Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue discomfort, Upper respiratory tract congestion, Urticaria, Vaccination site pain
Clinical narrative: Felt lungs congested/felt lungs sort of inflamed/felt lungs with mucosity in the inside; Felt like kind of coughing/felt like trying to cough something out; She felt her throat and lungs congested, sort of inflamed and with mucosity in the inside.; She felt her throat and lungs congested, sort of inflamed and with mucosity in the inside.; Dermatographia/can write on her skin/can´t use anything tight/the mark of a bracelet stays on her skin; Tongue felt really weird/tongue feels strange; Tongue felt inflamed/tongue felt a little bigger; Left knee started twitching; Nervous system was twitching; She developed a really bad delayed reaction, 11 days after, on 19Sep2021, with full body hives; Sore arm; Headache; Tired; Felt knee vibrating; Right eye started twitching/eye was winking; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (Felt lungs congested/felt lungs sort of inflamed/felt lungs with mucosity in the inside) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 011L20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS and LEVOTHYROXINE for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 08-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced VACCINATION SITE PAIN (Sore arm), HEADACHE (Headache) and FATIGUE (Tired). In September 2021, the patient experienced JOINT VIBRATION (Felt knee vibrating) and BLEPHAROSPASM (Right eye started twitching/eye was winking). On 19-Sep-2021, the patient experienced URTICARIA (She developed a really bad delayed reaction, 11 days after, on 19Sep2021, with full body hives). On an unknown date, the patient experienced PULMONARY CONGESTION (Felt lungs congested/felt lungs sort of inflamed/felt lungs with mucosity in the inside) (seriousness criterion medically significant), COUGH (Felt like kind of coughing/felt like trying to cough something out), THROAT IRRITATION (She felt her throat and lungs congested, sort of inflamed and with mucosity in the inside.), UPPER RESPIRATORY TRACT CONGESTION (She felt her throat and lungs congested, sort of inflamed and with mucosity in the inside.), MECHANICAL URTICARIA (Dermatographia/can write on her skin/can´t use anything tight/the mark of a bracelet stays on her skin), MUSCLE TWITCHING (Nervous system was twitching), TONGUE DISCOMFORT (Tongue felt really weird/tongue feels strange), GLOSSITIS (Tongue felt inflamed/tongue felt a little bigger) and MUSCLE TWITCHING (Left knee started twitching). The patient was treated with LEVOCABASTINE HYDROCHLORIDE (ZYRTEC [LEVOCABASTINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 09-Sep-2021, VACCINATION SITE PAIN (Sore arm), HEADACHE (Headache) and FATIGUE (Tired) had resolved. At the time of the report, PULMONARY CONGESTION (Felt lungs congested/felt lungs sort of inflamed/felt lungs with mucosity in the inside), COUGH (Felt like kind of coughing/felt like trying to cough something out), THROAT IRRITATION (She felt her throat and lungs congested, sort of inflamed and with mucosity in the inside.), UPPER RESPIRATORY TRACT CONGESTION (She felt her throat and lungs congested, sort of inflamed and with mucosity in the inside.) and MECHANICAL URTICARIA (Dermatographia/can write on her skin/can´t use anything tight/the mark of a bracelet stays on her skin) outcome was unknown and JOINT VIBRATION (Felt knee vibrating), MUSCLE TWITCHING (Nervous system was twitching), URTICARIA (She developed a really bad delayed reaction, 11 days after, on 19Sep2021, with full body hives), BLEPHAROSPASM (Right eye started twitching/eye was winking), TONGUE DISCOMFORT (Tongue felt really weird/tongue feels strange), GLOSSITIS (Tongue felt inflamed/tongue felt a little bigger) and MUSCLE TWITCHING (Left knee started twitching) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information also include Antihistamines. Apart from the treatment received, the caller was told to get an injection of Xolair, but she have not received it yet.  The caller stated that she went to see the allergist, dermatologist, immunologist, and her primary care doctor.  Company comment : This case concerns a 47-year-old female patient with no relevant medical history who experienced serious unexpected event of pulmonary congestion, that occurred after the 2nd dose of the mRNA-1273 however, the exact time to onset was not provided. Reportedly, the patient had kind of coughing, like trying to cough something out. She felt her throat and lungs congested, sort of inflamed and with mucus on the inside.  The rechallenge was not applicable due to occurrence after the 2nd dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-445039, MOD-2022-445047 (Patient Link).; Sender's Comments: This case concerns a 47-year-old female patient with no relevant medical history who experienced serious unexpected event of pulmonary congestion, that occurred after the 2nd dose of the mRNA-1273 however, the exact time to onset was not provided. Reportedly, the patient had kind of coughing, like trying to cough something out. She felt her throat and lungs congested, sort of inflamed and with mucus on the inside.  The rechallenge was not applicable due to occurrence after the 2nd dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.