Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Blood pressure measurement, Interchange of vaccine products, Oxygen saturation, Tryptase
Clinical narrative: Anaphylaxis; subsequently tolerated a dose of the Janssen COVID-19 vaccine; This literature-non-study case was reported in a literature article and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis) in a 66-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.   Concurrent medical conditions included Drug intolerance (had 8 unrelated drug intolerances noted in her medical record). Concomitant products included COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criterion medically significant) and INTERCHANGE OF VACCINE PRODUCTS (subsequently tolerated a dose of the Janssen COVID-19 vaccine). At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis) and INTERCHANGE OF VACCINE PRODUCTS (subsequently tolerated a dose of the Janssen COVID-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 151/63. On an unknown date, Oxygen saturation: 98 %. On an unknown date, Tryptase: no acute tryptase was obtained.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANAPHYLACTIC REACTION (Anaphylaxis) and INTERCHANGE OF VACCINE PRODUCTS (subsequently tolerated a dose of the Janssen COVID-19 vaccine) to be related.    No concomitant and treatment medications were reported.  The anaphylaxis episode was relatively mild and not felt by treating physicians to be life-threatening. Patient had symptoms hives and wheezing. Patient was not given second dose of the vaccine associated with the index events, but subsequently tolerated a dose of the Janssen COVID-19 vaccine.  Company Comment:  This is a literature non-study case concerning a 66-year-old female patient with relevant medical condition of multiple drug intolerance, who experienced the expected serious (medically significant per the IME list) event of Anaphylactic reaction, described as mild anaphylaxis episode, which occurred on the same day after receiving the first dose of mRNA-1273 vaccine. Patient also received a dose of Janssen COVID-19 vaccine on an unknown date with no reported adverse event (Interchange of vaccine products). It was reported that the patient had hives and wheezing with blood pressure was 151/63, pulse O2 of 98%, and no acute tryptase was obtained. Patient was given with unspecified medication within 6 hours post-vaccination. No further details about the diagnostic procedures were provided. Outcome of the event was unknown. The medical condition of multiple drug intolerance could be a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a literature non-study case concerning a 66-year-old female patient with relevant medical condition of multiple drug intolerance, who experienced the expected serious (medically significant per the IME list) event of Anaphylactic reaction, described as mild anaphylaxis episode, which occurred on the same day after receiving the first dose of mRNA-1273 vaccine. Patient also received a dose of Janssen COVID-19 vaccine on an unknown date with no reported adverse event (Interchange of vaccine products). It was reported that the patient had hives and wheezing with blood pressure was 151/63, pulse O2 of 98%, and no acute tryptase was obtained. Patient was given with unspecified medication within 6 hours post-vaccination. No further details about the diagnostic procedures were provided. Outcome of the event was unknown. The medical condition of multiple drug intolerance could be a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.