Received Dec 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3051995 | IM |
runny nose; I had literally water coming out of my eyes/ I had water coming down my face and everything from my eyes; delayed hypersensitivity reaction; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose), LACRIMATION INCREASED (I had literally water coming out of my eyes/ I had water coming down my face and everything from my eyes) and TYPE IV HYPERSENSITIVITY REACTION (delayed hypersensitivity reaction) in a 75-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3051995) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 3051995) for COVID-19 prophylaxis. The patient's past medical history included Delayed type hypersensitivity (delayed hypersensitivity reaction to hamster). Previously administered products included for Delayed type hypersensitivity: epinephrine (The patient had 5 shots of epinephrine and 3 long-term and 2 short acting). Past adverse reactions to the above products included No adverse effect with epinephrine. On 12-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 14-Sep-2025, the patient experienced RHINORRHOEA (runny nose), LACRIMATION INCREASED (I had literally water coming out of my eyes/ I had water coming down my face and everything from my eyes) and TYPE IV HYPERSENSITIVITY REACTION (delayed hypersensitivity reaction). On 18-Sep-2025, RHINORRHOEA (runny nose), LACRIMATION INCREASED (I had literally water coming out of my eyes/ I had water coming down my face and everything from my eyes) and TYPE IV HYPERSENSITIVITY REACTION (delayed hypersensitivity reaction) had resolved. No concomitant medications provided by the reporter. It was reported that for the patient the symptom started on Sunday 14-Sep-2025 morning and the for the patient had no cold except allergy. It was reported that it was not going to be the first time the patient had a delayed hypersensitivity. Because the patient had a hamster, a pet hamster and it took 1.5 years to develop an allergy to hamster. The patient had to have 5 shots of epinephrine which included 3 long-term and 2 short acted. It was reported that 2 days after vaccination, the patient ended up with came down with really runny nose, and for the next 3 to 4 days the patient had literally water came out of her eye. The patient got the vaccination on Friday and after that the patient nose was running it was liked a water fountain from her nose and eye. It was kind of unbelievable because she had water coming down from her face and everything from her eye. No treatment medications provided by the reporter. This case was linked to MOD-2024-775531 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 25-Nov-2025: Live significant information was received in which reporter detail was updated, patient other relevant history was added, suspect product coding was updated, new event of Delayed type hypersensitivity was added, for event of Runny nose and Lacrimation increased in which event start -stop date was added and event outcome was updated, case narrative was updated. New reference numbers were added.; Reporter's Comments: Patients medical history of other hypersensitivity reaction is a risk factor for the events. The benefit-risk relationship of product is not affected by this report.
Medical History/Concurrent Conditions: Delayed type hypersensitivity (delayed hypersensitivity reaction to hamster)