Sex: F
Vaccine: COVID19
Symptoms: Nausea, Rash pruritic
Clinical narrative: nausea/ within an hour I was so nauseous; violent rash that is covering me from head to toe and burning and itching like a raging fire/rashes all over her body; This spontaneous case was reported by a patient and describes the occurrence of NAUSEA (nausea/ within an hour I was so nauseous) and RASH PRURITIC (violent rash that is covering me from head to toe and burning and itching like a raging fire/rashes all over her body) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (She had always gotten the Moderna shots). Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 vaccine.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (nausea/ within an hour I was so nauseous) (seriousness criterion medically significant). an unknown date, the patient experienced RASH PRURITIC (violent rash that is covering me from head to toe and burning and itching like a raging fire/rashes all over her body) (seriousness criterion medically significant). At the time of the report, NAUSEA (nausea/ within an hour I was so nauseous) and RASH PRURITIC (violent rash that is covering me from head to toe and burning and itching like a raging fire/rashes all over her body) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient reported that after receiving the Moderna COVID shot, within an hour she was so nauseous, could not eat or get out of bed for two days. Finally, she called her doctor for nausea medications. On Monday morning she noticed a rash all over her body from head to toe and by reporting day she was on fire and had to go back to the doctor to get steroids to see if this would help this very violent rash that was covering her from head to toe and burning and itching like a raging fire.   Patient had a horrible experience with this shot. Patient mentioned that it had been a lot of pain and suffering.  Reporter causality was not reported.  Company comment-This spontaneous case concerns a female patient of unknown age, with no medical history reported, who experienced the unexpected and serious (medically significant) events nausea and rash pruritic after a dose of SPIKEVAX COVID-19 VACCINE NOS vaccine. It was reported that after receiving the Moderna COVID shot, within an hour patient was nauseous, could not eat or get out of bed for two days. Finally, she called her doctor for nausea medications. Two days after she noticed a rash all over her body from head to toe and by reporting day she was on fire and had to go back to the doctor to get steroids to see if this would help this very violent rash that was covering her from head to toe and burning and itching like a raging fire. No further details were provided for medical review. Outcome was reported as unknown. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-774436, US-MODERNATX, INC.-MOD-2024-774436 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-Sep-2024: Live Significant Follow-Up information received contains suspect product coding updated, new events added, narrative updated and references added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-774436:Husband case US-MODERNATX, INC.-MOD-2024-774436:wife case