Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer 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 patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Dose Number: 1- Batch/Lot No: EW0170- Location of injection: Arm Left) on 21-Apr-2021 and Pfizer / BioNTech (Dose Number: 2- Batch/Lot No: ER8736- Location of injection: Arm Left) on 12-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer / BioNTech and Pfizer / BioNTech. Concurrent medical conditions included Allergy to antibiotic (Azithromycin Allergy). Concomitant products included ETHINYLESTRADIOL, LEVONORGESTREL (LESSINA), MELATONIN, L-THEANINE and MAGNESIUM for an unknown indication. On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2022, the patient experienced the first episode of COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced the second episode of COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 07-May-2022 to 11-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, last episode of COVID-19 (COVID-19) had resolved and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2022, SARS-CoV-2 test: positive Positive. On an unknown date, SARS-CoV-2 test: negative Negative. It was reported that, patient had positive COVID test after negative test with sore throat, congestion, fatigue, severe migraine headaches day after completing Paxlovid treatment. Device date was reported as 16-May-2022. Company Comment: This is a spontaneous case concerning a patient of unknown age and gender no relevant medical history, who experienced the unexpected AESI non-serious events of Covid-19 (1st episode), Covid-19 (second episode) and Drug Ineffective. The event Covid-19 (1st episode) and Drug ineffective occurred 5 months and 20 days after the booster dose of mRNA-1273 COVID 19 Vaccine. On an unknown date event Covid-19 (2nd episode) occurred. Patient was treated with nirmatrelvir + ritonavir tablets. At the time of report Covid-19, Covid-19 had resolved; Event Drug Ineffective outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report. Reporter did not allow further contact. Sender's Comments: Company Comment: This is a spontaneous case concerning a patient of unknown age and gender no relevant medical history, who experienced the unexpected AESI non-serious events of Covid-19 (1st episode), Covid-19 (second episode) and Drug Ineffective. The event Covid-19 (1st episode) and Drug ineffective occurred 5 months and 20 days after the booster dose of mRNA-1273 COVID-19 Vaccine. On an unknown date event Covid-19 (2nd episode) occurred. Patient was treated with nirmatrelvir + ritonavir tablets. At the time of report Covid-19, Covid-19 had resolved; Event Drug Ineffective outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.