Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a patient of unspecified age, sex, race and ethnicity. Initial information was processed along with the additional information received on 20-MAR-2023. The patient's height, and weight were not reported. The patient's concurrent conditions included: mild-moderate asthma, supraventricular tachycardia (SVT), thoracic outlet syndrome, and mango allergy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on 12-MAR-2021 at right arm for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The patient additionally received non-company suspect vaccine included: Moderna (elasomeran) (dose number in series 2) (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered on 29-DEC-2021 at right arm for covid-19 prophylaxis which was associated with revaccination with different covid-19 vaccine (dose number in series 2). Concomitant medications included Atrantil (aesculus hippocastanum/mentha canadensis/schinopsis lorentzii heartwood) for drug used for unknown indication.  On an unspecified date in FEB-2023, the patient experienced sickness (covid 19 infection) for which patient received non-company suspect drugs included: Paxlovid (nirmatrelvir/ritonavir) (form of admin, route of admin, batch number and expiry date were not reported) dose and frequency were not reported from 25-FEB-2023 to 01-MAR-2023 for covid-19 treatment.  On 02-MAR-2023, the patient tested negative, day 6 of sickness (started paxlovid day 1). On 03-MAR-2023, the patient tested positive, day 7 of sickness (had confirmed covid 19 infection) (dose number in series 2) which resulted into confirmed clinical vaccination failure (dose number in series 1). At the time of reporting, the patient had headache, some shortness of breath, nose felt like breathed water. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable; and action taken with nirmatrelvir/ritonavir was not reported. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure and revaccination with different covid-19 vaccine was not reported.  This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000275617.; Sender's Comments: V0: 20230349388-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.