Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Urticaria, Vaccination site pain
Clinical narrative: Tenderness/Pain; Swelling-of-limbs, black and blue; Leg and feet and arms burning. My skin burned. I got skin burning from all of them, but this is bad/Skin red, and burning on feet, ankles, legs and Armsitchy rash/hives on skin on feet, legs, and arms.; Still has an itchy rash on the left arm injection site; injection site soreness/arm soreness/injection site reaction; Dizziness; Headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Tenderness/Pain), PERIPHERAL SWELLING (Swelling-of-limbs, black and blue), VACCINATION SITE PAIN (injection site soreness/arm soreness/injection site reaction), DIZZINESS (Dizziness) and HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7643E) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke (in fall 2020) in 2020 and Allergy. Previously administered products included for Shingles: VARICELLA ZOSTER VACCINES (Received a Shingle shot about 6 months ago.). Past adverse reactions to the above products included No adverse event with VARICELLA ZOSTER VACCINES. Concomitant products included CLONIDINE for an unknown indication.    On 06-Jul-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Tenderness/Pain), PERIPHERAL SWELLING (Swelling-of-limbs, black and blue), VACCINATION SITE PAIN (injection site soreness/arm soreness/injection site reaction), DIZZINESS (Dizziness), HEADACHE (Headache), URTICARIA (Leg and feet and arms burning. My skin burned. I got skin burning from all of them, but this is bad/Skin red, and burning on feet, ankles, legs and Armsitchy rash/hives on skin on feet, legs, and arms.) and INJECTION SITE RASH (Still has an itchy rash on the left arm injection site). At the time of the report, PAIN (Tenderness/Pain), URTICARIA (Leg and feet and arms burning. My skin burned. I got skin burning from all of them, but this is bad/Skin red, and burning on feet, ankles, legs and Armsitchy rash/hives on skin on feet, legs, and arms.) and INJECTION SITE RASH (Still has an itchy rash on the left arm injection site) had not resolved, PERIPHERAL SWELLING (Swelling-of-limbs, black and blue) outcome was unknown and VACCINATION SITE PAIN (injection site soreness/arm soreness/injection site reaction), DIZZINESS (Dizziness) and HEADACHE (Headache) had resolved.        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.   Patient had received Moderna monovalent dose 1 on 05JUN2022 lot number 084J21A and dose 2 on 15Jun2023 lot number 058A22-2A. Patient reported having health problems and was homebound and so she got the vaccine when she could.  Patient reported that she was not happy with the side effects she got from this the vaccine and stated that it was not good as patient was still experiencing the side effects. Patient reported that she was still bad and regret getting it now. Patient was getting very severe. Leg and feet and arms and skin were burning and reported that she will never get another one as this was awful. Patient had skin rashes/hives which looked like sunburn, and had been placing icepacks on skin for each episode. She had not seen a doctor and she was not using any topical medicine on the skin.   This case was linked to US-MODERNATX, INC.-MOD-2023-733394 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2023: Updated reporter information, patient demographics and medical history.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733394:Monovalent case