Received Jun 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 1 | — | — |
Couldn't feel her legs when attempting to walk; Swelling in her left neck; Neck pain; Pain in her upper back; Chest pain; Fatigue/Didn't feel well and went to bed; Received the 1st shot 3 weeks before; Respiratory failure; Mild Side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of CHEST PAIN (Chest pain), FATIGUE (Fatigue/Didn't feel well and went to bed) and RESPIRATORY FAILURE (Respiratory failure) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033c21a) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes mellitus and Blood pressure high. Concomitant products included Metformin for an unknown indication. On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. In May 2021, the patient experienced RESPIRATORY FAILURE (Respiratory failure) (seriousness criteria death and medically significant) and IMMUNISATION REACTION (Mild Side effects). On 26-May-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 1st shot 3 weeks before). On 27-May-2021, the patient experienced FATIGUE (Fatigue/Didn't feel well and went to bed) (seriousness criterion death). On 28-May-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion death). 28-May-2021, the patient experienced SENSORY LOSS (Couldn't feel her legs when attempting to walk), SWELLING (Swelling in her left neck), NECK PAIN (Neck pain) and BACK PAIN (Pain in her upper back). The patient died on 29-May-2021. The reported cause of death was Chest pain, Fatigue and Respiratory failure. It is unknown if an autopsy was performed. At the time of death, SENSORY LOSS (Couldn't feel her legs when attempting to walk), SWELLING (Swelling in her left neck), NECK PAIN (Neck pain), BACK PAIN (Pain in her upper back), IMMUNISATION REACTION (Mild Side effects) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 1st shot 3 weeks before) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-May-2021, Heart rate: no pulse. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient experienced mild side effects after the first shot. The patient's husband called her 1 hour before she passed on 29-May-2021. She was bedridden on 26-May-2021 and also on Thursday, 27-May-2021. By 28-May-2021, she was complaining of chest pain, left neck pain and swelling in her left neck and pain in her upper back. On 29-May-2021, patient's husband found her not responding, her eyes were not moving, and she had passed away. They called the medics and by the time they arrived, she had no pulse. The reporter stated that she was in fair health, but later when asked if she wasn't taking any medications, the reporter reported that he didn't know, but she was diabetic and had high blood pressure. He stated they had called her physician but had not received a call back. He did not know which arm the patient received the injection but knew that it was in the muscle of her upper arm. The patient was taking medication for diabetes. She had a severe reaction to the vaccine. The reporter was assuming that she died of a blood clot. On her death certificate, it stated that she died of natural causes, which the reporter felt to be untrue. It had been 4 years now since the patient died. No treatment medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2025-787078, US-MODERNATX, INC.-MOD-2021-237262 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2025: Upon receipt of follow-up information on 10-Jun-2025; it was determined during case processing that the case MOD-2021-229276 (US-MODERNATX, INC.-MOD-2021-229276) is a duplicate of the already existing case MOD-2021-226627 (US-MODERNATX, INC.-MOD-2021-226627). Therefore, all information from case MOD-2021-229276 (US-MODERNATX, INC.-MOD-2021-229276) was added and merged with the retained case MOD-2021-226627 (US-MODERNATX, INC.-MOD-2021-226627). Hence, the duplicate case MOD-2021-229276 (US-MODERNATX, INC.-MOD-2021-229276) will be nullified and deleted from the safety database. Significant follow-up received in which suspect product first dose administration date was added, new events added, event outcome for the event of Inappropriate schedule of vaccine administered was updated, case narrative was updated and from subordinate duplicate case new reference number was added. On 11-Jun-2025: Live follow up received contains no new information.; Reporter's Comments: Company comment: The medical history of Diabetes mellitus and Blood pressure high remains as confounders. The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787078:Case for multiple Patient (unknown) US-MODERNATX, INC.-MOD-2021-237262:Case for male patient (T-P); Reported Cause(s) of Death: Chest pain; Fatigue; Respiratory failure
Blood pressure high; Diabetes mellitus
Metformin
Test Date: 20210529; Test Name: Pulse; Result Unstructured Data: no pulse