Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Off label use, SARS-CoV-2 antibody test, Skin test
Clinical narrative: Anaphylaxis; patients received 0.05 mL, 0.1mL, 0.15 mL and 0.2 mL intramuscularly every 15 minutes; This literature-non-study case was reported in a literature article and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis) in a 31-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.   LITERATURE REFERENCE:     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 .5 milliliter. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criterion medically significant) and OFF LABEL USE (patients received 0.05 mL, 0.1mL, 0.15 mL and 0.2 mL intramuscularly every 15 minutes). At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis) and OFF LABEL USE (patients received 0.05 mL, 0.1mL, 0.15 mL and 0.2 mL intramuscularly every 15 minutes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: >20 >20; Reactive; SARS-CoV-2 AB (IGG), Spike, Semi-quantitative (after 183 days of second vaccination). On an unknown date, Skin test: negative (Negative) Negative (for polysorbate 20 and 80).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ANAPHYLACTIC REACTION (Anaphylaxis) and OFF LABEL USE (patients received 0.05 mL, 0.1mL, 0.15 mL and 0.2 mL intramuscularly every 15 minutes) to be related.    No concomitant and treatment medication provided.  Patient consented to undergo a second dose graded vaccine administration.  Patient was observed for 60 minutes after the last graded dose. Patient tolerated the graded dosing without evidence of allergic reaction.  Patient met diagnostic criteria for anaphylaxis based on the case definition and Criteria for Anaphylaxis.  Time in between 1st and 2nd Vaccination was 33 days.  Company Comment:  This literature-non-study case concerns a 31-year-old female patient with no medical history reported, who experienced the expected serious (medically significant) event of Anaphylactic reaction, that occurred on an unknown date after receiving the first dose of mRNA-1273 vaccine. Additionally, Off label use (patient received 0.05 mL, 0.1mL, 0.15 mL and 0.2 mL intramuscularly every 15 minutes) was also noted for the second dose administration of mRNA-1273 vaccine. SARS-CoV-2 antibody test, SARS-CoV-2 AB (IgG), Spike Semi-quantitative were reactive after 183 days of second vaccination.  Patient presented with negative COVID-19 vaccine component skin testing to polyethylene glycol and polysorbate 20 and 80.  Interval between the first and second dose of mRNA-1273 vaccines was 33 days. Study results showed that graded dosing administration with COVID-19 mRNA vaccines is safe for people who experienced anaphylactic reaction to previous dose and provides reactive SARS-COV2 spike protein antibody response at least 6 months after completion of the initial COVID-19 vaccination series. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-577031, US-MODERNATX, INC.-MOD-2022-577035, US-MODERNATX, INC.-MOD-2022-577036 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2022: Significant Follow up received by safety on 26-May-2022 has Email with full text article received contains significant information: Author information, lab test, product details, event details updated.; Sender's Comments: This literature-non-study case concerns a 31-year-old female patient with no medical history reported, who experienced the expected serious (medically significant) event of Anaphylactic reaction, that occurred on an unknown date after receiving the first dose of mRNA-1273 vaccine. Additionally, Off label use (patient received 0.05 mL, 0.1mL, 0.15 mL and 0.2 mL intramuscularly every 15 minutes) was also noted for the second dose administration of mRNA-1273 vaccine. SARS-CoV-2 antibody test, SARS-CoV-2 AB (IgG), Spike Semi-quantitative were reactive after 183 days of second vaccination.  Patient presented with negative COVID-19 vaccine component skin testing to polyethylene glycol and polysorbate 20 and 80.  Interval between the first and second dose of mRNA-1273 vaccines was 33 days. Study results showed that graded dosing administration with COVID-19 mRNA vaccines is safe for people who experienced anaphylactic reaction to previous dose and provides reactive SARS-COV2 spike protein antibody response at least 6 months after completion of the initial COVID-19 vaccination series. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-577031:Same article, 57 yr old female patient from Table 1 US-MODERNATX, INC.-MOD-2022-577036:Same article, 59 yr old female patient from Table 1 US-MODERNATX, INC.-MOD-2022-577035:Same article, 51 yr old female patient from Table 1