Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Inappropriate schedule of product administration, Off label use, SARS-CoV-2 antibody test, Skin test
Clinical narrative: met diagnostic criteria for anaphylaxis; patients received 0.05 mL, 0.1mL, 0.15 mL and 0.2 mL intramuscularly every 15 minutes; Time in Between 1st and 2nd Vaccination, days is 50 days; This literature-non-study case was reported in a literature article and describes the occurrence of ANAPHYLACTIC REACTION (met diagnostic criteria for anaphylaxis) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.      No Medical History information was reported.   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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (met diagnostic criteria for anaphylaxis) (seriousness criterion medically significant), OFF LABEL USE (patients received 0.05 mL, 0.1mL, 0.15 mL and 0.2 mL intramuscularly every 15 minutes) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Time in Between 1st and 2nd Vaccination, days is 50 days). At the time of the report, ANAPHYLACTIC REACTION (met diagnostic criteria for anaphylaxis), OFF LABEL USE (patients received 0.05 mL, 0.1mL, 0.15 mL and 0.2 mL intramuscularly every 15 minutes) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Time in Between 1st and 2nd Vaccination, days is 50 days) outcome was unknown. Related    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: 18.12 18.12; Reactive; SARSCOV2 AB (IGG), SPIKE, SEMIQUANTITATIVE (after 218 days of second vaccination). On an unknown date, Skin test: negative (Negative) Patient had negative COVID-19 vaccine component skin testing to polyethylene glycol and polysorbate 20 and 80.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANAPHYLACTIC REACTION (met diagnostic criteria for anaphylaxis), OFF LABEL USE (patients received 0.05 mL, 0.1mL, 0.15 mL and 0.2 mL intramuscularly every 15 minutes) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Time in Between 1st and 2nd Vaccination, days is 50 days) to be related.    Symptoms after first vaccination  included diffuse hives, throat swelling (within 60 minutes) +  Patient consented to undergo a second dose graded vaccine administration, which occurred 30 to 52 days after initial vaccination. Patient received 0.05 mL, 0.1mL, 0.15 mL and 0.2 mL intramuscularly every 15 minutes.  Patient was observed for 60 minutes after the last dose. Patient tolerated the graded dosing without evidence of allergic reaction.   No concomitant and treatment medications were reported  Patient met diagnostic criteria for anaphylaxis based on the RA Collaboration case definition.  Company Comment: This is a Literature non-study case, concerning a 57-year-old female patient, with no medical history reported, who experienced the expected and serious (due to medically significant) event of Anaphylactic reaction, on an unknown date after the second dose of mRNA-1273 vaccine. Inappropriate schedule of vaccine administered is also reported, as first and second dose were administered with an interval of 50 days. Off label use was also reported, as patient received 0.05 mL, 0.1mL, 0.15 mL and 0.2 mL intramuscularly every 15 minutes. SARS-CoV-2 antibody test: 18.12 18.12; Reactive; SARSCOV2 AB (IGG), SPIKE, SEMIQUANTITATIVE (after 218 days of second vaccination). Patient had negative COVID-19 vaccine component skin testing to polyethylene glycol and polysorbate 20 and 80. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-577021, MOD-2022-577035, MOD-2022-577036 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2022: Live significant follow up received by safety on 26-May-2022 has email with full text article and contains significant information. Reporter details, patient demographics, events, onset latency to reaction and laboratory test added.; Sender's Comments: This is a Literature non-study case, concerning a 57-year-old female patient, with no medical history reported, who experienced the expected and serious (due to medically significant) event of Anaphylactic reaction, on an unknown date after the second dose of mRNA-1273 vaccine. Inappropriate schedule of vaccine administered is also reported, as first and second dose were administered with an interval of 50 days. Off label use was also reported, as patient received 0.05 mL, 0.1mL, 0.15 mL and 0.2 mL intramuscularly every 15 minutes. SARS-CoV-2 antibody test: 18.12 18.12; Reactive; SARSCOV2 AB (IGG), SPIKE, SEMIQUANTITATIVE (after 218 days of second vaccination). Patient had negative COVID-19 vaccine component skin testing to polyethylene glycol and polysorbate 20 and 80. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.