Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19/ tested positive for covid/Coughing/ can't breathe/has the usual symptoms of COVID; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19/ tested positive for covid/Coughing/ can't breathe/has the usual symptoms of COVID) in a 55-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 027E22A) for COVID-19 prophylaxis.     The patient's past medical history included Adenocarcinoma (Lobectomy for Adenocarcinoma and patient tries to be very careful) in 2017 and Hearing loss. Previously administered products included for COVID-19 vaccination: Moderna COVID-19 vaccine (Within few weeks after the first shot of moderna vaccine patient had some hearing loss.). Past adverse reactions to the above products included Hearing loss with Moderna COVID-19 vaccine.    On 13-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Oct-2022, the patient experienced COVID-19 (COVID-19/ tested positive for covid/Coughing/ can't breathe/has the usual symptoms of COVID) (seriousness criterion medically significant). At the time of the report, COVID-19 (COVID-19/ tested positive for covid/Coughing/ can't breathe/has the usual symptoms of COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Oct-2022, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient clarified that it was tested positive for COVID on 17-Oct-2022 after the bivalent vaccine and previously tested for 2 days but it was shown as negative, and patient thought that those tests were performed wrongly. Patient reported that all the previous COVID vaccines were with Moderna only. It was reported that there is no idea about how the patient got COVID infection, the patient doesn't go out and wears a mask everywhere even on the sub way. The patient is in the street wearing a mask. The patient went out with another couple but they're fine. Patient has the usual symptoms of COVID that is just can't breathe, and coughing. Patient has not yet started the Paxlovid and about to take it. Patient had querying about the vaccine and interfering with efficacy. No treatment medications were reported.  Company comment: This spontaneous case concerns a 55-year-old, female patient with medical history of adenocarcinoma, (reported as lobectomy for adenocarcinoma), who experienced the unexpected, serious (medically significant) event of COVID-19. The event occurred approximately four days after receiving the mRNA-1273.222 vaccine. The patient was tested positive for COVID -19  four days after the vaccination and was previously tested for 2 days, but the test was negative. Symptoms included coughing, loss of breath ("can't breathe")  and it was also reported that the patient had the "usual symptoms of COVID". The patient's past COVID-19 vaccination included mRNA-1273 ("within few weeks after the first shot of mRNA-1273, the  patient "had some hearing loss"). No further details were provided. The outcome of the event was unknown at the time of the report. Medical history of adenocarcinoma (lobectomy for adenocarcinoma) remains as confounder for the event. The benefit-risk relationship of the mRNA-1273 original vaccine is not affected by this report.   This case was linked to MOD-2022-660865 (Patient Link).; Sender's Comments: This spontaneous case concerns a 55-year-old, female patient with medical history of adenocarcinoma, (reported as lobectomy for adenocarcinoma), who experienced the unexpected, serious (medically significant) event of COVID-19. The event occurred approximately four days after receiving the mRNA-1273.222 vaccine. The patient was tested positive for COVID -19  four days after the vaccination and was previously tested for 2 days, but the test was negative. Symptoms included coughing, loss of breath ("can't breathe")  and it was also reported that the patient had the "usual symptoms of COVID". The patient's past COVID-19 vaccination included mRNA-1273 ("within few weeks after the first shot of mRNA-1273, the  patient "had some hearing loss"). No further details were provided. The outcome of the event was unknown at the time of the report. Medical history of adenocarcinoma (lobectomy for adenocarcinoma) remains as confounder for the event. The benefit-risk relationship of the mRNA-1273 original vaccine is not affected by this report.