Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Maternal exposure during breast feeding, Maternal exposure during pregnancy, SARS-CoV-2 test
Clinical narrative: Tested positive for covid the first time on or around 1/13/24; Patient was in third trimester; Breastfeeding with formula supplemented; This spontaneous retrospective pregnancy case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for covid the first time on or around 1/13/24), MATERNAL EXPOSURE DURING PREGNANCY (Patient was in third trimester) and MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding with formula supplemented) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included Gestational diabetes. Previously administered products included for COVID-19 prophylaxis: PFIZER BIONTECH COVID-19 VACCINE (Patient was vaccinated twice with Pfizer). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Gluten sensitivity, Dairy intolerance and Postural orthostatic tachycardia syndrome (POTS which got from a concussion and was diagnosed with in October 2021) since October 2021.    On 26-Sep-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 26-Sep-2023, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient was in third trimester) and MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding with formula supplemented). On 13-Jan-2024, the patient experienced COVID-19 (Tested positive for covid the first time on or around 1/13/24). The cesarean delivery occurred, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. C-section baby would not come at after three and half hours of delivery, heart paused 5th day after delivery. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 15-Jan-2024 to 19-Jan-2024 for COVID-19, at a dose of 10 milligram twice a day and PARACETAMOL (TYLENOL EXTRA STRENGTH) from 15-Jan-2024 to 04-Feb-2024 at a dose of 1 pill q6h. On 26-Sep-2023, MATERNAL EXPOSURE DURING PREGNANCY (Patient was in third trimester) and MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding with formula supplemented) had resolved. At the time of the report, COVID-19 (Tested positive for covid the first time on or around 1/13/24) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2024, SARS-CoV-2 test: (Positive) patient tested positive for covid the first time on or around. On 23-Jan-2024, SARS-CoV-2 test: Negative. On 27-Jan-2024, SARS-CoV-2 test: Positive. In 2024, Body temperature: spiked to 102.         No concomitant medications were reported.  Patient was covid vaccinated three times before she got covid. Patient got covid for the first time in January 2024.  Patient OBGYN recommended to take Paxlovid so that her fever never got too high and didn't become dangerous for the baby. Patient waited after testing positive from covid to take it hoping maybe she had a mild case and not need to take a drug of any type, while unfortunately, her fever spiked to 102 and so at that time patient decided to take Paxlovid to help herself recover faster and not risk the fever spiking higher and becoming dangerous for the baby.   Patient tested negative about 5-7 days later and her fever never went higher than 102. However, patient relapsed with a positive test for covid and got re-occurring symptoms on or around 27-Jan-2024. Patient was very sick for the re-lapse again and her symptoms the second time matched her symptoms the first time (fever, congestion, sore throat, achy, tired). Patient missed work 1/15-1/19 and 1/29-2/2. Patient no longer had diabetes and did not have it prior to being. Infant was on breastfeeding with formula supplemented.  Company Comment: This is a spontaneous case of Maternal exposure during pregnancy and Maternal exposure during breastfeeding in a-female patient of unknown age, with relevant medical history of Gestational diabetes, and Postural orthostatic tachycardia syndrome, who experienced the non-serious unexpected event of COVID-19. The event occurred approximately four months after a dose of SPIKEVAX 2023-2024 vaccine received as the third (booster) dose of COVID-19 vaccination schedule; the patient had received PFIZER BIONTECH COVID-19 VACCINE twice before Moderna vaccine. Reportedly, the patient had a mild case, symptomatic for fever, so the patient was treated with Paxlovid. The patient tested negative about 5-7 days later and her fever never went higher than 102. However, she relapsed by the end of Jan-2024. The cesarean delivery occurred. The outcome of the pregnancy was reported as Delivered NOS. via C-section. The baby had heart paused 5th day after delivery (to be confirmed). The outcome of the event COVID-19 was reported as unknown. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2024: Follow-up received on 08-May-2024 which contains Significant information: patient's pregnancy details, medical history, suspect product details, treatment medications, events and narrative were updated On 09-May-2024: Live follow-up received which contains no new information.