Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Peripheral swelling, Pyrexia, Skin bacterial infection
Clinical narrative: EASILY BRUISES; SWELLING OF HANDS AND FEET; BLURRY VISION; SHORT TERM MEMORY NOT WHAT IT WAS BEFORE; DIFFICULTY WALKING, HARD TIME LIFTING FEET; URINE COLOR CHANGED TO ORANGE-BROWN COLOR; LOWER BACK PAIN; RASH/ECZEMA; FEELS EQUILIBRIUM IS OFF; THRUSH/DIFFICULTY SWALLOWING PILLS/TONGUE BURNING SENSATION/DROOLING; BACTERIAL INFECTION ON CHEST; BLOOD LOSS; SEVERE ANEMIA; ACHINESS/BODY ACHE; DRY COUGH; DIFFICULTY BREATHING; MALAISE; FEVER; HEADACHE; FATIGUE; 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 concurrent conditions included: allergic to antibiotics, rheumatoid arthritis, fibromyalgia, osteoarthritis, autoimmune disorder and other pre-existing medical conditions included: The patient was allergic to everything. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 20-JUL-2021 to left arm for prophylactic vaccination. Concomitant medications included metronidazole for dental cleaning and other oral medications. First few days, after receiving vaccine, On JUL-2021 the patient experienced mild symptoms fever, malaise, achiness/body ache, headache, difficulty breathing and that it was very difficult to catch her breath, dry cough, fatigue. And patient reported, a rash appeared all over her body which she did see a dermatologist for and, on 03-AUG-2021, diagnosed with eczema. On an unspecified date the patient experienced bacterial infection on chest, thrush/difficulty swallowing pills/tongue burning sensation/drooling (stated that tongue burning sensation was due to thrush), easily bruises, swelling of hands and feet, blurry vision, short term memory not what it was before, difficulty walking due to had a hard time lifting feet, urine color changed to orange-brown color, lower back pain, feels equilibrium is off. On 04-SEP-2021, the patient experienced blood loss and severe anemia. And the rash was subsiding.  On 04-SEP-2021 Laboratory data included: Blood test (NR: not provided) kidney function normal, but the patient was severely anemic (had blood loss). The patient stated that she had contacted her primary care physician regarding the events however her primary care doctor said he did not know what it could be. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rash/eczema, had not recovered from fever, dry cough, and difficulty breathing, and the outcome of malaise, achiness/body ache, headache, fatigue, bacterial infection on chest, easily bruises, swelling of hands and feet, blurry vision, short term memory not what it was before, difficulty walking, hard time lifting feet, urine color changed to orange-brown color, lower back pain, feels equilibrium is off, thrush/difficulty swallowing pills/tongue burning sensation/drooling, severe anemia and blood loss was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210925867-covid-19 vaccine ad26.cov2.-Blood loss. 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).