Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Pain, Pyrexia, Vaccination site pain, Vaccination site rash
Clinical narrative: She fainted, felt too much weakness; Stomach cramps; Diarrhea; Migraine pain; out of breath; cold sore; whenever close eye feel like falling down; admitted to ER because of dehydrated; body ache and pain all over the body; injection site in the left arm had big ball, big rash almost tennis ball size; pain a the injection site for a week; fever; knee got too weak; vomiting; nausea; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (She fainted, felt too much weakness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (She fainted, felt too much weakness) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (Stomach cramps), DIARRHOEA (Diarrhea), MIGRAINE (Migraine pain), DYSPNOEA (out of breath), ORAL HERPES (cold sore), DIZZINESS (whenever close eye feel like falling down), DEHYDRATION (admitted to ER because of dehydrated), PAIN (body ache and pain all over the body), VACCINATION SITE RASH (injection site in the left arm had big ball, big rash almost tennis ball size), VACCINATION SITE PAIN (pain a the injection site for a week), PYREXIA (fever), ARTHRALGIA (knee got too weak), VOMITING (vomiting), NAUSEA (nausea) and MYALGIA (Muscle pain). At the time of the report, LOSS OF CONSCIOUSNESS (She fainted, felt too much weakness), ABDOMINAL PAIN UPPER (Stomach cramps), DIARRHOEA (Diarrhea), MIGRAINE (Migraine pain), DYSPNOEA (out of breath), ORAL HERPES (cold sore), DIZZINESS (whenever close eye feel like falling down), DEHYDRATION (admitted to ER because of dehydrated), PAIN (body ache and pain all over the body), VACCINATION SITE RASH (injection site in the left arm had big ball, big rash almost tennis ball size), VACCINATION SITE PAIN (pain a the injection site for a week), PYREXIA (fever), ARTHRALGIA (knee got too weak), VOMITING (vomiting), NAUSEA (nausea) and MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  The patient stated, After getting dose, she had all kind of adverse events, including stomach cramp, diarrhea, nausea, vomiting, dizziness, migraine pain , pain at the injection site for the week, out of breath, fever, cold sore, whenever she closed her eyes, she felt like falling down. She had to go to emergency department because of she was too much dehydrated, they had to give nausea medication and migraine pain medication through IV, over. She fainted, felt too much weakness, knee get too weak, when she messaged her left arm after 2 days, there was big ball ( inflamed), when she message there was huge rash size of tennis ball, body ache, pain all over muscle and body. She thought she will gonna dye but 2 days later, she was okay.  Treatment for the event included nausea and migraine pain medication intravenously.  Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.