Received Oct 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19-2 | COVID19 (COVID19 (MODERNA BIVALENT)) | MODERNA | UNK | — | — |
A little pounding of the heart/Heart pounding; Ear pressure/Pressure in ear; Post nasal drip a little bit/A little bit of post-nasal drip; Fever; Tiredness; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (A little pounding of the heart/Heart pounding), EAR DISCOMFORT (Ear pressure/Pressure in ear), UPPER-AIRWAY COUGH SYNDROME (Post nasal drip a little bit/A little bit of post-nasal drip), PYREXIA (Fever) and FATIGUE (Tiredness) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Dry eye, Seasonal allergy (sometimes seasonal allergy), 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 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (A little pounding of the heart/Heart pounding), EAR DISCOMFORT (Ear pressure/Pressure in ear), UPPER-AIRWAY COUGH SYNDROME (Post nasal drip a little bit/A little bit of post-nasal drip), PYREXIA (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/Heart pounding), EAR DISCOMFORT (Ear pressure/Pressure in ear), UPPER-AIRWAY COUGH SYNDROME (Post nasal drip a little bit/A little bit of post-nasal drip), PYREXIA (Fever), FATIGUE (Tiredness) and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown. The current age of the patient was reported as 79-year-old. 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 information was not reported. 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 is non-significant. Reporter's phone number was added, allergy was added, reference number was 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 seasonal allergy)
Restasis