Age: 70.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Diarrhoea, Hypotension, Nasal congestion, SARS-CoV-2 test
Clinical narrative: Low blood pressure during the first week; congestion returned; Diarrhea; Rebound - still tested positive; This spontaneous case was reported by a patient and describes the occurrence of HYPOTENSION (Low blood pressure during the first week), NASAL CONGESTION (congestion returned), DIARRHOEA (Diarrhea) and COVID-19 (Rebound - still tested positive) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Asthma, Irritable bowel syndrome, Fibromyalgia, Allergic reaction to antibiotics (quinolones) and Drug allergy (opioid).   On 21-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. In May 2022, the patient experienced COVID-19 (Rebound - still tested positive). On 22-May-2022, the patient experienced HYPOTENSION (Low blood pressure during the first week), NASAL CONGESTION (congestion returned) and DIARRHOEA (Diarrhea). At the time of the report, HYPOTENSION (Low blood pressure during the first week), NASAL CONGESTION (congestion returned), DIARRHOEA (Diarrhea) and COVID-19 (Rebound - still tested positive) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medications were not reported. Patient tested positive COVID-19  on day eleven. Patient needed steroid inhaler because of tendency towards asthma. Treatment information was not provided. Device date reported as 24-May-2022. Company comment: This is a spontaneous case concerning a 70-year-old female patient, with no relevant medical history, who experienced the unexpected, non-serious of COVID-19 (reported as rebound-still tested positive), approximately 8 months after the third dose of mRNA-1273 vaccine. No details of previous doses were provided. As per source document, she experienced diarrhea, congestion, and low blood pressure during the first week and still tested positive after 11 days. She received Paxlovid as treatment and needed steroid inhaler because of tendency toward asthma. The co-suspect PAXLOVID remains as a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 70-year-old female patient, with no relevant medical history, who experienced the unexpected, non-serious  of COVID-19 (reported as rebound -still tested positive), approximately 8 months after the third dose of mRNA-1273 vaccine. No details of previous doses were provided. As per source document, she experienced diarrhea, congestion, and low blood pressure during the first week and still tested positive after 11 days. She received Paxlovid as treatment and needed steroid inhaler because of tendency toward asthma. The co-suspect PAXLOVID remains as a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.