Received Dec 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | — |
Got a COVID [coronavirus disease] shot and had a reaction to it; Wanting to die; Passed out, fainted/Fell; Cramping in legs and hands; Swelling in legs; He had to fight a black out; Oxygen dropped; Hard to breathe; can only take 10 steps and he has to sit down because he is extremely winded; difficulty talking; Tightness in chest; Cough is painful but when mucous moves it feels good to breathe/cough is painful; Short of breath; Missed 2 days of Tyvaso; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Got a COVID [coronavirus disease] shot and had a reaction to it), SUICIDAL IDEATION (Wanting to die) and LOSS OF CONSCIOUSNESS (Passed out, fainted/Fell) in a 68-year-old male patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. Suspect product included Pre-filled Syringe injection for COVID-19 immunisation and non-company product included Treprostinil sodium (Tyvaso) for Pulmonary arterial hypertension. The patient's past medical history included Hospice care (Receiving palliative services under hospice, but at home) since November 2025. Concurrent medical conditions included Pulmonary arterial hypertension, Pulmonary hypertension, Lung disease and Hypoxia. Concomitant products included Ibuprofen (Advil), Vitamins nos (Multivitamin), Esomeprazole magnesium (Nexium), Loperamide hydrochloride (Imodium), Salbutamol sulfate (Albuterol sulfate), Allopurinol, Acetylsalicylic acid (Aspirin), Curcuma longa (Turmeric), Nintedanib esilate (Ofev), Oxygen, Metformin hydrochloride (Metformin HCL), Fluticasone propionate, Salmeterol xinafoate (Wixela inhub), Prednisone, Morphine sulfate, Doxycycline hyclate and Benzonatate for an unknown indication. In 2025, the patient started Treprostinil sodium (Tyvaso) (Inhalation use) 48 microgram four times per day. In 2025, Treprostinil sodium (Tyvaso) (Inhalation use) dosage was changed to 54 microgram four times per day and Treprostinil sodium (Tyvaso) (Inhalation use) dosage was changed to 66 microgram four times per day. On 08-Oct-2025, Treprostinil sodium (Tyvaso) (Inhalation use) dosage was changed to 66 microgram four times per day. In November 2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In 2025, the patient experienced SUICIDAL IDEATION (Wanting to die) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (Passed out, fainted/Fell) (seriousness criterion medically significant), MUSCLE SPASMS (Cramping in legs and hands), PERIPHERAL SWELLING (Swelling in legs), PRESYNCOPE (He had to fight a black out), OXYGEN SATURATION DECREASED (Oxygen dropped), DYSPNOEA EXERTIONAL (Hard to breathe; can only take 10 steps and he has to sit down because he is extremely winded; difficulty talking), CHEST DISCOMFORT (Tightness in chest), PRODUCTIVE COUGH (Cough is painful but when mucous moves it feels good to breathe/cough is painful), DYSPNOEA (Short of breath) and PRODUCT DOSE OMISSION ISSUE (Missed 2 days of Tyvaso). In November 2025, the patient experienced IMMUNISATION REACTION (Got a COVID [coronavirus disease] shot and had a reaction to it) (seriousness criterion medically significant). In 2025, SUICIDAL IDEATION (Wanting to die) had resolved. On 16-Nov-2025, LOSS OF CONSCIOUSNESS (Passed out, fainted/Fell) had resolved. On 19-Nov-2025, PRESYNCOPE (He had to fight a black out) had resolved. At the time of the report, IMMUNISATION REACTION (Got a COVID [coronavirus disease] shot and had a reaction to it), MUSCLE SPASMS (Cramping in legs and hands), PERIPHERAL SWELLING (Swelling in legs), OXYGEN SATURATION DECREASED (Oxygen dropped), DYSPNOEA EXERTIONAL (Hard to breathe; can only take 10 steps and he has to sit down because he is extremely winded; difficulty talking), CHEST DISCOMFORT (Tightness in chest), PRODUCTIVE COUGH (Cough is painful but when mucous moves it feels good to breathe/cough is painful), DYSPNOEA (Short of breath) and PRODUCT DOSE OMISSION ISSUE (Missed 2 days of Tyvaso) outcome was unknown. Not Provided The action taken with mRNA-1283 (MNEXSPIKE PFS) (Unknown) was unknown. On the first day of Tyvaso therapy, the patient felt great and said he had more energy and could get up and go to the bathroom. But later, on an unspecified date, he began having chest tightness and painful coughing. Interestingly, when the mucus moved, he felt better and could breathe more easily. About a week before reporting, he also got his COVID shot. Then things got worse. On 13 November 2025, about a month after Tyvaso started, he began passing out. He fainted twice that day. His oxygen tanks also needed to be changed. After that, he fainted again once on 14 November 2025, three times on 15 November 2025, and twice on 16 November 2025. On the 16 November 2025, when he passed out, he fell. So now, whenever he coughs, he lies down so he doesn't fall if he faints. Two weeks before reporting, patient could walk about 20 steps before needing to sit down. But by 19 November 2025, he could only manage 10 steps before he had to sit because he was extremely winded, had trouble breathing, and even talking was hard. Later that same day, he started coughing and almost blacked out. His oxygen levels dropped, and needed more oxygen. On November 2025, patient had a reaction to the COVID shot. His doctor prescribed antibiotics and increased his metformin and steroid doses. After that, he experienced leg and hand cramps, swelling, and expressed wanting to die. He missed two days of Tyvaso, then restarted at a higher dose. He was being evaluated for a lung transplant and received palliative care support. Later, he said he wanted to get better. The reporter did not provide causality for the events of loss of consciousness, cough, presyncope, oxygen saturation decreased, dyspnoea exertional, chest discomfort, productive cough, and fall with Tyvaso. The reporter did not provide causality for the events of immunisation reaction, muscle spasms, peripheral swelling, and dyspnoea with Tyvaso.; Reporter's Comments: Causality for Loss of consciousness, Presyncope, Oxygen saturation decreased, Dyspnoea exertional, Chest discomfort, Productive Cough and Dyspnoea was assessed as not related, but more plausible explained by underlying pulmonary hypertension and lung disease. The benefit-risk relationship of product is not affected by this report.
Hospice care (Receiving palliative services under hospice, but at home); Hypoxia; Lung disease; Pulmonary arterial hypertension; Pulmonary hypertension
Advil; Multivitamin; Nexium; Imodium; Albuterol sulfate; Allopurinol; Aspirin; Turmeric; Ofev; Oxygen; Metformin HCL; Wixela inhub; Prednisone; Morphine sulfate; Doxycycline hyclate; Benzonatate; Tyvaso