Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hepatomegaly, Immune thrombocytopenia, Immunoglobulin therapy, International normalised ratio normal, Liver function test normal
Clinical narrative: BLOOD CLOTS IN BOTH LEGS; PLATELET COUNT DECREASED; ABDOMINAL PAIN; LEG CRAMPS; SEVERE CHILLS; SEVERE HEADACHE; FEVER OF UP TO 102 DEGREES; SEEING LINES; DIFFICULTY IN WALKING; LEG PAIN; This spontaneous report received from a patient concerned a 40 year old female. The patient's weight was 155 pounds, and height was 67 inches. The patient's past medical history included back surgery, and kidney stone removal, and concurrent conditions included alcohol use (one drink once or twice a month), and non smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. January 2021, she had a procedure and her platelet count was 300 (unit unspecified). The patient experienced drug allergy when treated with amitriptyline hydrochloride, heparin, oxybutynin, tramadol hydrochloride, and hydrocodone bitartrate/paracetamol. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: 20-JUN-2021) frequency 1 total, dose was not reported, administered to left deltoid on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  One week later, on 14-APR-2021, patient began experiencing a severe headache, severe chills, abdominal pain, leg cramps, and a fever of up to 102 degrees. She reported no history of headache or migraines, yet along with the headache, she said she was seeing lines.  She said that she called her doctor on 15-APR-2021 (the next day) who advised her to go to the hospital. On 16-APR-2021, patient went to the Hospital, where she was admitted for vaccine induced blood clots in both legs. After receiving the Janssen COVID vaccine, on 16-APR-2021, her platelet count was 27 (coded as platelet count decreased). While in the hospital, she was placed on a blood thinner drip, and her platelet count went as low as 9 (units unspecified). On 19-APR-2021, she was flown to another hospital. She remained in that hospital until 27-APR-2021 when she was discharged. Patient was hospitalized for a total of 11 days. She was currently taking Eliquis 5mg twice a day. She was still having leg pain, and could barely walk (coded as difficulty in walking). She was also concerned about her medical bills. She said that before getting the Janssen COVID vaccine, she was a healthy individual and had not taken any birth control or estrogen. She was continuing to follow up with her physician. Treatment medications (dates unspecified) included: apixaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe chills on 27-APR-2021, was recovering from severe headache, and fever of up to 102 degrees, had not recovered from abdominal pain, leg cramps, and leg pain, and the outcome of blood clots in both legs, seeing lines, difficulty in walking and platelet count decreased was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This spontaneous report received from a patient concerned a 40-year-old female (BMI 24.3 kg/m2), who experienced "blood clots in both legs" and platelet count decreased 9 days after vaccine. Past medical history included back surgery and kidney stone removal. Her baseline platelet count was 300,000 last checked 4 months before vaccine. The patient was not pregnant at the time of report. No concomitant medications were reported but she denied taking oral contraceptives or other forms of estrogen. Seven days after vaccine, the patient began experiencing a severe headache, severe chills, abdominal pain, leg cramps, and a fever of up to 102 degrees. She said that she called her doctor on day 8 who advised her to go to the hospital. On day 9, patient went to the hospital, where she was admitted for vaccine induced blood clots in both legs. No specific imaging modality or results were reported. Nine days after vaccine, her platelet count was 27,000. While in the hospital, she was placed on an unspecified blood thinner drip, and her platelet count went as low as 9,000. On day 12, she was flown to another hospital. She remained in that hospital until day 20 when she was discharged. She was started on Eliquis 5mg twice a day. As of this report, she was still having leg pain and difficulty walking. She was continuing to follow up with her physician. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from Brighton Collaboration-BC), the low platelet count and temporal relationship to vaccination (BC Criteria level 5), the events are assessed to have a plausible relationship with vaccination.