Received Jan 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 1 | — | — |
Possible Allergic Reaction/immediate hypersensitivity reaction; This literature-non-study case was reported in a literature article and describes the occurrence of TYPE I HYPERSENSITIVITY (Possible Allergic Reaction/immediate hypersensitivity reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. 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, the patient experienced TYPE I HYPERSENSITIVITY (Possible Allergic Reaction/immediate hypersensitivity reaction) (seriousness criterion medically significant). At the time of the report, TYPE I HYPERSENSITIVITY (Possible Allergic Reaction/immediate hypersensitivity reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered TYPE I HYPERSENSITIVITY (Possible Allergic Reaction/immediate hypersensitivity reaction) to be related. This case was identified during a retrospective clean-up activity initiated under [withheld] in response to a Health Inspection Observation. This case referred to patient 4 out of 8 patients who received Moderna vaccine (table 1). Concomitant medications and specific treatment medications were not reported This was a multicenter retrospective review of patients referred to the Allergy Clinics. The article described the evaluation and outcome of patients with suspected allergic reactions after mRNA COVID-19 vaccination from Jan-2021 to Nov-2021 and included patients with at least 1 symptom consistent with an immediate hypersensitivity reaction within 24 hours of the ?rst dose. The likelihood of anaphylaxis was based on the Brighton Collaboration Criteria used to determine the level of certainty of anaphylaxis. There were 391 patients referred for concern of an AEFI after either mRNA COVID-19 vaccine. A total of 65 patients met the inclusion criteria were included. Skin testing was performed to the Pfizer-BioNTech COVID-19 vaccine, polyethylene glycol, and polysorbate. Most of the patients included in the study were of female sex (78%), and the mean age was 42 (13-78) years. In addition, 58 (88%) of the patients received the P?zer-BioNTech COVID-19 vaccine and 8 received Moderna vaccine. Evaluation and determination of testing, vaccine challenge, or vaccine avoidance was based on the risk assessment of the evaluating allergist. In most of the cases, the vaccine and component testing were done with full-strength prick test followed by 1:100 dilution intradermal. Vaccine challenge was offered to most patients at full dose, except for 3 patients who received split dosing at the discretion of the treating allergist. Premedication was not routinely used. The primary symptoms reported were sensation of throat closure, pruritus, lightheadedness, flushing, urticaria, shortness of breath, nausea, angioedema, tachycardia, hoarse voice, or a combination. Nearly half of the cohort met the Brighton criteria for vaccine anaphylaxis. More patients in this group who received epinephrine as part of the treatment for their index reaction were advised against receiving the second dose and were skin tested. However, the vast majority of this cohort, at all levels of certainty of vaccine anaphylaxis, tolerated the vaccine challenge without recurrence of symptoms or had mild self-resolved symptoms. This study revealed that nearly 90% of patients with first-dose allergic symptoms tolerated the second dose with no recurrence of symptoms and all but one had symptoms that were mild and self-limited. Most of the reactions in this study were self-reported symptoms without objective findings of anaphylaxis. This case was linked to US-MODERNATX, INC.-MOD-2022-668304 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2022: Live follow up received by safety on 02-Nov-2022 has Email with Regulatory Authority received and contains significant information included Reporter information, literature information, event updated and seriousness added.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2022-668304:Master case (patient 1 out of 8)