Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dysphagia, Injection site pain, Lethargy, Pyrexia
Clinical narrative: DIFFICULTY SWALLOWING; WAKE UP ALMOST EVERY HOUR; CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; LETHARGY; SORENESS ON THE INJECTION SITE; This spontaneous report received from a patient concerned a 30 year old male. The patient's weight was 170 pounds, and height was 175 centimeters. The patient's concurrent conditions included Tourette's syndrome, seasonal allergy, penicillin allergy, non alcoholic, and cigarette smoker, and other pre-existing medical conditions included no drug abuse and illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, and expiry: 01-FEB-2023) dose was not reported, frequency 1 total, administered on right deltoid 07-APR-2021 for prophylactic vaccination. Concomitant medications included clonazepam for Tourette's syndrome.  On 07-APR-2021, the patient experienced soreness on the injection site which lasted for 2 weeks. He also experienced lethargy. Then on the last week of APR-2021, he developed throat pain, cough and high grade fever. His chest was hurt really bad and he felt as if his lungs was on fire. He was also coughing really hard that woke him up every hour. The fever lasted of a day and the rest of symptoms lasted for 3 days. He did not performed COVID test because he just thought the symptoms were just allergic reaction. Then, on the 24-MAY-2021, he started to develop the same symptoms that he had before. It was started as a pain on the throat, he thought it was just an allergy because he had a seasonal allergy. He had a difficulty swallowing which developed into cough. His chest hurt so bad that he felt as if his chest and lungs were on fire. He described his coughing associated with burning sensation that caused him to wake up almost every hour. He also noted that after vaccinated he still followed social distancing and wearing mask protocol. His HCP did not prescribe any medication for COVID-19 infection, but he was taking Tylenol, increased his fluid intake and started using a nasal spray.  On 28-MAY-2021, Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive., Fever (NR: not provided) 102 F and the patient had confirmed covid-19 infection, confirmed clinical vaccination failure.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargy, and soreness on the injection site on 21-APR-2021, had not recovered from difficulty swallowing, confirmed covid-19 infection, and wake up almost every hour, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210557859-Covid-19 vaccine ad26.cov2.s - CONFIRMED COVID-19 INFECTION and CONFIRMED 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