Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Post-Rebound rebound Covid. say May 22: began feeling bad again: sore throat, headache, congestion; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Post-Rebound rebound Covid. say May 22: began feeling bad again: sore throat, headache, congestion) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A, 011A21A and 029L20A) for COVID-19 vaccination.     Allergic reaction was reported for unspecified drug.  Concurrent medical conditions included Herpes virus infection and Hyperlipidemia (marginally elevated lipids). Concomitant products included ATORVASTATIN CALCIUM (ATORVASTATIN/MYLAN) from January 2000 to 14-May-2022, ACYCLOVIR [ACICLOVIR] from January 2000 to an unknown date and CENTRUM SILVER MEN 50+ from January 2000 to an unknown date for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Post-Rebound rebound Covid. say May 22: began feeling bad again: sore throat, headache, congestion). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 14-May-2022 to 19-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Post-Rebound rebound Covid. say May 22: began feeling bad again: sore throat, headache, congestion) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2022, SARS-CoV-2 test: positive (Positive) tested positive for Covid (rapid test). On 24-May-2022, SARS-CoV-2 test: negative (Negative) tested negative (rapid test). On 25-May-2022, SARS-CoV-2 test: positive (Positive) tested positive (rapid test).         It was reported that the patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.   Reported relevant past drug history as no and reaction as Allergy.  Reported that rebound Covid. Timeline, May 14: tested positive for Covid (rapid test). May 14 (PM) - May 19 (AM): 5 days treated with Paxlovid felt fully recovered around May 17, say, May-22: began feeling bad again: sore throat, headache, congestion, May 24: tested negative (rapid test), May 25: tested positive (rapid test).  Device Date  was reported as 26-May-2022.  Company Comment: This spontaneous case concerns a 69-year-old male patient, with relevant medical history of herpes virus infection and hyperlipidaemia, who experienced the unexpected non-serious AESI of COVID-19 that occurred 20 days after the 4th dose of mRNA-1273 vaccine. SARS-CoV-2 test was reported positive. Patient took Paxlovid and recovered fully after completion of 5 day treatment. But, three days later, patient reported post-rebound COVID, presented with sore throat, headache, and congestion. Repeat SARS-CoV-2 test was reported positive. The outcome of event was reported as not resolved. Herpes virus infection and hyperlipidemia could be considered as risk factors. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed non-serious based on medical judgement.; Sender's Comments: This spontaneous case concerns a 69-year-old male patient, with relevant medical history of herpes virus infection and hyperlipidaemia, who experienced the unexpected non-serious AESI of COVID-19 that occurred 20 days after the 4th dose of mRNA-1273 vaccine. SARS-CoV-2 test was reported positive. Patient took Paxlovid and recovered fully after completion of 5 day treatment. But, three days later, patient reported post-rebound COVID, presented with sore throat, headache, and congestion. Repeat SARS-CoV-2 test was reported positive. The outcome of event was reported as not resolved. Herpes virus infection and hyperlipidemia could be considered as risk factors. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed non-serious based on medical judgement.