Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Exposure during pregnancy, Feeling cold, Feeling hot
Clinical narrative: 10 out of 10 pain; Lethargy; Felt extremely hot, like volcanic hot, really really hot; Typically handles discomfort and pain well, her threshold is very had but this was out of control; Cold chills; Nausea/severe nausea; Pain in every part of her body from head to toe; Headache; Cold chills; 5 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PAIN (10 out of 10 pain), LETHARGY (Lethargy), FEELING HOT (Felt extremely hot, like volcanic hot, really really hot), DISCOMFORT (Typically handles discomfort and pain well, her threshold is very had but this was out of control) and FEELING COLD (Cold chills) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L201A, 032L20A and 045C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In 2021, the patient experienced EXPOSURE DURING PREGNANCY (5 weeks pregnant). In November 2021, the patient experienced PAIN (10 out of 10 pain), LETHARGY (Lethargy), FEELING HOT (Felt extremely hot, like volcanic hot, really really hot), DISCOMFORT (Typically handles discomfort and pain well, her threshold is very had but this was out of control), FEELING COLD (Cold chills), NAUSEA (Nausea/severe nausea), MYALGIA (Pain in every part of her body from head to toe), HEADACHE (Headache) and CHILLS (Cold chills). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of 650 milligram. At the time of the report, PAIN (10 out of 10 pain), LETHARGY (Lethargy), FEELING HOT (Felt extremely hot, like volcanic hot, really really hot), DISCOMFORT (Typically handles discomfort and pain well, her threshold is very had but this was out of control), FEELING COLD (Cold chills), NAUSEA (Nausea/severe nausea), MYALGIA (Pain in every part of her body from head to toe), HEADACHE (Headache) and CHILLS (Cold chills) outcome was unknown and EXPOSURE DURING PREGNANCY (5 weeks pregnant) had resolved.            Company Comment: This case concerns a 37-year-old, female patient with no relevant medical history, who experienced exposure during pregnancy and the unexpected events of pain, lethargy, feeling hot, discomfort, feeling cold and expected events of nausea, myalgia, headache and chills. The events occurred after the third dose of mRNA-1273. The patient was five weeks pregnant, as reported. The rechallenge was not applicable as no further dosing was reported or planned, based on information provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-395862 (Patient Link).; Sender's Comments: This case concerns a 37-year-old, female patient with no relevant medical history, who experienced exposure during pregnancy and the unexpected events of pain, lethargy, feeling hot, discomfort, feeling cold and expected events of nausea, myalgia, headache and chills. The events occurred after the third dose of mRNA-1273. The patient was five weeks pregnant, as reported. The rechallenge was not applicable as no further dosing was reported or planned, based on information provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.