Received Sep 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 7+ | 3042646 | — |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
emergency pericardio window to drain the fluid around her heart; Flinstone feet; starting not to feel well/ feeling woozy; starting not to feel well/ feeling woozy; The loud sound on her chest; Pneumonia/musculoskeletal chest pain; could not get off the floor or get into bed or anything; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDIAL EFFUSION (emergency pericardio window to drain the fluid around her heart) and PNEUMONIA (Pneumonia/musculoskeletal chest pain) in a 69-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch nos. 3042646, 3043391 and 3043391) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication. The patient's past medical history included Breast cancer (breast cancer survivor) in 2017 and Surgery (breast cancer survivor and undergone another surgery). Previously administered products included for Product used for unknown indication: Pfizer (Dose 1; Lot number: Pfizer ER2613) on 17-Mar-2021, Pfizer (Dose 2; Lot number: Pfizer EW0153) on 15-Apr-2021, Pfizer (Dose 3; Lot number: Pfizer FF2593) on 29-Oct-2021, Pfizer (Dose 4; Lot number: Pfizer FK9895/FF9895) on 30-Mar-2022, COVID-19 vaccine (Dose 5; Lot number: 6H9702) on 20-Sep-2022, Fluzone high dose (Shot 1) in 2023, RSV (Shot 2) in 2023, RSV (Shot 1) in 2023, Fluzone high dose (Shot 2) in 2023 and Spikevax 2023-2024 PFS (Dose 6; Lot number: Moderna 3030371/3030571) on 22-Sep-2023. Past adverse reactions to the above products included No adverse effect with COVID-19 vaccine, Fluzone high dose, Fluzone high dose, Pfizer, Pfizer, Pfizer, Pfizer, RSV, RSV and Spikevax 2023-2024 PFS. On 29-Aug-2024, the patient received seventh dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 01-Apr-2025, received eighth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2025, received ninth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) dosage was changed to 1 dosage form. On 04-Sep-2025, the patient received dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On 17-Mar-2025, the patient experienced PNEUMONIA (Pneumonia/musculoskeletal chest pain) (seriousness criterion medically significant) and BREATH SOUNDS ABNORMAL (The loud sound on her chest). In 2025, the patient experienced MOBILITY DECREASED (could not get off the floor or get into bed or anything). On 13-Aug-2025, the patient experienced PERICARDIAL EFFUSION (emergency pericardio window to drain the fluid around her heart) (seriousness criteria hospitalization and medically significant). On 17-Sep-2025, the patient experienced MALAISE (starting not to feel well/ feeling woozy) and DIZZINESS (starting not to feel well/ feeling woozy). On an unknown date, the patient experienced FOOT DEFORMITY (Flinstone feet). The patient was hospitalized from sometime in August 2025 to sometime in August 2025 due to PERICARDIAL EFFUSION. The patient was treated with Surgery (emergency pericardio window to drain the fluid around heart) for Pericardial effusion. At the time of the report, PERICARDIAL EFFUSION (emergency pericardio window to drain the fluid around her heart) had not resolved and PNEUMONIA (Pneumonia/musculoskeletal chest pain), MALAISE (starting not to feel well/ feeling woozy), FOOT DEFORMITY (Flinstone feet), BREATH SOUNDS ABNORMAL (The loud sound on her chest), MOBILITY DECREASED (could not get off the floor or get into bed or anything) and DIZZINESS (starting not to feel well/ feeling woozy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2025, Computerised tomogram: did not saw any break or any problem. In 2025, Imaging procedure: undergone numerous imaging procedures to determine if had a broken rib but the imaging resulted to no broken rib to be found. In 2025, Magnetic resonance imaging: did not saw any break or any problem. On an unknown date, Biopsy: During the biopsy, the doctors found out that the patient had pneumonia. Concomitant medication included antibiotic treatment. The patient went through an emergency pericardio window to drain the fluid around her heart and was in the ICU for 4 days. The fluid around her heart was building up again despite the draining. The procedure emergency pericardio window did not end the problem. The patient never had a problem with heart in her whole life. The patient was a breast cancer survivor and undergone another surgery, biopsy, a month later looking for lung cancer. The patient was currently on antibiotic treatment and had 2 more days left of the regimen, but her coughing had not stopped. On 17-Mar-2025, the patient heard a loud sound on her chest which felt like a broken rib and since then she was not feeling well. She had not been normal since the 17-Mar-2025. The loud sound on her chest was like she was going through chiropractic procedures but was a bit louder. The patient could not get off the floor or get into bed or anything for it seemed like 4 months really bad like she had to beg the doctor for a muscle relaxer just to sleep. As per the patient it might be the pneumonia that was causing a tremendous amount of pain. The patient had flintstone feet which shared to be a very big sign. The patient had to look every single day to see if ankles and feet look swollen because it could happen again. The patient's cardiologist was currently doing all kinds of massive testing like nuclear things. The patient experienced musculoskeletal chest pain (rib cage pain that goes back and forth on the right and left side), chest discomfort due to coughing dyspnea (difficult/labored breathing), dyspnea at rest, dyspnea exertional and lethargy. There was no history of COVID-19 infection nor any history of myocarditis/pericarditis. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2025: Live follow-up received contains non-significant information (reference number was added).; Reporter's Comments: Causality for Pneumonia was assessed as not related, due to lack of biological plausibility. Causality for Pericardial effusion and Breath sounds abnormal was assessed as not related, due to long latency. The benefit-risk relationship of product is not affected by this report.
Medical History/Concurrent Conditions: Breast cancer (breast cancer survivor); Surgery (breast cancer survivor and undergone another surgery)
Test Name: biopsy; Result Unstructured Data: During the biopsy, the doctors found out that the patient had pneumonia; Test Date: 2025; Test Name: CT scans; Result Unstructured Data: did not saw any break or any problem; Test Date: 2025; Test Name: Imaging procedures; Result Unstructured Data: undergone numerous imaging procedures to determine if had a broken rib but the imaging resulted to no broken rib to be found; Test Date: 2025; Test Name: MRI; Result Unstructured Data: did not saw any break or any problem