Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: pneumonia; ear canal infection; slight ringing in the ear that came and went; arm is red and swollen and itching like crazy; headache; shoulder pain, it was hurting and burning; Terrible chills; arm is red and swollen and itching like crazy; arm is red and swollen and itching like crazy; pretty bad side effects; piercing ear pain; could not sleep; ear shooting pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (pneumonia) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included VITAMINS NOS for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 21-Mar-2021, the patient experienced ADVERSE REACTION (pretty bad side effects), EAR PAIN (piercing ear pain), SLEEP DISORDER (could not sleep), EAR PAIN (ear shooting pain), VACCINATION SITE PRURITUS (arm is red and swollen and itching like crazy), HEADACHE (headache), ARTHRALGIA (shoulder pain, it was hurting and burning), CHILLS (Terrible chills), VACCINATION SITE ERYTHEMA (arm is red and swollen and itching like crazy) and VACCINATION SITE SWELLING (arm is red and swollen and itching like crazy). On 22-Mar-2021, the patient experienced EAR INFECTION (ear canal infection) and TINNITUS (slight ringing in the ear that came and went). On an unknown date, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and TRAMADOL at an unspecified dose and frequency. At the time of the report, PNEUMONIA (pneumonia), ADVERSE REACTION (pretty bad side effects), EAR PAIN (piercing ear pain), SLEEP DISORDER (could not sleep), EAR PAIN (ear shooting pain), EAR INFECTION (ear canal infection), VACCINATION SITE PRURITUS (arm is red and swollen and itching like crazy), HEADACHE (headache), ARTHRALGIA (shoulder pain, it was hurting and burning), CHILLS (Terrible chills), VACCINATION SITE ERYTHEMA (arm is red and swollen and itching like crazy) and VACCINATION SITE SWELLING (arm is red and swollen and itching like crazy) outcome was unknown and TINNITUS (slight ringing in the ear that came and went) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other treatments provided by the reporter: heating pad and ear drops. Patient had no side effects from first dose. Action taken with mRNA-1273 in response to the drug was not applicable. Concomitant drug included an unspecified high blood pressure medication.  Company Comment: This case concerns a 73 Y/O F with a serious unexpected event of pneumonia, and nonserious unexpected adverse reaction, ear infection, tinnitus, ear pain, sleep disorder, and expected headache, arthralgia, chills, vaccination site erythema, vaccination site swelling, and vaccination site pruritus. Event latency 1 day after 2nd dose. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 73 Y/O F with a serious unexpected event of pneumonia, and nonserious unexpected adverse reaction, ear infection, tinnitus, ear pain, sleep disorder, and expected headache, arthralgia, chills, vaccination site erythema, vaccination site swelling, and vaccination site pruritus. Event latency 1 day after 2nd dose. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.