepressant therapy, LOSARTAN for Blood pressure management, SIMVASTATIN for Cholesterol, OMEPRAZOLE for Gastrointestinal discomfort, COLECALCIFEROL (VITAMIN D3) for an unknown indication.    On 28-Sep-2022 at 10:00 AM, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Sep-2022, the patient experienced ILLNESS (he got sick/it got worse and worse/He felt he was dying). On 29-Sep-2022 at 5:00 AM, the patient experienced LOSS OF CONSCIOUSNESS (His wife found him unconscious and in a puddle of urine) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in the arm, slightly sore arm), ARTHRALGIA (Joint pain), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills), NAUSEA (Nausea), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products). On 30-Sep-2022, ILLNESS (he got sick/it got worse and worse/He felt he was dying) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (His wife found him unconscious and in a puddle of urine), ARTHRALGIA (Joint pain), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills) and NAUSEA (Nausea) had resolved, PAIN IN EXTREMITY (Pain in the arm, slightly sore arm) was resolving and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) outcome was unknown.            Patient had no allergies.  Caller had stated that he wanted to report a severe reaction to the bivalent vaccine. He said that he was okay, so there was no emergency reason to call. But he had stated that it almost killed him.  COVID positive test or acute and Chronic illnesses at the time of vaccination. He only experienced a mild headache after receiving the Pfizer vaccines. He received the vaccine at 10am and then at night (20 hours later) he got sick, and it got worse and worse. When he was unconscious, his wife called 911 and then he started to respond. After 30 minutes he started to feel better. It was reported that he probably had fever. Treatment included IV fluids and oxygen. AE had caused patient to seek medical care as went to the E.R and Chest XR was performed without any results provided. Company comment: This spontaneous case concerns 73- years-old male, with no relevant medical history, who experienced the unexpected serious (medically significant) event of Loss of consciousness which occurred next day after fifth dose of mRNA-1273.222 vaccine in COVID-19 vaccination series. He only experienced a mild headache after receiving the Pfizer vaccines. But he stated that he got sick, and it got worse and worse after current vaccination. When he was unconscious, his wife called 911 and then he started to respond. After 30 minutes he started to feel better. It was reported that he probably had fever. Treatment included IV fluids and oxygen. AE had caused patient to seek medical care as went to the E.R and Chest XR was performed without any results provided. At the time of reporting event was recovering. It was noted that patient received a dose with Pfizer prior to current vaccination (Revaccination with different COVID-19 vaccine and interchange of vaccine products). The benefit-risk relationship of mRNA-1273.222 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 03-Oct-2022: Live follow-up received with Significant information was received: New events, patient demographics was updated.  Vaccine information and treatment were reported.; Sender's Comments: This spontaneous case concerns 73- years-old male, with no relevant medical history, who experienced the unexpected serious (medically significant) event of Loss of consciousness which occurred next day after fifth dose of mRNA-1273.222 vaccine in COVID-19 vaccination series. He only experienced a mild headache after receiving the Pfizer vaccines. But he stated that he got sick, and it got worse and worse after current vaccination. When he was unconscious, his wife called 911 and then he started to respond. After 30 minutes he started to feel better. It was reported that he probably had fever. Treatment included IV fluids and oxygen. AE had caused patient to seek medical care as went to the E.R and Chest XR was performed without any results provided. At the time of reporting event was recovering. It was noted that patient received a dose with Pfizer prior to current vaccination (Revaccination with different COVID-19 vaccine and interchange of vaccine products). The benefit-risk relationship of mRNA-1273.222 is not affected by this report.