Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Exposure via breast milk, Paraesthesia, Pruritus, Rash
Clinical narrative: drug exposure during pregnancy; exposure via breast milk; initially started as an itchy in ears/ itching was everywhere, even down in the female areas; developed a serious skin rash and felt like throat was closing up/ rash down in the female areas; kept scratching everywhere else/ had to scratch between thumb and index finger and noticed that area turned into hives; tingly feeling in her ears; kept scratching everywhere else/ had to scratch between thumb and index finger and noticed that area turned into hives; developed a serious skin rash and felt like throat was closing up/ rash down in the female areas; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of PRURITUS (initially started as an itchy in ears/ itching was everywhere, even down in the female areas), THROAT TIGHTNESS (developed a serious skin rash and felt like throat was closing up/ rash down in the female areas), SCRATCH (kept scratching everywhere else/ had to scratch between thumb and index finger and noticed that area turned into hives), PARAESTHESIA (tingly feeling in her ears) and URTICARIA (kept scratching everywhere else/ had to scratch between thumb and index finger and noticed that area turned into hives) in a 70-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. A02920B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 2 diabetes mellitus, Irritable bowel syndrome, Blood pressure high, Mitral regurgitation, Drug allergy, Drug allergy and Drug allergy.    On 26-Oct-2023 at 4:00 AM, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 27-Oct-2023, the patient experienced PRURITUS (initially started as an itchy in ears/ itching was everywhere, even down in the female areas). 27-Oct-2023, the patient experienced THROAT TIGHTNESS (developed a serious skin rash and felt like throat was closing up/ rash down in the female areas), SCRATCH (kept scratching everywhere else/ had to scratch between thumb and index finger and noticed that area turned into hives), PARAESTHESIA (tingly feeling in her ears), URTICARIA (kept scratching everywhere else/ had to scratch between thumb and index finger and noticed that area turned into hives) and RASH (developed a serious skin rash and felt like throat was closing up/ rash down in the female areas). On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (drug exposure during pregnancy) and EXPOSURE VIA BREAST MILK (exposure via breast milk). The patient was treated with TRIAMCINOLONE (topical) for Rash, at an unspecified dose and frequency. At the time of the report, PRURITUS (initially started as an itchy in ears/ itching was everywhere, even down in the female areas), THROAT TIGHTNESS (developed a serious skin rash and felt like throat was closing up/ rash down in the female areas), PARAESTHESIA (tingly feeling in her ears) and RASH (developed a serious skin rash and felt like throat was closing up/ rash down in the female areas) had not resolved, SCRATCH (kept scratching everywhere else/ had to scratch between thumb and index finger and noticed that area turned into hives) and URTICARIA (kept scratching everywhere else/ had to scratch between thumb and index finger and noticed that area turned into hives) outcome was unknown and EXPOSURE DURING PREGNANCY (drug exposure during pregnancy) and EXPOSURE VIA BREAST MILK (exposure via breast milk) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 26-OCT-2023, she received Spikevax 2023-2024 vaccine, the side effect was different. She said that she had a horrible rash and itching that was uncontrollable. She couldn't stand it and she woke up in the middle of the night itching. She says it initially started as an itchy, tingly feeling in her ears. The outside of her ears became red which indicated to her that something wasn't right. On 27-Oct-2023 morning, she didn't go to work. Towards the evening on 28-Oct-2023, the rash and itching became worse. On 29-Oct-2023 morning, at around 12:30 AM, it was getting even worse and she started having uncontrollable itching. She said that the rash and itching was everywhere, even down in the female areas. The only places she didn't notice the rash was on her thighs, legs, and feet. She kept scratching everywhere else. She said that it wasn't like hives but if she scratched it a lot then that is what it looked like. she had to scratch between her thumb and index finger and noticed that area turned into hives.  Company comment: This spontaneous case concerns a 70-year-old female patient, with no relevant medical history reported, who received the fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine and experienced the non-serious and unexpected event of MATERNAL EXPOSURE BEFORE PREGNANCY and EXPOSURE VIA BREAST MILK, with no-serious events associated. No further clinical information was available for medical review. A query was raised due to the inconsistency of the information reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-747885, US-MODERNATX, INC.-MOD-2023-747893, MOD-2023-747894 (Patient Link).