Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling of eyelid, Vomiting
Clinical narrative: EYE DISCHARGE; MALAISE; CYST; HYPERSOMNIA; SWELLING FACE; SWELLING OF EYELID; ALOPECIA; NAUSEA; COLD SWEAT; DECREASED APPETITE; MIGRAINE; MOBILITY DECREASED; EYE PAIN; PYREXIA; HYPERHIDROSIS; FEELING ABNORMAL; FEELING OF BODY TEMPERATURE CHANGE; PAIN; PARAESTHESIA; VOMITING; ARTHRALGIA; ASTHENIA; INJECTION SITE PAIN; FATIGUE; AUTOIMMUNE DISORDER; EYE DISORDER; EYE OPERATION; DENTAL EXAMINATION NORMAL; OPHTHALMOLOGICAL EXAMINATION ABNORMAL; LABORATORY TEST ABNORMAL; BLOOD TEST; OPTIC NERVE DISORDER; NECK PAIN; LYMPHADENOPATHY; This spontaneous report received from a patient via Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 1471825); concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included low performing gallbladder, and sulfonamide allergy. The patient was healthy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 14-MAR-2021 in left arm for prophylactic vaccination. All required follow-up attempts have been made. The Batch number for COVID-19 Vaccine Janssen AD26.COV.2.S has not been provided. Concomitant medications included ursodeoxycholic acid. On 14-MAR-2021, patient had lightly sting nothing bad (injection site pain). About 40 min later, on both sides of her back she felt tingling right below her shoulder blades and then this spread out like a waterfall going down her back (paraesthesia). About an hour later it was like someone turned her power off. She was so tired she could barely open the car door and walk inside. She laid down and slept maybe 3 hours and woke up hurting and puking, hot and cold and exhausted. She slept next day. She was not hungry she ate a bite and threw it all up. She felt her body like broken glass and hurt to walk to the kitchen. Her eyelashes and nails hurted. She had dinner and threw it up. She was feverish, sweating hot cold (cold sweat, hyperhidrosis) and felt like a migraine headache around forehead and eyes. On 16-MAR-2021(day 3), she was nauseous. She took shower and big clumps of her hair fell out (alopecia). Her feet hurt and tingled and felt like a spike gone through her right side off and on. On 17-MAR-2021 (on day 4), she slept all day (hypersomnia) and had to drive 8 hours home. Her left eye hurt and was draining (eye pain and discharge). The left side of her face was swollen badly and eye about swollen shut. She felt bad, achy and had stabbing side pain. She went to urgent emergency room care due to face swelling. She had a cyst like pimple on left side under eye that went back up to eye lid, could not turn her neck as it was sore. She went to Chiropractor doctor. He and his assistant examined her and said she was not out of alignment but her lymph nodes around neck area and left side of spleen were very swollen (lymphadenopathy). He said to go to dentist over face swelling and she probably had an infected tooth, went to dentist. Teeth were fine but he said to go to the eye doctor. Still feeling sick and very achy. Hurt to walk. Knees hurt (arthralgia). Went to eye doctor. She had acute narrow angle eye closure and had to do emergency surgery. Still feel horrible Labs now came back with odd things. She had holes in her iris to relieve the pressure and other auto immune things going on. Doctor said tissue swelled on optic nerve. Saw glitter like out of side of eye. Laboratory data included: Blood test (not provided) Unknown, Dental examination (not provided) normal, Laboratory test (not provided) abnormal, and Ophthalmological examination (not provided) abnormal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from alopecia, arthralgia, asthenia, autoimmune disorder, cold sweat, cyst, decreased appetite, eye disorder, eye pain, fatigue, feeling abnormal, feeling of body temperature change, hyperhidrosis, hypersomnia, injection site pain, laboratory test abnormal, lymphadenopathy, malaise, mobility decreased, nausea, neck pain, ophthalmological examination abnormal, optic nerve disorder, pain, paraesthesia, pyrexia, swelling face, swelling of eyelid, vomiting, blood test, dental examination normal, eye discharge, eye operation, and migraine. This report was serious (Disability Or Permanent Damage).  Additional information was received on 28-Sep-2021.The following information was updated and incorporated into the case narrative: All required follow-up attempts have been made. The Batch number for COVID-19 Vaccine Janssen AD26.COV.2.S has not been provided, autolabeling mapped as per previous version.; Sender's Comments: Additional version created for follow up information as : The Batch number for COVID-19 Vaccine Janssen AD26.COV.2.S has not been provided, autolabeling mapped as per previous version. This updated information does not alter the causality of the previously reported events. 20210751492-Covid-19 vaccine ad26.cov2.S- Autoimmune disorder, alopecia, cold sweat, cyst, decreased appetite, eye disorder, eye pain, feeling abnormal, feeling of body temperature change, hyperhidrosis, hypersomnia, lymphadenopathy, mobility decreased, optic nerve disorder, neck pain, pain, paraesthesia, swelling face, swelling of eyelid, vomiting, eye discharge, eye operation,  migraine, dental examination normal, opthalmological examination abnormal, laboratory test abnormal, blood test. 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). 20210751492-Covid-19 vaccine ad26.cov2.S- Arthralgia, Malaise, Injection site pain, Fatigue, Pyrexia, Nausea, Asthenia. This event(s) is labeled per RSI and is therefore considered potentially related.