Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sensation of foreign body, Urticaria
Clinical narrative: Rash like traditional hives throughout his body, in his hair, head and when he took shower on his back; "sensation in his throat" and "Feels like he has a pill in his throat and it's called Globus sensation"; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Rash like traditional hives throughout his body, in his hair, head and when he took shower on his back) and SENSATION OF FOREIGN BODY ("sensation in his throat" and "Feels like he has a pill in his throat and it's called Globus sensation") in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Dec-2021, the patient experienced URTICARIA (Rash like traditional hives throughout his body, in his hair, head and when he took shower on his back) (seriousness criterion medically significant) and SENSATION OF FOREIGN BODY ("sensation in his throat" and "Feels like he has a pill in his throat and it's called Globus sensation") (seriousness criterion medically significant). At the time of the report, URTICARIA (Rash like traditional hives throughout his body, in his hair, head and when he took shower on his back) and SENSATION OF FOREIGN BODY ("sensation in his throat" and "Feels like he has a pill in his throat and it's called Globus sensation") had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: results not provided (Inconclusive) results not provided.         The patient had no allergies. The patient did not have history related to mentioned AE and both acute and chronic illnesses at the time of vaccination. No concomitant product use was provided by the reporter. Treatment medications included steroids and antihistamine.  On 22-Nov-2021, patient had booster dose. Patient had rash like traditional hives throughout body, in hair, head and when patient took shower on back. Hives lasted for about 2 1/2 months. Also, patient had sensation in throat. Felt like patient had a pill in throat and it's called Globus sensation. No change in symptoms was observed. AE caused patient to seek medical care from urgent care physician/primary care/allergist, ear, nose, throat specialist, GI specialist.  Company comment: This spontaneous case concerns a 45-year-old male patient, with no medical history reported, who experienced the serious (medically significant) unexpected events of urticaria and sensation of foreign body ( on his throat) 13 days after the third dose, reported as booster dose of mRNA-1273. The events were not resolved at the time of report.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 45-year-old male patient, with no medical history reported, who experienced the serious (medically significant) unexpected events of urticaria and sensation of foreign body ( on his throat) 13 days after the third dose, reported as booster dose of mRNA-1273. The events were not resolved at the time of report.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.