Age: 64.0
Sex: F
Vaccine: COVID19, RVX
Symptoms: Erythema, Fatigue, Gallbladder disorder, Illness, Malaise
Clinical narrative: I having gallbladder problems/being sick a little bit from the gallbladder problems; don't feel well; feel tired; I broke out in hives/ broke out in hives around my palms and my wrist; mouth broke out in sores; my face turned beet red and was itchy/my face is still a little red/my face got beet red like a pea cot roof. It was itchy/my chin's still itching; my face turned beet red and was itchy/my face is still a little red/my face got beet red like a pea cot roof. It was itchy/my chin's still itching; cold sores around my mouth/I broke out in cold sores around my mouth; I'm still sick/I have symptoms mirroring like I have COVID/sick; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (my face turned beet red and was itchy/my face is still a little red/my face got beet red like a pea cot roof. It was itchy/my chin's still itching), PRURITUS (my face turned beet red and was itchy/my face is still a little red/my face got beet red like a pea cot roof. It was itchy/my chin's still itching), ORAL HERPES (cold sores around my mouth/I broke out in cold sores around my mouth), ILLNESS (I'm still sick/I have symptoms mirroring like I have COVID/sick) and GALLBLADDER DISORDER (I having gallbladder problems/being sick a little bit from the gallbladder problems) in a 64-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 8080469) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product RSV VACCINE for an unknown indication.    The patient's past medical history included COVID-19 on 15-Jan-2023, Pancreatic cyst, Spleen disorder, Gallbladder disorder, Lumpectomy, Pancreatectomy (She had to lose half her pancreas and her entire spleen.) on 22-May-2023 and Splenectomy (She had to lose half her pancreas and her entire spleen.) on 22-May-2023. Previously administered products included for Product used for unknown indication: Pfizer in 2020. Past adverse reactions to the above products included No adverse event with Pfizer. Concurrent medical conditions included Type 2 diabetes mellitus (It takes her longer to get better from any cuts or bruises or anything) and Breast cancer (Had two different types of breast cancer, a lumpectoin right breast) since 13-Oct-2023.   On 04-Sep-2024, the patient received dose of RSV VACCINE (unknown route) 1 dosage form. On 11-Sep-2024, the patient received third dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 11-Sep-2024, the patient experienced ERYTHEMA (my face turned beet red and was itchy/my face is still a little red/my face got beet red like a pea cot roof. It was itchy/my chin's still itching), PRURITUS (my face turned beet red and was itchy/my face is still a little red/my face got beet red like a pea cot roof. It was itchy/my chin's still itching), ORAL HERPES (cold sores around my mouth/I broke out in cold sores around my mouth), ILLNESS (I'm still sick/I have symptoms mirroring like I have COVID/sick), STOMATITIS (mouth broke out in sores) and URTICARIA (I broke out in hives/ broke out in hives around my palms and my wrist). On an unknown date, the patient experienced GALLBLADDER DISORDER (I having gallbladder problems/being sick a little bit from the gallbladder problems), MALAISE (don't feel well) and FATIGUE (feel tired). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching and Hives, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (my face turned beet red and was itchy/my face is still a little red/my face got beet red like a pea cot roof. It was itchy/my chin's still itching), PRURITUS (my face turned beet red and was itchy/my face is still a little red/my face got beet red like a pea cot roof. It was itchy/my chin's still itching), ORAL HERPES (cold sores around my mouth/I broke out in cold sores around my mouth), ILLNESS (I'm still sick/I have symptoms mirroring like I have COVID/sick), GALLBLADDER DISORDER (I having gallbladder problems/being sick a little bit from the gallbladder problems), URTICARIA (I broke out in hives/ broke out in hives around my palms and my wrist) and FATIGUE (feel tired) was resolving and STOMATITIS (mouth broke out in sores) and MALAISE (don't feel well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2023, SARS-CoV-2 test: Positive. On an unknown date, SARS-CoV-2 test: Negative.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Patient had 4 boosters between Pfizer and Moderna.   Patient was hardly sick, sneezing and coughing.  Patient had other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient was still sick. Had symptoms mirroring like COVID. Symptoms had dissipated and they were not as bad as they were a week ago Wednesday 11-SEP-2024 when her face turned beet red and was itchy and broke out in hives and everything else. On 17-SEP-2024, she still had hives, and face was still a little red and mouth broke out in sores, and he still had a reaction. Patient never had a reaction to previous Moderna boosters before until now. Patient clarified onset of symptoms after receiving Spikevax vaccine on 11-Sep-2024. The same day within an hour or two face got beet red like a pea cot roof. It was itchy. Broke out in cold sores around mouth. Broke out in hives around palms and wrist.   Patient also added that she has had 10-15 vaccines in the last year and a half.   Patient did go buy Benadryl because chin was still itching and still had some hives, and it was still itchy and was feeling tired like had the flu but did not.   This case was linked to MOD-2024-774202 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Sep-2024: Live follow-up information received included significant information added new reporter, added events, added non-company suspect vaccination details, updated narrative and added reference numbers in reference section. On 18-Sep-2024: Live follow-up information received included non-significant information added medical history details, updated narrative and added reference numbers in reference section. On 18-Sep-2024: Live follow-up information received included non-significant information updated event verbatim and added reference numbers in reference section. On 18-Sep-2024: Live follow-up information received included no new significant information. On 19-Sep-2024: Live follow-up information received included significant information added an event of Feeling unwell.