Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Covid-19; 1st dose - 22-Mar-2021; 2nd dose - 29-Apr-2021; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 22-Mar-2021; 2nd dose - 29-Apr-2021) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 040A21A) for COVID-19 vaccination.     Previously administered products included for Flu vaccination: flu vaccine (She had flu vaccine sometime in Oct or Noc2021.) in 2021. Past adverse reactions to the above products included No adverse event with flu vaccine. Concurrent medical conditions included Asthma and Fibromyalgia. Concomitant products included OXYCODONE, GABAPENTIN and SERTRALINE for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 22-Mar-2021; 2nd dose - 29-Apr-2021). On 18-Jan-2022, the patient experienced COVID-19 (Covid-19). On 23-Jan-2022, COVID-19 (Covid-19) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 22-Mar-2021; 2nd dose - 29-Apr-2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2022, SARS-CoV-2 test: positive (Positive) Had Covid-19 on 18Jan2022.         The patient had no allergies.  Patient was receiving few other medications which she could not provide at the time of the call. The patient had flu vaccine sometime in Oct-2021 or Nov-2021. The patient had Covid-19 on 18-Jan-2022 which she described as the worst flu one could ever have for about 5 days. No treatment drug was reported.  Company comment: This spontaneous case concerns a 57-year-old female patient with no relevant medical history who experienced  non-serious unexpected AESI of COVID-19. The event occurred approximately 9 months after the 2nd dose of the mRNA-1273. Additionally, there was an inappropriate schedule of product administered since time between doses was more than 35 days. The patient described it as the worst flu she could ever have that lasted for about 5 days. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-513772 (Patient Link).; Sender's Comments: This spontaneous case concerns a 57-year-old female patient with no relevant medical history who experienced  non-serious unexpected AESI of COVID-19. The event occurred approximately 9 months after the 2nd dose of the mRNA-1273. Additionally, there was an inappropriate schedule of product administered since time between doses was more than 35 days. The patient described it as the worst flu she could ever have that lasted for about 5 days. The benefit-risk relationship of mRNA-1273 is not affected by this report.