Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Erythema, Feeling hot, Flushing, Headache
Clinical narrative: Tachycardia; Had a runny nose that day; pouring out mustardy yellow color out of nose; Nice mass of rash; Headache started to get worse/ then waxed and waned approximately 3-4 times; Lymph glands on underarm were swollen and sore; White spots; Redness on right arm; Heat; Face flushed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TACHYCARDIA (Tachycardia), FLUSHING (Face flushed), ERYTHEMA (Redness on right arm), FEELING HOT (Heat) and RHINORRHOEA (Had a runny nose that day) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Muscle spasm, Heart rate irregular (Fluctuating heart rate) and Bladder rupture. Family history included Migraine (Prone to migraines) since an unknown date. Concurrent medical conditions included Asthma, Fibromyalgia, Cholesterol, Perfume sensitivity (Very sensitive to the triggers to perfume), Contrast media allergy (Very sensitive to the triggers to perfume, dyes) and Detergent sensitivity (Very sensitive to laundry detergent sets off migraine). Concomitant products included MONTELUKAST for Asthma, ESTRADIOL (ESTRACE VAGINAL) for Bladder repair, EPINEPHRINE (EPIPEN) for Cholesterol, BUTALBITAL, CAFFEINE, CODEINE PHOSPHATE, PARACETAMOL (FIORICET WITH CODEINE) for Migraine, METAXALONE (SKELAXIN [METAXALONE]) for Muscle spasm, METOPROLOL TARTRATE, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), ALIROCUMAB (PRALUENT) and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced FLUSHING (Face flushed). On 10-Feb-2021, the patient experienced ERYTHEMA (Redness on right arm) and FEELING HOT (Heat). On 11-Feb-2021, the patient experienced SKIN DEPIGMENTATION (White spots) and LYMPHADENOPATHY (Lymph glands on underarm were swollen and sore). On 12-Feb-2021, the patient experienced RHINORRHOEA (Had a runny nose that day), NASAL DISCHARGE DISCOLOURATION (pouring out mustardy yellow color out of nose), RASH (Nice mass of rash) and HEADACHE (Headache started to get worse/ then waxed and waned approximately 3-4 times). On 16-Feb-2021, the patient experienced TACHYCARDIA (Tachycardia). The patient was treated with METOPROLOL TARTRATE (LOPRESSOR) for Tachycardia, at a dose of 12.5 mg. On 29-Jan-2021, FLUSHING (Face flushed) had resolved. At the time of the report, TACHYCARDIA (Tachycardia), ERYTHEMA (Redness on right arm), FEELING HOT (Heat), RHINORRHOEA (Had a runny nose that day), SKIN DEPIGMENTATION (White spots), NASAL DISCHARGE DISCOLOURATION (pouring out mustardy yellow color out of nose), LYMPHADENOPATHY (Lymph glands on underarm were swollen and sore) and HEADACHE (Headache started to get worse/ then waxed and waned approximately 3-4 times) outcome was unknown and RASH (Nice mass of rash) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Blood pressure measurement: 140/98 (High) blood pressure rose to 140/98. On 15-Feb-2021, Heart rate: 77 (normal) 77 beats per minute. On 16-Feb-2021, Blood pressure measurement: 140/90 (High) blood pressure was 140/90. On 16-Feb-2021, Heart rate: 95 (normal) 95 beats per minute.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient did DNA test for medication takes for migraine due to family history with sister having a bad reaction to a class of drugs   This case was linked to MOD-2021-090562 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Event details updated, outcome of events updated, second dose details updated; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Headache, lymphadenopathy and rash are consistent with the known safety profile of the vaccine. MOD-2021-090562:2 dose case