Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Incomplete course of vaccination, Malaise, Rash pruritic, Thinking abnormal
Clinical narrative: Passed the 36 day window to get the second shot; High blood pressure 169/95 for last 2 weeks; Corneal irritation; Felt tired; Could not think clearly; Had no taste; Not feeling well; Tested positive for Covid-19; Dry eyes/ eyes have been so dry, has made reading uncomfortable; Itchiness of the jaw line/ Rash on the face, left/right cheek/ itchy/rash on both cheeks, lower left/right cheek, pimple like and itchy; Hives / Two welts; This spontaneous case was reported by a consumer and describes the occurrence of INCOMPLETE COURSE OF VACCINATION (Passed the 36 day window to get the second shot), COVID-19 (Tested positive for Covid-19), URTICARIA (Hives / Two welts), DRY EYE (Dry eyes/ eyes have been so dry, has made reading uncomfortable) and RASH PRURITIC (Itchiness of the jaw line/ Rash on the face, left/right cheek/ itchy/rash on both cheeks, lower left/right cheek, pimple like and itchy) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PROPRANOLOL, LEVOTHYROXINE, LOSARTAN, ALLOPURINOL, SERTRALINE and ALENDRONATE SODIUM for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced URTICARIA (Hives / Two welts) and RASH PRURITIC (Itchiness of the jaw line/ Rash on the face, left/right cheek/ itchy/rash on both cheeks, lower left/right cheek, pimple like and itchy). On 01-Mar-2021, the patient experienced DRY EYE (Dry eyes/ eyes have been so dry, has made reading uncomfortable). On 26-Mar-2021, the patient experienced COVID-19 (Tested positive for Covid-19), THINKING ABNORMAL (Could not think clearly), AGEUSIA (Had no taste), MALAISE (Not feeling well) and FATIGUE (Felt tired). On 08-Apr-2021, the patient experienced CORNEAL IRRITATION (Corneal irritation). On 15-Apr-2021, the patient experienced HYPERTENSION (High blood pressure 169/95 for last 2 weeks). On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (Passed the 36 day window to get the second shot). At the time of the report, INCOMPLETE COURSE OF VACCINATION (Passed the 36 day window to get the second shot) had resolved, COVID-19 (Tested positive for Covid-19), THINKING ABNORMAL (Could not think clearly), AGEUSIA (Had no taste), MALAISE (Not feeling well), CORNEAL IRRITATION (Corneal irritation), HYPERTENSION (High blood pressure 169/95 for last 2 weeks) and FATIGUE (Felt tired) outcome was unknown, URTICARIA (Hives / Two welts) and DRY EYE (Dry eyes/ eyes have been so dry, has made reading uncomfortable) had not resolved and RASH PRURITIC (Itchiness of the jaw line/ Rash on the face, left/right cheek/ itchy/rash on both cheeks, lower left/right cheek, pimple like and itchy) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event, included a gel, eyedrops, topical creams, and steroid eye ointment.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: follow information received on 08-Apr-2021, events added On 29-Apr-2021: Follow up information received on 29-apr-2021, events were added; Sender's Comments: This report refers to a case of incomplete course of vaccination for mRNA-1273, lot # 011J20A  with associated AEs rash pruritic, urticaria and dry eye. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.