Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Ear pain, Lethargy, Limb discomfort, Pain in extremity
Clinical narrative: Heavy arm; Little lethargic; A little soreness on both sides below his earlobes; Pressure in ears, like a clogged ear, ears need to pop like being on an airplane; Puffiness (both sides under his ear/jawline area; Slight swelling (both sides under his ear/jawline area); A sore arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Heavy arm), LETHARGY (Little lethargic), EAR PAIN (A little soreness on both sides below his earlobes), EAR DISCOMFORT (Pressure in ears, like a clogged ear, ears need to pop like being on an airplane) and SWELLING FACE (Puffiness (both sides under his ear/jawline area) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergic to Demerol), Drug allergy (Allergic to Benadryl), Allergy to topical drugs (Allergic to topical iodine), Seasonal allergy and Complex regional pain syndrome Type II (CRPS Type II vagus (affects left arm)). Concomitant products included POTASSIUM, PROPRANOLOL, LISDEXAMFETAMINE MESILATE (VYVANSE), VITAMIN D NOS and MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 10-Feb-2021, the patient experienced LIMB DISCOMFORT (Heavy arm), LETHARGY (Little lethargic), EAR PAIN (A little soreness on both sides below his earlobes), EAR DISCOMFORT (Pressure in ears, like a clogged ear, ears need to pop like being on an airplane), SWELLING FACE (Puffiness (both sides under his ear/jawline area), SWELLING (Slight swelling (both sides under his ear/jawline area)) and PAIN IN EXTREMITY (A sore arm). At the time of the report, LIMB DISCOMFORT (Heavy arm), LETHARGY (Little lethargic), EAR PAIN (A little soreness on both sides below his earlobes), EAR DISCOMFORT (Pressure in ears, like a clogged ear, ears need to pop like being on an airplane), SWELLING FACE (Puffiness (both sides under his ear/jawline area), SWELLING (Slight swelling (both sides under his ear/jawline area)) and PAIN IN EXTREMITY (A sore arm) had not resolved.            On 09-Feb-2021, the patient received their second dose and stated they had a heavy arm at the time of report and a sore arm and was a little lethargic post receiving the vaccine. The patient also mentioned that they were experiencing a little soreness on both sides below their earlobes and also experienced slight swelling and puffiness on both sides under their ear/jawline area.   The patient also experienced pressure in their ears like a clogged ear and stated that it was like their ears need to pop like being on an airplane.  No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-029277 (Patient Link).