Sex: F
Vaccine: COVID19
Symptoms: Illness, Injection site pain, Laryngitis, Mucosal disorder, Mucosal haemorrhage
Clinical narrative: SORE THROAT; MUCUS; BLOOD-TINGED MUCUS; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; LARYNGITIS; BODY ACHES; LOSS OF APPETITE; DRY COUGH; CHILLS; ANERGIA; FATIGUE; ILLNESS/SICK; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 39 year old female. The patient's weight was 195 pounds, and height was 68 inches. The patient's concurrent conditions included Hashimoto's disease, Hypothyroidism diagnosed in approximately 2012, pemphigoid Gestationis diagnosed in September of 2017 during second pregnancy, vitiligo diagnosed in 1995 or 1996 (minor patch to shoulder and back), penicillin allergy, alcohol use (2 to 3 glasses of wine per evening), and non smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: unknown) frequency 1 total, dose was not reported, administered on 08-MAR-2021 to left deltoid for prophylactic vaccination.  No concomitant medications were reported.  On 08-MAR-2021, the patient experienced injection site pain. On an unspecified date in APR-2021, the patient became ill (coded as illness/sick). On 19-APR-2021, the patient experienced fatigue. On 19-APR-2021, the patient received a negative PCR finger prick test while at the Pediatrician's office where her boys, ages 4 and 6 both received positive antigen tests for the Covid-19 virus. On 20-APR-2021, the patient experienced dry cough, loss of appetite, chills, anergia. On 21-APR-2021, the patient experienced body aches. On 22-APR-2021, the patient experienced laryngitis, blood-tinged mucus and mucus. On 22-APR-2021, the patient had a positive rapid antigen nasal swab test performed at urgent care center, where she went for symptomatic treatment of her side effects, with positive result for COVID-19 infection (coded as confirmed COVID-19 infection and confirmed clinical vaccination failure). Patient stated that she thought if she did get the virus, she might not be as sick, but six or seven weeks after getting the vaccine, she got COVID virus and was sick. On 24-APR-2021, the patient experienced sore throat.  Laboratory data included: COVID-19 antigen test (NR: not provided) positive and COVID-19 PCR test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and loss of appetite on 27-APR-2021, laryngitis, and anergia on 26-APR-2021, blood-tinged mucus, and sore throat on 25-APR-2021, chills on 23-APR-2021, and injection site pain on 11-MAR-2021, was recovering from fatigue, dry cough, and mucus, and the outcome of confirmed covid-19 infection, confirmed clinical vaccination failure and illness/sick was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;COVID-19 VACCINE AD26.COV2.S -Suspected Clinical Vaccine Failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS