Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, COVID-19 immunisation, Fatigue, Headache
Clinical narrative: Sore throat; Left side of her neck felt puffy; high fever of 101.8 F; Sore arm; Muscle ache; Severe headache; Joint pain; felt nausea but never vomited; Tired; Revaccination with different COVID-19 vaccine; Interchange of vaccine products; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), SWELLING (Left side of her neck felt puffy), PYREXIA (high fever of 101.8 F), VACCINATION SITE PAIN (Sore arm) and MYALGIA (Muscle ache) in a 67-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Drug use for unknown indication: Pfizer (Dose Number: 1st dose, Lot number: EL8982, Route: Left arm IM, Expiration date: 31May2021) on 25-Jan-2021, Pfizer (Dose Number: 2nd dose, Lot number: EN6201, Route: Left arm IM, Expiration date: 30June2021) on 15-Feb-2021, Pfizer (Dose Number: 1st booster, Lot number: FF8839 and Route: left arm IM) on 27-Sep-2021. Past adverse reactions to the above products included Vaccination adverse reaction with Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Sulfonamide allergy (Itchy eyes), Pollen allergy, Dust allergy, Allergy to molds, Diabetes, Blood pressure high, Hyperthyroidism, Lichen sclerosus (Vaginal only, use steroid), High cholesterol, Fatty liver and Unilateral renal agenesis. Concomitant products included PLANTAGO OVATA (METAMUCIL [PLANTAGO OVATA]), CEPHALEXIN [CEFALEXIN], VALSARTAN, LEVOTHYROXINE, METFORMIN HYDROCHLORIDE (METFORMIN HCL), ATORVASTATIN, SITAGLIPTIN PHOSPHATE (JANUVIA), ESTRADIOL, ASCORBIC ACID, VACCINIUM SPP. (CRANBERRY [ASCORBIC ACID;VACCINIUM SPP.]), D-MANNOSE, PROBIOTICS NOS, COENZYME Q10 [UBIDECARENONE] and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 09-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 09-Sep-2022, the patient experienced COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On 11-Sep-2022, the patient experienced FATIGUE (Tired). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat), SWELLING (Left side of her neck felt puffy), PYREXIA (high fever of 101.8 F), VACCINATION SITE PAIN (Sore arm), MYALGIA (Muscle ache), HEADACHE (Severe headache) and ARTHRALGIA (Joint pain). an unknown date, the patient experienced NAUSEA (felt nausea but never vomited). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), SWELLING (Left side of her neck felt puffy), PYREXIA (high fever of 101.8 F), VACCINATION SITE PAIN (Sore arm), MYALGIA (Muscle ache), HEADACHE (Severe headache), ARTHRALGIA (Joint pain), NAUSEA (felt nausea but never vomited), FATIGUE (Tired), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.8 F..         She said she had a high fever of 101.8 F. She had sore arm, muscle ache, severe headache, and sore throat. The left side of her neck felt puffy. She also had joint pain. All her side effect started 16 hours after receiving the vaccine. 36 hours later, the next night she felt nausea but never vomited. Yesterday (11Sep2022) she woke up tired the next day. She stated she had similar side effect with the Pfizer vaccine. She believes with Pfizer vaccine the fever was slightly lower.  The patient never had COVID positive test or diagnosis.  No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  No treatment information was provided.