Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Inappropriate schedule of product administration, Lethargy, Myalgia, Pyrexia
Clinical narrative: late second dose (37 day interval); resting heart rate is up 20 beats per minute; resting heart rate about 20 bpm higher than usual ("typically low 60s, now low 80s"; mild headache; feeling generally achey; little bit of chills; very low grade fever; pretty lethargic; ears were ringing; felt like nerves fired up throughout the body; arm  was very sore; very bad headache; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (pretty lethargic), TINNITUS (ears were ringing), HEART RATE INCREASED (resting heart rate about 20 bpm higher than usual ("typically low 60s, now low 80s"), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (late second dose (37 day interval)) and BURNING SENSATION (felt like nerves fired up throughout the body) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 009D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history were reported.  Concomitant products included MONTELUKAST, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), FLUTICASONE PROPIONATE (FLOVENT), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced BURNING SENSATION (felt like nerves fired up throughout the body), MYALGIA (arm  was very sore) and HEADACHE (very bad headache). On 25-Jun-2021, the patient experienced LETHARGY (pretty lethargic). 25-Jun-2021, the patient experienced TINNITUS (ears were ringing), CHILLS (little bit of chills), PYREXIA (very low grade fever), MYALGIA (feeling generally achey) and HEADACHE (mild headache). On 26-Jun-2021, the patient experienced HEART RATE INCREASED (resting heart rate about 20 bpm higher than usual ("typically low 60s, now low 80s"). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (late second dose (37 day interval)) and HEART RATE ABNORMAL (resting heart rate is up 20 beats per minute). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. In May 2021, BURNING SENSATION (felt like nerves fired up throughout the body) had resolved. On 19-May-2021, HEADACHE (very bad headache) had resolved. On 21-May-2021, MYALGIA (arm  was very sore) had resolved. On 25-Jun-2021, TINNITUS (ears were ringing), PYREXIA (very low grade fever) and HEADACHE (mild headache) had resolved. At the time of the report, LETHARGY (pretty lethargic), HEART RATE INCREASED (resting heart rate about 20 bpm higher than usual ("typically low 60s, now low 80s"), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (late second dose (37 day interval)), HEART RATE ABNORMAL (resting heart rate is up 20 beats per minute), CHILLS (little bit of chills) and MYALGIA (feeling generally achey) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) his resting heartrate is about 20 bpm higher than usual..         Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-237274 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Non-Significant Follow-up received on 28-jun-2021 contains no new information.