Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Colonoscopy, Fibrin D dimer, Magnetic resonance imaging
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's past medical history included: Epstein-barr virus (30 years ago and April 2019), lesion, and genital herpes, and concurrent conditions included: celiac disease, anxiety, mild asthma, mild tachycardia, adenoma on the liver (MRI 2018 or 2019), pinched nerve in neck, perimenopause, and peg allergy, and other pre-existing medical conditions included: The had Mild physiologic mitral and bicuspid regurgitation. Before the vaccine, the patient's last menstrual period was in APR-2021. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) 1 total, dose was not reported, administered on 13-JUN-2021 on left arm for covid-19 prophylaxis. On AUG-2021, the patient experienced had two light periods (also in DEC-2021) after receiving the Janssen covid-19 vaccine (dose number in series 1). On 14-OCT-2021, Laboratory data included: Colonoscopy (NR: not provided) Two benign polyps. On an unspecified date, the patient experienced two small size benign polyps, feeling fatigued and tired, and feeling a little bit weak (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855190 expiry: UNKNOWN) 1 total, dose was not reported, administered on 13-JAN-2022 on left arm for covid-19 prophylaxis. Age at time of vaccination 51 years old. No concomitant medications were reported.  On 12-SEP-2022, the patient had post-nasal drip and sore throat, patient had done covid-19 test and tested negative. On 13-SEP-2022: patient had fever, tested negative at clinic (urgent care). On 14-SEP-2022: Patient had chills so bad that couldn't stop. Fever went up to 102 and was tested positive which associated with confirmed clinical vaccination failure and confirmed covid-19 infection (dose number in series 2). Now 3 months out from having covid-19, patient is recovered. Patient was not hospitalized. The patient was recommended to take supplements. Supplements were: antiviral lauricidin monolaurin supplement pellets. Anything patient took even if over the counter, it affected pretty strongly. Patient took 5 pellets total daily which equated to 100-150mg.  N-acetyl-L-cysteine 500mg 3 times a day and alpha lipoic acid 100mg once a day. Patient took them 2 hours apart from other prescribed medication: inhaler Albuterol, and Tylenol (gluten free). The patient took inhaler in coordination with primary care physician due to shortness of breath. On 30-SEP-2022 started inhaler. On 6-OCT-2022, patient couldn't catch breath so went to the ER (emergency room) and underwent tests (d-dimer and x-ray) everything was good, white cell count was a bit elevated. The patient had coughing and had rib pain. Even though my Oxygen was 96-98 patient was not able to catch breath. Albuterol inhaler last used on (21-Oct-2022).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This case, involving the same patient is linked to 20220109769. This report was associated with a product quality complaint.; Sender's Comments: V0-20221230972-Confirmed clinical vaccination failure. The event has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.