Received May 13, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3053481 | IM / RA |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 948403 | IM / LA |
recurrent otitis externa of both ears; Counting the 60 day BUD from those dates, she stated, "either way it was past the 60 days"; This spontaneous case was reported by a medical assistant and describes the occurrence of OTITIS EXTERNA (recurrent otitis externa of both ears) and EXPIRED PRODUCT ADMINISTERED (Counting the 60 day BUD from those dates, she stated, "either way it was past the 60 days") in a 7-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3053481) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection (batch no. 3053481) for COVID-19 prophylaxis and non-company product included Influenza vaccine (Flu) for an unknown indication. Concurrent medical conditions included Attention impaired (Inattention) since 23-Jan-2025 and Familial short stature since 23-Jan-2025. On 09-Mar-2026, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .25 milliliter and dose of Influenza vaccine (Flu) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 09-Mar-2026, the patient experienced OTITIS EXTERNA (recurrent otitis externa of both ears) and EXPIRED PRODUCT ADMINISTERED (Counting the 60 day BUD from those dates, she stated, "either way it was past the 60 days"). At the time of the report, OTITIS EXTERNA (recurrent otitis externa of both ears) had not resolved and EXPIRED PRODUCT ADMINISTERED (Counting the 60 day BUD from those dates, she stated, "either way it was past the 60 days") outcome was unknown. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. Concomitant medication was not reported. On 10-Dec-2025, the reporter received the shipment and the first dose from that shipment was given on 18-Dec-2025. The reporter was not sure if they were initially placed in the freezer or fridge, but the reporter was counting the 60-day BUD from those dates, either way it was past the 60 days. The mother was aware of the situation. She did not want to revaccinate and would get a call when the new shipment was received. Patient had no known drug allergies. The event did not cause the patient to seek medical care. There were no other factors that could have led to adverse event. It was unknown that patient experience a similar event in past. It was unknown if the patient experienced any additional symptoms/events. No treatment medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2026-795543 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 08-May-2026: Follow-up received contains significant information: Event 'recurrent otitis externa of both ears' was added, coding for short stature updated to Familial short stature, Flu vaccine updated to co-suspect, reporter information (Fax number) added, patient information updated, route of administration added, narrative updated.; Sender's Comments: US-MODERNATX, INC.-MOD-2026-795543: Master case (Patient 1 of 4).
Attention impaired (Inattention); Familial short stature