Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Insomnia, Malaise, Palpitations, Pruritus
Clinical narrative: FLARE UP OF CROHN'S DISEASE; CHEST PALPITATIONS; CHEST PAIN COMES AND GOES IT FEELS LIKE HAVING A HEART ATTACK; SHORTNESS OF BREATH; STRESS; ITCHING; BLOOD DOTS UNDER SKIN; FELT HOT; NOT ABLE TO SLEEP WELL; HEART RATE WENT UP; KNEE JOINTS HURT MORE THAN BEFORE; HEADACHE; OVER EXHAUSTED; FEVER BETWEEN 99 F TO 102 F; RASH ON LEFT ARM SPREADING ON OTHER ARM, NECK, SHOULDER; FEELING SICK; COULD NOT MOVE; RASH LOOKS LIKE BLISTERS THAT ARE PEELING LIKE SUNBURN, BURNS MORE THAN IT ITCHES; This spontaneous report received from a patient concerned a 59 year old  female. The patient's height, and weight were not reported. The patient's past medical history included joints hurt (knee), and concurrent conditions included Crohn's disease for 35 years, non-alcohol user, non-smoker, hypothyroidism, fibromyalgia, migraine, blood dots under skin. The patient was allergic to lot of medications and could not recall their names, but mentioned new migraine medications. The patient did not do well with steroid (unspecified). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 07-AUG-2021) dose was not reported, frequency 1 total, administered on 26-JUN-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On 29-JUN-2021, 3 days after vaccination patient started feeling sick and could not move. The patient experienced rash that started on the same arm where she got the vaccine (left arm) then spreading under arm, to the other arm, neck, shoulder. The patient described as it looked like blisters that were peeling (like a sunburn), it burned more than it was itching. It was reported that when the patient's heart rate went up, it hurt more. It felt so hot. On unspecified date, the patient experienced chest palpitations/chest pain that came and went (it felt like having a heart attack). The patient was having headache that did not go away (she usually got migraine that went away) but since she received the vaccine, the headache did not go away. She was also having a fever that ran between 99 F to 102 F. The fever started couple of days after vaccination and still did not resolve. The patient had not been able to sleep well. She had been over exhausted (fatigue). The patient's joints hurt (knee) more than before. The patient had a flare up of Crohn's disease that had not flared-up for 15 years. The symptoms worsened with any activity (even like driving for 25 minutes). It was reported that the patient had shortness of breath (she was on the mountain, not much air). She could get her Hydrocodone prescription because she was away from home. The patient also had little blood dots under the skin on her arm. She was not planning to get the vaccine but got it because she needed to travel to care for her parents and people were bugging her for not being vaccinated. She usually avoided getting any new investigational medications because she was allergic to a lot of medications and had Crohn's disease. She still walked around wearing her mask and took all her precautions. The patient's father passed away recently and her mom was in Hospice so she had been going through a difficult time and a lot of stress. The patient went to the emergency room and spoke with a doctor at her mom's facility, they told her that there was not much they can do other than giving her a steroid shot and she did not do well with steroid. At present the patient lived from 25 minutes away from town and she could not drive far because she got exhausted. On an unspecified date in 2021, Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Fever 99 F to 102 F, and Heart rate (NR: not provided) went up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on left arm spreading on other arm, neck, shoulder, fever between 99 F to 102 F, headache, chest palpitations, knee joints hurt more than before, shortness of breath, over exhausted, flare up of Crohn's disease, rash looks like blisters that are peeling like sunburn, burns more than it itches, and blood dots under skin, and the outcome of could not move, not able to sleep well, feeling sick, chest pain comes and goes it feels like having a heart attack, itching, heart rate went up, stress and felt hot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210729164 -Covid-19 vaccine ad26.cov2.s-flare up of Crohn's disease. This event is considered not related. The event 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 than the drug. Specifically: MEDICAL HISTORY