Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Fatigue, Feeling abnormal, Headache, Hepatic pain
Clinical narrative: pain the back; headaches; soreness on my left shoulder/pain in the shoulder/ pain in the joints and stuff; really tired/really tires; muscle aches; feels really wrung out,Feeling bad/scares her and is making her feel worse; She's still hurting; sweaty; feeling behind my ear; it felt like a sore throat, like a picking pinching feeling; pain and discomfort extended into my neck/pain in the neck; really bad hoarseness/a lot of hoarseness in her tonsil area; pain in my chest,twinges near my heart; earache; some symptoms in her liver area (under her ribs on the right side)/ pain very pronounced, pulsating which comes and goes; unable to sleep; malaise/ still feeling crappy; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (feels really wrung out,Feeling bad/scares her and is making her feel worse), PAIN (She's still hurting), HYPERHIDROSIS (sweaty), EAR DISCOMFORT (feeling behind my ear) and OROPHARYNGEAL PAIN (it felt like a sore throat, like a picking pinching feeling) in an 81-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient did not experienced a similar event in the past.  The patient's past medical history included COVID-19 in June 2021 and COVID-19 (she caught omicron last year) in October 2021. Previously administered products included for Product used for unknown indication: Pfizer (Dose 2) in July 2021 and Pfizer (Dose 1). Past adverse reactions to the above products included Hair loss with Pfizer; and No adverse event with Pfizer. Concurrent medical conditions included GERD, Allergy to antibiotic (allergy to tetracycline), Sulfonamide allergy (allergy to Sulfonamide), Allergy to NSAIDs (allergy to NSAIDs), Allergy NOS (allergy to Others) and Diabetes (controlled with diet). Concomitant products included DILTIAZEM and FAMOTIDINE for an unknown indication.    On 10-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In September 2022, the patient experienced FEELING ABNORMAL (feels really wrung out,Feeling bad/scares her and is making her feel worse), PAIN (She's still hurting), HYPERHIDROSIS (sweaty), EAR DISCOMFORT (feeling behind my ear), OROPHARYNGEAL PAIN (it felt like a sore throat, like a picking pinching feeling), NECK PAIN (pain and discomfort extended into my neck/pain in the neck), DYSPHONIA (really bad hoarseness/a lot of hoarseness in her tonsil area), CHEST PAIN (pain in my chest,twinges near my heart), EAR PAIN (earache), HEPATIC PAIN (some symptoms in her liver area (under her ribs on the right side)/ pain very pronounced, pulsating which comes and goes), SLEEP DISORDER (unable to sleep), MALAISE (malaise/ still feeling crappy), HEADACHE (headaches), ARTHRALGIA (soreness on my left shoulder/pain in the shoulder/ pain in the joints and stuff), FATIGUE (really tired/really tires) and MYALGIA (muscle aches). On an unknown date, the patient experienced BACK PAIN (pain the back). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (feels really wrung out,Feeling bad/scares her and is making her feel worse), PAIN (She's still hurting), HYPERHIDROSIS (sweaty), EAR DISCOMFORT (feeling behind my ear), OROPHARYNGEAL PAIN (it felt like a sore throat, like a picking pinching feeling), NECK PAIN (pain and discomfort extended into my neck/pain in the neck), DYSPHONIA (really bad hoarseness/a lot of hoarseness in her tonsil area), CHEST PAIN (pain in my chest,twinges near my heart), EAR PAIN (earache), MALAISE (malaise/ still feeling crappy), HEADACHE (headaches), ARTHRALGIA (soreness on my left shoulder/pain in the shoulder/ pain in the joints and stuff) and FATIGUE (really tired/really tires) had not resolved and HEPATIC PAIN (some symptoms in her liver area (under her ribs on the right side)/ pain very pronounced, pulsating which comes and goes), SLEEP DISORDER (unable to sleep), BACK PAIN (pain the back) and MYALGIA (muscle aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, SARS-CoV-2 test: (Positive) Positive. In October 2021, SARS-CoV-2 test: (Positive) Positive. In 2022, SARS-CoV-2 test: (Negative) negative with the home kit..     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient had omicron last year October into November. Patient took monoclonal infusion when she got COVID. It was reported that patient took dose 3 (first booster dose) on DEC-2021. It was reported that symptoms was improved for the event earaches. Patient did not had Covid as she got tested prior to the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 19-Sep-2022: Follow-up  Significant information accepted. Events added. On 19-Sep-2022: Live Follow-up  No New Information accepted