Moderna

Swelling, pain and redness for the first few days. Then led to an anaphylactic reaction and had to get IM steroids and Benadryl.

Stroke/left side of the body; Can't talk; can't walk; This spontaneous case was reported by a non-health professional and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke/left side of the body) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (no medical history reported). On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke/left side of the body) (seriousness criteria disability and medically significant), APHASIA (Can't talk) and GAIT INABILITY (can't walk). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke/left side of the body), APHASIA (Can't talk) and GAIT INABILITY (can't walk) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. There was no concomitant medications reported. No treatment medications were provided. Very limited information regarding these events has been provided at this time. Further information has been requested. Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

ITP, presented with undetectable platelets. No bleeding event to date. Remains hospitalized but responding to dexamethasone and IVIG.

idiopathic thrombocytopenic purpura/Hematoma on thigh that was softball size/rash everywhere on body; This spontaneous case was reported by an other caregiver and describes the occurrence of IMMUNE THROMBOCYTOPENIA (idiopathic thrombocytopenic purpura/Hematoma on thigh that was softball size/rash everywhere on body) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history was reported). On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced IMMUNE THROMBOCYTOPENIA (idiopathic thrombocytopenic purpura/Hematoma on thigh that was softball size/rash everywhere on body) (seriousness criteria hospitalization, medically significant and life threatening). The patient was hospitalized on 28-Apr-2021 due to IMMUNE THROMBOCYTOPENIA. At the time of the report, IMMUNE THROMBOCYTOPENIA (idiopathic thrombocytopenic purpura/Hematoma on thigh that was softball size/rash everywhere on body) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Platelet count: 3 (Inconclusive) diagnosed with idiopathic thrombocytopenic purpura (ITP). On 30-Apr-2021, Platelet count: 0 (Inconclusive) 0. On an unknown date, HIV test negative: (Negative) Negative/Condition was ruled out. On an unknown date, Hepatitis viral test: (Negative) Negative/Condition was ruled out. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient experienced a rash on 28 Apr 2021 everywhere on her body that kept getting worse. She also had a hematoma on her thigh that was softball size and she did not remember bumping it. She went to the emergency room at Hospital at about 5 PM. They did bloodwork and her platelet count was 3 she was diagnosed with ITP idiopathic thrombocytopenic purpura. She was perfectly healthy before this. This condition leads to bleeding and bruising her rash was actually very small bruises. That hospital felt she needed to be seen by a hematologist and oncologist so they transferred her to their main campus. Where she was admitted around midnight to the Hospital. They ruled out HIV and Hepatitis. They started her on a five day prednisone taper and did a 10% Privigen IV IG transfusion to try to increase her platelet count. In morning 30 Apr 2021, her platelet count was down to zero. Now they are going to do a brain magnetic resonance imaging (MRI) and a platelet transfusion. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event (ITP), a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event (ITP), a causal relationship cannot be excluded.

swelling of throat, difficulty swallowing. patient went to emergency room after leaving and reported diagnosis of anaphylaxis

Pericarditis and pericardial effusion with pulmonary effusion, fever, tachycardia and elevated inflammatory markers, knee pain, rash

The patient developed progressively worsening dyspnea, GI symptoms and fevers starting 5/16/2021, 3.5 weeks after receiving second Moderna vaccine. She was admitted 5/22/2021 with ARDS requiring intubation, found to have severe systemic inflammation with acute DVT of right right subclavian, axillary, brachial, and upper arm radial veins, chronic DVT of left subclavian, and possible thrombus tricuspid valve. Remains intubated with ongoing evidence of systemic inflammation. Working diagnosis EVALI.

8 days following the first Covid vaccine administration, patient started with vaginal bleeding that persists until today unless maintained on high dose oral contraceptives. She is currently under the care of a gynecologist who is trying to manage her symptoms.

After Moderna vaccine was given patient fainted from a standing position in our waiting area. A one inch cut was sustained to her left forehead in the fall. Patients pulse and breathing were checked while compression to forehead with gauze was used to stop bleeding. EMS responded and took over her care. Patient was transported to medical center.

The very next morning after the vaccination around 7:00 AM , my right arm was hurting, it was not red, or there wasn't any bruising. I had tightness in my throat, it was pretty much like an anaphylactic shock is how the doctors described it. I had white bumps, like welts, on the back of my throat and tongue. And the roof of my mouth and my tongue, my lips everything in my mouth was swollen. My eyes were almost swollen shut. On 12/27/2021, I had a doctor video visit. He advised me to take Benadryl, and Tylenol, I used my albuterol inhaler several times because I couldn't breath. So around 3:00 pm I went to the Emergency Room because I was still having a hard time breathing and the swelling wasn't going down. The doctor immediately gave me an Epi pen. and told me i had an allergic reaction to the vaccination. The doctor advised me that it was up to me to take the 2nd vaccination . He said it was up to me.

First vaccine received 3/27/21 Patient started to have irregular vaginal bleeding 4/22/21 Second vaccine received 4/24/21 Patient continued to have unscheduled irregular bleeding Recently followed up this month, reports bleeding resolved but did not recall exactly when bleeding stopped.

Patient received Moderna vaccine, Wednesday 12/30. On Saturday 1/3/2021 patient felt pressure/tightness in lower extremity. When patient touched area, a noticeable ball was felt under the skin, tender to the touch and warm. Patient went into urgent care on Monday 1/4/2021 with a confirmed dx of a superficial blood clot. Unknown etiology of whether this is from current birth control or the COVID19 Moderna vaccine.

The day of vaccination, the patient presented to the emergency room with a complaint of dizziness and syncope. Reported that she became dizzy, presyncopal feelings, and had a witnessed syncopal event. The patient stated she does have vasovagal syncopal events after blood draws in the past. The patient was assigned an overnight admission for a potential post-vaccination adverse event, new onset atrial fibrillation, dehydration, and syncope. Patient was discharged the following day.

One week after the shot (1-14-2021) Patient (19 y.o.)reported side pain and appeared constipated, Laxatives given along with Tylenol, on further assessment Patient was noted to have left leg redness and abdominal fullness. Dr. was updated and we had orders for close monitoring, the next day when she got up, her leg appeared better, and she had passed a small BM, but by lunch she had developed significant pain and edema in her left leg, and the color of her leg was reddened again. She was sent to the emergency room with her symptoms. She was admitted back to our facility yesterday, her diagnoses included Acute provoked left external illiac, femoral, popliteal, and peroneal DVT. Elevated Factor II levels, Elevated APC resistant, May-Thurner Syndrome, history of developmental disabilities, fecal impaction and urinary retention - suspected related to her fecal impaction. Vascular surgery was consulted, and pt. was started on a heparin drip, and mechanical thrombectomy was needed for both legs due to multiple clots. She was started on Eliquis and Plavix, and thigh high compression stockings were ordered, ace wraps being used until these are supplied. Her Fecal impaction was addressed also and the urinary retention resolved.

Syncope/Collapse 20 minutes after receiving the vaccine I was in AFIB and had a heart rate of 150, hospitalized overnight. Been dealing with high HR ever since, which has hindered my ability to run and train at my normal level. Had to wear a heart monitor for two weeks. Followed up with my cardiologist; have to get an echocardiogram done and then an electrophysiology test/heart cath done in the near future.

Our patient received her shot and stayed in the pharmacy area for 15 minutes and was released. Fifteen minutes late she returned to the pharmacy says she was dizzy and nauseated. We had her sit in the pharmacy for about 20 minutes at whichn time she said she felt better and was ready to go. We had one of our pharmacists walk her but she became dizzy and nauseated again and had to sit down. At this time she said she was hot and very light headed and her vision was starting to get blurry. A minute or so lefter that she sat up in her chair and stopped breathing and started to fall off. One of our pharmacists caugt her and at point she went into convulsions and started gagging and could not breath. 911 was called at this time and an Epi pen was administered. The convulsions stopped 30 seconds afer the Epi and her breathing eazed. The EmT's arrived with in 10 minutes and took her to local emergency room. Our pharmacist called the emergency room about a hour later and they said that She wwas doing well.

fatigue; difficulty swallowing.; allergic reaction; chest pain; shortness of breath; not feeling good; Weakness in Lower half of body; Difficulty breathing, brain is foggy, swelling in throat, excessive sweating, puffy face,having difficulty talking and her face became puffy; Feverish; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Difficulty breathing, brain is foggy, swelling in throat, excessive sweating, puffy face,having difficulty talking and her face became puffy), CHEST PAIN (chest pain), DYSPNOEA (shortness of breath) and FEELING ABNORMAL (not feeling good) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). Concomitant products included ISOTRETINOIN (ACCUTANE) and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced ANAPHYLACTIC REACTION (Difficulty breathing, brain is foggy, swelling in throat, excessive sweating, puffy face,having difficulty talking and her face became puffy) (seriousness criteria medically significant and life threatening), MUSCULAR WEAKNESS (Weakness in Lower half of body) and PYREXIA (Feverish). On 21-Jan-2021, the patient experienced CHEST PAIN (chest pain) (seriousness criterion medically significant), DYSPNOEA (shortness of breath) (seriousness criterion medically significant), FEELING ABNORMAL (not feeling good) (seriousness criterion medically significant) and HYPERSENSITIVITY (allergic reaction). On 22-Jan-2021, the patient experienced DYSPHAGIA (difficulty swallowing.). On an unknown date, the patient experienced FATIGUE (fatigue). At the time of the report, ANAPHYLACTIC REACTION (Difficulty breathing, brain is foggy, swelling in throat, excessive sweating, puffy face,having difficulty talking and her face became puffy), CHEST PAIN (chest pain), DYSPNOEA (shortness of breath), FEELING ABNORMAL (not feeling good), MUSCULAR WEAKNESS (Weakness in Lower half of body), HYPERSENSITIVITY (allergic reaction), DYSPHAGIA (difficulty swallowing.), FATIGUE (fatigue) and PYREXIA (Feverish) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product included birth control. Treatment information included anti nausea pills, aspirin, epiPen, benadryl, tylenol, injection for breathing and surmonside. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Two days after getting my 2nd dose I started heavy vaginal bleeding that is gushing more than I have ever experienced and is going on now for the 2nd day. I contacted my OB/GYN and she said that she has had a few patients with this and if it does not get any better to let her know in a few days. I have bled more in the last 2 days than ever having my period.

About 6-7 hours after receiving the vaccine, I started to develop hives around my body, including on feet, stomach, ears, face, back, and legs. I had fever and chills, muscle aches, joint pain, headaches, and nausea later that night as well. The next morning, my left eye was swollen, left side of tongue completely swollen, lips swollen, and left side of throat closed (anaphylaxis). I took prednisone, Benadryl, and Tylenol to relieve the symptoms, and the swelling around my left eye, tongue, throat, and lips went away. Throughout the day, more hives have developed around my body and face, including my right eye. I am continuing to take Benadryl and Tylenol and finish doses of prednisone. The fever and chills, muscles aches, joint pains, hives, headache, and nausea are still present.

Patient presented 5/16/2021 with 1 week dizziness, fever and sore throat, found to have acute myopericarditis c/b cardiogenic shock and bradycardic arrest.

extensive deep vein thrombosis with embolization and massive pulmonary embolism ; patient presented with shortness of breath and severe bilateral leg and back pain unable to move with extensive thrombosis noted. patient had cardiopulmonary arrest was on ecmo now decannulated and extubated , awake, alert oriented in recovery phase

Chest pain with elevated high sensitivity troponin level. Echocardiogram with normal LV function. LV longitudinal strain was -19.6, which is low normal. Cardiac MRI with no Myocarditis, but pericardial fluid. Findings were consistent with pericarditis. Patient was discharged to home.

can't remember things like what day it is or if she's taken her medicine; asthma; She's unable to work or be left alone; Can't drive; hypoglycemic; having seizures/grand mal seizures and she fell out of her chair; doesn't want to live anymore/gone downhill ever since she's received her first dose/unable to be left alone; diagnosed with epilepsy; depression; heart skipping a beat/trouble with her heart; This spontaneous case was reported by a consumer and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (having seizures/grand mal seizures and she fell out of her chair), SUICIDAL IDEATION (doesn't want to live anymore/gone downhill ever since she's received her first dose/unable to be left alone) and EPILEPSY (diagnosed with epilepsy) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In December 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (having seizures/grand mal seizures and she fell out of her chair) (seriousness criterion medically significant), SUICIDAL IDEATION (doesn't want to live anymore/gone downhill ever since she's received her first dose/unable to be left alone) (seriousness criterion medically significant), EPILEPSY (diagnosed with epilepsy) (seriousness criterion medically significant), DEPRESSION (depression), EXTRASYSTOLES (heart skipping a beat/trouble with her heart), MEMORY IMPAIRMENT (can't remember things like what day it is or if she's taken her medicine), ASTHMA (asthma), HYPOGLYCAEMIA (hypoglycemic), IMPAIRED WORK ABILITY (She's unable to work or be left alone) and IMPAIRED DRIVING ABILITY (Can't drive). At the time of the report, GENERALISED TONIC-CLONIC SEIZURE (having seizures/grand mal seizures and she fell out of her chair), SUICIDAL IDEATION (doesn't want to live anymore/gone downhill ever since she's received her first dose/unable to be left alone), EPILEPSY (diagnosed with epilepsy), DEPRESSION (depression), EXTRASYSTOLES (heart skipping a beat/trouble with her heart), MEMORY IMPAIRMENT (can't remember things like what day it is or if she's taken her medicine), ASTHMA (asthma), HYPOGLYCAEMIA (hypoglycemic), IMPAIRED WORK ABILITY (She's unable to work or be left alone) and IMPAIRED DRIVING ABILITY (Can't drive) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Concomitant medication information was not provided. Treatment information was not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Company Comment Very limited information regarding the events has been provided at this time.; Sender's Comments: Very limited information regarding the events has been provided at this time.

Progress Notes (Physician Assistant) Neurosurgery Cosigned by: MD at 2/2/2021 10:51 AM Expand All Collapse All STORMONT VAIL COVID VACCINE CLINIC 2/2/2021 DOB: 10/3/2000 Date: 2/2/2021 MRN: 9054917 Subjective She is a 20 y.o. female who was seen at SVH COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. Prior to her second injection patient informed the RN that she had a rash after her first injectio. We premedicated with Zyrtec and will monitor for any post injection reaction. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms. ALLERGY REVIEW OF SYSTEMS Previous Reactions: Rash Objective Vitals There were no vitals filed for this visit. Physical Exam No current rash Assessment/Plan Treatment included: antihistamines Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) Electronically Signed 2/2/2021 9:19 AM

Patient received first dose of Moderna vaccine. Later that day, patient experienced heavy vaginal bleeding that included blood clots and required the use of a sanitary pad. She had her period the previous week and it had since stopped so she does not believe it's her period. At the time of the call to the pharmacy, 8:30am the following day, patient was still actively bleeding. Advised patient to monitor for other signs and symptoms of bleeding such as excessive bruising, nose bleeds, gum bleeds, and to check her stool for the appearance of coffee grounds. Patient was calling to try to find a doctor nearby who could see her. Advised patient that if she could not find a doctor to go to urgent care if the bleeding continued or worsened.

I have been experiencing a small ulcerative colitis ?flare up? which I have not had in a while. I have experienced slight stomach pain and slight bleeding.

Awoke in the middle of the night to mild/moderate anaphylaxis - tingling throat and tongue, swelling of throat and tongue, difficulty breathing, nausea, gagging, diarrhea - lasting for about 30 minutes - all symptoms occurred at the same time

I felt severe shortness of breath and dyspnea on 3/30/21 at 3:30am, so I went to the ER and was diagnosed with pulmonary embolisms in both lungs and tachycardia. I was prescribed Eliquis. I am still experiencing shortness of breath today 4/13/21, but it has improved since the onset of symptoms.

Pt presented with 2-3 days of right-sided chest pain and dyspnea. CT demonstrates bilateral PE. Pt prescribed apixaban.

Headache onset 3-4 days after vaccine on 4/27/21. Subsequently developed visual changes (right homonymous hemianopsia/visual field cut) on 5/23/21 and presented to ED, diagnosed with cerebral venous thrombosis (left transverse, sigmoid and internal jugular thrombosis). On initial labs also had thrombocytopenia and mild leukocytosis.

April 21, 2021 Study Result Narrative Procedure: Duplex ultrasound examination of the lower extremity veins was performed using 2D imaging with color and spectral Doppler. General: 21 year old female presents for right LE venous duplex to rule out DVT. Pt complains of right posterior calf pain x3 days. Right: Abnormal right LE venous duplex reveals evidence of acute partial deep venous obstruction involving one of the paired peroneal veins from mid to upper calf level without extension into the popliteal vein at this time. Conclusions: Acute deep venous thrombosis in a right peroneal vein from mid to upper calf level without extension into the popliteal vein at this time.

blood clots in her legs and lungs; blood clots in her legs and lungs; back and legs were hurting; couldn't walk.; back and legs were hurting; alertness declining; activity declining; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clots in her legs and lungs), PULMONARY EMBOLISM (blood clots in her legs and lungs), BACK PAIN (back and legs were hurting), GAIT DISTURBANCE (couldn't walk.), PAIN IN EXTREMITY (back and legs were hurting), DEPRESSED LEVEL OF CONSCIOUSNESS (alertness declining) and DECREASED ACTIVITY (activity declining) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No medical history was reported. On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 27-May-2021, the patient experienced DEPRESSED LEVEL OF CONSCIOUSNESS (alertness declining) (seriousness criteria hospitalization, disability and medically significant) and DECREASED ACTIVITY (activity declining) (seriousness criteria hospitalization and disability). On an unknown date, the patient experienced THROMBOSIS (blood clots in her legs and lungs) (seriousness criteria hospitalization, disability and medically significant), PULMONARY EMBOLISM (blood clots in her legs and lungs) (seriousness criteria hospitalization, disability and medically significant), BACK PAIN (back and legs were hurting) (seriousness criteria hospitalization and disability), GAIT DISTURBANCE (couldn't walk.) (seriousness criteria hospitalization and disability) and PAIN IN EXTREMITY (back and legs were hurting) (seriousness criteria hospitalization and disability). The patient was hospitalized on 16-May-2021 due to BACK PAIN, GAIT DISTURBANCE, PAIN IN EXTREMITY, PULMONARY EMBOLISM and THROMBOSIS. The patient was treated with HEPARIN for Coagulopathy, at a dose of 1 dosage form; Surgery (thrombectomy and Intubated) for Thrombosis and Surgery (thrombectomy and Intubated) for Pulmonary embolism. At the time of the report, THROMBOSIS (blood clots in her legs and lungs), PULMONARY EMBOLISM (blood clots in her legs and lungs), BACK PAIN (back and legs were hurting), GAIT DISTURBANCE (couldn't walk.), PAIN IN EXTREMITY (back and legs were hurting), DEPRESSED LEVEL OF CONSCIOUSNESS (alertness declining) and DECREASED ACTIVITY (activity declining) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Blood creatinine: 5.37 (High) high. In May 2021, Blood potassium: high (High) high. In May 2021, Glomerular filtration rate: 9.5 (Low) low. In May 2021, Imaging procedure: abnormal (abnormal) had new imaging and she was still developing clots. In May 2021, Ultrasound abdomen: inconclusive (Inconclusive) inconclusive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. She was in the cardiac intensive care unit (ICU). She had a thrombectomy and was on heparin. They intubated her and put her on the ECMO machine on 19 May 2021. The patient got off ECMO on 24 May 2021 and the intubation tube was removed 25 May 2021. They were having trouble obtaining a non-hemolyzed sample from her since 27 May 2021. The patients concomitant medication information included birth control pills. Very limited information regarding these events have been provided at this time. However subject's use of birth control pills can be a confounding factor to the events thrombosis and Pulmonary embolism. No further information is expected.; Sender's Comments: Very limited information regarding these events have been provided at this time. However subject's use of birth control pills can be a confounding factor to the events thrombosis and Pulmonary embolism. No further information is expected.

Patient presented 0n 5/25/21 with chest pain, shortness of breath, nausea and headache. Work-up showed pericardial effusion with pericarditis. Drain placed. Patient responded to ibuprofen and colchicine therapy. Patient unsure of dates of vaccination. Stated April-May 2021.

It was weird again; Turning into a bruise; Felt crappy; A couple of bad breakthrough bleeding episodes; Menstrual cycle was interrupted; Felt off; In her right leg raised hive; Headache; A spontaneous report was received from a consumer concerning a 21-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a couple of bad breakthrough bleeding episodes, Menstrual cycle was interrupted, Felt crappy, Felt off, In her right leg raised hive, Headache, Turning into a bruise and It was weird again. The patient's medical history was reported as migraines. Concomitant medications were not reported. On 27 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013A21A) intramuscularly in the right thigh for prophylaxis of COVID-19 infection. On 27 FEB 2021, the patient experienced Raised hive (Urticaria) about the size of a half dollar, after that she "felt off" (fall) had a headache (Headache) and Felt crappy (Malaise), and she had a couple of bad breakthrough bleeding episodes (Hemorrhage) which was assessed as medically significant, and the patient also experienced interrupted Menstrual cycle (Menstrual disorder). On 07 MAR 2021, the patient experienced Turning into a bruise (Contusion) and on 08 MAR 2021 it was weird again (Feeling abnormal). Laboratory details were not provided. Treatment medication was provided as Tylenol. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the events Hemorrhage, Menstrual disorder, Contusion, Malaise, Feeling abnormal, Fall, Urticaria and Headache was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Vaginal mucosal bleeding and severe headaches hours after the vaccination, bleeding lasting for 8 days until stopped with tranexamic acid.

I developed Idiopathic thrombocytopenic purpura (low levels of platelets) and menorrhagia due to the vaccine according to my doctor. I believe there have been about 30 cases of this occurring so far. In my case, I took the vaccine and felt relatively tired for two days. There were no other symptoms. About a week later, I got my period after not having it for a couple months. The blooding was light for a few days, but then got extremely heavy. After about a week of very heavy bleeding, I went to urgent care. They took blood tests, and found that I had a critically low level of platelets (6 platelets when the normal range is 150-400). I was admitted to the ER for multiple days, and they gave a platelet transfusion and IVIG fluids, which has helped considerably. I also had to take steroids to suppress my immune system so that my platelets could increase.

Patient received vaccine on 3/31/21. Patient was admitted to our Special Care Unit 4/18/21 with Massive Bilateral Pulmonary Embolism- 1st Episode. She is currently on a Heparin drip. She has been on OC for 5 years with no history of clotting. Patient reported left rib pain starting 4/16/21 and worsening, prompting her ED visit. She reports having the same symptoms on the right side 2 weeks prior (approx 4/5/21).

By the evening of April 16th, I was experiencing a fever of 103.5 after already medicating an hour prior. On the 17th, my fever continued and I noticed vaginal bleeding. On the morning of April 18th, I went to the emergency room because I was still experiencing this bleeding, as well as bleeding from my nose. We came to the conclusion that I had an ovarian cyst rupture.

Left Transverse and sigmoid Cerebral Venous Sinus Thrombosis in a patient with Chronic left Mastoiditis and previous Hx of VTE. I do not believe this was likely an AE from vaccine

Immediately following the vaccination the patient was bleeding and told the immunizer she felt dizzy. She then instantly slumped over in her seat and blacked out. She was unconscious for a very short period of time (Only long enough for the immunizer to call the RPh for assistance). 911 was called when Madison regained consciousness she asked what had happened, explained her anxiety and then vomited twice . The paramedics arrived and evaluated her and a ride was called so she would not have to drive. She waiting in the pharmacy for around 40-45mins after the vaccination before leaving with her parents.

First pregnancy Weeks of brown bleeding prior to miscarriage Due 12/17/21 Miscarriage 05/22/21 at 1pm

Patient experienced a 104* fever along with nausea and vomiting following her second Moderna COVID-19 vaccination. She also developed hives all over her body and continues to have random moments of anaphylaxis.

Right after administration, patients arm started bleeding a lot so we cleaned up the blood and were going to switch out the bandaid and noticed her arm was already really swollen and hard (like a big marble under the skin). She then said that she was feeling really dizzy and thought she was going to pass out. She turned white and said she felt very sick. She leaned back in her chair and a cold ice pack was applied to her forehead and the injection site. This continued for about 30 minutes and then colored returned to her face and lips and she said she was feeling much better.

Patient recieved first vaccine 4/26/2021, reports she had no issues after this dose Patient recieved second vaccine 6/3/2021, and reports on 6/4/2021 she had heavy bleeding for 7 days. Bleeding spontaneously resolved.

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tachycardia-Mild, Additional Details: Had to use 1 epi pen in left upper thigh

Anaphylactic reaction; Burning sensation in eyeballs; Wheezing; Rales; Airways were closing; Can't breathe; A spontaneous report was received from a consumer concerning a 22-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an anaphylactic reaction, burning sensation in eyeballs/abnormal sensation in eye, wheezing, rales, airways were closing/obstructive airways disorder, and can't breathe/dyspnoea. The patient's medical history was not provided. No relevant concomitant medications were reported. On 05 Feb 2021, within 5 minutes prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 05 Feb 2021, within 5 minutes after receiving her second dose of vaccine, the patient reported a burning sensation in her eyeballs, followed by wheezing and rales in her lungs. She was given epinephrine and taken to the emergency room via an ambulance. She was given a second dose of epinephrine. Her airways were closing and she could not breathe. She was given a steroid, diphenhydramine, H2 antagonist and albuterol. Consent given for follow up calls. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the events, anaphylactic reaction, burning sensation in eyeballs, wheezing, rales, airways were closing, and can't breathe, was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.

Severe anaphylaxis allergic reaction; Passed out on the ground; A spontaneous report was received from a consumer concerning a 22-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and passed out on the ground and had a severe anaphylaxis allergic reaction. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unknown date, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. About 10 minutes after receiving the second dose of the Moderna vaccine, the patient passed out on the ground having a severe anaphylaxis allergic reaction. Treatment for the event included two doses of epinephrine IM in addition to diphenhydramine, ondansetron, and steroids to prevent a rebound reaction. 911 was called and after epinephrine and diphenhydramine were administered, the patient was immediately transported to the hospital where she stayed for 6 more hours for observation, fluids, and further medications. Action taken with mRNA-1273 in response to the events was not applicable. The events, passed out on the ground and severe anaphylaxis allergic reaction, were considered resolved; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Anaphylactic reaction is a listed event in CCDS.

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium

Heart arrhythmia on EKG which is ventricular tachycardia; A spontaneous report was received from a healthcare professional concerning a 22 years old, female patient who experienced Heart arrhythmia on EKG which is ventricular tachycardia(ventricular tachycardia). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 13 Feb 2021, the patient received their first of the two planned vaccine doses of mRNA-1273 (Batch number not provided) in her left arm with no associated symptoms. On 13 Mar 2021, prior to the onset of the symptoms, the patient received their second of the two planned vaccine doses of mRNA-1273 (Batch number not provided) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 14 Mar 2021, the patient's heart rate got up to 206bpm and was seen in the emergency room and stayed overnight. On the same day the EKG(Electrocardiogram) was performed for the patient which revealed heart arrhythmia, which is ventricular tachycardia and was advised that she might need a surgery like defibrillator placement for lifetime or ablation. She was reported to be home from work for a week while on cardiac monitor and appropriate surgery will be decided after results are received after a week of monitoring. cardioversion was reportedly performed, which was able to bring back her heartbeat back to normal. The event ventricular tachycardia was considered as medically significant. Treatment for the event included cardioversion. The patient received both scheduled vaccine doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. The outcome of the event, Heart arrhythmia on EKG which is ventricular tachycardia, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

The patient is a G3P2 with a history of 2 prior term vaginal deliveries. Her last menstrual period was 1/15/21. Estimated due date was 10/22/21 based on her last menstrual period. She had her first covid vaccine on 3/4/2021. She saw me for her first prenatal visit on 3/24/21 and was asymptomatic. Fetal heart tones were not appreciated on doppler. She was referred for a dating ultrasound, which she never completed. She began having some bleeding sometime after the appointment on 3/24. She got her 2nd covid vaccine on 4/1/21. She began having pelvic cramping on 4/3. went to emergency dept 4/4. u/s showed an 8week 2 day gestation with no heart beat. she continued to have bleeding and cramping 4/5 and likely completed the miscarriage that day.

Patient was sitting in observation area 5 minutes post vaccination, scheduled to be observed for 30 minutes total due to history of anaphylaxis. She was seated in the recliner She reported to have itchy watery eyes, chest tightness. Breath sounds were clear, with good air movement bilaterally, no wheezing or crackles, no accessory muscle use, normal speech. Patient's boyfriend noted her tongue and eyelids to appear slightly swollen compared to baseline. Patient denied dizziness, chest pain, shortness of breath, body rash or itching. Patient maintained normal speech and normal unlabored respirations. BP was checked and noted to be normal. O2 sat 99%. Patient received benadryl 50mg PO. She was observed for about 10 minutes before her tongue appeared more swollen and she complained of difficulty breathing. At this point, the patient appeared pale, 911 was activated. EPI-pen was administered via autoinjector in the left lateral thigh. O2 sat was 99%. Patient has increased chest tightness and new onset shortness of breath for which she was given an Albuterol nebulizer. Breath sounds were clear, no wheezing. O2 sat reassessed which decreased to 73%, she had bilateral cramping of hands and digits. Non-rebreather was applied, oxygen saturation improved and hand cramps resolved. 911 was called for a second time to report rapid desaturation. Patient's O2 saturation and HR fluctuated, BP remained stable throughout. EMS arrived. A right AC IV was placed, Solumedrol 125mg IVP was administered by EMS. Patient was transferred onto EMS stretcher, still requiring nonrebreather. Patient was escorted to ED for further management of anaphylxis post Moderna vaccine.

Consistent headache - Tylenol or Excedrine relieved Heavy period - began 4 days early. Excessive blood clots and amount of blood. Left arm pain- unable to move arm without pain x 3 days. Tylenol relieved Fever- began 2 days after. Tylenol reduces fever.

Post injection epileptic episode. Approx 10 minutes after receiving first dose of Modern vaccine: Tonic Clonic, Grand-mal seizure.

Grand mal seizure started within 1 minute of vaccine administration. Patient had full body stiffness, eyes rolled back, urinated herself, and had a brief loss of consciousness. Seizure spontaneously resolved within 10 seconds and patient had a several minute post-ictal phase. I rolled patient onto her side and monitored her O2 sat in the post-ictal phase. Patient reported dizziness and nausea during this period. EMS evaluated patient and recommended emergency evaluation, patient refused transport. Patient ambulated on her own out of the store after about 20 minutes.

found dead; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (found dead) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032m20a) for COVID-19 vaccination. Concurrent medical conditions included Traumatic brain injury, Movement disorder, Seizures (since she was a baby at 11 months old) and Speech loss. Concomitant products included CLONAZEPAM, OXCARBAZEPINE (TRILEPTAL) and GABAPENTIN for an unknown indication. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 04-Apr-2021 The patient died on 04-Apr-2021. The cause of death was not reported. An autopsy was not performed. Reporter stated that death certificate said the cause of death was natural causes. She did have her yearly physical exam after her first dose with her physician prior to her death and no other health issues were noted at the time of the exam. Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Natural causes

Patient received the first dose April 12th, second dose May 19th. She reported that she felt ill for 4 days and missed work for 4 days. She left abruptly today and stated she just received a call from her physician that she has a current pulmonary embolism and to report to the ER immediatly.

The day following my vaccination, I woke up to cramps and some spotting. I don?t typically bleed or have periods on my birth control, so this was out of the ordinary. It lasted for the day.

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Additional Details: Patient noticed redness and itching on chest approximately 20 minutes after injection but no other reported symptoms. Patient had already had a hive like rash on arm prior to injection. Patient was advised to stay in store for further observation. After an hour of observation patient denied any further new symptoms and departed. She was advised to stay near town and to call 911 if she developed any other symptoms. Patient called 911 approximately 2 hours after departure and was taken to ER.

Anaphylactic Shock about 1 hour post vaccination; Hives all over the body; Swollen Throat; Itching all over the body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic Shock about 1 hour post vaccination) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049B214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced URTICARIA (Hives all over the body), PHARYNGEAL SWELLING (Swollen Throat) and PRURITUS (Itching all over the body). On 04-Jun-2021 at 1:00 PM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic Shock about 1 hour post vaccination) (seriousness criteria hospitalization and medically significant). The patient was treated with EPINEPHRINE (EPIPEN) on 04-Jun-2021 for Anaphylactic shock, at a dose of 2 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 04-Jun-2021 for Hives, at a dose of 25 milligram every six hours. At the time of the report, ANAPHYLACTIC SHOCK (Anaphylactic Shock about 1 hour post vaccination) and PHARYNGEAL SWELLING (Swollen Throat) outcome was unknown and URTICARIA (Hives all over the body) and PRURITUS (Itching all over the body) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. It was reported that as of 07 JUN 2021, the patient still had hives and itchiness. Company comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

After 1st shot within 1 week developed DVT in left leg that was misdiagnosed and treated as a skin infection. After second shot ended up in ICU to have DVT in left leg confirmed and embolisms in both lungs. 1st week in March 2021, less than a week after second shot. May 27th back in hospital with multiple strokes, clots in all lobes, a brain hemorrhage and enlarged heart. Clots were showering to brain. Blood clots w/ low platelets (53,000). Released on eliquis after 1 week. July 1st admitted back into hospital with new stroke, hemorrhage is bigger. Clots, low platelets (40,000), gall stones, enlarged heart, fatty liver. Platelet transfusion, IVIG, steroid IV, Coumadin for life! Now being told possibly have autoimmune disorder called APS, not confirmed but never had any issues prior to COVID-19 vaccine. Lost function in right hand. Now have aphasia and going to rehab facility. Being told will be on Coumadin rest of life due to blood clots and low platelets.

Anaphylactic reaction; A spontaneous report was received from a 23-year-old, female consumer who was also a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic reaction. The patient's medical history included allergy to amoxicillin. Concomitant medications reported included gabapentin, escitalopram oxalate, and montelukast sodium. On 04 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) intramuscularly for prophylaxis of COVID-19 infection. On 05 Jan 2021, within 24 hours of vaccination, the patient experienced anaphylactic reaction. Treatment for the event included Diphenhydramine. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event, anaphylactic reaction, was considered resolved on 06 Jan 2021.; Reporter's Comments: This case concerns a 23 year old female patient, who experienced a serious unexpected event of Anaphylactic reaction. Event occurred apparently within 24 hrs. after first dose of mRNA-1273 (Lot# 011L20A) vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Anaphylactic reaction: tongue/throat numbness, throat closure, rapid heart rate, dizziness, body tremors.

1/29/21/after vaccination reported "numbness and tingling around her mouth and lips area and described it as feeling swollen. Pulse 80, breathing unlabored and red cheeks." reported neck pain in the back left which was similar reaction after 1st dose. She also reports having congestive heart failure. Observation for 20mins no swelling noted on mouth, tongue or lips. reported tingling has subsided. She was instructed to call doctor if symptom worsened and to return to ER. She stated that she text her heart doctor . Pt left with mother.

Bottom half of face tingling on fire/burning immediately after vaccine--resolved quickly, then night of vaccine extreme body aches which continued for 48 hours, accompanied with nausea, chills, headache and shortness of breath. aching for 2 days, 100 fever, headache, nausea, SOB CHF Resolved?by Sunday

Patient received Moderna Covid19 vaccine on the 18th of March. Patient began to experience symptoms the next day (shortness of breath, general body pains) on the 19th. Discovered that patient had bilateral PE on the 23rd. Physicians unable to confirm or deny if vaccine was a contributing factor, but due to timing I am reporting this. Patient received treatment for ~24 hours and

Anaphylaxis; Rash all across her leg; Swelling; Itching; Red; Hot; A spontaneous report was received from a consumer concerning a 22-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events anaphylaxis, rash all across her leg/rash, swelling, itching,/pruritus, red/erythema, hot/feeling hot. The patient's medical history was not provided. No relevant concomitant medications were reported. On 05 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 030M20A) Intramuscularly on right leg for prophylaxis of COVID-19 infection. On 10 Mar 2021, the patient experienced the event(s) anaphylaxis symptoms of swelling, itching, rash all across her leg. It was red, and hot.S he was a very fragile person with many syndromes and so they took her to the doctor. She was feeling better on 14 Mar 2021. Treatment for the events were none. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), anaphylaxis, rash all across her leg, swelling, itching, red, hot were reported as recovering on 14 Mar 2021..; Reporter's Comments: This case concerns a 23-year-old female who experienced a serious expected event of anaphylactic reaction along with unexpected rash, erythema, pruritus, swelling, and feeling hot. Event onset occurred on Day 6 after the first dose of mRNA-1273. Treatment not reported. Events resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

A few days after vaccination I had a high fever and began coughing so hard that I was throwing up. This lasted for about a week, I then became short of breath and tacchychardic. I went to the ER and was admitted for 5 days where they said I had acute bronchitis that triggered reactive asthma. I?m now on steroids and a bunch of medication. This all followed my first dose of Moderna as I?ve never had breathing issues before hand. I?ve never had bronchitis or asthma in my life so this is all new. I am now experiencing nerve pain on my left side which is where I received the vaccine.

EDD 11/8/21, onset of vaginal bleeding, within 3 days of 2nd dose of vaccine, pregnancy continues to be viable.

Chronic Muscle Pain (arms, back). Extreme Chest Pain and Severe headache/ head throbbing. Is currently diagnosed with Pneumonia in the lower lobes. Felt chills. This lasted from the morning after the first dose, and has gotten better due to receiving medical attention in the emergency room, I needed two IV?s and Tylenol with codine. They did blood work and a CT scan on my head and chest, and I received Azithromycin to treat the chest pain. I am feeling slightly better, however there have been occasional pangs of pain on my head (right side), and a persistent dull chest pain that is on and off. I also had some break outs on my back, and my back still aches and my bones crack more often than usual. I am also dealing with drowsiness and some nausea. On 05/02/2021 they kept me in the emergency room until nearly 10pm.

went into anaphylactic shock, couldn't breathe, tongue swelled up, light headed, legs heavy, slurred speech. Got benadryl shot at 11:49 pm, epipen at 11:58, was prescribed femotidine and prednisone.

experienced a leg cramp beginning Sunday, May 2. Went in to the ER Tuesday, May 11 with chest pains/short of breath. Diagnosed with bilateral pulmonary embolism. Put on blood thinners for next three months.

Spontaneous cerebral infarct suspected to be from venous thrombosis complicated by intracranial hemorrhage requiring intubation, EVD placement and emergent OR. Admitted to Neuro ICU

Central Venous Sinus Thrombosis in Superior Sagittal Sinus I arrived home at 12:38 on Sunday, 5/9, and opened the door to see my sister with facial droop, slurred speech and a contracted right hand/fingers. She was crying and immediately knew she was having a stroke. She had been trying to clasp some jewelry while getting ready for Mother's Day. She was able to walk down to the car with me no problem (no extremity involvement other than right hand/fingers). We arrived at the hospital within 10 minutes and she was a Code Stroke. A CT scan showed the clots as well as a tiny Subarachnoid bleed and she was admitted to NeuroICU. The symptoms waxed and waned for a few hours and at one point she developed the droop again, had headache and heartburn and vomited. A CT scan was repeated after some Heparin had entered her system and it was stable/not worse; subarach bleed was not changed and Heparin was continued. She has now been admitted for 3 days and the Heparin is complete. She is now being transitioned to oral Xaralto. She has no deficits whatsoever and has made a full recovery so far. We are still pending the results of her coagulation studies to see if she has a hereditary condition. The doctors believe the clot is due to her Nuvaring Estrogen, which is most likely. However, I would still like to report this event just in case.

Hospitalized for pulmonary embolism on 4/27/21. Discharged 4/28/21. No other notable risk factors besides oral contraceptives (taken since 2017).

10 minutes post vaccination patient suffered a syncopal event/seizure in the observation clinic. Tonic-clonic convulsions noted by nursing staff for 30-40 seconds with loss of consciousness for aprox 1minute total. Noted cyanosis that improved with application of O2 via nasal cannula. Patient taken by hospital code team to ER. DX with dehydration, possible UTI, and syncope.

About one week after vaccination, the patient developed symptoms of enlarged cervical LN, sinus pressure, fevers. This progressed to develop rash and eventually SIRS. She was admitted several times over the course of April and May to determine a diagnosis and had extensive workup for infectious, autoimmune and hematologic malignancy. The ultimate diagnosis was macrophage activation syndrome/HLH but it is unclear if this was triggered by the COVID vaccine or not. She is responding to steroids in taper and Anakinra and still recovering in the hospital at this point.

PT FAINTED WITHIN 5 MINUTES AFTER RECEIVING FIRST DOSE OF MODERMA COVID VACCINE ON 5/21/21. SHE HIT HER HEAD ON FLOOR FROM SEATED POSITION CAUSING A CUT IN HAIRLINE ABOVE FOREHEAD AND BLEEDING. PT WAS DIZZY, WEAK , AND EXPERIENCED BLURRED VISION. 911 WAS CALLED. PT REFUSED TO GO TO ER. PT STAYED AT PHARMACY FOR ANOTHER 20 MINUTES AFTER PARAMEDICS LEFT AND ATE A BANANA . SHE STATED SHE WAS FEELING BETTER, VISION WAS OK, AND LEFT WITH HER FRIEND. SHE WAS ADVISED TO CALL 911 OR GO TO ER IF NEEDED.

She is 11 weeks pregnant. On 5/19/2021 began feeling pain in her left groin area. Didn't think too much about it. 5/20/2021 swelling and pain in left groin area. Went to urgent care. scheduled ultrasound. Blood clot in Left groin detected. Hospitalized and treated for clot with blood thinners.

Prolonged vaginal bleeding- patient does not have periods with her Nexplanon, started bleeding after 2nd dose Moderna 5 weeks ago and has not stopped.

The morning of the 6th I had numbness in my face and hands and then my right side went numb. I had a stroke. Mini seizures afterwards.

Patient has syncopal episode on 7/10 began "foaming at the mouth" and vomiting. was brought in to the hospital and intubated briefly. Six days later came back to the hospital for right sided weakness and dizziness that led to a fall. Patient was found to have a pericardial effusion on 7/16 that led to a cardiac tamponade and ultimately cardiac arrest on 7/21.

called to Car after vaccine due to patient not feeling well. Quick history obtained: No pmh. Not pregnant per patient. nly allergy to milk. No history of anaphylaxis. She received vaccine at 5:42. Felt lightheaded and dizzy about 5 to 10 minutes after the vaccine. She noted chest tightness and tachycardia symptoms. We transported her via gurney to our observation area. She looked sleepy and had trouble arousing her. Blood pressure is 140/80, heart rate was in the 90s to 100s. Breath sound decreased bilaterally. No lip swelling. No rash. She noted throat felt uncomfortable. Suspect anaphalxis reaction given rapid decline in status while talking with her. epic pen at bedside immediately and then due to increasing heart rate and complaints of chest discomfort gave her epipen times one. Paramedics were called prior to decision for Epipen. She noted after a minute or two her chest felt better. Monitored her and blood pressure remains stable 140/80's, heart rate initially increase to 110 and then back down to 100 about 5 minutes after the first dose. Second dose of EPI readied as Paramedics not on site yet. At about 8 minutes from EPipen dose her heart rate increase to 160 and she noted additional symptoms of chest tightness again and re-gave a second Epinephrine pen. She was more somnolent but protecting airway. Oxygen was added 2 liters after second epi pen. Her sats dropped right around second epi pen to 94% but about 2-3 minutes later back to 98%. Paramedics arrived 5 minutes after 2nd epi dose and care was transferred to them. She was transported in stable condition. Once paramedics arrived it was determined that they got a level 3 request which was not as urgent and this should have been a level 1. We reviewed how this happened and they note that our site was listed as a level 3 site due to having staff on hand. We were advised to ask for LEVEL 1 paramedics in futures. This was communicated to all Medical staff as well as the Physician of the day orientation.

Initial adverse event occurred 25 minutes after injection. Sudden confusion, burning heat and hives and burning red rash spreading from injection site, up neck and throat and down arm to hand. 5 days after the injection, a severe allergic reaction occurred where my entire body broke into hives and a red burning rash, again starting at the injection site. Throat tightness, itchiness in scalp and groin, and difficulty concentrating (all my usual symptoms of anaphylaxis) occurred. Advised by health care provider to take Benadryl immediately and to have epi-pens on hand. Loratadine was prescribed.

on 04/29/2021 Resident was checked at 1830 and found to be at baseline status. At approximately 1855, resident was found pulses and apneic. CPR initiated and resident transferred to medical center. Resident expired 1939.

I skip period on birth control pills for half a year now, so I don?t get my period at all. After the first dose, I?ve been spotting everyday. It?s not a lot that I need a pad. It?s enough whenever I wipe after peeing, I see a little spot of blood. After the second dose, the spotting continues but start to become heavier. A week later after second dose, the spotting is a bit heavier that I need to wear a panty liner. This spotting been going for a month now since my first dose.

Began bleeding; Began spotting; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Began bleeding) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (Began bleeding) (seriousness criterion medically significant) and VAGINAL HAEMORRHAGE (Began spotting). At the time of the report, HAEMORRHAGE (Began bleeding) and VAGINAL HAEMORRHAGE (Began spotting) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. No treatment medication was reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Presented to ER with pleuritic chest pain and acute dyspnea. Her labs on admission were notable for WBC 23.5 with AEC 12.0 and IgE elevated at 1058 LV EF of 25%, Medium sized pericardial effusion with intermediate density concerning for pericarditis. Troponin 5000. Echocardiogram: small pericardial effusion and biventricular dysfunction with LV EF 25%, likely myopericarditis. CMR rest w/wo gadolinium showed global LV dysfunction and no evidence of T2 or LGE scar Patient started on 0.6 colchicine BID for treatment of suspected pericarditis given reports of periodic chest pains. CT chest w contrast: Dense consolidation in the RUL, RML with GGO throughout And patchy consolidation in the LLL with some microdularity with GGO. Significant mediastinal, subcarinal and hilar LN. Treatment with ceftriaxone and azithromycin

A week after second shot i had a fever off and on , no appetite, also felt like I couldn?t breath at one point and started hyperventilating?about four days later I had brown spotting , then intense cramping PMS symptoms for 2 weeks straight , I was also 16 days late on my period. When receiving my period it was 7 days as it normally is and was fine after period ended I am now having chest pains on the left side .

I was pregnant at the time of my first and second dose of the vaccine. My estimated due date was February 15th 2022. A half hour after my second dose I had a little bit of spotting and moderate to severe cramping. This was dismissed as gas pains. Later that night I went to the bathroom to find a substantial amount of blood in my underwear at which point I called a nurse line and was directed to go to the ER. They gave an ultrasound and ran blood work. Miscarriage was strongly suspected but not totally confirmed. I was also running a low fever and experiencing severe chills, muscle and joint pain and a severe headache. I was sent home and told to follow up with my doctor for more blood work to confirm the miscarriage. I continued to get severe cramping, bleeding and loss of uterine tissue vaginally. On Monday I saw my doctor had blood work and confirmed the miscarriage. I am still bleeding today.

I had pain in my left arm, and within an hour or two I was pretty exhausted and out of it. I figured it would go away, it got worse the next day, and finally on Saturday when I woke up it was hard for me to breathe and I had pain/tightness in my chest. I went into the ER on Sunday morning and after a day of testing was diagnosed with: - Deep vein thrombosis of bilateral lower extremities - Pulmonary embolism, bilateral - DVT, bilateral lower limbs I had at least 5 clots in my legs and several more in my lungs but they said there was no way to know the full amount. I had been on HRT for over two and a half years and had no problems, then 4 days after I received my first shot I was informed that I had almost died several times due to the clots. When I explained to my doctor that I thought the clots were related to my shot he shrugged it off, said it was impossible, told it was just my hormones, and said that "Covid is no big deal and we're overexaggerating how bad it is compared to other things...". So I don't think any of this was reported. Later I saw a blood specialist who told me it was impossible for hormones to do this much damage in the span of a few days without something else effecting it, and told me to cancel my next shot even after we learned I had APS. All and all I would really appreciate someone looking into this to at least make sure there isn't something else going on, as the timing of this is was too close and I know Covid shots have had the rare chance of causing the exact kind of thing I went through.

Patient found deceased in her bed on june 12, 2021, reported to Strongsville Police Department at 10:15am., taken to Cuyahoga Medical Examiner's Office the same day. Autopsy done. Results still pending for 4-5 months.

Anaphylactic reaction, with tachycardia, hypertension, throat swelling/dyspnea, facial swelling, and diffuse hives.

Brain hemorrhage (inflammation, swelling); Dizziness; Difficulty with coordination; Difficulty with balance; Vision changes in left eye; Drift in left arm; Issues going through daily routine; Neurological symptoms; Was confused; Headaches; Very nauseous; A spontaneous report was received from a consumer, who was a 25-years-old, white female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, very nauseous, neurological symptoms, headaches, dizziness, difficulty with coordination, difficulty with balance, vision changes in left eye, drift in left arm, issues going through daily routine, confusion, and brain bleed. The patient's medical history, as provided by the reporter, included gluten allergy. Products known to have been used by the patient, within two weeks prior to the event, included ethinylestradiol/ ferrous fumarate/ norethindrone acetate. On 06 Jan 2021 at 10:30am, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 06 Jan 2021, after receiving the vaccine, the patient became very nauseous through 08 Jan 2021. On 09 Jan 2021, the patient started having neurological symptoms. She started having headaches, dizziness, difficulty with coordination and balance, and vision changes in the left eye (not specified). She reported that she had a "drift" in the left arm and described it as "when you try to manipulate the arm, but it does not go where you want it to go". On 11 Jan 2021, the patient still had neurological symptoms, issues moving left arm, colliding with objects all day, and issues going through daily routine. On 12 Jan 2021, the patient was seen by a neurologist and magnetic resonance imagining (MRI) was scheduled. The MRI revealed inflammation, and brain bleed and swelling. The patient was sent to the emergency room and admitted on 19 Jan 2021. Treatment for the events included calcium carbonate for nausea, ibuprofen for headaches and diphenhydramine. Action taken with mRNA-1273 in response to the events was not reported. The event, very nauseous, was considered resolved on 08 Jan 2021. The events, neurological symptoms, headaches, dizziness, difficulty with coordination, difficulty with balance, vision changes in left eye, drift in left arm and issues going through daily routine, confusion, and brain bleed were considered not resolved. Follow-up received on 23 Jan 2021 included patient details, medical history, lab tests, concomitant medications, hospitalization, and updated events.; Reporter's Comments: This case concerns a female patient, who experienced a non-serious unexpected event of dizziness, coordination abnormal, balance disorder, visual impairment, movement disorder, loss of personal independence in daily activities, and neurological symptom, and non-serious expected event of nausea, and headaches. The events of nausea occurred 1 day (same day) after first dose of mRNA-1273, lot # unknown. The event of neurological symptoms, dizziness, coordination abnormal, balance disorder, visual impairment, loss of personal independence in daily activities, and movement disorder occurred 3 days after first dose of mRNA-1273, lot # unknown. Treatment for the events included, Tums, nauseam, ibuprofen and Benadryl. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.

Immediate: Flushing (transient), bleeding down my own arm and vaccinator (lasting about 2 min) 1 hour to 3 weeks post vaccination (inclusive) - ongoing pins and needles sensations in both hands and both feet. 10 hours to 72 hours post vaccination: - high fever (39.5 Celsius), causing temporary auditory and visual hallucinations (no history of psychiatric illness) - uncontrollable chills (pronounced) - transient tachycardia (3-4 episodes lasting 30 seconds to 2 minutes each time) - headache - myalgias - transient metallic taste on tongue once, lasting one minute - insomnia for two consecutive nights - anxiety - mild arm soreness at the site of injection

Headache started on 1/26. Woke up from a nap on 1/30 at 1:30pm and was having difficulty with speech. I could not say the words I wanted to and words that I could get out sounded very slurry. I went to the Emergency Room where I was stroke-activated. I was admitted to the hospital 1/30 and discharged 1/31.

After administration, patient had tingling in her left arm immediately and felt like her arm was "swelling immediately." After sitting down, her throat began to swell. She described it as "swallowing cotton balls", then "a large lump in her throat", then "narrowing of her throat so that it felt as if she was breathing through a closing straw." Patient was having an anaphylactic reaction to the vaccine. I (the pharmacist) administered an EpiPen once, then 50mg diphenhydramine IM, and called 911. Patient was evaluated by EMS and brought to the hospital for observation.

Pulmonary embolism; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 21-Mar-2021 to 24-Mar-2021 due to PULMONARY EMBOLISM. At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Treatment information included was blood thinner. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Vomiting, hives, swelling of face lips thoart and closing of airways. Causing anaphylaxis shock, was in hospital 6 different times. Still having sever reactions 3 months after. Still causing airways to close and swelling of lips thoart eyes and neck was admitted to hospital and them not being able to stop the reaction after 4 shots of epi april 11 2021 I was admitted

Acute ITP; Heart rate dropped to 47; Shortness of breath; Heart rate dropped to 47; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Acute ITP), the first episode of HEART RATE DECREASED (Heart rate dropped to 47), DYSPNOEA (Shortness of breath) and the second episode of HEART RATE DECREASED (Heart rate dropped to 47) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced IMMUNE THROMBOCYTOPENIA (Acute ITP) (seriousness criterion hospitalization). On 01-Apr-2021, the patient experienced the first episode of HEART RATE DECREASED (Heart rate dropped to 47) (seriousness criterion hospitalization), DYSPNOEA (Shortness of breath) (seriousness criterion hospitalization prolonged) and the second episode of HEART RATE DECREASED (Heart rate dropped to 47) (seriousness criterion hospitalization). The patient was hospitalized on 29-Mar-2021 due to DYSPNOEA, HEART RATE DECREASED and IMMUNE THROMBOCYTOPENIA. At the time of the report, IMMUNE THROMBOCYTOPENIA (Acute ITP) had not resolved and DYSPNOEA (Shortness of breath) and the last episode of HEART RATE DECREASED (Heart rate dropped to 47) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Platelet count: about 2000 (Low) About 2000. On 01-Apr-2021, Heart rate: dropped to 47 (abnormal) Dropped to 47. On 02-Apr-2021, Platelet count: low (Low) Low. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment included: steroids [also noted as dexamethasone (DECADRON)] and IV IgG. At the time of the report, the patient was being transferred to another hospital facility. Based on the current available information which includes a temporal association between the use of the product and onset of the reported events and excluding other etiologies, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the reported events and excluding other etiologies, a causal relationship cannot be excluded.

Vaccine given @ 03:50 pm; Patient complained feeling light headed @ 3:55pm, checked pulse 90 bpm, Pt was laid on the floor and raised leg for 5 minutes, patient complained getting cold and her throat was getting itchy and feeling hives. Injected Epipen 0.3mg @ 4:00 pm and called 911. Emergency arrived gave the patient 50 mg benadryl and checked blood pressure and heart rate . Pt was transported to hospital @ 4:30 pm . I called to check on the patient @ 6:00pm , she's doing fine : BP 130/80 , HR 98 , Oxygen @ 99.

pain in arm; Miscarried; No fetal heartbeat.; Menstrual bleeding; Pregnant; General sick and tired feeling; Did not want to get out of bed; Pretty tired; Headache; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarried) in a 25-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Anxiety on 01-Jan-2010. Concomitant products included FLUOXETINE for Anxiety, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Pregnancy, MISOPROSTOL (CYTOTEC) for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 15-Nov-2021. On 12-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). 12-Mar-2021, the patient experienced MALAISE (General sick and tired feeling), FEELING ABNORMAL (Did not want to get out of bed), FATIGUE (Pretty tired) and HEADACHE (Headache). On 22-Mar-2021, the patient experienced VAGINAL HAEMORRHAGE (Menstrual bleeding). On 01-Apr-2021, the patient experienced FOETAL GROWTH ABNORMALITY (Baby had not grown). On 09-Apr-2021, the patient experienced ABORTION SPONTANEOUS (Miscarried) (seriousness criterion medically significant), FOETAL HEART RATE ABNORMAL (No fetal heartbeat.) and HEREDITARY DISORDER (Genetic issue). On 12-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. On 09-Apr-2021, ABORTION SPONTANEOUS (Miscarried), FOETAL GROWTH ABNORMALITY (Baby had not grown) and FOETAL HEART RATE ABNORMAL (No fetal heartbeat.) had resolved. At the time of the report, VAGINAL HAEMORRHAGE (Menstrual bleeding), MALAISE (General sick and tired feeling), FEELING ABNORMAL (Did not want to get out of bed), HEREDITARY DISORDER (Genetic issue), FATIGUE (Pretty tired) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Ultrasound foetal abnormal: abnormal (abnormal) Had some bleeding and found out it was subchorionic hemorrhage. Bleeding is in another part of the uterus where is baby is not. On 01-Apr-2021, Ultrasound scan: abnormal (abnormal) Saw baby heartbeat but was informed baby had not grown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information provided mentioned ultrasound and cytotec. Action taken with mRNA-1273 in response to the event was not applicable as patient took both doses of the vaccine. Patient reported that she does not blame Moderna, as her OB feels the miscarriage was related to a "genetic issue. This case was linked to MOD-2021-060699 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Patient updated AE and mentions fetal complications resulting in miscarriage. Events and outcome of case thus updated with new information.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.

platelets were incredibly low at 16; RBC was 3.25; Autoimmune hemolytic anemia; Idiopathic thrombocytopenic purpura; yellowing of both eyes; felt tired/increasing fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT DECREASED (platelets were incredibly low at 16), RED BLOOD CELL COUNT ABNORMAL (RBC was 3.25), AUTOIMMUNE HAEMOLYTIC ANAEMIA (Autoimmune hemolytic anemia) and IMMUNE THROMBOCYTOPENIA (Idiopathic thrombocytopenic purpura) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 18-Mar-2021, the patient experienced FATIGUE (felt tired/increasing fatigue). On 27-Mar-2021, the patient experienced EYE COLOUR CHANGE (yellowing of both eyes). On 28-Mar-2021, the patient experienced PLATELET COUNT DECREASED (platelets were incredibly low at 16) (seriousness criteria hospitalization and medically significant) and RED BLOOD CELL COUNT ABNORMAL (RBC was 3.25) (seriousness criteria hospitalization and medically significant). On 05-Apr-2021, the patient experienced AUTOIMMUNE HAEMOLYTIC ANAEMIA (Autoimmune hemolytic anemia) (seriousness criterion medically significant) and IMMUNE THROMBOCYTOPENIA (Idiopathic thrombocytopenic purpura) (seriousness criterion medically significant). On 16-Apr-2021, PLATELET COUNT DECREASED (platelets were incredibly low at 16) outcome was unknown. At the time of the report, RED BLOOD CELL COUNT ABNORMAL (RBC was 3.25), EYE COLOUR CHANGE (yellowing of both eyes) and FATIGUE (felt tired/increasing fatigue) outcome was unknown and AUTOIMMUNE HAEMOLYTIC ANAEMIA (Autoimmune hemolytic anemia) and IMMUNE THROMBOCYTOPENIA (Idiopathic thrombocytopenic purpura) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, Platelet count decreased: 16 (Low) Low. On 28-Mar-2021, Red blood cell count: 3.25 (Low) Low. On 05-Apr-2021, Platelet count decreased: 90 (Inconclusive) 90. On 05-Apr-2021, Red blood cell count: 2.76 (Inconclusive) 2.76. On 16-Apr-2021, Platelet count decreased: 329 (Inconclusive) 329. On 16-Apr-2021, Red blood cell count: 3.47 (Inconclusive) 3.47. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. On either 23 Mar 2021 or 24 Mar 2021 (described as around the 5th or 6th day), the patient noticed bruises on both arms (described as 1 or 2 petechiae on chest, "a little bit on right leg," petechiae on both forearm but mostly on the left one, "a little bit on both arms but mostly on the left"). On 24Mar2021, the patient noticed a bruise on lower back. On 26 Mar 2021, the patient noticed bruising on both sides of both knees. On 27 Mar 2021, the patient had yellowing of both eyes. On 28 Mar 2021, the patient had increasing fatigue and saw their Nurse, who advised her to go to the emergency room to get blood tests. When the patient arrived at the emergency room, the patient had bruises on calves, and their platelets were incredibly low at 16, RBC was 3.25. While admitted, the patient had daily blood tests because the patient was notified that the "immune system started attacking red blood cells". The patient was initially treated with steroids, but didn't respond to steroids; then, the patient was treated with IVIG and responded. On 01 Apr 2021, the patient received a platelet transfusion and red blood cell transfusion. On 05 Apr 2021, the patient's platelets went up to 90, and RBCs were at 2.76. On 05 Apr 2021 around 1600, the patient was discharged with an official diagnosed with idiopathic thrombocytopenic purpura and autoimmune hemolytic anemia. On 16 Apr 2021, the patient's platelets were 329 and red blood cells were 3.47. Company comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

shortness of breath , difficulty breathing, stiff neck and stop breathing for few seconds 30 minutes after the 2nd moderna dose (while in the car) - returned to hospital and admitted to emergency department (but discharge dg that wrote allergy to medication.. not allergy to vaccine)

I received the vaccine on February 3, on February 4 at 0100 I woke up with chills. The rest of the day I would have chills and sweats. I was nauseous and threw up twice. I had a low grade fever of around 99 degrees but at one point it did go up to 101.3. My entire body hurt including my head and Tylenol and ibuprofen did not help. On February 5 I was feeling a little better, I still had body aches but could eat a little. On February 6 at around 0500 I woke up with chest pain. I waited a little while to see if it would go away but it had gotten more intense. I am a cardiac ICU nurse so I knew what chest pain could mean. I got out of bed and at that time my chest pain was a 10/10 and I was having shortness of breath. I woke my fiancé up and told him I needed to go to the ER. At the ER they ran test and admitted me to the hospital. They later diagnosed with myopericarditis with a small pericardial effusion.

Heart felt like it was pounding out of my chest on Monday evening on April 26, 2012. On Wednesday morning, around 8:30, April 28, I collapsed at at kickboxing class and was sent by ambulance to Hospital Emergency Room as my heart rate was very high and my oxygen was low. In the ER I was diagnosed with blood clots in my lungs, pulmonary embolism, and was sent by ambulance to another facility where I had a procedure to try to break up the clots (catheter directed thrombolysis). I spent 24 hours in the ICU, and another 24 hours in Cardiac Care. I was released on Friday, April 30 at around 2:30 pm. I am now prescribed Eliquis, have a follow up with my PCP on Monday, , May 10, a follow up with cardiology on May 24, and a follow up on June 14 with the Pulmonary Embolism group.

Menstrual cycle came two weeks early, no cramping at all (which is abnormal) thicker/ clotty, lasted a normal amount of time. I have had hx of abnormal menstrual cycles in the past, but not that come this early.

poor oral intake . Seizures. on admission she was found to have lactic acidosis. Transaminase elevation and thrombocytopenia and Cr of 1.2

01/12/21 (First dose on 1/9): Exhaustion/confusion (lasted for about three days), recognized episodes of tachycardia that lasted for weeks; severe pain in right arm at vaccination site that lasted about 2 days. 02/9/21: Received second dose of vaccine on 2/6/21, recognized raised, oblong, red rash not at the location of the vaccination site on the deltoid, but on the top of the upper arm and down near the antecubital fossa that slowly crept down the arm over several days, was gone in about a week; severe arm pain for about 2 days; episodes of racing heart continues, was relieved with rest. 03/15/21-03/26/21: Exhaustion; recognized multiple episodes of tachycardia that was not relieved with rest (around 140 bmp, each episode lasted between 3-6 hours). 03/23/21-03/24/21: Pain in right arm 03/26/21-04/2/21: Recognized exhaustion/confusion, tachycardia that was not relieved with rest. 04/2/21: Right arm swelling and pain. Tachycardia (140 bmp), not relieved with rest. Chest pain/tightness. Arm turned purple and all the vasculature was present in the right arm and chest. Admitted to hospital, ultrasound revealed the subclavian vein was completely occluded down to the basilic vein near the elbow. CT scan showed pulmonary emboli in both lungs. Was placed on heparin drip and released from hospital on 04/4/21. Started on 10 mg Eliquis BID for one week on 4/4, now on 5 mg Eliquis BID for 6 months. 05/19/21: Received diagnosis of Factor V Leiden heterozygous mutation. Arm pain/swelling remains periodically.

ON 3 JUNE 2021 @ 1453, "25-year-old female who presents to the emergency department with 2 days of worsening left-sided chest pain associated with some myalgias shortness of breath she received her second covid vaccination on the first of June. she also has some bilateral anterior shin pain soreness into her arms as well. Denied any fever and a productive cough any nausea or diarrhea". Patient was admitted to ICU on 3 June for NSTEMI in setting of chest pain/SOB with elevated TnT. Significant elevation of TnT >3K with unremarkable ECG. TIMI score 1, grace 52. Given her age etiology concerning for possible Myocarditis but will start appropriate tx for NSTEMI and order formal TTE.....Patient has been diagnosed with Myopericarditis. The patient didn't have any significant changes on her EKG, however, she did have elevated troponins up to 3134 ng/L which trended down to 2455 ng/L on recheck. Given the pleuritic nature of her chest discomfort, MD suspected Acute Myopericarditis. She is still symptomatic and thus, MD recommended she take high-dose NSAIDs. MD would not too keen on starting her on steroids and/or colchicine unless she doesn't get better on follow up evaluation. Echocardiogram showed intact ejection fraction. MD have sent off additional labs to look for other causes of myopericarditis. The patient should also be on a low-dose of beta blocker and ACE inhibitor. She'll follow with her primary care provider and cardiology.

I've been suffering from vaginal bleeding for 3 months. It started 10 days after my first dose. After 2 months of bleeding, I have seen a primary physician and a gynecologist. I was told to take birth control, i took it for a month but the bleeding didn't stop. The bleeding would occasionally stop only if I take 3 birth control pills. On top of that, I would randomly get a excruciating sharp pain in the lower abdomen area.

developed shortness of breath. was seen in the ER and diagnosed with PE. Only other risk factor was OCP's

PATIENT CAME IN AND CLAIMED HER ARM STILL HURTS SOMETIMES. SHE SAID IT ALSO BLEEDS AND LOOKS PUSSY AT TIMES