Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: was marked  a  allergy group due to her reaction, therefore she could not get an mRNA vaccine and got refused vaccination; COVID-19; angioedema in the face doubling the size on the left side with the tongue sticking of mouth; This spontaneous case was reported by a physician and describes the occurrence of ANGIOEDEMA (angioedema in the face doubling the size on the left side with the tongue sticking of mouth) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery in 2006. Concurrent medical conditions included Melanoma since 2003.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced ANGIOEDEMA (angioedema in the face doubling the size on the left side with the tongue sticking of mouth) (seriousness criterion medically significant). On 03-Jan-2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced OFF LABEL USE (was marked  a  allergy group due to her reaction, therefore she could not get an mRNA vaccine and got refused vaccination). At the time of the report, ANGIOEDEMA (angioedema in the face doubling the size on the left side with the tongue sticking of mouth) had resolved and COVID-19 (COVID-19) and OFF LABEL USE (was marked  a allergy group due to her reaction, therefore she could not get an mRNA vaccine and got refused vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2021, Blood immunoglobulin G: (Positive) Positive. On 10-May-2021, Blood immunoglobulin M: (Negative) Negative. On 03-Jan-2022, Blood immunoglobulin G: (Negative) Negative. On 03-Jan-2022, Blood immunoglobulin M: (Positive) Positive. On 03-Jan-2022, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANGIOEDEMA (angioedema in the face doubling the size on the left side with the tongue sticking of mouth) to be related. No further causality assessments were provided for COVID-19 (COVID-19) and OFF LABEL USE (was marked  a allergy group due to her reaction, therefore she could not get an mRNA vaccine and got refused vaccination).    This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No Concomitant medication was provided by reporter. No Treatment medication was provided by reporter. It was unknown if patient was enrolled in a covid-19 vaccine trial.  Patient had angioedema within 7 minutes of  vaccination, when it occurred patient face swelled on the  left side, and tongue was out of mouth, and patient decided she would lie down and not go to the  emergency room, so patient laid down for a few minutes,  then it subsided and patient went back to work. Patient stayed where patient got the vaccine for 6 minutes  instead of 15 minutes, and the vaccine site was shut  down, but it was not because of patient. Patient reported it was on 10 May 2021 that Patient had the results of the Blood immunoglobulin G (lgG) that was positive and the Blood immunoglobulin M (lgM) that was negative, which shows good strong  antibodies were there, and the lgM was negative because patient had never had the virus and illness. Patient was sick 31Dec2021, then 3Jan2022 lgG  disappeared, so patient did not know until 03 Jan 2022  when the lgM was positive when patient got the antibodies  test, lgG was negative, and Patient had a positive COVID-19 rapid test, test name unknown.   Company comment: This spontaneous case concerns a 54-year-old female patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) event of angioedema and non-serious event of COVID-19 (AESI). The event angioedema occurred approximately 7 minutes after the first dose of mRNA-1273 and the event COVID-19 occurred approximately 1 year after the first dose of mRNA-1273. The patient experienced swelling of the left side of her face which caused her tongue to stay out of her mouth. She did not go into the emergency room, but instead lied down for 6 minutes and the event resolved spontaneously without further treatment. The patient explains that due to this event she did not receive a second COVID-19 vaccine (off label use), which could be a risk factor for the event COVID-19. Outcome was reported as resolved for angioedema and unknown for COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.  Most recent FOLLOW-UP information incorporated above includes: On 12-Jan-2022: follow up received contains patient detail updated, patient history added.; Sender's Comments: This spontaneous case concerns a 54-year-old female patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) event of angioedema and non-serious event of COVID-19 (AESI). The event angioedema occurred approximately 7 minutes after the first dose of mRNA-1273 and the event COVID-19 occurred approximately 1 year after the first dose of mRNA-1273. The patient experienced swelling of the left side of her face which caused her tongue to stay out of her mouth. She did not go into the emergency room, but instead lied down for 6 minutes and the event resolved spontaneously without further treatment. The patient explains that due to this event she did not receive a second COVID-19 vaccine (off label use), which could be a risk factor for the event COVID-19. Outcome was reported as resolved for angioedema and unknown for COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.