Age: 78.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Asthenia, Pain, Syncope
Clinical narrative: fainted but was still awake; loads of pain in my hands and knees; really weak; This spontaneous case was reported by a patient and describes the occurrence of SYNCOPE (fainted but was still awake) in a 78-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051D22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. In 2022, the patient experienced SYNCOPE (fainted but was still awake) (seriousness criterion medically significant), PAIN (loads of pain in my hands and knees) and ASTHENIA (really weak). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency. In 2022, PAIN (loads of pain in my hands and knees) was resolving. At the time of the report, SYNCOPE (fainted but was still awake) and ASTHENIA (really weak) outcome was unknown.            Patient has received first dose of the Moderna COVID-19 vaccine by intramuscular injection on 19Jan2021, lot number 013L20A, second dose on 16Feb2021, lot number 010M20A, Third dose on 21Nov2021, lot number 010A21A, Fourth dose on 13May2022, lot number 004M21A. No concomitant medications was provided. Patient took another Advil which helped for 1.5 days. Patient has not had any pain in his knees like before.  Patient went to the emergency room 10 days ago.  Company comment: This spontaneous case concerns a 78-year-old male patient with no medical history reported, who experienced the unexpected serious (medically significant) event of Syncope that occurred unknown days after receiving mRNA-1273 Bivalent BA.4/BA.5 vaccine(fifth dose) in COVID-19 vaccination series. Latency could not be assessed as the exact onset date of the event was not available. Patient experienced pain in his knees and hands. No further information regarding risk factors, clinical course, medical history, concurrent conditions, investigations and treatment received were provided. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Bivalent BA.4/BA.5 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-682327 (Patient Link).; Sender's Comments: This spontaneous case concerns a 78-year-old male patient with no medical history reported, who experienced the unexpected serious (medically significant) event of Syncope that occurred unknown days after receiving mRNA-1273 Bivalent BA.4/BA.5 vaccine(fifth dose) in COVID-19 vaccination series. Latency could not be assessed as the exact onset date of the event was not available. Patient experienced pain in his knees and hands. No further information regarding risk factors, clinical course, medical history, concurrent conditions, investigations and treatment received were provided. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Bivalent BA.4/BA.5 is not affected by this report.