Received Nov 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
The tooth pull created a puncture in the sinus; Tooth cavity; slightly sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SINUS PERFORATION (The tooth pull created a puncture in the sinus) in a 60-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. Concurrent medical conditions included Chronic disease (Got chronic, like some health conditions). In October 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In 2024, the patient experienced PAIN IN EXTREMITY (slightly sore arm). In 2025, the patient experienced SINUS PERFORATION (The tooth pull created a puncture in the sinus) (seriousness criterion medically significant) and DENTAL CARIES (Tooth cavity). The patient was treated with Cefuroxime sodium (Cefuroxime) in 2025 at an unspecified dose and frequency. At the time of the report, SINUS PERFORATION (The tooth pull created a puncture in the sinus), PAIN IN EXTREMITY (slightly sore arm) and DENTAL CARIES (Tooth cavity) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2025, Computerised tomogram: They took a CAT scan and said that because of the sinus puncture, there might be a mild infection, or at least there was air in the sinuses. The patient was not feverish and did not show signs of a sinus infection. Concomitant medication use information was not provided by reporter. The patient always received the Moderna Covid vaccine every year (usually around October). The patient always felt a slightly sore arm for about 24 hours after the Covid vaccine, including the most recent dose in October of 2024. No other symptoms were reported other than a slightly sore arm; the patient had been totally fine. It was also reported that the patient had a tooth pulled recently due to decay under a crown. The tooth pull created a puncture in the sinus, and as a result, the patient was started on an antibiotic. The patient experienced something called a sinus puncture when the tooth was pulled about a month and a half ago, so they had the patient on an antibiotic called Cefuroxime. The patient was not going to get sick because of it. The patient was able to get a flu shot two weeks ago, and that was no problem whatsoever. The patient had a cavity. They put a crown over it. Decay got under the crown. They removed the crown. They said the tooth could not be saved, so it had to be pulled. So, it was not like the patient was in pain. It was unknown if the patient experienced any additional symptoms/events.; Reporter's Comments: Company comment: Events sinus perforation and dental caries were assessed as not related due to lack of biological plausibility. The benefit-risk relationship of the product is not affected by this report.
Chronic disease (Got chronic, like some health conditions)
Test Date: 2025; Test Name: CAT scan; Result Unstructured Data: They took a CAT scan and said that because of the sinus puncture, there might be a mild infection, or at least there was air in the sinuses. The patient was not feverish and did not show signs of a sinus infection