Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Influenza, Oral blood blister, Product dose omission issue, Pyrexia
Clinical narrative: Did not advised her to receive the 2nd dose of Moderna; Have flu last July 24; She ended up getting COVID; She had fever for 3 days; She had blood blisters on her mouth; This spontaneous case was reported by a consumer and describes the occurrence of ORAL BLOOD BLISTER (She had blood blisters on her mouth), INFLUENZA (Have flu last July 24), COVID-19 (She ended up getting COVID), PYREXIA (She had fever for 3 days) and PRODUCT DOSE OMISSION ISSUE (Did not advised her to receive the 2nd dose of Moderna) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GOLIMUMAB (SIMPONI ARIA) for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced ORAL BLOOD BLISTER (She had blood blisters on her mouth) and PYREXIA (She had fever for 3 days). On 24-Jul-2021, the patient experienced INFLUENZA (Have flu last July 24) and COVID-19 (She ended up getting COVID). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not advised her to receive the 2nd dose of Moderna). At the time of the report, ORAL BLOOD BLISTER (She had blood blisters on her mouth), INFLUENZA (Have flu last July 24) and COVID-19 (She ended up getting COVID) outcome was unknown and PYREXIA (She had fever for 3 days) and PRODUCT DOSE OMISSION ISSUE (Did not advised her to receive the 2nd dose of Moderna) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient taking Aria Symphony, which is like Chemotherapy drugs which she gets via IV every 8 weeks. Patient reported that after first dose of Moderna vaccine she had fever for 3 days and had blood blisters on her mouth. She talked to her RA Doctor who said that she will be okay but did not advised her to receive the second dose of Moderna. On 01 Aug 2021, patient went to the hospital at the Emergency Room (ER). Treatment reported included Monoclonal antibody, IV treatment for 15 minutes. After visiting ER, they made her signed a waiver that she have to wait 3 months to get the vaccine again. This is a case of product dose omission of this 49-year-old, female patient, with no relevant medical history, who experienced the non-serious, unexpected, AESI event of  Covid-19 and other non-serious events of influenza, oral blood blister and pyrexia. The events oral blood blisters and pyrexia occurred on the same day after first dose of vaccine, while events Covid-19 and Influenza occurred  6 months after first dose of Moderna vaccine. The rechallenge is not applicable as patient only received first dose. The patient's incomplete vaccination remain as confounder to event Covid-19. The benefit-risk relationship of Moderna vaccine is not affected by this report.; Sender's Comments: This is a case of product dose omission of this 49-year-old, female patient, with no relevant medical history, who experienced the non-serious, unexpected, AESI event of  Covid-19 and other non-serious events of influenza, oral blood blister and pyrexia. The events oral blood blisters and pyrexia occurred on the same day after first dose of vaccine, while events Covid-19 and Influenza occurred  6 months after first dose of Moderna vaccine. The rechallenge is not applicable as patient only received first dose. The patient's incomplete vaccination remain as confounder to event Covid-19. The benefit-risk relationship of Moderna vaccine is not affected by this report.