Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Functional gastrointestinal disorder, Nausea, Vaccination site erythema, Vaccination site pain
Clinical narrative: extreme weakness, almost fainted; severe nausea; intestinal episode, run to the bathroom; redness at the injection site; itching at the injection site; a little bit of soreness at the injection site; swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (extreme weakness, almost fainted), NAUSEA (severe nausea), FUNCTIONAL GASTROINTESTINAL DISORDER (intestinal episode, run to the bathroom), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 030M/20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hyperlipidemia in 1990. Concurrent medical conditions included Osteopenia in 1990, Joint pain in 1970 and Osteoarthritis. Concomitant products included CELECOXIB for Hyperlipidemia, PRAVASTATIN for Joint pain, CALCIUM CITRATE for Osteopenia, ACETYLSALICYLIC ACID (BABY ASPIRIN) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE PAIN (a little bit of soreness at the injection site). On 29-Jan-2021, the patient experienced ASTHENIA (extreme weakness, almost fainted), NAUSEA (severe nausea), FUNCTIONAL GASTROINTESTINAL DISORDER (intestinal episode, run to the bathroom), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE PRURITUS (itching at the injection site). On 23-Jan-2021, VACCINATION SITE PAIN (a little bit of soreness at the injection site) had resolved. On 29-Jan-2021, ASTHENIA (extreme weakness, almost fainted), NAUSEA (severe nausea) and FUNCTIONAL GASTROINTESTINAL DISORDER (intestinal episode, run to the bathroom) had resolved. On 02-Feb-2021, VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE PRURITUS (itching at the injection site) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (redness at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Immediately following administration of the first dose of the Moderna Covid-19 vaccine on January 22, 2021, the patient experienced no signifiant symptoms - only minimal soreness and redness at the injection site which abated within 24 hours. One week later, at between 8:45 am and 9:00 am on the morning of January 29th , the patient experienced the first symptoms: intense itching, a circle of redness and induration/swelling that was "sore"/painful to touch around the vaccination site on my left arm. The red swollen area increased in size and by the end of the day encircled my upper arm. The itching, redness and swelling gradually diminished and by January 31st there was just a pale red area around the vaccination site which disappeared in a few more days. By about 10 am on the morning of January 29th I experienced other symptoms - I suddenly felt so weak as if I was about to faint and lay down to avoid falling. The patient remained lying there for about an hour when I felt my strength had returned. Within that hour I experienced intense nausea which abated by the time I felt strong enough/back to normal and resumed my normal activities as if nothing had happened. I had no other symptoms after that. I self administered benedryl topical ointment to the red itching area, but did not not seek medical attention at the time. The patient had a video appointent a few days laterwith my internist to describe what had happened. The patient was concerned whether the patient might have a more adverse reaction with the 2nd vaccine administration. She consulted with others and told me to go ahead with the 2nd vaccination. She prescribed EpiPen for me to have ready after my second vaccinatio appointment and advised that the patient wait longer than the prescribed 15 minutes, but the second Covid 19 vaccination was uneventful.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Medical history, concomitant medication and narrative had been updated.