Sex: F
Vaccine: COVID19
Symptoms: Head injury, Influenza, Loss of consciousness
Clinical narrative: 3rd day after receiving her second Moderna Covid-19 vaccine monovalent booster dose the patient took a shower passed out hit head and had to be taken to the Emergency Room where she received 8 stitche; 3rd day after receiving her second Moderna Covid-19 vaccine monovalent booster dose the patient took a shower passed out hit head and had to be taken to the Emergency Room where she received 8 stitche; Patient was in bed for 3 days with  flu symptoms; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (3rd day after receiving her second Moderna Covid-19 vaccine monovalent booster dose the patient took a shower passed out hit head and had to be taken to the Emergency Room where she received 8 stitche) and HEAD INJURY (3rd day after receiving her second Moderna Covid-19 vaccine monovalent booster dose the patient took a shower passed out hit head and had to be taken to the Emergency Room where she received 8 stitche) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067H21A and 002S21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Janssen (patient had a Janssen primary series). Past adverse reactions to the above products included No adverse event with Janssen.   On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 100 microgram. On 19-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2022, the patient experienced INFLUENZA (Patient was in bed for 3 days with  flu symptoms). On 21-Apr-2022, the patient experienced LOSS OF CONSCIOUSNESS (3rd day after receiving her second Moderna Covid-19 vaccine monovalent booster dose the patient took a shower passed out hit head and had to be taken to the Emergency Room where she received 8 stitche) (seriousness criterion medically significant) and HEAD INJURY (3rd day after receiving her second Moderna Covid-19 vaccine monovalent booster dose the patient took a shower passed out hit head and had to be taken to the Emergency Room where she received 8 stitche) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (3rd day after receiving her second Moderna Covid-19 vaccine monovalent booster dose the patient took a shower passed out hit head and had to be taken to the Emergency Room where she received 8 stitche), HEAD INJURY (3rd day after receiving her second Moderna Covid-19 vaccine monovalent booster dose the patient took a shower passed out hit head and had to be taken to the Emergency Room where she received 8 stitche) and INFLUENZA (Patient was in bed for 3 days with  flu symptoms) outcome was unknown.            No concomitant medications were reported.  The patient received her first Moderna booster dose on 20-Oct-2021 but does not remember on which arm she received this monovalent Covid-19 vaccine.  The flu symptoms were reported as fever, chills and upset stomach.   No treatment information was reported.  Company Comment: This spontaneous case concerns an adult female patient of unknown age, with no medical history reported, who experienced Influenza (Flu symptoms of upset stomach, chills and fever) on the same day, loss of consciousness (passed out) and had a head injury on the 3rd day after receiving the second Booster dose of mRNA-1273. Patient was in bed for three days wiith Flu symptoms of upset stomach, chills and fever and on the 3rd day while taking a shower, passed out ,hit head and had to be taken to the Emergency Room where she received 8 stitches in her head. There was no information provided about the patient's underlying medical conditions, concomitant medications, if the patent had any associated symptoms before passing out. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.   This case was linked to MOD-2022-669858, MOD-2022-669829 (Patient Link).; Sender's Comments: This spontaneous case concerns an adult female patient of unknown age, with no medical history reported, who experienced Influenza (Flu symptoms of upset stomach, chills and fever) on the same day, loss of consciousness (passed out) and had a head injury on the 3rd day after receiving the second Booster dose of mRNA-1273. Patient was in bed for three days wiith Flu symptoms of upset stomach, chills and fever and on the 3rd day while taking a shower, passed out ,hit head and had to be taken to the Emergency Room where she received 8 stitches in her head. There was no information provided about the patient's underlying medical conditions, concomitant medications, if the patent had any associated symptoms before passing out. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.