Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Diarrhoea, Disorientation, Fatigue
Clinical narrative: Sore shoulder/Soreness on both legs, kness and ankles; Very fatigued; Headaches; Congestion in his chest all the way to his throat; Migraines; Felt his brain kind of funny, like he was on a boat; Soreness on both legs, knees and ankles; Continuous nasal drainage; Disoriented; Lost of balance; Numbness on the big toe and the palm of his left foot; Diarrhea; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (Congestion in his chest all the way to his throat) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (previous sinus surgery). Concurrent medical conditions included Migraine (He usually has migraines and headaches 2 to 3 times a week), Ischemic heart disease (ischemic heart condition), Blood pressure abnormal, Constipation, Nerve pain, Nasal discharge (He has a usual off and on nasal drainage because of a previous sinus surgery) and Prostatic disorder. Concomitant products included LORATADINE (CLARITIN [LORATADINE]) and BENZONATATE for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PULMONARY CONGESTION (Congestion in his chest all the way to his throat) (seriousness criterion medically significant), MIGRAINE (Migraines), FEELING ABNORMAL (Felt his brain kind of funny, like he was on a boat), PAIN IN EXTREMITY (Soreness on both legs, knees and ankles), RHINORRHOEA (Continuous nasal drainage), DISORIENTATION (Disoriented), BALANCE DISORDER (Lost of balance), HYPOAESTHESIA (Numbness on the big toe and the palm of his left foot), DIARRHOEA (Diarrhea), MYALGIA (Body aches), FATIGUE (Very fatigued) and HEADACHE (Headaches). On 17-Feb-2021, the patient experienced ARTHRALGIA (Sore shoulder/Soreness on both legs, kness and ankles). At the time of the report, PULMONARY CONGESTION (Congestion in his chest all the way to his throat), MIGRAINE (Migraines), FEELING ABNORMAL (Felt his brain kind of funny, like he was on a boat), PAIN IN EXTREMITY (Soreness on both legs, knees and ankles), RHINORRHOEA (Continuous nasal drainage), DISORIENTATION (Disoriented), BALANCE DISORDER (Lost of balance), HYPOAESTHESIA (Numbness on the big toe and the palm of his left foot), DIARRHOEA (Diarrhea), MYALGIA (Body aches), ARTHRALGIA (Sore shoulder/Soreness on both legs, kness and ankles), FATIGUE (Very fatigued) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 10 Mar 2021,  the patient received second dose of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  Additional concomitant medications included blood thinner and unspecified medications for his ischemic heart condition, blood pressure, prostate, constipation and nerve pains.   Reportedly, 4 or 5 days after vaccination, the patient's migraines and headache increased specially on the night when he took an horizontal position and went from his forehead all the way to his left temple.  Treatment medication included unspecified ointment for his chest.  Company Comment : This case concerns a 73-year-old male with a serious unexpected event of pulmonary congestion, and nonserious unexpected migraine, feeling abnormal, pain in extremity, rhinorrhea, disorientation, balance disorder, hypoaesthesia, diarrhoea, and expected myalgia, arthralgia, fatigue, headache. Event latency 4-5 days after mRNA-1273. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 73-year-old male with a serious unexpected event of pulmonary congestion, and nonserious unexpected migraine, feeling abnormal, pain in extremity, rhinorrhea, disorientation, balance disorder, hypoaesthesia, diarrhoea, and expected myalgia, arthralgia, fatigue, headache. Event latency 4-5 days after mRNA-1273. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.