Received Oct 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 4 | — | — |
heart pounding; pressure in her ears; a little bit of post-nasal drip; pain at the injection site; fever; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart pounding), EAR DISCOMFORT (pressure in her ears), UPPER-AIRWAY COUGH SYNDROME (a little bit of post-nasal drip), VACCINATION SITE PAIN (pain at the injection site) and PYREXIA (fever) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Dry eyes, Seasonal allergy (some allergies), Gastrooesophageal reflux disease (GERD which sometimes irritates the lungs a little bit), Irritable bowel syndrome and Asthma (asthma types but unspecified). Concomitant products included Ciclosporin (Restasis) for Dry eyes. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (heart pounding), EAR DISCOMFORT (pressure in her ears), UPPER-AIRWAY COUGH SYNDROME (a little bit of post-nasal drip), VACCINATION SITE PAIN (pain at the injection site), PYREXIA (fever) and FATIGUE (tiredness). At the time of the report, PALPITATIONS (heart pounding), EAR DISCOMFORT (pressure in her ears), UPPER-AIRWAY COUGH SYNDROME (a little bit of post-nasal drip), VACCINATION SITE PAIN (pain at the injection site), PYREXIA (fever) and FATIGUE (tiredness) outcome was unknown. Patient was healthy. Patient always received Moderna vaccines. She clarified that she never did two vaccines at one and said that she did not even do the flu vaccine because she always waited 2 weeks in between. The only side effects she 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. No treatment medication was provided. 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 which contains significant information, medical history, suspect product details were added.
Asthma (asthma types but unspecified); Dry eyes; Gastrooesophageal reflux disease (GERD which sometimes irritates the lungs a little bit); Irritable bowel syndrome; Seasonal allergy (some allergies)
Restasis