Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Illness, Influenza like illness, Myalgia
Clinical narrative: reports she got so sick after the 2nd dose/ got sick from the booster; got so ill reactogenicity; fever; vomiting; headaches; muscle aches / muscle pain / malagia; chills; nausea; like the worse flu they ever experienced; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (got so ill reactogenicity), PYREXIA (fever), VOMITING (vomiting), HEADACHE (headaches) and MYALGIA (muscle aches / muscle pain / malagia) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A, 0VIAZIA and 012H21B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for COVID-19 prophylaxis.    The patient's past medical history included Sjogren's syndrome (it is very mild and they only have like dry eye and dry mouth, no systemic side effects with it). Concurrent medical conditions included Hypertension. Concomitant products included DILTIAZEM (CARDIZEM [DILTIAZEM]) for Hypertension, AMPICILLIN TRIHYDRATE (FLU-AMP), PARACETAMOL (ACETAMINOPHEN), IBUPROFEN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced ILLNESS (got so ill reactogenicity), PYREXIA (fever), VOMITING (vomiting), HEADACHE (headaches), MYALGIA (muscle aches / muscle pain / malagia), CHILLS (chills), NAUSEA (nausea) and INFLUENZA LIKE ILLNESS (like the worse flu they ever experienced). On an unknown date, the patient experienced ILLNESS (reports she got so sick after the 2nd dose/ got sick from the booster). On 11-Apr-2021, ILLNESS (got so ill reactogenicity), PYREXIA (fever), VOMITING (vomiting), HEADACHE (headaches), MYALGIA (muscle aches / muscle pain / malagia), CHILLS (chills), NAUSEA (nausea) and INFLUENZA LIKE ILLNESS (like the worse flu they ever experienced) had resolved. At the time of the report, ILLNESS (reports she got so sick after the 2nd dose/ got sick from the booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient had horrendous headache and nausea vomiting, malagia, muscle pain, like the worse flu they ever experienced. They said at the most it should not be happening past 24 and 48. Caller said it did not decrease in severity over those 3 to 4 days until the last 24 hours. Pain scale from 1 to 10 was a 12, really over worse than a 10. Never felt anything quite like that. Caller could not move could not get out of bed. Caller recently had the flu vaccine and had no reaction. Caller reports 8-10,12 hours after the second dose they started getting chills. Caller has no localized reaction it was systemic. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Dec-2022: Live follow up received included- Suspect product Comirnaty added.