Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, Tryptase, Type I hypersensitivity
Clinical narrative: Immediate hypersensitivity reaction; Revaccination with different COVID-19 vaccine; Interchange of vaccine products; This literature-non-study case was reported in a literature article and describes the occurrence of TYPE I HYPERSENSITIVITY (Immediate hypersensitivity reaction) in a 29-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE:     Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced TYPE I HYPERSENSITIVITY (Immediate hypersensitivity reaction) (seriousness criterion medically significant), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). The patient was treated with EPINEPHRINE at an unspecified dose and frequency. At the time of the report, TYPE I HYPERSENSITIVITY (Immediate hypersensitivity reaction), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Tryptase: 13.7 microgram per litre.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered TYPE I HYPERSENSITIVITY (Immediate hypersensitivity reaction), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) to be related.    Concomitant medications were not reported.  Patient did not have history of anaphylaxis, allergy to vaccine, allergic comorbidities and COVID-19 infection.  Patient experienced swelling in lip and face, dizziness, and pre-syncopal episode within 5 minutes after first dose and vaccine excipient T-test was not done. She experienced an immediate hypersensitivity reaction (within 4 hours) to a first dose of any mRNA COVID-19 vaccine.  Patient received the second dose of vaccine in incremental doses at 30-minute intervals to a cumulative dose of 0.3 ml, patient was pre-medicated with a second-generation H1 antihistamine on the day of vaccination, and patient was observed for 1 hour after the final vaccine dose.  Patient received unspecified steroids and antihistamine for management of reaction to the first dose in emergency department.  COVID-19 spike antibody levels were measured at least 2 weeks after the procedure.  Cumulative time for second dose was reported as 3.5 hours, It was reported that 0.03, 0.04, 0.05, 0.06, 0.06, 0.06 mL of sequential dose of vaccine was administered to complete a cumulative dose of 0.3 mL, reactions during graded dosing were none.   This case was linked to US-MODERNATX, INC.-MOD-2022-655520, US-MODERNATX, INC.-MOD-2022-655521, US-MODERNATX, INC.-MOD-2022-655522 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2022: Live Follow up received by safety on 06-Oct-2022 has email with full text article received and contains significant information. Reporter information, literature information, laboratory data, product, treatment and event details were updated.  Company Comment: This is a literature case concerning a 29-year-old female patient, with no relevant medical history, who experienced the serious (due to medically significant) unexpected event of type i hypersensitivity, within 5 minutes of the first dose of the mRNA-1273 vaccine. She experienced lip and fase swelling, dizziness, and presyncopal episode and received epinephrine, steroids and antihistamine as treatment. On an unknown date a laboratory with Tryptase of 13.7 microgram per-litre was performed. She received the Pfizer mRNA COVID-19 vaccine as the second dose of the vaccine Schedule (Interchange of vaccine products & Revaccination with different COVID-19 vaccine). No further information was provided for medical reviewing. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a literature case concerning a 29-year-old female patient, with no relevant medical history, who experienced the serious (due to medically significant) unexpected event of type i hypersensitivity, within 5 minutes of the first dose of the mRNA-1273 vaccine. She experienced lip and fase swelling, dizziness, and presyncopal episode and received epinephrine, steroids and antihistamine as treatment. On an unknown date a laboratory with Tryptase of 13.7 microgram per-litre was performed. She received the Pfizer mRNA COVID-19 vaccine as the second dose of the vaccine Schedule (Interchange of vaccine products & Revaccination with different COVID-19 vaccine). No further information was provided for medical reviewing. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-655521:33 yr old female US-MODERNATX, INC.-MOD-2022-655522:35 yr old female US-MODERNATX, INC.-MOD-2022-655520:24 yr old female