Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; Lack of drug effect; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of the first episode of COVID-19 (COVID-19), the second episode of COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. O17F21A, O21B21A and O30A21A) for COVID-19 vaccination.     The patient's past medical history included Drug allergy (Patient had experienced reaction allergy to an unspecified historical drug.).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2022, the patient experienced the first episode of COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of drug effect). On 28-Apr-2022, the patient experienced the second episode of COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 15-Apr-2022 for COVID-19 treatment, at a dose of 1 dosage form and NIRMATRELVIR, RITONAVIR (PAXLOVID) on 21-Apr-2022 for COVID-19 treatment, at a dose of 1 dosage form. At the time of the report, last episode of COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2022, SARS-CoV-2 test: positive Positive. On 19-Apr-2022, SARS-CoV-2 test: negative Negative. On 20-Apr-2022, SARS-CoV-2 test: negative Negative. On 28-Apr-2022, SARS-CoV-2 test: positive Positive.         Concomitant medication information was not provided by the reporter.  An unspecified historical past drug was reported.   It was reported that the patient was not taking any other medications or products within two weeks of starting COVID-19 treatment.  On 14-Apr-2022, the patient had first symptoms runny nose and sneezing on evening.  On 15-Apr-2022, doctor prescribed Paxlovid. Took 1st dose in pm.   The patient never had temp. Felt better on Sunday (17-Apr-2022) and improved each day.   On 21-Apr-2022, took last dose of Paxlovid on morning.   On 28-Apr-2022, the patient was symptom free until evening.   Device date was reported as 29-Apr-2022.  Company Comment:  This spontaneous case concerns a 68-year-old female patient, with no relevant medical history, who experienced unexpected, non-serious ADR Covid-19 (laboratory confirmed) approximately 5 months and 1 week after receiving a third dose of mRNA-1273.  Drug ineffective is also reported.  The patient presented with symptoms of runny nose and sneezing.  A doctor prescribed Paxlovid (nirmatrelvir/ritonavir) which was taken for around 7 days, and she initially recovered.  However, around one week later there was recurrence of unspecified symptoms and patient again tested positive for Covid-19 using a home test.  The outcome of the second bout of Covid-19 is unknown.  The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 68-year-old female patient, with no relevant medical history, who experienced unexpected, non-serious ADR Covid-19 (laboratory confirmed) approximately 5 months and 1 week after receiving a third dose of mRNA-1273.  Drug ineffective is also reported.  The patient presented with symptoms of runny nose and sneezing.  A doctor prescribed Paxlovid (nirmatrelvir/ritonavir) which was taken for around 7 days, and she initially recovered.  However, around one week later there was recurrence of unspecified symptoms and patient again tested positive for Covid-19 using a home test.  The outcome of the second bout of Covid-19 is unknown.  The benefit risk relationship of mRNA-1273 is not affected by this report.