Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: fainted in the bathroom / fainted again in the kitchen; headache; mild nausea; tired; experienced uncontrollable shaking; chills; This spontaneous case was reported by a patient and describes the occurrence of SYNCOPE (fainted in the bathroom / fainted again in the kitchen) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient had no medical history, concomitant disease or risk factor.  Previously administered products included for Product used for unknown indication: Influenza on 12-Oct-2022 and TETANUS VACCINE. Past adverse reactions to the above products included No adverse event with Influenza and TETANUS VACCINE. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 07-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 07-Nov-2022, the patient experienced TREMOR (experienced uncontrollable shaking) and CHILLS (chills). On 08-Nov-2022, the patient experienced HEADACHE (headache), NAUSEA (mild nausea) and FATIGUE (tired). On 08-Nov-2022 at 6:00 AM, the patient experienced SYNCOPE (fainted in the bathroom / fainted again in the kitchen) (seriousness criterion medically significant). On 09-Nov-2022, SYNCOPE (fainted in the bathroom / fainted again in the kitchen), TREMOR (experienced uncontrollable shaking), CHILLS (chills), HEADACHE (headache), NAUSEA (mild nausea) and FATIGUE (tired) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   On 15-Jan-2021, the patient received first dose of Moderna COVID-19 Vaccine with batch number 039K20A via intramuscular route. On 09-Feb-2021, the patient received second dose of Moderna COVID-19 Vaccine with batch number 031L20A via intramuscular route. 02-Nov-2021, the patient received third (first booster) dose of Moderna COVID-19 Vaccine with batch number 071F21A via intramuscular route.  Patient reported after each dose of the Covid vaccine patient experienced uncontrollable shaking chills approximately 8-10 hrs. after receiving the vaccine. That was resolved by the morning of the following day. The day after the vaccine patient had a headache and mild nausea, which was usually resolved within 24 hrs. after the injection. With the second booster dose 07-Nov-2022, patient had the shaking chills, but upon waking the next morning about 06:00, patient fainted in the bathroom while washing hands at the sink. The patient did not had the chills at the time, patient was not dizzy, nor dehydrated. After sleeping for another 3 hours, patient woke up and walked downstairs and fainted again in the kitchen. Again, patient was not dizzy upon awakening. After the episodes, patient was tired and nauseated for the remainder of the day. Symptoms were mostly resolved two days after the injection. The patient did not experienced any additional symptoms/events.  No treatment information was provided.  Company Comment: This is a spontaneous case regarding a 68-year-old female patient, with no medical history, who experienced medically significant event of syncope and non serious events of tremor, chills, headache, nausea and fatigue after receiving mRNA-1273.222 bivalent vaccine (Original/Omicron BA.4/5), reported as the fourth dose of the COVID-19 vaccination schedule. According to the report, patient had shaking chills on the same day after vaccination and, upon waking the next morning she fainted in the bathroom. She did not have the chills at the time, she was not dizzy, nor was she dehydrated. After sleeping for another 3 hours, she woke and fainted again. Again, she was not dizzy upon awakening. After those episodes, patient was tired and nauseated for the remainder of the day. Symptoms were mostly resolved two days after vaccination. No further details were disclosed. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.   This case was linked to MOD-2022-679145 (Patient Link).; Sender's Comments: This is a spontaneous case regarding a 68-year-old female patient, with no medical history, who experienced medically significant event of syncope and non serious events of tremor, chills, headache, nausea and fatigue after receiving mRNA-1273.222 bivalent vaccine (Original/Omicron BA.4/5), reported as the fourth dose of the COVID-19 vaccination schedule. According to the report, patient had shaking chills on the same day after vaccination and, upon waking the next morning she fainted in the bathroom. She did not have the chills at the time, she was not dizzy, nor was she dehydrated. After sleeping for another 3 hours, she woke and fainted again. Again, she was not dizzy upon awakening. After those episodes, patient was tired and nauseated for the remainder of the day. Symptoms were mostly resolved two days after vaccination. No further details were disclosed. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.