Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Body temperature, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: "Cold symptoms began 5/10 evening, tested positive for COVID by rapid test 5/11 morning. Paxlovid taken as prescribed 5/11 PM through 5/16 AM. Symptoms improved by 5/12 AM except for low-grade fever (99.2- 99.8 F) which persisted through 5/23. Negati; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 ("Cold symptoms began 5/10 evening, tested positive for COVID by rapid test 5/11 morning. Paxlovid taken as prescribed 5/11 PM through 5/16 AM. Symptoms improved by 5/12 AM except for low-grade fever (99.2- 99.8 F) which persisted through 5/23. Negati) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Patient had no known allergies.  The patient's past medical history included Overweight. Previously administered products included for Product used for unknown indication: Janssen (Dose No: 1, Batch No: 205A21A, Location: Arm Left and Time: 12:00PM) on 09-Apr-2021. Past adverse reactions to the above products included No adverse event with Janssen. Concurrent medical conditions included Blood pressure high (treated), Thyroid function decreased (Low thyroid function (treated)) and Seasonal allergy. Concomitant products included ATENOLOL, HYDROCHLOROTHIAZIDE, LEVOTHYROXINE and FLUTICASONE for an unknown indication.   On 05-Nov-2021 at 2:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2022 at 3:00 AM, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 11-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 ("Cold symptoms began 5/10 evening, tested positive for COVID by rapid test 5/11 morning. Paxlovid taken as prescribed 5/11 PM through 5/16 AM. Symptoms improved by 5/12 AM except for low-grade fever (99.2- 99.8 F) which persisted through 5/23. Negati). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 11-May-2022 to 16-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. On 20-May-2022, COVID-19 ("Cold symptoms began 5/10 evening, tested positive for COVID by rapid test 5/11 morning. Paxlovid taken as prescribed 5/11 PM through 5/16 AM. Symptoms improved by 5/12 AM except for low-grade fever (99.2- 99.8 F) which persisted through 5/23. Negati) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2022, SARS-CoV-2 test: positive (Positive) Tested positive for COVID by rapid test 5/11 morning. On 20-May-2022, SARS-CoV-2 test: negative (Negative) Negative rapid test 5/20. On 23-May-2022, SARS-CoV-2 test: positive (Positive) Positive rapid test 5/23 AM (day 13 since initial infection).         On 10 May 2022 evening, cold symptoms began. On 12 May 2022 AM, symptoms improved except for low-grade fever (99.2- 99.8 F) which persisted through 23 May 2022. On 22 May 2022, cold symptoms (runny nose, cough, fatigue, throat tickle) returned.  Company Comment: This spontaneous case concerns a 51-year-old, female patient with pre-existing hypertension, who experienced the unexpected, non-serious adverse event of special interest COVID-19. There was also interchange of vaccine products wherein the patient received the single dose COVID-19 VACCINE NRVV AD26 (JNJ 78436735) as primary COVID-19 vaccine, mRNA-1273 as dose 2 (first booster) and Tozinameran as Dose 3 (second booster). The event occurred approximately 6 months after receiving mRNA-1273 as first booster dose. The patient initially presented with cold symptoms and tested COVID-19 positive by rapid test a day after. She was then treated with a full course of NIRMATRELVIR/RITONAVIR (Paxlovid) and noted eventual symptom improvement, although low-grade fever still persisted post-treatment. She tested negative on rapid test 4 days after completion of NIRMATRELVIR/RITONAVIR. Two days after, the patient reported recurrence of runny nose, cough, fatigue and itchy throat, and tested positive again to the virus on rapid antigen test. Details on confirmatory testing done, medical consult and intervention administered after were not provided in the case. The concurrent hypertension and ongoing COVID-19 pandemic remains a confounder for contracting the infection. Tozinameran, given as second booster dose, is cited as co-suspect in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 51-year-old, female patient with pre-existing hypertension, who experienced the unexpected, non-serious adverse event of special interest COVID-19. There was also interchange of vaccine products wherein the patient received the single dose COVID-19 VACCINE NRVV AD26 (JNJ 78436735) as primary COVID-19 vaccine, mRNA-1273 as dose 2 (first booster) and Tozinameran as Dose 3 (second booster). The event occurred approximately 6 months after receiving mRNA-1273 as first booster dose. The patient initially presented with cold symptoms and tested COVID-19 positive by rapid test a day after. She was then treated with a full course of NIRMATRELVIR/RITONAVIR (Paxlovid) and noted eventual symptom improvement, although low-grade fever still persisted post-treatment. She tested negative on rapid test 4 days after completion of NIRMATRELVIR/RITONAVIR. Two days after, the patient reported recurrence of runny nose, cough, fatigue and itchy throat, and tested positive again to the virus on rapid antigen test. Details on confirmatory testing done, medical consult and intervention administered after were not provided in the case. The concurrent hypertension and ongoing COVID-19 pandemic remains a confounder for contracting the infection. Tozinameran, given as second booster dose, is cited as co-suspect in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.