Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Haemorrhagic stroke
Clinical narrative: STROKE; FATIGUE; NOT FEELING WELL; This spontaneous report was received from a consumer (patient's husband) and from a company representative via social media, and concerned a 63 year old female. The patient's height and weight were not reported. The patient's concurrent conditions included high blood pressure, thyroid disorder, thyroid goiter surgery (to remove portion of thyroid), and alcohol use (very little wine occasionally). The patient had no known allergies to vaccine, drugs or food, non-smoker and no history of drug abuse. The patient had a family history of stroke and hypertension. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070) 0.5 ml, administered on 08-MAR-2021 at 11:30am to left deltoid for prophylactic vaccination. Concomitant medications included levothyroxine sodium for thyroid disorder and unspecified medication for blood pressure.  The patient and her husband both received the injection from the same lot number, but different people administered their vaccines. The patient's husband stated that his wife started to complain shortly after she received the vaccine. First thing after they received the vaccine they went to lunch and the patient was complaining of feeling fatigued. As the day went on the patient was feeling more and more fatigued. The patient asked her husband if the nurse mentioned any problem that she might have taking the vaccine. It was mentioned by the nurse to not take aspirin or Tylenol and try to make the antibodies build up. The patient questioned her husband again, "did anybody say anything about blood pressure?". She asked if anything was on the written material regarding conditions that need to be looked at more serious with the vaccine. Her husband mentioned no personalization with her at the vaccine center. They went to bed real early that night. The next day, the patient woke up and went to work at the local university. The patient came home at 5:00pm and had dinner. The patient kept complaining, looking at the paperwork, and was not feeling well and very tired. The patient went to bed around 10:00pm. The patient snored, which was typical, and her husband went into the other room to sleep. The husband woke up at 8:15 am and went into her room. He reported that his wife was sitting back with the TV on. It looked like she was watching TV. The husband came back in another time and it looked like she was resting once again. The husband went back in around 8:30-8:40 am (approximate time). The husband had a 9:00 am call for work. The patient seemed okay and was resting before he went on his call. After the call around 9:30 am and a short follow up call, the husband checked on his wife and she was not saying anything. He tried to lift her up. There was no response, and he started yelling at her to wake up. He felt her forehead, and it was cool. The husband gave her mouth to mouth and tried to pull her up and she fell to the other side of the bed. He pulled her back up. The patient was lying face down for a little bit. He moved her to her back and then gave her CPR (Cardiopulmonary Resuscitation). At that time he called 911 in a panic, and 911 gave him further instructions for CPR. The husband performed CPR for a few minutes and then the paramedics arrived and took over, and told him to get out of the room. The paramedics stated they could not do a shock because there was no pulse. The patient passed away and was pronounced dead. A death certificate stated contributed to J&J vaccine. An autopsy was performed on 12-MAR-2021. The husband stated her last doctor's appointment was 6 months ago.  The patient's daughter reported via a media post that the patient died from a stroke. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).  Additional information was received from a consumer on 20-MAR-2021, 21-MAR-2021, 22-MAR-2021 and 23-MAR-2021. The following information was updated and incorporated into the case narrative: new event of stroke was added to the case according to daughter on media, family history of stroke and hypertension according to published article.; Sender's Comments: V4: Follow-up added event of Stroke and a family history of stroke and hypertension, per report from the subject's daughter on a media. Company causality remains unchanged. A 63-year-old female with a history of hypertension, hypothyroidism, and snoring died of unknown causes (also reported as "stroke" in media) 2 days after receiving Janssen COVID-19 Vaccine Ad26.COV2.S (suspension for injection, intramuscular and batch number: 1802070.) Family history is significant for stroke and hypertension. Concomitant medications included levothyroxine and an unknown blood pressure medication. Per report from her husband, the patient started complaining of fatigue shortly after the vaccine, which progressed throughout the day. She went to bed early and went to work the next day and came home for dinner. She was complaining of not feeling well with continued fatigue. She went to bed and approximately 11 hours later was found unresponsive by her husband. He initiated cardiopulmonary resuscitation (CPR) efforts, called 911, and paramedics arrived to assume care and continued CPR. Per husband, "a shock could not be delivered because no pulse" and the patient was pronounced dead. Autopsy was performed and the report is pending. This case has insufficient information to make a meaningful medical assessment. Additional information has been requested, including autopsy findings.; Reported Cause(s) of Death: STROKE