Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Dyspepsia, Eructation, Headache
Clinical narrative: Very huge reaction in that injection site; Injection arm is very very uncomfortable; Stomach issues; Burping and that kind of things; Digestive issues; Aches; Localized redness at the injection site about 5 by 4 inches; Localized inflammation at the injection site about 5 by 4 inches; Localized swelling at the injection site about 5 by 4 inches; Chills; Fever; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Very huge reaction in that injection site), VACCINATION SITE DISCOMFORT (Injection arm is very very uncomfortable), ABDOMINAL DISCOMFORT (Stomach issues), ERUCTATION (Burping and that kind of things) and DYSPEPSIA (Digestive issues) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 006M20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu shot (got the flu shot about 2 weeks prior to the boostertook higher dose because of her age.) in October 2021. Past adverse reactions to the above products included No adverse event with Flu shot.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced VACCINATION SITE REACTION (Very huge reaction in that injection site), VACCINATION SITE DISCOMFORT (Injection arm is very very uncomfortable), ABDOMINAL DISCOMFORT (Stomach issues), ERUCTATION (Burping and that kind of things), DYSPEPSIA (Digestive issues), PAIN (Aches), VACCINATION SITE ERYTHEMA (Localized redness at the injection site about 5 by 4 inches), VACCINATION SITE INFLAMMATION (Localized inflammation at the injection site about 5 by 4 inches), VACCINATION SITE SWELLING (Localized swelling at the injection site about 5 by 4 inches), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of 1 dosage form; PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form; CORTISONE for Adverse event, at a dose of 1 dosage form and LIDOCAINE for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE REACTION (Very huge reaction in that injection site) and VACCINATION SITE DISCOMFORT (Injection arm is very very uncomfortable) had not resolved, ABDOMINAL DISCOMFORT (Stomach issues), ERUCTATION (Burping and that kind of things), DYSPEPSIA (Digestive issues), PAIN (Aches), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea) was resolving and VACCINATION SITE ERYTHEMA (Localized redness at the injection site about 5 by 4 inches), VACCINATION SITE INFLAMMATION (Localized inflammation at the injection site about 5 by 4 inches) and VACCINATION SITE SWELLING (Localized swelling at the injection site about 5 by 4 inches) outcome was unknown.            It was reported that patient had allergy injections for almost 35 years and patient never had this reactions. Patient's arm continued to react for at least a month when the patient got allergy shots for the last two times.  Patient's treatment details reported also included icing. No concomitant medication was reported.   This case was linked to MOD-2021-009697, MOD-2021-363676 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Follow up received contains updated batch number for dose two. On 25-Oct-2021: Follow-up received contains no new information.