Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Palpitations, Pruritus, SARS-CoV-2 test, Tinnitus, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; SHORT TIME MEMORY GOT LITTLE WORSE; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; RINGING IN EARS; HEART RACING FAST; MIGRAINES; ITCHINESS; STOMACH ISSUES; This spontaneous report received from a patient via other manufacturer (Moderna) concerned a 55 year old female of an unspecified race and ethnicity. Initial information processed with additional information received on 27-OCT-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (Mycins, doxycycline), mitral valve prolapse (mitral valve prolapse since she was 19 year old), seasonal allergies, and bladder infection (medication), and patient did not have the best immune system and gets sick easily. Patient did not have acute or chronic illness at the time of vaccination. Patient had never experienced any similar events in past. The patient was previously treated with influenza vaccine.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on 31-MAR-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included clonazepam and antidepressant. On an unspecified date in 2021, patient experienced like relentless pounding headaches which did not leave, feeling very stuffy, heart racing fast, having to stay in bed, her head felt like was going to explode, itchiness, chills, aches, fever, migraines and stomach issues and ringing in ears (dose number in series 1). On an unspecified date, the patient experienced short time memory got little worse (dose number in series 1). The patient additionally received non-company suspect vaccine included: Moderna covid-19 vaccine (Elasomeran) (dose number in series 2) (form of admin, and route of admin were not reported, batch number: 0139406 and expiry: UNKNOWN) dose was not reported, administered on 05-NOV-2021 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 2). Patient got COVID-19 in DEC-2021 (confirmed covid-19 infection) (dose number in series 2) which led to confirmed clinical vaccination failure (dose number in series 1). Patient went to the hospital in JAN-2022 because of COVID. Laboratory data included: COVID-19 virus test Positive. Patient was sick in JAN, FEB and MAR-2022. Patient's HCP told her that she had long COVID. Patient experienced diarrhea, sore throat, weird cough, high fever when she had COVID. Patient received tylenol for migraine but it did not work. She stated that it took a while to recover, and she still had a low grade fever sometimes, tiredness, and fatigue. On an unspecified date, patient experienced ringing in her ears (dose number in series 2). Patient experienced ringing in her ears with all the vaccines. Patient was seeing a pulmonologist and getting tests done. The patient additionally received non-company suspect vaccine included: Moderna covid-19 vaccine (Elasomeran) (dose number in series 3) (form of admin, and route of admin were not reported, batch number: 026l21A and expiry: UNKNOWN) dose was not reported, administered on APR-2022 (07 or 09-APR-2022) for covid-19 prophylaxis. On an unspecified date patient experienced ringing in her ears (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, and elasomeran was not applicable. The patient recovered from migraines, itchiness, and stomach issues, was recovering from confirmed covid-19 infection, had not recovered from heart racing fast, ringing in ears, and short time memory got little worse, and the outcome of confirmed clinical vaccination failure and revaccination with different covid-19 vaccine was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This report was associated with a product quality complaint: 90000256969.; Sender's Comments: V0: 20221051581-confirmed clinical vaccination failure. 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. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.  20221051581-confirmed covid-19 infection. The event is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. Therefore, this event is considered inconsistent with vaccine administration.