Received Jul 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | 3046714 | IM |
was a slight rise in temperature last night, it was 101.5F; little bit of headache; significant chest pain tightening and burning; significant chest pain tightening and burning; achy; lethargy; AFib; type 2 diabetes; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (AFib) and TYPE 2 DIABETES MELLITUS (type 2 diabetes) in a 75-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046714) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Jun-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In June 2025, the patient experienced ATRIAL FIBRILLATION (AFib) (seriousness criterion medically significant), TYPE 2 DIABETES MELLITUS (type 2 diabetes) (seriousness criterion medically significant) and LETHARGY (lethargy). On 21-Jun-2025, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced CHEST DISCOMFORT (significant chest pain tightening and burning), CHEST PAIN (significant chest pain tightening and burning), PAIN (achy) and HEADACHE (little bit of headache). On 24-Jun-2025, the patient experienced PYREXIA (was a slight rise in temperature last night, it was 101.5F). The patient was treated with Tirzepatide (Mounjaro) in June 2025 for Type 2 diabetes mellitus, at an unspecified dose and frequency; Apixaban (Eliquis) in June 2025 for AFib, at a dose of 5 milligram twice a day; Ibuprofen (Advil) in June 2025 at a dose of UNK, qid and Famotidine (Pepcid) in June 2025 at a dose of UNK, bid. At the time of the report, ATRIAL FIBRILLATION (AFib), TYPE 2 DIABETES MELLITUS (type 2 diabetes), CHEST DISCOMFORT (significant chest pain tightening and burning), CHEST PAIN (significant chest pain tightening and burning), PAIN (achy), LETHARGY (lethargy), PYREXIA (was a slight rise in temperature last night, it was 101.5F) and HEADACHE (little bit of headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jun-2025, Electrocardiogram: proved that there had been no change to a prior EKG that took place just 45 days ago. On 24-Jun-2025, Body temperature: there was a slight rise in temperature last night, it was 101.5 F.. No concomitant medications provided by the reporter. Patient was received Moderna Covid-19 vaccine since outbreak of Covid and post vaccination patient used to shake it off in 1 or 2 days. This was probably his 7th or 8th booster on 20-Jun-2025. It was reported that patient symptoms were now on day five. Post booster dose of vaccination he experienced a significant chest pain tightening and burning. Cardiologist thought that he might have experienced myocarditis. He received treatment medication of a couple of Advil 4 times a day and to add on top of that some Pepcid 2 times a day. The symptoms started on Saturday, 21-Jun-2025. Patient had the normal reaction, a little bit of headache, achy. He took a couple Advil. Saturday afternoon it started coming in, and it was pretty intense. He went to see the cardiologist. The cardiologist took an EKG on Monday at 2 o'clock. The symptoms had not resolved. The intensity of the pain/the heat around his heart has subsided significantly, like by 80%, but in the evening, there was a slight rise in temperature last night, it was 101.5F. He took a couple Advil and sweat it out, etc. But the symptom of aches and lethargy were continued for patient. It was also reported that, following vaccination with Moderna covid-19, the patient was prescribed Eliquis 5 mg twice daily for AFib and Mounjaro for type 2 diabetes. This case was linked to MOD-2025-787797 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2025: Live non-significant follow-up information received in which new reference number was added. On 25-Jun-2025: Live significant follow-up received in which suspect product lot/batch number was added, new treatment medication Mounjaro and Eliquis was added, new event of Atrial fibrillation and Type 2 diabetes mellitus was added. Case narrative was updated, and new reference number was added.; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.
Test Date: 20250624; Test Name: slight rise in temperature; Result Unstructured Data: there was a slight rise in temperature last night, it was 101.5 F.; Test Date: 20250623; Test Name: EKG; Result Unstructured Data: proved that there had been no change to a prior EKG that took place just 45 days ago