Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Malaise, SARS-CoV-1 test
Clinical narrative: Patient started feeling sick; Lack of drug effect; Roughly 5-6 days after finishing the anti-vitals, and after testing negative, Patient started feeling sick and tested positive again; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Patient started feeling sick), DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (Roughly 5-6 days after finishing the anti-vitals, and after testing negative, Patient started feeling sick and tested positive again) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: PfizerBioNTech COVID-19 vaccine (Dose Number: 1 Batch/Lot No: EM0204 Location of injection: Arm Left) on 16-Mar-2021 and PfizerBioNTech COVID-19 vaccine (Dose Number: 2 Batch/Lot No: EW0151 Location of injection: Arm Left) on 06-Apr-2021. Past adverse reactions to the above products included No adverse event with PfizerBioNTech COVID-19 vaccine and PfizerBioNTech COVID-19 vaccine. Concurrent medical conditions included Blood pressure high and Allergy to antibiotic (Keflex). Concomitant products included NORETHISTERONE (CAMILA) for Birth control.    On 06-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2022, the patient experienced COVID-19 (Roughly 5-6 days after finishing the anti-vitals, and after testing negative, Patient started feeling sick and tested positive again). On an unknown date, the patient experienced MALAISE (Patient started feeling sick) and DRUG INEFFECTIVE (Lack of drug effect). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 02-May-2022 to 07-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, MALAISE (Patient started feeling sick) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown and COVID-19 (Roughly 5-6 days after finishing the anti-vitals, and after testing negative, Patient started feeling sick and tested positive again) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-1 test: positive (Positive) Positive.         The patient took other medications/products within 2 weeks of starting COVID-19 treatment.   Patient previously received a COVID-19 Vaccine.  Roughly 5-6 days after finishing the anti-vitals, and after testing negative, the patient started feeling sick and tested positive again.  Treatment medication was not provided. Company comment: This spontaneous case concerns a 36-year-old female patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19 (with a positive SARS-CoV-2 test) that occurred 188 days after receiving the third dose of mRNA-1273 Vaccine. Additionally, Drug ineffective was also reported. The initial two doses of Pfizer were given approximately 7 months prior, the interval between the first and second doses of Pfizer was noted to be 21 days. Outcome of the events was unknown at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 36-year-old female patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19 (with a positive SARS-CoV-2 test) that occurred 188 days after receiving the third dose of mRNA-1273 Vaccine. Additionally, Drug ineffective was also reported. The initial two doses of Pfizer were given approximately 7 months prior, the interval between the first and second doses of Pfizer was noted to be 21 days. Outcome of the events was unknown at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.