Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINE FAILURE; COVID-19; CHEST PAIN; COUGH; DYSPNOEA; SENSORY DISTURBANCE; SLEEP DISORDER; This spontaneous report received from a health care professional via a Regulatory Authority (VAERS ID: 1761569) concerned a 38 year old male of an unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, expiry: unknown) dose was not reported, with frequency time 1 total administered on 27-MAY-2021 on left arm for an unknown indication. No concomitant medications were reported.  On 24-SEP-2021, the patient was diagnosed with Covid-19 infection with symptoms onset on the same day. As, a result the patient had suspected clinical vaccination failure. The patient had been dealing with shortness of breath during the course of his infection but overnight he awoke due to his symptoms stating that he felt like he was drowning. On the same day, the patient also experienced dyspnea, sensory disturbance, sleep disorder, nonproductive cough, and diffuse chest pain. On an unspecified date in OCT-2021 (reported as this morning), the patient presented to the emergency department (ED) due to shortness of breath. On an unspecified date, the patient was hospitalized due to the events. The number of days hospitalized and discharged date were not provided.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the Covid-19, chest pain, cough, dyspnoea, sensory disturbance, sleep disorder and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with Product Quality Complaint: 90000198427. The suspected product quality complaint has been confirmed to be not voided. The reported allegation could not be confirmed, a manufacturing related root cause could not be identified based on product quality complaint (PQC) evaluation/investigation performed.  Additional information received from Central Complaint Vigilance department on 17-NOV-2021 The following information was updated and incorporated into the case narrative: Product quality complaint investigation result added.; Sender's Comments: V2: The version updates Product quality complaint investigation result. This updated information does not alter the causality of previously reported events. 20211032369-COVID-19 VACCINE AD26.COV2.S- Covid-19, chest pain, cough, dyspnoea, sensory disturbance, sleep disorder. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211032369-COVID-19 VACCINE AD26.COV2.S-  suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS