Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: Was symptom free of Covid and 4 days later came down with very bad head congestion, headache, extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Was symptom free of Covid and 4 days later came down with very bad head congestion, headache, extreme fatigue) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012FHA, 006B21A and 024M20A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Hypothyroidism, Asthma chronic and Drug allergy. Concomitant products included LEVOTHYROXINE and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 21-May-2022, the patient experienced COVID-19 (Was symptom free of Covid and 4 days later came down with very bad head congestion, headache, extreme fatigue). At the time of the report, COVID-19 (Was symptom free of Covid and 4 days later came down with very bad head congestion, headache, extreme fatigue) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was free from COVID symptoms and 4 days later came down with very bad head congestion, headache, extreme fatigue.  No treatment information was provided.  Device Date was reported as 25-May-2022. Company comment: This is a spontaneous case concerning a 60-years-old female patient with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (COVID-19) which occurred 6 months 4 days after the third dose of mRNA-1273vaccine. The event COVID-19 was reported as; Was symptom free of Covid and 4 days later came down with very bad head congestion, headache, extreme fatigue.  Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This is a spontaneous case concerning a 60-years-old female patient with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (COVID-19) which occurred 6 months 4 days after the third dose of mRNA-1273vaccine. The event COVID-19 was reported as; Was symptom free of Covid and 4 days later came down with very bad head congestion, headache, extreme fatigue.  Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.