Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; tested positive again; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive again) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Dose Number: 1 Batch/Lot No: Unknown. Misplaced/discarded Location of injection: Arm Left) on 13-Mar-2021 and Pfizer / BioNTech (Dose Number: 2 Batch/Lot No: Unknown. Misplaced/discarded Location of injection: Arm Left) on 03-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer / BioNTech and Pfizer / BioNTech. Concurrent medical conditions included Drug allergy.    On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022 at 7:00 AM, the patient experienced COVID-19 (tested positive again). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 08-May-2022 to 12-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (tested positive again) was resolving and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2022, SARS-CoV-2 test: positive (Positive) positive. In 2022, SARS-CoV-2 test: positive (Positive) positive, negative (Negative) Negative (on day five) and negative (Negative) Negative (on day six).         She tested positive for Cove at 19 and took Paxelvid after four days of testing positive unpacked of it she tested negative for Covid on an antigen test on day five. She tested negative again on day six. She felt good and thought she was in the cleared. Four days after the first negative test she had all symptoms back and tested positive again   No concomitant medication were reported.  Company comment: This spontaneous case concerns a 43 year old female patient with no reported medical history, who experienced the unexpected non serious AESI of COVID-19, about 7 months and 4 days after receiving the third dose with mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the previous two doses with Pfizer vaccine, the last dose being given about 8 months and 18 days prior to mRNA-1273 vaccine, with no reported adverse events. Interchange of vaccine products was noted. She tested positive for Covid-19 and took Paxlovid after four days of testing positive; tested negative on the fifth day. Four days after the negative test, developed all the symptoms back and tested positive again. No further information on risk factors and co morbidities was available in the report. The event was resolving. The ongoing COVID-19 pandemic could be a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 43 year old female patient with no reported medical history, who experienced the unexpected non serious AESI of COVID-19, about 7 months and 4 days after receiving the third dose with mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the previous two doses with Pfizer vaccine, the last dose being given about 8 months and 18 days prior to mRNA-1273 vaccine, with no reported adverse events. Interchange of vaccine products was noted. She tested positive for Covid-19 and took Paxlovid after four days of testing positive; tested negative on the fifth day. Four days after the negative test, developed all the symptoms back and tested positive again. No further information on risk factors and co morbidities was available in the report. The event was resolving. The ongoing COVID-19 pandemic could be a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.