Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth, Lymphadenopathy
Clinical narrative: ELEVATED BLOOD PRESSURE; ELEVATED HEART RATE; SWOLLEN HANDS; DIDN'T FEEL WELL; TEMPERATURE 103; ITCHINESS EVERYWHERE/HANDS BECOME VERY ITCHY; SWELLING ALL OVER LEGS, ARMS, CHEST, TORSO; VERY ITCHY, RED RASH ON HER WHOLE BODY; SHIVERING UNCONTROLLABLY; COULDN'T STOP SHAKING; ALMOST PASSED OUT/FELT LIKE PASSING OUT; COULDN'T GET WARM; PSORIASIS ON THE LOWER LEFT CALF; SMALL BLOOD CLOT IN THE LEFT ARM; SWOLLEN FACE; SWOLLEN EARS AND COULD NOT HEAR WELL DUE TO SWELLING; LOW PLATELETS; INJECTION SITE SWELLING; INJECTION SITE REDNESS; INJECTION SITE HARDNESS; INJECTION SITE HOTNESS; LYMPH NODES UNDER THE ARMPITS; SUPER, VERY PAINFUL INJECTION SITE/SUPER SORE INJECTION SITE; VERY PAINFUL LEFT ARM; REDNESS ON THE NECK DOWN TO HER CHEST AND ARMS/LOOKED SUNBURNT ALL OVER; SHORTNESS OF BREATH WHEN WALKING/BREATHING HEAVILY AFTER WALKING; SKIN PEELED OFF THE SOLES OF FEET; BROWN SPOT ON THUMB; SUPRAVENTRICULAR TACHYCARDIA; This spontaneous report received from a patient concerned a 39 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's had skin cancer (mole) which was removed in JUN-2021 and was suffering from psoriasis. The patient was severely allergic to dust and dust mites and had a reaction to MMR vaccine 19 years ago. The patient was also allergic to penicillin and had seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) 1 total dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination on left arm. No concomitant medications were reported.  On 10-SEP-2021, the patient experienced itchiness everywhere on torso, chest, arms and redness on neck, down to chest and arms. On 11-SEP-2021, the patient felt injection site was super, very painful and could feel in her sleep for overnight. The patient woke up and after shower, her left arm was very painful and injection site was super sore and hard and felt hot, red and swollen. The patient did not feel well so she laid down and was shivering uncontrollably. The patient's hands became very itchy and swollen and called her primary care provider who advised to take additional dose of Allegra and Benadryl, along with her doses which she took. The patient noted that she couldn't get warm and stop shaking and when she stood her eyes went black and couldn't hear. She almost passed out so she laid down for bit and when she could stand up again she left to hospital. The patient was driven by her partner and notes she was out of it on way to urgent care. On the same day she attended emergency room which was connected to hospital. The patient felt like throwing up or passing out during triage so she laid down in bed and IV has started. The temperature was 103 F and was still shivering, her heart rate and blood pressure were elevated and she had swelling all over(legs, arms, torso, chest) and had very itchy, red rash on her body. The heart rate went up to 130 when lying and 160 when on bed and settled to over 100. The patient had CT of chest and fund that there were no blood clot in lungs but prominent lymph nodes under armpit. Laboratory data included: Blood pressure (NR: not provided) Elevated, Body temperature (NR: not provided) 103 F, Chest CT (NR: not provided) no blood clots in lungs, and Heart rate (NR: not provided) 130 {beats}/min, Over 100, Elevated, 160 {beats}/min. She was admitted in the hospital and received Tylenol and Benadryl until 12-SEP-2021 and was given with Prednisone which made her feel better. On 12-SEP-2021, Prednisone was stopped and Benadryl was given along with allergy medication. On 13-SEP-2021, the patient had swollen ears due to which couldn't hear, face body, elevated heart rate, low platelets and was given with Prednisone. Laboratory data included: Heart rate (NR: not provided) Still elevated, and Platelet count (NR: not provided) Too low. On 14-SEP-2021, the patient experienced small blood clot in the left arm. Laboratory data included: Diagnostic ultrasound (NR: not provided) small blood clot in left arm. Laboratory data included: Heart rate (NR: not provided) Still elevated, and Platelet count (NR: not provided) Too low. On 14-SEP-2021, the patient experienced small blood clot in the left arm. Laboratory data included: Diagnostic ultrasound (NR: not provided) small blood clot in left arm. On 14-SEP-2021, ultrasound of arms showed small blood clot in left arm and got 2 blood thinner injections and got discharged on 14-SEP-2021. The patient had follow up and ultrasound, mammogram which were normal, echo was fine, VIO patch, electrocardiogram monitor for 2 weeks with no results and 3 day cardiac monitor showed 1 episode of SVT. Laboratory data included: Diagnostic ultrasound (NR: not provided) small blood clot in left arm. On an unspecified date, the patient experienced elevated blood pressure, elevated heart rate, and psoriasis on the lower left calf Laboratory data (dates unspecified) included: Cardiac monitoring (NR: not provided) 1 episode of SVT, unknown, Echocardiogram (NR: not provided) normal, Heart rate (NR: not provided) 85-95, 60-90, 100-140, Mammogram (NR: not provided) Normal, and Ultrasound breast (NR: not provided) Normal. On 22-OCT-2021, the patient consulted PCP who stated her heart would take a month to go back to normal. The redness, itchiness, rash went away 2 weeks ago, injection site pain, arm pain remained for 2 weeks and injection site remained hard for weeks. The patient stated that hot, swollen, itchiness around injection site subsided in SEP-2021. The patient felt like heart rate was 100-140 and when sitting it was 60-90 which was high for her. The patient also felt shortness of breathe while walking and was being noticed with breathing heavily after 90 seconds of walking. When the heart rate would go down to 85-95, shortness of breathe would go away. The patient experienced a thick layer of skin peeling in sole of both feet and developed a new brown spot on her thumb, between thumb knuckles that was itchy and had a size of small dime. The patient was told to keep a look on the spot by her PCP. The patient also stated that she did not experience outbreak of psoriasis in 8 years until she got vaccinated and developed a patch on her left inner calf. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shivering uncontrollably, couldn't stop shaking, couldn't get warm, almost passed out/felt like passing out, itchiness everywhere/hands become very itchy, swollen hands, swelling all over legs, arms, chest, torso, very itchy, red rash on her whole body, redness on the neck down to her chest and arms/looked sunburnt all over, injection site hardness, swollen face, swollen ears and could not hear well due to swelling, and very painful left arm, temperature 103 on 12-SEP-2021, and super, very painful injection site/super sore injection site, injection site hotness, injection site swelling, and injection site redness on SEP-2021, had not recovered from elevated blood pressure, elevated heart rate, and shortness of breath when walking/breathing heavily after walking, and the outcome of lymph nodes under the armpits, low platelets, small blood clot in the left arm, supraventricular tachycardia, skin peeled off the soles of feet, brown spot on thumb, psoriasis on the lower left calf and didn't feel well was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20211056242-Covid-19 vaccine ad26.cov2.s-couldn't stop shaking, almost passed out/felt like passing out, itchiness everywhere/hands become very itchy, swollen hands, swelling all over legs, arms, chest, torso, elevated blood pressure, elevated heart rate . These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events 20211056242- Covid-19 vaccine ad26.cov2.s- small blood clot in left arm, couldn't get warm, didn't feel well, very itchy, red rash on her whole body, temperature 103, shivering uncontrollably. These events are labeled and are therefore considered potentially related.