Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Cataract, Confusional state, Flushing, Skin discolouration
Clinical narrative: LITTLE BROWN LESIONS ON CHEST AREA AND FACIAL AREA; CATARACT UNDERNEATH THE LENS; BROWN SPOTS ON BODY SIZE ON BOTH  ARMS AND BOTH ANKLE; CONFUSION STATE; FLUSHING; CARDIAC ARRHYTHMIAS; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's past medical history included cataracts surgery (performed in 2019). Patient had not been diagnosed with Covid. Concurrent conditions included cardiovascular issues (heart disease), multiple chemical sensitivity (sensitive to chemical ethylene oxide and as in everything hence reacted to so many things), lung issues, and asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 02-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. Patient had cataract surgery in 2019 and had researched about the lenses and she found that the acrylic Johnson and Johnson was the best. On 02-APR-2021, immediately within a minute on day of the vaccination, she had cardiac arrhythmias, shortness of breath, she was in a confused state, and had flushed. She was unsure of blood pressure status and stayed a little extra time at vaccination clinic as she did not wished to drive. On 28-MAY-2021, she had brown spots on body size of a 2.5 by 3 inch flag and in 4 locations on body, both arms. Her left side of the arm was darker on arm than right arm especially on forearm, on left ankle same shape and size as on arms except the left ankle was darker, right ankle not as much, saw ankle as brown appeared to be vascular. She took picture and it faded out and then occasionally and returned except the one on the left arm that had been there all along but very light compared to initial occurrence and she saw the vein very close by the lesion that was not noticeable before. On 16-OCT-2021, her vision in both eyes had faded. She was not sure about the dates of exact start days of the symptoms. On 10-NOV-2021, she had also developed little brown lesion that was on chest area and one developed on facial area. She had a cataract underneath the lens at the time of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flushing on 02-APR-2021, and was recovering from brown spots on body size on both arms and both ankle, little brown lesions on chest area and facial area, cardiac arrhythmias, confusion state, and cataract underneath the lens. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211136209-Covid-19 vaccine ad26.cov2.s-Cardiac arrhythmias. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY 20211136209-Covid-19 vaccine ad26.cov2.s- Cataract underneath the lens. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).