Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deafness unilateral, Loss of consciousness, Paraesthesia, Road traffic accident
Clinical narrative: LOST CONTROL OF CAR AND HIT A TREE; LOST CONSCIOUSNESS; BODY ACHES; INJECTION SITE FELT SORE; COULD NOT HEAR FROM LEFT EAR AT ALL; TINGLY FEELING; FELT WARM; DIZZINESS, LIGHT-HEADED; INCREASED HEARTRATE; This spontaneous report received from a patient via a company representative concerned a 41 year old white male. The patient's height, and weight were not reported. The patient's past medical history included hives, and concurrent conditions included morphine allergy, no alcohol use, and non-smoker. There was no history of drug abuse or illicit drug use. The patient received COVID-19 vaccine Ad26.COV2.S (suspension for injection, route of admin not reported, batch number: 042A21A and expiry: UNKNOWN) on 06-APR-2021 at 14:15 to the left arm for prophylactic vaccination. Dose was not reported. No concomitant medications were reported. On 06-APR-2021, the patient experienced felt a "warm, tingly feeling as if the vaccine was going through his body (25 to 30 minutes after receiving the vaccine)". The patient was advised to wait approximately 15 to 20 minutes after receiving the vaccine before leaving the site. At approximately 14:35, the patient left the vaccination site and drove home. At an unspecified time, the patient experienced increased heartrate, dizziness, light-headed and lost consciousness whilst driving. The patient then lost control of the car and hit a tree. The patient regained consciousness at 14:45 but had not harmed or hit anyone or destroyed anyone's else property. The subject was hospitalized due to the accident and the loss of consciousness but was discharged the same day on 06-APR-2021. On 07-APR-2021, the patient could not hear from his left ear at all but was not sure if the hearing loss was from the accident's impact or from vaccine in left arm. The patient was also experiencing body aches as well but was unsure if it was from the accident or the vaccination. His left arm was also sore at the injection site.  Patient also noted that his left ear wasn't very sore after the accident. The patient had scheduled an appointment to see an ear specialist.  The action taken with COVID-19 vaccine Ad26.COV2.S was not applicable. The patient recovered from increased heartrate, and lost consciousness on 06-APR-2021, and tingly feeling, felt warm, and dizziness, light-headed on an unspecified date, had not recovered from could not hear from left ear at all, and body aches, and the outcome of injection site felt sore and lost control of car and hit a tree was not reported. This report was serious (Hospitalization Caused / Prolonged, Other Medically Important Condition, and Life Threatening).; Sender's Comments: v0 A 41-year-old male patient with a past medical history of hives, and concurrent conditions included morphine allergy, no alcohol use, and non-smoker, no history of drug abuse or illicit drug use experienced a "warm, tingly feeling as if the vaccine was going through his body" 25 to 30 minutes after receiving Janssen COVID-19 Vaccine Ad26.COV2.S.  Later that day at an unspecified time, the patient experienced increased heartrate, dizziness, light-headed and lost consciousness while driving. The patient then lost control of the car and hit a tree. The next day the patient could not hear from his left ear at all but was not sure if the hearing loss was from the accident's impact or from vaccine in left arm. The patient was also experiencing body aches and his left arm was also sore at the injection site. Based on the close temporal relationship and the lack of a plausible alternative explanation, the causality for the events of "warm, tingly feeling as if the vaccine was going through his body", increased heartrate, dizziness, light-headed, lost consciousness while driving and his left arm was also sore is assessed related to the vaccination. The causality for the inability to hear out of his left ear is unassessable.  The causality for body aches is assessed as not related as it is more likely due to the accident.