Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Bladder pain, Chills, Diarrhoea, Erythema
Clinical narrative: bladder pain; sore legs/left arm pain; Headache; feeling tired; fever; chills; Nausea; heard more voice after vaccine; flank pain; noduler rash on legs; Felt like body was on fire; Redness; Hypersensitivity reaction; feet were swollen; throat got sore; Diarrhea; big knots on top of her feet coming from her toe all the way to ankle; body was swollen; back pain; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION, AUDITORY (heard more voice after vaccine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. HRS039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Back pain and Joint pain. Concurrent medical conditions included Diabetic (diabetic) since 05-Apr-2015, Hypertension, Drug allergy (Ibuprofen cause swells up), Penicillin allergy (cause vomiting), Drug allergy (Codeine), Sulfonamide allergy and Allergy to antibiotic (Tetracycline).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced HALLUCINATION, AUDITORY (heard more voice after vaccine) (seriousness criterion medically significant), PERIPHERAL SWELLING (feet were swollen), OROPHARYNGEAL PAIN (throat got sore), DIARRHOEA (Diarrhea), LIMB MASS (big knots on top of her feet coming from her toe all the way to ankle), SWELLING (body was swollen), BACK PAIN (back pain), FLANK PAIN (flank pain), NODULAR RASH (noduler rash on legs), FEELING HOT (Felt like body was on fire), ERYTHEMA (Redness), HYPERSENSITIVITY (Hypersensitivity reaction), FATIGUE (feeling tired), PYREXIA (fever), CHILLS (chills) and NAUSEA (Nausea). On an unknown date, the patient experienced BLADDER PAIN (bladder pain), PAIN IN EXTREMITY (sore legs/left arm pain) and HEADACHE (Headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; CEFALEXIN (CEPHALEXINE) at an unspecified dose and frequency and ACYCLOVIR [ACICLOVIR] at an unspecified dose and frequency. At the time of the report, HALLUCINATION, AUDITORY (heard more voice after vaccine), BLADDER PAIN (bladder pain), PERIPHERAL SWELLING (feet were swollen), OROPHARYNGEAL PAIN (throat got sore), DIARRHOEA (Diarrhea), LIMB MASS (big knots on top of her feet coming from her toe all the way to ankle), SWELLING (body was swollen), BACK PAIN (back pain), PAIN IN EXTREMITY (sore legs/left arm pain), FLANK PAIN (flank pain), NODULAR RASH (noduler rash on legs), FEELING HOT (Felt like body was on fire), ERYTHEMA (Redness), HYPERSENSITIVITY (Hypersensitivity reaction), HEADACHE (Headache), PYREXIA (fever), CHILLS (chills) and NAUSEA (Nausea) outcome was unknown and FATIGUE (feeling tired) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Company comment:This is a spontaneous  case concerning a 72 year-old female patient , with medical history  of back pain, joint pain, hypertension, drug allergy and diabetes, who experienced the serious  unexpected event of HALLUCINATION, AUDITORY, on the same day after receiving the first dose of mRNA-1273 plus others non serious events.    The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.   This case was linked to MOD-2021-260329 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Significant Follow-up received on 15-NOV-2021: contains Historical condition ,current condition, allergic condition added, new events added .; Sender's Comments: This is a spontaneous  case concerning a 72 year-old female patient , with medical history  of back pain, joint pain, hypertension, drug allergy and diabetes, who experienced the serious  unexpected event of HALLUCINATION, AUDITORY, on the same day after receiving the first dose of mRNA-1273 plus others non serious events.    The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.