Received Sep 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | — | — |
squamous cell cancer; basal cell cancers; some abnormalities in eyes; About 3 or 4 months ago had a melanoma surgery due to a discovery of a mole at the tip of nose/ melanoma in situ, that was called stage 0; This spontaneous case was reported by a physician and describes the occurrence of MALIGNANT MELANOMA STAGE 0 (About 3 or 4 months ago had a melanoma surgery due to a discovery of a mole at the tip of nose/ melanoma in situ, that was called stage 0), SQUAMOUS CELL CARCINOMA (squamous cell cancer) and BASAL CELL CARCINOMA (basal cell cancers) in an 85-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product COVID-19 vaccine mRNA for an unknown indication. The patient's past medical history included Atrial fibrillation (it was up to 41% of the time. Did not had a fibrillation now for about a year and a half), Nosebleed (ENT consultation for a nosebleed and was going to go on anticoagulants (Eliquis)), Cardiac pacemaker insertion, Cardiac ablation and Cardiac operation NOS (3 cardiac procedures). Previously administered products included for Product used for unknown indication: Shingrix on 02-Feb-2022 and Pfizer COVID-19 vaccine (late of 2023) in 2023. Past adverse reactions to the above products included No adverse effect with Pfizer COVID-19 vaccine and Shingrix. Family history included Rheumatic heart disease (Mother-in-law) since an unknown date, Atrial fibrillation (Mother-in-law) since an unknown date, Clot blood (formed a clot/ went to her brain and killed mother-in-law) since an unknown date and Malignant melanoma stage III (daughter; was on the buttock/ serious melanoma, a stage 3). Concurrent medical conditions included Hypertension, Supraventricular tachycardia, Sick sinus syndrome (was going to do a cardiac ablation, but then he developed a very slow heart rate, 28 per minute due to what was called sick sinus syndrome), Pre-diabetes and Telangiectasia (took care of that, so he was able to go on the anticoagulant). Concomitant products included Apixaban (Eliquis) for an unknown indication. On 24-Jun-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 27-Sep-2024, the patient received dose of COVID-19 vaccine mRNA (unknown route) 1 dosage form. In 2025, the patient experienced MALIGNANT MELANOMA STAGE 0 (About 3 or 4 months ago had a melanoma surgery due to a discovery of a mole at the tip of nose/ melanoma in situ, that was called stage 0) (seriousness criterion medically significant). On an unknown date, the patient experienced SQUAMOUS CELL CARCINOMA (squamous cell cancer) (seriousness criterion medically significant), BASAL CELL CARCINOMA (basal cell cancers) (seriousness criterion medically significant) and EYE DISORDER (some abnormalities in eyes). The patient was treated with Surgery (Melanoma surgery) for Malignant melanoma stage 0; Surgery (Melanoma surgery for squamous cell cancer) for Squamous cell carcinoma and Surgery (Melanoma surgery for basal cell cancers) for Basal cell carcinoma. At the time of the report, MALIGNANT MELANOMA STAGE 0 (About 3 or 4 months ago had a melanoma surgery due to a discovery of a mole at the tip of nose/ melanoma in situ, that was called stage 0), SQUAMOUS CELL CARCINOMA (squamous cell cancer), BASAL CELL CARCINOMA (basal cell cancers) and EYE DISORDER (some abnormalities in eyes) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 255 heart beats per minute and 28 heart beats per minute. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter considered EYE DISORDER (some abnormalities in eyes) to be not related. No further causality assessments were provided for MALIGNANT MELANOMA STAGE 0 (About 3 or 4 months ago had a melanoma surgery due to a discovery of a mole at the tip of nose/ melanoma in situ, that was called stage 0), SQUAMOUS CELL CARCINOMA (squamous cell cancer) and BASAL CELL CARCINOMA (basal cell cancers). The patient had 3 vaccinations with Shingles vaccines- Shingrix on 02-Feb-2022 and 2 other shingles shots, which were also given 7 to 8 years ago but were not as effective as Shingrix vaccine. Patient had undergone melanoma surgery for basal cell cancers and a squamous cell cancer which was performed since the patient has had his last dose. The patient had some abnormalities in his eyes and would be seeing the ENT physician in about 2 weeks for an annual checkup. The reporter stated that when the patient was getting to be 85 years old, patient would just start falling apart. About 3 or 4 months ago, patient had undergone a melanoma surgery due to the discovery of a mole at the tip of nose which patient found an unusual place to have melanoma as well as an obvious site, so it was discovered early. The reporter mentioned it as melanoma in situ, stage 0. That meant it was almost pre-cancerous. The patient wanted to find mNEXSPIKE in the country. The patient had received a total of 6 COVID-19 shots. The patient had not received any COVID-19 shots in the past 6 months but probably a year since his last COVID-19 vaccine. He had the COVID-19 vaccines when they had first started to make it available which was 3-4 months since the first release making sure that people were not having horrendous reactions. The patient thought that it was back in 2021. He had the first series with Pfizer, and the third shot was Moderna and then every other one as one Moderna dose and one Pfizer dose afterwards. The patient did not experience any additional symptoms/events. No treatment drug was reported.; Reporter's Comments: Co-suspect non-company product COVID-19 vaccine is a confounder for the events. Due to lack of biological plausibility, the causality of the events malignant melanoma stage 0, squamous cell carcinoma and basal cell carcinoma were assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report.
Atrial fibrillation (Mother-in-law); Clot blood (formed a clot/ went to her brain and killed mother-in-law); Hypertension; Pre-diabetes; Rheumatic heart disease (Mother-in-law); Sick sinus syndrome (was going to do a cardiac ablation, but then he developed a very slow heart rate, 28 per minute due to what was called sick sinus syndrome); Supraventricular tachycardia; Telangiectasia (took care of that, so he was able to go on the anticoagulant)
Medical History/Concurrent Conditions: Atrial fibrillation (it was up to 41% of the time. Did not had a fibrillation now for about a year and a half); Cardiac ablation; Cardiac operation NOS (3 cardiac procedures); Cardiac pacemaker insertion; Malignant melanoma stage III (daughter; was on the buttock/ serious melanoma, a stage 3); Nosebleed (ENT consultation for a nosebleed and was going to go on anticoagulants (Eliquis))
Eliquis
Test Name: heart rate; Test Name: heart rate