Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient started experiencing Covid symptoms again and tested positive; Interchange of vaccine products; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient started experiencing Covid symptoms again and tested positive) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     The patient had previously received a COVID-19 vaccine.  Previously administered products included for COVID-19 vaccination: Pfizer / BioNTech (Dose Number: 1, Batch/Lot No: ER8735) on 12-Apr-2021, Pfizer / BioNTech (Dose Number: 2 and Batch/Lot No: EW0170) on 05-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer / BioNTech and Pfizer / BioNTech. Concurrent medical conditions included Blood pressure high (Elevated blood pressure), Raynaud's syndrome, Hypothyroidism, Eczema, Rosacea, Penicillin allergy and Topical adhesive allergy (allergy to plastic adhesive bandages). Concomitant products included ETHINYLESTRADIOL, NORETHISTERONE ACETATE (JUNEL), LOSARTAN POTASSIUM from 26-Apr-2022 to an unknown date, LEVOTHYROXINE, SPIRONOLACTONE, DULOXETINE and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (AMPHETAMINE MIXED SALTS) for an unknown indication.    On 08-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient started experiencing Covid symptoms again and tested positive). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 16-May-2022 to 20-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Patient started experiencing Covid symptoms again and tested positive) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2022, SARS-CoV-2 test: neagtive (Negative) tested negative. On 30-May-2022, SARS-CoV-2 test: positive (Positive) tested positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included D Amphetamine salt combo.  The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  On 28-May-2022, the patient experienced COVID symptoms again.  The device date was reported as 31-May-2022.  Company comment: This is a spontaneous case concerning a 49-year-old, female patient with no relevant medical history and with vaccine history of receiving first and second dose of Covid-19 BioNTech, who experienced the unexpected non-serious event of Covid-19. The event occurred approximately 6 months after the unknown dose of mRNA-1273 vaccine administration. Allegedly the event was described as, approximately 189 days after the unknown dose number of mRNA-1273 vaccine administration patient took Nirmatrelvir + Ritonavir (Paxlovid) as treatment medication for Covid-19. Patient finished the 5-day course of Paxlovid and patient tested negative. Approximately 8 days after the last dose of Paxlovid, patient experienced Covid-19 symptoms again. Approximately 2 days after the reoccurrence of symptoms, patient tested positive. No other information surrounding the event was reported. The outcome of the event was reported as not resolved. The current Covid-19 pandemic remain confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 49-year-old, female patient with no relevant medical history and with vaccine history of receiving first and second dose of Covid-19 BioNTech, who experienced the unexpected non-serious  event of Covid-19. The event occurred approximately 6 months after the unknown dose of mRNA-1273 vaccine administration. Allegedly the event was described as, approximately 189 days after the unknown dose number of mRNA-1273 vaccine administration patient took Nirmatrelvir + Ritonavir (Paxlovid) as treatment medication for Covid-19. Patient finished the 5-day course of Paxlovid and patient tested negative. Approximately 8 days after the last dose of Paxlovid, patient experienced Covid-19 symptoms again. Approximately 2 days after the reoccurrence of symptoms, patient tested positive. No other information surrounding the event was reported. The outcome of the event was reported as not resolved. The current Covid-19 pandemic remain confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.