Johnson & Johnson

Admitted 4/3 with a cerebral sinus venous thrombosis, portal vein thrombosis and pulmonary embolus. Pt received covid vaccine 3/18. Symptoms began 3/26 which started with chills and body aches. Then on 3/27- developed a severe headache in the back of her head with associated nausea. On 3/28 she had the most severe headache on the right side of her head. She was vomiting from 3/28-3/30. On 3/30 she went to the ER for evaluation of her severe headache. She was given a "migraine cocktail", no imaging was completed and she was sent home. Appetite improved on 3/31 and she had a small headache relieved with Excedrin. Then on 4/1-4/2 she had severe bloating , abdominal pain and fever of 100.4. She had been visiting her mom for the holidays and came to the ER. Imaging revealed cerebral sinus venous thrombosis, portal vein thrombosis and pulmonary embolus. She was started on a heparin drip and brought to ICU for monitoring.. She is not on any oral contraceptives and does not have any family history of clotting disorders.

Had no side effects whatsoever for many hours. Felt completely fine until about 7:30 pm, while I was making my plate of dinner. Felt lightheaded, dizzy, and hot. I began to black out, so I sat down, which helped for a few moments to subside lightheadedness. I was still feeling hot, so I walked a few feet to my back door and sat down on the steps outside to cool off. Within minutes, my vision blurred completely, I saw stars, and completely blacked out. My mother, who was nearby, heard me fall on the steps. She said my eyes rolled back, my body was completely limp, I was not breathing but rather making gurgling noises from my throat. She propped my head up, which allowed me to breathe properly, and I came to. If my mother had not been nearby, I am convinced I would be dead right now. I saw the light, saw the other side, saw my relatives. I have had a near death experience once before, and this was exactly like that.

Chills 12 h after receipt of vaccine followed by low grade fever (101 F) and body ache with minor headache. Symptoms subsided by the end of the following day. 1st menstrual period post-vaccination was noticeably heavier with more clots than usual.

5 Blood clots coming from right nostril, headache, fatigue, stomach pains Nose bleed with clots lasted 15-20 minutes. Headache, fatigue, stomach pains lasted throughout the day.

Patient presented to ED for 2 syncopal episodes and went into cardiac arrest 5 minutes prior to ED arrival in ambulance. She received ACLS measures and alteplase was mixed and administered for pulmonary embolism concern.

BLOOD CLOT; This spontaneous report received from a pharmacist concerned a 26 year old female of unknown ethnicity. The patient's height, and weight were not reported. The patient had no known drug allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: unknown) dose was not reported, 1 total dose, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date (after vaccination), the patient experienced blood clot. The pharmacist thought, that she has been treated, and at the time of this report she was at home, but he was not 100% sure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210522731-Covid-19 vaccine ad26.cov2.s-blood clot. 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).

BODY PAIN; HEART PALPITATIONS; VAGINAL BLEEDING; FEVER; This spontaneous report received from a patient concerned a 26 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies and was not taking any medications. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 27A21A, expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced body pain. On 15-MAY-2021, the subject experienced heart palpitations. On 15-MAY-2021, the subject experienced vaginal bleeding. On 15-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from fever, body pain, heart palpitations, and vaginal bleeding. This report was non-serious.

Experienced 2 days of worsening fever, chills, myalgias, mild chest pain, fatigue and malaise. Went to the ER after having a low grade fever, chills, shortness of breath, mild chest pain, and an elevated resting heart rate. Was diagnosed with SIRS as a response to the covid vaccine and hospitalized for observation. Was discharged the next day. Diagnosed with SIRS, possibly due to the COVID vaccine with a secondary diagnosis of asthma.

05/19/2021 Nosebleed and 20 to 30 to stop. Abdominal pain. 05/27/2021 Infection, hospitalized to prevent infection to shunt. 06/01/2021 Pneumonia

Believe I may have passed a blood clot through urine or vagina early this morning. It appeared to be quarter sized. Non painful, one time event. Also have intense back pain and leg aching. Still feverish and have mild headache as well.

On 03/18/2021 at 03:30AM I had a lot of arm pain from my shoulder to my elbow in my left arm. This lasted until 03/31/2021. On 03/18/2021 I woke up with a headache that would not go away. Next, at about 03:15PM I was not able to walk for about 10 minutes. Then, at about 05:00PM I started menstruating. At 07:00PM I had severe pain in my pelvic area for an hour and a half. At approximately 08:30PM I passed a softball sized blood clot vaginally. I bled heavily through the night. On 03/19/2021 I still had a headache and no energy at all. I continued to bleed heavily all day as well. 03/20/2021 was the exact same as the days prior. 03/21/2021 I was still bleeding heavily throughout the day with no energy. I still had the headache as well. I started feeling dizzy while walking on this day. 03/22/2021 I went to work like normal. I was cold all day. I was still bleeding, headache and dizziness. It was hard to stand for 30 minutes. While climbing the stairs I got very light headed and dizzy. I could not go up the stairs at a normal pace. 03/23/2021 I had the same symptoms all day but I was getting short of breath walking short distances. I still had very little energy and a headache. I also lost all color in my face and hands. I was still cold all day. I noticed some slight swelling in my ankles. 03/24/2021 The symptoms were getting more intense. I was still cold. I finally took some aspirin for the headache because it was very severe. The medication didn't help with it. This routine went on for the next week and the symptoms intensified with each day. Throughout this time I was still passing clots that ranged in size from golf/ping pong ball to baseballs. They were very painful when they passed. The days from 03/25/2021 to 04/01/2021 were all the same as far as how I felt. On 04/02/2021 I woke up with the same symptoms but now I could not stay awake for anything. I slept on and off all day. I only ate one meal a day because I was so tired and I had no appetite. The headache was getting worse as the days went on. The bleeding was still happening. It was not as heavy as the weeks before, but enough to be painful still. I also started having abdominal pain. On 04/03/2021 I was seeing stars when I moved too quickly. My heart rate was elevated with shortness of breath along with the rest of the previous symptoms. My headache however was very intense. 04/04/2021 I still couldn't stay awake on top of all the other symptoms. The dizziness and stars were more frequent. I couldn't move my head without seeing stars. 04/05/2021 I couldn't get warm and I still felt the same way. I called and made a doctor?s appointment for Wednesday the 7th. I had all the same symptoms still and they were getting worse. I had to move in slow motion so I could try to function. 04/06/2021 I woke up drained of all my energy and color. I couldn't shower because of the pain in my body. I couldn't stand because I felt like I was going to fall down. I could barely stand up straight let alone walk very far. I was shaking from being so cold. I had all the same symptoms from the days prior. I was in severe pain. I couldn't sit because of the pain in my abdomen I couldn't stand because of the weakness in my legs. I could barely see anything because of the stars I was seeing. At this point I had no color and I was barely conscious. That is when my family took me to the emergency room.

6-48h: joint pain, fever, chills, headache, nausea, sore arm and pain around injection site, extreme pain below knees 48h+: original symptoms subsided but developed numbness and weakness left leg and left arm 56 hours: left face partially paralyzed and/or swollen to the point where couldn?t move week. Prickly feeling left skull. Weakness and numbness in leg and arm persisting (decreased feeling on skin on left side of the body) 1 week: saw GP, neurologist, and sought emergent care at hospital for symptoms as doctors feared potential small stroke. MRI, chest X-ray, and blood works all clear. Discharged same day. 1 week+: partial facial paralysis gone, numbness and weakness in left side located to below the knee, but not present in both legs. Pain and uncomfortable feeling in both calves when lying down .

a 27 y.o. female with a history of Covid infection December 26, 2020, positive covid test December 29, 2020. She had approximately 2 weeks of symptoms including generalized body ache and generalized weakness. Fatigue and some headache. Had some persistence of symptoms after that time. Had some benefit from ibuprofen. Was seen at emergency room on January 27, 2021 stating that she felt that all her symptoms of Covid had resolved except for some chest pain which awoke her on January 27. She presented to the emergency room. Had sinus tachycardia at 113 but otherwise unremarkable physical exam, laboratory studies with white blood count elevated 16,004-20, hemoglobin 13.7 g hematocrit 41.8%, MCV 87.1, RDW 12.7%, platelet count 329,000, segs 72.8%, lymphs 20.6%, monocytes 4%, eosinophils 1%, basophil 0.6%. BUN 10.1, creatinine 0.8, AST 24, ALT elevated 56, alkaline phosphatase 68, total protein 7.6, total bilirubin 0.3, albumin 3.6, globulin by subtraction 4.0, troponin less than 0.02, D-dimer quantitative 0.22, urine pregnancy test normal. Chest x-ray normal. Chest pain appears to be musculoskeletal and was reproduced by palpation of her chest wall. No evidence of deep venous thrombosis or pulmonary embolism. D-dimer was normal. Heart rate returned to normal after some intravenous fluids. Patient discharged on Zithromax 500 mg day 1 and then to 50 mg days 2 through 5. Also continued on ibuprofen. Received Johnson and Johnson vaccine April 5, 2021. Over the next week patient started having increasing soreness. Her joints hurt more than usual and her headache was worse. She had a sensation that her legs were "numb and tingly" starting at her buttocks and extending down her leg. Because of reported incidence of cerebral sinus thrombosis or cerebral vein thrombosis patient appropriately presented for screening in the emergency room and was sent for appropriate imaging. April 16, 2021 CT scan of head with and without contrast no acute intracranial hemorrhage, no mass-effect or midline shift. On contrast-enhanced images there appears to be a lobular nonocclusive filling defect in the far lateral right transverse sinus. Lobular occlusive filling defect is also likely present in the mid to central right transverse sinus. Short segment filling defect in the medial left transverse sinus. Remainder of sinuses and internal cerebral veins are patent. Focal lobular filling defect within the confluence of the right and transverse sinus most likely related to arachnoid granulation. No edema hemorrhage of the cerebellum or cerebrum. No other significant findings. April 16, 2021 confirmatory MRI angiogram of head without contrast with no restricted diffusion to suggest acute or subacute infarct. Contrast void in the middle to central right transverse sinus consistent with occlusive thrombus. Nonocclusive thrombus in the far lateral right transverse thrombus. Narrowing of the medial left transverse sinus without complete occlusion. April 16, 2021 2345 hrs. inital hematology consultation. D-dimer and fibrinogen levels have been requested stat and are still pending. If fibrinogen level is low will replace with cryoprecipitate. If D-dimer is elevated barely confirms diagnosis of possible vaccine related thrombosis. The fact the patient is not thrombocytopenic at this time is encouraging, however despite the lack of thrombocytopenia she still has clearly documented symptomatic nonocclusive and occlusive thrombus in her cerebral sinus. From UPtoDate.com Ad26.COV2.S (Janssen COVID-19 vaccine, also referred to as the Johnson & Johnson vaccine) ? On April 13, 2021, the US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) recommended pausing administration of AD26.COV2.S to further investigate rare cases of cerebral venous sinus thrombosis and thrombocytopenia [33]. As of that date, six cases had been reported, all in females aged 18 to 48 years with onset 6 to 13 days after vaccination; during this period, 6.8 million doses were administered (with 1.5 million doses in females of that age range) [121-123]. Since some vaccine recipients have not been followed for longer than the time frame over which these symptoms develop, the incidence may change with additional follow-up. Initial symptoms included headache, backache, chills, and fatigue, and progressed to focal neurologic deficits. Intracerebral hemorrhage and thromboses at other sites were also seen in some patients. All of the five patients who were tested for the anti-PF4 HIT antibody tested positive. Another case, in a young male who was a vaccine recipient in one of the pre-emergency use authorization efficacy trials, had been previously reported. These cases appear similar to those reported following ChAdOx1 nCoV-19/AZD1222, another adenovirus-vector vaccine. Although rare, the observed number of events exceeded the expected rate among females <50 years old. Given the extreme rarity of these events, the FDA and CDC acknowledge that they recommended the pause out of an abundance of caution and to ensure awareness of these rare events. ?Evaluation and management of possible thrombotic complications ? Recipients should be aware of the possible association and seek immediate care for signs and symptoms suggestive of thrombocytopenia (eg, new petechiae or bruising) or thrombotic complications (including shortness of breath, chest pain, lower extremity edema, persistent severe abdominal pain, unabating severe headache, severe backache, new focal neurologic symptoms, and seizures) [117]. In such cases, some experts suggest evaluation with complete blood count and differential (including the platelet count), quantitative D-dimer, HIT testing, and imaging of any suspected site of thrombosis [113,114,125]. Onset 4 to 20 days after vaccination, platelet count <150,000/microL, elevated D-dimer, and a positive anti-PF4 antibody (HIT antibody) suggest the diagnosis. Treatment with a non-heparin/non-warfarin anticoagulant (eg, argatroban or direct oral anticoagulant) and intravenous immune globulin has been suggested. The CDC recommends not using heparin in individuals with thromboses following receipt of Ad26.COV2.S unless HIT testing is negative [126]. (See "Cerebral venous thrombosis: Etiology, clinical features, and diagnosis" and "Clinical presentation and diagnosis of heparin-induced thrombocytopenia", section on 'Terminology and HIT variants' and "Management of heparin-induced thrombocytopenia", section on 'Role of IVIG'.) As stated above all the 6 cases were "all in females aged 18 to 48 years with onset 6 to 13 days after vaccination" this would certainly fit the timeframe that we are seeing in this case. Recommendations from national guidelines would be to start treatment with dexamethasone immediately while awaiting intravenous gammaglobulin. To pursue intravenous gammaglobulin treatment at 1 g/kg over 1 to 2 days. It is recommended to avoid heparin and instead use direct factor X inhibitor such as Eliquis, which this patient is already been started on. There is unfortunately considerable risk that even though patient's symptoms appear mild at this time, that she may deteriorate in the very near future and I would recommend treating her aggressively at this time with dexamethasone and intravenous gammaglobulin while we are awaiting further testing. Patient clearly has had unusual thrombosis, especially in a 27-year-old. With the fact that she had headache dating back to January, it is impossible to determine the acute versus chronic nature of her venous sinus thrombosis. Covid infection does cause increase in coagulation as well. However, given the small risk of tragic outcome with cerebral vein and sinus thrombosis in the setting of Covid vaccinations, we will proceed aggressively with treatment starting tonight with intravenous gammaglobulin and intravenous dexamethasone. Will require rapid fasting glucoses to evaluate possible hyperglycemia from high-dose dexamethasone. Will consider stopping dexamethasone at 48 hours. Current recommendation for gammaglobulin would be single 1 g/kg or 500 mg/kg over 2 days. No recommendations for treatment beyond this point. Current recommendations for gammaglobulin dosing would recommend using an adjusted dose for patients with greater than 125% of their ideal body weight. This patient at 122 kg on a 5 foot 2 inch frame does qualify for adjusted dose and her orders reflect that. I appreciate the opportunity see this patient this evening and consultation requested by Dr. We will follow patient in hospital. Hopefully she will have gradual improvement and avoid any serious or tragic complications of her cerebral sinus thrombosis. We will have pharmacy report possible adverse reaction to Johnson & Johnson vaccine to the FDA as required by law. April 17, 2021 follow up. No new events. Laboratory studies remained excellent. White blood count is further elevated, however, this may be secondary to high-dose dexamethasone with a white blood count of 16,060. Hemoglobin 14.0 g hematocrit 42.8%, MCV 86.8, RDW 12.9%. Platelet count is actually increased slightly at 374 as of 9:10 AM this morning. Differential shows left shift as expected with dexamethasone. Results from yesterday showed fibrinogen normal at 369 (180?415) pro time normal at 10.4 seconds with INR of 0.97, PTT 26.7. D-dimer 0.23 (0.19?0.50). With platelet count, fibrinogen and D-dimer normal I am inclined to believe that this is not an acute post vaccination HIT-like phenomena. If it were I would still expect to see some degree of thrombocytopenia elevated D-dimer and perhaps low fibrinogen. The other explanations for her cerebral venous sinus thrombosis are either idiopathic spontaneous and merely coincidentally associated at the exact same time as her Covid infection or more likely, cerebral venous sinus thrombosis secondary to hypercoagulable state secondary to her Covid infection from December 2020. Unfortunatly there is no way to accurately date the acuity of the venous thrombosis in her cerebral sinus. HIT Testing is still pending and most likely will not be available for 3-4 more days despite being ordered stat. Have called the laboratory and asked them to check with our outside reference lab what the expected return time is on this test. (LabCorp says "Tuesday April 20, 2021). Patient refused intravenous gammaglobulin infusion which has been ordered last night. Patient has been receiving dexamethasone which was a bridge until intravenous gammaglobulin could be administered. Current guidance from the expert hematology panel (EHP) on Covid vaccine induced thrombosis dated April 7, 2021 from the public health would state that a patient who has a reduced platelet count without thrombosis with a D-dimer normal and normal fibrinogen or thrombosis with a normal platelet count and D-dimer normal and normal fibrinogen are "unlikely cases". They recommend for probable cases who have D-dimers that are elevated to send HIT assay and then give immediate intravenous gammaglobulin while awaiting results. They recommend fibrinogen supplementation, if needed. They recommend a direct acting antithrombin agents such as the Eliquis this patient is receiving. They recommend steroids particularly if there is a delay in getting intravenous gammaglobulin delivered. With the fact that we now have 24 hours in the hospital with no evidence of thrombocytopenia, no evidence of increased fibrinolytic activity or active thrombosis, and no evidence of hypofibrinogenemia, I would argue that her presentation is subacute. In this setting, I do not feel intravenous gammaglobulin would be necessary and does involve a small risk as well as considerable cost. Dexamethasone also involves small risk and negligible cost. I have discontinued both of these medications. My overall impression would be that this was not related to her Johnson & Johnson vaccination which was recent, but rather her more distant Covid infection. It is impossible to definitively answer the question however. The next question is duration of anticoagulation. Risk of recurrent cerebral sinus venous thrombosis is relatively small but the morbidity can be high. Studies have been performed showing medications in the same class as Eliquis have been associated with a decrease in incidence of the recurrence. Most hematologist recommend 3 months of anticoagulation for provoked venous thrombosis including cerebral sinus venous thrombosis. I feel this patient's thrombosis is "provoked", with her association at the same time of her Covid infection (and possibly vaccination). I would recommend Eliquis (apixaban) 5 mg twice daily or Xarelto (rivaroxaban) 20 mg daily with food. I would feel comfortable in discharging patient for outpatient follow up IF Dr and other speciality services agree. Plan 3 months of full dose anticoagulation with direct factor X inhibitor. Circulation 2010 Jun 29;121(25):2740-6 "Long-term evaluation of the risk of recurrence after cerebral sinus-venous thrombosis", Background: The clinical course of cerebral sinus-venous thrombosis (CSVT) is largely unknown because prospective studies with a long follow-up and with the goal to assess thrombosis recurrence rate and predisposing factors for recurrence are lacking. Methods and results: One hundred forty-five patients with a first CSVT were followed up for a median of 6 years after discontinuation of anticoagulant treatment. End points were recurrent CSVT or other clinical manifestations of venous thromboembolism. CSVT recurred in 5 patients (3%) and other manifestations of venous thromboembolism (deep vein thrombosis of the lower limbs or pulmonary embolism) were seen in 10 additional patients (7%), for a recurrence rate of 2.03 per 100 person-years (95% confidence interval, 1.16 to 3.14) for all manifestations of venous thromboembolism and 0.53 per 100 person-years (95% confidence interval, 0.16 to 1.10) for CSVT. Nearly half of the recurrences occurred within the first year after discontinuation of anticoagulant therapy. Risk factors for recurrent venous thrombosis were male sex (adjusted hazard ratio, 9.66; 95% confidence interval, 2.86 to 32.7) and, for thromboses other than CSVT, severe thrombophilia resulting from antithrombin, protein C, protein S deficiency, anti-phospholipid antibodies, or combined abnormalities (adjusted hazard ratio, 4.71; 95% confidence interval, 1.34 to 16.5). Conclusions: The risk of recurrent CSVT is low and is higher in the first year after discontinuation of anticoagulant treatment and among men. Mild thrombophilia abnormalities are not associated with recurrent CSVT, but severe thrombophilia entails an increased risk of deep vein thrombosis of the lower limbs or pulmonary embolism. April 19, 2021 Follow up, no change in condition. Discussed case with Dr, will order Factor V Leiden, prothrombin gene mutation, anti phospholipid and anti cardiolipin antibodies, if she will allow draw. Expect Heparin Induced Thrombosis testing result tomorrow, but with no thrombocytopenia after given heparin, expect will be normal. Will await result. If discharged, would recommend 3 months direct thrombin inhibitor (Eliquis/Xarelto/Pradaxa) at full anticoagulation dose. Then stop, no taper. Overall still feel "provoked" thrombosis due to December Covid, unrelated to J&J Covid vaccine, but can not definitively prove that..

Patient presented on 4/17 to urgent care afer significant vaginal bleeding (soaking through a pad every 1 hour to 1.5 hours) and petechia on multiple extremeties. She also had a nose bleed and bleeding in mouth earlier in the day that resolved spontaneously. After obtaining CBC, platelets were <1000. She was on oral contraceptives. She is a non smoker. She received work up for thrombosis, not indication of thrombosis. She did have some muscle aches and fever and fatigue the day after vaccine. Histroy notable for mild diffuse petechiae on all 4 extremeties. As inpatient received solumedrol 125 mg (then switched to prednisone 80 mg daily), IVIG 1 g/kg x 2 doses. she was discharged on 4/19 d/t rising platelets, Vaginal bleeding slowing and Petechia much fainter.

Initial severe headache after vaccine- this resolved in 24-48 hours. Had some LEFT flank pain for a few days. This resolved on its own. Then awoke on 4-17-2021 with LEFT calf pain that was constant and persistent. Called triage on Monday 4-19-2021 for guidance- came to Urgent Care. D dimer done and was positive. Was then sent to ER for imaging with + Doppler U/S LLE DVT- started on Eliquis.

Within 15 mins of receiving vaccine client informed EMTs she was feeling itchiness around face. First vitals at 1630: blood pressure 138/89, pulse 129, oxygen 98%. PHN joined shortly after. Per client had anaphalaxis reaction to 1st dose Pfizer vaccine and was recommended to receive Janssen. Client with flushed face, rash on chest, neck and left arm. Client denied shortness of breath, chest pain, or trouble swallowing. PHN offered client Benadryl. Per client had pre-medicated with Benadryl 1.5hrs ago. Client informed she would we kept an additional 30 mins in observation. 1635 vitals: blood pressure 134/81, pulse 118, oxygen 98%. Client stated symptoms same, denied shortness of breath. Rash on chest, neck and left arm same, not spreading. PHN asked client if she had followed up with provider after first reaction. Per client did speak with provider and was given steroids afterwards. Medical history: Ehlers-Danlos Syndrome and mass cell activation. Current medications: Cromolyn Sodium, Clonidine, Corlanor, Klonopin, Hydrocodone, Flexeril, Metropolol, Microgestin, Singulair, Vitamin B, Vitamin B12, Claritin, Iron, Magnesium, Famotidone, Zyrtec, and Probiotic. Per client no past history of allergies to vaccines. 1640 vitals: blood pressure 123/93, pulse 108, oxygen 97%. Per client itchiness resolved, rash to chest, neck improving. Vitals at 1650: blood pressure 121/79, pulse 100, oxygen 98%. Per client throat felt "weird", denied shortness of breath, closing of throat, no swelling of tongue. Client able to answer all questions and breathing normal. Per client itchiness was resolved. Rash to chest and neck resolved, left arm with improved rash. 1655 vitals: blood pressure 110/80, pulse 95, oxygen 98%. Per client feeling much better. Denied shortness of breath, no itchiness, rash resolved. Client given ER precautions. Per client not driving, was getting picked up. Client left facility with steady gait at 1705.

Initially presented with 5 out of 10 chest pain (substernal, no radiation, no exacerbating or relieving factors), nausea, vomiting, diarrhea, dyspnea on exertion, and fatigue. Further history obtained included decreased exercise tolerance since four weeks prior to presentation (noticeable during runs). She was found to have an abnormal EKG at an urgent care and was sent to an outside hospital emergency department. She ultimately was found to have heart failure with preserved ejection fraction (56%), Stage C, Class III, and myocarditis. The highest suspicion for the etiology of her myocarditis is viral vs. autoimmune (given response to steroids) vs. genetically-mediated myocarditis. She was discharged on aspirin, a prednisone taper, colchicine, metoprolol, and Entresto with cardiology follow-up. Patient discharged with 4 week monitor to monitor for arrhythmia as per EP service. Infiltrative cardiomyopathy evaluation pending as well- plan for SPEP/UPEP, serum/urine protein electrophoresis, immunofixation, and alpha-galactosidase (not sent due to specific tube not available).

4/3/21 - Noticed Skin eruptions on arms and legs 4/11/21 Skin eruptions were getting worse 4/19/21 - began heavy vaginal bleeding 4/20/21 - began feeling dizzy, light headed, hard to breath 4/22/21 - admitted into hospital with Cellulitis, Sepsis, Sever Anemia - discharged 8 days later Red blood count was 5

HEAVY MENSTRUATION; IRREGULAR SPOTTING; NAUSEA; This spontaneous report received from a patient concerned a 27 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 23-JUN-2021) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, the subject experienced heavy menstruation. On 19-MAY-2021, the subject experienced irregular spotting. On 19-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 20-MAY-2021, had not recovered from heavy menstruation, and the outcome of irregular spotting was not reported. This report was non-serious.

Was 5 weeks pregnant at time of vaccine with strong HCG levels, approximately 2 weeks after vaccination patient suffered a miscarriage. Vaginal bleeding, cramping and passed large clots including a sac like tissue.

Patient is a 28 y.o. year old G1P0 at 38w6d who presented for fevers, chills and decreased fetal movement. She received her first COVID vaccine 8 hours prior. No cough. She felt well before the shot. No bleeding or leaking fluid. Her COVID test was negative. She was tachycardic to the 140's and the baby was tachycardiac to the 180's starting at presentation. She was treated with oral tylenol and IV fluids. After about 90 minutes of monitoring a prolonged fetal heart rate deceleration was noted to the 60's for 6 minutes. This recovered with repositioning. After another hour a reactive tracing was noted with a normal heartrate for baby. In induction of labor was started.

Vomiting for 48 hours, nausea, headache, chills, fever 102 for two days; period started and bleeding increases daily. Vaginal bleeding still heavy with dime size clots.

Started with chest pain, a couple of days after the shot. Fainted on 3/13/21, transported by EMS to emergency room. CT scan was done, Dr. said she has blood clots in her lungs. Was given a prescription for Eliquis 5 mg twice daily.

28 y/o female with h/o obesity (120kg), anxiety and depression, received the J&J vaccine on 3/5/2021 (Lot 1805020). Home meds included only citalopram and an OCP which she had stopped on 3/10. On 3/15 she developed a predominantly R sided headache 9/10 pain, described as the worst of her life that didn't remit with over the counter analgesics and eventually became global in distribution, lasting 4 days. She was seen for this in urgent care on 3/19, given a shot of Toradol and then transferred to the emergency department where CBC showed platelets of 33, WBC 9.1 53% PMNs, 43% lymphs, Hgb 14.1, MCV 87, PT 15.7 INR 1.2. Chemistries were all normal. CT brain was unremarkable.

Severe headache for two days. Extreme chills, nausea, cold sweats, fatigue for three days. On the third day previous symptoms went away and I got an extreme head cold, congestion, tiredness, lethargic. My varicose veins have been midly painful but it might be from laying all day for a week. On day five I started my menstrual cycle two weeks early, it was completely black and clumpy (not normal). It is now day 10 and I still have a slight cold, very tired, and am still on my period.

I have severe, random, and unprovoked bruising covering both legs. I have abdominal pain that has persistent since being vaccinated. I?m dizzy. I?m bleeding in my urine, stool, and vaginally. Period came early (unrelated to previous vaginal bleeding) and is not clotting. Just significant amounts of red blood, soaking through one ultra absorbency tampon an hour. I have a headache. Went to the ER and my platelets were (345) and my blood sugar low. My bp was 145/90 which is high for me, from the bleeding. They said I have a ?higher chance of being bitten by a shark? than having a side effect. They diagnosed me with a single contusion and sent me home. Have been feeling worse since leaving the hospital.

Fever over 105, chills, cough, soar throat. aches and pain for 2 days. Led patient to go to the ER on monday 4/12. MD found blood clot at that point. No treatment was given patient was told to follow up with her PCP. Did not go to PCP as yet.

Pt admitted to the ED with chest pain one day following the vaccination. Pt described this as subtle at first that increased to wake pt up in pain. Sharp pleuritic pain localized in the center of her chest and slightly in the epigastric region. No prior symptoms previously. Pt has been diagnosed with bilateral pleural effusion, acute pericardial effusion and acute pulmonary embolism.

Fatigue, weakness, Acute kidney injury, shock liver, thrombocytopenia, pneumonia, syncope, wide complex tachycardia over last 2 weeks

Review of ED notes show she received IV infusion of normal saline, and IV push of benadryl and compazine after going to the ER for severe headache on 04/17/2021. She first noticed pain when streching the arm shortly after the IV infusion but didn't pay attention to it, then 5 day later she noticed localized swelling and redness. Patient was sent for US doppler which left cephalic vein thrombus detected on duplex US. Was treated with aspirin and had follow up doppler of UE for follow up on LUE cephalic vein thrombosis-negative 5/13/21.

Patient was about 15 weeks pregnant and this was her first pregnancy. Her anticipated due date was Oct 1st 2021. On April 9th 2021 during a scheduled doctor visit at 3pm both baby and mother were in good health. On the same evening after the appointment she went for vaccination at Pharmacy and received the J&J vaccine. After receiving the vaccine in about 15 mins she felt like urinating and noticed blood in the urine and felt vaginal dilation. Within the next 15 to 20 mins she started experiencing mild labor pains and contractions. In the next 30 mins she started bleeding and was immediately taken to the ER. In the ER it was confirmed that she was having a miscarriage and the fetus was delivered. She also had to undergo emergency surgery to remove any remaining placenta in the uterus.

small blood clot when tried to donate blood 2.5 weeks after shot, preventing me from finishing donation

Patient with complaints of persistent headache and insomnia the night of the vaccination. Patient developed bruising on her leg, shoulder and abdomen the next day. Patient presented to ER on day 4 post vaccination and is admitted at the hospital with ITP.

Patient presented to the emergency department with right-sided pleuritic chest pain-she has a pulmonary embolism on CT angiogram. She was started on heparin and admitted to the medical center. She received her Johnson and Johnson vaccine on 03/04/2021.

In ED on 3/11 0246 with the following Chief complaint - I got the johnson and johnson covid vaccine 3/10 at 4pm and now I can't stop throwing up" c/o emesis, fever, body aches. HR 140s. pt is A/O x3. + nasuea, chills fever 101.2. denies throat swelling or SOB. pt presents with swelling at vaccine site and rash to both shoulder blades She does feel lightheaded and dizzy. Denies any recent illnesses. Denies any prior intolerance to vaccines. Fever 101.7F Patient has low-grade fever but nontoxic-appearing. Blood work shows mild leukocytosis with left shift likely reactive otherwise within normal limits. After 3 L of IV fluids she remains persistently tachycardic in the high 130s to 140s. Additional information for Item 18: She states she was feeling fine prior to her vaccine, denies any recent illness, sick contacts, recent travel, CP, SOB, abd pain, dysuria. After eating and drinking patient states she feels a little nauseous and having some indigestion so was given some more Zofran and Maalox. She continues to be presenting tachycardic in the 130s. Given the rest of the reassuring ED work-up I think this is likely autoimmune response to the vaccine however given her current heart rate I cannot discharge her safely. Will admit her to medicine team for observation. SIRS, likely 2/2 vaccine - hold off on antibiotics for now without clear source of infection, procalcitonin negative - tylenol prn for fever Principal Problem: SIRS (systemic inflammatory response syndrome) Active Problems: Tachycardia Asthma 3/12 discharge summary She was given 3L IVF bolus in the ED -- still tachycardic in the 110s, fever has improved. There was concern for adverse reaction to vaccine and she was given prednisone 60 mg x 1 in the ED. Her symptoms have improved and she is able to tolerate PO without vomiting. Of note, she says her entire family had a respiratory viral illness approx 1 year ago which her PCP suspected was COVID 19, but were unable to be tested at the time. Fever has resolved, has been afebrile x24 hours, leukocytosis has resolved tachycardia has improved although still HR in the 110's with ambulation, ordered an echo however patient did not want to stay wanted to follow-up with PCP and have this done there. Vital signs have been stable, patient states back to her baseline and feeling great. Would like to go home.

Arm hurt very badly immediately during and after vaccine in similar sensation to ulnar nerve being struck in arm, bled only a little but caused swelling and then a large bruise developed over the evening of 4/4/2021 and is still dark today (4/7/2021). Concerned my bone was hit with a too long vaccine needle. Had chills/fever evening of 4/4/2021 into morning of 4/6/2021?had to take off work. Have had neurological symptoms ongoing with ?brain fogginess? since 4/5/2021. On 4/6/2021, began to see flashes/spots of light in vision of left eye, which worsened through today. Took off afternoon from work and went to an eye clinic to have eye dilated and looked at, but the spots in vision continue through reporting time (4/7/2021, 5pm CT).

Hot flashes without fever, tiredness, redness and welting at injection site, abdominal cramping, vaginal spotting, menstrual cramping

14 DAYS POST VACCINE EXPERIENCED LEFT CALF PAIN...SHARP PAIN. Applied warm compress and took tylenol. Pain persisted and increased. Visited Urgent Care center on Tuesday, 3/23 and was advised immediate ultrasound needed. Went to Radiology Facility same day and was advised I had a DVT in leg and I needed to go to ER. Went to Hospital ER on 3/23 and was treated in ER with blood thinners (IV) and advised I also had numerous PEs in chest. Released with RX for Eliquis and advised to follow up with PCP and Hemotologist asap. Friday, 3/26 leg was swelling and patient was dizzy with chest and arm sensations. Went back to ER. Double Doppler done. DVT has moved. Assumed another PE has occurred . Continue Eliquos RX. Following up with Hemotologist, Cardiologist and Pulmonologist.

Day of vaccine- Within hours, site soreness, raised red, approx size of a quarter, mildly painful, with a "lump (that is still palpable) under the surface of the skin". Within 5-6 hours following vaccine administration, she reports she developed fever, chills for approx 2 days with fatigue and hot flashes on and off. ** On 4/7/2021, patient states that in the morning she developed pain in her right calf. She saw her PCP.

The adverse symptoms I experienced were abnormally severe/heavy menstrual bleeding and abdominal pain. I was on Day 4 of my menstrual cycle on the day of my injection (April 3, 2021). My menstrual cycle usually starts to go away on Day 4 and concludes by Day 7. But the day after my injection, in addition to experiencing the common side effects of fever, chills, aches, and headaches, I also experienced an uptick in bleeding, which included severe/heavy menstrual bleeding with very frequent and large blood clots. That same day (April 4), I started my new birth control cycle as prescribed. By Day 8 (April 7, 2021), my menstrual bleeding continued to be so severe/heavy that I went to my OB-GYN for testing. The OB-GYN ruled out everything but the vaccine as an environmental factor. It was suggested that I take 600mg of Motrin every 6-hours for 48 hours. My menstrual bleeding continued for several more days until concluding on Day 12 (April 11, 2021) but I am still experiencing abdominal pain.

On April 16, 2021 (Day 13 after Vaccine) I was diagnosed with acute deep vein thrombosis (DVT) of my femoral vein in my left leg by Hospital. In other words, I was diagnosed with a blood clot in my upper left leg. Pain in both my legs had started on April 13, 2021 (Day 10 after Vaccine). On April 16, I had a virtual appointment with my doctor, Dr. , who prescribed an ultrasound to rule out DVT. I went to an ultrasound appointment at Radiology at 3:30pm where a blood clot was found in my left leg. I was admitted into the emergency room at Hospital and prescribed medication and follow ups from there. These adverse symptoms developed after I submitted other adverse symptoms to VAERS on April 13, 2021 (Temporary VAERS E-Report Number: 435841).

Around 5:30 pm in the evening following my vaccine I started having chills, headache, nausea, and fever of 101. Chills got worse, whole body was shaking and shivering. Nausea progressed into constant dry heaving. Head was pounding with the worst pain I have ever felt in my life, worse than natural child birth and worse than running marathons. The nausea was so bad and I could feel my fever burning and getting worse. I was about to vomit so got out of bed to go to the toilet to vomit and the whole room started spinning completely out of control. My heart was racing and I could hear it and feel it pounding rapidly through my ears. I couldn?t walk and was so disoriented I crawled to the bathroom to throw up in the toilet. My husband heard me and came and picked me up off the bathroom floor and carried me to our bed. As the night progressed fever got worse, head was in almost unbearable pain, severe body aches over my whole body, heart racing and horrible nausea and dry heaving. I made it through the night. For two days after I had a headache and fever and nausea and body aches and couldn?t get out of bed to care for my children. By the third and fourth day I was able to get out of bed at times and still felt fatigue, nausea, headache and body aches. Anytime I would stand up for 10 days after the vaccine it felt like I was rocking on a boat. I am almost at 2 weeks and still feel fatigue and dizziness at times. On April 15th, 9 days after my vaccination I had symptoms of a blood clot in my leg. I went to the Emergency Room and was diagnosed with a superficial blood clot of the leg as well as swelling in the vein. I am thankful to be alive!

30yo female has been on combination oral contraceptive for 15 years, no PMH, no person/family hx of VTE. 2 weeks prior received Johnson & Johnson COVID vaccine, 2 days later develops bilateral calf pain which progressed until 3 days prior to Emergency Dept arrival when PCP ordered ultrasound, showed non-occlusive DVT in the left common femoral vein and no right leg DVT. Non-smoker. D-dimer 0.32 ug/mIFEU, platelets normal at 269k. Treated by starting apixaban and stopping combination oral contraceptive, discharged home from Emergency Dept with follow-up.

On April 16, 2021 (Day 13 after Vaccine) I was diagnosed with acute deep vein thrombosis (DVT) of my femoral vein in my left leg by Hospital. In other words, I was diagnosed with a blood clot in my upper left leg. Pain in both my legs had started on April 13, 2021 (Day 10 after Vaccine). On April 16, I had a virtual appointment with my doctor who prescribed an ultrasound to rule out DVT. I went to an ultrasound appointment at Radiology at 3:30pm where a blood clot was found in my left leg. I was admitted into the emergency room at Hospital and prescribed medication and follow ups from there...

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Systemic: Hyperventilation-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tachycardia-Medium

Immediate abdominal cramping. Bleeding, bloating, numb legs, ovarian pain, nausea, diarrhea, vomit, dizziness, chills.

Irregular menstrual cycle after years of being 100% regular. Extreme cramping, clotting, shorter cycle and heavier bleeding.

30 year old female pregnant with EDC 12/12/21. Prenatal lab work detected no chromosomal anomalies. Pt had 3 prior uncomplicated term pregnancies. Pt began bleeding at 12.3 weeks pregnant and went to hospital. Pt passing copious amounts of blood clots. Fetus with heartbeat detected on ultrasound prior to spontaneous vaginal delivery of deceased male fetus.

Pt presented w/ chest pain, pulmonary embolism confirmed via CTA Chest on 4/15/2021 1 week after J&J vaccination (4/7). Also tested positive covid on 4/15. Being treated with heparin infusion

PE. Pt was placed on therapeutic Lovenox and supplement oxygen which was weaned off and pt discharged home.

Presented to ED 4/18 with severe L sided chest pain since 4/17. Arm weakness and numbness 4/18 that lasted a few hours but resolved. No vision changes. O2 sat was 100% on room air. Diagnosed with PE. No recent mobilization. Does not smoke or use illicit drugs. Was admitted to the hospital telemetry unit 4/18-4/20. Discharged on apixaban. I do not have any information on the vaccine Lot number received.

THROMBOSIS; Dizziness; Pass Out; Weakness in the all side of the body; This spontaneous report received from a patient. The patient's height, and weight were not reported. The patient's concurrent conditions included sea food allergy, and other pre-existing medical conditions included the patient did not had any other illness at the time of vaccination and to one month prior and chronic or long standing health condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 02-APR-2021 11:25 for prophylactic vaccination. The batch number was not reported. As per procedure, no follow-up will be requested for this case. Concomitant medications included metformin for drug used for unknown indication. On an unspecified date, the subject experienced thrombosis, dizziness, pass out, and weakness in the all side of the body, and was hospitalized (date unspecified). Laboratory data (dates unspecified) included: X-ray (NR: not provided) heart, head and lungs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from thrombosis, dizziness, pass out, and weakness in the all side of the body. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0: This is a report of a patient, who was noted to have thrombosis on unspecified time after receiving the covid-19 vaccine ad26.cov.2. Patient's height and weight were not reported. Patient medical history was not reported. Concomitant medications included metformin for unknown indication. Patient is allergic to seafoods. On an unspecified date, the subject experienced dizziness and passed out. She also had weakness on the left side of the body. Patient was noted to have thrombosis. Patient was hospitalized, where laboratory and diagnostic tests were done. Results were not reported. The information provided precludes a meaningful medical assessment. Additional information requested.

On the 28th of April, 18 days from the shot, I went for a walk and came home around 6:30 p.m. to the outside of my right calf bright red and hot. I went to the ER where an ultrasound was performed and they found a DVT blood clot. I am now on an anticoagulant, Xarelto and have an appointment with my doctor on the 5th to schedule more imaging and blood work.

10 hours after vaccination, began fever, sweating, muscle aches and cramping, chills, and vomiting. 30 hours after vaccine lips swelled and began experiencing angioedema and anaphylaxis.

On Wednesday May 12th around 615 pm I started having symptoms of a stroke. I was scrambling my words, couldn?t talk right and my left side of my face wouldn?t move when I spoke or smiled. When I smiled my whole smile shifted to the right. I had my girlfriend call 911 because I knew I was having a stroke. The symptoms lasted about 6 or 7 minutes. By the time the emt got there I was talking fine and my face was back to normal. I went to hospital where a cat scan was done on Wednesday night and came back fine. The doctors decided to admit me because they wanted me to get an MRI in the morning, which I did and came back that I had a minor stroke. The doctors think the stroke had something to with me being on an estrogen birth control as well as some family history but my primary care doctor recommend me report this because I did get the Jansen vaccine and it could have triggered what happened. I was discharged on Friday 5/14/2021 and I know have to take aspirin every day for the rest of my life, plavix for 21 days, and Lipitor until my doctor thinks I can come off.

Suffered a stroke on May 9, 2021. Rushed to the ER and administered TPA, then surgery was performed to get out the rest of the clot. Symptoms: Fainting, Right side paralysis, slurred speech

Right after my vaccination my period was 15 days late. It?s usually on the date by one day less or more but never 15. Period is very heavy with tons of blood clots some have been as big as a strawberry ( I?ve never had blood clots in my period ever ) cycle is completely off days are all messed up I?m ovulating the day my period stops.

Bilateral Pulmonary embolism based on CT chest, symptoms started after 5-6 days of J&J COVID vaccine. Possible pancreatitis

Fever and spotting (very early in pregnancy. About 4 weeks) spotting happened with fever. No damage to the pregnancy know so far. Spotting stopped

7:00 pm Friday started getting left arm: numbness on whole left side of body, left side of face swelling and droopy. Felt a sharp pain in left arm near basilic vein and started swelling like a ball. Felt shortness of breath and dizzy with blurry vision. Almost passed out when stood up. Was rushed to the ER. Had Sharp pains shooting through left leg.

I have experienced breakthrough vaginal bleeding for the first time in the 15 years I have been on birth control. I am aware that they are looking at links between the vaccine and menstration and I wanted to share this abnormal event.

Janssen COVID-19 Vaccine EUA Patient received Janssen vaccine 4/9/2021. Patient presented to ED 4/14/2021. Patient is a very pleasant 32-year-old female, with past medical history significant for taking bromocriptine for prolactin issues as well as metformin for type 2 diabetes, presents to the emergency department for evaluation of continued headache over the last 1 week. Patient also reports chills, sweats, body aches ever since receiving the Johnson and Johnson coronavirus vaccination 1 week ago. The headache started after receiving the vaccination and has been continuing ever since. It does not fluctuate in intensity. It is caused her blurred vision and difficulty focusing. No tinnitus or hearing loss. No slurred speech, vomiting, numbness or weakness or tingling to the extremities or any facial droop. No history of strokes or aneurysms. She is not on blood thinning medication at all. No upper nor lower extremity swelling or redness. No abdominal pain, nausea, vomiting or diarrhea. She reports the continued subtle shortness of breath and body aches since the vaccination as well. No rapid heart rate, long flights, long car rides, surgeries nor oral contraceptive use. Patient started on heparin drip. Neurologist recommended transferring patient to higher level of care. emergency department physician is willing to accept the patient at their facility. Patient transferred to the facility.

Patient received J&J Janssen vaccine 4/8. She reported nausea, abd pain, fevers, and fatigue since received vaccine. On 4/13/2021 presented with worst headache of life, trouble speaking, and abnormal gait. Exam showed L sided motor weakness and impaired sensation. Initial CT normal, received tPA for presumed stroke. Platelet count normal. Currently admitted to critical care unit at Hospital.

Abnormal vaginal bleeding. Last menstrual cycle was 4/3/21, next one scheduled for 5/2/21, cycles are described as very light. On 4/16/21 at 4:00 pm clumpy bleeding started and continues through today 4/19/21.

4 days of right upper extremity pain and swelling with diagnosis of right upper extremity axillary vein DVT that was treated with DOAC apixaban.

I have APS and am on warfarin maintained at a therapeutic level of 2.5-3.5. I received the Johnson & Johnson Vaccine on April 7,2021. On April 9,2021, I noticed swelling and tightness in my left leg, on April 13,2021 I noticed severe swelling in my right leg too. I met with my primary care physician who sent me for imaging which confirmed clotting. I was referred to the Emergency Room since my INR was 3.7 but I was still clotting. I was sent home with out treatment from Medical Center because I was therapeutic on my warfarin. On Friday April 14, I went to the ER after speaking with a hematologist at the facility. I was admitted and was put on fondaparinux.

Overly tired, shortness of breath, chest pain, leg pain After 3wks of symptoms patient(self) went to hospital and it has been discovered patient has ( self) has a blood clot in Right lung. Patient (self) has no record or history of blood clots. Was treated with heparin while in hospital. Has since been discharged and sent home with a prescription for anticoagulant.

Patient is a 32-year-old female new patient 5 months post partum & currently breastfeeding, with seasonal and perennial allergic rhinitis and history of childhood asthma, referred by the emergency department to discuss anaphylaxis like reaction to the Johnson Johnson COVID-19 vaccination on 4/28/21. She received her vaccine around 2:00 p.m. She began developing itchiness in her palms/soles of feet and scalp that quickly developed into a a welt like rash about 3-1/2 hours after receiving the vaccine while on a walk with her husband; this was shortly followed by facial swelling over her right eye. They made it home and she got in a cold shower to cool down, became dizzy, started seeing spots and had difficulty breathing. Her husband called EMS and she was hypotensive when they arrived. She was given 2 doses of epinephrine (0.2 mg each per ED note) and a dose of Benadryl which helped. Shortly after the 2nd dose, she began having difficulty swallowing, maintaining the ability to breathe through her nose. She was given a 3rd dose of epinephrine and transferred to the ED; during transport an IV was started with an epinephrine drip. She was seen at Emergency Department; she was given IV fluids, solu medrol, tryptase level and had a normal EKG. She was discharged with an epi pen prescription. Tryptase is still pending at the time of her visit. She started a new prenatal vitamin at 11 am 4/28/21. Otherwise, she reports no new foods, medications or topical products. She did eat before going on a walk, pepper jack cheese, wheat thins, and black bean hummus. She is pretty sure she was not stung by a bee prior to onset of symptoms yesterday. Interestingly she reports recent urticarial episodes that occurred in February of 2021. These occurred when she was visiting her in-laws and occurred in the middle of the night, 2 nights in a row during the middle of her visit. She has never had hives previously. She reports no family history of hives or anaphylaxis. She reports no use of new topical products or medications.

Lost use of my right arm so I went to the hospital they checked for a clot I teated slightly positive with the blood test then the did an ultrasound and couldn?t find one. The only explication for my Paralysis is a mini stroke.a Also besides the numbness and loss of use I have hyperreflexia.

My whole body tensed up and I began shaking and my arms and legs pulled up into the fetal position and I couldn't breathe all I could do was stare. It felt like a seizure.

Patient transferred from outlying hospital for higher level of care. Patient had previously presented to ED with complaint of localized pain in the right calf for 4-5 days. Patient also noticed swelling in R calf. CT chest showed acute pulmonary embolism within distal right pulmonary artery extending into the segmental arteries to both right upper and right lower lobes. Patient was treated with heparin drip. Echo showed EF 68% and hypokinetic free right ventricular wall and apex. Echo also showed reduced right ventricular function. Patient underwent bilateral lower extremity duplex ultrasound which showed acute right femoral, popliteal, posterior tibial and peroneal vein thrombosis. Patient was transitioned and discharged to home. Patient received J&J COVID-19 vaccine in March 2021. Patient denies cigarette smoking/vaping, illicit drug use, ETOH use. Denies recent travels or long distance travels. Denies use of oral contraceptives.

Had her Johnson and Johnson covid vaccine on 4/8/21 LMP 4/14/21 Pt began spotting 5/9/21 which was day 25 of her cycle Day 2-5 very heavy bleeding Day 5 passed clot 11 days of bleeding Pregnancy test positive on 5/19/21 and 5/20/21 Presented to ED w/ intermittent RLQ abdominal pain and vaginal bleeding and spotting since 5/9 with positive hCG, 52 on 5/20 and 209 on 5/27 with OB ultrasound on May 28 that showed no IUP and small hyperechoic nodule adjacent to the right ovary that could represent an ectopic pregnancy and patient opted to avoid methotrexate treatment at the time. Returned to the ED on 5/30 with ongoing symptoms of RLQ cramping but no vaginal bleeding. OB ultrasound shows right adnexal structure measuring 2.6 cm, larger than structure 2 days ago. Pt diagnosed w/ Right ectopic pregnancy - successfully treated with methotrexate

I had been off my period for 2 days when I got the vaccine and started my period again 3 days later (day 5 of my cycle). The period lasted for 13 full days and was the heaviest period I?ve ever had with thick clotting and blood. After that period I went 2 full months with no period. This has NEVER happened to me before.

Had generalized tonic-clonic convulsions. CT scan of the head revealed a subarachnoid hemorrhage in the L cerebral hemisphere.

Tachycardic and anaphylactic shock. Heart beat over 140 out of the blue while laying on couch, throat felt like something was lodged in it, Voice became very raspy, felt out of breath.

I was 9 months pregnant at the time of the vaccination. My due date was April 3, 2021. The actual date of delivery was March 20, 2021 by C-section. I gave birth to a son weighing 8 lbs 6 oz. I had no complications during this pregnancy. I left the hospital on March 22nd. On March 25, I was experiencing shortness of breath and a low pulse (35 bpm; my usual pulse is in the 50s-60s). My OBGYN told me to go to the emergency room, where they did a CT scan. The CT scan showed a small pulmonary embolism. I was in the hospital until March 27th, where I was treated with Heparin and then was released with Lovenox injections. I am currently on the Lovenox. After seeing the pulmonologist for a follow-up appointment, he advised me that I would be able to stop the injections after 3 months.

I found out about my pregnancy the day I got the vaccine (which was after I got the vaccine). After that I proceeded to get a pregnancy test confirmation (march 26) and it came back positive from the doctors office. On March 28 I began to have bleeding and I passed a blood clot the size of a baseball. I called the nurse line that next day and they told me they could not give me any medical advice because I had not been seen by a doctor for this pregnancy. During that week I began to experience a rash that began in the middle of my chest and proceeded to spread All over my stomach and back. It is now April 19 in the rash has continue to spread all over my limbs. On April 5 I went to the pregnancy clinic and was also getting a ultrasound and they were unable to locate the embryo in the uterus. On April 15 I got an ultrasound transvaginal and they were unable to locate an embryo or in a heartbeat. I then went to the hospital the next day on April 16 the hospital that I received my vaccine at and they did not give me any care and told me that my rash was a possible contact to something I may have come in contact recently. I try to express to the doctor that I?ve been experiencing issues since I received the vaccine and he did not connect any of the dots to my experiences. As of today April 19 I have come across several Different websites that state that red spot is a part of the symptoms an adverse reaction to the vaccine or should be of concern.

Patient presented to the ER on 4/20/21 with headache. On Saturday (4/17/2021), the patient had "the worst headache I have ever had" along with severe inner left ear pain. Patient took an ibuprofen which helped with the pain for about an hour then the pain came back. Pain got worse 2 hours later when she drove home from work. She called the RN line and was told to take ibuprofen and follow up in the AM. The next day 4/18/2021, patient went to urgent care and received Toradol and was told it was a migraine. Today 4/20/21, patient still had pain and noted feeling left sided facial numbness and blurry vision that correlated with when she got the headache. Patient went to an urgent care today and CT scan revealed a blood clot. She was then sent to the ED for evaluation. In the ED, she has no headache and facial numbness and has minimal left ear pain. Her headache is localized to the left side of her head. Patient denies fever, chills, and COVID symptoms. Patient was started on argatroban drip per hematology recommendation.

Pt had a brain bleed on April 14th at approximately 2:00 in the afternoon and was emergency airlifted to Medical Facility. She stayed at hospital until April 21st. Pt is currently unable to read and recall information such as words, and her own birthday.

Patient got the J&J Covid vaccine on 4/2/2021, presented to the ER on 4/20/2021 with complaint of left chest and shoulder pain. This has been progressively getting worse over the past 3 days. She denies any overt shortness of breath or cough and her vital signs are stable.

Client complained of pain and swelling in right calf area 2 -3 days before going to ER , at ER. Doppler study confirmed popliteal DVT

Patient received COVID J&J vaccine on 4/6, Presented to ED on 4/27/21 with complaint of 3 days of increasing leg pain and SOB

4-5-21 vommiting ,headache 4-6-21 spine pain , headache cont ,vomiting 4-7-21 spine pain , headache cont ,vomiting reaction to morphine and oxy (anaphalactic shock ) x 2 er visits 4-8-21 spine pain , headache cont ,vomiting, seizures/ trimmers ,confussion/memory loss ,bladder incont. numb and teng in right side face and arm. facale swelling and drooping Er Visit 4-9-21 spine pain , headache cont ,vomiting, seizures/ trimmers ,confussion/memory loss ,bladder incont. numb and teng in right side face and arm. facale swelling and drooping 4-10-21 spine pain , headache cont ,vomiting, seizures/ trimmers ,confussion/memory loss ,bladder incont. numb and teng in right side face and arm. facale swelling and drooping ER 4-11-21- 4-14-21 spine pain , headache cont ,vomiting, seizures/ trimmers ,confussion/memory loss ,bladder incont. numb and teng in right side face and arm. facale swelling and drooping 4-14-21 spine pain , headache cont ,vomiting, seizures/ trimmers ,confussion/memory loss ,bladder incont. numb and teng in right side face and arm. facale swelling and drooping went to my PCP she sent me staright to hospital due to facial drooping and swelling in Face and convosiont/trimmeres. 4-22-21 spine pain , headache cont ,vomiting (min), seizures/ trimmers ,confussion/memory loss ,bladder i numb and teng in right side face and arm. facale swelling and drooping Fallow up with pcp waiting to see nerology for sezure activity 4-23-21-5-2-21 spine pain , headache cont ,vomiting, seizures/ trimmers ,confussion/memory loss . numb and teng in right side face and arm. facale swelling and drooping

Presented with stroke-like symptoms less than 2 months after injection. 2 days in hospital, plus return to Emergency Room 2 days after release. Confirmed with neurology on 6/8 that it was indeed a stroke with no pre-existing conditions. Previous blood work (prior to covid short) came back normal.

7 hours post administration, patient had an anaphylactic reaction. she took liquid Benadryl, administered herself an EpiPen, used an albuterol inhaler and went to the er. Patient recovered while in the er and returned home. At pharmacy on the day of the vaccination clinic, patient stayed in a waiting area 15 mins after getting the vaccine. The way our set up was in the store, patient was sitting next to a kiwi plant in the garden and plant area. she is allergic to kiwi. patient is not certain what caused the reaction.

Pt received vaccination. Pt reports that she started feeling more fatigued and short of breath the week following injection. However, on 09Apr2021 pt had increased SOB and chest pain while shower, went into the doctor. After scan discovered Massive PE. Pt decompensated quickly and required intubation. Upon transfer to medical center, there were complications with ET tube and pt coded and required resuscitation for 6 minutes. Pt recovered and was transferred. Pt had Chest Xray, doppler of Blilateral lower extremities. Confirming PE and also left Popliteal DVT. Pt was on heparin drip which was switched to lovenox for proper anticoagulation. Pt was extubated on the 11th, is recovering. .

Approximately 5 hours after the vaccine I developed a very bad headache followed by chills, sweats, congestion, chest pain, body pain, muscle pain, fatigue and fever. The muscle pain and weakness was so bad I would loose balance when walking. I then started to menstruate clots, not my normal cycle timing, which lasted about 2 days. The clots subsided but I am still bleeding today. I was in bed for 4 days with severe immune response symptoms. After those symptoms subsided the fatigue was so extreme it was hard to function.

Blood clots (i started heavy menstrual cramps a day after the shot and I saw exceeding amount of blood clots which has never happened this excessively before) Fever, chills, headchae, nausea (all very severe level)

Unusual Heavy menstrual bleeding with clots starting hours after receiving shot. Headache and fatigue day after shot. Menstrual heavy bleeding continued for 6 days outside of normal cycle. Day 7 having moderate leg pains and stomach pains and occasional headaches.

DVST: R internal jugular, transverse/sigmoid sinus thrombus with associated intraparenchymal hemorrhage in R temporal lobe. Presented transfer from outside hospital after presented with 2 weeks headaches, blurry vision and 2-3 days neck stiffness and nausea with 1 episode of vomiting.

Janssen COVID-19 Vaccine EUA: patient presents to the emergency deaprtment (ED) reporting headache (10 out of 10 pain, difficult to keep eyes open) with neck pain, blurred vision, nausea, and photophobia for two weeks prior to arrival. Patient is four month post partum and breastfeeding. Patient diagnosed with cerebral venous sinus thrombosis and intraparenchymal hemorrhage. Admitted and underwent venous sinus thrombectomy. Currently still hospitalized.

1) Bilateral acute appearing pulmonary embolism right greater than left, clot burden moderately large. 2) . Probable portal vein thrombosis with partial superior mesenteric vein thrombosis. 3) Changes of mild diffuse colitis are suspect. Potential etiologies for colitis includes infectious processes, inflammatory processes, as well as ischemic etiologies. 4) Splenomegaly. 5) Thrombocytopenia. Platelets of 39000

patient admitted 4/23 for a multitude of symptoms and signs suggestive of a multisystem autoimmune inflammatory disorder of unclear etiology. Her past medical history is relevant for mild intermittent asthma, history of recurrent idiopathic urticaria, history of migraine headaches, hypothyroidism on supplemental levothyroxine, history of bipolar affective disorder on antipsychotropic medications (lamotrigine) and ADHD on stimulant medication (Focalin). Notably, the patient received a Johnson and Johnson COVID19 vaccine on 4/10. She reports current symptom onset on 4/17. Symptoms include pleuritic type chest pain, myalgias, arthralgias, diffuse interstitial edema, urticaria and objectively evidence of diffuse inflammation manifested by rising leukocytosis 16,000, CRP 9.3 from 5.7 just days ago, ESR 71 from 34 just several days ago, and new acute hepatitis. Pt admitted to the hospital and hospitalist states "Unclear etiology definitively but the clinical features all developed approximately 1 week after administration of the Janssen/Johnson & Johnson COVID-19 adenovirus vaccine which raises suspicion for this vaccine setting off the disease process" and "Strongly recommend consideration for reporting of possible adverse reaction to the Johnson Johnson vaccine".

During my menstrual cycle I usually have no symptoms other than tender breasts. So these symptoms were very unusual. Leg pains, pain and pressure in pelvis, clitoral pain, pain around vaginal opening, stinging like acid during urination that sent a shock through my entire body, uncontrollable bladder, nausea, large blood clots, lower stomach pain, flank pain, hot/cold chills, if I touch my belly button the pain radiated to my vagina, ovaries hurt, cervix pain, dryness, unable to get comfortable, crawling out of my skin, and constant urge to urinate, depression. I landed myself in the ER where they told me to take Tylenol and Motrin and sent me on my way. These medications were not able to control the amount of pain I was in. I have now reached out to a couple specialists.

4 days after the vaccine I started having periodic sharp pains in my uterus which made me think my period was coming. 6 days post vaccine I started bleeding lightly and the periodic sharp pains continued. 8 days post vaccine I woke up in the most excruciating pain of my life. It was the most severe menstrual type cramps I have ever experienced. I also had a severe headache which I never get. I took 600mg of ibuprofen. The pain continued for hours and I tried my best to breath through it. When I went to the restroom there was only a little blood but large amounts of fleshy tissue began discharging from me. Later that day when the tissue seemed to slow down the pain began to subside to a tolerable threshold (although still more severe than normal). I then began to bleed heavier than any other previous cycle. Normally I have a medium bleed for 2.5 days. This heavy bleeding lasted 6 days. I felt extremely dizzy and weak. Finally when the bleeding stopped I started to feel myself regain strength over the next few days although the sharp intermittent jabs of pain in my uterus lasted about three days after the bleeding stopped. I now am feeling back to normal and recovered. I never went to the ER but came very close to going during that time.

HEADACHE; BLURRY VISION; NECK STIFFNESS; NAUSEA; VOMITING; CEREBRAL VENOUS SINUS THROMBOSIS; DURAL VENOUS SINUS THROMBOSIS; RIGHT INTERNAL JUGULAR VEIN THROMBOSIS; INTRAPARENCHYMAL HEMORRHAGE; LOW PLATELET COUNT; This spontaneous report received from a patient via the VAERS (Vaccine Adverse Event Reporting System)(VAERS ID: 1224712) and concerned a 34-year-old white female. The patient's weight and height were not reported. The patient medical history included being 4 months post-partum. The patient had no drug, food or other product allergies, and had no chronic or long-standing conditions. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, route of administration and batch number not reported), dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. From an unspecified date, the patient had 2 weeks of headaches and blurry vision, 2 to 3 days of neck stiffness and nausea with 1 episode of vomiting and had been transferred to the current hospital from another. On 04-APR-2021 (12 days post-vaccination), the patient was diagnosed with dural venous sinus thrombosis (DVST), transverse/sigmoid (cerebral venous) sinus thrombus (CVST) with associated intraparenchymal hemorrhage in the right temporal lobe as well as thrombosis of the right internal jugular vein (thrombus). Magnetic resonance imaging (MRI) impressions showed there was a re-demonstrated of intraparenchymal hematoma in the right posterior temporal lobe measuring approximately 6.2 x 3.6 cm in maximal axial dimensions. There was surrounding edema and associated mass effect with effacement of the right temporal horn and right-to-left midline shift measuring 5 mm. There was medialization of the right uncus without transtentorial herniation. The basal cisterns were otherwise patent. There was dural thickening and hyperenhancement overlying the hemorrhage. There was prominent cortical veins along the right frontal temporoparietal convexity consistent with venous congestion. There was also a small are of vasogenic edema in the right anterior temporal lobe separate from the hematoma. There was a right mastoid effusion, but normal orbitals and the calvarium and skull base were unremarkable. Magnetic resonance venography (MRV) results revealed non-opacification of the torcula, right transverse sinus, right sigmoid sinus and upper internal jugular vein compatible with occlusive thrombosis. A small amount of thrombus also extended into the left transverse sinus. The superior sagittal sinus, remainder of the left transverse sinus, left sigmoid sinus, left upper internal jugular vein, straight sinus, vein of Galen and bilateral internal cerebral veins demonstrated normal contrast opacification. The patient's platelet count was 126 upon admission (normal range [NR] not provided), with other workup laboratory test results reported as pending. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The outcome of the right internal jugular thrombus, intraparenchymal hemorrhage, DVST, CVST, headache, blurry vision, neck stiffness, nausea and vomiting was reported as unknown. This report was serious (caused/prolonged hospitalization and other medically important condition).; Sender's Comments: V0: This case concerns a 34-year-old white female who experienced cerebral venous sinus thrombosis (CVST), dural venous sinus thrombosis, right internal jugular vein thrombosis, and cerebral hemorrhage 12 days after receiving covid-19 vaccine ad26.cov2.s for prevention of symptomatic SARS-CoV-2 virus infection. The patient was noted to be 4 months post-partum. She presented for medical assistance with a 2-week history of headaches, blurry vision, and neck stiffness for 2 to 3 days as well as nausea with 1 episode of vomiting. Magnetic resonance imaging showed a large hematoma in the right posterior temporal lobe with surrounding edema and associated mass effect resulting in effacement of the right temporal horn and right-to-left midline shift measuring 5 mm and occlusive thrombus within the torcula, right transverse sinus, right sigmoid sinus, and upper internal jugular vein. A small amount of thrombus extended into the medial aspect of the left transverse sinus. The platelet count on admission was 126,000. Although the post-partum status of the patient may have contributed, based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from Brighton Collaboration) and considering the low platelet count and temporal relationship to vaccination, we consider the events to have a plausible relationship with vaccination.

Patient admitted to acute care hospital approximately 7 weeks after receiving Janssen vaccine with thrombocytopenia. Platelet count 4000 at PCP and patient advised to present to the ED. On admission 5/5/21, repeat platelet count 8000. Emergent CT completed which ruled out cerebral venous sinus thrombosis. PT, INR, fibrinogen and d-dimer were normal. Hematology felt that it was most consistent with immune thrombocytopenia and unknown if any relation to her COVID vaccination.

I was fine for a week and a half and then I began to have pain in my leg, I also got bit by a dog. I went to emergency room hospital and they did ultra sound of my leg found four DVT and kept me over night.

The patient came in from the hospital with a confirmed Nonocclusive Deep Vein Thrombosis (DVT) in the lower left popliteal vein.

I have had pain in my calves so I stopped the birth control mini pill. My period had also been incredibly irregular, super heavy and clotted bleeding. I?ve felt dizzy and weak on the heaviest days I?ve been bleeding as well. I?m passing clots - similar to when I?ve miscarried in the past.

BLOOD CLOT; TISSUES NECROSIS; UNABLE TO WALK; CAPILLARIES EXPLODED; This spontaneous report received from a 35 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) frequency one total, dose was not reported, administered on 07-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. The patient reported about 3 weeks after vaccination his health problems started. He had been to numerous ERs, to primary neurologist, finally at 3rd hospital visit he was admitted and was in the ICU for 5 days. On 07-JUN-2021, they concluded a blood clot had formed in leg and traveled down to feet in toes where all capillaries exploded and tissues in toes necroded and died. The patient was unable to walk by self. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot, tissue necrosis, unable to walk and capillaries exploded was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210648314-covid-19 vaccine ad26.cov2.s-blood clot, tissue necrosis, unable to walk, capillaries exploded. 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).

I work in public security. On June 22, they gave me the Johnson vaccine, at 11:15 a.m., that day I get off at night and to this day I continue to menstruate a lot and many clots I went to the gynecologist and he gave me contraceptives to cut the period but I am still menstruating a lot and I feel weak and would like information or what can I do? I do not omit that days before the Johnson vaccine I had my menstruation which was June 17, 18, 19 and on the 20th it stopped, (which was my normal period without any anomaly), on Tuesday June 22 when I got the vaccine for the Tomorrow night I started to menstruate, it is already 14 days menstruating a lot, which is not normal, I feel my body weak and tired. I hope news soon I would appreciate it very much!

I fainted in my backyard on June 9th. I was brought to the hospital by ambulance and had elevated heart enzymes and a problem with my EKG. A subsequent CT scan was done and it was found that I had a massive saddle pulmonary embolism. I was air transferred to another hospital and given a TPA to break up the clot. I was in the ICU for 3 days and then the cardiac floor for 2 days. I also had a bleed where my central line was put in in my groin and a subsequent hematoma. The PE was most likely caused by a DVT in my right leg, believed to be caused because of a dislocated ankle and estrogen-based birth control.

At approximately 9PM on 4/11 my body became very itchy including abnormal redness / swelling in my chest and face. The injection site of the vaccine was hot to the touch. I have a history with severe food and medical reactions and know what my body feels like when it is about to go into anaphyisis so I immediately took 3 Benadryl. During this time my body tempature rose from 97.8 to 98.6. After an hour, the symptoms passed.

Anaphylactic reaction Swelling in face and throat Passing out feeling Rapid eyelid movement Trouble breathing, trouble swallowing

Atrial fibrillation at 2:15AM (110-138 BPM) - resolved at 9AM. Fatigue - onset 4/11 at 5AM , resolved at 9PM.

6hrs after the vaccine I started having chills, body aches, light headed, & headache. Also at the same time I started spotting which I found out it was the symptoms of a miscarriage. On 04/11/2021 I continued with the same symptoms then later on that night i started feeling dizzy the bleeding continued. Around 2am on 4/12/2021 I was bleeding a lot & at 7am I went to the ER and they confirmed I had a miscarriage. I was 11 weeks pregnant. My estimated delivery date was 10/28/2021. On my previous appointments they said everything was going good with my pregnancy the only complication was hyperthyroidism which I had been taking medication for.

RANDOM VAGINAL SPOTTING; SWOLLEN LIP; NAUSEA; VOMITING (THREW UP TWICE); FELT "FUZZY"; CHILLS; FEVER; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's past medical history included nausea, and vomiting, and concurrent conditions included acne, and allergies, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included spironolactone for acne, and cetirizine hydrochloride for allergies. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced felt "fuzzy". On 11-APR-2021, the subject experienced vomiting (threw up twice). On 11-APR-2021, the subject experienced nausea. On 12-APR-2021, the subject experienced swollen lip. On 13-APR-2021, the subject experienced random vaginal spotting. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt "fuzzy", vomiting (threw up twice), and nausea on 11-APR-2021, swollen lip on 12-APR-2021, and chills, and fever on 10-APR-2021, and had not recovered from random vaginal spotting. This report was non-serious.

MIGRAINE; FEVER; HEADACHE; ARM PAIN; POTENTIAL BLOOD CLOT; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's past medical history included stroke, and concurrent conditions included non-smoker, and sulfa allergy (anaphylactic). The patient experienced drug allergy when treated with nitrofurantoin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, patients arm was hurting and on the 11-APR-2021, night patient started having a headache. On 11-APR-2021, the patient had a fever of 103 and a migraine on 12-APR-2021. Patient took 2 Tylenol and rested in bed for the whole day. On 12-APR-2021, patient saw the physician due to her migraine. The physician was concerned that the patient may have a potential blood clot since the patient has had a stroke in 2016. Physician wanted her to get a MRV (Magnetic Resonance Venography) with contrast of the brain to make sure patient does not have another stroke and also prescribed baby aspirin until she can get the MRV The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm pain, fever, and headache, had not recovered from migraine, and the outcome of potential blood clot was not reported.. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210443400-Covid-19 vaccine ad26.cov2.s-Potential blood clot. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: MEDICAL HISTORY

I experienced headaches, nausea, diarrhea, chills. I felt very weak. On the second day, my symptoms were the same. On the third day i started to feel itchy and was super red. On Monday morning, I woke up with the rash all over my body and feeling very dizzy. I went to urgent care and he checked me that I had an allergic reaction to the J&J vaccine. I also experienced vaginal bleeding, uncontrollably and he did the exams and I was told it was my menstrual cycle which lasted one week. I have not gotten my menstrual cycle since the J&J vaccine. I do not have my lot # at the moment.

I developed a cough on or about beginning of May 1, 2021. After accidentally double dosing myself with my ACE inhibitor I went into the ER on 5/11 with light headedness/high heart rate and cough. After multiple tests were done it was discovered that I had a large satellite embolism. in my lung and another one in my left leg.

I went to the ER on 05/14/2021 because I had swelling in one ankle. I am pregnant so I was concerned. I was tested and a Deep Vein Thrombosis in my right leg. The swelling was in my left leg. There is no redness or swelling in that leg. I am taking subcutaneous injection of Lovenox 0.8 ml twice daily. I was 27 weeks pregnant at the time. I am currently experiencing injection site pain and I am seeing a maternal Fetal Medicine Specialist monthly. A birth plan has to made for when I deliver because of the medication. The diagnosis states Right Popliteal and Proximal calf DVT. Due-Date-08-09-2021 Pregnancy-First Pregnancy

35 Y female no signif PMH but with OCP (TriSprintec) since at least 2018, family hx of strokes in family members' 40s, daily marijuana use, and recently (10 days ago) seen in clinic for shortness of breath who per chart review was in her usual state of health until 10:30 am today shen she developed R sided headache, slurred speech, and L arm weakness while she was working out at the gym. At the time she was doing light cardio exercise including jumping jacks and lunges. On arrival stroke scale - 3 for facial palsy, left arm drift, and mild dysarthria. CT H demonstrated hyperdense R MCA which corresponded with a filling defect in the R MCA (M2/M3 segment) c/w thrombosis; her CTa neck was normal and there were no e/o hemorrhage. Furthermore, this same CTa showed extensive bilateral PE. An extended stroke alert was called and she was given IV tenecteplase at 1250pm and underwent thrombectomy. 2 weeks ago (6/2) she was seen in clinic for sudden onset shortness of breath, thought at that time by that clinician to be most likely exercise-induced asthma vs less likely ACS. She was advised to use her already written albuterol and had follow up in 2 days (6/4). At that time it was noted she had more SOB with exercises and increased chest tightness that were both relieved with inhaler use. She has a family history of strokes: Maternal uncle and maternal aunt strokes in their 40s Recent surgeries/immobility/travel: No surgeries, no more than a 2 hour car ride Smoking history: Dialy cannabis smoking but no tobacco smoking Age appropriate cancer screen: Yes Family history of cancer: breast cancer in grandmother Baseline functional status Full IADL's and A&O x4. At time of ICU consult, temp 98, BP 140/89, HR 88, RR 18. Patient received: intraop NS, Versed, fentanyl, tenecteplase for thrombectomy Labs notable for All labs wnl 35 y.o female with no significant PMH on OCP presented with shortness of breath and slurred speech and LUE weakness found to have acute right M1 occlusion. She underwent thrombolysis with successful recanalization. Deficits resolved. She was also found bilateral PE and non occlusive DVT. Repeat imaging stable. TTE with evidence of small PFO. Today, she is feeling well, denies shortness of breath or new neurological complaints/deficits. 1. R MCA infarct s/p TNK and thrombectomy 6/14 with no residual deficits - secondary to paradoxical embolism. Appreciate neurology recommendations. Small PFO found on TTE, appreciate cardiology evaluation for closure. 2. Bilateral PE/non occlusive DVT - mildly elevated homocysteine level. Rest of hypercoagulable workup pending. Continue heparin gtt, transition to Pradaxa with Lovenox bridging.

6/5/2021 Positive PCR for COVID-19 and onset of chills, fatigue, headache (had a previous COVID-19 positive PCR 1/14/2021) 6/5/2021 Acute R MCA ischemic stroke 2/2 M1 occlusion s/p thrombectomy (HCC) PFO (patent foramen ovale) 6/12/2021 Discharged to inpatient rehabilitation

Hard headaches Tiredness Numbness up to this moment 76% Blood clots Short breath up to this moment Chest pain comes and go up to this moment Hard coughing up to this moment Sweating while sleeping at night up to this moment. High blood pressure at the time I visited the ER. Made my Anxiety worse since I took the vaccine.

CEREBRAL HEMORRHAGE; DURAL VENOUS SINUS THROMBOSIS; THROMBOCYTOPENIA; seizure; LOSS OF CONSCIOUSNESS; SEVERE FRONTAL HEADACHE, OCULAR HEADACHE; NAUSEA, VOMITING; PHOTOPHOBIA; SODIUM LEVEL HIGH; This spontaneous report received from a health care professional via a Regulatory Authority the VAERS (Vaccine Adverse Event Reporting System) concerned a 35 year old female. Additional information was also received on 22-JUN-2021 from a literature article: The patient's height, and weight were not reported. The patient's concurrent conditions included codeine allergy, migraines, depression, and chronic thrombocytopenia. Patient had no adverse events following any previous vaccine and no recent abortive therapy. The patient had no cerebral venous sinus thrombosis risk factors. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805025) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included aripiprazole, bupropion hydrochloride, butalbital/caffeine/paracetamol, fluoxetine, propranolol hydrochloride, risperidone, and topiramate. On an unspecified date in APR-2021 around 8 PM, patient presented to emergency room (ER) with a severe frontal headache since around 2 PM. She took TYLENOL and marijuana candy for relief at 4 PM with no help. Patient had computerized tomography (CT) venogram and CT head at 10:19 PM with normal results. She was given Toradol, Compazine, Decadron, and magnesium and discharged at 2 AM. Her platelet count at that time was 114 x10*3/mcL and was consistent with the patient's description of chronic thrombocytopenia. On an unspecified date in APR-2021 at 2 AM, the patient presented to ER. She again had an ocular headache that was different and clearly more severe than her typical migraines. Still had significant nausea and vomiting along with photophobia. Unspecified laboratory results and imaging were reviewed. She again received morphine, Toradol, Reglan, Benadryl, dexamethasone. She was discharged at 06:00 feeling a little bit better. On 15-APR-2021 at 22:30, the patient had an acute worsening of headache and experienced loss of consciousness. At 23:30, her husband found her unresponsive and called EMS. The patient presented to emergency room at 01:30 after sustaining a seizure in route and was subsequently intubated on arrival. She had a Glasgow coma scale of 1 with fixed pupils and no gag reflex. Platelet count was 10 x10*3/mcL and reached a nadir of 9 x10*3/mcL. The D-dimer peak value was 13.47 mcg/mL, the fibrinogen nadir was 128 mg/dL, international normalized ratio (INR) was 1.2 and the activated partial thromboplastin time (aPTT) was 24.1 seconds. The result of a SARS-CoV-2 polymerase chain reaction (PCR) test was negative, and Heparin-platelet factor (PF)4 test result was positive (value of 2.2). CT head without contrast was performed which revealed intraparenchymal and subarachnoid hemorrhage with significant sulcal and cisternal effacement and mild migration of the cerebellar tonsils below the level of the foramen magnum. Intracranial hemorrhage locations were also reported as the right temporal lobe and left cerebellar hemisphere within the literature article. Increased density within the right transverse, sigmoid and superior sagittal sinus and questionably with in the sagittal sinus may reflect underlying dural venous sinus thrombosis. The patient was also found to have sigmoid sinus thrombosis. Neurology and neurosurgery evaluated the patient around 03:00 in person. Independently, imaging and clinical presentation was deemed to be incompatible with life. Because of the sedating medications required for intubation and subsequently her sodium rising to 170, the brain death physical examination by neurology was not performed. Repeat imaging to evaluate central nervous system vasculature was under consideration by the clinical team. Action taken with vaccine was not applicable. The outcome was recovering for severe frontal headache, ocular headache, nausea, vomiting, and photophobia, and the outcome of seizure, thrombocytopenia, cerebral hemorrhage, dural venous sinus thrombosis, loss of consciousness and sodium level high was not reported. This report was serious (Hospitalization Caused / Prolonged, Life Threatening, and Disability Or Permanent Damage). This case, from Same Literature article is linked to 20210354798, 20210408478, 20210428484, 20210407314, 20210416236, 20210444498, 20210415297, 20210439653, 20210444501, 20210444497 and 20210448310. Additional information was received on 22-JUN-2021 from a literature article. The following information was updated and incorporated into the case narrative: no cerebral venous sinus thrombosis risk factors, additional late signs/symptom included loss of consciousness (added as event), additional location of sigmoid sinus thrombosis and (intra)cerebral hemorrhage locations of the right temporal lobe and left cerebellar hemisphere, timeline of events, platelet nadir, other laboratory results, and linked case numbers.; Sender's Comments: V3: Follow-up from literature confirms no CVST risk factors, symptoms, anatomic location of CVST, and lab tests. This case concerns a 35-year-old white female with a history of migraines, depression, and chronic thrombocytopenia who was hospitalized for cerebral venous sinus thrombosis (CVST) and thrombocytopenia 7 days after vaccine. Concomitant medications included aripiprazole, bupropion hydrochloride, butalbital/caffeine/paracetamol, fluoxetine, propranolol, risperidone, and topiramate. On an unspecified date the patient presented to the emergency department (ED) with a severe frontal headache. A computerized tomography (CT) venogram and CT of the head were unremarkable. She was given Toradol, Compazine, Decadron, and magnesium and discharged. Her platelet count at that time was 114, thought to be consistent with the patient's description of chronic thrombocytopenia. The patient later presented again to the ED with a severe ocular headache. She was evaluated and discharged again with morphine, Toradol, Reglan, Benadryl, dexamethasone. On day 7, the patient had an acute worsening of headache and was found unresponsive that night. She was taken back to the ED by EMS, sustained a seizure in route and was intubated on arrival. She had no gag reflex. Sodium was 170, platelet nadir was 10, D dimer was 13.47 mcg/mL, Anti-PF4 ELISA was 2.2 and COVID test was negative. A CT revealed intraparenchymal and subarachnoid hemorrhage with mild migration of the cerebellar tonsils below the level of the foramen magnum as well as a suggestion of an underlying dural venous sinus thrombosis. She was determined to have brain death. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from Brighton Collaboration), the low platelet count and temporal relationship to vaccination, we consider the events to have a plausible relationship with vaccination.

SUDDEN ONSET GRAND MAL SEIZURES; SUICIDAL THOUGHTS AND IDEATIONS; COULD NOT SLEEP; COULD NOT EAT; NOT ABLE TO LIVE LIFE ANYMORE; This spontaneous report received from a consumer concerned a 35 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the patient could not sleep, could not eat; also experienced suicidal thoughts and ideations, and not able to live life anymore. On 29-APR-2021, the patient experienced sudden onset grand mal seizures. She had been having countless doctor visits. On an unspecified date, she was hospitalized. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sudden onset grand mal seizures, could not sleep, could not eat, suicidal thoughts and ideations, and not able to live life anymore. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210726025- covid-19 vaccine ad26.cov2.s- sudden onset grand mal seizures, could not sleep, could not eat, suicidal thoughts and ideations, and not able to live life anymore.. This event(s) is considered un-assessable. 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).

CEREBRAL ARTERY OCCLUSION; CEREBROVASCULAR ACCIDENT; ATRIAL SEPTAL DEFECT; THROMBECTOMY; CONFIRMED COVID-19 INFECTION; SARS-COV-2 TEST POSITIVE; CHILLS; FATIGUE; HEADACHE; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS ID: 1463769), concerned a 35 year old female patient of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent condition included antiphospholipid syndrome. The patient had no allergies reported. On 14-JAN-2021, the patient was tested positive for coronavirus disease (COVID-19) via the COVID-19 polymerase chain reaction (PCR) test. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 201A21A and expiry: unknown) dose was not reported, 1 total, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medication included Xarelto (rivaroxaban). On 05-JUN-2021, the patient experienced onset of chills, fatigue, headache and was tested positive for COVID-19 via COVID-19 PCR test [severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) test positive, confirmed covid-19 infection and confirmed clinical vaccination failure]. The patient went to emergency room visit and was hospitalized (date unspecified in report). On 05-JUN-2021, she had acute right middle cerebral artery (R MCA) ischemic stroke (cerebrovascular accident), 2/2 M1 occlusion (cerebral artery occlusion) status post (S/P) thrombectomy '(HCC)' (as reported), and had atrial septal defect [patent foramen ovale (PFO)]. On 12-JUN-2021, she was discharged to inpatient rehabilitation. The patient was hospitalized for 8 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the atrial septal defect, cerebral artery occlusion, cerebrovascular accident, chills, confirmed covid-19 infection, fatigue, headache, thrombectomy, SARS-COV-2 test positive and confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, Other Medically Important Condition, Life Threatening, and Disability Or Permanent Damage). This report was associated with product quality complaint : 90000187446. Version created to amend previously reported information on 23-JUL-2021. Upon review following information amended. Event chills, fatigue and headache were updated from labeled to unlabeled. Additional information received from Consumer Complaint Vigilance Organization on 27-JUL-2021. The following information updated and incorporated into the case narrative. product quality complaint number was added.; Sender's Comments: V1: Follow-up information updates the labeling and adds a product quality complaint number; this does not change the previous assessment. This spontaneous report received from a Regulatory Authority [VAERS ID: 1463769] concerns a 35-year-old female patient of unspecified ethnicity who had an acute right middle cerebral artery (R MCA) ischemic stroke with cerebral artery occlusion and was hospitalized 58 days after receiving the Janssen Covid-19 vaccine. Concurrent condition included antiphospholipid syndrome. The patient was previously COVID-19 polymerase chain reaction (PCR) test positive 3 month prior to vaccination. On the day of hospitalization, the patient noted chills, fatigue, headache; COVID-19 PCR test was positive. The patient underwent thrombectomy "HCC"; atrial septal defect was noted. The subject's anti-phospholipid syndrome and SARS-COV-2 infection may have increased the risk for the events to occur. However, considering the temporal relationship with vaccination, a relationship with Janssen Covid-19 vaccine cannot be ruled out. Therefore, the relationship is considered indeterminate.

The morning after the shot, I noticed vaginal bleeding/light spotting. I thought maybe it was just a slight reaction. By the evening, it had become heavier. By the following day, it was heavy and clotting was starting to develop. The Tuesday and Wednesday following the vaccine I had extremely heavy vaginal bleeding and clotting - going through a super plus tampon every hour and a half to two hours. By Thursday it had subsided a bit. By Friday it had lightened tremendously and by the following Saturday it was gone. But then Saturday evening the spotting picked up again. Sunday (3/14) the flow picked up again and by Monday (3/15) it was heavier with small clotting. Today (3/16) it is heavier with clotting again. My gynecologist did an exam and advised that I double my birth control for a few days to see if that will control it. She also took blood work (results not in yet).

Janssen COVID-19 Vaccine EUA I have a known prior history of thrombocytopenia that has historically worsened with infections/flares in immune system. My platelet count was 111 two days prior to vaccination. Two days after receiving vaccine, my platelet count dropped to 73 (but I remained asymptomatic). At 6 days post vaccine, my platelet count increased to 88.

Site: Pain at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild

36 y.o. female referred for the above chief complaint. She has no significant medical history and presented with a headache that became severe 3 days ago. She received the Johnson and Johnson COVID vaccine on March 25th and had a mild headache following that which she attributed to the vaccine. 3 days ago the pain became excruciating and was associated with vomiting. This prompted presentation to the ED where she was treated with Dilaudid. She was discharged home and has been using her mom's headache cocktail with some transient relief. She presented back to the ED today with continued symptoms. MRV revealed a venous sinus thrombosis and neurology was therefore consulted. She has no history of clots personally or in the family. Her dad did have a stroke in his 50s. Patient otherwise denies any other associated speech change, vision change, extremity numbness, extremity weakness, coordination difficulty, or dizziness. Patient admitted to the neurology ICU and started on anticoagulation.

Normal side effects until 4/4/21, when chest pressure and paid began at night, with shortness of breath. Appt with Dr on 4/6/21 and was sent for a CTA that confirmed a pulmonary embolism.

Patient presented with new onset dvt 5 wks post covid 19 vaccination. 36 yr old female with solitary risk factor of previous history of DVT. Of note, pt had dvt in 2002 which occurred while on birth control (and pt became pregnant).

1 I had fever till 99.8F so I took tylenol twice. it lasted about 6 hours the second day. 2 I had rash on my neck. 3 i had sore muscle for over 48 hours since i took the vaccine. 4 arm pain for over 72 hours. 5 tired for over 5 days after the vaccine. 6 vagina blood a little bit 2 weeks later 7 the next period late for 5 days 8 most important. i went to antibody test 33 days after the vaccine and it showed all negative.

Received Janssen COVID vaccine on 3/19/2021 around 8 am. Was in ER on 3/20/21 around 3 pm. Was found to have acute occlusive deep venous thrombosis of the left popliteal vein, peroneal veins and one of the paired left posterior tibialis veins proximally.

Pt had right sided chest pain x3 days starting 4/12/21, had a week of cough, fever, "general not feeling well" prior to ER admission 4/15/21. Had CT scan in ER on 4/15/21 - per radiology report a clot and pneumonia noted in RUL of lung. WBC count >22, elevated D Dimer, T Max in ER was 102.2. Was given PO Tylenol, 100mg Lovenox Subq, and IV antibiotics and flown to hospital.

4/9 Shot hurt and burned going in around 5:50 pm and after the injection for about an hour. Mild dizziness after vaccine and then foggy in the head until I went to bed around 10:30 pm. 4/10 Woke up shaking uncontrollably because I was so cold at midnight, chattering teeth. Extreme neck, back and jaw pain the next day as a result. Fever of 103.5 started at 2 am and lasted for about five hours. I took one 500 mg Tylenol at 2 am for the fever and again at 6:30 am . Fever went down to 101.8. Then it came back at 103.5 at 2 pm that afternoon and I felt horrible. Throughout this I had insomnia and when I was cold (two times) numbness in fingers/toes or at the tips of them, chest congestion, mild cough, sore throat, dry mouth, fatigue, dehydration, muscle aches, achy bones and joints in lower back to knees and ankles. I had random pain on the inside of my right leg a few inches above my knee for a couple of hours that morning. I had a headache and then sweating late the morning starting around 8 am. Headache increased as the day went on. I had mild abdominal pain throughout the day. At 5 pm I basically felt fine. 4/11 Abdominal pain, headache, fatigue, sweating and vaginal spotting, mild dizziness in the afternoon snd pain on left side of neck ( not something I?ve had with a period). Period type cramps started late evening. I am five weeks postpartum, exclusively breastfeeding. In prior pregnancy I had to supplement at two months and didn?t start period until 8 months postpartum. 4/12 3:30 am period started. 4/13-4/15 Abdominal Pain

Acute ITP - Platelet 2K on admission, previously 279K in Feb 2021 - Reports receiving J&J COVID vaccine 1 month prior - s/p 2 units platelet transfusion (4/9 and 4/10) - s/p IVIG x 4 days - Continue Prednisone taper (80mg daily for 2 more days, then 60mg daily until follows up with Hematology and repeat CBC). - Plan to follow-up with PCP on 4/16 and Hematology on 4/19

Very sick for three days as reported through CDC checking site. On 4/18 I began feeling extremely nauseous and had diarrhea and then began vomiting blood for over twelve hours. I went to the ER on 4/19 where they did an MRI and found two hemmorhaging lesions on the right side of my brain.

patient called EMS with pain crisis and noted that she had lost vision in both eyes. was transported to Emergency room by EMS and had cardiac arrest and died.

Patient describes muscle pain and bruising/"blood clots" on left side. The onset was 5/9/2021. Describes as severe pain that increased till seen at healthcare provider's office by healthcare provider.

The day of the vaccine I was told that my arm might be sore. I felt sore right away and as soon as I got in the car to drive home I was extremely tired and I slept for the entire six hour car ride home. I was very fatigued that night and then I got a bad headache, fever and it lasted for 48 hours. After that, the headache was less intense and they were intermittent but my arm still hurt and I couldn't lay on it. I was still fatigued for a week. On the fourth day I started to get a weird feeling of vibrations and twitching all over my body. It is especially worse in my temple. It has been a month but I still get the twitching in different parts of my body. My face, arms, legs and temples. It is in different places. It happens less often now, it is not all day but it is still daily and mostly in my head and my legs. I had it happen in my temples last night. I had my menstrual cycle since the vaccine and it was about three days later than expected. I had a lot of blood clots which was unusual for me. I have had flu like symptoms this week and I have a cough, runny nose and headaches but I am planning on trying to go to the doctor this week.

On 5/10/21 got up with sever pain in my left side neck, shoulder and arm pain. Initially thought it was a muscle pull. Pain was out of control on Tuesday 5/11/21 Night. Took Advil, used equate cool & heat pain relieving liquid. On Wednesday 5/12 discovered I have bruises and blood clots on my back and left side. Took appointment with PCP on 5/14. Prescribed Methylprednisolone 4 MG tables for 6 days. Pain continued with blood clots and bruise marks. Developed left side ear pain, Shivering and mild fever. Visited PCP again on 5/21/21. Prescribed Cyclobenzaprine. Over the past 1 months have lost weight, had a sever pain on left leg, blurry vision.

After injection 2:01pm - almost passed out. Immediate injection site pain. 4:00pm vaginal bleeding, pain in left and right arm Continuing throughout day- pain in both arms, fatigue, pain in back, feverish and joint pain. 5/22- headache, fever, fatigue, vaginal bleeding, pain under left rib. (Not persistent pain in left rib) feverish and joint pain. 5/23- pain in both arms, shoulder pain, joint pain, fatigue vaginal spotting. Took 1 ibuprofen. 5/24- lessening arm and back pain, fatigue and vaginal spotting, shoulder pain. Pain below left rib (not persistent) and joint pain now localized in left hand/fingers and left ankle area. Took 1 ibuprofen.

Janssen COVID-19 Vaccine EUA High fever started 9 hours after vaccination, continued until 24 hours after vaccination. Nausea and dizziness started 9 hours after vaccination, continued until 12 hours after vaccination. 5 weeks pregnant- spotting started 25 hours after vaccination. No proven correlation between potential miscarriage and Vaccine. Generalized, spotty red rash, slightly raised, no itch, on the front torso, from top of legs, groin area, up to shoulders, on front torso only (not on arms or back) 33 hrs after vaccination.

Obtained from patient. Patient is a 37-year-old female with past medical history of asthma, bipolar disorder, history of anxiety and joint pain, came to Emergency Room with above complaints. Patient works as a investigator and getting her first COVID-19 vaccination, Johnson and Johnson. Patient was at work receiving her first dose. After dose, the patient was planned to be observed. The patient is stating that 3 minutes, the patient started getting her tongue started feeling funny. Four minutes into vaccination, patient felt her throat was closing and the patient started drooling. Nurse practitioner immediately gave the patient 2 shots of epinephrine with Benadryl. 911 was called and patient was admitted to the Emergency Room. In the Emergency Room, the patient diagnosed with anaphylactic reaction to COVID-19 vaccination. With the patient's persistent tachycardia, still having symptoms of throat itching, the patient requested to be admitted for further observation.

I went to a community event (held at a church) for the COVID vaccine. After the vaccine, I wanted the 15 minutes and felt ok - just hot. I went out to my car and over the next few minutes - I was getting hotter - My face was extremely hot and flushed, and hives started developing on my arms and chest. They were burning and itching; my skin was hot to the touch. My chest felt tight and my throat felt swollen, but I was able to breathe (breathe felt a little short, but I was able to take a full breathe). I was also dizzy and felt nauseous. I went to the ER, where they treated me for anaphylaxis with Benadryl, Pepcid, Breathing treatment, and a steroid. After about an hour or so I felt fine, and the dr gave me some medications to take over the next few days.

Pulmonary embolism and bilateral DVTs, received vaccine on 3/11/21, was admitted to the hospital on 3/29/21

Heavy Vaginal bleeding (not from period), bright red, moderate to severe uterine cramping that started 12 hours after vaccine. Bleeding and cramping continue 48 hours later. Tylenol decreases the cramping but does not completely resolve.

Since vaccination the patient has had a severe headache (unlike her typical episodic migraine), and then developed left hemibody anesthesia, LUE drift. CTA demonstrated Right ICA dissection (of unknown duration) with string sign, acute right MCA artery to artery sub-occlusive embolus, MRI shows right MCA ischemic infarct.

Began having severe muscle aches followed by dark colored urine. Went to the emergency room and they determined I had rhabdomyolysis.

Per hospital chart notes, known timeline of events is pieced together as follows: 2021-03-23 - patient received J&J COVID-19 vaccine at Drug Store 2021-03-24 - patient developed myalgias, headache, shortness of breath, and chills - resolved within 24 hours 2021-04-02 - patient developed headache intermittent from right to left side of head for which patient was seen at an urgent care. Patient was prescribed Fioricet (butalbital/acetaminophen/caffeine). 2021-04-05 - patient developed right-sided neck pain 2021-04-06 - patient got tested for COVID-19, resulted negative on 2021-04-07 2021-04-08 - patient seen at Medical Center emergency department for headache and right-sided neck pain that shoots to (2021-04-08 cont.) the head and shoulder, for which patient self-medicated with ibuprofen. Patient reported to ED provider that using ibuprofen nearly relieves headache and makes her functional and had the most improvement the day she visited the ED prior to her visit. Patient received a CT scan of the head without contrast that was unremarkable. Patient was diagnosed with headache and neck sprain and was prescribed ibuprofen 600 mg, take 1 tablet by mouth every 8 hours, and diazepam 5 mg, take 1 tablet by mouth 3 times a day as needed for muscle spasm. 2021-04-12 - patient developed left lower extremity pain 2021-04-14 - patient followed up with Neurologist outpatient as directed by ED provider and was advised to get an MRV and left lower extremity doppler. Patient was prescribed tramadol 50 mg and butalbital/acetaminophen/caffeine (Fioricet) by the Neurologist. 2021-04-15 - patient presented to Medical Center ED before outpatient MRV and LLE doppler could be done due to worsening right-sided neck pain and inability to ambulate comfortably due to lower extremity pain that had been worsening over several days. Upon examination, there is subtle swelling to left lower extremity and doppler revealed multiple DVTs in left lower extremity. CT head without contrast was unremarkable, however, CT venogram of the brain reveals thrombi of the right transverse sinus and sigmoid sinuses, as well as IJ. Patient was initiated on argatroban and admitted to inpatient at the time of this report. "Heparin induced platelet antibody" and "lupus anticoagulant evaluation" tests are ordered and pending.

Thrombosed Hemorrhoids. Extreme pain, bleeding. Went in to urgent care after 3 days and they cut them open to remove blood clots. There was no clear event that triggered these to appear.

I received the vaccine on the 7th and in the night a migraine started along with fever on and off and on the 16th I went to the Emergency room with a migraine and chest pains and after running some tests I have pulmonary embolisms

Approx 6:30 pm headache 7:05 pm headache immediately subsided, right arm grew numb 7:09 pm speech became difficult. Trouble stringing words together. 7:15 difficulty spelling/texting 7:25 pm numbness speed to lower right quadrant of face. Speech became more labored. 7:40 arrived in ER, numbness in face resolved Approx 8:00 speech improved, arm numbness resolved CT scans, MRI/MRV, echocardiogram, blood work including platelets and d-dimer, all normal. Kept in hospital under observation until approx 6:30 4/14. Discharged with diagnosis of suspected TIA. Followup scheduled with primary physician and neurology consult.

Within 10 minutes after my vaccine, the roof of my mouth began to itch, and 3 days after my vaccine, I developed hives across my abdomen that started at 5am and did not subside until I was able to take a Benedryl before bedtime. Three weeks after my vaccination, my shot site began to hurt and then I started to exhibit an allergic reaction to foods I had never been allergic to previously. First it was ground turkey, and then two days later, I had an allergic reaction (hives, itchy mouth, and anaphylaxis) to chicken. A few days later I developed the same reaction to beef, and now I have the same reaction to berries and vegetables. My body seems to be attacking everything I eat.

Fifteen minutes after receiving the shot, I went into anaphylactic shock. They had to use two EpiPen's. I was given an IV with Benadryl and a steroid that I do not know the name of. I did not follow up with my doctor. I was taken to the ER and put under observation.

Patient received COVID vaccine approximately one week prior to admission. Patient developed acute rhabdomyolysis requiring hospitalization. She developed pain and stiffness in her neck which spread to her back and generalized muscles to the point where she had difficulty moving in the next 12 hours. She did not have difficulty swallowing but she did have difficulty chewing and complained of throat pain. Upon arrival to the emergency room she was unable to lift her legs to get out of the car. In the emergency room she was found to have a CK of 130,000 along with a creatinine of 1.1 and potassium of 6.8 with a calcium of 7.0. She was admitted to the hospital ward and given aggressive IVFs. The following am she was having trouble breathing and was started on BIPAP; the repeat CK level climbed to 543,500. She continued to worsen, developing increased swelling around the mouth and neck. She became anuric with acute kidney injury; and was subsequently transferred to CCC upon which she was intubated and initiated on CRRT.

Jannsen covid-19 vaccine EUA Shortness of breath. Leg swelling. Myocarditis, fluid retention, fatigue, weakness. Heart failure symptoms

Patient's first day of last menstrual period was 3/23/2021. Patient has a predictable monthly cycle with an average length of 30 days. Patient reports two positive at home urine pregnancy tests on 4/30/21 and 5/1/21. Conception likely occurred on or around 4/6/21. Patient reports vaginal bleeding that started on 5/14/21. Patient had transvaginal ultrasound on 5/17/21. Impression: FIRST TRIMESTER ULTRASOUND, SINGLETON An early intrauterine singleton pregnancy is visualized. A fetal pole is visualized but fetal cardiac activity is NOT present. The fetal biometry is appropriate for gestational age. Anatomic survey is precluded by early gestational age. As the CRL <7mm (measures 2.6mm) a definitive diagnosis of a missed miscarriage can not be made I would recommend a follow up ultrasound in 10-14d. Follow up ultrasound on 5/27/21 could not visualize pregnancy. Impression: The endometrium measures 14.39 mm, with heterogenous echotexture suggestive of retained products. The right and left ovaries appear normal.

IN Mid Mar 2021 - recd the j and j vaccine. About 4 weeks later started having pain in the right thigh. Lasted for 5 mins - was a spasm. Intermittent. End april started having pain in the left shoulder - like a knot and then w/ sob / chest pains. Came to er and was found to have a PE. Also then a right LE DVT. Started on heparin -- > argatroban HIT panel was neg. Now on eliquis.

My menstrual cycle has been incredibly irregular. I have been having breakthrough bleeding and extremely heavy clotting which I have never had before. I have been bleeding for 25 days straight at the time of reporting this, and my clots are getting bigger and the bleeding is getting heavier.

Admitted with complaints severe headache x 10 days, chills and cough , a few hours after admission patient complained of severe RLE pain

Vaginal spotting began two days after with increased volume each day (no reason for spotting and have never spotted). Neck pain started on day three. Took ibuprofen to reduce pain. Pain returned after medication wore off.

The patient was experiencing headaches 1 week ago. She also had aphasia later in the week. She went to an outside hospital on 3/24/2021 and was found to have intraparenchymal hemorrhage in addition to venous sinus thrombosis. She is being treated for the venous sinus thrombosis with heparin.

Patient presented with acute abdominal pain, DIC , thrombocytopenia and found have small bowel gangrene due to SMA thrombosis. Underwent Laparotomy with small bowel resection. Was in the ICU and currently on TPN and IV antibiotics.

Janssen COVID-19 Vaccine EUA Patient presented to ED on 4/2/2021 with complaints of "worst headache of my life", waking her up at 2 am on 4/1/202. Describes the headache as being 10/10, sharp, and located at the back of her head. Associated fevers of 101.2F, chills, generalized weakness and dizziness. The patient states she took ibuprofen with mild improvement of her symptoms, so called her PCP and had a CT head done. The patient states she received a call from her PCP prior to arrival stating to go to the closest emergency department because her CT head showed an acute cerebellar hemorrhage. Patient admitted to Medical Center. Cerebral angio performed on 4/5/2021 which demonstrated dural sinus thrombus. Platelet count 255 on 4/2/2021 (Range 193 - 255 from April 5th through April 14th).

Pt states that on Monday she noticed that she couldn't put pressure on her leg to walk. (04-12-21) Pt called and made an appointment on 04-13-21 and saw her PCP. Ultrasound was ordered and was dx with near occlusive vein thrombosis in the distal right femoral vein. Pt was prescribed Lovenox 100mg to take now and was also prescribed eliquis 5 mg twice daily, and acetaminophen-codeine to help with the pain.

I was contacted by physician assistant who informed us that patient was at HCF being treated for clotting believed to be secondary to having received the Janssen Covid19 vaccination. He said that she was diagnosed as having a focal dural venous thrombosis in the superior sagittal sinus and was being treated with Eliquis. He requested that we report this event to VAERS.

38 y/o F pt with a PMH of DVT, CVA, presents to the ED with complaints of left thigh and calf pain. Diagnosis of DVT in left leg.

Blood clot in my left forearm. I first noticed it on 4/20 around 7pm. There was a bump (the size of a dime) and small bruise. Overnight the bump got a bit smaller and the bruise expanded. Over the next several days the bump kept diminishing. The bruise remained about the same size and kept getting darker. It?s been one week now and the bump is very tiny (size of a small pea), and the bruise is incredibly dark, but showing more of a healing process color.

COMPUTERISED TOMOGRAM HEAD ABNORMAL; VENOUS SINUS THROMBOSIS; INTRACEREBRAL HAEMATOMA; THROMBOCYTOPENIA; EXPERIENCING HEADACHES 1 WEEK AGO; This spontaneous report received from a healthcare professional via VAERS (Vaccine Adverse Event Reporting System) (VAERS reference number 1133212) and concerned a 38 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included amoxicillin allergy. The patient, age 38, received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the patient was "experiencing headaches 1 week ago", and also had aphasia later in the week. On 24-MAR-2021, the patient went to an outside hospital and was found to have intraparenchymal hemorrhage in addition to venous sinus thrombosis and developed intracerebral haematoma. On 25-MAR-2021, Computerized tomography (CT) of the head without contrast showed parenchymal hemorrhage and persistent hyperdensity in the left transverse sinus, consistent with known venous sinus thrombosis. The patient was being treated for the venous sinus thrombosis with heparin. On an unknown date, platelet count was 78,000 (thrombocytopenia). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of events thrombocytopenia, intracerebral haematoma, venous sinus thrombosis, experiencing headaches 1 week ago, and computerized tomogram head abnormal was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). Version 3 was created on 26-APR-2021 for the purpose of quality improvement. The following corrections were made: platelet count was added as the event of thrombocytopenia.; Sender's Comments: V2: Follow up added additional laboratory information. This report received via VAERs database (ID# 1133212) concerned a 38-year-old female patient who experienced intraparenchymal hemorrhage and venous sinus thrombosis 16 days after vaccination. Diagnosis was confirmed on computerized tomography (CT) of the head. Platelet count was 78,000. Medical history and concomitant medications were not reported. Presenting symptoms included headache and aphasia. Treatment included heparin. Outcome was not reported. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS), the low platelet count and temporal relationship to vaccination (Criteria level 2), the events are assessed to have a plausible relationship with vaccination.

vaccine 4/9 surgery 5/5 on shoulder 5/10 clinic neg US of leg for DVT due to pain 5/13 PE with increased short of breath and tachycardia

THROMBOSIS IN RIGHT HAND MIDDLE FINGER KNUCKLE; RIGHT ARM AND HAND COLD; RIGHT ARM AND HAND NUMB,LEFT HAND NUMB; WEAK LEFT HAND AND WEAK LEGS; CRAMP IN INNER MIDDLE FOOT LEFT FOOT; PAIN ALL OVER BODY; CHILLS; FEVER; HAND AND LEG STIFFNESS,STIFF NECK; RED/BLUE BRUISE; This spontaneous report received from a patient concerned a 38 year old white and Hispanic or Latino female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 205A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 03-MAY-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the patient experienced red/blue bruise. On 03-MAY-2021, the patient experienced pain all over body, hand and leg stiffness for 10 minutes, stiff neck, chills and fever. On 04-MAY-2021, the patient experienced cramp in inner middle foot left foot. On 09-MAY-2021, the patient experienced thrombosis in right hand middle finger knuckle, right arm and hand cold, right arm and hand numb, left hand numb and weak left hand and weak legs. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cramp in inner middle foot left foot on 04-MAY-2021, pain all over body on MAY-2021, and chills, and fever on 03-MAY-2021, was recovering from right arm and hand cold, right arm and hand numb, left hand numb, and weak left hand and weak legs, had not recovered from thrombosis in right hand middle finger knuckle, and hand and leg stiffness, stiff neck, and the outcome of red/blue bruise was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210516231-covid-19 vaccine ad26.cov2.s - thrombosis in right hand middle finger in Hispanic or Latino patient. 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).

Many weeks ago (end of March, into April) i noticed I was short of breath, and a few weeks later a cough developed (mid-April). Also mid-April, on April 17, I had a sudden subjunctive hemorrhage happen in my right eye for no apparent reason. There was no injury to my eye and my ophthalmologist told me it would heal in a few weeks. Two weeks ago (beginning of May) a terrible, nearly unbearable headache began. A few days later, I continued to feel strange and began to get more frequently short of breath and my cough worsened. On 5/5/2021 I went to my doctor , Family Medicine, and was then sent to the local hospital, and had a cat scan done of my lungs, around 9 AM. I was I was diagnosed with a Pulmonary Embolism in my right lung, that is so large that it is taking up 2/3 of the lung and its pushing on my heart. I am currently taking Eliquis and waiting to be seen by a specialist. I still have shortness of breath, headaches, and chest pain as a result of my PE.

The next day of vaccine on 03/31/2021 I had a severe headache, nauseas, I had diarrhea. As the days passed I started getting worst and worst I was loosing mobility in my body my husband had to take me to the restroom. On 04/06/2021 is when I went to the Emergency Room. When I got to the hospital I could not breath my ribs hurt a lot & I had horrible back pain. They put me oxygen and gave me fluids but they said I had to get transfer to another hospital and they transferred me on an ambulance. In the other hospital us where they transferred me they kept poking my stomach when I asked them why they kept poking it they told me that it was to stop the blood cloths. I was hospitalized for 5 days. When I was sent home I was still not feeling good I was feeling sick still I've been trying to recover slowly but I am not the same. I'm still in a lot of pain I can't move my arms because of how much it hurts my back keeps hurting a lot as well. I want to go back to normal to how I was I can't do anything I can't even cook for my kids. I now have depression.

Presented to the ED for evaluation of heart palpitations, bilateral lower leg pain, bilateral arm pain, and headache onset two weeks (6 weeks from vaccine) Patient got a CT angiogram of the chest which indicated faintly visible peripheral subsegmental emboli within the left greater than right lower lobe pulmonary arterial distribution. Patient received 0.9% sodium chloride 250 mL and apixaban 10 mg.

On 03/10/2021 bad headache, fever, leg arm went numb . Headache lasted for three days, other symptoms went away after 24 hours. I had several A-VIB events in the 24 hours, and went into kidney failure, and was hospital for three days. The Thyroid, Cholesterol and kidney failure.

The day after, I woke up with a bad headache and I had the headache for a good 19 days. The doctors thought I was over-reacting. It was a bad headache on left side of head. I was just not feeling well. On the 19th day, it went away. I still from time to time I do still feel pain in the head on the left side. I had a lot of tightness in my left leg. In previous years, I have had blood clot in my leg and after birth in my stomachs - so with the pain in calf I called a doctor and went. They did a visual. After a lump appearing in my leg, an ultrasound was scheduled. I went Urgent care on May 10 - she ordered an ultrasound but her office didn't ever follow up with me. On 17th, I saw my Primary care and she sent me straight to get an Ultrasound - on the 18th, it revealed I had a blood clot.

vaginal bleeding (did bloodwork to check for thrombocytopenia - was negative); fever & chills - this happened the night after the vaccine - continued for 3 days; upper respiratory infection - the fever and chills morphed into this over the following days; cystic acne outbreak (this took about 3 weeks to show up - but was unrelated to anything else in my lifestyle/diet so the only conclusion I can draw is it was from the vaccine).

On April 06,2021 I took the Johnson and Johnson vaccine the next day I threw up and my leg would fall asleep I advised my doctor she sent me to the emergency room I went to the hospital. They did a ultrasound they didn?t find and blood clots I also advised them that I had been having headaches and they told me take over the counter pills. The head aches continued I was with the pain for a month in half my doctor sent me for a MRI and to a neurologist. The headaches still continue finally my neurologist sent me to the hospital. They conducted MRI MRV MRA I was admitted to the hospital for 14 days I haven?t been able to return to work I am not 100% I am on blood thinners. They ended up finding a blood clot on the right side of my head I am still not able to return to work still having headaches and still having to go to follow ups.

Shortness of breath, pleuritic R lower chest pain since 6/15. Was seen in ED on 6/16 and diagnosed with right lower lobe pulmonary embolism. Then had OCP discontinued, and was started on Xarelto for anticoagulation treatment. Was discharged from ED 6/16. Returned to clnic on 6/17 and still having symptoms of pleuritic chest pain of right lower chest, however does not have SOB or dyspnea on exertion.

Heavy and painful period lasting over 7 days. Large blood clots larger than silver dollar. Fatigue. After 3 months period still has blood clots size of a quarter but are still lasting 7 days. Was 5 days prior to vaccine.

Developed a blood clot in pinky, went to ER and triage PA said it was a superficial venous thrombosis and nothing to worry about. Discharged home with no blood work.

Within approximately 2 minutes of receiving vaccine, anaphylactic reaction began. Patient's cheeks became very flush/red, & her throat became itchy and tingly. Within the next minute or 2 she started vomiting. She then felt tightness in her chest, and shortness of breath. Complained of lips feeling numb and "heavy". Dr was present and ordered an IV to be started, and placed patient on oxygen and a cardiopulmonary monitor with pulse oxmeter after she used a ProAir inhaler. Patient was given IV steroid SoluCortef, IV Zofran for the vomiting, IV Pepsid, and IV Benedryl all for the allergic reaction. She also received 500 ml IV fluids. Symptoms lessoned within one hour, and she was observed for another hour and a half on cardiac monitor and pulse ox by nursing staff as well as Dr. Vitals stable throughout event.

I started experiencing flu-like symptoms at around 5 PM on 3/14/21. I was feverish and had chills, muscle aches, and a headache. I had very strong chills for a few hours and then I noticed that my resting heart rate was around 128 bpm at around 1:30 AM on 3/15/21. I was running a 100.6 fever at that time. My fever subsided in the morning and the headache persisted throughout the day, and I was very tired as I did not get much sleep the night before. I did not work that day (Monday, 3/15). At the time I was about 7 weeks pregnant. I noticed some very light spotting later in the day on 3/15, and then I continued spotting on 3/16. I consulted a midwife at the facility at 4 PM on 3/16/21 and took a blood test to measure my hCG hormone levels. The following day, 3/17, I received the results that I had a normal level of hCG hormone and normal hemoglobin levels. As the day continued, the spotting turned into bleeding, and eventually the bleeding became heavy starting around 4 PM. I received an ultrasound on 3/18/21 at 8 AM and later spoke with a midwife from facility at 11 AM that day, confirming that there was no viable pregnancy detected via ultrasound. I had lost quite a bit of blood at that point. I am, as of 8:35 PM on Friday, March 19th, still bleeding and experiencing the impact of miscarriage.

Fever 100 degrees for 36 hrs Fatigue for 48 hrs Headache for 1 week post Menstrual cycle started 6 days early Menstrual cycle was heavier and many clots noted

Possible blood clot in L knee, appears to be superficial. I get these frequently (about once a year).

1st night very out of breath. O2 at 93 on sensor at home. Felt better next day. 3/29/21 - went to ER for blood clot in left leg.

Had a huge blood clot come out of my nose after a nose bleed. I do not get nose bleeds so this was very strange. Took me 15 minutes to get it to stop bleeding.

The minute after the vaccination I had fainted, vision went, low blood pressure, after laying down became better. Rested almost an hour in order to be able to walk. next day, I had severe headache, with nausea, and a day later I had bleeding. Bleeding became severe, I had miscarriage. I was 7 weeks pregnant.

Patient complained of fever and chills on 4/18. Patient continued to have symptoms, suspected to be acute frontal sinusitis. On 4/21, patient complained of bilateral leg heaviness, felt weighed down, difficult to walk, no weakness, swelling, or redness. Patient elevated legs and felt better on 4/22. Patient later presented to the ED with acute mental status changes. Patient fell at home and had a seizure according to family. Patient is currently intubated and critically ill.

PULMONARY EMBOLISM IN CHEST; TIREDNESS; This spontaneous report received from the patient's mother concerned a 39 year old. The patient's weight was 251 pounds, and height was 66 inches. The patient's past medical history included a previous pulmonary embolism on 12-JUL-2012, which the reporter said the physician attributed to the patient being "obese and lays on her bed and doesn't exercise". Concurrent conditions included irregular menstruation, schizoaffective disorder, panic attacks, anxiety attacks, depression, incontinence, gastritis, constipation, sciatica nerve pain, asthma, obese, and doesn't comprehend well. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 expiry: UNKNOWN) dose was not reported, 1 in total administered on 06-MAR-2021 at left arm for prophylactic vaccination. Non-Company suspect included ethinylestradiol/ferrous fumarate/norethisterone acetate, "for two months" for irregular menstruation. On 17-MAR-2021, the patient's physician ordered the patient to stop taking. Concomitant medications included salbutamol, lactulose for constipation, clozapine, gabapentin (noted as the doctor was trying to wean patient off medication), oxybutynin hydrochloride, pantoprazole, risperidone, valproate semisodium, vilazodone hydrochloride, and unspecified breathing treatments. In MAR-2021, the patient's mother stated that the first few days after vaccination the patient was fine. After a few days, patient was more tired than usual. On 16-MAR-2021, the patients mother noticed the patient's right leg was swollen and decided to take the patient to the Emergency Room. She was diagnosed with pulmonary embolism in the chest verified with radiology tests of chest and many other tests. Treatment included Eliquis 5 mg 2 times a day to treat the pulmonary embolism in her chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pulmonary embolism in chest was not reported. The patient had not recovered from tiredness. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This 39-year-old obese (BMI 40.5 kg/m2) female patient was diagnosed with pulmonary embolism 10 days after receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection. Concurrent conditions includes irregular menstruation, schizoaffective disorder, panic attacks, anxiety attacks, depression, incontinence, gastritis, constipation, sciatica nerve pain, asthma, obese, difficulty in comprehension. Concurrent medications includes ethinylestradiol/ferrous fumarate/norethisterone acetate, salbutamol, lactulose, clozapine, gabapentin, oxybutynin hydrochloride, pantoprazole, risperidone, valproate semisodium, vilazodone hydrochloride, and unspecified breathing treatments. There was prior history of pulmonary embolism (PE) 9 years prior to vaccination and was advised to be due to obesity and lack of physical activity. Emergency room consult for leg swelling 10 days after vaccination; diagnosed with PE with radiology and many other unspecified tests; treated with Eliquis. Th event is confounded by increased risk with prior history of pulmonary embolism, obesity, OCP, and risperidone (class effect). The information available precludes a complete and meaningful assessment. However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded. Additional information was requested.

Sudden onset of menstrual period, lasting 2 weeks with extremely heavy flow and pain. Saw my Dr. and she did a blood test to check for platelet count, which all labs done were normal. Period lasting from 4/7 to 4/21 all the while I take my birth control as normal with no missed doses. Now on 5/7 having severely heavy flow again with clotting. Dr. prescribed naproxen and an extra "mini-pill" hormone supplement on top of my regular birth control. Will monitor.

The day before she got her vaccine she had started her menstruation cycle. She is not on any medications, everything was normal, went to work and went to get her vaccine. She got her vaccine and around 4:15 she started gushing, which is abnormal for her and having clots the size of a half dollar and covered in blood. This is not normal for her periods, and she is now in the bathroom every hour and a half and looks like a murder scene. Her normal menstrual cycle is heavy for one day and then gradually lessens and only lasts a few days. She does occasionally have small clots with hers, but this are large and bleeding profusely. The only side effect she has is that she is extremely tired. She slept from 4:30 yesterday to 2:00 AM and feels like she could sleep the rest of the day. Her arm is a little bit sore, but otherwise fine from the injection site. Is concerned due to the heavy volume of bleeding, which is extremely abnormal for her. She has taken Tylenol and drinking a lot of fluids.

I experienced after my J&J vaccine, had a uterine ablation May of last year. I had severe severe vaginal bleeding, had to go to the doctor and receive an ultrasound. I have had my menstrual cycle, with oain.

PT states after her J&J vaccine of 05-05-2021, she experienced phlebitis in the vein, left leg that resulted in a blood clot as per PCP. She states her PCP told her that her phlebitis would go away in a few weeks. PT states she still continues with the phlebitis in her left leg but now is less painful but still present.

Chest pain, abdominal pain and right flank pain 12 days after vaccination. Admitted to the hospital for a pulmonary embolism 13 days after receiving vaccine and discharged the following. Prescribed blood thinner and will be following up with my doctor in a week.

Intracerebral hematoma SAH (subarachnoid hemorrhage) Cerebrovascular accident, unspecified mechanism Seizures

Symptoms included swelling of both right and left ankles, pain in right leg, shortness of breath 5 days after receiving the vaccine. They put me on oxygen and started administering Lovenox twice a day.