Received Mar 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
it's now called long COVID/he was going crazy at the time, and then it came out long-covid/fatigue/muscle and joint pain, cough/definitely brain fog/sleep disturbance; he feels delirious sometimes, like he can't get words out.; He's got blood in his stool also; He's got a cough, and when he coughs blood comes up; He's got skin rashes/rashes in his face; his brother also got covid; This spontaneous case was reported by a patient family member or friend and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (it's now called long COVID/he was going crazy at the time, and then it came out long-covid/fatigue/muscle and joint pain, cough/definitely brain fog/sleep disturbance), DELIRIUM (he feels delirious sometimes, like he can't get words out.) and HAEMATOCHEZIA (He's got blood in his stool also) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced POST-ACUTE COVID-19 SYNDROME (it's now called long COVID/he was going crazy at the time, and then it came out long-covid/fatigue/muscle and joint pain, cough/definitely brain fog/sleep disturbance) (seriousness criterion hospitalization), DELIRIUM (he feels delirious sometimes, like he can't get words out.) (seriousness criterion medically significant), HAEMATOCHEZIA (He's got blood in his stool also) (seriousness criterion medically significant), HAEMOPTYSIS (He's got a cough, and when he coughs blood comes up), RASH (He's got skin rashes/rashes in his face) and COVID-19 (his brother also got covid). At the time of the report, POST-ACUTE COVID-19 SYNDROME (it's now called long COVID/he was going crazy at the time, and then it came out long-covid/fatigue/muscle and joint pain, cough/definitely brain fog/sleep disturbance), DELIRIUM (he feels delirious sometimes, like he can't get words out.), HAEMATOCHEZIA (He's got blood in his stool also), HAEMOPTYSIS (He's got a cough, and when he coughs blood comes up) and RASH (He's got skin rashes/rashes in his face) had not resolved and COVID-19 (his brother also got covid) outcome was unknown. No concomitant medications were reported. It was reported that the reporter does not know and not sure if his brother received Moderna or Pfizer or another brand of COVID-19 vaccine. Reporter also confirmed that his brother experienced an adverse reaction after receiving a covid-19 vaccine. It has been 4 years now. Reporter does not know the lot number of the vaccine and when he got the vaccine. Reporter does not remember all the side effects his brother experienced and stated he will look at post-covid vaccine symptoms to jog his memory. Reporter knows one of them is definitely brain fog and reporter does not know when this brain fog started, but this had been going on for almost 4 years now. In the four years brother also experienced sleep disturbance and he always tell that he can't sleep, it's keeping brother up, he was taking loads of pills and everything, he's went to loads of doctors and psychiatrists and he's been in the hyperbaric chamber, and he's been in hospitals. He said he felt delirious sometimes, like he can't get words out. He used to speak fluently, and he was able to run 6 miles a day, but he can't do any of that. He lost his job because of his symptoms, it was reported that he can't work anymore, and he has not been working for like 4 years now. He definitely had fatigue, muscle and joint pain, and loss of stamina. He's got skin rashes. If he eats certain foods like 90% of the foods out on the market, he gets rashes in his face. He's got a cough and when he coughs blood comes up and he's got blood in his stool also. And reporter guessed it's now called long covid. Reporter confirmed his brother also got covid. He had the vaccine, and he got the covid. Reporter believed his brother's symptoms started after the vaccine. No treatment medications were reported. Company comment: The company causality for the events of COVID-19 and Post-acute COVID-19 syndrome is not applicable. Regarding the event of Rash, as it was stated that the patient got rash on his face after eating certain foods, the causality is assessed as not related to the suspect product, as temporal relationship is more suggestive to food intake. Regarding the remaining events, as start date was not provided, the causality is assessed as related. The benefit-risk relationship of the product is not affected by this report.