Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: 01may2022 was diagnosed with Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (01may2022 was diagnosed with Covid-19) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2022, the patient experienced COVID-19 (01may2022 was diagnosed with Covid-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from May 2022 to May 2022 for COVID-19 treatment, at a dose of 1 dosage form. On 31-May-2022, COVID-19 (01may2022 was diagnosed with Covid-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-May-2022, SARS-CoV-2 test: negative (Negative) Negative.         The concomitant medications were not reported. It was reported that 01may2022 patient was diagnosed with Covid-19.  Patient reported that post one week of taking paxlovid she had cough, congestion, congestion drips, headache, chest tightness and ear pops and was not recovered even after taking paxlovid. Later Health care professional reported to patient that the symptoms are rebound of covid and was prescribed steroid shot  and the symptoms got recovered. Patient was upset of paxlovid. HCP stated that patient was no longer covid positive but the virus was still in the body.  The treatment information was reported as hot water gargling, nasal spray and hot shower.  Company comment-This spontaneous case concerns a 68-year-old female patient with no medical history reported, who experienced the unexpected non serious AESI of Covid 19 infection 6 days after receiving the 4th dose(second booster) of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that the patient was treated with paxlovid in May-2022 for covid 19 treatment for 5 days. A week later patient had cough, headache, congestion, consulted an HCP diagnosed as rebound covid after Paxlovid treatment. She was treated with Steroids for the same. COVID-19 virus test done on 31st May 2022 was negative. The current pandemic situation of COVID 19 may remain as confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.; Sender's Comments: This spontaneous case concerns a 68-year-old female patient with no medical history reported, who experienced the unexpected non serious AESI of Covid 19 infection 6 days after receiving the 4th dose(second booster) of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that the patient was treated with paxlovid in May-2022 for covid 19 treatment for 5 days. A week later patient had cough, headache, congestion, consulted an HCP diagnosed as rebound covid after Paxlovid treatment. She was treated with Steroids for the same. COVID-19 virus test done on 31st May 2022 was negative. The current pandemic situation of COVID 19 may remain as confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.