Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Nightmare
Clinical narrative: I had a really bad reaction and was intubated and placed on a ventilator in the ICU/it impossible to live after an almost lethal reaction to the vaccine; I'm heavily affected by the trauma I went through and continue to go through; I have nightmares, flashbacks and bouts of insomnia; I have nightmares, flashbacks and bouts of insomnia; I have nightmares, flashbacks and bouts of insomnia; It's been rough for me to keep employment because of other illness; Missed so much work; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (I had a really bad reaction and was intubated and placed on a ventilator in the ICU/it impossible to live after an almost lethal reaction to the vaccine) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination. 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 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (I had a really bad reaction and was intubated and placed on a ventilator in the ICU/it impossible to live after an almost lethal reaction to the vaccine) (seriousness criteria hospitalization and life threatening), INJURY (I'm heavily affected by the trauma I went through and continue to go through), NIGHTMARE (I have nightmares, flashbacks and bouts of insomnia), FLASHBACK (I have nightmares, flashbacks and bouts of insomnia), INSOMNIA (I have nightmares, flashbacks and bouts of insomnia), ILLNESS (It's been rough for me to keep employment because of other illness) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Missed so much work). At the time of the report, IMMUNISATION REACTION (I had a really bad reaction and was intubated and placed on a ventilator in the ICU/it impossible to live after an almost lethal reaction to the vaccine), INJURY (I'm heavily affected by the trauma I went through and continue to go through), NIGHTMARE (I have nightmares, flashbacks and bouts of insomnia), FLASHBACK (I have nightmares, flashbacks and bouts of insomnia), INSOMNIA (I have nightmares, flashbacks and bouts of insomnia), ILLNESS (It's been rough for me to keep employment because of other illness) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Missed so much work) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No Concomitant medication was reported.  No treatment information was provided.   Patient stated that had a reaction to the Moderns COVID -19 vaccine and had a really bad reaction and was intubated and placed on a ventilator in the ICU and stated that heavily affected by the trauma went through and continue to go through. Patient had nightmares, flashbacks and bouts of insomnia. It's been rough for to keep employment because of other illness combined with everything that went on.  Company comment: This Spontaneous case concerns a female patient of unspecified age with no medical history reported, who experienced the unexpected life threatening serious (hospitalization)event of Immunisation reaction occurred on unspecified day after receiving a dose of mRNA-1273 vaccine (dose number not specified) in COVID-19 vaccination series. It was reported that patient had a reaction to the Moderna COVID -19 vaccine and had a really bad reaction and was intubated and placed on a ventilator in the ICU and stated that heavily affected by the trauma went through and continue to go through. Patient had nightmares, flashbacks and bouts of insomnia. It's been rough for to keep employment because of other illness combined with everything that went on. Further no information was provided regarding the symptoms, clinical course, other labs, and diagnostic procedures done and treatment details. The benefit-risk relationship of mRNA-1273 is not affected by this report. Seriousness assessment assessed as per medical judgement.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jul-2022: Non-Significant follow up received contained no new information On 04-Jul-2022: Live Non-significant follow up contained no new information; Sender's Comments: This Spontaneous case concerns a female patient of unspecified age with no medical history reported, who experienced the unexpected life threatening serious (hospitalization)event of Immunisation reaction occurred on unspecified day after receiving a dose of mRNA-1273 vaccine (dose number not specified) in COVID-19 vaccination series. It was reported that patient had a reaction to the Moderna COVID -19 vaccine and had a really bad reaction and was intubated and placed on a ventilator in the ICU and stated that heavily affected by the trauma went through and continue to go through. Patient had nightmares, flashbacks and bouts of insomnia. It's been rough for to keep employment because of other illness combined with everything that went on. Further no information was provided regarding the symptoms, clinical course, other labs, and diagnostic procedures done and treatment details. The benefit-risk relationship of mRNA-1273 is not affected by this report. Seriousness assessment assessed as per medical judgement.