Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urticaria
Clinical narrative: Red marks will just appear down her body. Red marks itch a little bit but not nearly as bad as before.; Has a cold; Red marks will just appear down her body. Red marks itch a little bit but not nearly as bad as before.; Shortness of breath; Woke up with hives broken out on back, legs, arms, and torso/but now the hives are worse then they were before; Scalp itched uncontrollably; Fever; Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Woke up with hives broken out on back, legs, arms, and torso/but now the hives are worse then they were before) and DYSPNOEA (Shortness of breath) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 044B21A and 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PROGESTERONE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt) and PYREXIA (Fever). On 19-Dec-2021, the patient experienced PRURITUS (Scalp itched uncontrollably). On 20-Dec-2021, the patient experienced URTICARIA (Woke up with hives broken out on back, legs, arms, and torso/but now the hives are worse then they were before) (seriousness criterion medically significant). On 23-Dec-2021, the patient experienced DYSPNOEA (Shortness of breath) (seriousness criterion medically significant). On 05-Jan-2022, the patient experienced ERYTHEMA (Red marks will just appear down her body. Red marks itch a little bit but not nearly as bad as before.), NASOPHARYNGITIS (Has a cold) and PRURITUS (Red marks will just appear down her body. Red marks itch a little bit but not nearly as bad as before.). The patient was treated with FAMOTIDINE (PEPCID [FAMOTIDINE]) on 01-Jan-2022 at a dose of afternoon; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; PREDNISONE at a dose of 20 mg for 7 days and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 2 Zyrtec in morning. At the time of the report, URTICARIA (Woke up with hives broken out on back, legs, arms, and torso/but now the hives are worse then they were before), ERYTHEMA (Red marks will just appear down her body. Red marks itch a little bit but not nearly as bad as before.), NASOPHARYNGITIS (Has a cold) and PRURITUS (Red marks will just appear down her body. Red marks itch a little bit but not nearly as bad as before.) had not resolved and DYSPNOEA (Shortness of breath), PAIN IN EXTREMITY (Arm hurt), PRURITUS (Scalp itched uncontrollably) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No medical history was reported.  The patient began to take Benadryl orally and on the 23-Dec-2021, started to have shortness of breath and went to urgent care, where she received a shot of Benadryl intramuscularly and prescribed. They also instructed her to take 2 Zyrtec in the morning and evening and Benadryl every 4 hours, but now she was taking 2 Zyrtec in morning and 2 Benadryl in the evening. Patient reports she just finished the course a couple of days ago.If off dose of antihistamine by an hour, begins to itch profusely.  Company Comment: This case concerns a 45 year-old female patient with no reported medical history who experienced the unexpected serious events of urticaria and dyspnea which occurred 13 to 16 days after vaccination with mRNA-1273 administered as a third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 45 year-old female patient with no reported medical history who experienced the unexpected serious events of urticaria and dyspnea which occurred 13 to 16 days after vaccination with mRNA-1273 administered as a third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.