Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pain in extremity, Rash macular, Swollen tongue, Urticaria
Clinical narrative: breathing was being affected by the swelling, dropped 150 from my normal; tongue felt and looked like it was swelling; spots on neck, back of neck, shoulders, all over my legs; multiple whelps in the whole upper arm part, moved down right arm to elbow, whelps moved over to left arm; A little bit of a sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (breathing was being affected by the swelling, dropped 150 from my normal) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), CALCIUM and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (A little bit of a sore arm). On 28-Apr-2021, the patient experienced URTICARIA (multiple whelps in the whole upper arm part, moved down right arm to elbow, whelps moved over to left arm). On 30-Apr-2021, the patient experienced RASH MACULAR (spots on neck, back of neck, shoulders, all over my legs). On 01-May-2021, the patient experienced DYSPNOEA (breathing was being affected by the swelling, dropped 150 from my normal) (seriousness criterion medically significant) and SWOLLEN TONGUE (tongue felt and looked like it was swelling). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; PREDNISONE (oral) at a dose of High dose prednisone; PREDNISONE (oral) at a dose of prednisone taper #1 and PREDNISONE (oral) at a dose of Prednisone taper #2. At the time of the report, DYSPNOEA (breathing was being affected by the swelling, dropped 150 from my normal), PAIN IN EXTREMITY (A little bit of a sore arm), URTICARIA (multiple whelps in the whole upper arm part, moved down right arm to elbow, whelps moved over to left arm), RASH MACULAR (spots on neck, back of neck, shoulders, all over my legs) and SWOLLEN TONGUE (tongue felt and looked like it was swelling) outcome was unknown.            On 01May2021 when patient experienced feeling of/appearance of tongue swelling, the patient checked their breathing on a device they use to check their outward breathing everyday. The patient noted the measurement that day dropped 150 from their normal. No other information on expiratory breathing device (assumed to be spirometer/peak flow meter).   After initial nine day prednisone taper, patient reported that spots went away and arms calmed down quite a bit. Thereafter, the spots started to come back and she was prescribed a second six day round of prednisone. Once this second course of prednisone was completed, the spots went away. The   No further information regarding clinical course was reported.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.