Received Oct 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
A little pounding of the heart; Pressure in her ears; A little bit of post-nasal drip; Like a little fever; Tiredness; Pain at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of PALPITATIONS (A little pounding of the heart), EAR DISCOMFORT (Pressure in her ears), UPPER-AIRWAY COUGH SYNDROME (A little bit of post-nasal drip), PYREXIA (Like a little fever) and FATIGUE (Tiredness) in a 77-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Dry eye, Seasonal allergy (Sometimes), GERD (GERD which sometimes irritates the lungs a little bit), Irritable bowel syndrome, Asthma (asthma types but unspecified) and Allergy (Some allergies). Concomitant products included Ciclosporin (Restasis) for Dry eyes. In September 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (A little pounding of the heart), EAR DISCOMFORT (Pressure in her ears), UPPER-AIRWAY COUGH SYNDROME (A little bit of post-nasal drip), PYREXIA (Like a little fever), FATIGUE (Tiredness) and VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, PALPITATIONS (A little pounding of the heart), EAR DISCOMFORT (Pressure in her ears), UPPER-AIRWAY COUGH SYNDROME (A little bit of post-nasal drip), PYREXIA (Like a little fever), FATIGUE (Tiredness) and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. The current age of the patient was reported as 79 years. The patient was pretty healthy. The patient always received Moderna vaccines. She clarified that she never received two vaccines at once and said that she did not even get the flu vaccine because she always waited 2 weeks in between. The only side effects patient had experienced were fever, tiredness, heart pounding, pressure in her ears and a little bit of post-nasal drip, and pain at the injection site. It was unknown if the patient experienced any additional symptoms/events. Treatment medication use information was not provided by reporter. This case was linked to MOD-2025-786055 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2025: Live follow up received that contains non-significant information includes reporter's phone number, allergy and reference numbers were added.
Allergy (Some allergies); Asthma (asthma types but unspecified); Dry eye; GERD (GERD which sometimes irritates the lungs a little bit); Irritable bowel syndrome; Seasonal allergy (Sometimes)
Restasis