Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: injection site extremely sore; dizziness all night and dizziness during work day; headaches; insomnia; The injection site is also itchy like it's infected with fleas; redness at the injection site that keeps getting bigger and is enlarging; rash like she is experiencing right now; she had a sore arm for a couple of days; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (insomnia), DIZZINESS (dizziness all night and dizziness during work day), VACCINATION SITE PRURITUS (The injection site is also itchy like it's infected with fleas), VACCINATION SITE PAIN (injection site extremely sore) and VACCINATION SITE ERYTHEMA (redness at the injection site that keeps getting bigger and is enlarging) in a 63-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031047) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lumbar disc disease (Lumbar issues, problems with lower spine), Scoliosis, Brain tumor (Brain tumor in right eye in remission) and COVID-19 in 2020. Previously administered products included for Product used for unknown indication: Pfizer (Dose 4, Lot - FJ9943) on 08-Apr-2022, Pfizer (Dose 5 and Lot - GJ3275) on 28-Oct-2022. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Osteoporosis and Osteopenia.  On 01-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 01-Nov-2023, the patient experienced INSOMNIA (insomnia), VACCINATION SITE PRURITUS (The injection site is also itchy like it's infected with fleas), VACCINATION SITE ERYTHEMA (redness at the injection site that keeps getting bigger and is enlarging), RASH (rash like she is experiencing right now), PAIN IN EXTREMITY (she had a sore arm for a couple of days), PYREXIA (fever) and CHILLS (chills). On an unknown date, the patient experienced DIZZINESS (dizziness all night and dizziness during work day), VACCINATION SITE PAIN (injection site extremely sore) and HEADACHE (headaches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INSOMNIA (insomnia), DIZZINESS (dizziness all night and dizziness during work day), VACCINATION SITE PRURITUS (The injection site is also itchy like it's infected with fleas), VACCINATION SITE PAIN (injection site extremely sore), VACCINATION SITE ERYTHEMA (redness at the injection site that keeps getting bigger and is enlarging), RASH (rash like she is experiencing right now), PAIN IN EXTREMITY (she had a sore arm for a couple of days), PYREXIA (fever), CHILLS (chills) and HEADACHE (headaches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, SARS-CoV-2 test: (Positive) But no symptoms.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  On 27-Jan-2021, the patient received first dose Lot number: 011L20A. On 03-Mar-2021, the patient received second dose Lot number: 01M20A. On 22-Nov-2021, the patient received third dose Lot number: FH8028.   The patient was given injection on 01-Nov-2023 about 10 am. The patient had all prior inoculations and boosters in the past for covid, but this was first time having very bad experience physically with this Spikevax vaccination by Moderna. The patient kept right arm moving all day despite doing that at work and even last night in bed. Injection site extremely sore and had insomnia, dizziness all night and dizziness during workday the site of injection does not even look like a typical bruise. It was widening in odd form not even a simple circle, as if something was spreading. The patient was very alarmed about this and wondering if this was a mistake.  The patient even massaged the site with a low-speed massager and that did not give relief nor did taking tylenol extra strength.  The patient has been given the COVID-19 vaccinations since they first started. She has received a mix of Moderna and Pfizer COVID-19 vaccines, but her initial series were Moderna. She said that she has never experienced a rash like she was experiencing right now. At most, she had a sore arm for a couple of days. She said that a couple hours after receiving her shot of the Spikevax 2023-2024 vaccine on 01-Nov-2023, she started having a reaction at the injection site. She said it was not bruised but like a rash that was enlarging. She also had a fever, chills, and insomnia for 2 days. She said there was some redness at the injection site that keeps getting bigger and was enlarging. She explained that it was wider, and it was increasing in circumference, and it seemed to be spreading. The injection site was also itchy like it was infected with fleas. She was a little disturbed as to why this was happening with this shot.   This case was linked to US-MODERNATX, INC.-MOD-2023-748333, US-MODERNATX, INC.-MOD-2023-748403, US-MODERNATX, INC.-MOD-2023-748404, US-MODERNATX, INC.-MOD-2023-748342, US-MODERNATX, INC.-MOD-2023-748352 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2023: Live follow-up information received included added reference number in reference section. On 03-Nov-2023: Live follow-up information received included added events of Rash, Pain in extremity, Pyrexia, Chills, Vaccination site erythema and Vaccination site pruritus. On 03-Nov-2023: Live follow-up information received included AE number added and updated narrative. On 06-Nov-2023: Live follow-up information received included added an event of Headache.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748333:Reporter's case US-MODERNATX, INC.-MOD-2023-748404:same reporter US-MODERNATX, INC.-MOD-2023-748352:Reporters case US-MODERNATX, INC.-MOD-2023-748403: US-MODERNATX, INC.-MOD-2023-748342:Reporters case