Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: Return of Covid symptoms 5 days after stopping Paxlovid treatment. These included a very runny nose, cough, fatigue, migraine headache and night sweats.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Return of Covid symptoms 5 days after stopping Paxlovid treatment. These included a very runny nose, cough, fatigue, migraine headache and night sweats.) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Hypothyroidism, Depression, Arthritis and Allergy NOS (past drug history, name of the drug not reported.). Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN), CELECOXIB (CELEBREX) and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.   On 07-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 27-May-2022, the patient experienced COVID-19 (Return of Covid symptoms 5 days after stopping Paxlovid treatment. These included a very runny nose, cough, fatigue, migraine headache and night sweats.). At the time of the report, COVID-19 (Return of Covid symptoms 5 days after stopping Paxlovid treatment. These included a very runny nose, cough, fatigue, migraine headache and night sweats.) was resolving.            Patient birth date was reported  It had been reported that Covid symptoms included a very runny nose, cough, fatigue, migraine headache and night sweats.  Wel butrin reported as Concomitant medication.  It had been reported that he patient taken other medications/products within 2 weeks of starting COVID-19 treatment.  Company comment: This spontaneous case concerns a 60-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 17-may-2022 to 22-may-2022. Patient had covid symptoms 5 days after stopping paxlovid treatment that included a very runny nose, cough, fatigue, migraine headache and night sweats.The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 60-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 17-may-2022 to 22-may-2022. Patient had covid symptoms 5 days after stopping paxlovid treatment that included a very runny nose, cough, fatigue, migraine headache and night sweats.The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.