Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Lack of drug effect; Covid Relapse; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid Relapse) and DRUG INEFFECTIVE (Lack of drug effect) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Dose Number: 3 Batch/Lot No: 30145BA) on 24-Sep-2021. Past adverse reactions to the above products included Allergy with Pfizer / BioNTech. Concurrent medical conditions included Hypertension and High cholesterol.   On 01-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 27-Apr-2022, received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 07-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Covid Relapse). On an unknown date, the patient experienced DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Covid Relapse) had not resolved and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  The patient was taking other medications or products within 2 weeks of starting COVID-19 treatment. Patient received a COVID-19 vaccine previously.  Device date was reported as 07-May-2022.  Treatment details were not reported by the reporter. Company comment: This spontaneous case concerns a 71-year-old male patient with no reported medical history, who experienced the unexpected, serious (medically significant) adverse event of special interest COVID-19 (with a positive SARS-CoV-2 test) that occurred 36 days after receiving the fourth dose of mRNA-1273 Vaccine. Additionally, Drug ineffective was also reported. The patient was given a dose of Pfizer vaccine 10 days prior to the occurrence of the event. The event was conservatively considered as related since the temporal association cannot be assessed/excluded due to the limited information available. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 71-year-old male patient with no reported medical history, who experienced the unexpected, serious (medically significant) adverse event of special interest COVID-19 (with a positive SARS-CoV-2 test) that occurred 36 days after receiving the fourth dose of mRNA-1273 Vaccine. Additionally, Drug ineffective was also reported. The patient was given a dose of Pfizer vaccine 10 days prior to the occurrence of the event. The event was conservatively considered as related since the temporal association cannot be assessed/excluded due to the limited information available. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.