Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: I woke up are very sore, my whole body muscles and joints are very sore.; I woke up are very sore, my whole body muscles and joints are very sore; She added though that when she woke up this morning, her whole body, muscled and BONES are very sore.; I woke up are very sore, my whole body muscles and joints are very sore.; Patient went on to say that pain started a few hours after receiving the vaccine; Patient went on to say that paint started a few hours after receiving the vaccine. It started in the left arm and started traveling.; Patient confirms that she is pregnant with triplets but is unsure of gestational week(s); This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of BONE PAIN (She added though that when she woke up this morning, her whole body, muscled and BONES are very sore.), PAIN (I woke up are very sore, my whole body muscles and joints are very sore.), VACCINATION SITE PAIN (Patient went on to say that pain started a few hours after receiving the vaccine), MYALGIA (I woke up are very sore, my whole body muscles and joints are very sore.) and ARTHRALGIA (I woke up are very sore, my whole body muscles and joints are very sore) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058856) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Moderna (1st dose, lot number GJ3268) on 04-May-2023, Moderna (2nd dose and lot number AS7180B) on 07-Jul-2023; for Product used for unknown indication: Pfizer. Past adverse reactions to the above products included No adverse event with Moderna, Moderna and Pfizer. Concurrent medical conditions included Hypertension and HPV infection. Concomitant products included VITAMINS NOS (MULTIVITAMINS [VITAMINS NOS]) for an unknown indication.    On 02-Nov-2023, the patient received third 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 02-Nov-2023, the patient experienced VACCINATION SITE PAIN (Patient went on to say that pain started a few hours after receiving the vaccine), PAIN IN EXTREMITY (Patient went on to say that paint started a few hours after receiving the vaccine. It started in the left arm and started traveling.) and MATERNAL EXPOSURE DURING PREGNANCY (Patient confirms that she is pregnant with triplets but is unsure of gestational week(s)). On 03-Nov-2023, the patient experienced BONE PAIN (She added though that when she woke up this morning, her whole body, muscled and BONES are very sore.), PAIN (I woke up are very sore, my whole body muscles and joints are very sore.), MYALGIA (I woke up are very sore, my whole body muscles and joints are very sore.) and ARTHRALGIA (I woke up are very sore, my whole body muscles and joints are very sore). On 02-Nov-2023, MATERNAL EXPOSURE DURING PREGNANCY (Patient confirms that she is pregnant with triplets but is unsure of gestational week(s)) had resolved. At the time of the report, BONE PAIN (She added though that when she woke up this morning, her whole body, muscled and BONES are very sore.), PAIN (I woke up are very sore, my whole body muscles and joints are very sore.), VACCINATION SITE PAIN (Patient went on to say that pain started a few hours after receiving the vaccine), MYALGIA (I woke up are very sore, my whole body muscles and joints are very sore.), ARTHRALGIA (I woke up are very sore, my whole body muscles and joints are very sore) and PAIN IN EXTREMITY (Patient went on to say that paint started a few hours after receiving the vaccine. It started in the left arm and started traveling.) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided.  Company Comment:  This spontaneous prospective case concerns a adult female pregnant patient with medical history of Concurrent medical conditions included Hypertension and HPV infection, Previously administered moderna vaccines for COVID-19 prophylaxis without adverse events who experienced the unexpected events of maternal exposure timing unspecified (use during pregnancy), bone pain, pain and other expected events beginning the same day after received 3rd. dose of mRNA-1273.815 vaccine. As the SD information, there were more than 35 days between first two doses, then Inappropriate schedule of vaccine administration was noted in this case.  The benefit-risk relationship of mRNA-1273.815 is not affected by this report.   This case was linked to 75936 (Parent-Child Link).   See case 75936 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2023: Significant follow up received contains medical history added, historical vaccines added, suspect drug information added, event added.