Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Influenza like illness, Polymerase chain reaction, SARS-CoV-2 test
Clinical narrative: flu like sympt; COVID-19; testing positive on May 2, 2022 / COVID 19 Treatment; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), DRUG INEFFECTIVE (testing positive on May 2, 2022 / COVID 19 Treatment) and INFLUENZA LIKE ILLNESS (flu like sympt) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939893) for COVID-19 vaccination.     Concurrent medical conditions included RA, Kidney stones and Drug allergy (Cipro).   On 17-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021 at 12:30 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2022, the patient experienced COVID-19 (COVID-19) and DRUG INEFFECTIVE (testing positive on May 2, 2022 / COVID 19 Treatment). On 11-May-2022 at 9:00 AM, the patient experienced INFLUENZA LIKE ILLNESS (flu like sympt). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 02-May-2022 to 06-May-2022 for COVID-19 treatment, at a dose of full course. At the time of the report, COVID-19 (COVID-19) and DRUG INEFFECTIVE (testing positive on May 2, 2022 / COVID 19 Treatment) outcome was unknown and INFLUENZA LIKE ILLNESS (flu like sympt) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 09-May-2022, Polymerase chain reaction: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  It was unknown if the patient took any other medications or products within 2 weeks of starting COVID-19 treatment It was reported that the patient was scheduled for surgery on 23-MAY-2022. Device Date was reported as 11-May-2022 Company comment: This spontaneous case of vaccination failure concerns a patient of a 70-year-old female patient, with no relevant medical history, who experienced the non-serious unexpected AESI of COVID-19 (among other non-serious events) approximately 9 months after the third dose of mRNA-1273 vaccine. As per narrative of the source document, she started Paxlovid (ritonavir) after testing positive, but a week later a PCR test was performed due to a scheduled surgery with negative results. No further clinical information was provided for medical reviewing. In the source document are reported five dates of vaccination with Moderna vaccine: Extra dose administered case. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case of vaccination failure concerns a patient of a 70-year-old female patient, with no relevant medical history, who experienced the non-serious unexpected AESI of COVID-19 (among other non-serious events) approximately 9 months after the third dose of mRNA-1273 vaccine. As per narrative of the source document, she started Paxlovid (ritonavir) after testing positive, but a week later a PCR test was performed due to a scheduled surgery with negative results. No further clinical information was provided for medical reviewing. In the source document are reported five dates of vaccination with Moderna vaccine: Extra dose administered case. The benefit-risk relationship of the mRNA-1273 is not affected by this report.