Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Pyrexia, Rash, Skin warm, Tenderness
Clinical narrative: Her arm is warm to the touch as well; chills; fever; soreness in her arm/She says that today that area is still tender with the swelling and itchiness; redness; rash in her arm; arm has been swollen; She says that was really sick the night; She says that it is itchy as well; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (She says that was really sick the night), VACCINATION SITE PRURITUS (She says that it is itchy as well), VACCINATION SITE WARMTH (Her arm is warm to the touch as well), CHILLS (chills) and PYREXIA (fever) in a 76-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu shot (Flu shot 2 weeks prior to Spikevax). Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Hypertension, Vegetable allergy (mushrooms), Penicillin allergy and Drug allergy (Paxil).    On 27-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced VACCINATION SITE PRURITUS (She says that it is itchy as well). On 27-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced ILLNESS (She says that was really sick the night), CHILLS (chills), PYREXIA (fever), VACCINATION SITE PAIN (soreness in her arm/She says that today that area is still tender with the swelling and itchiness), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE RASH (rash in her arm) and VACCINATION SITE SWELLING (arm has been swollen). On 02-Nov-2023, the patient experienced VACCINATION SITE WARMTH (Her arm is warm to the touch as well). The patient was treated with CORTISONE at an unspecified dose and frequency; ACRIVASTINE (BENADRYL [ACRIVASTINE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ILLNESS (She says that was really sick the night), VACCINATION SITE PRURITUS (She says that it is itchy as well) and VACCINATION SITE WARMTH (Her arm is warm to the touch as well) outcome was unknown and CHILLS (chills), PYREXIA (fever), VACCINATION SITE PAIN (soreness in her arm/She says that today that area is still tender with the swelling and itchiness), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE RASH (rash in her arm) and VACCINATION SITE SWELLING (arm has been swollen) had not resolved.            Concomitant medication not reported.   The patient had 1st Dose on 5 FEB 2021 with Lot no 030L20A, 2nd Dose on 5 MAR 2021, Lot no 025A21A, 3rd Dose on 24 APR 2022 with Lot no 020F21A, 4th Dose on 12 OCT 2022 with Lot no 030G22B.  On 27-Oct-2023, Body temperature was 99.9 Fahrenheit.  She had taken cortisone and Benadryl cream for the rash in her arm, but they did not provide a lot of relief. She was also taking Tylenol every 6 hours initially but had been able to get that down. On 29 Oct 2023, she started feeling better. However, the swelling, rash, and itching in her arm continued and was still ongoing. She said on 2 Nov 2023 that area was still tender with the swelling and itchiness. Her arm was warm to the touch as well.   This case was linked to US-MODERNATX, INC.-MOD-2023-748150, US-MODERNATX, INC.-MOD-2023-748151 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748150:Same patient (Moderna covid-19 vaccine) US-MODERNATX, INC.-MOD-2023-748151:Same patient (Bivalent dose)