Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain, Vaccination site warmth
Clinical narrative: room started to spin and almost fell; arm had a baseball size Red lump, lump was about 1'' high and hot (injection site); could not tilt head back, forward or to the sides; extremely dizzy/ whole room was spinning; arm had a baseball size Red lump, lump was about 1'' high and hot (injection site); Felt nauseous at this time; Soar at injection site; arm had a baseball size Red lump, lump was about 1'' high and hot (injection site); This spontaneous case was reported by a consumer and describes the occurrence of FALL (room started to spin and almost fell), VACCINATION SITE WARMTH (arm had a baseball size Red lump, lump was about 1'' high and hot (injection site)), POSTURE ABNORMAL (could not tilt head back, forward or to the sides), DIZZINESS (extremely dizzy/ whole room was spinning) and VACCINATION SITE MASS (arm had a baseball size Red lump, lump was about 1'' high and hot (injection site)) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018F21A, 011J20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic since 01-Jan-2010 and Fruit allergy (Avocados). Concomitant products included CETIRIZINE HYDROCHLORIDE (CETRIZINE) from 01-Jan-2012 to an unknown date for Allergy, METFORMIN from 01-Jan-2012 to an unknown date and GLIMEPIRIDE from 01-Sep-2021 to an unknown date for Diabetes, IRON from 01-Jan-2015 to an unknown date for Iron deficiency, LISINOPRIL from 01-Jan-2012 to an unknown date for Kidney disorder, VITAMIN C [ASCORBIC ACID] from 01-Jan-2015 to an unknown date and FISH OIL from 01-Jan-2015 to an unknown date for Nutritional supplementation, OMEPRAZOLE from 01-Jan-2012 to an unknown date for Stomach discomfort, VITAMIN D3 from 01-Jan-2015 to an unknown date for Vitamin D deficiency.   On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced FALL (room started to spin and almost fell), VACCINATION SITE WARMTH (arm had a baseball size Red lump, lump was about 1'' high and hot (injection site)), POSTURE ABNORMAL (could not tilt head back, forward or to the sides), DIZZINESS (extremely dizzy/ whole room was spinning), VACCINATION SITE MASS (arm had a baseball size Red lump, lump was about 1'' high and hot (injection site)), NAUSEA (Felt nauseous at this time), VACCINATION SITE PAIN (Soar at injection site) and VACCINATION SITE ERYTHEMA (arm had a baseball size Red lump, lump was about 1'' high and hot (injection site)). On 27-Nov-2021, DIZZINESS (extremely dizzy/ whole room was spinning) had resolved. At the time of the report, FALL (room started to spin and almost fell), VACCINATION SITE WARMTH (arm had a baseball size Red lump, lump was about 1'' high and hot (injection site)), POSTURE ABNORMAL (could not tilt head back, forward or to the sides), VACCINATION SITE MASS (arm had a baseball size Red lump, lump was about 1'' high and hot (injection site)), NAUSEA (Felt nauseous at this time), VACCINATION SITE PAIN (Soar at injection site) and VACCINATION SITE ERYTHEMA (arm had a baseball size Red lump, lump was about 1'' high and hot (injection site)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported. Patients height was 5.11 inch. The patient administered first dose of Moderna COVID-19 Vaccine on 30th December 2020. The concomitant product administered by the patient was MULTIVITAMIN [VITAMINS NOS] from 01-Jan-2011 to an unknown date for Nutritional supplement.  Reporter stated that after receiving Moderna booster dose, on 21st November 2021 at 05:45 he awaken because the room was spinning. He went to stand but the room started spinning again for 30 seconds. When he tried to lift the seat of toilet, room started to spin again, and he almost fell. He needed to stay upright and could not tilt head back forward or the sides because he would get dizzy instantly. His arm got sore and a baseball size red lump which was high and hot. The dizziness lasted until 27th November 2021 till about 12 noon and it went away.   This case was linked to MOD-2021-403175, MOD-2021-403189 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Significant FU: HCP added, patient's demographic information, updated Lot number for dose 1 provided, Allergic condition added, medical history added, concomitants added, additional events added and updated narrative provided.