Moderna

Patient received the Moderna COVID-19 vaccine at her place of employment as a phase 1A essential frontline healthcare worker in a skilled nursing LTC facility on January 6 2021. The day after receiving the vaccine (1-7-21), she started to feel increased shortness of breath (she has shortness of breath at baseline due to chronic health conditions- CHF, asthma), a heavy feeling in her chest/lungs, sweating and fatigue. She contacted the pharmacy on January 8th, as we were the entity that vaccinated her to ask about vaccine reaction. Due to her medical history of MI and CHF, pharmacist did not want to dismiss this as a reaction to the vaccine, and recommended that she contact her doctor for further guidance. She did reach out to her care team, and ended up going to the emergency room for testing due to cardiac history and presentation of symptoms. She had diagnostic testing done (see item 19) and the ER doctor attributed her symptoms to an exacerbation of CHF and asthma, noting that vaccine involvement in the worsening of her symptoms can not be ruled out. Treatment/discharge instructions include: follow up with cardiology/pulmonology, furosemide dose was increased, potassium supplement restarted, and instructed to use inhalers already on hand when needed. As of time of report on January 9 2021, the patient was resting at home, doing well except still having symptoms upon exertion.

It bled a little, right away I felt jittery. Later that night I got chills, and I had to change my shirt twice because I was drenched in sweat. The morning I had a head ache and just felt achy, my arm was very painful. I was able to sit down and run some errands. I was feeling sick like when you have flu. The 26th I felt the same, the 27th I felt the same and my arm was hurting and the injections site was red and very big. On the 28th I decided to go to the Urgent Care. The Dr told me I had an infection on my arm, he gave me an antibiotic shot for the infection and another shot for the pain. I continued taking antibiotics and Benadryl and was feeling much better by Wednesday and my arm swelling went away. I had Covid in October and Urgent care saved my life, I love going there.

This person was found to be deceased on routine rounds during the night, 3am. No symptoms of reaction noted post vaccine. No injection site reaction. No reports of any allergic reaction.

Woke up the next morning with slurred speech, right side weakness, illegible writing, balance issues. Next day all symptoms worse. Went to Urgent Care, was transferred to Hospital. Diagnosed with stroke.

Anaphylaxis within 15 minutes. Throat tightened wheezing began given Benadryl at clinic then taken to ER downstair at Hospital. Given more benadryl, then epinephrine, Decadron, then breathing treatment. once undercontrol sent home and then recommended seen by own doctor. I saw doctor on the 21st.

chills, shortness of breath, new onset a-fib, overall ache, extreme fatigue Still in a-fib w/ shortness of breath

On 1/27/2021 was to have stress echo done with imaging -- when injected with Lumason -- I had an immediate, severe anaphylaxis shock requiring transport to hospital, intubation, and short MICU stay -- was referred to allergist who felt the PEG in Covid vaccine sensitized me to the PEG in Lumason thus resulting in severe allergy

immediate LUE localized injection site discomfort. Status post 1.5 hours - head ache. Approximately 10 hours status post vaccination administration - chills, decreased and loss of taste & smell. PMD notified, ER visit recommended. Patient developing increased chills and diarrhea. ER unable to assist, recommending home discharge with increased fluids and OTC Tylenol. Signs and symptoms continuing x5 days. Chronic dry, non-productive cough continued.

10 daya after receiving Moderna vaccine: 60 year old right handed woman with migraine + chronic headaches, nephrolithiasis, who presented to the hospital with expressive aphasia and right facial weakness and was found to have at least to distal left MCA occlusions for which she received IV tPA. MRI brain shows a small left frontal cortical acute ischemic stroke. Post tPA ICU course has been notable for angioedema of the tongue now improved. TTE showed PFO. LDL 111, new diagnosis HLD.

Acute CVA with Multiple small Infarcts to left Pariaetal and occipitral area Admitted to Medical Center Admit 02/19/2021, DC 02/22/2021

No rxn to dose 1. Dose 2: @10 min had tingling of lips; at 12 min had tingling of tongue [and anxiety from the tingling]; @ 15 min had some SOB and knew this was not just anxiety. Had zero intention of being taken to ER as I could easily tx myself. Took inhalers, extra cetirizine. Did not take epi, though have several pens. @4 hour started feeling weak, severe arm pain. At 6 hours, unbearable arm pain, extreme weakness [did not take BP or pulse ox--though I can and wish I had]. Exceeding thirst, could not get water down fast enough. Reactivation of arachnoiditis symptoms. Started unusual muscle fasciculations in arms, leg, and face [face not normal for me]-took valium and baclofen. Next 36 hours unable Additional information for Item 18: next 48 hours, unable to get out of bed other than to get water. Severe HA upon waking [@16 H post injection]. Severe myalgias, but in areas of known arachnoiditis that have been quiescent for quite some time. Forgot to mention, as I find this strange: prior to going to sleep I had left eye conjunctivitis. Left eye only that still is slightly persistent and doesn't require any care [for me at least] I am currently 72 hours post. Still with HA and some fatigue, though worked today [I WAH for a population health company]. L arm is not as painful as the excruciating pain @ hour 4-16, and no need for additional acetaminophen. I have an exceedingly high pain tolerance due to the arachnoiditis, but this was the first time I took a narcotic in 5 years. 2 .5 mg oxycodone x1, then 600 mg ibuprofen x1, then 1 gm acetaminophen 2 over next 24 hours and nothing since, but it is still quite painful today. Different today than yesterday is the development of what feels like left shoulder bursitis. We'll have to see how this goes over time. There is extensive edema at the site, but not clear erythema [I'm dark skinned]. Still just can't seem to get enough water. Had my first meal last night [made chicken soup]. It's still pretty early on. I'm not even at the 72 hour mark yet, so hopefully things will settle down over the next weeks. I checked the box as life threatening because that was likely early anaphylaxis -- though at first I seriously thought at first I was just anxious because of the lip tingling. This is in defense of the fact I did not self administer epi when I became SOB. I likely should have, but know myself well and did fine without it and with asthma and allergy care. I didn't need extra albuterol after the first 24 hours [though writing this makes me feel SOB just from reliving it]. This second dose is a doozy. Hope this was helpful. I provided you guys with my cell but if you want to follow up, I use my phone for work so if you text first I cant tell you availability.

Hypotension in the 70s/40s despite IV fluid replenishment. Per our MD DC/transfer note: PEG displacement, ongoing sepsis, hypoglycemia. Assess for other reason for hypotension including sepsis, cardiogenic shock, acute abdominal processes. patient was transferred to the Hospital ER where she expired

She received vaccine on 12.28.21. On 12.30.21 she went to the ER and was subsequently sent to Hospital. Not sure what the findings were, but she was discharged after several hours. I spoke with her on the phone on 1.1.21,, She wasn't feeling well. I asked her what was going on because she had been doing really well for a few months. She stated "Every since I took the vaccine, I have felt really bad." She died on 1.5.21. Timeline: 12.28.20 Vaccine 12.30.20 ER 1.1.21 Continues to feel bad and reports feeling worse and worse since vaccine. 1.5.21 Died at home.

On 2/1/2021 they performed CBC, the result was aseptic bacteria so it came out and she was taken to the hospital. They removed the tube in the hospital, (she remained in the hospital) First she was hospitalized and then she was transferred to the Medical Center Hospital to auscultate bleeding in the stool and to be evaluated by the Gastroenterologist. This specialist performs the necessary studies, they do not give a diagnosis and in the process she dies. The hospital indicated that she had a blood drain and heart failure.

I received my vaccine on Sunday March 7 and in the morning of March 12, I woke up to a large bruise with a hard clot on the inside of my right forearm measuring 7cm x 4cm with a large clot in the bruise. I also have a smaller spot which has a firm bump under the skin. I did not hit my arm or injure it during my sleep or before going to bed.

Had my first Moderna vaccine on 3/3/2021 and have been diagnosed with pneumonia in left lung on 3/15/2021. Visited my surgeon who follows up with me every 6 months. She listened to my lungs and said she heard crackles in my left lung. Sent me for a chest x-ray immediately after visit on 3/15/2021. I am having no symptoms such as coughing, fever, etc. I?m concerned this could be a side effect of the vaccine. Was also tested for Covid on 3/17/2021. Test result was NEGATIVE.

Patient admitted to hospital on 3/6/21 with sudden onset right-sided hemiplegia and aphasia. CT showed acute intraparenchymal brain bleed. Family chose palliative care over neruosurgical intervention due to sever neurologic impairment and inability to communicate. Patient was discharged to home hospice on 3/9/21.

****I want to note that I am submitting on behave of my mother who passed away yesterday. The medical examiner has declined 2x for an autopsy to be done. My mother was healthy and was absolutely fine besides the rash (dr diagnosed her with cellulitis week of March 14). I do not agree with the rule of death being ?natural causes? neither does her doctor.

She got her vaccine and had no reactions at all. On 3/12/21 she was in her car and started having stabbing pain in the left side of her chest under the rib. She thought it was gas pains and dismissed it, and then it started radiating towards the front and the stomach. On 3/16/21 she went to the ER and they did a CT scan that showed that she had a blood clot on her spleen. With that they gave her the diagnosis of idiopathic splenic infarction. She was then sent by ambulance to another hospital to be admitted in case she was needing surgery. She was given heparin and on that for 2 1/2 days. They determined that 60% of her spleen is dead, blood supply cut off to it, and the other 40% is nonfunctional. On 3/19/21 they gave her vaccines of Prevnar 13, HIB, meningococcal, meningococcal B, and a flu vaccine. She was discharged on the 3/20/21 with Plavix. She saw her regular doctor yesterday and he diagnosed her with functional asplenia and to continue the Plavix. She is no longer having any symptoms after dissolving the blood clot.

Pt stated her "tongue felt thick" and felt her "heart racing" immediately after injection. Pt moved to observation area and offered oral diphenhydramine, pt declined. Pt BP and HR were initially elevated at 168//80 and 129. BP decreased to 140/80 and HR to 100 after five minutes of observation. Pt reported gradual improvement with symptoms for 30 minutes, until reporting a sudden worsening of angioedema, "tingling all over", tachycardia, and syncope. RN administered 0.5 mg of epinephrine IM to L upper thigh and called 911 for ambulance transport. Pt reported some improvement in symptoms after administration of epi, but symptoms not resolved. RN considered administering second epi dose, but deferred when ambulance and EMTs arrived five minutes after first dose of epi. Pt transported to local hospital for further follow up.

Patient presented to ED due to sudden onset of chest pain and dyspnea. Symptoms worsened with exertion and relieved with rest. She received 2nd dose of Moderna Covid-19 vaccine on 4/4/21 and began having left calf pain on 4/5/21. She was mildly hypoxic on room air with ambulation and tachycardic. Prior COVID 19 infection in December 2020. CTA showed bilateral moderate burden of disease and was found to have developed bilateral pulmonary emboli.

admitted to the hospital with recurrent hypoxemic and hypercarbic respiratory failure. discharged home. passed away at home after discharge.

On February 5th, I received my second Moderna vaccine. Monday the 8th, I was working from home and wasn?t feeling well. I went to lay down and was not able to. It was hard to breath. I got up, went to another room where there was a recliner and sat in it trying to catch my breath. It got harder to breathe. I had my husband call 911. I went to the ER, had a CT scan of my chest and was found to have ?extensive PE?s?, ground glass and signs of pneumonitis. I was admitted to the CICU for two days and was transferred for two days. I was told by my orthopedic surgeon that there was a high unlikelihood of PE?s developing from my ankle fracture 3 months later. I had home health care for approximately one month.

I had a stroke one week to the day from taking the moderna vaccine. It affected my entire left side. Had weeks of physical therapy and still not back to normal. I have a long road ahead of me with rehab.

Symptoms: Loss of Short Term Memory for 7 hours Event: Ischemic stroke on right parietal superior cortex 1.2cm Treatment: aspirin 325 mg 1 daily; atorvastatin 40 mg 1 daily Outcome: hospital stay, 2 days. Sent home for recovery. Follow up with Primary Care Physician in 1 week

on 03/22/2021 I had a red inflamed area on left Achilles tendon area, off work for two days, negative US for DVT I had twisted my knee on 03/29/2021, negative DVT MRI meniscus tear I got a blood clot behind my left knee on 04/04/2021 left calf started hurting on 04/01/2021, got intense on 04/04/2021 went to UC US was positive for DVT I have never had one, no health issues, was advised to report blood clot

Patient presented to with 4 day history of progressively worsening pitting edema and swelling in bilateral lower extremities. She reports mild shortness of breath. She also reports flank pain and dysuria. Cardiac murmur and rales noted on exam. Patient found to have a heart failure exacerbation and UTI. Patient is being treated with levofloxacin and furosemide and is admitted to the hospital.

Stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for an unknown indication. The patient's past medical history included Thrombectomy. On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization, medically significant and life threatening). The patient was treated with Rehabilitation therapy for Cerebrovascular accident. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Company Comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Per SD date of administration of the first dose of vaccine is either 22-feb-2021 or 28-feb-2021. To be checked on query response.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Per SD date of administration of the first dose of vaccine is either 22-feb-2021 or 28-feb-2021. To be checked on query response.

anaphylactic reaction/she had symptoms of lightheadedness and sensation of throat closure; lightheadedness; throat closure; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic reaction/she had symptoms of lightheadedness and sensation of throat closure) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unk and unk) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Latex allergy. Concurrent medical conditions included Environmental allergy (dust mites). 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced ANAPHYLACTIC REACTION (anaphylactic reaction/she had symptoms of lightheadedness and sensation of throat closure) (seriousness criterion medically significant), DIZZINESS (lightheadedness) and THROAT TIGHTNESS (throat closure). At the time of the report, ANAPHYLACTIC REACTION (anaphylactic reaction/she had symptoms of lightheadedness and sensation of throat closure), DIZZINESS (lightheadedness) and THROAT TIGHTNESS (throat closure) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Tryptase: elevated (High) Elevation persisted 3 weeks. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Before her 2nd dose, she pre-treated with Motrin and Claritin. Concomitant product use was not provided by the reporter. Treatment for the event anaphylactic reaction included EpiPen and intravenous Benadryl. 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. This case was linked to MOD-2021-073832 (Patient Link).; 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.

4/5/21: Patient admitted to ED at 12:55 PM (last known well 1AM) with symptoms suggestive of stroke including: left side weakness, facial droop, slurred speech, dysphagia and fall x 3. NIH stroke scale = 7. Diagnosis: acute right MCA infarct (embolic stroke). Patient was not a candidate for TPA. Risk Factors: diabetes mellitus, hyperlipidemia, hypertension, smoking and hypercoagulable state due to systemic inflammation from second COVID-19 vaccine. Throughout her stay, dysphagia and slurred speech improved but patient still had residual weakness and headache. While inpatient, patient received DVT prophylaxis with Lovenox, rectal aspirin 325 mg, normal saline fluids, sliding scale insulin, analgesics as needed, Requip, and antihypertensives as needed. She also received stroke education, diabetes education, smoking cessation counseling, PT, OT, and speech therapy. A loop recorder implant was placed on 4/7. The patient fell while in the hospital on 4/8. 4/9/21: Patient was discharged to Inpatient Rehab approx. 8:30 AM on the following medications: -- acetaminophen (TYLENOL) 325 MG tablet Take 2 (two) tablets (650 mg total) by mouth every 6 (six) hours as needed --aspirin 81 mg chewable tablet Chew and Swallow 1 (one) tablet (81 mg total) daily . --atorvastatin (LIPITOR) 80 MG tablet Take 1 (one) tablet (80 mg total) by mouth nightly . --bisacodyL (DULCOLAX) 10 mg suppository Insert 1 (one) suppository (10 mg total) into the rectum daily as needed for constipation . --cyclobenzaprine (FLEXERIL) 10 MG tablet Take 1 (one) tablet (10 mg total) by mouth 3 (three) times a day as needed (Restless legs) . --enoxaparin (LOVENOX) 40 mg/0.4 mL Syrg Inject 0.4 mL (40 mg total) under the skin nightly for 20 days . --insulin glargine (LANTUS) 100 unit/mL injection Inject 5 (five) Units under the skin nightly . --insulin lispro (HumaLOG) 100 unit/mL injection Inject 0 (zero) Units to 15 (fifteen) Units under the skin at bedtime . -- insulin lispro (HumaLOG) 100 unit/mL injection Inject 0 (zero) Units to 30 (thirty) Units under the skin 3 (three) times a day before meals . --nicotine (NICODERM CQ) 21 mg/24 hr Place 1 (one) patch on the skin daily . --sulfamethoxazole-trimethoprim (BACTRIM DS,SEPTRA DS) 800-160 mg per tablet Take 1 (one) tablet by mouth every 12 (twelve) hours for 5 days . --traMADoL (ULTRAM) 50 mg tablet Take 1 (one) tablet (50 mg total) by mouth every 8 (eight) hours as needed --continue home doses of metformin, glipizide, bupropion, and omeprazole. --discontinue lisinopril.

low grade fever, headache for approx 24 hrs., body aches 24-48 hours, 5 days after injection heavy bleeding from cut on my tongue. A small cut developed when eating and then bleed profusely for 2 1/2 to 3 hours. My blood wasn't clotting. That has never been a problem. Very heavy bleeding from a very small cut finally stopped after putting ice on it.

Rashes, hives and total face, neck, and torso and arms completely red as the hives grow. Several episodes where it was so bad I had anaphylaxis requiring epinephrine injections with O2 sat down to 70! This went on every day for 3 1/2 weeks. I was already taking Allegra, Xzyzal, singularity, and famotidine to stabilize my mast cells. Cromolyn and Benadryl added.

They thought they were having a stroke; Facial paresthesia; The right side of their face felt numb, like with paralysis; Their face was swollen; Right upper extremity paresthesia; Blurry vision; Dizzy; Nervous as hell; Felt like someone hit them with a gun in the right temple with Novocain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (They thought they were having a stroke), PARAESTHESIA (Facial paresthesia), HYPOAESTHESIA (The right side of their face felt numb, like with paralysis), SWELLING FACE (Their face was swollen) and PARAESTHESIA (Right upper extremity paresthesia) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) 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 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced VISION BLURRED (Blurry vision), DIZZINESS (Dizzy), NERVOUSNESS (Nervous as hell) and FEELING ABNORMAL (Felt like someone hit them with a gun in the right temple with Novocain). On 14-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (They thought they were having a stroke) (seriousness criterion hospitalization), PARAESTHESIA (Facial paresthesia) (seriousness criterion hospitalization), HYPOAESTHESIA (The right side of their face felt numb, like with paralysis) (seriousness criterion hospitalization), SWELLING FACE (Their face was swollen) (seriousness criterion hospitalization) and PARAESTHESIA (Right upper extremity paresthesia) (seriousness criterion hospitalization). The patient was hospitalized from 14-Apr-2021 to 19-Apr-2021 due to CEREBROVASCULAR ACCIDENT, HYPOAESTHESIA, PARAESTHESIA, PARAESTHESIA and SWELLING FACE. On 11-Apr-2021, VISION BLURRED (Blurry vision), DIZZINESS (Dizzy), NERVOUSNESS (Nervous as hell) and FEELING ABNORMAL (Felt like someone hit them with a gun in the right temple with Novocain) had resolved. At the time of the report, CEREBROVASCULAR ACCIDENT (They thought they were having a stroke), PARAESTHESIA (Facial paresthesia), HYPOAESTHESIA (The right side of their face felt numb, like with paralysis), SWELLING FACE (Their face was swollen) and PARAESTHESIA (Right upper extremity paresthesia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood pressure measurement: normal (normal) Normal. In April 2021, Blood test: normal (normal) Normal. In April 2021, Echocardiogram: normal (normal) Normal. In April 2021, Lumbar puncture: negative (Negative) Negative for Lyme disease. In April 2021, Magnetic resonance imaging brain: normal (normal) Normal (2x). In April 2021, Ultrasound Doppler: normal (normal) Normal. In April 2021, X-ray: normal (normal) Normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Concomitant product use was unknown. Treatment information was not provided.; 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. Further information is requested.

Went into the er because I was shaking like I was having a seizure and I was delirious. During the testing they found a blood clot in my lung. I am being treated with anti biotics and blood thinners

Hospitalized: 3/13-3/22/21. Pericardial effusion, pleural effusion. Have had 3 thoracentesis as outpatient since release from hospital: 4/8/21 (removed 800ccs fluid), 4/19/21 (removed 1400ccs fluid), 4/26/21 (removed 1500ccs fluid). Scheduled 4th thoracentesis for 5/3/21 - have appt with thoracic surgeon on 5/13/21.

About 9 am, April 14, after breakfast, some fatigue and dizziness, a feeling of nausea, then tingling in face, then numbness, followed by numbness in left arm, and finally numbness in leg. Whole episode was probably about an hour. Numbness on left side lasted maybe 20 minutes, possibly more. (The day before-April 13 -- I had tingling in the face and arm but it resolved almost immediately, also after breakfast.) Numbness of left arm returned for about 10 minutes that night while in hospital, but resolved except for remaining tingling in left hand.

Patient received first Covid Moderna vaccination on 4/5/21 and on Thursday 4/8/21 was admitted to the hospital with a pulmonary embolism. She was released and put on Eliquis. The patient has been unable to reach via phone.

3 days after 2nd vaccine shot I started experiencing sporadic chest pain and a feeling of being light headed. The next day I still had the same symptoms so I described them to my doctor. She recommended going to a urgent care facility. I was diagnosed with 2 small blood clots - one in each lung. I'm on anti-coagulants for the next 6 months.

This 60 year old female received the Covid shot on 2/26/21 and went to the ED on 3/3/21 and was admitted on 3/3/21 with the following diagnoses listed below. R65.10 - SIRS (systemic inflammatory response syndrome) (CMS/HCC)

Sudden episode of afib with rvr needing to go to the ER. Passing out, confusion, shortness of breath. Resolved on own approximately 2 hrs followed by extreme fatigue and headache for 2 days. Still experiencing moderate to heavy fatigue and heavy sleepiness throughout the day.

Anaphylaxis 2 minutes after administration; gagging and heaving; throat swelling until she couldn't breathe; 0.3 mg EPIPEN administered into left thigh; EPIPEN relieved acute throat swelling so that patient was able to breathe; blood pressure 182/127 and pounding headache; transported to hospital by EMS.

Cough, went to the Dr. for breathing trouble. I have not been able to walk with out sitting down to get so I can breath, I was told that I now have fluid with my heart. My feet have been swealing up so bad, I feel sick all the time now.. If I knew this would happen i would not have gotten the vaccines.

Only nine days after my second Moderna shot, I broke my ankle. I then had to wear an immobilizing boot for 5-6 weeks. Despite taking one baby aspirin a day during the immobilization period, I developed a blood clot in my paroneal calf vein 5 weeks into the immobilization. I am wondering if the proximity of my immobilization to my Moderna vaccination put me at an increased risk of developing a blood clot.

Admission to hospital with pericardial effusion and pleural effusions on 4/10/2021. Also with chest pain. The patient was having some subacute systemic symptoms of fatigue, chest pain, dyspnea that predated the vaccine by more than a month.

She got her vaccine, she wasn't feeling good right there and didn't know what it was going to progress to. She then at 2:00 AM the next morning she rolled out of the bed and fell to the floor and got stuck between the bed and was not able to stand up, and crawled down 14 stairs and then couldn't move. She could not tell him why she couldn't and she was not able to stand up (large women). Her husband did not see any signs of stroke. They called his son and noticed that her face was sagging and he said that it looked like a stroke. They called the paramedics and they sent her to hospital and she was flown to Clinic and diagnosed with a stroke. She had surgery and they tried to remove the blood clot and her blood pressure went high and they cut a huge part of her skull to remove the pressure, but not able to remove the clot that he is aware of. She is in rehab right now, and it's not really showing any signs of promise. She has a lot of stroke symptoms of being combative and she has a blood clot that has moved to her arm as well. She had 6 blood clots on her brain when they went into it, and now has blood clots in each arm. She is aware of her surroundings to some degree and thinks that she is somewhere else and feels like she has wet herself. Her husband said that the rehab does not look promising. She is still in the hospital and they are having a meeting tomorrow regarding how long they feel she may be there. She has very little headway in rehab. She cannot move her left side, hand or leg. She is able to move her right side though. Husband feels it has destroyed her life and it will be a miracle if she comes out of it.

After the first dose of the vaccine I was very tired. After the second dose I was extremely tired. I started to have trouble breathing at night and I developed a cough one week after the second dose. After two weeks I went to an Urgent Care and they did not find anything on X-Ray. Two weeks later I was not improving so I went back because my breathing was worse. X-Ray showed Pneumonia in both lower lungs. I recovered a little over two weeks after antibiotics. I had Covid-19 in July of 2020 and I had not felt well since then. I was only working two days a week up until the time of the first dose of the vaccine. I was originally given a Benzoate capsules but those did not help. My breathing seems to better than it was for the time period since I got the Covid-19 last year. I still have a dry cough and I get short of breath on occasion. I use Flonase currently and I am able to work more now.

I developed pericardial effusion on Feb. 23 and had 750 ml of fluid removed from my heart. On April 27 another pericardial effusion developed and I had to have surgery to have a pericardial window created.

nauseous, vomited, faint, then ambulance went unconscious within 15 minutes of vaccine. Then one week later inverted T waves and hospitalized, recovered then about a week or two later Transient ischemic attack unable to speak recovered. then have been having abdominal pain/pelvic pain.

Shortness of breath began the first week of April. Thought I had caught Covid. Shortness of breath became increasingly worse throughout the month of April. Could not breathe at night. Went to emergency room May 5. Diagnosed heart failure 30% function. No known medical issues before vaccination. Currently wearing defibrillator. Kidney function stage three. Had a very active busy lifestyle, upstairs apartment Before vaccination. Now fighting for my life.

Went unresponsive at home after experiencing diarrhea. Pulses were lost at home and regained by EMS prior to transport to the emergency room. Pulses lost again in the emergency room. ACLS performed for approximately 40 minutes before pronouncement of death was made.

4/14/21 12 hours post shot extreme dyspnea lasting 7 weeks now. Dizzy light headed.Emergency room visit 4/17/21 blood work indicated increase troponin and potential blood clot in lung. Heart attack 4- 27-21. Second ER visit 5/8/21 which showed additional increase in troponin levels. Second heart attack on 5/22/21. Intense back pain between shoulder blades over shoulders and on chest. Additional squeezing in chest and neck pain.

When she goes to the bathroom blood gushes out in clot/the blood just start gushing out; been bleeding since i got the shot/bleeding; felt like peeing and blood start pouring out/feeling like they are having a period for 3 days then stop then come back; got pain, had to sit down, like someone pulling your insides out pain was excruciating/pain/there is so much pain/pain everyday/pain like period or having a baby; egg like secretion down there; waking up soaking wet down there; pain in the belly; Leg gave out/feels like someone is pulling her bones apart down below/left leg felt like coming apart; anemic; bleeding every week for 2 to 7 days followed by white stuff and back to bleeding; Other staff is coming from my body/ feeling something travelling through my body; Blow up in leg; pain different from sciatica; afraid for my life; don't feel like I am going to live/feeling terrible; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE URINARY TRACT (When she goes to the bathroom blood gushes out in clot/the blood just start gushing out) in a 60-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. Concomitant products included GABAPENTIN for Sciatica. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced ANXIETY (afraid for my life) and FEELING OF DESPAIR (don't feel like I am going to live/feeling terrible). On an unknown date, the patient experienced HAEMORRHAGE URINARY TRACT (When she goes to the bathroom blood gushes out in clot/the blood just start gushing out) (seriousness criterion medically significant), HAEMORRHAGE (been bleeding since i got the shot/bleeding), GENITAL HAEMORRHAGE (felt like peeing and blood start pouring out/feeling like they are having a period for 3 days then stop then come back), PAIN (got pain, had to sit down, like someone pulling your insides out pain was excruciating/pain/there is so much pain/pain everyday/pain like period or having a baby), GENITAL DISCHARGE (egg like secretion down there), HYPERHIDROSIS (waking up soaking wet down there), ABDOMINAL PAIN (pain in the belly), LIMB DISCOMFORT (Leg gave out/feels like someone is pulling her bones apart down below/left leg felt like coming apart), ANAEMIA (anemic), VAGINAL DISCHARGE (bleeding every week for 2 to 7 days followed by white stuff and back to bleeding), FEELING ABNORMAL (Other staff is coming from my body/ feeling something travelling through my body), PERIPHERAL SWELLING (Blow up in leg) and PAIN (pain different from sciatica). The patient was treated with GABAPENTIN at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, HAEMORRHAGE URINARY TRACT (When she goes to the bathroom blood gushes out in clot/the blood just start gushing out), HAEMORRHAGE (been bleeding since i got the shot/bleeding), GENITAL HAEMORRHAGE (felt like peeing and blood start pouring out/feeling like they are having a period for 3 days then stop then come back), PAIN (got pain, had to sit down, like someone pulling your insides out pain was excruciating/pain/there is so much pain/pain everyday/pain like period or having a baby), GENITAL DISCHARGE (egg like secretion down there), HYPERHIDROSIS (waking up soaking wet down there), ANXIETY (afraid for my life), FEELING OF DESPAIR (don't feel like I am going to live/feeling terrible), ABDOMINAL PAIN (pain in the belly), LIMB DISCOMFORT (Leg gave out/feels like someone is pulling her bones apart down below/left leg felt like coming apart), ANAEMIA (anemic), VAGINAL DISCHARGE (bleeding every week for 2 to 7 days followed by white stuff and back to bleeding), FEELING ABNORMAL (Other staff is coming from my body/ feeling something travelling through my body), PERIPHERAL SWELLING (Blow up in leg) and PAIN (pain different from sciatica) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Smear cervix: normal (normal) normal. Patient sought out help from Primary care, was referred to a OBGYN, got a pap smear normal and said that the HCPs did not provide information on what may be causing the symptoms. She received Gabapentin and Tylenol as treatment without symptoms' relief. Reporter provide additional phone number Company Comment: 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. 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. This case was linked to MOD-2021-163813 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: updated reporter information and new events.; 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.

Acute bilateral pulmonary emboli - onset of shortness of breath 1 day prior to diagnosis on 6/14/2021

Immediately after the shot I felt fatigued for weeks and on Friday went into AFib and have been in the hospital since with rapid irregular heart beat, extreme chest pain and fatigue. My heart rate will drop to 88/67 then jump to 157/100 it feels like my heart wanted to come out my chest. I was put on a blood thinner and I?m currently in the hospital being monitored waiting for more testing to be done .

Patient presented to the ED and was subsequently hospitalized for Severe sepsis with septic shock within 6 weeks of receiving COVID vaccination.

I received my first covid vaccine 03/18/2021 Lot #047A21A. After that vaccine I had headaches and a flushed face and was very tired. I an not a headache person so this is new to me. This continues. I received my second covid vaccine 04/19/2021. Since that vaccine, I have had continued headaches, am tired and have had brain fog. Trouble concentrating and focusing. I even had to see a neurologist. These symptoms continue as well. I was just diagnosed with a DVT 06/23/2021. This all is new to me and I believe are all related to my covid vaccines.

Sweaty; tongue feel raw and sore; feels feverish; Anaphylactic reaction; Heart rate more than 100 beats per min; Blood pressure which was 188/143.; Systolic blood pressure <90 mmHg; throat started to swell; Abdominal cramping; Feeling hot; her face became red and than blue; Started to gag/gagging sensation; Flushing; nausea; tongue felt huge; couldn't breathe; Mouth pain; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for an unreported indication: DIPHTHERIA TETANUS PERTUSSIS VACCINE on 29-Jan-2021. Concurrent medical conditions included Sulfonamide allergy (FACE SWELLING HALF OF TONGUE SWELLED WHEEZING HARD TIME BREATHING) since 2016 and Blood pressure high on 30-Jun-2020. Concomitant products included LISINOPRIL from 30-Jun-2021 to an unknown date for Blood pressure, ATORVASTATIN from 01-Feb-2021 to an unknown date for Cholesterol, GABAPENTIN from 04-Feb-2021 to an unknown date for Nerve pain, DULOXETINE, MELOXICAM and VITAMIN D NOS for an unknown indication. On 22-Apr-2021 at 2:22 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021 at 5:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced HEART RATE INCREASED (Heart rate more than 100 beats per min), BLOOD PRESSURE INCREASED (Blood pressure which was 188/143.), BLOOD PRESSURE SYSTOLIC DECREASED (Systolic blood pressure <90 mmHg), PHARYNGEAL SWELLING (throat started to swell), ABDOMINAL PAIN (Abdominal cramping), FEELING HOT (Feeling hot), ERYTHEMA (her face became red and than blue), RETCHING (Started to gag/gagging sensation), FLUSHING (Flushing), TONGUE DISORDER (tongue felt huge), DYSPNOEA (couldn't breathe), ORAL PAIN (Mouth pain), VOMITING (vomiting) and NAUSEA (nausea). On 20-May-2021 at 5:00 PM, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant). On 21-May-2021, the patient experienced HYPERHIDROSIS (Sweaty), GLOSSODYNIA (tongue feel raw and sore) and PYREXIA (feels feverish). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; EPINEPHRINE (EPIPEN) at an unspecified dose and frequency; ALUMINIUM HYDROXIDE, DIMETICONE, MAGNESIUM HYDROXIDE (ANTACID [ALUMINIUM HYDROXIDE;DIMETICONE;MAGNESIUM HYDROXIDE]) at an unspecified dose and frequency and DULOXETINE HYDROCHLORIDE (CYMBALTA) ongoing from 29-Jan-2021 for Pain, at a dose of 60 mg twice a day. On 20-May-2021, BLOOD PRESSURE SYSTOLIC DECREASED (Systolic blood pressure <90 mmHg) had resolved. On 20-May-2021 at 8:00 PM, ANAPHYLACTIC REACTION (Anaphylactic reaction) had resolved. On 21-May-2021, GLOSSODYNIA (tongue feel raw and sore) and ORAL PAIN (Mouth pain) had resolved with sequelae. At the time of the report, HEART RATE INCREASED (Heart rate more than 100 beats per min), BLOOD PRESSURE INCREASED (Blood pressure which was 188/143.), PHARYNGEAL SWELLING (throat started to swell), ABDOMINAL PAIN (Abdominal cramping), FEELING HOT (Feeling hot), FLUSHING (Flushing), DYSPNOEA (couldn't breathe), VOMITING (vomiting) and NAUSEA (nausea) had resolved and ERYTHEMA (her face became red and than blue), RETCHING (Started to gag/gagging sensation), TONGUE DISORDER (tongue felt huge), HYPERHIDROSIS (Sweaty) and PYREXIA (feels feverish) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2021, Blood pressure measurement: 188/143 (High) high. On 20-May-2021, Blood pressure systolic: less than 90 mmhg (abnormal) abnormal. On 20-May-2021, Heart rate: 100 breaths per minute (High) high. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANAPHYLACTIC REACTION (Anaphylactic reaction) to be possibly related. No further causality assessments were provided for HEART RATE INCREASED (Heart rate more than 100 beats per min), BLOOD PRESSURE INCREASED (Blood pressure which was 188/143.), BLOOD PRESSURE SYSTOLIC DECREASED (Systolic blood pressure <90 mmHg), PHARYNGEAL SWELLING (throat started to swell), ABDOMINAL PAIN (Abdominal cramping), FEELING HOT (Feeling hot), ERYTHEMA (her face became red and than blue), RETCHING (Started to gag/gagging sensation), FLUSHING (Flushing), TONGUE DISORDER (tongue felt huge), HYPERHIDROSIS (Sweaty), GLOSSODYNIA (tongue feel raw and sore), DYSPNOEA (couldn't breathe), ORAL PAIN (Mouth pain), VOMITING (vomiting), PYREXIA (feels feverish) and NAUSEA (nausea). It was reported that patient called in after receiving her 2nd dose of the Moderna covid vaccine on 20-May-2021. After receiving her vaccine approximately within 2 minutes, she started to gag, throat started to swell, and she was told by the staff members that her face became red and than blue. The pharmacist immediately administered an epi-pen and she slowly was able to stop gagging. The pharmacy dialed 9-1-1 and the EMS came. They took her blood pressure which was 188/143. They took her to the hospital and about 10 minutes in the ambulance she experienced the gagging sensation and her tongue felt huge. They administered the epi-pen again along with Benadryl and an antacid. She was monitored at the hospital for four hours and discharged. While at the hospital she had the gagging experience again and tongue felt huge. They administered the epi-pen again and she remained on IV which she believes contained Benadryl and an antacid. She is contacting the hospital to find out exactly what she was prescribed there. Today, 21may2021 she has to clear her throat a lot, feels feverish, sweaty, tongue feel raw and sore. She is highly allergic to sulfa. She wanted to know if these symptoms have been reported before and if the medications, she was administered at the hospital are going to effect the vaccine efficiency. She was wondering if Moderna could provide any compensation for her medical costs. 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. Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow up information received on 24-Jun-2021 and included New reporter details were added, Suspect vaccine dosing details were updated, Patient demographics (race) was updated, new medical history was added, concomitant drugs indications, dosing and start dates were added, new concomitant drug Cymbalta was added, New historical vaccine was added, New serious event anaphylactic event was added, New non serious events were added, New lab tests were added. Suspect vaccine Batch number was added.; 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.

Patient received Moderna COVID vaccine on 3/27/21 and 4/24/21. Patient states that she had a large gathering of family and friends on 7/4/21. Since then some people at the gathering had developed mild fevers and cough. Most however doing fine and have no acute symptoms. Patient however states that beginning 7/10/21, she began to have horrible asthma exacerbation, patient on prednisone 10 mg daily at this time but states she took 40 mg of prednisone secondary to concern for asthma exacerbation. On 7/11/21, patient again took 40 mg of prednisone, multiple rounds of her beta agonist without symptom relief. Patient noted that her home oxygen saturations on home pulse oximeter 85%. Patient is brought to ED for evaluation and eventually admitted. On 7/12/21, patient had respiratory decompensation failing HFNC and BiPAP, O2 desaturation in the 60's, and was extremely short of breath. FiO2 was increased to 100% without recovery. Patient was intubated and transferred to CCU on 7/12/21. This event is being reported due to COVID cases resulting in hospitalization even though patient was fully vaccinated.

Daughter stated that patient passed on 07/06, a few weeks after getting her 1st vaccine. Daughter stated that she noticed that her mother had stomach pains the day before and the day of passing. Daughter stated tat Mother had EKG test and heart inflammation was found. Patient passed due to heart inflammation.

Patient received first Moderna vaccine on April 28th. Did not complain of any adverse effects. Patient received second Moderna vaccine on May 26th at approximately 11am. Spoke to son at 11pm that night and reported that she felt fine, her arm felt fine, the only complaint was "mouth feels funky" and she felt dehydrated. Was in typical spirits. She passed on May 27th. Time of death cannot be confirmed as an autopsy was not completed but the assumption is between 6-9am. This would have been less than 24 hours after she received the second vaccine.

3 days after second vaccine. Surface veins right leg midthigh to midcalf enlarged. Doppler US showed multiple clots.

Patient was brought to the ED after receiving the Moderna vaccine for difficulty breathing. Per RN progress note: "Pt arrived via wheelchair from auditorium, pt had received her first COVID vaccine left deltoid, approx. 10 minutes later pt appeared to have an anaphylactic reaction, pt arrives wheezing and tachypneic, labored breathing with accessory muscle use." The patient was placed on supp oxygen and received epinephrine 0.5mg IM x1, Benadryl 50mg IV x1, hydrocortisone 200mg IV x1, lorazepam 1mg IV x1. Pt discharged after 6 hour observation with Rx's for EpiPen, prednison, Benadryl, and famotidine.

Around 00:50am on 01/15/21, C.N.A. reported that the resident looked different and not responding. Initiated Code Blue and started CPR. 911 arrived and pronounced resident dead at 1:01 am.

Covid positive 1/29/21. 2/1/21, hypoxia, tachycardia. Admitted to hospital 2/1/21. Diagnoses: UTI, Covid-19 infection, hypoxia, sepsis.

Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Additional Details: 5 minutes after taking the vaccine pt stated that she felt dizzy and lighheaded. After about 10minutes later she started grabbing her throat indicating she cannot breath. we gave her 2 epipens 5 minutes after the 1st dose and called the ambulance

Received notification from county director that patient is currently hospitalized beginning two days after Moderna vaccination, spoke to patient today 2/26/2021. Patient received vaccine Monday morning 2/22/2021 around 9:07am, by 9pm Monday evening patient reports weakness, fatigue, sore arm, fever, chills, and no appetite. Patient states symptoms persisted all day Tuesday 2/23/2021. On Wednesday 2/24/2021 at 11:30am patient was eating a peanut butter sandwich and felt something inside mouth. Upon looking in mouth patient noticed "black sores." Patient then called husband and was taken to ER and was then transferred to Hospital. Patient states she has been diagnosed with ITP idiopathic thrombocytopenic purpura.

Acute anaphylactic reaction. Presented with dyspnea, wheeze and chest tightness. Received IM epi 0.4mg x 2 - 20 minutes apart, IV Benadryl (50mg) and solumedrol IV 125, continuous albuterol med x 1 hr.

Patient had first COVID -MODERNA immunization on 1/6/2021 (chills and fever for one day) and 2/23/2021. Patient began feeling weak, nauseated and dizzy. She was evaluated at the ER on 2/22/2021. She was given fluids and sent home. She continued to feel weak, dizzy and nauseated. She experienced elevated heart rate. She went back to the ER on 2/23/2021. She was diagnosed with atrial fibrillation.

Chills fever diarrhea in the evening, short of breath next day with exertions, continued decreased activity tolerance until unable to go up one flight of stairs without fatigue and SOB, after 1 week slight foot swelling, 2 weeks, swelling of left foot and leg (pitting). Increased weight gain on 5 pounds, abdominal bloating. Had cardiac blood test come back abnormal showing heart failure, DVT ruled out, echo showed LA enlargement mitral tricuspid prolapse, increase RA pressure. While scheduling abdominal scan swelling went away. Repeated bloodwork and it came back normal. Stress test 3 weeks later normal. Plan to repeat echo in 6 months

Experienced anaphylactic shock 4.5 mins after given 30 min timer. Developed severe red splotchy rash around neck. Arm remained super sore for a week, then developed a huge red whelp the size of my hand with constant itching & burning (resembled a reaction to a hornet sting & I am NOT allergic). The whelp disappeared but itching & burning finally went away into 3rd week. Developed severe depression 2 days afterwards that lasted approximately 5 days.

Weakness Confusion Falling down Vision impairment Legs really weak All of the above symptoms started on March 14, 2021 On March 18,2021 she was not out of bed except for just a few minutes. On March 19, 2021 she was on the floor laying beside of the bed and my father noticed blood looking stuff on her shirt and bed covers. She was really confused and lethargic. She was really weak and could not stand. She was extremely fatigued. At around 10:30 she fell again on the floor and my father and sister in law was able to get her back up and put her in a chair and she went to sleep. At 12:55 my father noticed she was not breathing and called 911. When they did CPR blood was coming from her mouth and nose. When the ambulance arrived they immediately took her to the hospital where she was pronounced dead at around 3:30 pm.

Severe acute immune thrombocytopenia, now refractory to steroids and IVIG developed 10 days after second dose of vaccine. Patient developed spontaneous wet purpura, petechiae and vaginal bleeding on 3/19/2021. CBC showed undetectable platelet count. Normal hemoglobin and platelets. Did not respond to dexamethasone 40md daily x 4 or multiple IVIG doses. Started romiplostim on 3/25/21 and is currently on dose escalations with platelets persisting undetectable. On 3/28 developed acute anemia with a 2 to 3 g/dL hemoglobin drop and was found to have a spontaneous hemoperitoneum . Treated with tranexamic acid, multiple platelet transfusions and an additional dose of romiplostim. Bleeding has since resolved but platelets remain undetectable.

This is a 61 year old female, with history of hypertension, who presents to the ED via EMS for evaluation of cardiac arrest prior to arrival. Patient's husband came from anouther [sic] room and found patient take a big gasp then suddenly became unresponsive. EMS gave patient a total of 4 rounds of Epi, 1 Narcan, and 2 shocks en route. EMS reports with glucose level of 92. Unknown if patient is on any anticoagulation. Patient presents in asystole. Epi and bicarb given. Compressions performed. Lungs equal with bagging. Bedside US performed which did not reveal any meaningful cardiac activity. Code called. Discussed with family, they state she had been having some cardiac issues and her daughter died of cardiac problems in her 30s.

On the day after the vaccine, 4/8/21 I woke up and felt heaviness in both legs as I walked around my home.That lasted for 2 days. on Saturday 4/10/21 those symptoms diminished slightly and I felt sleepy all day long. On Sunday 4/11/21 I woke up with numbness and heaviness on the entire left half of my body and was unable to walk properly. That evening I went to the Emergency Department. After review of CT and MR, I was diagnosed with having a stroke. I remained there for about 18 hours . My symptions decreased to tingling , so Iwas discharged, no treatment received. As of today, my sympttions are reduced almost amost 50% and i am able to walk with a walker..

Anaphylaxis; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included TOCILIZUMAB (ACTEMRA) for an unknown indication. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medication provided Very limited information regarding this event/s has been provided at this time. Further information has been requested. Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

Pneumonia; Fainting; Vomiting; Fever; Muscle aches and pains; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) and SYNCOPE (Fainting) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) 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). On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant), VOMITING (Vomiting), PYREXIA (Fever) and MYALGIA (Muscle aches and pains). On 23-Mar-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). On 18-Mar-2021, PYREXIA (Fever) had resolved. At the time of the report, PNEUMONIA (Pneumonia) had not resolved and SYNCOPE (Fainting), VOMITING (Vomiting) and MYALGIA (Muscle aches and pains) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Chest X-ray: revealed pneumonia (Inconclusive) Revealed pneumonia. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

On April 10, 2021, patient reported losing vision in right eye. Saw primary physician on 4/14/2021 and had ultrasound of the neck done on 4/14/2021. Patient reported per phone on 4/15/2021 that she was told that she had a stroke in her right eye. Was placed on ASA 325mg and Clotidogrel 75mg.

on Saturday, March 27th, patient noticed swelling in left lower leg with Shortness of breath, and heart racing. on 3/39, the patient presented to the ED and was admitted and diagnosed with a blood clot from left groin to left ankle, with "clot in heart and lungs". heparinized and discharged home on Coumadin currently taking 5 mg on Sunday, Monday, Wednesday, and Saturday and 2.5 mg on Tuesday and Friday each week.

within 15 min of injection, my throat got itchy and tight. difficult to swallow. I got dizzy and my face and chest felt like sunburn. The EMT on duty took my vitals with extremely high BP. he had another EMT confirm. They transferred me via ambulance to hospital ER for anaphalaxis. I was given benedryl on the way in iv. At the hospital, dr gave steroid and epinepherine in iv port. this helped me swallow and my vitals stabilized and i was released hours later with scrips for prednisone, pepsid and benedryl. Follow up with my primary care dr.

Anaphylactic reaction; Vertigo; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 61-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. The patient's past medical history included Vertigo. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant). an unknown date, the patient experienced VERTIGO (Vertigo). At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction) and VERTIGO (Vertigo) outcome was unknown. Patient had an anaphylactic reaction within 10 minutes of administration and was administered an Epi Pen and Benadryl. Patient went to the ER and was discharged the same day. Since then, the patient has been experiencing vertigo intermittently.no history for the treatment of Vertigo was provided Concomitant medications were not reported. Action taken with mRNA-1273 in response to the events was not Applicable. 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. However, the previous history of Vertigo is a confounder. This case was linked to MOD-2021-076365 (E2B Linked Report).; 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. However, the previous history of Vertigo is a confounder. MOD-2021-076365:1st dose of vaccine

Resident was found kneeling over walker with face down in the bathtub right before 1700. Code called and initiated. Resident pronounced dead at 1721 by EMS.

Pain started on the upper thigh in left leg, caused staying in bed for three days. Tried to stretch out the legs, but had pain every time. ON 4/11/21 had difficulty breathing, so called 911 and was taken to the ER. Diagnosed with pulmonary embolism/

received the vac on 4/6, starting aprox 8th -9th I start to not feel good... just thought is was a mild reaction to the shot... by the 12th I felt terrible, very short of breath and unable to walk with out thinking I was going to die...... waiting as long as I could then I went to urgent care on the 14th and was told I probably have asthma and was given a few medications... on the 18th things were not any better and I no longer could take the pain and not being able to breathe... so I went to the hospital and was admitted to the PPC floor of the hospital after being in the ER. the next morning I had to have a procedure to break up BLOOD CLOTS in my lungs... I spent 4 days in the PPC ward and now home trying to recover from this... I was told my condition was very serious and was lucky I came in... Of course the doctors will not say this was a direct link to the shot ... i never had any problems before and never any blood clots. The doctor who did the procedure told me to make sure I REPORTED IT.... I was released from the hospital on the afternoon of the 21st.. 4 days!

Stroke; More than 36 days have passed since first dose, still didn't get second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension and Cholesterol. Concomitant products included AMLODIPINE, ENALAPRIL and METOPROLOL TARTRATE for Blood pressure abnormal, ATORVASTATIN and EZETIMIBE for Cholesterol total abnormal NOS, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication. On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion hospitalization). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days have passed since first dose, still didn't get second dose). The patient was hospitalized from 29-Mar-2021 to 15-Apr-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days have passed since first dose, still didn't get second dose) had resolved. 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: 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. However, the patient's past medical history of Hypertension, cholesterol. may remain risk factor for this event.; 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. However, the patient's past medical history of Hypertension, cholesterol. may remain risk factor for this event.

Bilateral pulmonary embolism; DVT; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Bilateral pulmonary embolism) and DEEP VEIN THROMBOSIS (DVT) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included COVID-19. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (Bilateral pulmonary embolism) (seriousness criteria hospitalization and medically significant) and DEEP VEIN THROMBOSIS (DVT) (seriousness criterion hospitalization). At the time of the report, PULMONARY EMBOLISM (Bilateral pulmonary embolism) and DEEP VEIN THROMBOSIS (DVT) outcome was unknown. The HCP got the vaccine several weeks after quarantine after that. After her second dose, she had a clotting issue which she had never had before. She experienced bilateral pulmonary embolism and DVT and was in the ICU twice. Action taken with the mRNA 1273 in response to the events was not applicable as the patient completed both the doses. Reporter did not provide the causality. Treatment information was not provided. Company comment: 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.

Deep vein thrombosis; Pulmonary embolism; Shortness of breath; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (Deep vein thrombosis) and PULMONARY EMBOLISM (Pulmonary embolism) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 012220A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 on 03-Jan-2021. Concomitant products included PARACETAMOL (TYLENOL), MAGNESIUM and VITAMIN B3 for an unknown indication. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced DEEP VEIN THROMBOSIS (Deep vein thrombosis) (seriousness criterion hospitalization) and PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced DYSPNOEA (Shortness of breath). The patient was hospitalized for 2 days due to DEEP VEIN THROMBOSIS and PULMONARY EMBOLISM. At the time of the report, DEEP VEIN THROMBOSIS (Deep vein thrombosis) and PULMONARY EMBOLISM (Pulmonary embolism) outcome was unknown and DYSPNOEA (Shortness of breath) had not resolved. Not Provided The patient received Xarelto and IV blood thinner at hospital. Company comment: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. This case was linked to MOD-2021-083811 (Patient Link).; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded

Longstanding chronic ITP with platelet counts 40-50,000 since 2016. Platelet count was found to be 11,000 on 3/9/21 when it happened to be checked 6 days after her immunization. Previous value 39,000 12/3/20 which was her stable number. Plts rechecked over next 3 days and stayed 11,000. Given 2 doses of IVIG (500 mg/kg) and plts rose to 227,000 over the next week then fell to her 68,000 on 3/30/21 prior to her 2nd dose of Moderna. Fell to 38,000 the following day then rose to 49,000 the following week. Remained asymptomatic the entire time.

could not breath; in induced coma; went into cardiac arrest; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COMA (in induced coma), CARDIAC ARREST (went into cardiac arrest) and DYSPNOEA (could not breath) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043021A and 037A21B) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 18-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced COMA (in induced coma) (seriousness criterion hospitalization) and CARDIAC ARREST (went into cardiac arrest) (seriousness criterion hospitalization). On 19-Apr-2021 at 1:00 AM, the patient experienced DYSPNOEA (could not breath) (seriousness criterion hospitalization). The patient was hospitalized on 19-Apr-2020 due to COMA, then on 19-Apr-2021 due to CARDIAC ARREST and DYSPNOEA. The patient was treated with Manual therapy (CPR) for Cardiac arrest and Manual therapy (CPR) for Dyspnoea. At the time of the report, COMA (in induced coma), CARDIAC ARREST (went into cardiac arrest) and DYSPNOEA (could not breath) outcome was unknown. No concomitant medications were reported. Company comment: 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.

"Moderna COVID-19 Vaccine EUA" -- received 1st dose 3/27/2021 Received 1st Moderna vaccine in R arm on 3/27/21. Within first hour, she had a headache, R eye pain, and felt tired; symptoms subsided after she laid down. On 3/31 in early AM, felt sudden and more severe headache and same eye pain, and "electrical contractions down neck, back, and spine." Went to medical facility, then transferred to hospital, and transferred to another hospital via helicopter. 61-year-old female, generally very healthy, on no medications, here complaining of sudden onset right sided stabbing/electrical headache which began 30 minutes prior to arrival. She states she was standing at work when had sudden onset severe headache radiating into her right eye. Stating that it feels like my right eyeball is going to explode. She ranks the pain a 9 out of 10. She does have a history of migraine headaches which have never been evaluated with imaging or by neurology. They were normally frontal, and she has not had one in more than 2 years. She states that this headache is dramatically different than her prior migraines. Patient states associated with this sudden onset headache, she had bilateral neck pain, and substernal chest pain. Upon arrival to clinic, she points to her substernal region as the site of her chest pain. She denies associated shortness of breath, irregular heart rate/rhythm, presyncope. She does feel slightly weak. Of note, patient states she had a MODERNA COVID-19 vaccine on Saturday and subsequently had some right-sided shoulder pain. Her symptoms are on the same side. - 7:50 AM: BP 165/109 (R arm); pulse 86; no antihypertensives given, given a total of 100 mcg fentanyl over 1 hr - 9:04 AM: BP 150/92 (R arm); pulse 60; transferred to hospital and then to transfered to another hospital via helicopter for SAH 3/31/2021 ED - given nicardipine IV, dexamethasone IV, levetiracetam, and antiemetics. Nero noted that no associated trauma, LOC, or seizure with the HA, Neuro assessment - day 4 (plus possible re-rupture within last 24 hours) of good clinical grade HH2 low volume aSAH due to ruptured R ICA ANR 4/1/2021 - completed successful and uncomplicated RICA oblong aneurysm coiling (successful coil elimination & preservation adjacent PcommA infundibulum). Patient was admitted to critical care for post procedure care, monitoring, and management of sodium, blood pressure, and headache. Levetiracetam discontinued since patient did not have any seizures. 4/7/2021 - discharged

mouth burning; face burning; hot and cold issues with nerves; she gets burning hot and heat waves come up; chills; metallic taste in mouth; difficulty in breathing\ntermittent difficulty in breathing; hives rash around throat and face; chest wall tingling/throat tingling/Tingling in her arms, legs, mouth, face; throat burning; throat closing; chest wall burning; chest wall closing; light-headed; anaphylactic reaction; This spontaneous case was reported by a health care professional and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic reaction) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy. Concomitant products included TAFLUPROST (ZIOPTAN) for Glaucoma, LIOTHYRONINE SODIUM and LEVOTHYROXINE for Thyroid disorder. On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced ANAPHYLACTIC REACTION (anaphylactic reaction) (seriousness criterion medically significant), DYSPNOEA (difficulty in breathing\ntermittent difficulty in breathing), URTICARIA (hives rash around throat and face), PARAESTHESIA (chest wall tingling/throat tingling/Tingling in her arms, legs, mouth, face), THROAT IRRITATION (throat burning), THROAT TIGHTNESS (throat closing), CHEST PAIN (chest wall burning), CHEST DISCOMFORT (chest wall closing) and DIZZINESS (light-headed). On 05-Apr-2021, the patient experienced DYSGEUSIA (metallic taste in mouth). On an unknown date, the patient experienced ORAL DISCOMFORT (mouth burning), BURNING SENSATION (face burning), DYSAESTHESIA (hot and cold issues with nerves), FEELING HOT (she gets burning hot and heat waves come up) and CHILLS (chills). On 05-Feb-2021, ANAPHYLACTIC REACTION (anaphylactic reaction) had resolved. At the time of the report, DYSGEUSIA (metallic taste in mouth), DYSPNOEA (difficulty in breathing\ntermittent difficulty in breathing), URTICARIA (hives rash around throat and face), PARAESTHESIA (chest wall tingling/throat tingling/Tingling in her arms, legs, mouth, face), THROAT IRRITATION (throat burning), THROAT TIGHTNESS (throat closing), CHEST PAIN (chest wall burning), CHEST DISCOMFORT (chest wall closing), DIZZINESS (light-headed), ORAL DISCOMFORT (mouth burning), BURNING SENSATION (face burning), DYSAESTHESIA (hot and cold issues with nerves), FEELING HOT (she gets burning hot and heat waves come up) and CHILLS (chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, COVID-19: positive (Positive) Positive. On 31-Jan-2021, COVID-19: negative (Negative) Negative. On 02-Feb-2021, COVID-19: negative (Negative) Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. She was not admitted to the hospital. She stated she had to go back to the emergency room a few times since then for symptoms of burning and tingling in her arms, legs, mouth, face, as well as hot and cold issues with her nerves, and tightening of her throat and chest. She immediately treated with Bedadryl (unknown dosage), Pepcid40mg, Prednisone 40mg, ongoing- Prednisone 5mg daily, Pepcid 20mg daily, Claritin 10mg daily. Company comment: This case concerns a 61 Y/O F with a serious expected anaphylactic reaction, and dyspnea, urticaria, paraesthesia, throat irritation, throat tightness, chest pain, chest discomfort, dizziness, dysgeusia, oral discomfort, burning sensation, feeling hot, chills, and nervous system disorder. Event onset immediately after second dose. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to US-MODERNATX, INC.-MOD-2021-087026, US-MODERNATX, INC.-MOD-2021-087026 (E2B Linked Report).; Sender's Comments: This case concerns a 61 Y/O F with a serious expected anaphylactic reaction, and dyspnea, urticaria, paraesthesia, throat irritation, throat tightness, chest pain, chest discomfort, dizziness, dysgeusia, oral discomfort, burning sensation, feeling hot, chills, and nervous system disorder. Event onset immediately after second dose. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-087026:Case for dose 1 US-MODERNATX, INC.-MOD-2021-087026:case for dose 2

2 days of flu-like sx. She then developed sudden onset of bleeding of gums bruising and vaginal bleeding. High concern for thrombocytopenia. her Sx resolved at day 5 post-vaccine. Her platelets were slightly low 7 days post-vaccine. High clinical suspicion for low platelets

Patient self-reported TIA approx. 40 mins after receiving 1st dose of moderna vaccine. Pt states she did not go in for diagnostic imaging or medical care, but knows what a TIA "feels like," as she has had approx. 6 in her lifetime (self-reported, only 1 TIA found on her medical record).

Had right chest and lower back pain and sweating during night of April 15, 2021. Also had unexplained cough for one month prior to vaccine. Pain was gone by morning. Did regular exercise of walking 4 miles in morning. Same pains came back afternoon of April 16. Went to ER at 4pm on 4/16. D-Dimer and Troponin were elevated and CT scan showed pulmonary embolism in right lung. Was given Lovenox and was admitted to hospital for 2 days. Was released on Eliquis 2x per day for at least 3 months. Had two plane rides lasting for 2 hours each on 3/21 and 3/31 where I walked to bathroom once so it is unlikely these plane rides caused embolism. I am active and walk about 20 miles per week. Doctors so far have not found likely cause for this event.

Case had COVID-19 in November 2020 as part of an outbreak in the SNF she lives in. She recovered then received her first COVID-19 vaccination on 1/4/21. She received her 2nd dose of Moderna on 2/1/21. On 4/11/21 she became ill and was transferred to the hospital where she tested PCR positive for COVID-19. She continued to decline and was intubated. She died on 4/28/21 while still in the hospital. The diagnosis on her death summary from the hospital is COVID-19 pneumonia.

3-4 days after vaccine pt devolped DVT and PE no other known provoking factors, pt did have VTE in 2019 and was no longer on anticoagulation

stated that her mother in law died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (stated that her mother in law died) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 06-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 07-May-2021 The patient died on 07-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided Concomitant medications and treatment information was not provided. A 61-year-old female patient who received mRNA-1273 died 2 days after the first dose of vaccine. No medical condition or conmeds were provided. The cause of death was not reported. Very limited information has been reported at this time. Further information is being followed up.; Sender's Comments: A 61-year-old female patient who received mRNA-1273 died 2 days after the first dose of vaccine. No medical condition or conmeds were provided. The cause of death was not reported. Very limited information has been reported at this time. Further information is being followed up.; Reported Cause(s) of Death: Unknown cause of death

Patient showed up to the hospital after her 2nd Moderna vaccine with AFib w/RVR and failed cardioversion. Patient was recently diagnosed with AFib a couple of days after receiving the first dose of the Moderna vaccine

Immediately had blurry vision, neck stiffness, systolic blood pressure up to 150s. Patient reports that she has been unwell since her second vaccine. Having myalgias and fevers up to 102. She was diagnosed with lingular pneumonia at urgent care on 5/10/2021. She believes that this is related to the vaccine. After treatment with doxycycline, she is starting to improve.

Fell again, breaking left leg; Breaking ankle; Breaking foot; Passed out; Stroke; Fell again; Swollen arm; Did not get second Covid shot; Joint pain; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Mar-2021. The most recent information was received on 12-May-2021 and was forwarded to Moderna on 13-May-2021. This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke), LOSS OF CONSCIOUSNESS (Passed out), LOWER LIMB FRACTURE (Fell again, breaking left leg), ANKLE FRACTURE (Breaking ankle) and FOOT FRACTURE (Breaking foot) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced ARTHRALGIA (Joint pain). On 30-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization prolonged and medically significant), LOWER LIMB FRACTURE (Fell again, breaking left leg) (seriousness criterion hospitalization), ANKLE FRACTURE (Breaking ankle) (seriousness criterion hospitalization), FOOT FRACTURE (Breaking foot) (seriousness criterion hospitalization), FALL (Fell again), PERIPHERAL SWELLING (Swollen arm) and INCOMPLETE COURSE OF VACCINATION (Did not get second Covid shot). The patient was hospitalized for 13 days until 12-Apr-2021 due to CEREBROVASCULAR ACCIDENT, then until 12-Apr-2021 due to ANKLE FRACTURE, FOOT FRACTURE, LOSS OF CONSCIOUSNESS and LOWER LIMB FRACTURE. The patient was treated with Physical therapy for Cerebrovascular accident; Physical therapy for Lower limb fracture; Physical therapy for Ankle fracture and Physical therapy for Foot fracture. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), PERIPHERAL SWELLING (Swollen arm) and ARTHRALGIA (Joint pain) outcome was unknown, LOSS OF CONSCIOUSNESS (Passed out), FALL (Fell again) and INCOMPLETE COURSE OF VACCINATION (Did not get second Covid shot) had resolved and LOWER LIMB FRACTURE (Fell again, breaking left leg), ANKLE FRACTURE (Breaking ankle) and FOOT FRACTURE (Breaking foot) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant product use was reported. Treatment medication included Benadryl. Very limited information regarding these events has been provided at this time. This case also refers to an incomplete schedule of vaccination. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Case upgraded to serious (Hospitalization), Added Additional events experienced, Events description, and updated Treatment information.

Pt reports she had constant left arm pain, located in the deltoid region from the date of the 1st injection. 2nd injection was given 3/11/21 and the pt has had pain radiating upward to posterior right shoulder, axillary area, and distal upper arm. The pt did supportive care, took otc analgesics and pain continued to worsen. Pt was evaluated in the ER 6/1/2021 and diagnosed with a DVT to left upper arm brachial vein.

Patient presented to the ED and was subsequently admitted for NSTEMI within 6 weeks of receiving COVID vaccination.

Currently in hospital as of 06/ 05/ 21 kidney blockage/ surgery needed, Uti, pneumonia, possibly more. Daughter also was in hospital with lung problems...got shots at same time.

Unsure, Department followed up on her positive COVID results in 10/2020 and 11/2020. It came to our attention last week that the reason stated for her death on 5/28/21 was due to COVID. Due to having 2 positive tests late last fall and then seeing that she had been vaccinated for COVID in March and April 2021, I was instructed to complete a VAERS.

on 5/19/21 pt experienced "tingling and a rushing feeling" throughout her body. she then could not move the left side of her body. Per ER records, pt suffered an infarct in the brain that day: .ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY THROMBOSIS OF RIGHT INTERNAL CAROTID ARTERY

Patient received the second Moderna vaccine shot on 041021.Wednesday morning at 6:15am , May 19 she felt bad that morning, She received a 4mm stent for the 100% blockage in the left anterior descending artery. She had a massive heart attck. She remained in the hospital for 3 days. She has 0 Risk factors for heart disease. Hospital. 3 day Stay May 19 before noon, released May 22 2021

Pulmonary embolism in Right lung. Subsequent finding was multiple blood clots throughout both lungs. Gave blood 3 weeks after second Moderna injection, blood clotting would not allow a full donation (right arm). Upon checking in to the ER for chest pain on April 17, blood clotting would not allow IV hook up in right arm.

At around 5:30 a.m. on the day after 2nd Moderna dose, resident was found non-responsive with no vital signs. CPR was performed. Time of death 6:20 a.m. There were no acute illnesses or changes in condition noted prior to receiving vaccine.

Patient received 1st dose 2/10/21, 2nd dose on 3/10/2021 She presented to the ED on 4/27 with dyspnea and found to have large pericardial effusion with early tamponade. Was transferred to hospital and on 4/28 had therapeutic pericardiocentesis. Started on colchicine for presumed viral/immune pericarditis. Seen in cardiologist office on 6/9/2021. Doing wqell with resolution of effusion.

Patient declined second vaccination due to adverse; nausea; stabbing pain in heart and her internal defibrillator sent the manufacturer a message that she was have an arrhythmia and/or heart attack; stabbing pain in heart and her internal defibrillator sent the manufacturer a message that she was have an arrhythmia and/or heart attack; chest pain; blisters on head becoming infected; skin on entire body became red; skin on entire body became red, itchy; entire body having a burning sensation; scalp became purple and developed multiple blisters; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ARRHYTHMIA (stabbing pain in heart and her internal defibrillator sent the manufacturer a message that she was have an arrhythmia and/or heart attack) and MYOCARDIAL INFARCTION (stabbing pain in heart and her internal defibrillator sent the manufacturer a message that she was have an arrhythmia and/or heart attack) in a 61-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. The patient's past medical history included MRSA wound infection. Concurrent medical conditions included Anginal pain, Heart failure, Post-traumatic stress disorder, COPD, Neuropathy, Mucous discharge, Yeast infection (under breasts and abdomen fold), Acid reflux (esophageal), Cholesterol total abnormal NOS, Sleep problem, Depression and Cardiac assistance device user (implantable defibrillator). Concomitant products included RABEPRAZOLE SODIUM (ACIPHEX) for Acid reflux (esophageal), NITROGLYCERIN for Anginal pain, METOPROLOL and ISOSORBIDE DINITRATE (ISOSORBIDE [ISOSORBIDE DINITRATE]) for Anginal pain and Heart failure, IPRATROPIUM and MONTELUKAST for COPD, ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, FLUOXETINE and BUPROPION for Depression, ACETYLSALICYLIC ACID (ASPIRIN 81) for Heart disorder, POTASSIUM and BUMETANIDE;POTASSIUM for Heart failure, GUAIFENESIN for Mucous discharge, GABAPENTIN for Neuropathy, CABERGOLINE for Pituitary disorder NOS, TERAZOSIN HYDROCHLORIDE (PROZOSIN) for Post-traumatic stress disorder, DULOXETINE HYDROCHLORIDE (DOXETIN) for Sleep disorder, NYSTATIN for Yeast infection. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced ERYTHEMA (skin on entire body became red), PRURITUS (skin on entire body became red, itchy), SKIN BURNING SENSATION (entire body having a burning sensation) and BLISTER (scalp became purple and developed multiple blisters). On 05-Apr-2021, the patient experienced BLISTER INFECTED (blisters on head becoming infected). On 18-May-2021, the patient experienced CHEST PAIN (chest pain). On 30-May-2021, the patient experienced ARRHYTHMIA (stabbing pain in heart and her internal defibrillator sent the manufacturer a message that she was have an arrhythmia and/or heart attack) (seriousness criterion medically significant), MYOCARDIAL INFARCTION (stabbing pain in heart and her internal defibrillator sent the manufacturer a message that she was have an arrhythmia and/or heart attack) (seriousness criterion medically significant) and NAUSEA (nausea). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (Patient declined second vaccination due to adverse). The patient was treated with NITROGLYCERIN (intravenous) on 30-May-2021 for Arrhythmia and Heart attack, at a dose of 1 dosage form and CEFRADINE (LINDEX [CEFRADINE]) (topical) for Scalp blister, at a dose of 1 dosage form. At the time of the report, ARRHYTHMIA (stabbing pain in heart and her internal defibrillator sent the manufacturer a message that she was have an arrhythmia and/or heart attack), MYOCARDIAL INFARCTION (stabbing pain in heart and her internal defibrillator sent the manufacturer a message that she was have an arrhythmia and/or heart attack), ERYTHEMA (skin on entire body became red), PRURITUS (skin on entire body became red, itchy), SKIN BURNING SENSATION (entire body having a burning sensation), BLISTER (scalp became purple and developed multiple blisters), BLISTER INFECTED (blisters on head becoming infected) and NAUSEA (nausea) outcome was unknown, CHEST PAIN (chest pain) had not resolved and INTENTIONAL DOSE OMISSION (Patient declined second vaccination due to adverse) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2021, Troponin: normal (normal) normal. On 30-May-2021, Troponin: normal (normal) normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient reported that on 18-MAY-2021 she experienced chest pain and went to the emergency room via ambulance. Patient did not receive any medication in emergency room and was discharged 17 hours later because her Troponin levels were normal. On 30-MAY-2021 patient had stabbing pain in heart and her internal defibrillator sent the manufacturer a message that she was having an arrhythmia and/or heart attack. The patient was air lifted to the hospital. The patient stated that she was put on a Nitroglycerin IV drip and antiemetics in the emergency room. The patient's troponin levels came back normal and was discharged after 12 hours in the emergency room. At the time of report, on 02-JUN-2021, patient stated that she still had chest pain, and the pain remained 3 out of 10. Company Comment: 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. further information has been requested. For the event "Intentionally missed dose" causality assessment is not applicable.; 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. further information has been requested. For the event "Intentionally missed dose" causality assessment is not aplicable.

stroke and MI came in with symptoms of stroke but symptoms for 24 hours so did not receive tPa. MRI showed brainstem infarct. Statin was increased and started on plavix 75 mg daily for 3 weeks due to small stroke with low NIH. Patient came back in 3 days later due to STEMI and went into cardiac arrest. patient died after 1 hour of resuscitation

Indigestion; Hiatal hernia; Weakness; Inflammation; Heart attack; Reflux gastritis; Headache; Fever; Sleep disturbance; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), SPIRONOLACTONE, LISINOPRIL, TICAGRELOR (BRILINTA), ATORVASTATIN and METOPROLOL SUCCINATE for an unknown indication. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced SLEEP DISORDER (Sleep disturbance), HEADACHE (Headache) and PYREXIA (Fever). On 09-May-2021, the patient experienced REFLUX GASTRITIS (Reflux gastritis). On 19-May-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria medically significant and life threatening). On an unknown date, the patient experienced DYSPEPSIA (Indigestion), HIATUS HERNIA (Hiatal hernia), ASTHENIA (Weakness) and INFLAMMATION (Inflammation). The patient was treated with MAGNESIUM OXIDE HEAVY, SODIUM BICARBONATE (ANTACID C) at a dose of 1 dosage form; NITROGLYCERIN at a dose of 1 dosage form and Surgery (Stent insertion) for Myocardial infarction. At the time of the report, MYOCARDIAL INFARCTION (Heart attack), SLEEP DISORDER (Sleep disturbance), DYSPEPSIA (Indigestion), HIATUS HERNIA (Hiatal hernia), ASTHENIA (Weakness), INFLAMMATION (Inflammation), REFLUX GASTRITIS (Reflux gastritis), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Electrocardiogram: abnormal (abnormal) abnormal. In 2021, Endoscopy: abnormal (abnormal) abnormal. Treatment information included proton pump inhibitor. 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. This case was linked to US-MODERNATX, INC.-MOD-2021-108529, BE-MODERNATX, INC.-MOD-2021-108559 (E2B Linked Report). This case was linked to MOD-2021-213971 (Patient Link).; 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. US-MODERNATX, INC.-MOD-2021-108529:(crosslink) BE-MODERNATX, INC.-MOD-2021-108559:(crosslink)

Myocardial infarction probable silent after acute and sustained symptoms of upper arm and leg discomfort. Elevated diastolic bp and heart pounding. No prior history suggestive of CAD.

After years of being in menopause, I had vaginal bleeding for 7 days, it became very light after 4 days.

Day after vaccine had extreme version of usual vaccine reactions, took Tylenol, still lingering effects the next day, extremely winded while trying to walk, several weeks later symptoms worsened. Extreme fatigue. 2 weeks after shot, was at elevation and extremely winded (usually not someone with respiratory issues). Missed work, drove to ER, lungs clotted. Doctor did not find any clot in legs, assumed it was Covid but did not have any other symptoms of Covid and negative covid test. 6 month recovery expected. Taking Xarelto coagulant, initially was on Eliquis, but responded poorly now on Xarelto.

Fully vaccinated patient test positive for COVID upon admission to the hospital. Admitted 06/20/21 for stroke. No s/s of COVID throughout stay. No fever, cough, O2 needs. Discharged without any COVID concerns.

My lips were numb 45 minutes after my vaccine and 7 or 8 days later I had a mini stroke but unsure if related to the vaccine.

Patient given first dose of COVID vaccine - Moderna. Shortly after, patient started experiencing itching and hives all over body as well as some nausea. Patient called EMS and was brought to ED

Anaphylactic reaction; A spontaneous report was received from a 62-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an anaphylactic reaction. The patient's medical history, as reported, included 4 previous anaphylactic reactions since she was 9 years old, history of throat problems and swelling, bronchitis, and her brother died in 1997 due to an anaphylactic reaction to poison ivy and bee stings. Concomitant medications reported included thyroid medication (not specified), blood pressure medication (not specified), gabapentin, sleep medicine (not specified) and curcuma longa rhizome. On 24 Jan 2021, about 15 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 24 Jan 2021, 30 minutes prior to receiving the vaccine, the patient took prednisone (dose unknown), per instructions from her doctor due to her history of anaphylactic reactions. She did notify the vaccinators of her history and there was an ambulance present. About 15 minutes after receiving the vaccine, the patient started coughing, had heavy chest pain, trouble breathing, and felt like her throat was constricting more than usual. No rash developed. She approached the ambulance and asked if she could take diphenhydramine. She took one dose, followed by 3 other doses, and felt a bit better. Consent given for Safety to follow up with patient. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event, anaphylactic reaction was resolving at the time of this report.; Reporter's Comments: This case concerns a 62 year old female patient with medical history of included 4 previous anaphylactic reactions since she was 9 years old, history of throat problems and swelling, bronchitis, and her brother died in 1997 due to an anaphylactic reaction to poison ivy and bee stings. Concomitant medications reported included thyroid medication (not specified), blood pressure medication (not specified), gabapentin, sleep medicine (not specified) and curcuma longa rhizome. She experienced a serious unexpected event of Anaphylactic reaction that needed treatment diphenhydramine. The event occurred approximately 15 minutes after first dose of the study medication administration even thought the patient took prednisone prior to receiving the vaccine. 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.

On 1/23/21 the patient had a single-car accident, slid off icy road into snowbank. She was seen in our ER, diagnosed w/ trauma and L4 compression fracture. She was transported to Hospital for further trauma workup. We believe she was treated and released. On 1/31/21 the patient had a headache but did not seek medical attention. In the morning of 2/1 she became unresponsive and was pronounced dead on the scene when EMS arrived. Autopsy showed a left temporal subdural hematoma.

Jan 25- chills, fever, headache Jan. 27- obtained rapid and PCR COVID SWABS- which resulted negative Jan 30- started antibiotics from primary doctors with no relief of fevers. Jan 31 - Brought to ER And was admitted for observation . Multi Covid testing negative. Cat scan showed pneumonia picture. SARS COVID IGG was negative, but antibody for vaccine was positive

Anaphylaxis. Used epiPen, taken to ER. Given solumedrol 125 mg, bendadryl, 25 mg IV monitored 4hours. Sent home with solumedrol dose packet and new epipen

Patient received 1st dose of Moderna vaccine on 01/30/2021. Patient received second dose on 2/27/2021 and within an hour noticed slurred speech and drooped face. Patient went to ER and was transferred to another Hospital on 2/27/21 due to stroke. Now patient believes stoke may have started 2/26/21, as she was somewhat confused that day, but didn't realize stroke until after vaccine.

Determined she had a mild stroke yesterday, March 21. Had slurred speech, could not form words, couldn't cook. Symptoms actually started on March 17th, one week after having the vaccine. She is currently hospitalized at hospital where she received her vaccination.

Patient reported the following: I went to the ER last Thursday because my left leg was red and swollen. They did a sonogram and the results came back as tendentious and a superficial blood clot. The ER physician at Health suggested that I report the blood clot because it is of unknown origin and I did receive both vaccines.

It was sent for low pressure on 02/12/2021 to the Hospital Medical Center. He died of respiratory arrest.

? Maderna vaccine #1 on 3/16 at clinic ? Provider visit 3/22 dx bronchitis due to COVID-19, z pak and steroids ? ED 3/25 syncopy, full arrest and patient expired patient states she had COVID in February

24 hours after vaccine, and 7 hours after onset of expected fever/chills/aches, triggered atrial fibrillation w/ RVR (130 BPM) with longest duration ever experienced - 3 days . Intent of this reporting is that patients with afib may need to choose a Covid vaccine that doesn't have the higher fever, flu symptom response as Moderna does, which could trigger the afib. Was about to need to visit ER to get converted to NSR, when self converted after 3rd day.

Stroke symptoms, double vision, numbness of lips, tongue , mouth and gums. General weekness, shaking and confusion. Symptoms began receding after 20 minutes. As EMS arived

Patient reported to the pharmacy that she was admitted to the hospital for blood clots shortly after receiving the vaccination and was there for at least 10 days

Bled down her leg; Hematoma on lower leg; Creepy; Rash on legs, hands, wrists, fingers; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of HAEMORRHAGE (Bled down her leg), HAEMATOMA (Hematoma on lower leg), FEELING ABNORMAL (Creepy) and RASH (Rash on legs, hands, wrists, fingers) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (Bled down her leg), HAEMATOMA (Hematoma on lower leg), FEELING ABNORMAL (Creepy) and RASH (Rash on legs, hands, wrists, fingers). At the time of the report, HAEMORRHAGE (Bled down her leg), HAEMATOMA (Hematoma on lower leg), FEELING ABNORMAL (Creepy) and RASH (Rash on legs, hands, wrists, fingers) had resolved. 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. This case was linked to MOD-2021-059458 (Patient Link).; Sender's Comments: This case concerns a 62-year-old female with a serious unexpected event of hemorrhage, and nonserious unexpected hematoma, feeling abnormal and expected rash. Event onset with unknown latency after first dose mRNA-1273. Events resolved. 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.

Patient received her second dose of Covid vaccine on 04/08/2021 around 2 PM. She reported around 2 AM Friday 04/09/2021 she woke up feeling lightheaded as if she was going to pass out. She is an RN and felt that her pulse was irregular. She proceeded to the emergency department where she was treated. She reports her EKG showed a-fib with RVR and an xray showed new onset mild "CHF" or fluid around her heart. They did not cardio-vert her as she reports she was "stable". She was sent home on eliquis and metoprolol. Over the weekend 04/09-04/11/2021 she reported irregular pulse anywhere from 45-135 BPM. She did report a 5 pound weight gain during that time. On Monday 04/12/2021 she followed up with her primary care physician, Dr. of Health. She reports on her way to the doctor she felt as if "something changed" and her heart rate was no longer irregular. She did have another EKG done in office and she reports that EKG showed normal sinus rhythm. She is seeing a cardiologist on Wednesday 04/14/2021. She reports after her first vaccine on 03/11/2021 she had mild side effects of fatigue, fever, and chills. She states she does not have any cardiac issues but does report "a few years ago" she had drank a energy drink and had a-fib from that.

Blood clot; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot) in a 62-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. The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication. 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 THROMBOSIS (Blood clot) (seriousness criterion medically significant) and COVID-19 (COVID-19). At the time of the report, THROMBOSIS (Blood clot) and COVID-19 (COVID-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) postive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Products known to have been used by the patient, within two weeks prior to the event, included blood thinner medication. Treatment information was not provided. 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.

Per the patient's husband, on 03/26/2021, the day after vaccination, the decedent complained of nausea with vomiting, and had difficulty driving. On 03/27/2021, her nausea continued and she complained of shortness of breath while walking. On 03/28/2021, she was short of breath before vomiting a small amount. She then became unresponsive. Death was pronounced a short time later. Per her treating physician who signed the death certificate, the cause of death is felt to be probable myocardial infarction due to electrolyte abnormalities due to complications of her diabetes mellitus.

Patient had anxiety on arrival to the Covid vaccine clinic. Went into rapid atrial fibrillation on arrival due to anxiety. This occurred prior to receiving the vaccine. Patient recovered on her own and later received the vaccine. She then went back into rapid Afib and was transferred to the Emergency Department. Patient has a long history of A fib. Does not appear to be vaccine related.

Received her first COVID vaccine on Thursday, March 18. On 3/23/21 she started to have new onset of generalized muscles aches and weakness. She started feeling some pain in her back, which then spread to arms and legs. She is now beginning to feel weakness in her core and extremities. Having difficulty lifting arms above head. She is still able to walk without difficulty but legs do feel weak. Increase in SOB as well. Myalgias and chest pain resolved within a week, however she continued to feel weak, tired, and had DOE. She developed "brain fog" and talked to her boss about taking short-term disability as it had been hard to work. No appetite. On 4/1/21, she presented to the ED with 2 weeks of worsening generalized weakness, SOB, lightheadedness, dizziness and found to have acute anemia. Was admitted for further workup. Hgb at admission was 5.4. This admission diagnosed her with a new warm autoantibody hemolytic anemia. This is new since the COVID vaccine was administered. Upon admission there was no thrombocytopenia, so there was low suspicion for microangiopathic hemolytic anemia, TTP/HUS, or DIC. Peripheral blood smear at that time suggested a leukoerythroblastic blood picture (could be Bone Marrow recovery post chemo) but with marked normocytic, normochromic anemia, and with increased circulating erythroid precursors and increased red blood cell regeneration; spherocytes and fragments are present supporting hemolysis. DAT positive (both IgG and C3) along with other hemolysis lab including elevated LDH, Bilirubin, haptoglobin 3, and PBS c/w hemolysis; no evidence of MAHA. So warm autoantibody hemolytic anemia is the most likely explanation. She had negative cold agglutinin antibodies <1:32 on 4/9. Started on methylprednisolone on 4/2/21, but Hgb continued to steadily decline despite treatment. Continued on methylprednisolone 87.5mg daily. Rituxan 375mg/m2 was started on 4/6/21 with plans for weekly infusions for a total of 4 weeks. there was concern for a GI bleed on 4/10-4/11 due to bright red fluid appearing like blood in the toilet after a stool. This led to her receiving roughly 5 units of pRBCs. After these 5 units she started urinating red urine and we became highly concerned for hyperhemolysis. She did not have any further stools so we did not think a GI bleed was likely. She was given 1 dose of Eculizumab (Soliris) (4/12). This treatment is for complement mediated intravascular hyperhemolysis. Unfortunately it did not appear to help her. On 4/14, we were thinking TTP could be contributory with numerous schistocytes on peripheral smear. Her T bili was up to 7.8, and her hemoglobin plasma was trending up, in the 380 -- > 610 and in the 800s today. Cr was worsening. Platelet count was dropping. With her worsening condition and concern for both hyperhemolysis and possible TTP, we decided to start her plasma exchange followed by her second dose of Rituximab. Unfortunately she became disoriented/confused following line placement and while receiving plasmaphoresis. CT head returned without acute findings. She then had an allergic reaction with a rash during PLEX which was stopped (4L completed with a goal of 5L). Improved with benadryl. She was then administered rituximab. Then she developed worsening sinus tachycardia and HTN. Her respiratory status deteriorated and she eventually required high-flow oxygen to maintain saturations > 90%. CXR showed bilateral opacities, not drastically changed from previous films. Rituximab was stopped halfway through its infusion in case this was an adverse effect to the drug. She was given 20 mg IV Lasix per the nighttime sign-out. She was initially given ceftriaxone and azithromycin IV to cover CAP but later ABx were broadened to vanc and Zosyn with rising lactate of unknown source. Ultimately she had acute respiratory failure with hypoxia and need BiPAP. She was eventually intubated and a code blue was called. She unfortunately died shortly after intubation.

Date and time adverse event started: 26th March, Monday evening, had stroke-like symptoms. Went to hospital on the 27th, dx of a stroke. Patient has a dx of a stroke, went to hospital, since d/c'd to home with residual. patients reports no changes, was diagnosed with a TIA and pending follow ups with heart doctor & neurologist. Q99- asked if she should take the 2nd dose. recommended she follow up with her PCP and neurologist to discuss risks and benefits of the 2nd dose, patient verbalized understanding.

My wife started to fall and pass out had no strength to get up this happened two to three times cinch she got the shot the last time she past out in the shower and i rushed her to hospital were she pasted away from blood clots to the right side of the neck and stated bleed on the brain

She was transferred from one ER to another for intraparenchymal bleed and subarachnoid hemorrhage with midline shift. On the week of April 11th she was seen by her periodontist of a bone graft in preparation for a tooth implant. She took minimal ibuprofen and norco after this procedure. However, she also began to feel very nauseated which led to anorexia and worsening malaise. This prompted the pt to present to ER on 4/16 evening, where was given Phenergan, and discharged to home. Symptoms worsened and she re-presented to ED where she was admitted and diagnosed with UTI and colitis. She was started on ciprofloxacin. She denied having had any dysuria or diarrhea. Patient's son says that at 0130 on 4/19 his mother was using both sides of her extremities equally. She had been complaining of headache and leg pain, but by 0130 on 4/19 family did not notice any other obvious changes in patient's movements or behavior. However, at 0730 on 4/19 nurses noticed that patient was unable to move her L arm or leg. She had a CT scan done, which revealed multiple intraparenchymal hemorrhages bilaterally as well as subarachnoid hemorrhage with midline shift. The transferring physician told me that patient had not been on any anticoagulation. Patient and her family deny any history of falls or trauma, denied family history of coagulopathies, and use of blood thinners (including aspirin). No records, labs, or inpatient med list was sent with patient upon transfer. Family says that patient had her first Moderna COVID19 vaccine 3 weeks ago and was due for her second vaccine on 4/23. Labs on admit here are significant for leukocytosis with WBC of 21.9, Hgb of 12.1, platelets of 306, sodium of 140, potassium of 3.1, Bicarb of 22, creatinine of 0.7, glucose of 126, magnesium of 1.8, INR of 1.2. Patient is normotensive, afebrile, and satting well on room air. Angiogram showed multiple cortical vein thromboses. Will send hypercoagulable work up, HIT antibody given COVID vaccine 3 weeks ago (Moderna).

Very ill evening post 2nd dose on 1/25/21 with extreme nausea, fatigue. Some headache, sore arm. Mid Feb began to experience heart palpitations, PAC and PVCs. Went to see Cardiologist and with stress echo dx with pulmonary hypertension. Getting right heart cath today

18 hours after my 2nd moderna vaccine, I experienced slurred speech. When I arrived by car at my destination, I checked into a motel, looked into the mirror and noticed my left side of my face was drooping. I knew this was sign of stroke. I called 911 right away. I was taken to hospital. They did a CBC the night I arrived and the next day as well. They did 2 cat scans with and without contrast. Dr. in the ER determined that I had suffered a Transient Ischemic Attack which was brought on in less than 24hours of the 2nd Modern vaccine shot, and that the TIA was from the vaccine. THe cat scans did not reveal any blood clots at the time of the scans. Dr. concluded that they had broken up quickly and that was why he diagnosed me with TIA.

At the time of first vaccination shot, I experienced an anaphylaxis reaction including constriction of throat, difficulty swallowing, inside of cheeks swelling, lips numb and inability to take a deep breath. I waited at the vaccination site for 30 minutes. No treatment was requested since I began to feel a little bit better after 30 minutes. It took approximately 4-1/2 hours to 5 hours to completely be able to swallow without difficulty and feel that I could actually take a deep breath. I contacted my Primary Care Physician and she advised that she is "not comfortable with my receiving the second shot" and told me to cancel my second shot.

found several blood clots in her lungs; it (difficulty breathing) became worse; difficulty breathing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (found several blood clots in her lungs) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039AZ1A) 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.). Concomitant products included APIXABAN (ELIQUIS) for an unknown indication. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced DYSPNOEA (difficulty breathing). On 05-Apr-2021, the patient experienced CONDITION AGGRAVATED (it (difficulty breathing) became worse). On 07-Apr-2021, the patient experienced PULMONARY EMBOLISM (found several blood clots in her lungs) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 07-Apr-2021 to 11-Apr-2021 due to PULMONARY EMBOLISM. On 15-Apr-2021, DYSPNOEA (difficulty breathing) and CONDITION AGGRAVATED (it (difficulty breathing) became worse) had resolved. At the time of the report, PULMONARY EMBOLISM (found several blood clots in her lungs) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, COVID-19: negative (Negative) Test results came back negative on 06Apr2021. On 07-Apr-2021, X-ray: abnormal (abnormal) Blood clots in lungs. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. After x-ray at urgent care on 07-Apr-2021 showed several blood clots in lungs, the patient was taken to the ER (emergency room) and was subsequently admitted to the hospital. Treatment information was not provided. On 12-Apr-2021 the patient went to their PCP (primary care physician) who stated that the clots most likely were not due to the vaccination and that the 2nd dose was safe for her to receive. At the time of this report on 15-Apr-2021, the patient reported feeling fine. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events 1-3 days after the vaccination, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. Further information has been requested.; 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 1-3 days after the vaccination, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. Further information has been requested.

After eight hours after receiving the second dose, the normal sx of the COVID vaccine occurred (muscle aches, fatigue). On the morning of 04/23/21, the patient completely lost consciousness and was not breathing. The caregiver (son) performed CPR and the patient regained consciousness. Paramedics were called and performed and EKG, blood glucose, and BP/HR - all were normal. Pt is resting but still in pain.

Nausea, vomiting, burning in stomach, high blood sugars- symptoms started the day after the vaccine. Found obtunded 3 days after vaccine given. 911 called in route to the hospital had a cardiac arrest, resuscitated, arrested again and resuscitated. Upon admission to the hospital diagnosed with diabetic ketoacidosis and died the next day- 4 days after the vaccine was administered

stroke at vision site; partial sight lost in left eye; feeling weak; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke at vision site) and BLINDNESS (partial sight lost in left eye) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Implantable cardioverter defibrillator insertion. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke at vision site) (seriousness criteria hospitalization and medically significant), BLINDNESS (partial sight lost in left eye) (seriousness criteria hospitalization, disability and medically significant) and ASTHENIA (feeling weak). The patient was hospitalized from 20-Apr-2021 to 21-Apr-2021 due to BLINDNESS and CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke at vision site), BLINDNESS (partial sight lost in left eye) and ASTHENIA (feeling weak) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, Computerised tomogram: (abnormal) Stroke at vision site. On 20-Apr-2021, Magnetic resonance imaging: (abnormal) Stroke at vision site. No concomitant medication were reported. The reporter stated that the patient was taking medicines but doctor changed her medication and she did not want to talk so she did not give names.; 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.

atrial fibrillation (not sure when started, still continuing, scheduled for cardioversion on May 27, 2021) minor side effects - chills, nausea, extreme fatigue (probably due to a-fib), also (don't laugh) a lot of burping (not normal for me), frequent need to urinate for about 24 hours - these minor issues all cleared up within 48 hours other than fatigue

Pulmonary Embolism - desaturating to the 70's on admission, requiring 4L NC oxygen supplementation and heparin gtt

Patient admitted to hospital after 2-3 days of shortness of breath and calf pain, swelling in foot distal to calf with pain. Admission date 4/23, vaccinated with second moderna dose on 4/12 Two clots identified: right lower extremity DVT "Positive study for acute DVT in the right lower extremity, extending from the calf veins up through the right external iliac vein. Positive study for acute superficial thrombophlebitis involving the imaged lesser saphenous vein." and PE: "Acute pulmonary embolism involving the main pulmonary arteries (saddle pulmonary embolism) and extending to the lobar, segmental branches bilaterally with some extension of the subsegmental branches in the right lower lobe, overall worse in the right lower lobe with occlusive segmental branches. " Was initially started on lovenox when admitted, switched to Eliquis, no IVC filter was placed discharged in stable condition on 4/26, Of note: Patient had bone marrow biopsy of right iliac crest of April 15th 2021 - carries diagnosis of chronic lymphocytic leukemia but is currently in remission

Renal failure; Liver failure; Unresponsive; Died; Stomach pain; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of UNRESPONSIVE TO STIMULI (Unresponsive), DEATH (Died), RENAL FAILURE (Renal failure) and HEPATIC FAILURE (Liver failure) in a 62-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. Concurrent medical conditions included Primary biliary cirrhosis. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain) and NAUSEA (Nausea). On 08-Apr-2021, the patient experienced UNRESPONSIVE TO STIMULI (Unresponsive) (seriousness criterion hospitalization). On 23-Apr-2021, the patient experienced DEATH (Died) (seriousness criterion death), RENAL FAILURE (Renal failure) (seriousness criterion hospitalization) and HEPATIC FAILURE (Liver failure) (seriousness criterion hospitalization). On 23-Apr-2021, RENAL FAILURE (Renal failure) and HEPATIC FAILURE (Liver failure) had resolved and NAUSEA (Nausea) outcome was unknown. The patient died on 23-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, UNRESPONSIVE TO STIMULI (Unresponsive) and ABDOMINAL PAIN UPPER (Stomach pain) outcome was unknown. The concomitant medication included liver medications, as reported by the reporter. On 07Apr2021 around 1230pm, the patient experienced stomach pain and nausea which the family attributed to her liver medications. The patient went to sleep later that evening. The next day, 08Apr2021, the patient was found to be sleeping around 8am but was unresponsive around 1:30pm. She was taken by ambulance to the local hospital. The patient was eventually placed on life support and passed on 23Apr2021. No other treatment medication were reported. Company comment: Very limited information regarding this events has been provided at this time. However, 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. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. However, 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. Further information has been requested.; Reported Cause(s) of Death: unkown cause of death

Acute Ischemic Stroke / Cerebrovascular Accident right-sided weakness, pressure behind right eye and right sided headache. inability to grasp with right hand and keep right leg up. denies recent illness

heart palpatations, heaviness, flush. did not contact a doctor two weeks later I had the same symptoms and heart rate as 106 without any exertion. BP was 129/74 but hear rate was 106. went to ER. diagnosed with heart attack and got a stent in Left anterior descending artery.

Developed severe abdominal pain 3/22/2021. Hospitalized and dx w ISCHEMIC COLITIS, MESSENTERIC ISCHEMIA, TYPE II NSTEMI, ANEMIA and THROMBOCYTOSIS. Hospitalized 9 days

Developed a rare blood disorder known as TTP (Thrombotic thrombocytopenic purpura). Suffered various strokes. Outcome is pending but doctors are predicting permeant right side paralysis and inability to communicate.

Bilateral saddle pulmonary embolus 12 days post 2nd Moderna vaccination, Shortness of breath worsened 6 days after vaccination, lasting 1 week until presentation to hospital ED. Was found with severe hypoxemia, and bilateral PE and right heart strain requiring interventional radiology procedure and catheter directed thrombolytic therapy, subsequent treatment and follow-up in the ICU Initial Moderna vaccine given 04/12/2021: Vial number 0 3 0 B21A Second Moderna vaccine given 05/10/2021 file number 031 B 21A Patient described mild shortness of breath beginning 1 month prior to 1st vaccine, but significant and severe shortness of breath developing less than 1 week after 2nd vaccine

stroke; tested positive for Covid; Covid-19; lost bowel function; got sick 4 hours later; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 62-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. The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included INSULIN DETEMIR (LEVEMIR) and INSULIN for Type 2 diabetes mellitus. On 03-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced FUNCTIONAL GASTROINTESTINAL DISORDER (lost bowel function) and ILLNESS (got sick 4 hours later). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant), SARS-COV-2 TEST POSITIVE (tested positive for Covid) and COVID-19 (Covid-19). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), FUNCTIONAL GASTROINTESTINAL DISORDER (lost bowel function), ILLNESS (got sick 4 hours later), SARS-COV-2 TEST POSITIVE (tested positive for Covid) and COVID-19 (Covid-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative and positive (Positive) Positive. The patient had stroke 2 days later to the second dose vaccination and was rushed/admitted to the ER for a while. 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. Based on the mechanism of action of mRNA-1273, the event (Covid-19) is assessed as unlikely related to mRNA-1273. This case was linked to MOD-2021-117175 (Patient Link).; 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. Based on the mechanism of action of mRNA-1273, the event (Covid-19) is assessed as unlikely related to mRNA-1273.

PT RECEIVED MODERNA #1 3/17/2021. SHE BEGAN TO EXPERIENCE LEG CRAMPS ON THE LEFT 4/12/2021. SHE RECEIVED MODERNA #2 4/14/2021 SHE WAS DIAGNOSED WITH LEFT LEG DVT 4/19/2021 AND STARTED ON XARELTO. SHE WAS ADMITTED 5/3/2021 AND DIAGNOSED WITH PULMONARY EMBOLI SHE HAS SEEN HEMATOLOGY DR. 5/5/2021 MANY LABS ARE PENDING

have not received second dose; terrible feeling/ feeling off; No strength; No strength to walk; lethargic; had vomited; lost control of bowels; tingling all over my body; Stroke; completely lost consciousness; Seizure; barely move her arm; lightheaded; sick to my stomach/ Stomach issues; arm was painful; interrupted her sleep; vaccination was given directly into the infected area; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke), LOSS OF CONSCIOUSNESS (completely lost consciousness) and SEIZURE (Seizure) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Spider bite. On 15-Apr-2021 at 7:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm was painful), INSOMNIA (interrupted her sleep), DIZZINESS (lightheaded), GASTROINTESTINAL DISORDER (sick to my stomach/ Stomach issues), PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (vaccination was given directly into the infected area) and HEADACHE (headache). On 16-Apr-2021, the patient experienced MONOPARESIS (barely move her arm). On 17-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (completely lost consciousness) (seriousness criterion medically significant), SEIZURE (Seizure) (seriousness criterion medically significant), PARAESTHESIA (tingling all over my body) and ANAL INCONTINENCE (lost control of bowels). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (have not received second dose), FEELING ABNORMAL (terrible feeling/ feeling off), ASTHENIA (No strength), GAIT DISTURBANCE (No strength to walk), LETHARGY (lethargic) and VOMITING (had vomited). On 15-Apr-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (vaccination was given directly into the infected area) had resolved. On 16-Apr-2021, INSOMNIA (interrupted her sleep) had resolved. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), LOSS OF CONSCIOUSNESS (completely lost consciousness), SEIZURE (Seizure), DIZZINESS (lightheaded), FEELING ABNORMAL (terrible feeling/ feeling off), GASTROINTESTINAL DISORDER (sick to my stomach/ Stomach issues), ASTHENIA (No strength), PARAESTHESIA (tingling all over my body), GAIT DISTURBANCE (No strength to walk), ANAL INCONTINENCE (lost control of bowels), LETHARGY (lethargic), HEADACHE (headache) and VOMITING (had vomited) outcome was unknown, PRODUCT DOSE OMISSION ISSUE (have not received second dose) had resolved and PAIN IN EXTREMITY (arm was painful) and MONOPARESIS (barely move her arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: inconclusive (Inconclusive) inconclusive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. The patient's left arm was already itchy and swollen from a spider bite. Pharmacist injected arm where the spider bite was located, even though she noted the spider bite. During the night her arm was painful and interrupted her sleep. The next day, she could barely move her arm and it was very painful. The patient was transported to hospital emergency room. IVs and CT scan for over two weeks followed were performed. 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. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Patient demographics, new serious events ,new non serious events added. event outcome of painful arm( unknown to not recovered), and arm discomfort( unknown to not recovered) were changed.; 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. Further information has been requested.

She got her vaccine, she came home and started noticing some pain and burning. She looked down and she had a big red bump the size of a nickel or a little large, flat. Then about an hour later it started to raise, and every 4 days they started going away and then come back with more of them. They are hot, red and raised and itchy when they come on. She is still getting them, popping up on her while I was talking to her. She subsequently got the 2nd vaccine on 3/26/21, LOT#028A21A. She said that now when they come since the 2nd vaccine they come in bunches 3-5 of them come up at a time. She did call her doctor and saw Dr. who gave her Triamcinolone cream to use. She then saw her provider and gave her some stronger cream to use. The one that she got from him last relieves the itching and pain and also takes hydroxyzine and he's also given her betamethasone diproprionate cream which again relieves the pain but does not get rid of anything according to her, they still continue to come back. They are now popping up every day. When it first started it was every 4 days, and then they would go away and then they would pop up again. Now, they are popping up every day. Her left side of her face swelled on one side and went numb on 4/25/21. She then went to the doctor on 4/27/21 and he told her that it came from the vaccine. Her face is still swollen on the left side. He did not give her anything for that. She went and had an echocardiogram on 5/19/21 and they called with the results yesterday and told her that she had a myocardial infarction, but she did not know when. Her PCP told her to just continue taking the medications that she is already taking. She is supposed to go back for a FU on 7/29/21. She cannot sleep and is getting aggravated that these bumps will not go away. They look bad and she has pictures of what they look like. She would like somebody to tell her doctor what to do to treat her symptoms so that they will go away and not come back.

Stroke symoton inckuding fiund brain bloid clot loss of peripheral vussion left side numbness side of face habds fibger tips confusion

I received Moderna shots as follows: o March 18, 2021 - Dose #1 o April 15, 2021 - Dose #2 o COVID-19, Moderna dose #1 (lot 045A21A) was administered as in injection in my Right arm on 03/18/21 at. o The next morning (3/19/21), I experienced tremor/pulling type sensation in my right lower lip / jaw area that lasted a few seconds, then subsided. o COVID-19, Moderna dose #2 (lot 022B21A) administered as in injection in my Right arm on 04/15/21 at. o The next morning (4/16/21), I woke up to Left side jaw pain that lasted several hours, then subsided. Mid-morning of that same day, I experienced a strong spasm type pain in my Left leg (inner groin area to knee area), lasting a few seconds, then subsided. That same day I felt tired and experienced a loss of appetite. o Over the next few weeks, I felt an unusual lack of energy and little appetite, resulting in weight loss.

several strokes occurred from April 9, 2021 thru April 24th, 2021 resulting in hospital stays both dates. patient has lost some peripheral vision and cannot drive at this time. Dizzy, light headed. Feels like in a fog all the time.

Saddle Pulmonary Embolism; DVT; This spontaneous case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (Saddle Pulmonary Embolism) and DEEP VEIN THROMBOSIS (DVT) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect products included non-company products UBLITUXIMAB for an unknown indication, UMBRALISIB for an unknown indication and VENETOCLAX for an unknown indication. Concurrent medical conditions included Hypertension, Mantle cell lymphoma, Leukemia (relapsed or refractory CLL/SLL) and Richter's syndrome. On 28-May-2020, the patient started UBLITUXIMAB (Intravenous) 900 milligram and UMBRALISIB (Oral) 800 milligram. On 02-Sep-2020, the patient started VENETOCLAX (Oral) 400 milligram. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced DEEP VEIN THROMBOSIS (DVT) (seriousness criteria hospitalization and medically significant). On 24-Apr-2021, the patient experienced PULMONARY EMBOLISM (Saddle Pulmonary Embolism) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 23-Apr-2021 to 26-Apr-2021 due to DEEP VEIN THROMBOSIS and PULMONARY EMBOLISM. The patient was treated with HEPARIN on 23-Apr-2021 for DVT, at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (Saddle Pulmonary Embolism) and DEEP VEIN THROMBOSIS (DVT) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Ultrasound scan: dvt (abnormal) Ultrasound of lower right extremity showed acute deep vein thrombosis, DVT.. On 24-Apr-2021, Computerised tomogram: saddle pulmonary embolism (abnormal) CT on chest with IV contrast showed a saddle pulmonary embolism .. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medications were 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.

patient has lost peripheral vision and can not drive anymore.; Patient has had about 8 strokes from the date of administration of the vaccine till date; This spontaneous case was reported by a physician and describes the occurrence of CEREBROVASCULAR ACCIDENT (Patient has had about 8 strokes from the date of administration of the vaccine till date) and VISUAL FIELD DEFECT (patient has lost peripheral vision and can not drive anymore.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Patient has had about 8 strokes from the date of administration of the vaccine till date) (seriousness criterion medically significant). On an unknown date, the patient experienced VISUAL FIELD DEFECT (patient has lost peripheral vision and can not drive anymore.) (seriousness criterion disability). At the time of the report, CEREBROVASCULAR ACCIDENT (Patient has had about 8 strokes from the date of administration of the vaccine till date) and VISUAL FIELD DEFECT (patient has lost peripheral vision and can not drive anymore.) had not resolved. 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. The patient has had about eight strokes from the date of vaccine administration till date of report. The patient had their blood pressure controlled and had not yet taken the second dose. She is unable to drive. Concomitant products were not provided/unknown. Treatment was reported as palliative care. Company Comment 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 This case was linked to MOD21-109853 (Patient Link).; 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

Pt states 05/22/2021 ER visit, mult-pulmonary clots in both lungs, also blood clot found in left leg. Hemoglobin 6.2, blood transfusion, 75 O2, 06/04/2021 ER visit 4 days of observation hospitalized. Per Dr. 2 months out of work.

dose 1 4/4/21, dose 2 5/5/21, had a stroke on 6/1/21, no underlying conditions known, suspects possibly from vaccine, since then has relly ry eyes and is still in therapy from post- seizure

auto immune disorder; suspected reaction from covid vaccine; felt it was a dermatitis; intermittent numbness in fingers; difficulty breathing, winded; both hands are weak; Redness of both hands; Dry persistent cough/ cough; both hands are painful; interstitial lung disease; Pneumonia suspect; low grade fever; swelling in her hands equally on the right and left with tingling/swelling of both hands/hands inflamed; swelling in her hands equally on the right and left with tingling/prickling/ tingling; had her first dose of Moderna vaccine on 7Jan21 and had that 2nd dose on 19Feb21; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (auto immune disorder), INTERSTITIAL LUNG DISEASE (interstitial lung disease) and PNEUMONIA (Pneumonia suspect) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 021L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma (mild), Penicillin allergy (rash and chills), Osteopenia and Contrast media allergy (Rash). Concomitant products included MULTIVITAMIN [VITAMINS NOS], VITAMIN D NOS and CALCIUM for an unknown indication. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had her first dose of Moderna vaccine on 7Jan21 and had that 2nd dose on 19Feb21). On 13-Mar-2021, the patient experienced PARAESTHESIA (swelling in her hands equally on the right and left with tingling/prickling/ tingling) and PERIPHERAL SWELLING (swelling in her hands equally on the right and left with tingling/swelling of both hands/hands inflamed). On 18-Apr-2021, the patient experienced PYREXIA (low grade fever). On 27-Apr-2021, the patient experienced PNEUMONIA (Pneumonia suspect) (seriousness criterion medically significant). On 24-Jun-2021, the patient experienced INTERSTITIAL LUNG DISEASE (interstitial lung disease) (seriousness criterion medically significant). On an unknown date, the patient experienced AUTOIMMUNE DISORDER (auto immune disorder) (seriousness criterion medically significant), VACCINATION COMPLICATION (suspected reaction from covid vaccine), DERMATITIS (felt it was a dermatitis), HYPOAESTHESIA (intermittent numbness in fingers), DYSPNOEA (difficulty breathing, winded), MUSCULAR WEAKNESS (both hands are weak), ERYTHEMA (Redness of both hands), COUGH (Dry persistent cough/ cough) and PAIN IN EXTREMITY (both hands are painful). The patient was treated with PREDNISONE at a dose of 1 dosage form; DOXYCYCLINE at a dose of 1 dosage form and AZITHROMYCIN on 18-Apr-2021 for Bronchitis, at an unspecified dose and frequency. On 19-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had her first dose of Moderna vaccine on 7Jan21 and had that 2nd dose on 19Feb21) had resolved. At the time of the report, AUTOIMMUNE DISORDER (auto immune disorder), INTERSTITIAL LUNG DISEASE (interstitial lung disease), PNEUMONIA (Pneumonia suspect), VACCINATION COMPLICATION (suspected reaction from covid vaccine), DERMATITIS (felt it was a dermatitis), PARAESTHESIA (swelling in her hands equally on the right and left with tingling/prickling/ tingling), DYSPNOEA (difficulty breathing, winded), MUSCULAR WEAKNESS (both hands are weak), PERIPHERAL SWELLING (swelling in her hands equally on the right and left with tingling/swelling of both hands/hands inflamed), COUGH (Dry persistent cough/ cough) and PYREXIA (low grade fever) outcome was unknown and HYPOAESTHESIA (intermittent numbness in fingers), ERYTHEMA (Redness of both hands) and PAIN IN EXTREMITY (both hands are painful) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, SARS-CoV-2 test: negative (Negative) negative. On 27-Apr-2021, Chest X-ray: pulmonary infiltrates at base of lungs. Pneumonia suspect. On 12-May-2021, Chest X-ray: pulmonary infiltrates still present but improved. On 26-May-2021, Chest X-ray: pulmonary infiltrates unchanged. On 08-Jun-2021, Antinuclear antibody: inconclusive (Inconclusive) inconclusive. On 08-Jun-2021, Computerised tomogram: pulmonary infiltrates present. On an unknown date, Antinuclear antibody: positive (Positive) positive Suspect reaction from covid vaccine.. On an unknown date, Blood pressure measurement: inconclusive (Inconclusive) inconclusive. On an unknown date, Body temperature: inconclusive (Inconclusive) inconclusive. On an unknown date, Heart rate: inconclusive (Inconclusive) inconclusive. On an unknown date, Respiratory rate: inconclusive (Inconclusive) inconclusive. Patient allergic to contrast results in delayed while body rash Treatment for the events included Zpak for bronchitis and nebulizer .Action taken with mRNA-1273 in response to the events was not Applicable. 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. This case was linked to US-MODERNATX, INC.-MOD-2021-065219 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Patient demographics, medical history, laboratory data, concomitant medications, treatment medications were updated. Additional serious and non serious events and reporter details were added.; 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. US-MODERNATX, INC.-MOD-2021-065219:Dose 1

Started having worsening shortness of breath, exertional dyspnea, paroxysmal nocturnal dyspnea 3 days after 2nd dose of COVID 19 modern a vaccine. transthoracic echocardiogram showed heart failure with reduced EF of 20-25%.

Low Blood Pressure; Had a heart attack; Very Dizzy; Hot; Very Weak; Very Sick; Eye Color changed; sharp pain behind the right eye; COVID ARM From injection site to elbow; COVID ARM Itchy From injection site to elbow; Swollen Lymph Node; COVID ARM Red Rash From injection site to elbow; COVID ARM Red Rash From injection site to elbow; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDIAL INFARCTION (Had a heart attack) and HYPOTENSION (Low Blood Pressure) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21-2A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced ILLNESS (Very Sick), EYE COLOUR CHANGE (Eye Color changed ), EYE PAIN (sharp pain behind the right eye), LYMPHADENOPATHY (Swollen Lymph Node), VACCINATION SITE ERYTHEMA (COVID ARM Red Rash From injection site to elbow) and VACCINATION SITE RASH (COVID ARM Red Rash From injection site to elbow). 28-Apr-2021, the patient experienced VACCINATION SITE REACTION (COVID ARM From injection site to elbow) and VACCINATION SITE PRURITUS (COVID ARM Itchy From injection site to elbow). On 14-Jul-2021, the patient experienced MYOCARDIAL INFARCTION (Had a heart attack) (seriousness criteria hospitalization and medically significant), DIZZINESS (Very Dizzy), FEELING HOT (Hot) and ASTHENIA (Very Weak). On an unknown date, the patient experienced HYPOTENSION (Low Blood Pressure) (seriousness criterion hospitalization). The patient was hospitalized from 14-Jul-2021 to 16-Jul-2021 due to HYPOTENSION and MYOCARDIAL INFARCTION. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Rash, at a dose of 1 dosage form. On 30-Apr-2021, ILLNESS (Very Sick), VACCINATION SITE REACTION (COVID ARM From injection site to elbow), VACCINATION SITE PRURITUS (COVID ARM Itchy From injection site to elbow), LYMPHADENOPATHY (Swollen Lymph Node), VACCINATION SITE ERYTHEMA (COVID ARM Red Rash From injection site to elbow) and VACCINATION SITE RASH (COVID ARM Red Rash From injection site to elbow) had resolved. On 16-Jul-2021, MYOCARDIAL INFARCTION (Had a heart attack) had resolved. At the time of the report, HYPOTENSION (Low Blood Pressure), DIZZINESS (Very Dizzy), FEELING HOT (Hot) and ASTHENIA (Very Weak) outcome was unknown and EYE COLOUR CHANGE (Eye Color changed ) and EYE PAIN (sharp pain behind the right eye) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jul-2021, Myocardial necrosis marker: high (High) HIGH. On an unknown date, Blood pressure measurement: low (Low) low. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication information was provided by the reporter. Patient reported that her eye color changed from hazel to blue and reported to have a yellow ring around the blue color. She also stated that when she fell dizzy and hot while doing the yard work she called in 911 for ambulance and was transported to emergency room and thereon was hospitalized. Patient reported that the paramedics did not give her any medication for her low blood pressure. 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.; Sender's Comments: 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.

EE received Covid-19 Moderna vaccine on 12/29/20 at 5:10 p.m. at Covid vaccination site. 12/30/20 at 3:00 a.m.EE had pain in left side, hip and leg waking EE up from sleep . Lesions times two, one on hip and one on posterior upper leg. MD insructed EE to double Vitamin C orally and to place Bacitracin on the two lesions, which at first appeared to contain bloody drainage. Lesions are now dry. VAERS document completed.

Developed hives within 2 hrs/took Benadryl that night; swelling that traveled up the arm and neck in the morning with shortness of breath/used rescue inhaler at 0400 and then again at 0800; and then anaphylaxis by 0900. Treated in ED with EpiPen then IV Solumedrol, Benadryl and Famotidine. Recovered and started on prednisone taper pack starting at 6 tabs for 3 days etc. Suggested to make follow up Dr appt for one week following incident/set for Feb 8

got up in the night and stated that she couldn't breath, ambulance was called, pt expired in route to hospital. *relayed to me by Facility staff RN.

02/08/21--2 days after vaccine--Resident stated that she "didn't feel good" (She is developmentally delayed and less able to communicate how she feels than those in the community) and stopped eating most foods; also had fatigue. Vitals, coloring, & behavior were normal. 02/09/21--Belly was firm and mildly distended (although she stated it didn't hurt); she coded this evening and CPR was performed before EMT could transport her to the hospital. 02/10/21--Resident passed.

Patient called EMS approximately 1pm on 2/15 with complaints of generalized weakness. Upon arrival EMS found her to be diaphoretic and she had a witnessed syncopal episode with question of v-fib and seizures. She became unresponsive and had no pulse. CPR was begun and she was transported to ED. She remained asystole throughout. CPR was initially continued in the ED for approximately 30 minutes and then stopped with Time of Death noted at 13:27. ED notes noted "suspect given history that patient experienced massive MI, PE or ruptured AAA". Death certificate notes indicate "signficant conditions contributing to death after cardiac arrest; ASCVD".

Very dizzy; Threw up; Episode of afib; Light headache; A spontaneous report was received from a consumer (patient), 63 years-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced, episode of A-fib (atrial fibrillation), very dizzy (dizziness), threw up (vomiting), and light headache (headache). The patient's medical history included episode of A-fib. Current conditions included diabetic and high blood pressure. No concomitant medications were reported. On 03 FEB 2021, seven days prior to the onset of events, the patient received their first of planned doses of mRNA-1273 (batch number: 038K20A), intramuscular in the left arm for the prophylaxis of COVID-19 infection. It was reported that two days ago, the patient had an episode of atrial fibrillation on 10 FEB 2021. The patient doesn't know if it was from the vaccine or something else. The patient usually has 2-3 times of atrial fibrillation a year. She didn't have any other side effects at all right after the vaccine. The patient was a diabetic and didn't call her doctor about this, because it went away. The patient described the atrial fibrillation episode as uncomfortableness and beating of the heart. The patient has an appointment with her cardiologist 2 days before her second shot, and she'd ask him about it. The patient was also wondering that the side effects occurred 8 or 9 days after the shot. She has high blood pressure and took a measurement, and it was normal at 93 (unknown units). The patient had the injection on her left arm because she has a diabetic monitor on right arm. The patient didn't take any treatment for the side effect except one time she took acetaminophen about three days ago when she had a light headache. On 12 FEB 2021, at about 10 am in the morning, the patient got very dizzy and had to sit down on the floor, and she threw up. After that, the patient was feeling fine. The patient gave consent to follow up from safety and to her doctor. No further treatment medications were reported. Action taken with second dose of mRNA-1273 in response to the events was not reported. The outcome of the events, episode of A-fib, and light headache were unknown and that of events very dizzy, and vomiting was recovering.; 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's medical history of having 2-3 times of atrial fibrillation a year, diabetic and high blood pressure are the risk factors and confounds to the causality.

Individual received her COVID vaccine and had no prior symptoms. 24 hours after the injection she developed significant shortness of breath and was seen in the ER where she was diagnosed with bilateral pulmonary embolism.

No reported adverse effects after vaccine was administered. Someone reported to our clinic that patient was found dead at home on Sunday

Patient had an adverse reaction to her first shot, unreported, mostly local to the injection. For this 2nd dose, she was not feeling well the day after the shot, but was at work. She did not show up for work on Friday and was found dead. Time of death was undetermined. She lived alone. An autopsy was not performed.

The nurse gave me shot however did not get in muscle was in subcutaneous area. Left large bruise and swelling and moderate bleeding after shot. My concern is did I get enough of the vaccine in me Since this was administration error.

DVT blood clot in left calf verified via utrasound on 2/17/2021. Symptoms: pain in left calf and foot proceeded by chills/fever and right fingers/hand inflammation. Symptoms began 2/08/2021.

Pt received injection of moderna second dose on March 09. 2021. PT was found unresponsive at 1:15pm on 3/14/2021 at home. was taken via EMS to ER. PT found to have subarachnoid hemorrhage. was transferred to a critical care facility for a higher level of care. Critical care services provided in ICU pt diagnosis of diffuse SAH likely aneurysmal. pt prognosis life threatening.

Patient received the first Moderna vaccine at nine o'clock Thursday morning, felt fine until 2pm. She began to feel feverish, achy, nauseous, weak. All symptoms lasted through Sunday when she passed out early in the morning. We found her on the kitchen floor, having hit her head and bleeding. She was conscious and alert but a little disoriented and very weak. We called for an ambulance which took her to the same facility where she had been vaccinated. She was diagnosed with a concussion and low blood pressure (62/49). Today she still feels weak and dizzy and nauseous. She has not returned to work yet, pending recommendation from her cardiologist and PCP.

I was achy and my arm was sore that night. I was fine until I started experiencing symptoms on the 1/5. So that night, I checked my temperature and had a low grade fever. I took a COVID test on 1/6 and was positive and I got treatment on 1/7. I ended up being out of work for two months due to a sinus infection and pneumonia. I'm still experiencing symptoms such as lung inflammation and SOB, so I'm on an inhaler, nasal spray, allergy meds and I did a sputum test today. I'm also scheduled to see a pulmonologist, who I also saw prior to COVID for breathing issues. I've had to do 3 rounds of antibiotics to resolve my pneumonia.

blood clots in upper thigh down to foot; swelling of the foot; tingling; clot was burning and hot; A spontaneous report was received from a consumer concerning a 62-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events blood clots in upper thigh down to foot, swelling of the foot, tingling, and clot was burning and hot. The patient's medical history included insertion of a blood clot filter. Concomitant medications reported were Xarelto for drug use for unknown indication. She is also taking 17 other medications (not provided) and has other medical issues (not provided). She also has a blood clot filter inside her body (location not provided). She also wears compression and diabetic socks. On 25 Feb 2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: L014M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the event(s) blood clots in upper thigh down to foot, swelling of the foot, tingling, clot was burning and hot. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), blood clots in upper thigh down to foot, swelling of the foot, tingling, clot was burning and hot 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.

Very hard to breath for few minutes; Swollen arm; Nausea; Headaches; Blood clogging; A spontaneous report was received from a consumer concerning a 63 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events very hard to breath for few minutes/dyspnoea, blood clogging/thrombosis, headaches, nausea, swollen arm/peripheral swelling. The patient's medical history included high blood pressure. Concomitant product use was not provided by the reporter. On 15 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot: 027L20A) for prophylaxis of COVID-19 infection. On 08 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (lot: 0101M20A) for prophylaxis of COVID-19 infection. The first dose of vaccine was taken in non dominant arm and second dose was taken in right dominant arm. On an unknown date, the patient experienced swollen arm. In between the two doses she felt very hard to breath for few minutes and when she took a deep breath it was fine. She had tylenol for the headaches after the second dose on 08 February 2021. She also had nausea along with headaches. She had blood clogging when she was in a blood donation camp. The event very hard to breath for few minutes and blood clogging were considered as medically significant. Thiamine was provided as medication The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. Follow-up received on 17 Mar 2021 included updated date for first dose of vaccine, and the events very hard to breath for few minutes/dyspnoea, blood clogging/thrombosis.; Reporter's Comments: Based on the current available information which shows a strong temporal association between the use of the mRNA-1273 and the reported events and excluding all other etiology, a causal relationship cannot be excluded. Nausea and headache are consistent with the safety profile of the product

pain in left arm, numbness. Then developed a itchy rash and a lump in the cubital fossa and swollen lymph nodes. Initially took benadryl, then went to the ED. An ultra sound showed a clot located in her left cubital fossa. Transferred to Med center started on eliquis and released from the hospital. Now complaining of pain in the left leg. Adv caller to follow up with her pcp about the pain.

Patient started losing her voice and having to clear her throat. Had history of anaphylaxis reactions to other medications in past. The reaction started happening approximately 5 minutes after vaccine given. Patient was given Benadryl 50mg IM in R arm. Vital signs were taken and noted to be stable except high blood pressure. Vital signs taken again after 5 minutes and remained stable with only slight decrease in BP. After approximately 10minutes patient had stopped clearing throat and her voice had returned and she was back to her baseline health. Was told to go to Emergency Room for elevated BP.

bilateral pneumonia required ICU admission required 6 liters of oxygen, all cultures , viral pathogens screen, blood and sputum were negative

See patient's account of the event below. Patient is not an established patient and did not receive care for her symptoms at our facility: On March 18th I received my 2nd Moderna vaccination. On Friday the 19th at approximately 4 pm I began to have the symptoms of an immune response in my body. Sat the 20th was spent in bed with chills, body aches, fever, stiff neck, and bad headache. On Sunday I was having pain on inhalation along with everything else. Monday the pain resolved into left side lung pain on inhalation. Tuesday the 23rd I called my provider who directed me to go to the Emergency Dept. I drove to Superior Hospital. After being accessed I was transported; with pericarditis and the additional mentioned immune response symptoms, and a pronounced heart murmur. On Wednesday the 24 I shook uncontrollably with chills for 4 hours and 2 min and went into atrial fib for about 12 minutes, resolved with medication. Thursday the 25th I woke to all symptoms being gone. I was released on Friday the 26th with the statement my issues had resolved themselves. I was told to report this to where I got my vaccine so it could be passed along.

I had a discoloration on my left breast and slight pain underneath my left arm. I had NO redness, NO swelling and NO heat underneath my arm. I had a mammogram and the radiologist asked for an ultrasound. The ultrasound revealed a deep vein thrombosis underneath my left arm.

I ended up with DVT blood clot. Injection was very painful and pain lasted 2 days, expected that. Day 3 woke with bright red rash, itchy, swollen and lumpy on inside upper arm. Could not get answers, lived on Benydril for 3 days. Day 4 called CDC, FDA, Health Dept & Moderna. Moderna was only person that I was able to talk to someone, had no clue. Had to google to find out I had Covid Arm since no one knew anything. Day 5 ..The lump moved or maybe different one to inside my inner elbow and was painful. Did not read pain as a symptom of Covid Arm and went to ER

After patient received vaccine she was accompanied by RN to observation area. In observation area patient was sitting in the chair with her head against the wall. RN asked patient if she was alright, patient stated, "she was not well". She was noted to be pale, glassy eyed. RN called for immediate assisatance. Pt was transferred with assitance to recliner. Patit responded to verbal commands, leaned back with feet elevated. Within Vitals 4 minutes were B/P 118/82, HR 99, Spo2 99% on room air, patient noted to be responsive. Patient stated she thinks she was having a panic attack. Vitals were taken B/P 56/40, unable to get reading for heart rate or pulse ox. Code called, Pt was transferred to ED, patient responsive.

may have had a heart attack; pressure in her chestuncomfortable feeling which lasted for a week; 6 short chest pains that felt like something was moving in her chest; felt really bad; tired/worn out; chills; a fever all night; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (may have had a heart attack) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 036A21A) 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). Concomitant products included LEVOTHYROXINE, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication. On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced FEELING ABNORMAL (felt really bad), FATIGUE (tired/worn out), CHILLS (chills) and PYREXIA (a fever all night). On 08-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (may have had a heart attack) (seriousness criterion medically significant), CHEST DISCOMFORT (pressure in her chestuncomfortable feeling which lasted for a week) and CHEST PAIN (6 short chest pains that felt like something was moving in her chest). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) from 08-Mar-2021 to 13-Mar-2021 for Heart attack, at a dose of UNK UNK, bid. On 11-Mar-2021, MYOCARDIAL INFARCTION (may have had a heart attack), CHEST DISCOMFORT (pressure in her chestuncomfortable feeling which lasted for a week), FEELING ABNORMAL (felt really bad), FATIGUE (tired/worn out), CHILLS (chills), PYREXIA (a fever all night) and CHEST PAIN (6 short chest pains that felt like something was moving in her chest) had resolved. Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

burning sensation in the lung; had labored breathing,they found several clots in right leg and lungs; It was shiny and hard and calf blewup twice the size,they found several clots in right leg; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (had labored breathing,they found several clots in right leg and lungs) and THROMBOSIS (It was shiny and hard and calf blewup twice the size,they found several clots in right leg) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Family history included Clot blood (Family history of clots; her father and his sister had clots after surgery). Concurrent medical conditions included Burning sensation. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced PULMONARY EMBOLISM (had labored breathing,they found several clots in right leg and lungs) (seriousness criterion medically significant) and THROMBOSIS (It was shiny and hard and calf blewup twice the size,they found several clots in right leg) (seriousness criterion medically significant). On an unknown date, the patient experienced BURNING SENSATION (burning sensation in the lung). At the time of the report, PULMONARY EMBOLISM (had labored breathing,they found several clots in right leg and lungs), THROMBOSIS (It was shiny and hard and calf blewup twice the size,they found several clots in right leg) and BURNING SENSATION (burning sensation in the lung) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound Doppler: several clots in right leg and lungs (abnormal) several clots in right leg and lungs. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant products were reported. Patient was taken to the ER (emergency room). The physician suspected blood clots and treatment included was blood thinner. Patient reported that "patient got ultrasound done on Monday, and they found several clots in right leg and lungs".; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded

Client was monitored after being Vaccinated for 15 minutes and staff observed no symptoms. DHS CRT was made aware of the death two days prior to 2nd dose Vaccine Clinic.

atrial fibrillation; achy; hand pain; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (atrial fibrillation) in a 63-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. The patient's past medical history included Atrial fibrillation. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criterion medically significant), MYALGIA (achy) and PAIN IN EXTREMITY (hand pain). At the time of the report, ATRIAL FIBRILLATION (atrial fibrillation), MYALGIA (achy) and PAIN IN EXTREMITY (hand pain) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Although the patient has history of atrial fibrillation, based on a strong temporal association, a causal relationship between the administration of and the event s reported cannot be excluded.; Sender's Comments: Although the patient has history of atrial fibrillation, based on a strong temporal association, a causal relationship between the administration of and the event s reported cannot be excluded.

Homebound visit complete 4/14/21 around 1230-1300, monitored for 15 minutes, left attended with home health nurse. Patient was found dead per EMS and had passed sometime during the night.

8 hours after shot severe headache that started in back of neck, freezing cold, shaking and shivering uncontrollably. Back ache. Shakes and shivers lasted 4 hours. Headache and back ache lasted 48 hours. Severe fatigue for first 24 hours, last 24 hours moderate fatigue. After 48 hours, I was back to 100% health. I took aspirin to begin with for the headache, then switched to ibuprofen when aspirin didn?t work for headache. Ibuprofen helped back ache immensely. Also, when pharmacist gave me the 2nd shot when I got home and changed clothes I realized I had bled a lot. Blood had oozed out from the bandage and down to my elbow. Arm sore for 2 days, and still swollen on 4th day a bit larger than golf ball size.

Herpes in genital area. This spot is where i generally have a herpes outbreak, but it was different this time. The lesion bleeds. Feels just like other herpes lesions. I am not sexually active, and have not had a herpes outbreak for a long time. When i had the first shot, which was 3/19/21, Moderna through, lot #037A21B, about a week after the first immunization, i developed a rash on my right abdomen, just below the rib cage. It was fine, closely spaced red bumps, very itchy. I thought at first it was chiggers, but the weather is cool and seems in the wrong place for chiggers. It seemed to become tiny blisters, and i started wondering if it was shingles. It stung and hung on for several days, weeping a little blood. but it cleared up quickly. While it was scabbing over, i had a larger blister on my right wrist. It looked almost like a fire ant blister, but again no ants. Felt very itchy, tingly, like the rash below my ribs. Within a day, the blister burst and bled. It took three or four days to heal. I thought these were weird at the time, but did not connect them to the vaccination, until i had the second dose, and my genital herpes blister bled. This is not yellowish pus, it is bright, arterial style blood, thin, but definitely blood.

Pt was in her usual state of health. Denied any past hx heart problems, works full time past medical hx sign for dm-2, obesity, htn and crohns disease. lifelong non smoker, no etoh use. received her 2nd covid 19 vaccination on 3/24/2021 then began having progressive sob starting on 3/28/2021. presented to the emergency room on 4/11/2021 with sign sob. cxr showing b/l pulmonary edema. pt admitted to the hospital with new onset heart failure. She ultimately underwent an angiogram which showed minimal non obstructive coronary artery disease after echocardiogram showed severe global hypokinesia and ejection fraction of 15%. She was diagnosed with idiopathic non ischemic cardiomyopathy. CT scan of the chest also showed new medistinal lymphadenopathy.

Confusion, slurred speech, ptosis of the right eyelid, lightheadedness, right facial droop and trouble with memory with associated soreness in right arm post Moderna vaccination second dose for COVID-19 on 23 March 2021. TIA vs vaccine reaction (symptom onset roughly 45 minutes post injection) CT of the head without contrast, CTA head and neck and MRI of brain without contrast, CTA head and neck showed mild beaded appearance of the distal cervical segment of the left vertebral artery consistent with fibromuscular dysplasia. There is no stenosis. MRI brain showed chronic microvascular ischemia DC with Plavix and neurology referral, symptoms resolved

pneumonia; sore back maybe from coughing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (pneumonia) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) 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 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced BACK PAIN (sore back maybe from coughing). On 03-Apr-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (pneumonia) and BACK PAIN (sore back maybe from coughing) had not resolved. 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. The patient's treatment included Prednisone 20mg 2pills for 5 days, Doxycycline 100mg twice a day for 10 days and Cefuroxime 500mg twice a day for 7 days.

Describe events and outcomes: Abrupt onset of palpitations on the morning of March 22, 2021. Went to previously scheduled medical appointment where they found my pulse rate to be over 200. ECG was performed and atrial fibrillation was diagnosed. Transported by ambulance to Hospital. Spontaneous conversion during the ambulance transport. Duration of symptoms: approximately 3 hours. Non-ST Elevation MI diagnosed in the hospital. Echocardiogram showed pericardial effusion. Hospitalized 1 day.

I had a A fib occurrence I had never had one before the 2nd shot. I went to the ER. They gave me 3 different medications to get back in rhythm. I was dehydrated and low on potassium so they gave me saline and potassium pills. So I got the shot at 2:30 pm and at 7:00 pm I started with the pounding in my chest. I called ask a nurse and she told me to go immediately to the ER. My pulse was 157. My blood pressure was 158/114. I was in the ER from 8:00 pm till 3:00 am. The doctor wanted to admit me but I refused. We went home when my rhythm was normal.

cardiac arrest, ventricular fibrillation, new large brain aneurysm. anoxic brain injury. She was found in her car down with cardiac arrest in ventricular fibrillation. She was intubated and found to have brain aneurysm that is new. She suffered anoxic brain injury and was in vegetative state. aneurysm is left alone due to poor neurologic function per neurosurgery. Pt is placed on comfort care and waiting for expiration

a week after receiving the vaccine I started feeling shortness of breath. It progressively got worse and on April 23, 21 was admitted into Hospital with blood clots to the left leg and to my lungs.

Fever up to 104, pneumonia diagnosis, very high blood pressure over 200. Hospitalized on antibiotics for 24 hours.

Stroke; Sounded delirious; Could not form words; My blood pressure was 250 over something; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke), DELIRIUM (Sounded delirious), APHASIA (Could not form words) and BLOOD PRESSURE SYSTOLIC INCREASED (My blood pressure was 250 over something) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21-2A and 014M20A) for COVID-19 vaccination. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included METHOTREXATE for Rheumatoid arthritis, FOLIC ACID, ALENDRONATE SODIUM (FOSAMAX), VITAMIN B12 [VITAMIN B12 NOS] and CALCIUM for an unknown indication. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion hospitalization), DELIRIUM (Sounded delirious) (seriousness criterion hospitalization), APHASIA (Could not form words) (seriousness criterion hospitalization) and BLOOD PRESSURE SYSTOLIC INCREASED (My blood pressure was 250 over something) (seriousness criterion hospitalization). The patient was hospitalized from 03-Apr-2021 to 05-Apr-2021 due to APHASIA, BLOOD PRESSURE SYSTOLIC INCREASED, CEREBROVASCULAR ACCIDENT and DELIRIUM. On 05-Apr-2021, CEREBROVASCULAR ACCIDENT (Stroke) had resolved. At the time of the report, DELIRIUM (Sounded delirious), APHASIA (Could not form words) and BLOOD PRESSURE SYSTOLIC INCREASED (My blood pressure was 250 over something) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure systolic: 250 (High) 250. In 2021, Magnetic resonance imaging: abnormal (abnormal) confirmed that Patient had a stroke. Patient stated that on 3APR2021, 4 days after receiving the 2nd dose of the COVID-19 vaccine, she experienced a stroke. She says that she was with her daughter and per her daughter, the patient starting sounding delirious and not making any sense. She could not form words. The patient's daughter called 911. When the paramedics checked her blood pressure, the systolic number was 250. Patient does not remember the diastolic blood pressure. She was told to go to the ER. When she reached there, she says that she was having difficulty forming words. This was happening randomly and not all the time. She was admitted to the hospital for 2 days. An MRI done at the hospital confirmed that the patient had suffered a stroke. She was put on Lipitor and Plavix at the hospital and told to continue those medications for a month. She was discharged from the hospital and sent back home on 5APR2021. She states that with all the tests that were done at the hospital, the doctors are unsure what could have caused the stroke. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. 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.

I felt fatigued, tired , no appetite and ran low grade fever starting the evening after vaccination. This continued with dry heaves, poor appetite and vomiting Sunday and Monday. Tuesday evening I ran fever of 102.4, took Tylenol and promptly vomited. Then I noticed my heart racing. Took my BP which was 107/60 and hear rate 150s. I had my brother take me to the Medical Center where I was admitted for observation. I was told the I was in A Fib with rapid ventricular response. I was given 15 mgm of dialtizem IV x two, one liter of IVF and then converted to NSR. I was admitted overnight for observation

Client admitted to the hospital on 4/26/2021 with Covid symptoms, body aches, SOB and chest pain. Diagnosed with Covid -19 pneumonia. Antigen test positive for Covid-19 on 4/26/2021. Subsequent admission on 5/4/2021 with cardiac arrest secondary to hypovolemic shock from UGI bleed, likely variceal. Client died 5/5/2021.

Acute hypoxic respiratory insufficiency secondary to Covid pneumonia with concerns for possible superimposed bacterial pneumonia. feeling increasingly sick, with fevers, nausea, chills, shortness of breath, loss of taste, and poor appetite. Please take Augmentin 1 g twice daily for 1 day. Please continue taking dexamethasone 6 mg once daily for the next 5 days. Please start taking Lipitor 40 mg once daily.

epiploic appendages; nausea; dizziness; blood clot; pain on left side of abdomen; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D17B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced THROMBOSIS (blood clot) (seriousness criterion medically significant) and ABDOMINAL PAIN (pain on left side of abdomen). On 03-May-2021, the patient experienced DIZZINESS (dizziness) and NAUSEA (nausea). On an unknown date, the patient experienced EPIPLOIC APPENDAGITIS (epiploic appendages). At the time of the report, THROMBOSIS (blood clot), ABDOMINAL PAIN (pain on left side of abdomen), DIZZINESS (dizziness), EPIPLOIC APPENDAGITIS (epiploic appendages) and NAUSEA (nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Computerised tomogram: epiploic appendagitis Epiploic Appendagitis. 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. Treatment given included antibiotic amoxicillin/clavulanic acid. Company Comment: 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. However, Very limited information regarding this events has been provided at this time. Further information has been requested.; 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. However, Very limited information regarding this events has been provided at this time. Further information has been requested.

Pt w/hx of COPD/current smoker presented to ED w/2 week episode of dizziness, syncopy, poor appetite, chills, N/V/D with no SOB or fevers. Pt stated that she may have had COVID infxn months ago prior to receiving Moderna vaccines on 2/25 & 3/25. CXR impression consistent w/known COVID-19 infection upon workup and subsequent positive COVID test (5/8). Admitted on 5/5 for additional management of acute hypoxic respiratory failure d/t bilat PNA. Pt received dexamethasone, convalescent plasma, and tocizumab and is still in hospital requiring 9L of O2.

DVT of bilateral lower extremities and bilateral pulmonary edema. Treated with apixaban 5 mg per standard dosing. Hospitalized 4/27/2021 and discharged 5/4/2021. Patient convalescing at home. Tentative return to work date 5/24/2021. Follow-up hematologist consult due on 5/10/2021 and follow-up pulmonary consult due on 5/19/2021.

May 5 ,2021 patient became dizzy, diarrhea, syncopal poor appetite, feeling lethargic, having chills. "I couldn't keep anything down"

The patient states she woke up the morning after the vaccination and was in A-Fib. She states she has a pacemaker and has been in A-Fib before, but has not had an episode in "quite a while" She wondered if the episode could be related to the vaccine.

Patient presents with 7 day history of shortness of breath. Ct angiogram showed multiple pulmonary emoblism with ventricular strain. Patient required EKOS procedure for clot dissolution and bridging from Lovenox to warfarin.

After second vaccination: Initially: Sudden experience of very low BP - 91/41 - fatigue, shortness of breath, dizziness, unable to go to work. Vertigo. One week later and continuing: heart palpitations, a fib, fluttering, shortness of breath, dizziness, fatigue, nausea, low BP, and unable to go to work.

Pt. presents to ED on 06/02/2021 at 0900 with c/o dizziness and sweaty while she was doing dishes. Pt. reported "feeling like she was drunk". Pt. denied any pain or SOB. Pt. does have hx. of A-fib. Pt. also admitted to not eating any breakfast. Pt. was discharged to home with diagnosis of thrombocytopenia, instructed to hold her Eliquis and to contact her PCP in the next few days. EKG did not show A. Fib so PA-C felt okay to hold Eliquis.

Idiopathic thrombocytopenia purpura, rash starting 1 week prior to presenting to the hospital on 6/15/2021

Bleeding; Pain in hip; Flu; pain; arthritis waking up; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bleeding) in a 63-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. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. Concurrent medical conditions included Rheumatoid arthritis, Fibromyalgia and Osteoarthritis. On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 13-Apr-2021, the patient experienced INFLUENZA (Flu). In April 2021, the patient experienced ARTHRITIS (arthritis waking up) and PAIN (pain). On an unknown date, the patient experienced HAEMORRHAGE (Bleeding) (seriousness criterion medically significant) and ARTHRALGIA (Pain in hip). At the time of the report, HAEMORRHAGE (Bleeding), ARTHRITIS (arthritis waking up), INFLUENZA (Flu) and PAIN (pain) outcome was unknown and ARTHRALGIA (Pain in hip) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Arthrogram: abnormal (abnormal) found blood in it. On an unknown date, Arthroscopy: unknown (Inconclusive) unknown and unknown (Inconclusive) unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Lab tests also included Left and right hip arthroscopy but the results were unknown. She got arthrogram of her hip done and there was blood in it and she got injected with an unspecified steroid gel. The patient also underwent a total knee replacement. Company comment: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.

I formed bl9od clots in rt. leg. Discovered when foot swelled. Went to PCP and later was sent to er for ultrasound on leg. On 6/09/2021.

Went into Afib with RVR. Required treatment at emergency room. Heart rate converted. Only 7/5/21 again had episode of Afib, required treatment at hospital and admisson to hospital. Discharged requiring 3 medications. Now in controlled heart rate with periods of normal sinus rhythm that goes into Afib and returns to normal rhtthm

After receiving dose 1 of the Moderna COVID19 vaccine on 4/6/2021 I suffered a heart attack (MI) on 4/21/2021.

3 weeks after initial dose I had a stroke. In hospital 2 weeks in rehab 2 weeks. Many CT Scans and MRI'S. Heart checked, blood work, neurologist. Reason for stroke unknown

Three days (03/06) I had go to the emergency room. I was diagnosed with a Pulmonary embolism. I couldn't breathe good.

DVT blood clot from the vaccine; lost 10 lbs that I can not afford to lose, 105 lbs now; Anxiety; pain in my legs; itchy rash that went from her elbow all the way up to her shoulder from her vaccination arm; feeling nauseous; lump on the underside of her biceps; arm sore all day at the injection site and the next day she couldn't even lift it up; Arm sore at the injection site, couldn't lift up arm; This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (DVT blood clot from the vaccine) in a 63-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. Concurrent medical conditions included Iodine allergy. Concomitant products included CLONAZEPAM for Anxiety, CITALOPRAM and MORPHINE SULFATE (MORPHINE SULPHATE) for an unknown indication. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm sore at the injection site, couldn't lift up arm). On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm sore all day at the injection site and the next day she couldn't even lift it up). On 25-Mar-2021, the patient experienced NODULE (lump on the underside of her biceps), RASH PRURITIC (itchy rash that went from her elbow all the way up to her shoulder from her vaccination arm) and NAUSEA (feeling nauseous). On an unknown date, the patient experienced DEEP VEIN THROMBOSIS (DVT blood clot from the vaccine) (seriousness criterion medically significant), WEIGHT DECREASED (lost 10 lbs that I can not afford to lose, 105 lbs now), ANXIETY (Anxiety) and PAIN IN EXTREMITY (pain in my legs). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and APIXABAN (ELIQUIS) ongoing since an unknown date for DVT, at an unspecified dose and frequency. At the time of the report, DEEP VEIN THROMBOSIS (DVT blood clot from the vaccine), WEIGHT DECREASED (lost 10 lbs that I can not afford to lose, 105 lbs now), ANXIETY (Anxiety), NODULE (lump on the underside of her biceps), PAIN IN EXTREMITY (arm sore all day at the injection site and the next day she couldn't even lift it up), PAIN IN EXTREMITY (pain in my legs), RASH PRURITIC (itchy rash that went from her elbow all the way up to her shoulder from her vaccination arm), VACCINATION SITE PAIN (Arm sore at the injection site, couldn't lift up arm) and NAUSEA (feeling nauseous) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication taken by the patient included steroid injection for her back. On an unknown date, the patient stated they had been to the hospital three separate times after receiving their first Moderna COVID-19 vaccine. While in the emergency room (ER) the patient suggested they do an ultrasound of the beet red, swollen, hot and itchy lump of the left arm. The ultrasound was performed and confirmed the patient had a deep vein thrombosis (DVT). It was recommended the patient had a scan of her lungs. However, the patient had an allergy to iodine and the hospital at that time did not have a machine that could perform such scan. The patient was transferred to a new hospital to have the scan performed. The unspecified scan of the lungs did not show any clots. On an unknown date, the patient reported going back to the hospital on two separate occasions for pain in the legs. An ultrasound was performed and confirmed no clots in the legs. The patient reported fear and anxiety after experiencing the DVT. This case concerns a 63-year-old female with a serious unexpected event of deep vein thrombosis, and nonserious weight decreased, anxiety, nodule, pain in extremity, rash pruritic, and vaccination site pain. Event latency within 24 hours after first dose mRNA-1273. 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. Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Case Upgraded to Serious. Added lab data which includes Ultrasound. Added allergy to iodine. Added new events DVT blood clot from the vaccine, weight loss and anxiety.; Sender's Comments: This case concerns a 63-year-old female with a serious unexpected event of deep vein thrombosis, and nonserious weight decreased, anxiety, nodule, pain in extremity, rash pruritic, and vaccination site pain. Event latency within 24 hours after first dose mRNA-1273. 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.

Fever up to 103.6 F for 3 days; rigors; headache; fatigue; bilateral pneumonia, cough, occasional vomiting

Pt. presented to the ER with abd pain and septic shock. Pt. reported to feel ill shortly after receiving the vaccine.

Deep vein thrombosis; pulmonary embolism; A spontaneous report was received from a 64-year-old female consumer who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed deep vein thrombosis and pulmonary emboli. The patient's medical history was not provided. Concomitant product use was not provided. On 05 Jan 2021, approximately 3 weeks prior to the onset of the events, the patient received first dose of mRNA-1273 (Lot number: 037K20A) intramuscularly for prophylaxis of COVID-19 infection. On 26 Jan 2021, the patient reported she was hospitalized for deep vein thrombosis and pulmonary emboli. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, deep vein thrombosis and pulmonary emboli, were considered unknown.; Reporter's Comments: This case concerns a 64-year-old, female patient. The patient's medical history was not provided. The patient experienced serious, unexpected event of Deep vein thrombosis and pulmonary embolism. The events occurred 22 days after the first dose of mRNA-1273 (Lot number: 037K20A) administration. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Additional information has been requested for further assessment.

Moderna vaccine #1. High heart rate and atrial fibrillation reported by Watch over three day period beginning about 3 hours + after injection. . Resting heart rate was up to 167 at one time and sleeping rate was up and down in the low 100?s Did several ECGs and atrial fibrillation reported several times. Heart rate began to subside after a full two days with spikes. Monitored through weekend to be sure no further spikes. Have copies of reports. Called and reported to physician on 2/16. Called VARES and Moderna to report and no return calls as yet as no choice but to leave voice mail.

Platelet count of 28,000; Generalized body pain all over; Weakness; On and off Chills; Low grade fever; Injection site soreness; A spontaneous report was received from a consumer who was a 64-year-old, female patient who developed a platelet count of 28,000 (thrombocytopenia), generalized body pain all over (general body pain), weakness (asthenia), on and off chills (chills), low grade fever (pyrexia), and vaccination site soreness (injection site pain). The patient's medical history was not provided. Concomitant product use was not provided. The patient received their first of two planned doses of mRNA-1273 (lot number 039K20A) on 31 Dec 2020. On 28 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (lot number 209K20A) in the left arm for prophylaxis of COVID-19 infection. On an undisclosed date the patient experienced injection site soreness, generalized body pain all over, chills, low grade fever and weakness. She also went to the hospital because she had a platelet count of 28,000. Treatment of these events was not provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable. The outcome of the events, platelet count of 28,000, generalized body pain all over, weakness, on and off chills, low grade fever, and vaccination site soreness, 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 events, a causal relationship cannot be excluded.

Per ED note: Brought in ED by EMS at 1945 for acute shortness of breath and hypotension. Patient was placed on supplemental oxygen and covid test completed. Patient was placed on BiPAP to maintain oxygen greater than 90%. Found to be in metabolic acidosis. Patient became unresponsive and pulse could not be palpated. Chest compressions were initiated. ACLS medications given and pulses regained. Patient lost pulse 30 mins later and never regained pulse. Per ED noted; likely developed a PE. Passed away at 2127

Moderna COVID-19 Vaccine EUA adverse event. Approximately 7 hours after the 1st COVID vaccination on 2/22/2021, patient developed symptoms of fatigue, aches, chills & fever. Her symptoms worsened into 2/23/21 with increasing shortness of breath. On arrival in the emergency center on 2/23/21, she was hypoxic with SpO2 81% on room air. Oxygen supplement via nasal cannula was given which improved her oxygenation. Covid 19 test negative. Chest Xray shows pulmonary edema and CTA chest shows no PE. She was admitted to the hospital and provided supportive care. Pulmonary Edema and inflammatory process is likely associated with the vaccine. Patient appeared to be improving, however, on 2/26/21, she was working with Physical Therapy/Occupational Therapy and had a pulse ox reading of 75% on room air. She was on 10 Liters of oxygen via nasal cannula by the time she make it back to bed and her pulse ox was 89%. Neurology exam shortly afterward the above event demonstrated an NIHSS of 21. Patient became non-verbal and stat imaging revealed an acute hemorrhage in the left occipatal lobe likely representing a SAH. Patient then transferred to another hospital that could provide neurosurgical intervention.

Atrial fibrillation; Feeling fluttery; Heart rate was racing and was increasing, went up to 175 just sitting; A spontaneous report was received from a consumer concerning a 64-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced atrial fibrillation, feeling fluttery, and heart rate was racing and was increasing, went up to 175 just sitting. The patient's medical history was not provided. Concomitant medications included Travatan for glaucoma. On 12 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot/batch: 030M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 12 Feb 2021, five hours after vaccination, the patient experienced a fluttery feeling, heart rate was racing and was increasing, heart rate went up to 175 just sitting. She took an EKG on her watch and it was atrial fibrillation. When she was sleeping, her heart rate was at 102 or the 90s, normally it would be in the 60s. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the events, atrial fibrillation, feeling fluttery, and heart rate was racing and was increasing, went up to 175 just sitting, was unknown.; Reporter's Comments: This case concerns a 64 year old female patient, who was on hospice care experienced a fatal event of death, 1 day after receiving second dose of mRNA- 1273 (Lot# 030M20A). Very limited information regarding this event has been provided at this time. Further information has been requested.

Patient received first vaccine dose on 3/10/21, waited for approximately 1 hour in Pharmacy after. Was walking to her vehicle and became short of breath. Patient got to her vehicle and called 911 due to severe shortness of breath. Rescue arrived on scene at approximately 11:00am, found patient in distress and administered epinephrine, methylprednisolone, and diphenhydramine. Patient placed on CPAP in rescue en route to ER, became unresponsive, frothing pink sputum. Intubated by paramedics en route with iGel device. Patient arrived to ER at 11:22am, went into cardiac arrest at 11:24am. Patient continued to be unstable, had multiple rounds of cardiac arrest and ROSC. Patient ultimately did not survive arrests, and pronounced dead at 2:37pm. Medications received during course in the ER - epinephrine 1mg x18 doses, sodium bicarbonate 50mEq x4 doses, calcium chloride 1g, insulin regular 10 units x1, furosemide 80mg x1, epinephrine titrated infusion, sodium bicarbonate infusion.

No adverse reactions at the time of vaccine. Was admitted to hospital 5 days later with BLL pneumonia and passed away on 03/10/2021

Acute stroke (Expressive aphasia) . Went to emergency room, and hospitalized for 2 days. Left temporal ischemic stroke was diagnosed. Aspirin, Plavix, tPA, Atorvastatin were used. Discharged in 2 days with pretty good recovery.

3/20/21 06:22 pm Resident c/o Nausea and feeling full- Tube feeding placed on Hold- Resident started vomiting- Zofran 4 mg given- Positive outcomes. 03/21/2021- 0430 Resident found unresponsive on morning rounds- w/ weak pulse, shallow breathing. O2 via NC increased to 5 L, NP, Family ( Code Status DNR)- Power of attorney ordered to send out- MR notified- Upon arrival no rhythm detected- Death pronounced at 0445

Patient has A. Fib and on the first dose the EMS was called because of her rapid heart rate. Patient HR became 115 bpm after second dose. Onsite EMS was called vitals HR 95 BP 175/96. Symtoms subsides and was able to go home.

2/25/2021 She was taken to the hospital for aspiration. 03/09/2021 was discharged, but relatives were informed that she was unwell. 3/13/2021 When they went to take the rounds she was without signs, she was sleeping. He refers that the patient died of Aspiration Pneumonia and was tested at the Hospital with negative results. They certify death due to cardiovascular arrest

Brain bleed; Platelet count droppped to 40; Bruises all over the body; Organs shut down; A spontaneous report was received from a consumer concerning a 64-year-old female patient, who experienced bruises all over the body (contusion) , brain bleed (cerebral haemorrhage), platelet count dropped below 40 (platelet count decreased) and organs shutdown (multi organ failure). The patient's medical history included bacterial infection 2 days prior to receiving vaccine dose. Product known to have been used by the patient, within two weeks prior to the event, included antibiotics (not specified). On 02 Mar 2021, the patient received her first of the two planned vaccine doses of mRNA-1237 (Lot # unknown) for prophylaxis of Covid-19 infection. On 03-Mar-2021, the patient developed severe bruises all over her body. On 04 Mar 2021, within 2 days after receiving the vaccination, the patient was rushed to the hospital where it was determined that she had sustained a brain bleed. She had all her organs shutdown and her platelet count had dropped below 40. On 04 Mar 2021, it was reported that the patient died. The cause of death was reported as organ failure. Plans for autopsy were not provided. Action taken with the mRNA-1273 in response to the events was not applicable. The outcome of the events, bruises all over the body(contusion), brain bleed(cerebral haemorrhage), platelet count dropped below 40(platelet count decreased) were 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. However, the patient's underlying history of bacterial infection could be a contributory factor. Awaiting further clarification.; Reported Cause(s) of Death: Organ Failure

Stroke; Bad headache; Very tired; Right side of her body numb; A spontaneous report was received from a consumer, concerning a female patient (herself) of 64-years-old, who received Moderna's COVID-19 vaccine and experienced headache, tiredness, stroke/ Cerebrovascular accident and right side of her body numb/hypoaesthesia. The patient's medical history included high blood pressure, migraine, high cholesterol, obesity, fusion of spine and neck surgery and numbness on the right side. Products known to have been used by the patient, within two weeks prior to the event included unspecified blood pressure medications. On 18 Mar 2021, approximately four days prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number: 006B21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 18 Jan 2021 night, the patient experienced a bad headache and was very tired. On 20-Mar-2021, the patient felt better and went for a walk. On 21 Mar 2021, Sunday, at 1:00 am the patient experienced stroke and was hospitalized subsequently. The event stroke was considered as medically significant and required hospitalization. On 24 Mar 2021, the patient was discharged from hospital and she stated that the stroke had left her entire right side of the body numb. Treatment for the events included atorvastatin, aspirin. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events headache, tiredness, stroke/cerebrovascular accident was considered as resolved/recovered on 24 Mar 2021. The outcome of the event right side of her body numb/hypoaesthesia was considered as not recovered at the time of this report.; 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.

After having immunization on 3/25/2021, began feeling weak with low grade fever (99.9) after feeling like that for a day, daughter (nurse) noticed drawing of facial muscles and weakness to left side. took her to local hospital where they then transferred her to another hospital where they admitted her and performed a CT of brain which was positive for a stroke. Patients daughter states patient continued to run low grade temp until yesterday and is being discharged today

Had systems of fatique and chest pain. Went to hospital of 4/12/2021 . Learned that had blood clots in lungs that I previously did not

Shortness of breath , extreme pain 3 hospital visits until blood clot was detected,now on blood thinner Eliquis

immune mediated thrombocytopenia, anemia, pulmonary embolism, pulmonary infiltrates. treated with IVIG x 2 days and prednisone 120 mg daily. started on heparin drip.

Cranial and spinal SAH hematoma at roughly same time as heart attack. Cause of hematoma was unknown. Potentially a side effect of elliquis; but her cardiologist does not believe ellipsis was the cause. Heart attack at similar time due to blood clot and blocked artery and possibly reaction of body to hematoma. We do not have any hard data that either are related to the vaccine; but are reporting them under the advice of a doctor to give information for science.

Patient per tracking received 2nd COVID vaccine on 4/5/2021 from Health Department. Patient to Hospital Emergency department via EMS 4/6/2021 with cardiac arrest and death

64 year old female with a history of Non-ischemic cardiomyopathy with defibrillator in place. She received the Moderna Vaccine at clinic on 2/26 and on 3/26 (Lot# 014M20A and 031A21A respectively). She had not received any device therapy for at least one year and had not been hospitalized in over one year. She presented to ED on 3/27 after her defibrillator fired. She was transferred to hospital and evaluated by EP there who felt that ventricular fibrillation prompting defibrillator therapy was triggered by COVID vaccine. After discharge on 3/31, she had another VF episode. On 4/2 admitted awaiting EP consultation. 4/5/21 DISCHARGE SUMMARY STATES: #Recurrent defibrillator therapy in setting of Recurrent VF : AICD interrogation showed underlying rhythm to be Vfib. Possible adverse event associate with vaccine reported to VAERS. Interrogation at emergency department on 3/27 revealed 14 beats of polymorphic V. tach, possible lead misplacement. S per hospital showed lead appropriately positioned. Repeat echocardiogram done at hospital demonstrated an EF of 45 to 49%, device was reinterrogated there. She was seen by EP at that time with recommendations to continue home beta-blocker and follow-up. Upon return to emergency department, cardiology was reconsulted and communicated with EP with recommendation for stopping metoprolol and starting Nadolol 40mg BID and Mexiletine 150 BID. She did not have any further ventricular tachycardia for over 48 hours after this change and was felt safe for discharge home on these two medications.

about 10 hours later increased sob and chest tightness and then hypoxia and hospitalization x 4 days and IV steroids Patient is a 64 y.o. female with PMH notable for von Willebrand disease, asthma, OSA on CPAP, DMT2, HLD, lumbar stenosis, chronic opioid use, GERD, PUD, and anxiety who presents with SOB, weakness, fever. Patient with history asthma, controlled on symbicort and PRN albuterol, now with progressive worsening SOB since the day prior to admission, patient received 2nd dose of Moderna COVID-19 vaccine on 03/10/21. Also, with chest tightness, body aches, headache and chills. Was up last night with fever 101F, took ibuprofen. She had worsening wheezing and SOB while bring dog to dog groomer and had groomer call ambulance. EMS called, received albuterol nebs in route with some improvement in symptoms. Chest tightness has improved. SOB improved now at rest but still winded when up to bathroom. Vitals on arrival notable for BP 144/55, HR 125 (sinus tach on EKG), temp 102.1F, RR 22, 92% on RA. Labs notable for WBC 8.6, CR 0.54. Normal LFTs. Lactate 3.3. D-dimer 0.9. pBNP 56, troponin <0.012. COVID-19 PCR panel negative. CXR with Chronic linear atelectasis or scarring at the lung bases, unchanged. CT PE study negative for PE, possibly some mild pulm congestion, increased interstitial markings. Patient given 2L NS in ED as well as ceftriaxone 2g and doxycycline 100mg. Patient will be admitted to inpatient for further evaluation and management of sepsis. Met sepsis criteria given fever, tachycardia, elevated lactate. Infectious source most likely pneumonia (though only slight increase interstitial markings on CT). Could be atypical or viral pneumonia. However, timing of symptoms could also fit with reaction to COVID-19 vaccine and asthma exacerbation. COVID-19 negative and influenza negative. Was treated with abx for CAP and prednisone + albuterol for asthma exacerbation. Lactate normalized with IVFs, fevers and tachycardia resolved. Patient able to wean to RA, dyspnea and wheezing slowly improved. Abx narrowed to cefzil, doxycycline. 1/2 admission blood cultures positive for streptococcuss. Patient was febrile and septic on admission. Subsequent blood culture without growth to date. Abx returned to IV ceftriaxone given strep + BCx.. Low blood cultures x2 were negative at 48 hours. Dr. was consulted over the phone and he recommended 5 days of oral amoxicillin on discharge. Chronic medical conditions were stable while hospitalized. No medication changes were made.

Presented to the ED on 4/18/21 with tachycardia and shortness of breath. Found to have bilateral DVTs and bilateral pulmonary emboli - confirmed with imaging. As a result, was found to have obstructive shock with presumed right heart failure. She received 50mg of systemic TPA along with catheter directed thrombolysis. Remains critically ill in the ICU.

Patient was admitted to Hospital on 4/12 with shortness of breath and diagnosed with Acute Pulmonary Embolism .

On April 13th, patient noted a black spot in her vision with her right eye. As the day progressed, she began experiencing a headache which worsened in severity despite treating with medication. She started treating with Tramadol; when that didn't help, she took her prescription oxycodone (5mg/325mg) 3 hours later, q6 hours x 2. That evening, patient experienced 1 episode of emesis and thought she may not be feeling well, so went to bed. When she woke the next morning, she felt better, but still noted the black spot in her vision. She sought care with her Ophthalmologist, who evaluated her, and he did not believe it was related to her vision. He referred her for an MRI, immediately. MRI revealed a stroke in the occipital region. She was admitted and given IV fluid along with another panel of testing. She was seen by Neurologist and Hospitalist; more testing was completed on Friday, including bloodwork which revealed high potassium levels which was treated. She was also given 1 unit of blood. She discharged on Friday and was started on Clopidogrel (75 mg). Follow up appointments are scheduled with eye doctor, neurology, internist. Right eye was affected and vision will not likely return, per her doctors.

Diagnosed with Bell´s Palsy; Stroke; Second dose scheduled 2 days past her 42 days; terrible dizziness; double vision; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and FACIAL PARALYSIS (Diagnosed with Bell´s Palsy) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included High cholesterol, Hypertension and Thyroid disorder. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant), DIZZINESS (terrible dizziness) and DIPLOPIA (double vision). On 10-Apr-2021, the patient experienced FACIAL PARALYSIS (Diagnosed with Bell´s Palsy) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose scheduled 2 days past her 42 days). The patient was hospitalized from 28-Mar-2021 to 31-Mar-2021 due to CEREBROVASCULAR ACCIDENT, and then from 10-Apr-2021 to 13-Apr-2021 due to FACIAL PARALYSIS. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), FACIAL PARALYSIS (Diagnosed with Bell´s Palsy), DIZZINESS (terrible dizziness) and DIPLOPIA (double vision) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose scheduled 2 days past her 42 days) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient had a stroke that affected her right side and affected her vision. She stated she had a very mild case of bells palsy, her mouth and her left side was drooping a bit, her left eye did not blink and would not close, she could chew and she could talk pretty good, she had to drink with the right side with a straw. Products known to have been used by the patient, within two weeks prior to the event, included unspecified cholesterol medication, high blood pressure medication and unspecified thyroid medication. Treatment medications included: prednisone, 5 or 6 medications for the heart and valacyclovir HCL 1g tablet. This report refers to a case of Inappropriate schedule of product administration for mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events (stroke, facial paralysis, dizziness, and diplopia), a causal relationship cannot be excluded.; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events (stroke, facial paralysis, dizziness, and diplopia), a causal relationship cannot be excluded.

She had the vaccine, felt shortness of breath and fever and chills on 4/16/21. On 4/18/21 she felt pain and discomfort on the left leg, and she had left leg DVT and bilateral pulmonary embolisms. Left leg was found on US, and pulmonary embolism was found on 4/22/21 on CT. She has been given Heparin drip and he does not know when she will be released. She is having difficulty breathing, shortness of breath mainly with activity.

I because confused and unsteady. I then fell. My husband helped me up but he knew something was wrong. He called 911 an ambulance took me to the hospital but I was transferred to another hospital. In case I needed surgery. It was touch and go. I was suffering a stroke. A blood clot was also found. I was in the hospital ICU for 3 days then transferred to another room. For another day.

anaphylactic shock; difficulty breathing; faced was paralyzed; rash on arms and chest; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic shock), DYSPNOEA (difficulty breathing) and FACIAL PARALYSIS (faced was paralyzed) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 008B21A) 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 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (anaphylactic shock) (seriousness criterion life threatening), DYSPNOEA (difficulty breathing) (seriousness criterion medically significant), FACIAL PARALYSIS (faced was paralyzed) (seriousness criterion medically significant) and RASH (rash on arms and chest). At the time of the report, ANAPHYLACTIC REACTION (anaphylactic shock), DYSPNOEA (difficulty breathing), FACIAL PARALYSIS (faced was paralyzed) and RASH (rash on arms and chest) outcome was unknown. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment medication included epinephrine injection. 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. This case was linked to MODERNATX, INC.-MOD-2021-081859 (E2B Linked Report).; Sender's Comments: 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. MODERNATX, INC.-MOD-2021-081859:Crossed linked

MULTIPLE BILATERAL PULMONARY EMBOLI NONOCCLUSIVE RIGHT POPLITEAL DVT OCCLUSIVE RIGHT POSTERIOR TIBIAL VEIN AND RIGHT SMALL SAPHENEOUS VEIN THROMBOSIS PATIENT BEGAN TO DEVELOP LEFT FLANK PAIN FOUR DAYS FOLLOWING VACCINATION FOLLOWED BY SEVERE SHORTNESS OF BREATH WITHIN THE FOLLOWING DAYS

On Monday January 18th, I woke up grapping for air, unable to breathe. Was taken to the ER at hospital and admitted with blood clots in my lungs.

Thrombocytopenia. No bruising or symptoms stated since last dose of vaccine on 01/27/2021. Patient just went for annual labs and discovered it. Experienced Dry. crusty rash on body. Patient is on high-dose corticosteroid therapy. Patient seeing Hematologist.

Received Moderna vaccine, 2nd dose 4/19/2021. On 4/24.2021 experienced a stroke . Pt awoke morning of 4/24/2021 with "severe vertigo and vomiting".

Vaccine was administered at 12:10pm The patient was observed for 15 minutes and sent over to her oncologist for an appointment. A CT scan was ordered- CT done (no contrast) in the same building with daughter transporting. Daughter states mother became unresponsive after CT scan. She alerted the doctor and staff who responded. They moved her to an exam room. Noted agonal breaths on vital signs. CPR started. CPR stopped shortly after per the families request. Death pronounced at 2:34pm.

I had the same sore arm, head ache, body aches, fatigue after the second dose as I did after the first dose. However on day 5 I developed the worst fever blister on my lower lip. On day 13 I experienced an anaphylactic episode. I noticed my hands started itching about 30 mintues after eating breakfast (coffee, oatmeal, blueberries, almonds). I took my dog for a walk and started to feel nausaus and extremely tired. I went to bed. Hives started. Had abdominal cramps, loose stool. Took benadryl 25 mg. then another 25 mg. Initially felt better after taking the benadryl. About 30 minutes later, more nausea and cramps. I went to the bathroom and while sitting on the toilet I could tell I was going to pass out. I lay down on the floor and was competely weak. I was aware that my bowels were moving, but I could do nothing about it. I was able to call for my husband (approximately 20 minutes later). He called an ambulance. Blood work from ER was normal except for WBC 15.4, Neutrophils 88.9%, Lymphocytes 6.6%, Eosinophils 0.1%, ANC 13.8, absolute granulocytes 13.7, glucose 152, and MPV 9.2, I saw an allergist because they thought I had developed a food allergy but that was ruled out. I have an epi pen now.

Headaches, Blurred eye-site, Exhausted! Went to Urgent Care 1/30/21 did Covid test again gave me steroids. Went to GP March 7. did blood work. Gave me stronger antibiotics and more steroids. Feb 11-13 in Hospital. Taken by ambulance to ER. BP was 195/100 heart rate 120. Had high blood counts on many things! Sugar levels high for 5 days. 145-165 usually normal. ER doctors suggested I see a Neurologist. I had a mild stroke in right Occipital lobe. Went to Clinic on March 1. Prelim appt. Checking on Chiari Malformation mostly. April 1-2 Clinic. Botox in head for migraine headaches. Diclofenac Sod 50 mg & Cyclobenzaprine 10 mg. I'm still very weak/exhausted, eyes blurry and feel swollen and memory is awful with shaking in hands. Saw Eye specialist, I have 20/20 vision. I haven't been able to work since Jan 23, 2021. I can't drive and am having a tough time with remembering anything.

She was found dead in her home one week after the injection. She died the day of the injection according to the coroners office. There was blood on the bed and down her chest.

Passing Out, Loss Of Voice, Throat Closing Up, Can Not Breath, Chess and Body Pains, Headaches, Face Swelling, Face Red

Sever headache beginning about 10 hours after vaccination, with nausea, and passed blood clots through nose about 16 hours following vaccine with small further amounts on May 15. All accompanied by extreme fatigue. It was the passing of blood through my nose that was unexpected and seemed worth reporting.

I started bleeding vaginally about four days after the shot, plus was fairly dizzy for the first week. I haven't bled vaginally for nearly 13yrs and am very healthy. Tests were run and all came back normal. Medication solved the problem, but I bled for nearly two weeks.

64 y.o. female who presented with SOB. She has a history of CAD, diabetes, CHF, CKD and DVT presents to the ED in respiratory distress. Patient was brought in by EMS from nursing home. Patient had reported onset of shortness of breath and respiratory distress over the last 6-7 hours. Patient has O2 sat of 90% on 6 L. Patient only uses 2 L nasal cannula oxygen all day long. Patient is coherent and initially was placed on BIPAP but then stated she wanted to go back, now after ER doc spoke to her she is ok with being admitted but does not want BIPAP or to be placed in the ICU. She is DNR/DNI. She is working hard to breathe currently. Patient is unsure if she is making urine at this time. Workup in the ER revealed AKI on CKD and covid + pneumonia. Patient elected hospice and expired 5/20/2021. It was reported that patient had received vaccines at Walmart.

The spouse reported onset of symptoms on 5/20/21 including lethargy. He reported that on 5/27/21, her speech became slurred and she died. Per spouse, an autopsy is pending.

Acute onset stroke symptoms the afternoon of 4/13/21 after returning home from room. EMS transported pt to local hospital. Dx with aortic arch/proximal subclavian artery thrombus, migration into axillary artery. Treated at local hospital with TNK for aortic arch clot & ischemic stroke. Transferred to tertiary medical center. Pt had massive stroke (left & right side) with brain stem herniation. Pt CMO after 16hrs and expired on 4/14, <32 hrs after symptom onset.

Spinal fusion on January 12, 2021 one week after first vaccine. Second vaccine on Feb 2, 2021. Developed blood clot in right calf & pulmonary embolism in right lung the week of Feb 15th. May have been post op problem but I had no issue until after the 2nd vaccine. Surgeon felt that post op pts usually get a blood clot within 2 weeks after surgery- that's why I feel it was from the 2nd vaccine.

5/21 started feeling poorly, fatigue, shortness of breath, evening headaches 5/24 Fatigue, shortness of breath, unable to complete any task, low grade fever 99.8, unable to eat or drink well 5/25 severe heartburn, shortness of breath continued, extreme fatigue 5/28 went to ER with continued extreme shortness of breath and fatigue. CT scan revealed multiple clots in lungs and was admitted for needing oxygen and to start anticoagulation.

Pt is 64 Had viral type pneumoia with out pos Covid test in January 2021. She was left oxygen dependent at 2 liters of oxygen by NC. on the 14th of April she recieved her second Moderna Covid shot. Two days later she was begining to become very short of breath. Needed to turn up her oxygen. Paramedics came to her house and found that O2 sat on RA was 60. In my Emergency room her O2 sat was only 87 percent on her two liters and on 15 liters of oxygen she was only 94 Percent.

I am allergic to Moderna COVID-19 Vaccine; itching; hives; diarrhea; Anaphylactic reaction; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D38B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Interstitial lung disease (interstitial lung disease and pulmonary emphysema) in April 2018, Emphysema pulmonary (interstitial lung disease and pulmonary emphysema) in April 2018 and Obstructive sleep apnea syndrome on 22-Oct-2018. Previously administered products included for Product used for unknown indication: Premarin (hives and itching) on 02-Sep-2009, Premarin (hives and itching) on 02-Sep-2009 and ACTEMRA on 08-Oct-2018. Past adverse reactions to the above products included Anaphylaxis with ACTEMRA; Hives with Premarin; and Itching with Premarin. Concurrent medical conditions included Seasonal allergy (sneezing, itching, watery eyes, runny nose.) since 10-Aug-2009, Seropositive rheumatoid arthritis since 13-Dec-2016, Hypothyroidism since 25-Sep-2009, Type 2 diabetes mellitus on 24-Sep-2019, Joint stiffness, Pain and Inflammation. Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for Hypothyroidism, METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) for Inflammation, CHLORZOXAZONE for Joint stiffness, IBUPROFEN for Pain, TOFACITINIB CITRATE (XELJANZ XR) for Rheumatoid arthritis. On 07-Apr-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant), PRURITUS (itching), URTICARIA (hives) and DIARRHOEA (diarrhea). On an unknown date, the patient experienced ALLERGY TO VACCINE (I am allergic to Moderna COVID-19 Vaccine). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) (oral) from 12-Apr-2021 to 20-Apr-2021 at a dose of UNK, qd. On 15-Apr-2021, ANAPHYLACTIC REACTION (Anaphylactic reaction) had resolved. At the time of the report, ALLERGY TO VACCINE (I am allergic to Moderna COVID-19 Vaccine), PRURITUS (itching), URTICARIA (hives) and DIARRHOEA (diarrhea) had resolved. 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. Patient stated hives were visible on 09Apr2021 became severe on 11Apr2021. 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. Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Follow-up received on 31-May-2021: Added medical history, concomitant medications and events. Upgraded the case as serious due to IME event anaphylaxis. Updated the outcome of the events as recovered.; 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.

patient received the Moderna covid-19 vaccine and two days later states she was admitted to the ER with blood clots. patient did not report the even to the pharmacy until the week of June 1st

Patient presented to the ED and was subsequently hospitalized for Bacteremia gram + cocci, severe sepsis, likely from line infection within 6 weeks of receiving COVID vaccination.

After first dose for two days I couldn't move my arm; Swollen with circular black and blue bruises in the injection site; Trouble raising her arm; The huge sore became hot to touch; Blue bruises in the injection site; I think this happened because the person that administered the vaccine did it wrong; I don't think I received a full dose vaccine from first dose.; Arm bleed; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Arm bleed) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Kidney stone (More than once) and Shingles (More than once). Concurrent medical conditions included Multiple allergies (had a lot of allergies) and Chronic pain. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On 29-Apr-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced HAEMORRHAGE (Arm bleed) (seriousness criterion medically significant), PRODUCT ADMINISTRATION ERROR (I think this happened because the person that administered the vaccine did it wrong), INCORRECT DOSE ADMINISTERED (I don't think I received a full dose vaccine from first dose.) and PAIN IN EXTREMITY (sore arm). On 01-May-2021, the patient experienced LIMB DISCOMFORT (Trouble raising her arm), VACCINATION SITE WARMTH (The huge sore became hot to touch), VACCINATION SITE BRUISING (Blue bruises in the injection site) and VACCINATION SITE SWELLING (Swollen with circular black and blue bruises in the injection site). On an unknown date, the patient experienced LIMB DISCOMFORT (After first dose for two days I couldn't move my arm). On 29-Apr-2021, PRODUCT ADMINISTRATION ERROR (I think this happened because the person that administered the vaccine did it wrong) and INCORRECT DOSE ADMINISTERED (I don't think I received a full dose vaccine from first dose.) had resolved. At the time of the report, HAEMORRHAGE (Arm bleed), VACCINATION SITE WARMTH (The huge sore became hot to touch), PAIN IN EXTREMITY (sore arm) and VACCINATION SITE SWELLING (Swollen with circular black and blue bruises in the injection site) outcome was unknown and LIMB DISCOMFORT (Trouble raising her arm), VACCINATION SITE BRUISING (Blue bruises in the injection site) and LIMB DISCOMFORT (After first dose for two days I couldn't move my arm) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. The patient wanted to report the side effects they experienced post receiving their first shot of Moderna vaccine. After a few hours their arm developed a huge sore 1 and ½ inches in size and the patient had trouble raising their arm. The patient day before reporting woke up and had a problem lifting their arm. The patient reported that the huge sore became hot to touch, was swollen with circular black and had blue bruises in the injection site. The patient mentioned that they had a lot of allergies. On 02-Jun-2021, the patient reported adverse reaction patient had from dose one and reported huge adverse reaction to dose two. The patient post first dose for two days was not able to move their arm and had a bruise that lasted for two weeks. The patient stated that now they think this happened because the person that administered the vaccine did it wrong and vaccine went into wrong place. Post receiving their first dose the patient said one of their arms was bleeding. The patient went back to the vaccination site and had been complaining so much because the registered nurse let the patient know that the Nurse didn't wore gloves nor shield and was anti-vaccinated. The patient also stated that they don't think that they received a full dose vaccine from first dose. The patient also reported that they were a chronic pain patient and had kidney stone and shingles more than once and understood pain. The patient wanted antibody test done because the patient think they didn't receive a full active first dose and wanted to have it after first dose but couldn't get it and still wanted to do this post second dose. Concomitant medication reported also included over the counter medicine but didn't specified the name. No treatment medication was reported. The patient informed that they slept and drunk a lot. No specific treatment was taken. Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Vaccination site swelling are consistent with the known safety profile of the vaccine. This case was linked to MOD-2021-201885 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Email response. No significant information found. On 02-Jun-2021: Added Reporter Details. Added current and historical conditions under relevant medical history. Updated action taken. Updated concomitant medication in I-narrative supplement field. Added new events and updated the event description and outcome of the events.; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Vaccination site swelling are consistent with the known safety profile of the vaccine.

Develop shortness of breath. In January I had Covid. Called the doctor on June 4 and a register nurse took the message for the doctor. The doctor called me back and said to put cold compress pads in my chest and recommend some pills. I took those for 1 week but on June 11 I could not breath and went to the emergency room and the doctor said not to take the 2nd dose of the vaccine. I got diagnosed with Pneumonia and have been taking antibiotics. I feel better but still feel sick. Next appointment with the doctor is June 9, 2021.

High fever, headache, diagnosed with pneumonia. Received an antibiotic shot and two prescriptions of different antibiotics. Still experience fatigue and feel unwell most days.

Death; Dysarthria; Lethargy; This case was received via FDA VAERS (Reference number: 1358542) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death), DYSARTHRIA (Dysarthria) and LETHARGY (Lethargy) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The patient's past medical history included Back surgery (History of multiple back surgeries including a rod placement.). On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced DEATH (Death) (seriousness criteria death and medically significant), DYSARTHRIA (Dysarthria) (seriousness criterion death) and LETHARGY (Lethargy) (seriousness criterion death). The patient died on 27-May-2021. The cause of death was not reported. An autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment information was not reported. On 27 May 2021, autopsy was performed. As per the spouse, the autopsy results were pending. 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.Very limited information regarding the events have been provided at this time.; 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.Very limited information regarding the events have been provided at this time.; Reported Cause(s) of Death: Unknown cause of death

Dual Pulmonary Embolism, Dr. Office ordered labs, called to go to ER stat. ER did Ultrasound of heart- the Cat scan of lungs. Sent by ambulance to HCF that day - taken to Cath lab that same evening for a clot busting procedure and administered tPA and heparin.

After receiving the vaccine, on 4/14, I had a hysterectomy and came home. I began feeling a dull pain in my back. It started getting worse. I contacted my doctor who sent me to the emergency. They took my blood and from there i began falling to pieces. I couldn't breathe, My upper back around my lungs was hurting so bad. They gave me many different pain medications but nothing was helping the pain. They determined I had 2 blood clots in my right lung. I started going downhill from there. They told me my blood was contaminated. I was put on many different machines. All COVID tests came back negative. Nothing hurt from the hysterectomy. My blood pressure wouldn't stay up. I was on pain medications every 2 hours. Currently, it has still not been determined whether this was a result of the vaccine or not. I am now taking Eliquis which I will be taking for 6 months.

03/19/2021 wife had severe stomach pain, went to urgent care, referred to hospital for cat-scan, admitted to hospital for observation and tests, tests inconclusive, Monday, 03/22/2021 @ 02:42 wife declared dead.

My first Moderna dose was 2/26. I had a low-grade temp and body aches on the 9th day for 24 hours. The second dose was on 3/26. That afternoon my eyes were burning with eye strain. On Saturday into Sunday had low grade temp escalating to 101.5 p.o. with severe body aches, fatigue, and loose stools. My blood pressure dropped to BPS of 80's on Monday morning. On Thursday following had leg discomfort ? sciatica and episode of SOB. On Friday, another episode of SOB. On Sunday (April 4th), noted left ankle/leg swelling which persisted on and off for next two months. Swelling went down with leg elevation. Early June, had developed severe sciatica on left. Appointment with primary provider June 18th. Left leg remained swollen and sciatica was severe enough to cause difficulty with ambulation. Doppler studies completed 6/21/2021. Results below in #19.

I had been on weekly diflucan for toe fungus starting in late March. I got the first Moderna shot April 13. On April 22 I had some chest tightness which I attributed to the Diflucan as it listed chest tightness as a side effect. On May 2nd the pain extended from the chest, neck, headache and all my teeth hurt and I ended up in the hospital for the first of 3 hospitalizations Below is the summary of doctor?s notes on my hospitalizations. They ran several tests to eliminate lupus, sjogrens, cancer, kidney issues, bacterial or fungus issues, etc. It was not caused by the Diflucan side effect. They decided it might be viral. Given the current report of some people getting pericarditis after the vaccine, my doctor and I felt we should report this incident. Given the timing, it could have been the vaccine that caused the reaction. I'm currently on prednisone for another month and colchicine for several more months and remain under the care of cardiology. SUMMARY OF DOCTOR?S NOTES: She presented to the ER 5/2/2021 with chest pain. When she presented, she had tachycardia with interior ST changes. CT showed no PE but there was a large pericardial effusion. Subsequently her blood pressure began dropping with narrowing pulse pressure and she was thought to have early tamponade physiology so was taken to the cath lab and pericardiocentesis was performed. She did well and was started on colchicine and ibuprofen. 5/14 When I saw her back, she was doing well. Since then, she has had back to back admissions: 5/24/2021-5/27/2021-CAP of LLL with bilateral pleural effusions and pericarditis treated with antibiotics but afterwards, felt to be viral. She was seen by Pulmonary at this hospital stay. Rheumatologist work up was started. ECHO was stable. 5/29 Second Moderna shot (was delayed 2 weeks due to concern about confusing the potential normal side effects with the pericarditis issues). 6/13/2021-6/15/2021-Serositis with tachycardia, cough and fever. Rheumatology did not see but was curb sided and recommended Prednisone (long taper) with clinic visit in the next 2 weeks. Limited ECHO was stable. 6/16 Patient is doing well. No chest pain. She is taking the Prednisone without issues. No GI upset and no loose stools.

Patient presented to the ED and was subsequently hospitalized for severe sepsis within 6 weeks of receiving COVID vaccination.

discomfort in her back like she slept wrong; could not take a deep breath without pain; she felt like something was off/felt vaguely like she did in 2012 (when she had a pulmonary embolism); 3 blood clots in her lungs/clotting factors in the blood test were four times over a certain number of normal/she had two blood clots in her left lung and one blood clot in her right lung/clotting factors in the blood test were four times; pain if take a deep breath and sneeze; lethargy; slight tenderness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (3 blood clots in her lungs/clotting factors in the blood test were four times over a certain number of normal/she had two blood clots in her left lung and one blood clot in her right lung/clotting factors in the blood test were four times) and PAIN (pain if take a deep breath and sneeze) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026a21a and 031m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Pulmonary embolism in 2012, Legionnaire's disease in 2012 and Sprained ankle in 2012. Previously administered products included for Pulmonary embolism: Warfarin (She was placed on warfarin at that time along with an injection in her abdomen that she did not recall the name of the shot.) in 2012. Concurrent medical conditions included COPD. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jun-2021, the patient experienced THROMBOSIS (3 blood clots in her lungs/clotting factors in the blood test were four times over a certain number of normal/she had two blood clots in her left lung and one blood clot in her right lung/clotting factors in the blood test were four times) (seriousness criteria medically significant and life threatening), PAIN (pain if take a deep breath and sneeze) (seriousness criterion medically significant), MUSCULOSKELETAL DISCOMFORT (discomfort in her back like she slept wrong), DYSPNOEA (could not take a deep breath without pain) and FEELING ABNORMAL (she felt like something was off/felt vaguely like she did in 2012 (when she had a pulmonary embolism)). In 2021, the patient experienced LETHARGY (lethargy) and VACCINATION SITE PAIN (slight tenderness in her arm). The patient was treated with APIXABAN ongoing from 14-Jun-2021 for Clot blood, at a dose of 10 mg twice a day and APIXABAN ongoing from 22-Jun-2021 for Clot blood, at a dose of 5 mg twice a day. In June 2021, PAIN (pain if take a deep breath and sneeze), MUSCULOSKELETAL DISCOMFORT (discomfort in her back like she slept wrong), DYSPNOEA (could not take a deep breath without pain) and FEELING ABNORMAL (she felt like something was off/felt vaguely like she did in 2012 (when she had a pulmonary embolism)) had resolved, LETHARGY (lethargy) and VACCINATION SITE PAIN (slight tenderness in her arm) had resolved. At the time of the report, THROMBOSIS (3 blood clots in her lungs/clotting factors in the blood test were four times over a certain number of normal/she had two blood clots in her left lung and one blood clot in her right lung/clotting factors in the blood test were four times) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jun-2021, Blood test: high clotting factor (abnormal) The clotting factors in the blood test were four times over a certain number of normal.. On 14-Jun-2021, Scan: blood clots (abnormal) Two blood clots in her left lung and one blood clot in her right lung. The concomitant medications on use were not provided. On 13-Mar-2021, received second dose of Moderna COVID-19 Vaccine. On 14-Jun-2021, the patient experienced THROMBOSIS (3 blood clots in her lungs/clotting factors in the blood test were four times over a certain number of normal/she had two blood clots in her left lung and one blood clot in her right lung/clotting factors in the blood test were four times. 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.

6/18/21: Guest experienced episode of hypoxia. Was able to be corrected with use of )2. Chest X-ray and bloodwork completed. 6/28/21: Seen by NP for weight loss. Ongoing issue prior to vaccine r/t poor appetite 7/1/21: Incident of hypoxia that required increase in 02, SOB, and lethargy. Sent to the hospital. Guest did end up passing at this hospital

Patient was airlifted to the hospital where she was diagnosed with a heart attack; Difficulty breathing; Numbness; Discomfort; Nausea; Vomiting; Burning/arm felt sore; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Patient was airlifted to the hospital where she was diagnosed with a heart attack), DYSPNOEA (Difficulty breathing), HYPOAESTHESIA (Numbness), DISCOMFORT (Discomfort), NAUSEA (Nausea) and VOMITING (Vomiting) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01003807772739901769) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Patient was airlifted to the hospital where she was diagnosed with a heart attack) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced DYSPNOEA (Difficulty breathing) (seriousness criterion medically significant), HYPOAESTHESIA (Numbness) (seriousness criterion medically significant), DISCOMFORT (Discomfort) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), VOMITING (Vomiting) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Burning/arm felt sore). At the time of the report, MYOCARDIAL INFARCTION (Patient was airlifted to the hospital where she was diagnosed with a heart attack), DYSPNOEA (Difficulty breathing), HYPOAESTHESIA (Numbness), DISCOMFORT (Discomfort), NAUSEA (Nausea), VOMITING (Vomiting) and PAIN IN EXTREMITY (Burning/arm felt sore) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. The patient was discharged several days later. Very limited information regarding this event/s has been provided at this time. Further information has been requested. This case was linked to MOD-2021-237455 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Non-significant follow-up added to include Lot number; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

5/11/21 developed chest pain, had initial improvement, then worsening on approx 5/26/21. on 6/4, she was diagnosed with pericarditis and acute CHF, afib with RVR. Pericarditis has been treated with indomethacin, colchicine, and she is improving with CRP normalized. Afib treated successfully with cardioversion. she was treated with diuretics for her CHF.

Did not have a history of seizures and no diagnosis and had Gran Mal Seizures following second shot of Moderna Covid Vaccine

chest tightness, occasional pain in the chest area, discomfort and pain when changing position from vertical to horizontal. symptoms persisted. hospitalized with a diagnosis of pericarditis, pericardial effusion and pleural effusion.

increased fatigue with exercise and being out in the sun; memory is shot, memory problems; trouble with sleep at times; double vision episode, had some double vision; bottom of my feet, they are cold, like I am stepping in ice water. sensation of walking in ice water; big crowds cause her stress; wording is getting worse; worsening bladder control; drunken walk, she was like walking in like she's drunk, and running into the door way; steroids gave him black sticky diarrhea; speech has been slurred; dry mouth; nurse was not able to clarify some cognitive issue; severe cold/ bad cold; she was hospitalized for a blood infection; filed for disability worsening of her MS; bruising; hair loss or bald spots/hair thinning; feel the burning in both feet; numbness on bottom of both feet; steroids gave him black sticky diarrhea; balance disorder; had a lapse on therapy, was out of medicine for about a week; dizziness; felt like a train ran over her; underdose of the medications; had an ulcer in her stomach, which was new to her and bleeding also; started breaking the medication in half/ has been braking 14mg in half to make it last longer; had tingling off and on for the past 2 month in her hands and feet, had tingling on bottom of her feet/ tingling on hands off and; This spontaneous case was reported by a health care professional and describes the occurrence of FEELING ABNORMAL (felt like a train ran over her), BALANCE DISORDER (balance disorder), GASTRIC ULCER HAEMORRHAGE (had an ulcer in her stomach, which was new to her and bleeding also), SEPSIS (she was hospitalized for a blood infection), MULTIPLE SCLEROSIS (filed for disability worsening of her MS), CONTUSION (bruising), DIZZINESS (dizziness), FATIGUE (increased fatigue with exercise and being out in the sun), MEMORY IMPAIRMENT (memory is shot, memory problems), INSOMNIA (trouble with sleep at times), DIPLOPIA (double vision episode, had some double vision), PERIPHERAL COLDNESS (bottom of my feet, they are cold, like I am stepping in ice water. sensation of walking in ice water), SOCIAL ANXIETY DISORDER (big crowds cause her stress), APHASIA (wording is getting worse), URINARY INCONTINENCE (worsening bladder control), GAIT DISTURBANCE (drunken walk, she was like walking in like she's drunk, and running into the door way), FAECES DISCOLOURED (steroids gave him black sticky diarrhea), DYSARTHRIA (speech has been slurred), DRY MOUTH (dry mouth), COGNITIVE DISORDER (nurse was not able to clarify some cognitive issue), NASOPHARYNGITIS (severe cold/ bad cold), PARAESTHESIA (had tingling off and on for the past 2 month in her hands and feet, had tingling on bottom of her feet/ tingling on hands off and), ALOPECIA (hair loss or bald spots/hair thinning), BURNING SENSATION (feel the burning in both feet), HYPOAESTHESIA (numbness on bottom of both feet), DIARRHOEA (steroids gave him black sticky diarrhea), PRODUCT DOSE OMISSION ISSUE (had a lapse on therapy, was out of medicine for about a week) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (started breaking the medication in half/ has been braking 14mg in half to make it last longer) in a 64-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. Co-suspect products included non-company products TERIFLUNOMIDE for an unknown indication, BUPROPION HCL for an unknown indication and WARFARIN SODIUM (COUMADIN) for an unknown indication. The patient's past medical history included Rheumatic fever, Application site reaction, Diplopia and Cardiac valve prosthesis user in 2007. Concurrent medical conditions included Allergy to animal, Drug hypersensitivity (Triple antibiotic), Iodine allergy (Iodine dye), Polyuria, Dermatitis contact, Drug hypersensitivity (Dilantin) and Multiple sclerosis. Concomitant products included LEVOTHYROXINE, IRON, METOPROLOL, FUROSEMIDE, PRAVASTATIN, WARFARIN SODIUM (JANTOVEN), VITAMIN D3, ACETYLSALICYLIC ACID (ASPIRIN COX [ACETYLSALICYLIC ACID]) and SERTRALINE for an unknown indication. On 15-May-2014, the patient started TERIFLUNOMIDE (unknown route) 14 milligram once a day. On 14-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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, BUPROPION HCL (unknown route) 1 dosage form and WARFARIN SODIUM (COUMADIN) (unknown route) at an unspecified dose. In March 2015, the patient experienced PARAESTHESIA (had tingling off and on for the past 2 month in her hands and feet, had tingling on bottom of her feet/ tingling on hands off and) (seriousness criteria hospitalization prolonged and disability). In January 2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (started breaking the medication in half/ has been braking 14mg in half to make it last longer) (seriousness criteria hospitalization prolonged and disability). On 14-Feb-2021, the patient experienced GASTRIC ULCER HAEMORRHAGE (had an ulcer in her stomach, which was new to her and bleeding also) (seriousness criteria hospitalization prolonged, disability and medically significant). On 14-Mar-2021, the patient experienced FEELING ABNORMAL (felt like a train ran over her) (seriousness criteria hospitalization prolonged and disability). 14-Mar-2021, the patient experienced UNDERDOSE (underdose of the medications). In May 2021, the patient experienced DIZZINESS (dizziness) (seriousness criteria hospitalization prolonged and disability) and PRODUCT DOSE OMISSION ISSUE (had a lapse on therapy, was out of medicine for about a week) (seriousness criteria hospitalization prolonged and disability). On 19-Jun-2021, the patient experienced BALANCE DISORDER (balance disorder) (seriousness criteria hospitalization prolonged and disability). On an unknown date, the patient experienced SEPSIS (she was hospitalized for a blood infection) (seriousness criteria hospitalization prolonged, disability and medically significant), MULTIPLE SCLEROSIS (filed for disability worsening of her MS) (seriousness criteria hospitalization prolonged, disability and medically significant), CONTUSION (bruising) (seriousness criteria hospitalization prolonged and disability), FATIGUE (increased fatigue with exercise and being out in the sun) (seriousness criteria hospitalization prolonged and disability), MEMORY IMPAIRMENT (memory is shot, memory problems) (seriousness criteria hospitalization prolonged and disability), INSOMNIA (trouble with sleep at times) (seriousness criteria hospitalization prolonged and disability), DIPLOPIA (double vision episode, had some double vision) (seriousness criteria hospitalization prolonged and disability), PERIPHERAL COLDNESS (bottom of my feet, they are cold, like I am stepping in ice water. sensation of walking in ice water) (seriousness criteria hospitalization prolonged and disability), SOCIAL ANXIETY DISORDER (big crowds cause her stress) (seriousness criteria hospitalization prolonged and disability), APHASIA (wording is getting worse) (seriousness criteria hospitalization prolonged and disability), URINARY INCONTINENCE (worsening bladder control) (seriousness criteria hospitalization prolonged and disability), GAIT DISTURBANCE (drunken walk, she was like walking in like she's drunk, and running into the door way) (seriousness criteria hospitalization prolonged and disability), FAECES DISCOLOURED (steroids gave him black sticky diarrhea) (seriousness criteria hospitalization prolonged, disability and medically significant), DYSARTHRIA (speech has been slurred) (seriousness criteria hospitalization prolonged and disability), DRY MOUTH (dry mouth) (seriousness criteria hospitalization prolonged and disability), COGNITIVE DISORDER (nurse was not able to clarify some cognitive issue) (seriousness criteria hospitalization prolonged, disability and medically significant), NASOPHARYNGITIS (severe cold/ bad cold) (seriousness criteria hospitalization prolonged and disability), ALOPECIA (hair loss or bald spots/hair thinning) (seriousness criteria hospitalization prolonged and disability), BURNING SENSATION (feel the burning in both feet) (seriousness criteria hospitalization prolonged and disability), HYPOAESTHESIA (numbness on bottom of both feet) (seriousness criteria hospitalization prolonged and disability) and DIARRHOEA (steroids gave him black sticky diarrhea) (seriousness criteria hospitalization prolonged, disability and medically significant). The patient was treated with OXYBUTYNIN ongoing since an unknown date for Urinary incontinence, at a dose of 1 dosage form; PARACETAMOL ongoing since an unknown date for Insomnia, at a dose of 1 dosage form; DIPHENHYDRAMINE ongoing since an unknown date for Insomnia, at a dose of 1 dosage form and BENZOCAINE ongoing since an unknown date for Hypoaesthesia and Burning sensation, at a dose of 1 dosage form. On 23-Feb-2021, GASTRIC ULCER HAEMORRHAGE (had an ulcer in her stomach, which was new to her and bleeding also) had resolved. At the time of the report, FEELING ABNORMAL (felt like a train ran over her), BALANCE DISORDER (balance disorder) and SEPSIS (she was hospitalized for a blood infection) had resolved, MULTIPLE SCLEROSIS (filed for disability worsening of her MS), CONTUSION (bruising), DIZZINESS (dizziness), FATIGUE (increased fatigue with exercise and being out in the sun), MEMORY IMPAIRMENT (memory is shot, memory problems), DIPLOPIA (double vision episode, had some double vision), PERIPHERAL COLDNESS (bottom of my feet, they are cold, like I am stepping in ice water. sensation of walking in ice water), SOCIAL ANXIETY DISORDER (big crowds cause her stress), APHASIA (wording is getting worse), URINARY INCONTINENCE (worsening bladder control), GAIT DISTURBANCE (drunken walk, she was like walking in like she's drunk, and running into the door way), FAECES DISCOLOURED (steroids gave him black sticky diarrhea), DYSARTHRIA (speech has been slurred), DRY MOUTH (dry mouth), NASOPHARYNGITIS (severe cold/ bad cold), ALOPECIA (hair loss or bald spots/hair thinning), DIARRHOEA (steroids gave him black sticky diarrhea), PRODUCT DOSE OMISSION ISSUE (had a lapse on therapy, was out of medicine for about a week), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (started breaking the medication in half/ has been braking 14mg in half to make it last longer) and UNDERDOSE (underdose of the medications) outcome was unknown and INSOMNIA (trouble with sleep at times), COGNITIVE DISORDER (nurse was not able to clarify some cognitive issue), PARAESTHESIA (had tingling off and on for the past 2 month in her hands and feet, had tingling on bottom of her feet/ tingling on hands off and), BURNING SENSATION (feel the burning in both feet) and HYPOAESTHESIA (numbness on bottom of both feet) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood count: low (Low) Low. On an unknown date, International normalised ratio: 6.28 (Inconclusive) 6.28. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. 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. Further information has been requested.; 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. Further information has been requested.

nerve damage; entire body became inflamed - Huge inflammation; can't move arm/can't hold on to anything/can't move left leg/can hardly move; Shaking; Bad reaction; coagulation problem; Tremors in the head (brain); Blood pressure went to roof - high blood pressure "169"; cannot walk down; unable to work for a month and half; wrists are swollen - right knee is swollen; Feeling awful; In pain/hurts at 10 on pain scale from 1-10 and whole-body hurts; whole-body hurts; Passing out; kidneys are shutting down; Von Willebrand disease (spelled it out on phone as"gon wille brand'l"; paralyzed; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (Passing out), RENAL IMPAIRMENT (kidneys are shutting down), VON WILLEBRAND'S DISEASE (Von Willebrand disease (spelled it out on phone as"gon wille brand'l") and PARALYSIS (paralyzed) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passing out) (seriousness criteria disability and medically significant), RENAL IMPAIRMENT (kidneys are shutting down) (seriousness criteria disability and medically significant), VON WILLEBRAND'S DISEASE (Von Willebrand disease (spelled it out on phone as"gon wille brand'l") (seriousness criteria disability and medically significant), PARALYSIS (paralyzed) (seriousness criteria disability and medically significant), NERVE INJURY (nerve damage), INFLAMMATION (entire body became inflamed - Huge inflammation), MOBILITY DECREASED (can't move arm/can't hold on to anything/can't move left leg/can hardly move), TREMOR (Shaking), VACCINATION COMPLICATION (Bad reaction), COAGULOPATHY (coagulation problem), HEAD TITUBATION (Tremors in the head (brain)), BLOOD PRESSURE INCREASED (Blood pressure went to roof - high blood pressure "169"), GAIT INABILITY (cannot walk down), IMPAIRED WORK ABILITY (unable to work for a month and half), JOINT SWELLING (wrists are swollen - right knee is swollen), FEELING ABNORMAL (Feeling awful), PAIN (In pain/hurts at 10 on pain scale from 1-10 and whole-body hurts) and MYALGIA (whole-body hurts). At the time of the report, LOSS OF CONSCIOUSNESS (Passing out), RENAL IMPAIRMENT (kidneys are shutting down), VON WILLEBRAND'S DISEASE (Von Willebrand disease (spelled it out on phone as"gon wille brand'l"), PARALYSIS (paralyzed), NERVE INJURY (nerve damage), INFLAMMATION (entire body became inflamed - Huge inflammation), MOBILITY DECREASED (can't move arm/can't hold on to anything/can't move left leg/can hardly move), TREMOR (Shaking), VACCINATION COMPLICATION (Bad reaction), COAGULOPATHY (coagulation problem), HEAD TITUBATION (Tremors in the head (brain)), BLOOD PRESSURE INCREASED (Blood pressure went to roof - high blood pressure "169"), GAIT INABILITY (cannot walk down), IMPAIRED WORK ABILITY (unable to work for a month and half), JOINT SWELLING (wrists are swollen - right knee is swollen), FEELING ABNORMAL (Feeling awful), PAIN (In pain/hurts at 10 on pain scale from 1-10 and whole-body hurts) and MYALGIA (whole-body hurts) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood creatinine: 0.50 (Inconclusive) Patient stated her creatinine was 0.50. On an unknown date, Blood pressure measurement: 169 (High) high blood pressure 169. On an unknown date, C-reactive protein: 34/7 (Inconclusive) huge inflammation with c-reactive protein. C-reactive protein at 34.7. On an unknown date, Computerised tomogram: inconclusive (Inconclusive) chest suggested no blood clots per patient. On an unknown date, Fibrin D dimer: 3.89 (Inconclusive) Patient reported that D-dimer (which was usually found after blood clot was present and was in process of breaking down). On an unknown date, Haematocrit: 32.9 (normal) normal. On an unknown date, Haemoglobin: 10.8 (Inconclusive) It was 14 before 3 week ago and was normal and 14 (Inconclusive) It was 14 before 3 week ago. On an unknown date, Monocyte count: 0.91 (High) monocytes are high. On an unknown date, Pain assessment (1-10): 10 (abnormal) hurts at 10 on pain scale from 1-10. On an unknown date, Red blood cell sedimentation rate: 69 (Inconclusive) Sedimentation rate was 69. On an unknown date, Sepsis: negative (Negative) tested negative. On an unknown date, X-ray: inconclusive (Inconclusive) right knee is swollen per x-ray. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered LOSS OF CONSCIOUSNESS (Passing out), RENAL IMPAIRMENT (kidneys are shutting down), VON WILLEBRAND'S DISEASE (Von Willebrand disease (spelled it out on phone as"gon wille brand'l"), PARALYSIS (paralyzed), NERVE INJURY (nerve damage), INFLAMMATION (entire body became inflamed - Huge inflammation), MOBILITY DECREASED (can't move arm/can't hold on to anything/can't move left leg/can hardly move), TREMOR (Shaking), VACCINATION COMPLICATION (Bad reaction), COAGULOPATHY (coagulation problem), HEAD TITUBATION (Tremors in the head (brain)), BLOOD PRESSURE INCREASED (Blood pressure went to roof - high blood pressure "169"), GAIT INABILITY (cannot walk down), IMPAIRED WORK ABILITY (unable to work for a month and half), JOINT SWELLING (wrists are swollen - right knee is swollen), FEELING ABNORMAL (Feeling awful), PAIN (In pain/hurts at 10 on pain scale from 1-10 and whole-body hurts) and MYALGIA (whole-body hurts) to be related. Concomitant product use was not provided by the reporter. No treatment information was provided. The patient stated that she had gone to hospital on 14th and 16th of June 2021 and on 06 Jul 2021. The patient stated that her doctor told her that if she was not treated within a week or 2, she will be gone. The patient stated that due to coagulation problem, she should not have gotten the vaccine per patient and said it was her doctor's fault. The patient stated that she will have to go to ER if anything happens and stated that Moderna vaccine gave her all symptoms and the patient stated that she did not get Covid and was now scared that she will die. Company Comment: Very limited information regarding the events has been provided at this time. Additional information required. Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow up received on 9 Jul 2021 contain new serious and non serious events , suspect product dose details, lab data and narrative updated.; Sender's Comments: Very limited information regarding the events has been provided at this time. Additional information required.

Daughter, came to clinic and informed participant, passed away on 6/2/21 from COVID complications at Hospital.

The doctors at the hospital diagnosed as a stroke/She was discharged the next day; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (The doctors at the hospital diagnosed as a stroke/She was discharged the next day) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03B21A and 037A21B) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included APIXABAN (ELIQUIS), QUINAPRIL and ATORVASTATIN for an unknown indication. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (The doctors at the hospital diagnosed as a stroke/She was discharged the next day) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 13-May-2021 to 14-May-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (The doctors at the hospital diagnosed as a stroke/She was discharged the next day) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information were not provided. On 13May2021, she had started with numbness on fingertip of right side of the hand and it progressed to the whole right side. She called 911 and she ended up in hospital on 13May2021. The doctors at the hospital diagnosed as a stroke. She was discharged the next day (14May2021). 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.

belching; diarrhoea; blurred vision; experienced a headache describing that " an explosion happened in my head; lightheadedness; drying of the mouth and throat; vertigo; nausea; Dehydration; Tingling all the way to fingertips; general fatigue; trouble walking; inability to lift right leg; hypoaesthesia; lethargy; lethargy; dizziness; anaphylactic reaction; vaccination site bruising; blood pressure increase; paraesthesia left arm; dehydration; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheadedness), DIZZINESS (dizziness), DRY MOUTH (drying of the mouth and throat), VERTIGO (vertigo), ERUCTATION (belching), DEHYDRATION (Dehydration), PARAESTHESIA (Tingling all the way to fingertips), FATIGUE (general fatigue), GAIT DISTURBANCE (trouble walking), MOVEMENT DISORDER (inability to lift right leg), HYPOAESTHESIA (hypoaesthesia), the second episode of LETHARGY (lethargy), HEADACHE (experienced a headache describing that " an explosion happened in my head), VISION BLURRED (blurred vision), DIARRHOEA (diarrhoea), NAUSEA (nausea), the first episode of LETHARGY (lethargy) and ANAPHYLACTIC REACTION (anaphylactic reaction) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Fusion cervical spine. Concurrent medical conditions included Anaphylaxis, Coronary artery disease, Asthma, Gastroesophageal reflux disease, Osteoarthritis, Hypoglycemia, Hypothyroidism, Hypertension, Allergy to antibiotic (levaquin), Drug allergy (vioxx), Shellfish allergy, Arrhythmia, Epilepsy and Allergy (steroids). Concomitant products included EPINEPHRINE (EPIPEN), TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), ASPIRIN [ACETYLSALICYLIC ACID], ATENOLOL (TENORMIN), UBIDECARENONE (COQ10 [UBIDECARENONE]), LEVETIRACETAM (KEPPRA [LEVETIRACETAM]), GABAPENTIN (NEURONTIN), VITAMIN B12 [VITAMIN B12 NOS], CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), NITROGLYCERIN, ALBUTEROL [SALBUTAMOL], BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET), MONTELUKAST SODIUM (SINGULAIR), LEVOTHYROXINE SODIUM (SYNTHROID), ROSUVASTATIN CALCIUM (CRESTOR) and DONEPEZIL HYDROCHLORIDE (ARICEPT) for an unknown indication, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR). On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced DIZZINESS (dizziness) (seriousness criterion hospitalization prolonged), the first episode of LETHARGY (lethargy) (seriousness criterion hospitalization), VACCINATION SITE BRUISING (vaccination site bruising), BLOOD PRESSURE INCREASED (blood pressure increase), PARAESTHESIA (paraesthesia left arm), DEHYDRATION (dehydration) and FATIGUE (fatigue). On 18-Jun-2021, the patient experienced DIZZINESS (lightheadedness) (seriousness criterion hospitalization prolonged), DRY MOUTH (drying of the mouth and throat) (seriousness criterion hospitalization prolonged), VERTIGO (vertigo) (seriousness criterion hospitalization prolonged), DEHYDRATION (Dehydration) (seriousness criterion hospitalization prolonged), PARAESTHESIA (Tingling all the way to fingertips) (seriousness criterion hospitalization prolonged), FATIGUE (general fatigue) (seriousness criterion hospitalization prolonged), GAIT DISTURBANCE (trouble walking) (seriousness criterion hospitalization prolonged), MOVEMENT DISORDER (inability to lift right leg) (seriousness criterion hospitalization prolonged), HYPOAESTHESIA (hypoaesthesia) (seriousness criterion hospitalization prolonged), the second episode of LETHARGY (lethargy) (seriousness criterion hospitalization prolonged) and NAUSEA (nausea) (seriousness criterion hospitalization prolonged). On 19-Jun-2021, the patient experienced HEADACHE (experienced a headache describing that " an explosion happened in my head) (seriousness criterion hospitalization prolonged). On 20-Jun-2021, the patient experienced VISION BLURRED (blurred vision) (seriousness criterion hospitalization prolonged). On 21-Jun-2021, the patient experienced ERUCTATION (belching) (seriousness criterion hospitalization prolonged) and DIARRHOEA (diarrhoea) (seriousness criterion hospitalization prolonged). On an unknown date, the patient experienced ANAPHYLACTIC REACTION (anaphylactic reaction) (seriousness criterion medically significant). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DIZZINESS (lightheadedness), DIZZINESS (dizziness), DRY MOUTH (drying of the mouth and throat), VERTIGO (vertigo), ERUCTATION (belching), DEHYDRATION (Dehydration), PARAESTHESIA (Tingling all the way to fingertips), FATIGUE (general fatigue), GAIT DISTURBANCE (trouble walking), MOVEMENT DISORDER (inability to lift right leg), HYPOAESTHESIA (hypoaesthesia), the last episode of LETHARGY (lethargy), HEADACHE (experienced a headache describing that " an explosion happened in my head), VISION BLURRED (blurred vision), DIARRHOEA (diarrhoea), NAUSEA (nausea), ANAPHYLACTIC REACTION (anaphylactic reaction), VACCINATION SITE BRUISING (vaccination site bruising), BLOOD PRESSURE INCREASED (blood pressure increase), PARAESTHESIA (paraesthesia left arm), DEHYDRATION (dehydration) and FATIGUE (fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jul-2021, Blood pressure measurement: high (High) 172/95-98. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient has Coronary Artery Disease for which they Artery Disease for which they have three cardiac stents. The patient is RH negative. Company Comment: Based on the currently available information and temporal association between the use of the product and the start date of the immediate events following vaccination with a start date of 21May2021, a causal relationship cannot be excluded. Very limited information regarding the events with an onset date of 18Jun2021 and 19Jun2021 has been provided at this time. Further information has been requested and is necessary for assessing a causal relationship. This case was linked to MOD-2021-264136 (Patient Link).; Sender's Comments: Based on the currently available information and temporal association between the use of the product and the start date of the immediate events following vaccination with a start date of 21May2021, a causal relationship cannot be excluded. Very limited information regarding the events with an onset date of 18Jun2021 and 19Jun2021 has been provided at this time. Further information has been requested and is necessary for assessing a causal relationship.

-First night had a pain in my arm pit of the arm I received the shot -Second day still had a pain in my arm pit and now chest pains, along with fatigue, chills and nausea sick like I had a flu, all my muscle and joint ached. I had a headache. -I was sick for the next four days in bed. -Fifth day still having chest pains, went to the ER were they ran test and found out I had blood clots in my lungs and my left leg, -

PATIENT RECEIVED VACCINE 1/7/21 AT 1000. THE NEXT DAY, PATIENT PRESENTS TO ER ON 1/13/21 WITH COMPLAINTS OF PALPITATIONS AND DIZZINESS OCCURING SINCE HER FIRST DOSE OF VACCINE. "The patient states she has had these episodes for the last 6 days and they started when she got her COVID vaccine. The patient states she has had numerous episodes over the last 6 days of this that lasts between 2 and 4 hours. The patient can feel her heart fluttering and she gets a little dizzy with it. The patient has not had any nausea, shortness of breath or chest pain with these episodes however. The patient has not had any prior episodes of this. The patient takes no regular medications apart from vitamins." PATIENT WAS DIAGNOSED WITH NEW FOUND A. FIB WITH RVR. ADMITTED TO HOSPITAL FOR OBSERVATION. PATIENT RETURNED TO NORMAL SINUS RHYTHM THE NEXT DAY AFTER INITIATING DILTIAZEM AND ELIQUIS.

Anaphylactic Shock - Dizziness at about 18 minutes after shot. Tongue swelled / Throat swelled Two Epi Pens given by pharmacist Taken by ambulance Given IV steroids (not sure if other meds) in ambulance. Stayed in Emergency Room for several hours. Discharged w/ Epi Pen and steroid pills.

I felt a sensation immediately after the injection. Ten minutes later I began to feel fuzzy but not that noticeable. The left muscle in my left side of my neck stiffened. As we left the area and headed down the street I was getting anaphalactic: numb jaw, swelling tongue, closed throat, eyes closing, inner cheeks numb - as if I was severely novacained from the dentist. I was able to breathe ok to get home hoping it would pass and drank wanter to keep things fluid. I was there for one hour. On advice, I went to the ER to get checked out.

Vaccinee was in 15 min observation area and just before that time was up, she called for the Nurses because she "was feeling lightheaded and her hands were tingling". She was talking but seemed alarmed. Lungs were clear BP was 148/98 which is high for her. EMS on site and called over to respond. They transported her to hospital and en route gave Epi and Bendaryl IM, she was further treated at the ER. She was discharged home at about 6pm.

Patient received Moderna COVID Vaccine. Minutes after receiving the vaccine, patient reported swelling in throat and a cough. Patient took an Epi-Pen, 50mg injectable diphenhydramine, and 20mg famotidine. EMS was activated. Upon arrival, EMS administered 125mg Solu-Medrol and 25mg additional diphenhydramine. Patient was taken to ED and observed for 2 hours. Labs were drawn, charted diagnosis was anaphylaxis.

Patient had the first Moderna Covid vaccine on Thursday 1/21/2021. She had a bit of sore arm on that day and the day after. On Saturday 1/23/2021, she had a fever of 100.5 F (11AM), nausea, light headache and chills. The temperature went down after she took ibuprofen. Patient's husband enrolled her to V-Safe to report all the adverse effects she experienced. On Sunday 1/24/2021, her temperature was 98.3F. She still had nausea and no appetite. She and her husband watched a football game in their bedroom upstairs. Husband noticed that his wife was pacing around the room many times. At 7Pm, Husband went downstairs for dinner but she refused to come down to eat. He went upstairs around 8pm, TV was still on. He turned off TV and went down stairs again thinking his wife felt as sleep while watching TV. He went back upstairs for bed around 10:30 PM. Husband said his wife had a deviated septum so she would snore very loudly when asleep. He didn?t hear her snoring so he went to check on her and found her not responsive. Husband called emergency services. Paramedic came at 10:45 and said patient was passed. Husband sent many texts to V-safe after that to report the incident. No response was received from V-safe. Patient?s doctor told her husband that she died due to cardiac arrest.

Patient expired on the morning of 2/11/2021. No known adverse events prior to death. Patient was observed for 20 to 25 minutes after administration of vaccine and reported experiencing no signs or symptoms of adverse events at that time.

Stroke with right upper extremity weakness. Weakness improved, has mild residual weakness at this time. That still may improve in the coming months.

Pt began having nonstop vomiting and diarrhea at 730am the day after vaccination, February 17th. Persisted for over 24 hours so patient came to ER. Pt found to be in a ventricular tachycardia and hypotensive. Pt pale and cool and sts "its hard catching my breath". Pt becoming less responsive and required emergency intervention to stabilize her heart rate and blood pressure. Pt had multiple medications, IV fluids and ultimately emergent cardioversion to stablize heart rhythm.

Developed severe left breast pain had X-rays done thought pneumonia was on antibiotics went back for another X-rays it was worse did contrast CTscan fluid on left lung had to have fluid taken out 720cc still no cause and I still have tightness in lung

Presents with nosebleed and diffuse petticae. Also has epistaxis and thrombocytopenia. Pateitn reports symptoms for 2 days.

Atrial fibrillation event after 27 hours of second Moderna Covid-19 shot; Atrial fibrillation event after 5 days of first Moderna Covid-19 shot.

Had vaccine on 3/3/2021 at approximately 1 PM. She was found on her couch deceased on 3/8/2021. Possible death on 3/5/2021. She called her sister and told sister that back hurt worse than usual and she would lay on the couch and rest. This is where she was found. Unknown if from vaccine, but due to vaccination on Wednesday proceeding her death, report is being filed.

Patient died 2 days after COVID vaccination, concern for vaccine related death. Autopsy showed bilateral pulmonary emboli. No evidence death was vaccine related.

Severe flu symptoms, weakness painful gut hard red vaccine site, skin rash. Day 11, severe cold symptoms, inflamed sinuses, infection in lungs. Seriously considered hospitalization

After my 2nd dose Moderna vaccine, I experienced chills, fever, nausea, coughing and was coughing up mucus. The day after felt very weak and ate very little, had only sprite to drink, water and crackers. The next day my legs buckled up and felt weakness to my legs. My cough started to get worse and on 02-03-2021 I went to an urgent care facility where x-rays of the chest were performed. They also performed a Covid test. The x-ray of the chest demonstrated a touch of pneumonia in my right lung. I was given steroid medication and places on antibiotics and it is when I started to slowly feel better. I do not know what cause my symptoms after my second dose. I also received my first dose Moderna vaccine on 01-01-2021 and I only had left arm soreness but no other reaction. (Lot#: 037K20A)

I had a painful nodule on the left side of my neck, I applied pressure to it and I had complete loss of sensation and paralysis in my right arm that lasts 5-7 hours. MRI confirmed I had a small stroke. 85% recovered. fatigue and loss of energy.

Patient called today to report her adverse event. Patient reports several hours after getting her vaccines being at the ER for stroke like symptoms. Patient reports that after several test were performed they confirmed she had sustained a stroke. Patient was hospitalized for 9 days including rehab.

Pt received dose 2 of Moderna COVID19 vaccine on 2/12. Admitted to the hospital 2/24/21 with acute ITP. Subsequently admitted 3/19 with extensive bilateral LE DVTs and pulmonary embolism.

On March 13, I developed double vision, dizziness and nystagmus. I was transferred by ambulance to a hospital due to stroke symptoms. Admitted overnight. Diagnosis: Transient Ischemic Attack. This occurred one month after second Covid injection.

Sudden onset of shortness of breath early morning 3/15/2021. EMS called, transported patient to Adventist to ER code blue in asystole. Asystole on arrival, no response to resuscitative efforts, pronounced dead in ER.

Patient experienced severe vomiting and fatigue 24 hours after receiving vaccine. This occurred throughout 48 hours after and patient was found d/c on 03/20/2021.

About 3 days after the vaccine my daughter mentioned to me that I was not breathing right. It was harder to breathe and I could not even take a shower that I would be out of breath. My daughter checked my pulsox and it was 85. I couldn't really walk or do anything so my daughter transported me to ER and lots of labs were done so since my D Dimer was too high they did a CT scan and it showed some blood clots in my lungs. They admitted me because they were concerned with the location of one of them. They did some heart tests too and put me on Eloquis and then sent me home. I stayed for 2 days. Then they scheduled me FUs with a heart doctor and a pulmonologist.

cardiac arrest; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC ARREST (cardiac arrest) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 011A21A) for COVID-19 vaccination. The patient's past medical history included Heart attack in September 2020. Concomitant products included LEVOTHYROXINE, ATORVASTATIN, CLOPIDOGREL BISULFATE (PLAVIX), CARVEDILOL, ACETYLSALICYLIC ACID (ASPIRIN 81), VITAMIN D3, ALENDRONATE SODIUM (ALENDRONATE), LISINOPRIL and FAMOTIDINE for an unknown indication. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced CARDIAC ARREST (cardiac arrest) (seriousness criterion hospitalization). The patient was hospitalized on 27-Mar-2021 due to CARDIAC ARREST. At the time of the report, CARDIAC ARREST (cardiac arrest) outcome was unknown. Cardiac catheterization to be performed on the patient on 31-MAR-2021. Based on the current available information and temporal association between the use of the product and the onset date of the reported event of cardiac arrest, a causal relationship cannot be excluded. However, patient's recent myocardial infarction may have been contributory.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event of cardiac arrest, a causal relationship cannot be excluded. However, patient's recent myocardial infarction may have been contributory.

02/23/21, 7 pm - upset stomach and sore arm at injection site 02/24/21, 7 am to 11 pm - upset stomach, headache, body aches & chills and sore arm at injection site 02/25/21, 7 am to 02/27/21, 7 am - sore and swollen left underarm and breast, itchy rash extending down upper arm from injection site 02/27/21, 7 am to 02/28/21, 11 pm - swelling of left knee and left ankle 03/03/21, 7am to 03/06/21, 10 pm - back pain along bottom of right shoulder blade 03/08/21, 8 pm to 03/18/21, 10 pm - chest pain under right breast, especially with deep breathing, and highly elevated blood pressure

On 3/4/2021 I was diagnosed with metastatic lung cancer which further studies showed that there were innumerable bone and organ metastases. On 3/12/2021 I was further diagnosed with multiple pulmonary emboli.

Vaccine breakthrough hospitalization - SOB with O2 sat 50% when EMS arrived. On non-rebreather satting 70%. Chills, fever, cough, and chest pain. BP 152/79, HR 93, RR 20, SpO2 91%. Had been scheduled to receive COVID mAb day of admission, but clinical course worsened. Admitted to Medical ICU for acute respiratory failure with hypoxia and ARDS secondary to COVID-19. Placed on BIPAP and Rx with Remdesivir, dexamethasone, & tociluzumab. Treated for presumed pulmonary embolism with full-dose anticoagulation. Pt expressed wishes to remain DNR/DNI, ultimately she elected to transition to comfort measures only given worsening hypoxia.

Dose 1 - Fever 104.1 degrees, severe chills, dizziness, temporary loss of bladder control (12 hrs. duration), weakness, muscular body aches all over. Symptoms commencing eleven (11) hours after dose 1. Ended in about 24 hours. Dose 2 - Myocardial infarction, Acute Congestive Heart Failure commencing eleven (11) hours after dose 2. Hospitalized 3 days. Symptoms of m/i: couldn't breathe, dizziness. 911 summoned.

At 9pm I took my dog for a walk and upon return home at 9:20 I had a mild anaphylactic episode with hives and some mouth/throat swelling. I took Benadryl and went to bed. I have not had any idiopathic anaphylactic episodes for 2 years.

Bilateral pulmonary embolisms requiring ICU admission. Patient presented to Emergency Room on 4/13/21 with presented to the ED with shortness of breath and chest pain. The patient notes that she developed shortness of breath, particularly with exertion, about 1 week prior to presentation. 2-3 days prior to presentation, she developed pleuritic chest pain on the right anterior chest. She denies any recent fevers, chills, weight changes, palpitations, cough, sputum production, abdominal pain, nausea, vomiting, diarrhea, constipation, lower extremity edema. She does note that she received her first dose of the COVID-19 vaccine on 3/16/2021 and was due for dose#2 on the day of admission. She denies a personal history of blood clots and denies current smoking, estrogen use, or recent surgery. She does note a history of blood clots in her sister, but she is unsure whether they were provoked or unprovoked. Patient required BiPAP on admission and was initiated on a heparin drip. Initial CT w/ some concern for R heart strain, however, echocardiogram showed no signs of R heart strain and she was hemodynamically stable. She was weaned from the BiPAP to Non-rebreather, and eventually nasal cannula. The heparin drip was transitioned to lovenox with plans to go home on a DOAC. Still hospitalized at time of event report.

her left leg was swollen; two red clots on left leg; right feet was hurting; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (two red clots on left leg) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (her left leg was swollen), THROMBOSIS (two red clots on left leg) (seriousness criterion medically significant) and PAIN IN EXTREMITY (right feet was hurting). At the time of the report, PERIPHERAL SWELLING (her left leg was swollen), THROMBOSIS (two red clots on left leg) and PAIN IN EXTREMITY (right feet was hurting) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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. Further information has been requested.

systemic inflammatory response syndrome; falls/legs had given out from under her; This literature-non-study case was reported in a literature article and describes the occurrence of SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (systemic inflammatory response syndrome) in a 65-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. LITERATURE REFERENCE: The patient's past medical history included Hypertension and Diabetes. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (systemic inflammatory response syndrome) (seriousness criterion medically significant) and FALL (falls/legs had given out from under her). At the time of the report, SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (systemic inflammatory response syndrome) and FALL (falls/legs had given out from under her) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood culture: normal (normal) normal. In 2021, Body temperature increased: 39.1 (abnormal) 39.1 degree celsius. In 2021, C-reactive protein: 63.4 (Inconclusive) 63.4 milligram per litre. In 2021, Computerised tomogram abnormal: pulmonary nodule (abnormal) multiple pulmonary nodules measuring up to 1o1 cm. In 2021, Culture urine: normal (normal) normal. In 2021, Fibrin D dimer: high (High) 5267 ng/ml.. In 2021, Heart rate: 88 (normal) 88 BPM. In 2021, Positron emission tomogram: abnormal (abnormal) It showed uptake in the fat stranding posterior to the right deltoid,moderate uptake with in right axillary lymph nodes and diffusely increased uptake in spleen and no uptake in pulmonary nodules showing they are benign.. In 2021, Red blood cell sedimentation rate: 63.4 (Inconclusive) 63.4 mm/h. In 2021, Respiratory rate: 25 (abnormal) 25 breaths per minute. In 2021, SARS-CoV-2 test: negative (Negative) negative. 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. 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.

Headache chills fever body aches lump in throat nausea followed by pneumonia low oxygen level very high white blood count

101.5 fever Friday night, followed by a seizure at 3am. She was found unresponsive late Saturday afternoon, and was pronounced dead at the hospital. Sudden cardiac arrest.

Beginning in day after receiving 2nd vaccine: Systemic inflammation, severe joint pain, abdominal pain, digestive/intestinal issues (ranging from constipation to diarhea and excessive gas), loud ringing in the ears (tinnitis)

Spouse reported that patient was taken to The Hospital after unresponsive in the home on 4/2/2021. States was told that cause of death was heart failure.

Blood clot in Right leg and bilateral lungs. Patient also reported headache for >1 week, fatigue, shortness of breath and blood pressure that elevated above 210 systolic.

Second vaccine given 3-4-21 on 4-21-21 was treated at the ER for blood clot in right calf . My calf was tight and a bit swollen. My heart beat was rapid with shoulderblade pain and tightness in chest. Tightness and blade pain started on 4/20 pm with a hard calf. Morning pain worse and leg was more swollen and warm

March 31, I woke up with very stiff joints, making walking and doing household chores exceedingly difficult. This lasted for 5 days. Beginning on April 5th I felt like I could not catch my breath, so I called my doctor?s office for an appointment; I saw the PA and she felt I needed to have an EKG. I called them and the earliest I could see them was the 20th. I contacted my Doctor?s office, and they sent an order for the testing ASAP, I never received a call from them to reschedule. As the week continued, I got worse and went to the ER. After numerous tests and blood draws, I was admitted to the hospital. I spent 2 days in the hospital, 24 hours on oxygen.

Shortness of breath; Difficulty breathing; Heaviness in chest; Went to ER and had chest x-rays and CT scan of my lungs. Found out I had numerous pulmonary embolisms in all 5 lobes of my lungs. They did a COVID test and it was negative. They did an EKG and sonogram on my heart and it was fine. They checked for blood clots in my legs. There were none. They checked for signs of cancer. There were none. They started a heparin drip through my IV and the dissolved the largest clot with an embolectomy. I'll be on blood thinners for 6 months.

On 4/19/21, Pt began with pain in her left leg. Pain continued to worsen so that she could not sleep at night and she became unstable on her feet. On 4/23, she developed a 102 degree fever, severe nausea and severe abdominal pains and she drove to Hospital ER on 4/24. She was diagnosed with Deep Vein Thrombosis behind her left knee.

left lower extremety swelling, redness, pain within one week of second COVID vaccine. DVT confirmed at ED visit.

I had a fever, vomiting, SEVERE Migraine, aches, diarrhea - With both shots. I got COVID 8/31/2020, hospitalized from 10/9/2020 - 10/16/2020 with double pneumonia. Very dehydrated, fever was uncontrolled, vomiting, diarrhea.

Patient arrived to the healthcare facility with complaint of left upper quadrant abdominal pain on and off for approx 2 weeks. Noticed it began shortly after receiving the COVID vaccination. On April 15th, patient stated they had an increase in the left upper quadrant abdominal pain and new shortness of breath. Upon admission to ED patient had CT angio chest with contrast completed, results showed b/l pulmonary embolism with distention of the main pulmonary artery.

Moderna COVID-19 Vaccine EUA vaccine second dose about 2 or 3 hrs after shot, I had anaphylactic symptoms on the side of the injection. swelling of throat and tongue, sneezing, coughing, wheezing, trouble breathing. I was not going to call 911 cause I could still breath on the other side, and I could not drive to hospital to get epinephrine shot so I took 3 or 4 benaydrel every few hours and it finally went away.

Saturday 30 minutes after administration patient felt nausea lethargy and stiff neck and back. Next morning Sunday patient woke with a fever of 99.6 and large blood clot in mouth. Two days post vaccine Monday patient work with large blood clot on pillow. That evening patient had 2 more blood clots spontaneously coming from teeth. Tuesday morning upon arising from chair pt experienced an intense metallic taste. Patient then experienced several 8 mouth fulls of blood on 3 occasion in same evening. Patient states it was pushing out from gums.

April 17, 2021 I developed a severe sore throat April 21, 2021 went to an urgent care. Negative strep, negative Covid, sent home to take Tylenol April 23, 2021 telemedical with primary physician, put on AmoxClav anti-biotic for severe sore throat and swelling April 24, 2021 went to see an ear, nose and throat specialist who diagnosed Shingles in my throat Prescribed Prednisone (20 mg x 2 daily) for inflammation Prescribed Clarithromycin (500 mg x 2 daily) to avoid any bacteria such as pneumonia from shortness of breath and trouble swallowing Prescribed Valacyclovir (1G x 3 daily) for Shingles IRONY: Shingrix vaccine July 13, 2018

Spontaneous Cortical Non aneurysmal subarachnoid hemorrhage with diagnostic suspicion but not confirmation of cortical venous thrombosis, and spontaneous ventricular tachycardia.

Noticed bleeding in the mouth/gums. Looked inside and found bloody holes in my cheeks about 1/2" big. I noticed the top of my hands we also very bruised although I did not get hurt. I went to the ER and they took me in and ran blood tests. They diagnosed me with Immune Thrombocytopenia Purpura. My platelet level was at 8,000, and 6 months prior I was at 180-200,000. They began giving me platelets and were working up to giving my Immunoglobulen. After 2 doses of platelets they gave me 2 doses of benadryl intravenously and I had a scary reaction (I've never had a reaction to benadryl prior to vaccine). My body went numb, it felt like my muscles fell asleep, I felt like I could not breath. It's as if my body attacked anything that came in. Then I was given a sedative to calm down. As the sedative faded I began feeling immense pain in my abdomen, they thought it was internal bleeding, but after a CT scan they found 3 kidney stones. I was then put on fluids. Due to pain, my blood pressure went up and stayed up for about 8-10 hrs at around 255. I was given about 3 does of blood pressure medication throughout that time to lower it as well as morphine to help with the pain. The next morning (Day 3) I was finally given the Immunoglobulin (3 bottles = 1 dose). platelets went up to about 60,000. Then I was given a second dose and released on day 4 (but the second dose was not completed in full, only 1 or 2 bottles of the 3 were given. I was released and came back after 2 days for a blood test. I was given steroids to take for a few months. My platelets were at 120,000. I thought that I was getting better, but then a few days letter came in for another blood test and it showed I was back at 60,000 platelets. Thats where I am now.

loss of taste and small April 18 - 24, 2021 Racing heart rate, significant weight/pressure on chest, difficulty catching breath: - first episode April 24, 2021 - second episode included cold sweats May 4, 2021. I called 911 and was transported to Emergency Department. ED team diagnosed issue as atrial fibrillation.

Initially, experienced swelling in left foot, leg, progressive pain, difficulty walking. Referred for test, after seeing doctor on 4/21/21, progressive pain, gradual and increasing shortness of breath. Went to Urgent care on 4/26/21. Recommended Emergency care. Hospitalized 4/26/21 to 4/30/21. Diagnosed DVT, Pulmonary Embolism, Afib.

Dose 1 - 1/19/21 - On 1/26/21, I got developed a bad case of SOB. I called my cardiologist and she told me to get tested for COVID. I went to the county facility to get tested and it took 3 days for results, which finally came back negative. During my wait, I went to a Urgent care and they did a Chest Xray, EKG and another COVID test, which was negative and the other tests were normal. I was sent back to cardiologist. She scheduled a stress text on 2/11 and everything was fine. I was also feeling fine by then. Dose 2 - 2/16/21 - The next day, I had a headache, aches, pain, fever and basically felt like I had the flu. I took Tylenol and that lasted about 36 hours. On 2/25, I was doing my 2 mile walk and I start experiencing the SOB again. So, I relaxed and figured it would go away. On 3/1, we drove to a park and back home 3 days later. On 3/3, I was really exhausted, so I took a nap for 3 hours and awakened with calf pain and a low grade fever. That lasted for 3 days, so I went to the ER on 3/6. They did an ultrasound on my leg and found a DVT in my right leg. They did CT Scan of my lung and found several clots (pulmonary emboli). I was in the hospital overnight and put me on a blood thinner, Eliquis 5mg, twice a day. Since then, I've continued to take the Eliquis and I'm following up with a hematologist on June 21. The hematologist has already tested me for two factors came negative and he will test me for the third one at my next visit.

presents 5/8/2021 with red/bloody lesions inside bilateral cheeks, lower lips for the past 5 days or so. Patient denies any new medications. Patient denies any pain in her body, she noted increased bruising (right hand), and small dots on her skin appear everywhere. She has never had low platelets before. She denies taking any new supplements. She only takes levothyroxine and no other medications at home. She denies taking Aspirin and denies . admit to inpatient Med Surg, patient with most likely ITP with wet purpura, diffuse petechiae and with platelet of 12K. Patient is currently not actively having any without GI bleed or profuse bleeding. HGB 12.0 Patient received IV IG infusions on 5/11 and 5/12, as well as continued steroids, and received platelets transfusions , Platelets improved to > 50 K by 5/12/2021 , and felt well and ready to go home . On 5/25/21 patient readmitted due to worsening thrombocytopenia during outpatient follow-up. At last admission, patient had thrombocytopenia with minor oral bleeding and petechial rash, and was sent home on steroid taper. Patient reports tapering down on prednisone as directed, but she began to note increased bruising all over her body, most prominently on her arms. Notes her gums began to ooze again a couple days ago. No hematuria, no melena or dark tarry stools. will treat with IVIG 1g/kg and rituximab.

I have had heavy vaginal bleeding for 8 days ,now spot bleeding... Also bad cramps in feet?s and pains in legs on and off,besides headaches.

INITIALLY: Patient described having Flu- like symptoms of fatigue, body aches, also nausea within hours of receiving the vaccine. She had to stay in bed for 2 days because of it and her arm was "extremely" sore, and the symptoms were on and off for the subsequent 2 weeks. THEN: Patient gets admitted to the hospital on 5/15/21 (two weeks from the shot) for a HEART ATTACK. She presented with atypical symptoms, describing a "pulling sensation" in the back of her head and extreme weakness where she couldn't stand. Patient was then hospitalized twice due to the heart attack, and will require open heart surgery which she is scheduled for later this month. Patient is on several new medications now.

I experienced menstrual like cramps and minor lower back aches. Later during the day the cramps started to calm down, At nighttime I experienced flu like symptoms, I started to feel a sore throat that was by my tonsils. I also had aches under my eyes The next day I still had a sore throat and I also experienced earaches. A couple days later the eye aching got worse. I also started to have sharp pains in my stomach. I also wasn't able to eat anything , when I did eat one snack I felt very stuffed. I experienced a minor headache. At night a couple days later I still had experienced some more stomach aches that became very painful. When I start going to the bathroom I saw some blood. Couple weeks later I felt a little bit better , I by chance pushed on my lower stomach area close by my pelvis and it felt very sore. After all this I felt better and gained my energy back. Then that's when I felt the stomach pains by my kidney again and the menstrual like cramps. Not until May did all of my cramps and pains come to a stop.

I started to get a rash around the injection area and a stiff neck. Both resolved after about 5 days. On the 29th, I couldn't see after I got out of the shower. I went to the hospital and they gave me the TPA drug. I told them I had the vaccine and they said they weren't sure if it could be the cause. I was hospitalized for 3 days. Doctor thought it was a Cerebellum Stroke in the back of my head and think the drug broke up the clot. My vision did return after the drug. They didn't have any ICU beds and weren't equipped to handle my case, so they did telemed appt with Neurological ICU, where they did more testing. I have to follow up with their stroke clinic next week. They put me on new meds, to include Norvas, baby aspirin and Crestor.

Moderna shots given at a vaccine facility on 2/6/21 and 3/10/21. She has had a gradual onset of shortness of breath. Seen by me on June 1. Dx cardiomyopathy, Class 3 CHF. Hospitalized at local Medical Center. Currently still being treated by cardiology team.

Pericarditis Went to the emergency room April 18 miss- diagnosed for phenmonia treated w ant biotics Returned to emergency room April 25 admitted April 25- 28 diagnosed pericarditis

Patient presents after falling in her shower. She has been having dark stools for a couple weeks and weakness and dizziness for a couple days. In the emergency room, she was found to have macrocytic anemia and thrombocytopenia. Treatments patient has received include steroids, rituximab, and eltrombopag

Patient presented to the ED and was subsequently hospitalized for NSTEMI within 6 weeks of receiving COVID vaccination.

1/9/2021 fever of 101.3, chills, 1/10/2021 fever 99.6, diarrhea, pain in injection site slight. Tylenol

Presented to MD'S office on 01/05/2021 with cough, HA, fever 101.9, chills, and fatigue. Returned on 01/07/2021 with no improvement. Returned on 01/11/2021 with fatigue, elevated temp 101.2, SOB, 02 Sat at 90%, Rocephin 1G IM administered, CXR revealed pneumonia. MD received call from patients husband stating worsening 02 Sat levels at 81-82%. Was transferred to hospital and admitted with pneumonia..

Pt had anaphylaxis reaction 10 minutes after administration. Sensation of light headed, could not talk, sensation of tongue swelling and throat closing. Pt was immediately given one dose of epi using standard adult epi pen, IVF, and 25mg benadryl IV. Pts vitals were always wnl, including oxygen. Pt stabilized and in 60 minutes was ready to go home wo any adverse outcome.

66 yo WF with PMH asthma, allergic rhinitis, morbid obesity (112kg), chronic low back pain with sciatica, hyperlipidemia, CKD 3a, endometiral CA was at the clinic for COVID19 Moderna Vaccination. History of allergies to Paclitaxel (anaphylaxis) and adhesive tape (pruritis). Takes allergy shots 3 x week. Dose given in patient's left deltoid at 1600 (lot # 011J20A). At 1630 patient started to complain of dry eyes. Patient took 5mg levocetirizine from her own supply with no relief. Patient was registered to urgent care for further evaluation and management. Patient started to clear throat and complain her throat feels swollen and her mucus was thick. BP elevated 160's. Solumedrol 125mg IV given at 1702;

Resident received 2nd Covid 19 vaccine from Moderna on 1/26 in Rt deltoid. Immediately felt a little lightheaded during the 15 min window afterward but was able to ambulate independently with walker just afterward. After taking a nap, she woke with a headache, chills, a little shaky and feeling very tired. She was able to eat and take Tylenol at the time. For the rest of the day, she felt under the weather. The next morning she was very weak, unable to ambulate and tachycardic prompting nursing staff to send her to the hospital for assessment.

Pt admitted 1 day after 2nd dose Moderna COVID-19 Vaccine, for fever, muscle aches and diagnosed PNA. Pt stable on discharge with abx for PNA tx.

Patient collapsed and could not be revived. There was no prior warning. She was otherwise in good condition for her age. The death was listed as probable cardiac arrest but no autopsy was performed. Since it occurred so close to the vaccine shot I thought someone may want to know.

fever 101.2 at 2pm took 2 tylenol and it broke Went to the urgent care Feb 8, on 14th ER treated her as a sepsis pt. and did a whole check up and was negative (WBC and platelets returned back normal) WBC on the 8th was 2.4 now WBC 02/14 5.82 platelets 1750, now 26200 02/14 Recommended: please see a doctor just to confirm otherwise I would still recommend you get the second dose of the vaccine benefits outweight the risk

After vaccination I experienced very fatigue, nauseous, chills, fever, so cold, and sore, and today 48 hours it appears to have a menstrual cycle or vaginal bleeding that started today, I had a hysterotomy 20 years ago.

The day following the vaccine I was fine until approximately 1:30 p.m. when I suddenly got very, very dizzy, had disequilibrium and began to feel nauseous, and had diarrhea. The dizziness increased from mild to so bad I had to hold onto the wall to walk to the bathroom. I took half a Benadryl but it continued to escalate and I took another half a Benadryl at which time it stopped escalating but did not dissipate until approximately 4:45 p.m. I called my physician who was unavailable so I just depended on the Benadryl. There were no breathing difficulties but I had a scratchy throat in the middle of the attack and my tongue went numb and tingly.

Anxious; Tired; Blood clots in left leg, right leg and brain; A spontaneous report was received from a consumer who was also a 66-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed blood clots in the left leg, right leg, and brain, anxious and tired. The patient's medical history was not provided. Concomitant medications reported included vitamin D, magnesium, lisinopril, and vitamin B12. On 14 Jan 2021, approximately 3 days prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 16 Jan 2021, the patient experienced immense pain in the middle of the night, and subsequently saw her primary physician. An ultrasound revealed blood clots in her left leg, right leg and brain. A hematologist and vascular surgeon were consulted. Patient was treated with apixaban while they are doing blood work. The patient also became tired and anxious. She noted that she never had comorbidities before and was upset that her life has completely changed. A repeat ultrasound was scheduled for 19 Feb 2021. The mRNA-1273 dose was discontinued in response to the event of blood clots in the left leg, right leg, and brain, anxious and tiered. The outcome of events, blood clots in the left leg, right leg, and brain was considered unknown at the time of this report. The outcome of the events, tired and anxious were considered not resolved at the time of this report.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

autoimmune hemolytic anemia & immune thrombocytopenia which worsened rapidly post-vaccine symptoms - bleeding, short of breath, incredibly tired, pale, weak - symptom onset 8 hours post-vaccine rapid progression for first 24 hours post-vaccine) blood transfusion, platelet transfusion, treatment with steroids' (still undergoing treatment and seeing no improvement at this point)

My mother felt pain increasing in her back. On Saturday the 6th she went to her clinic Dr. He gave her a ex-ray. He saw a mass and told her to ho to the hospital for more test. She went to hospital where they per f order a CT scan and many other test and found a blood clot on her lungs. She was advised to be admitted immediately. She was there getting many test taking blood thinners to shrink the clot. Monday after all her test came back the doctors could not find a source of the clot. She was sent home with blood thinner prescriptions and follow up appointments.

Slight sore arm for two days, fatigue for 4 days, migraine headache for 5 days, extreme chills for 1.5 days, nausea for 4 days, fever 100.4 for 1 day, vaginal bleeding on day 3 for 1.5 days

Saddle blood clot in lung. Place in ICU for 1 day. Then regular room. Heparin drip to Apixaban. No activity. All medical tests indicated no cause of blood clot. Vitals great. Past out twice and threw up night it started

Patient was found unresponsive the morning of March 14, 2021. She was pronounced dead at 5:33 AM. The medical examiner quoted natural cause of death.

anaphylaxis, asthma attack, heart racing, dizziness, severe headache, pain in left side from shoulder to waist, numbness in both hands, pain in right arm from shoulder to hand with numbness and tingling sensation. Inabiltiy to walk or stand, red eyes, swollen faces, shortness of breath, weakness in legs, rise in blood sugar levels, feeling light headness, fever, sore throat, chills.

next morning woke with fevers, body aches, chills, nausea and headaches. today diagnosed with new onset atrial fibrillation and LLL pneumonia.

Death; A spontaneous report was received from a consumer concerning a 66-year-old, female patient, who received Moderna's covid-19 vaccine (mRNA-1273) and died. The patient's medical history included covid-19 infection on 04 Nov 2020. No relevant concomitant medications were mentioned. On 28 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number:unknown) intramuscularly for prophylaxis of COVID-19 infection. On 09 Mar 2021, the patient died. CT was done and did not find any atherosclerosis but found her lungs were whited out,heavily filled with fluid which he described could've been pulmonary edema. She had tested Covid positive back on 04 Nov 2020. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the event was fatal. The patient died on 09 Mar 2021 and the cause of death was unknown. An autopsy was planned on 11 Mar 2021.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death

Pin Stroke; A spontaneous report was received from a consumer concerning a 66-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event pin stroke. The patients medical history was not provided. Products known to have been used by patient with in last two weeks included montelukast , alendronate and varenicline tartrate. On 04-Mar-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA (Lot number: 010A21A ) through intramuscular route of administration in the left deltoid for prophylaxis of COVID-19 infection. On 06-Mar-2021, patient experienced pin stroke and was hospitalized for four days. Laboratory tests performed included magnetic resonance imaging and electro cardiogram and the results was not provided. No treatment information was provided.. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event pin stroke was considered unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.

Symptoms: tingling on right side of body--face, arm and hand, foot First event on 3/22/2021 starting at about 4:15 pm, lasted about 15 minutes Second event on 3/23/2021 starting at about 10:15 am, lasted over an hour. Went to ER during this event; had additional tingling on site in the ER.

right upper extremity DVT. Symptoms began 5 days after receiving vaccine. Presented with right arm redness and swelling. Found to have DVT on Day 9 following vaccination. Does have a previous history of provoked DVT (following leg fracture). No known coagulation disorder and not on chronic anticoagulation.

Moderna COVID-19 Vaccine EUA Hospitalized for weakness and muscle aches, unable to walk, rhabomyolysis

Pt presented to the ER on 2/26 with hemorrhagic CVA basal ganglia, left sided hemiparesis, dysarthria, WBC elevated to 19,000, platelets elevated 568,000, new anemia, CRP markedly elevated

stroke; light headed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included CML (CML Leukemia though she's in remission now) in 1999 and Surgery (Open eye surgery (2 & half year ago)). Concurrent medical conditions included Prediabetes, Blood pressure (Taking medication for blood pressure) and Renal disorder NOS (Taking medication for her kidneys). Concomitant products included METOPROLOL for BP, ATORVASTATIN for Cholesterol, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)). On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization and life threatening). On 05-Apr-2021, the patient experienced DIZZINESS (light headed). The patient was hospitalized from 20-Mar-2021 to 23-Mar-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) had resolved and DIZZINESS (light headed) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment of these events were not provided. 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. However, patient's past medical history of CML, hypertension, Hyperlipidemia may contribute to this event. Further information is requested.; 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. However, patient's past medical history of CML, hypertension, Hyperlipidemia may contribute to this event. Further information is requested.

Left calf pain & swelling on 1/28/21. Seen in ED on 1/28; diagnosis left calf DVT. Started double dosing of Eliquis twice daily. Leg swelling increased and upper left leg began to swell. Seen in ED again on 1/3121; new ultrasound showed extensive clotting both lower and upper left extremity. Continued double dosing of Eliquis with no resolution of clots. Seen by cardiovascular surgeon on 2/10/21; new ultrasound showed continued extensive clotting, now in pelvis as well as entire left leg. Referred to Interventional Radiologist. Procedure performed on 2/12/21: TPA & heparin infused through popliteal vein for 24 hours/in the intensive care unit

Blood clot on middle joint of right hand pinky finger. Pressure bandage, heat, Advil. Decreasing in size after 18 days.

unknown, death at home, with no one in attendance. Pt with mulitple medical conditions, when RN adminstered 2nd dose on 4/07/2021. They dicussed how the first one went. Pt states, besides sore arm nothing. She did have acid reflux, (common for her) which she took regular medication which took care of it. But denied any other problems with first dose. Seccond dose given with no reaction during 15 min observation time. EMS was called to scene on 4/08/2021 at approx 1630 hrs, to find pt deceased, spine in bed. approx down time 2-3 hrs. Pt's primary Dr. contact as well as corner. With pt's medical history no further investigation was done.

EMS was dispatched to patient's home for "non breathing." EMS found patient on the floor in the kitchen with sheet already over her. No pulse, patient cold to the touch, jaw was locked shut. Patient's family members stated the last time they saw the patient alive was around 2:30 am on the same day. Patient pronounced dead on arrival at 6:20 am. No evidence of foul play noted.

On March 11 I had shortness of breath laying down. March 17 I was up all night with heart rate up to 125 and oxygen saturation as low as 80%. On March 18 I went to ER and was diagnosed with Congestive Heart Failure after a 3 day hospital stay of tests. I have no history of high blood pressure or heart issues except for high cholesterol controlled with Lipitor. No family history of heart problems. I am now on Entresto and Carvedilol.

3 days of dyspnea on exertion, dry cough and right thigh pain. CT chest with acute submassive pulmonary emboli, saddle PE across main pulmonary arteria. Right lower extremity DVT. Echo - mild RV dilation and reduced RV systolic function.

Patient received Moderna vaccine and was in her usual state of health. Developed shortness of breath and dyspnea of exertion for 2 weeks. Presented to her Physician's office who ordered a CT Angio which revealed multiple acute pulmonary emboli throughout both left and right main pulmonary arteries and lobar branches with ventricular strain. Patient underwent EKOS procedure to remove clot burden and was initiated on Xarelto. Patient is requiring 4L of oxygen at this time.

66-year-old lady with severe COPD on home 2L O2 (initiated 3/21), newly diagnosed SCC of lung (not currently on treatment), HFpEF, schizoaffective disorder, and recent COVID-19 infection (dx 4/6) who presented with shortness of breath on 4/16 in the setting of receiving first dose of Covid vaccine 1 week prior. Found to have sepsis physiology w/ hypoxic respiratory failure from COVID-19 pneumonia. CXR with multifocal pneumonia in the setting of chronic interstitial changes and required up to 6 L nasal cannula. Started on IV remdesivir (x 5 days ending 4/20) and Decadron x6 days, ending 4/21. Clinically improved and weaned to her baseline 2 L O2 and discharged on 4/21 to rehab

Blood clots in both lungs upper and lower chambers New stage 2 HBP Chest pain and tightness Shortness of breath Fever, headache, joint pain severe, chills, nausea

Entered hospital on 3/22/21 At around 8am in the emergency room. Had ultrasound of left leg and was placed in ICU for a massive blood clot in the left leg. Had surgery at around 4pm on 3/22/21 and placed back in ICU until the next surgery on 3/23/21 to remove the blood clot. Was released on 3/25/21.

That night chills, fever 102, diarhrea, Shortness of breath. Shortness of breath continued to get worse, 3rd day went to ER. Stated I was in heart failure. Took multiple doses of lasix, BNP was over 2200, followed up with family Dr. contacted Cardiologist, he had echo and lab work done, BNP down to 1200. I did not have the shortness of breath until after vaccine. Still am having. See primary Dr Monday and follow-up with Cardiologist the 28th.

Had three blood clots within 36 hours. One in left leg, one right leg and one in groin. Also, rheumatological problems in tendons in arms and legs.Hearing in left ear diminished by 10%.

Shortness of breath; COVID-19 pneumonia; COVID-19 infection; Hypoxic respiratory failure; sepsis; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of RESPIRATORY FAILURE (Hypoxic respiratory failure), SEPSIS (sepsis), COVID-19 PNEUMONIA (COVID-19 pneumonia), COVID-19 (COVID-19 infection) and DYSPNOEA (Shortness of breath) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Heart failure with preserved ejection fraction. Concurrent medical conditions included COPD exacerbation (On 2 liters of oxygen at baseline), Squamous cell carcinoma of lung, Schizoaffective disorder and oxygen. On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced COVID-19 PNEUMONIA (COVID-19 pneumonia) (seriousness criteria hospitalization and medically significant) and COVID-19 (COVID-19 infection) (seriousness criterion hospitalization). On 16-Apr-2021, the patient experienced DYSPNOEA (Shortness of breath) (seriousness criterion hospitalization). On an unknown date, the patient experienced RESPIRATORY FAILURE (Hypoxic respiratory failure) (seriousness criteria hospitalization and medically significant) and SEPSIS (sepsis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized until 21-Apr-2021 due to COVID-19, COVID-19 PNEUMONIA, DYSPNOEA, RESPIRATORY FAILURE and SEPSIS. At the time of the report, RESPIRATORY FAILURE (Hypoxic respiratory failure), SEPSIS (sepsis), COVID-19 PNEUMONIA (COVID-19 pneumonia) and COVID-19 (COVID-19 infection) had resolved and DYSPNOEA (Shortness of breath) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Chest X-ray: abnormal (abnormal) multifocal pneumonia in the setting of chronic Interstitial changes.. 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. Treatment information provided included 6L O2 Nasal cannula, Remdesivir for 5 days (stop date : 20 - Apr - 2021) ,Decadron for 6 days (stop date : 21 - Apr - 2021) . The patient was discharged on 21 Apr 2021 to rehabilitation on baseline 2L O2 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. Reporter did not allow further contact; 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.

Increased weakness, shortness of breath, falls, dyspnea and orthopnea, acute kidney injury, bilateral lower extremity swelling, nausea, abdomen pain. Treated at ER 3/10/2021 - discharged home so patient could recieve dose 2 on 3/11/2021. Admitted 3/20/2021 for worsening of all symptoms and Cardiac cathe performed. Discharged to rehab facility 3/30/2021

Patient is a 66-year-old female with a history of diabetes hyperlipidemia hypertension low back pain who presents from vaccine clinic complaining of numbness and tingling in her left lower extremities. Patient also states she has been having nausea and mild headache. she notes that she took her blood pressure medicines this morning as per her usual. She denies any chest pain palpitations domino pain or diarrhea. Patient states she thinks she may have history of sciatica note that this pain feels different from her normal numbness and tingling in the lower extremity.

Covid19 vaccine: The patient received her second dosage of Moderna on 3/23.Patient called family medicine triage on 4/1 regarding arm/shoulder pain from her vaccine site that was not improving. Pain started out near injection site but last couple days has been spreading to shoulder, some possible swelling, per patient. Finding it hard to sleep. Denies redness, warmth. Feels warm but no chills, doesn't have thermometer at home. The patient refused to call the COVID hotline. She was calling for an in-person appointment and was triaged for her symptoms. The next in-person appointment was not until Saturday 4/3, and it was given to the patient. She did not want to go to the ED. She suffered a witnessed massive heart attack the same day in her home and her partner called 911. Per parnter's report, walked around a little that day, in discomfort. Then came home and laid down with more arm pain. She had acute L arm pain and then agonal breathing - passed in order of 2-3 minutes. Likely cardiac arrest after MI for few days. She was BIBA the EMTs continued CPR for ~20 minutes but was unable to revive patient. She was pronounced dead on 2023.

Summary:66-yof with past medical history of ESRD HDD Monday Wednesday Friday, COPD not on home oxygen, hypertension, depression, hyperlipidemia, who comes to the ED with 4 weeks duration of generalized malaise, fatigue, and loose stool. Incidentally she reports her daughter tested positive for Covid on Sunday and she was exposed at that time, but sx pres for several wks . She was noted have a fever of 102.3. Ferritin 1086. Her O2 sats declined to 92 percent the emergency room. She also tested positive for Covid 19.

On Saturday, April the 3rd, my wife's left leg became numb, and she had a tingling feeling. I took her immediately to ER, where they perform CT and MRI. She was internally transferred to the hospital, where she stayed there until April the 14th, when she was transferred to (the Rehabilitation Institute) to begin physical and occupational therapy. As of today, mi wife doesn't have proprioception in neither of her legs nor her belly (she has no control on bowel and bladder).

In the hours following the first dose on 3/19/2021, sustained fever between 100 - 102 degrees, headaches, chills, clammy. The symptoms continued all day on the 3/20/2021. Sometime after 5:30 am on the 3/21/2021 she could not breathe. Pulse oximeter registered 57. contacted ambulance, within their arrival 10-15 minutes later, pulse oximeter was down to 43. Lips were blue skin was pale and clammy. At hospital she received high doses of oxygen and was treated for other symptoms.

Stroke; Encephalitis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and ENCEPHALITIS (Encephalitis) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. Concurrent medical conditions included Blood disorder NOS (blood clotting disorder from 20 years). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant) and ENCEPHALITIS (Encephalitis) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) and ENCEPHALITIS (Encephalitis) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient reported that magnetic resonance imaging (MRI scan) performed months back detected encephalitis, stroke and stated as totally asymptomatic. The patient reported to be taking Clopidogrel (Plavix) to treat the event. 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. This case was linked to MOD-2021-101992 (Patient Link).; 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.

"Moderna COVID-19 Vaccine EUA" -- patient hospitalized with covid19 after receiving one dose moderna vaccine. 66 y.o. female with hypertension and diabetes admitted with sharp abd pain, nausea, vomiting for several days. CT abd with cecal distention, findings concerning for cecal volvulus. Extended resp panel positive for SARS-CoV-2 (received 1st dose of COVID vaccine on 3/22). Went to OR for exploratory laparotomy, lysis of adhesion and right colectomy. Patient was also found to be Covid-19 positive and needed supplemental oxygen in ED (3L NC at the time). Imaging showing bilateral pulmonary infiltrates/effusions (and also cecal volvulus, as stated above, pt underwent exloratory laparotomy, lysis of adhesion, right colectomy with ilecolostomy). Patient was recovering on medical floor when she clinically decompensated and needed increased oxygen and had a drop in blood pressure (confused, hypotensive, hypoxic). Labs notable for BUN 37, creatinine 2.16, procalcitonin 17.62, Hgb 6.4 (10 on admission). ABG 7.35/ 28/ 73/ 16/ 94% on nasal cannula. 1 unit PRBC given. BP continued to be borderline and was placed on vasopressor briefly. Empiric antibiotics vancomycin/cefepime/Flagyl, and patient was also started on remdesivir and dexamethasone. Nadir O2 sat was 82% on 3/31/2021. T=102.2 on 3/31/21. Patients had multiple family members with Covid-19. Treatments as stated above included Remdesivir and Dexamethasone. Cultures negative - exact source of sepsis unclear: bacterial pneumonia vs. covid vs. intra-abdominal source In ICU from 3/31 to 4/3. Medical floor 4/3 to 4/7. Patient was discharged home 4/7/21.

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID injection. Diagnosis was acute pulmonary embolism.

Patient began experiencing some shortness of breath 15 minutes after the injection with audible wheezing. This nurse assessed her and found the following: LS tight/rhonci whole L side w/wheezing in bilat upper lungs, O2 sat 96% on RA, skin pink/warm, no change in color, no diaphoresis noted, HR regular/98. Patient was able to converse. 911 was activated, paramedics heard air movement throughout lungs, still 96% on RA, BP 141/92. Taken by ambulance to ED due to long history of asthma and no recue inhaler on her person.

2 DAYS POST SECOND MODERNA VACCINATION (4/30) PTNT BEGAN EXPERIENCING SHORTNESS OF BREATH AND CHEST PAIN. 6 DAYS POST SECOND SHOT (5/4) PTNT WENT TO PRIMARY DOCTOR WHO DID BLOOD WORK. PATIENT WAS ADMITTED TO HOSPITAL ON MAY 19TH FOR CONFIRMED PULMONARY EMBOLISM TREATMENT. PATIENT DISCHARGED FROM HOSPITAL ON MAY 20TH ON 6 MONTH COURSE OF XARELTO.

Sepsis; Pyrexia; This regulatory authority case was reported by an other health care professional and describes the occurrence of SEPSIS (Sepsis) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for Vaccination: Flu (seizure like activity). Past adverse reactions to the above products included Seizure with Flu. Concurrent medical conditions included Sulfonamide allergy (sulfa (Bactrim) facial swelling), Allergy (environmental allergies), Factor V Leiden mutation (TSVT) and Asthma. Concomitant products included METOPROLOL, WARFARIN and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for an unknown indication. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced SEPSIS (Sepsis) (seriousness criterion medically significant) and PYREXIA (Pyrexia). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever, at an unspecified dose and frequency. At the time of the report, SEPSIS (Sepsis) and PYREXIA (Pyrexia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Blood test: 1750 (Inconclusive) 1750. On 08-Feb-2021, White blood cell count: 2.4 (Inconclusive) 2.4. On 14-Feb-2021, Blood test: 26200 (Inconclusive) 26200. On 14-Feb-2021, White blood cell count: 5.82 (Inconclusive) 5.82. 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. 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

About 1 month after her second dose of Moderna Covid vaccine she started noticing some shortness of breath with activity. She thought it was related to her subglottic stenosis that she gets dilated often. A month after her symptoms started she was seen in clinic by ENT for the stenosis and was noted to have significant leg swelling and sent to ED where she was admitted for heart failure & significant PVC burden on telemetry (about 30%). She was diuresed & discharged with the plan to do a Holter monitor and decided if she was a candidate for ablation for PVCs.

2 days later, she had diffuse joint pains, legs felt tight, still able to walk. She got second dose on 3/16. A few days after that, diagnosed by bilateral lower extremity DVTs

Patient presented to ED 5/31 with complaints of dizziness for past 2 days, after taking 1st shot of vaccine 5/26. Patient admitted to hospital services after CT head revealed recent right hippocampal infarct

My mother was the patient in question She had a Moderna Covid Vaccine in Feb/March of 2021. She then had 2 doses of Rituxan on April 28th of 2021. After her second dose of the medication, she tested positive for covid 3 days later. She was hospitalized on May 8th and was not able to recover. She passed away on May 20th. The Drs at the Hospital in told me the rituxan essentially wiped the vaccine from her body. The reason I'm reporting this is to warn others in her position about the possible side effects. My mom had a very false sense of security.

4/7/2021--Patients boyfriend called to report that patient has had adverse reaction to her 2nd dose of Moderna vaccine given on 4/1/21. He reports that after the vaccine was given she bled a lot and is concerned if this has contributed to her adverse reaction. She has had headache, cloudy vision, dizziness, brain fog, muscle fatigue, body aches and chills. She is still experiencing most of these side effects even though it's been about 6 days since her shot. Some of this are listed as common side effects to the vaccine but the cloudy vision, dizziness and brain fog were concerning to me - I recommended that she follow up with provider, especially if side effects have not improved by end of the day. It sounds like she's already been to the urgent care about this but did not receive much help there.

I developed vaginal bleeding that resulted in a prescription of vaginal estrogen cream. Because I had already had a hysteroscopy and D&C done on 03/03/2021 from the reaction of the first dose. The bleeding lasted 3 days and stopped on it's own. I had a known fibroid on the uterus.

heart attack; Heart palpitations elevated; Heart rate went high; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (heart attack), PALPITATIONS (Heart palpitations elevated) and HEART RATE INCREASED (Heart rate went high) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criteria hospitalization and medically significant), PALPITATIONS (Heart palpitations elevated) (seriousness criterion hospitalization) and HEART RATE INCREASED (Heart rate went high) (seriousness criterion hospitalization). At the time of the report, MYOCARDIAL INFARCTION (heart attack), PALPITATIONS (Heart palpitations elevated) and HEART RATE INCREASED (Heart rate went high) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) High. Other concomitant product include high blood pressure medication. Treatment information was not reported. Action taken with mRNA-1273 in response to the event was Not Applicable Company Comment: 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.

Developed shortness of breath two weeks after second vaccine in March 2021. Diagnosed with pneumonia on 5/28/21. Severe chest and back pain. No cough, no fever. 100% healthy prior to vaccine. For 3 days after second vaccine developed swollen arm, high fever 103.5. Then 2 weeks later SOB.

Scratched silly to the point of bleeding; Itching didn't stop; Hives got worse; Hives under neck and back but they had not come out; Hives started on her arms; Rash appeared on left hip which was itchy; Anaphylactic reaction; Itching; Rash is so bad/Rash on right hip; Ready to rip her skin off; Hive/Legs both front and back were covered in hives/Hives on legs; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Bee sting (Reaction: Swelling at the site of sting) and Shellfish allergy (Reaction: Hives). Concomitant products included PRAVASTATIN SODIUM (PRAVACHOL) for Cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroiditis, unspecified. On 21-Jan-2021 at 10:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced SKIN EXFOLIATION (Ready to rip her skin off), URTICARIA (Hive/Legs both front and back were covered in hives/Hives on legs), PRURITUS (Itching) and RASH (Rash is so bad/Rash on right hip). On 21-Jan-2021 at 4:30 PM, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant). On 22-Jan-2021, the patient experienced RASH PRURITIC (Rash appeared on left hip which was itchy). On 02-Feb-2021, the patient experienced URTICARIA CHRONIC (Hives got worse), URTICARIA (Hives under neck and back but they had not come out), URTICARIA (Hives started on her arms) and PRURITUS (Itching didn't stop). On an unknown date, the patient experienced SCRATCH (Scratched silly to the point of bleeding). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itchy, at a dose of 1 dosage form; CORTISONE for Itchy, at a dose of 1 dosage form; PREDNISONE for Hives, at a dose of 1 dosage form; OATMEAL at a dose of 1 dosage form; BAKING SODA at a dose of 1 dosage form; PREDNISONE (DELTASONE [PREDNISONE]) for Rash, at a dose of 40 mg and HYDROXYZINE HCL for Rash, at a dose of 25 mg. On 01-Mar-2021, ANAPHYLACTIC REACTION (Anaphylactic reaction) had resolved. At the time of the report, SCRATCH (Scratched silly to the point of bleeding), SKIN EXFOLIATION (Ready to rip her skin off), URTICARIA (Hive/Legs both front and back were covered in hives/Hives on legs), URTICARIA CHRONIC (Hives got worse), URTICARIA (Hives under neck and back but they had not come out), URTICARIA (Hives started on her arms), RASH PRURITIC (Rash appeared on left hip which was itchy), PRURITUS (Itching), PRURITUS (Itching didn't stop) and RASH (Rash is so bad/Rash on right hip) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 119/85 (abnormal) abnormal. On an unknown date, Body temperature: 36.4 (Inconclusive) Inconclusive. On an unknown date, Heart rate: 94 (Inconclusive) Inconclusive. On an unknown date, Oxygen saturation: 100% (Inconclusive) Inconclusive. On an unknown date, Respiratory rate: 18 (Inconclusive) Inconclusive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient also took cold bath as treatment. On an unknown date, it was reported that the patient had a dermatologic examination where the dermatologist look at the patient's hives/rash; results were not provided. 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. Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up received on 16 Jun 2021, Added Patient's race, height, weight, lab details and information concomitant medications and new event details.; 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.

CVA- 4 BLOCKAGES IN SEPARATE LOBES ON LEFT SIDE OF BRAIN, OCCURRED IN TEMPORAL, THALAMUS, OCCIPITAL LOBES HAS EXTREME WEAKNESS ON THE RIGHT SIDE OF BODY, UNABLE TO USE RIGHT ARM AT TIME OF SUBMISSION, CAN MOVE RIGHT LEG MINIMALLY, CAN STAND WITH ASSISTANCE, SEVERE APHASIA

blood clotting.; pain in right leg and knee; pain in right leg and knee; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clotting.) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included ADHD, Anxiety, Inflammatory arthritis and Blood pressure high. Concomitant products included ATOMOXETINE HYDROCHLORIDE (STRATTERA) for Anxiety, SULFASALAZINE for Arthritis, PROPRANOLOL HYDROCHLORIDE (INDERAL) for Blood pressure high, PREDNISONE for Inflammatory arthritis. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, the patient experienced PAIN IN EXTREMITY (pain in right leg and knee) and ARTHRALGIA (pain in right leg and knee). On 11-Jun-2021, the patient experienced THROMBOSIS (blood clotting.) (seriousness criterion medically significant). The patient was treated with APIXABAN (ELIQUIS) for Clot blood, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (blood clotting.), PAIN IN EXTREMITY (pain in right leg and knee) and ARTHRALGIA (pain in right leg and knee) had not resolved. 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. Patient visited ER due to pain the leg and knee and was diagnosed with blood clotting. 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. Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Added Reporter information(address, contact details), patient demographic information, medical history. Added vaccine batch number, route of administration, concomitant medication information. Start dates of the events pain in extremity and arthralgia added.; 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.

Systemic Lupus Erythematosus, cardiac arrest for 6 minutes requiring CPR, global heart dysfunction, respiratory failure, received ECMO therapy Patient originally presented with new symptoms of diarrhea, rash, proximal weakness, and functional decline. Her outpatient workup included positive ANA and anti-SSA. She was then referred to Rheumatology for new diagnosis of Lupus. 6/11/2021 she was referred to the hospital for management of acute lupus flair. On admission she was found to have acute kidney injury and thrombocytopenia. AIR team was consulted given concern for active lupus, she was started prednisone as well as Plaquenil. On 6/17/2021, she brought emergently to MICU for lethargy, WOB, hypoxia, and new onset A-Fib. She was intubated and continued to clinically deteriorate with persistent lactic acidosis. An ECHO showed severely depressed EF and right heart dysfunction. On 6/17/2021 she experienced PEA arrest with 6 minutes of CPR. She was placed on VA ECMO with Impella. Patient was extubated on 6/19/2021 and was reintubated on 6/20/201 for hemoptysis. A CT on that day showed RP bleed on the left with extension into the left thigh and ground glass opacities throughout suggestive of ARDS. She tolerated a slow ECMO wean and was explanted successfully on 06/23. She was extubated on 06/25. Over the next several days she was able to be successfully weaned from HFNC and was transitioned to NC. On 6/28 she passed her swallow evaluation and was okayed for a PO diet. Plan is to transition patient to the floor in the next few days

Swelling and pain in my left calf and ankle; the ER performed an ultrasound and determined that I have an extensive deep vein thrombus.

I was hospitalized with severe lung infection. Covid was suspected but proved negative after testing. Ugly green phlegm was being expelled.

I did get "moderna arm" following 2nd dose but it is the aforementioned issues (VASCULAR) with my LEFT EYE and blood clot in LEFT LEG

Following the shot I had a little bit of ache and arm soreness and tiredness and when the reaction hit, I laid down for a short nap woke up walked to kitchen and couldn't catch my breath. I called my an ambulance and went to hospital the doctor said I had blood clots in both lungs and an enlarged heart.

Second part. Took Advil 400 mg and was fine after vaccine. Had at fib at about 10:45 pm and woke up with at fib at 2 am 1/24/21.

On 01/26/21, 67 yo F with anemia, asthma, Afib (on rivaroxaban), fibromyalgia, DM2, HLD, and osteoarthritis was administered COVID-19 Moderna vaccine 0.5 mL in left deltoid (Lot #011J20A, Exp: 05/11/21). Pt has numerous documented allergies including iodine (hives, facial swelling), Shellfish Containing Products (Hives, facial swelling) and penicillin (edema). Pt initially tolerated injection without incident and was sent for post-injection observation. Within 10 minutes, pt developed acute SOB, increased WOB, wheezing, and cough. Pt also reported itching skin and scratchy throat. Provider notified and exam found pt in respiratory distress with increased work of breathing, bronchospasm and wheezing. Pt had no rash, lip swelling or vomiting. Vitals assessed as O2 sats >96%, BP 140-150s/60s, HR 70-80s. Pt was administered albuterol 2.5 mg via nebulization x 2, diphenhydramine 50 mg IM and epinephrine 0.3 mg IM. Pt was subsequently transported to ED. By time of arrival, pt's symptoms had significantly improved. Pt administered famotidine 20 mg IV and prednisone 60 mg PO and placed on continuous cardiac and pulse oximetry monitoring. After complete symptom resolution, pt was discharged in stable condition. Pt's allergy profile was updated to include Moderna Covid-19 Vaccine (eua) (rxn: Anaphylaxis; severity: High).

Patient presented to the Emergency Department complaining of chest pain, pale, cool diaphoretic, and hypotensive. The patient was discovered to have a large saddle pulmonary embolism, went into cardiac arrest and expired. Of note, the patient received her second Moderna COVID vaccine on 1/23, which would place her first one approximately 12/25 if she received them at the appropriate interval. This information is from the patient's daughter and the ED record, the information is not available in CAIR. Per the daughter, the patient started feeling ill on 1/21, improved on 1/25, and then acutely worsened on 1/27, resulting in the ED visit.

Chest discomfort with high heart rate and shortness of breath, dizzy upon standing. In ER HR was 156 with atrial fibrillation with RVR. BP 146/89. 2/7/21 1546 - Patient complaining of left side peripheral field deficit, CT showed subacute right occipital lobe infarct

Cerebral stroke. Symptoms onset was documented by nursing home staff on 1/13/21. Second dose of vaccine was received on 1/12/21. I am unsure at this time if it was the Pfizer or Moderna vaccine. Patient has severe defecits at this time but the brain is still healing. Several weeks in the hospital, patient now has peg tube and picc line. Flaccid right side and speech severely impacted.

feeling much worse; Bloodwork with elevated parameters (troponins); Couldn't take food; Couldn't get up from bed; Fever (101°F); Atrial fibrillation; Pericarditis; A spontaneous report was received from a non-healthcare professional concerning a 67-year-old, female patient who developed a fever of 101 degrees Fahrenheit, feeling much worse, couldn't take food, couldn't get up from bed, bloodwork with elevated troponin, pericarditis, and atrial fibrillation. The patient's medical history was not provided. Concomitant products known to have been used by the patient, within two weeks prior to the event, included Pentasa, metformin, insulin, Zoloft and atorvastatin. The patient received their first of two planned doses of mRNA-1273 (lot number 028L20A) on 20 Jan 2021 in the right arm for prophylaxis of COVID-19 infection. The patient developed a fever on 25 Jan 2021, and it got up to 101 degrees Fahrenheit on 26 Jan 2021. On 26 Jan 2021 she felt must worse, couldn't take food, and couldn't get up from bed. On 27 Jan 2021, she was taken to the emergency room where her oxygen saturation was low, but the fever was gone. She was placed on oxygen, and blood work had elevated troponin. The patient was diagnosed with pericarditis and she was kept overnight. On 28 Jan 2021 she had atrial fibrillation and the medical team couldn't convert her chemically. She was stabilized on 30 Jan 2021 and she was feeling much better. Treatments of these events included oxygen and ibuprofen. The events, fever of 101 degrees Fahrenheit, feeling much worse, couldn't take food, couldn't get up from bed, bloodwork with elevated troponin, pericarditis, and atrial fibrillation were considered Recovering.; Reporter's Comments: This case concerns a 67 year old female who experienced serious unexpected events of feeling abnormal, decreased appetite, bedridden, elevated troponin, pericarditis, and atrial fibrillation, and a serious expected event of fever. The events began 6 days after first dose of mRNA-1273. Treatment with ibuprofen. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.

diarrhea low gas pain chills / sweating dry mouth sleepy no apatite cough with phlegm dizzy loss of bladder control blood clots in nose mucus

Vaccine administered 02/08/2021 , by Thursday 02/11/2021 patient almost nonverbal, by Monday 02/15/2021 patient went to the hospital with bruising, sores on her stomach and clots reported as thrombocytopenia, deceased by Friday 02/19/2021.

MODERNA COVID-19 VACCINE EUA Patient's arm was sore after injection and later that evening pain spread down to her elbow. In the following days she states that it spread to her fingers and included temporary numbness which resolved in a short period of time. Her arm remained sore with warmth and redness about the size of a quarter at the injection site. The warmth, redness and pain did not resolve so she went to the emergency room today.

Swollen tongue; severe nausea; golf ball-size swelling at injection site; joints aching; severe headache; temperature of 97; difficulties swallowing; A-Fib.

ER admit for CP and Jaw pain, exhaustion, Aortic arteritis normal SED rate found on CT scan hospital admit IV medications required Solumedrol and Actemra questionable how much medications received d/t IV's not working. Released from care on 2/19 with prednisone . Symptoms still present off and on. 2/21 922pm CP Jaw Pain severe EMT's called EKG done reported no heart attack, pain better, EMTs left. 10/15 severe Pain collapsed with no pulse and no breathing, EMTs returned unable to obtain a shock-able rhythm time of death pronounced. reason for death on certificate Aortitis - hospitalist thinks aortic dissection d/t severe inflammation

On 2/22 I developed fever, fatigue, horrible muscle aches and general not feeling well. On Sat 3/28/21 I developed very large red hive like lesions all over my neck, under ears, and one very large one on my left side. These lasted for 4 days. They were very large welt line lesions but were nit itchy like hives. I also developed some vaginal spotting. I also became very flushed and very hot and fatigued with any excercise despite not having fever except for second day. I have pictures of these red hive like spots

3 DAYS AFTER THE 2ND INJECTION, I DEVELOPED 2 BLOOD CLOTS AT THE BASE OF MY LUNGS - 1 ON EACH LUNG. IN CONNECTION WITH THAT, I DEVELOPED SEVER PAIN IN MY LOWER RIGHT FLANK AREA THAT RADIATED TO MY SHOULDER AS WELL AS HIGH BLOOD PRESSURE. THERE IS NO HISTORY IN MY FAMILY OF ANY CLOTTING ISSUES AND I MYSELF HAD NEVER HAD SUCH A THING OCCUR. THE PAIN BECAME SO BAD IT FORCED ME TO GO TO A HOSPITAL EMERGENCY DEPT. AFTER CT SCANS CONFIRMED THE PRESENCE OF THE CLOTS, I WAS SUBSEQUENTLY ADMITTED FOR OBSERVATION ON A REGIMEN OF DRUGS, BLOOD THINNER, PAIN MED, AND A CLOT BUSTER (NOT SURE WHICH MANUFACTURER.) I AM STILL EXPERIENCING PAIN IN MY RIGHT FLANK AREA - SOMEWHAT RADIATING TO MY RIGHT SHOULDER DAY 1 POST DISCHARGE AND AM HAVING TO RELY ON OPIOID PAIN MED AS WELL AS THE CLOT BUSTING MED AND A HIGH BLOOD PRESSURE MED. TO ME, IT SEEMS THAT THIS MAY NOT BE JUST COINCIDENTAL. I WAS FEELING FINE PRIOR TO THE S 2ND DOSE OF THE MODERNA VAC AND THIS SEEMS TO ME THAT IT MIGHT BE RELATED TO THE 2 DOSE.

Blood clots in arm; Arm was sore; A spontaneous report was received from a healthcare professional concerning a 67-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm/pain in arm and blood clot in her arm/thrombosis. The patient's medical history, as provided by the reporter included diabetes. Concomitant medications were not included. On 15 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031M20A) in the left arm for prophylaxis of COVID-19 infection. On 15 Feb 2021, post vaccination the patient experienced sore arm and her condition got worse. She was then taken to emergency room with blood clots in her arm. Action taken with mRNA-1273 in response to the events were not reported. The outcome of the events, sore arm and blood clot in her arm, were not known.; Reporter's Comments: This case concerns a 67-year-old, female patient, who experienced thrombosis and pain in arm. 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's medical history of diabetes is a risk factor. Further information has been requested.

I became warm and flushed all over a few minutes after shot , then foggy feeling with congestion in sinus. I waited about 20 minutes and left I spoke to my allergist and he said that I had experienced mild anaphylaxis and should not take dose 2 of the vaccine

Both patient and spouse we given their Moderna prime dose on 2-10-21. Both patient and spouse agreed to observe the post vaccination waiting period and reported no concerns. On 3-10-2021, they returned for their boost dose at 12:30 PM. Prior to administration of their second dose, they reported only mild headache and fatigue that presented approximately 12 hours after their first dose was administered. Once again, spouse and patient observed the post vaccination waiting period and reported no issues. On 3-11-21, I was notified that patient had passed away at home. In speaking to spouse, he stated that they both went to bed that evening with with a mild headache and fatigue. Spouse stated that he woke up early that morning with a more pronounced headache and had difficulty sleeping. He noted that at approximately 5:18 AM patient seemed to breathing heavily and may have gasped a bit. He checked on her again around 6:40 and determined that she had passed away. He contacted EMS and the technician confirmed that she had passed away. Spouse reports that the state will perform and autopsy in the next few days at the direction of Medical staff.

2/18/21 chest soreness, shortness of breath. 2/19/21 chest soreness, tired body aches, shortness of breath increased slightly. Continued for 3 days. 2/23/21 seen Dr extreme shortness of breath, chest pain, body aches, headaches, extreme tiredness. Blood work, chest X-ray, ekg ordered and completed that same day. 2/25/21 seen at clinic increase in symptoms, COVID test completed. Evening of 2/25/21 went into a-fib hospitalized for 3 days.

Awoke in the night following the 2nd dose of the vaccine, with an irregular heart rhythm and elevated heart rate. I contacted the Hospital and was told to come in for an ER eval. --I did go to the ER and was treated for Rapid Atrial Fibrillation. My heart rate was approx. 130 and B/P was approx. 158/100 --both are very elevated for me. (my resting heart rate avg is 50-55 and B/P is avg 124/80) Was given Cardizem IV push and then tablet of Cardizem while in the ER. Then later on same day saw my Cardiologist, who confirmed I was still in Afib.

Pt was vaccinated on 2/28 and on 3/2 began to experience worsened sob from baseline, development of sternal chest pain, abdominal bloating, nausea and fatigue. She presented to the hospital on 3/9 c/o intractable pain and nausea/vomiting that was worsening. Imaging revealed no change in her cancer from same imaging in jan 2021. PE ruled out. No sepsis. She had acute kidney injury/dehydration. started on ivf. renal imaging normal. echo normal. ekg normal. she rapidly progressed to anuric renal failure and died 3/13/2021. oncology ruled out tumor lysis. she was not felt to be a candidate for dialysis.

Dizziness, Arthralgia & Palpitations The problems began with frequent PVCs which were recorded with the patient's loop recorder (has for paroxysmal atrial fibrillation and has occasional PVCs) but these worsened then on 2/14/2021 developed 20 second run of slow VT at the rate of 160 bpm. Palpitations subsided and then February 18 began having arthralgias of bilateral hips and knees. This eased and then on February 20 had sudden severe pains in the right knee which continued to progress until both bursae were bulging and patient could bare walk with toe touch only the right due to the pain. This persisted until March 8 when the patient developed fever of 101 with chills. Went to ER on March 9 where noted to have increased WBCs with Neutrophil shift. Knee improved after IV Tylenol and Rocephin - still tightened quadricep tendon with occasional pain.

Patient reported that she started feeling bad the night of the vaccination. Patient went to the hospital and was admitted. Patient was told she had COVID-19 and a UTI. She says she was given convalescent plasma for COVID-19. She said she had pneumonia, fever, cough, fever and chills.

Systemic: amxious and rerestlessness-Medium, Systemic: Stroke-Medium, Systemic: Tachycardia-Medium, Systemic: Unable to Sleep-Medium, Additional Details: patient has autoimmune disease.

Pneumonia in right lung; Shooting pains in her chest; Cold; Sweats; Felt unwell; Fever up to 102.4 F; Shakes; A spontaneous report was received from a pharmacist for a 67 year old female patient who experienced pneumonia in right lung (pneumonia), shakes (tremors), felt unwell (malaise), cold (nasopharyngitis), fever up to 102.4 degrees Fahrenheit (pyrexia), sweating(hyperhidrosis), and shooting pains in chest (pain). The patient's medical history was not provided. No concomitant product use was reported. On 08 Mar 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: 048A21A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 08-Mar-2021, an hour after the administration of vaccine, the patient felt unwell, was cold, had fever up to 102.4 degrees Fahrenheit, sweats, and shooting pains in chest. On 10-Mar-2021, the patient went to emergency room and was diagnosed with pneumonia in the right lung. The symptoms were persisting at the time of the report. Treatment information included paracetamol and doxycycline hydrochloride. Action taken with mRNA-1273 was unknown. The outcome of the events, pneumonia in right lung (pneumonia), shakes (tremors), felt unwell (malaise), cold (nasopharyngitis), fever up to 102.4 degrees Fahrenheit (pyrexia), sweating(hyperhidrosis) and shooting pains in chest (pain) is 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.

Reported side effects of fever, chills and headache that began within 24 hours, also reports burning in throat. Was evaluated by a specialist after 1 week due to continued burning and pain in throat. Reports was diagnosed with edema around vocal chords. Approximately 2 weeks after vaccination developed swelling in left arm. She was seen by her physician who sent her for an ultrasound and they found a blood clot. Patient called to report these symptoms.

Pt was hospitalized from 3/19-3/21 for intractable n/v following COVID-19 vaccination and subsequently had a type 2 NSTEMI. Pt states she got her vaccine on Thursday and then developed severe GERD sx that night. She states she normally does not have GERD and she tried antacids and PPI for her sx. She states she tried to sleep but awoke with projective vomiting and was unable to stop this. She also had myalgias and fatigue. She went to ER and hospital notes indicate supportive care was given and sx resolved quickly. Pt never developed any CP or SOB.

Post vaccine 2/9/21, I experienced drop in O2 Sat over a period of several weeks as I log my daily vitals (blood sugar, BP, Temp, Pulse rate and O2 Sat in percent). I have O2 concentrator that I use as needed via nasal cannula. I do have SOB with exertion due to Sarcoidosis of the Lung. I notified my PCP on 2/19 of a morning sat of 89 which came up with O2 and breathing exercises, I also took a 20mg. Lasix and Mucinex chewable which usually helps with congestion. With O2 and rest, my O2 Sat improved and extra O2 was stopped. Then again my O2 steadily dropped over a period of a week, I coughed more (always have come cough), SOB. On March 7th, getting ready for bed, I became severely SOB, O2 Sat now 82, I called 911. Was alert, oriented when Paramedics arrived, but needed 100% O2 and transported to Hospital, SOB was severe, gasping/drowning, loss of awareness, apparently resp. arrested, was intubated. STAT CT with Contrast, and Echocardiogram, R/O PE, Lung collapse, etc. (No PE/or collapse). MY supposition is that I had a slow moving allergic response to Moderna Vaccine (I am a former healthcare worker of 20 years) and currently work in healthcare medical devices in Ultrasound. I closely watch vaccine development and read research articles on Sarcoidosis, vaccines and COVID. I participated and continue with a Sarcoidosis Study). I think I experienced cytokine storm with my ultrasensitive immune system. I use oral steroid (QVAR 40mics inhaled daily) which I doubled after taking the vaccine for a few weeks. I have had a MMR vaccine last June 2020 and Quadvalent Flu vaccine last August 2020.

anaphylactic reaction; tingling; itching; throat tightening; problems breathing; generalized allergic reaction; A spontaneous report was received from a consumer concerning a 67 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, anaphylatic reaction/anaphylactic reaction, generalized allergic reaction/hypersensitivity, tingling/parasthesia, itching/pruritis, throat tightening/throat tightness, problems breathing/dyspnoea. The patient's medical history was not provided. No relevant concomitant medications were reported. On 16 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch:unknown) for prophylaxis of COVID-19 infection. After that she had numbness, tingling and itching in left side of her face, which has stayed. Then, almost immediately after shot she had an anaphylactic reaction: throat tightening and problems breathing. In the ER, they gave her Benadryl and that was enough to stop it. Now, she says the numbness is similar to being numb from going to the dentist. On 16 Mar 2021, immediately after the shot, the patient experienced the event(s) anaphylatic reaction/anaphylactic reaction, generalized allergic reaction/hypersensitivity, tingling/parasthesia, itching/pruritis, throat tightening/throat tightness, problems breathing/dyspnoea. The event anaphylactic reaction is medially significant. So, this is a serious case. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), anaphylatic reaction/anaphylactic reaction, generalized allergic reaction/hypersensitivity, tingling/parasthesia, itching/pruritis, throat tightening/throat tightness, problems breathing/dyspnoea was unknown.; Reporter's Comments: This case concerns a 67 Y/O M had a serious expected event of anaphylactic reaction and nonserious unexpected hypersensitivity, pruritus, dyspnea, throat tightness, and paresthesia. Event onset immediately after first dose mRNA-1273. Event outcomes unknown. 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.

The patient has passed away 3 days after receiving the 2nd dose of the Moderna Covid vaccine. They were pronounced dead Friday March 19. The patient lived alone and was on unreachable Thursday March 18th. The patient was found deceased the next day at their residence.

Pulmonary embolism; Shortness of breath; A spontaneous report was received from a physician, concerning a 67 years old female patient, who received Moderna's COVID-19 vaccine and experienced shortness of breath and pulmonary embolism. The patient's medical history was not provided. Concomitant product details were not provided by the reporter. On 15-Feb-2021, prior to the onset of events, the patient received her first of two planned doses of mRNA-1273 (lot number unknown) via intramuscular route for COVID-19 infection prophylaxis. On 15-Mar-2021, after the recovery from the events, the patient received her second of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis. On 18-Feb-2021, after first dose of vaccine, the patient experienced shortness of breath and required 2 days hospitalization for pulmonary embolism. Treatment using Enoxaparin was reported. The shortness of breath was gone once being discharged from the hospital. Rivaroxaban was prescribed as the discharge medication. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the events shortness of breath was considered resolved and of event pulmonary embolism 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 events, a causal relationship cannot be excluded.

4/5/21 triage: Pt was in ED with son who was a pt today. Pt walked outside where she became light headed & briefly loss consciousness. This nurse witnessed pt knees begin to buckle & son lowered her to ground. Pt states "sometimes I get light headed if I haven't had enough water". Pt alert/oriented @ this time. C/o upper back pain that she states is new for her. orthostatic positive HPI: 67 y.o. female who presents with a near syncopal episode just PTA. She feels that she is dehydrated. No chest pain. Some cough, no dyspnea or fever. No hx of CAD. elevated troponin 1.28; 2.27 transferred to other HCF hpi: History of Present Illness: The patient is a 67 y.o. female with a past medical history notable for diabetes mellitus, hypertension, glaucoma who presents with chief complaint of "short of breath." Patient lives at home.Patient code status is: Full code status. Patient reports she has been battling a head cold over the past 2 weeks. Patient has had low-grade fever of 99° F. Otherwise, patient has done well. Patient had brought her son to the hospital emergency department. When patient was getting ready to leave his room in the emergency department she says she felt sudden shortness of breath and dizziness. Patient reported that she said ?I do not think I can make it.? Patient then proceeded to get weak and syncopized. Patient's son was already at her side and laid her on the ground. Patient never hit her head. When patient had return of consciousness, she continued to feel short of breath and dizzy. Patient reported that sometimes she feels a sensation at home when she is dehydrated and has not drink in enough fluids. Patient denies having any chest pain, fever, nausea, or vomiting. Patient presented to the ED with the following vital signs: Temperature 97.5°, heart rate 88, blood pressure 183/99, respiratory rate 24, oxygen saturation 85% on room air. EKG was read as normal. Laboratory findings reported as troponin I 0.11, repeat troponin I 3 hours later revealed 1.28. Other laboratory findings significant for glucose 127, BUN 30, creatinine 1.2. Chest x-ray was read as unremarkable. Patient given the following medications in the emergency department: IV fluids x2 L bolus, 324 p.o. Aspirin, nitroglycerin ointment, treatment dose Lovenox. During my evaluation of patient, patient denied having any chest pain. Patient reported that she was feeling okay. Patient was admitted to Internal Medicine service for further management of NSTEMI.

Pt received #2 moderna vaccine. Pt had no problems with #1 other that fatigue for 1 day. Went to store and passed out in the parking lot after passing out and hit her head on the pavement. Pt was transported to hospital. Pt was transferred to different hospital. Pt died at Hospital ER. 3 weeks ago pt diagnosed with heart murmur. Echo showed aortic valve function at 65%. Dr states he will just watch pt. no meds given. Pt family stated pt has a heart attack while at store.

Approxinately 14+ hours after 2nd dose on 03/30/2021 patient found unresponsive and brought to ER. DX with MI and Heart Block

Family member reported patient deceased. Was found on 3/21/21. She had told a friend she wasn't feeling well on the night of 3/19/21.

She had both doses of Moderna COVID vaccine and finished the series in mid February. She was admitted 4/5/21 with bilateral PE and popliteal vein thrombus in the left leg. She had been sedentary the week before with a "cold" and has morbid obesity.

eyes hurt; Dizzy; feel like in a fog; sore throat; dizzy, balance is gone; head still hurts; most intense pain felt like i was having heart attack; face red; tremendous sinus congestion; head killing me, felt like 100 lbs of weight on head, about to explode; chills; Fever; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (most intense pain felt like i was having heart attack) in a 68-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. The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (most intense pain felt like i was having heart attack) (seriousness criterion medically significant), ERYTHEMA (face red), SINUS CONGESTION (tremendous sinus congestion), HEAD DISCOMFORT (head killing me, felt like 100 lbs of weight on head, about to explode), CHILLS (chills), PYREXIA (Fever) and ARTHRALGIA (joint pain). On 08-Mar-2021, the patient experienced EYE PAIN (eyes hurt), DIZZINESS (Dizzy), FEELING ABNORMAL (feel like in a fog), OROPHARYNGEAL PAIN (sore throat), BALANCE DISORDER (dizzy, balance is gone) and HEADACHE (head still hurts). At the time of the report, MYOCARDIAL INFARCTION (most intense pain felt like i was having heart attack), SINUS CONGESTION (tremendous sinus congestion), HEAD DISCOMFORT (head killing me, felt like 100 lbs of weight on head, about to explode), EYE PAIN (eyes hurt), DIZZINESS (Dizzy), FEELING ABNORMAL (feel like in a fog), OROPHARYNGEAL PAIN (sore throat), BALANCE DISORDER (dizzy, balance is gone), CHILLS (chills), PYREXIA (Fever), ARTHRALGIA (joint pain) and HEADACHE (head still hurts) outcome was unknown and ERYTHEMA (face red) had not resolved. Treatments to the event include Tylenol. This case concerns a 68-year-old female with serious unexpected events of myocardial infarction, and nonserious unexpected erythema, dizziness, balance disorder, feeling abnormal, oropharyngeal pain, eye pain, head discomfort, sinus congestion and expected fever, chills, headache, arthralgia. 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. This case was linked to MOD-2021-034793 (Patient Link).; Sender's Comments: This case concerns a 68-year-old female with serious unexpected events of myocardial infarction, and nonserious unexpected erythema, dizziness, balance disorder, feeling abnormal, oropharyngeal pain, eye pain, head discomfort, sinus congestion and expected fever, chills, headache, arthralgia. 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.

Diagnosed with multiple pulmonary emboli after presenting to ED with pleuritic chest pain and DOE. Unclear time of onset of symptoms, possibly preceding 2nd dose of vaccine by about 1 month. unclear temporal relation to initial vaccine dose.

Pulmonary embolism; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization prolonged and life threatening). The patient was hospitalized on sometime in April 2021 due to PULMONARY EMBOLISM. At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter.Treatment information was not provided. This case refers to a 67 year-old elderly female patient who developed pulmonary embolism about two weeks after receiving the second dose of mRNA-1273 vaccine. Very limited information has been provided at this time.; Sender's Comments: This case refers to a 67 year-old elderly female patient who developed pulmonary embolism about two weeks after receiving the second dose of mRNA-1273 vaccine. Very limited information has been provided at this time.

after vaccination, I sat there for 15 minutes and started to drive home, stopped to get food, driving down the street I stopped somewhere and ended up sitting there for 6-8 hours according to the restaurant manager. I went to the hospital they said that I had a weird heart attack and I was dehydrated.

My mother and I received the Moderna vaccine on January 20th. About two weeks later on January 31st, she complained about her leg. It was swollen. Later on that day, she collapsed, was rushed to the hospital. Died on February 4th due to anoxic brain injury due to DVT that caused a massive pulmonary embolism.

I did not feel well starting the day after my second Moderna shot, 2/15/2021, arm swollen, hard and red throughout week. Started having difficulty breathing within a couple of days, brushed it off and tried to function as normal but by 2/21/2021 I could no longer function and had difficulty breathing if I tried to do anything and went to emergency room. Diagnosed with multiple blood clots in both lungs.

4/1/21 Patient developed breathlessness, it progressed until she presented to local ER 4/13 with hypoxemia, tachycardia due to Submassive pulmonary emboli, also found to have R pulmonary infarct and asymptomatic DVTs in R femoral and popliteal, L popliteal veins. Patient was admitted to hospital, treated with IV UFH, doing well. Anticipate discharge in 1-2 days. Note hospitalization data below is tentative as pt is still in hospital

Hospitalization 3/14 to 4/21 with sepsis and hickman line infection. Admitted again from clinic 4/8/21 with worsening shortness of breath and progressive leg swelling with abdominal distension. Has not had any issues with chronic diseases prior that required hospitalizations

Patient admitted for acute hypoxic respiratory failure, COPD exacerbation , subsequently found COVID1-9 positive.

CHF; lymphedema; did not receive 2nd Dose within 35 days; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE CONGESTIVE (CHF) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) 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 was reported.). On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced CARDIAC FAILURE CONGESTIVE (CHF) (seriousness criterion hospitalization prolonged). On an unknown date, the patient experienced LYMPHOEDEMA (lymphedema) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not receive 2nd Dose within 35 days). The patient was hospitalized from 10-Mar-2021 to 07-Apr-2021 due to CARDIAC FAILURE CONGESTIVE. At the time of the report, CARDIAC FAILURE CONGESTIVE (CHF) and LYMPHOEDEMA (lymphedema) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not receive 2nd Dose within 35 days) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. Treatment information was not provided. This report refers to a case of INAPPROPRIATE SCHEDULE OF PRODUCT for mRNA-1273, lot # 011M20A with associated AEs of CONGESTIVE CARDIAC FAILURE and LYMPHOEDEMA. Based on the current available information and temporal association between the use of the product and the start date of the event of LYMPHOEDEMA , a causal relationship cannot be excluded. The event of CONGESTIVE CARDIAC FAILURE Was assessed as unrelated due to lack of biological plausibility.; Sender's Comments: This report refers to a case of INAPPROPRIATE SCHEDULE OF PRODUCT for mRNA-1273, lot # 011M20A with associated AEs of CONGESTIVE CARDIAC FAILURE and LYMPHOEDEMA. Based on the current available information and temporal association between the use of the product and the start date of the event of LYMPHOEDEMA , a causal relationship cannot be excluded. The event of CONGESTIVE CARDIAC FAILURE Was assessed as unrelated due to lack of biological plausibility.

Unprovoked pulmonary embolisms (PEs). I am uncertain why this patient developed bilateral pulmonary embolisms. patient to hold on receiving her 2nd Moderna vaccine. obtain hematological consultation for input in regard to the patient receiving another Moderna vaccine, and also ask Hematology to proceed with any further evaluation and workup in regard to these unprovoked PEs, as they deem appropriate. 6 months of anticoagulation, but I would also like input from Hematology in regard to this.

Received vaccine on 03/12/2021 and on 03/18/2021 client went for a walk and her legs became like "jello". She did not think she was going to make it back to her apartment. Upon returning to her home, she had numbness in her lower extremity. She felt terrible and contacted her healthcare provider. She was seen and it was noted that she may have had a mild TIA but her blood pressure was significantly elevated and she was placed on hypertension medication. The weakness has resolved.

Sore arm badly aches for a few days then a week after began having shortness of breath on exertion was diagnosed with Pulmonary embolism on Aril 7 2021

Altered mental status, CVA vs Sepsis. Patient reports "clot was seen" put records are not forthcoming at this time. Symptoms started about 2 weeks after vaccination.

My mom was very ill with fever like symptoms following her first vaccination on January 26th. The symptoms were even worse after her second vaccination March 2nd and included muscle cramping in her legs. Once she was recovered she only had a persistent cough which she attributed to allergies as the pollen count had been high. In the early morning hours of March 19th she was having difficulty breathing and chest pains. She was rushed to the emergency room where she subsequently died of cardio pulmonary embolism which the coroner indicated began within three weeks of her death.

I developed severe lower back/flank pain about 4 days after receiving my 2nd Moderna vaccination. The pain was most pronounced while lying supine and , while in that position, manifested a creeping , fluid nature, i.e. migrating from my lower back to my shoulder. I was unable to lie down comfortably. In thinking about the nature of this pain, I determined that it was possibly/probably from a PE as it seemed as if pain was migrating from my lower back to my shoulder. I'm "not a doctor but play one on TV" (LOL ) so surmised that it was something serious that decided that this was something needing attention. I presented to a hospital ER for care and was ultimately told I had 2 small PE blood clots - 1 in the base of each lung. My diagnosis was confirmed by a CT scan and I was subsequently admitted for observation. I was discharged the following day with blood thinners and blood pressure medication.

Vaccine was administered at 1215, patient was monitored for 15minutes per CDC guidelines with not adverse reactions noted. Approximately one hour after administration of vaccine patient noted to be moaning, fingerstick BS at 59mg/dL, Dextrose administered, pt proceeded in to cardiac arrest, CPR was initiated and EMS activated. Pt expired approximately 4 hours after incident at ER.

Blood clot in leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot in leg) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 002A21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 02-Apr-2021, the patient experienced THROMBOSIS (Blood clot in leg) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 02-Apr-2021 to 06-Apr-2021 due to THROMBOSIS. The patient was treated with Surgery (Angioplasty) for Thrombosis. On 06-Apr-2021, THROMBOSIS (Blood clot in leg) had resolved. Not Provided Concomitant product use was not provided by the reporter. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.; Sender's Comments: Based on current available information and the temporal association between product use and the stat date of the events a causal relationship cannot be excluded.

heart attack; Bood clot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (heart attack) and THROMBOSIS (Bood clot) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criteria death and medically significant) and THROMBOSIS (Bood clot) (seriousness criterion death). The patient died on 23-Mar-2021. The reported cause of death was Heart attack and Clot blood. It is unknown if an autopsy was performed. Not Provided No concomitant medication were reported. No treatment information was provided.; Reported Cause(s) of Death: Heart attack; Clot blood

Patient states shortly after getting the vaccine and alone in her apt her head began to hurt and her back aching. States her chest began feeling "funny" and she tried calling her daughter. With no answer she called the ambulance and was transported to ER. She was told upon arrival she was having a heart attack and transferred to cath lab. Blockages were found and 3 stents placed to right coronary artery.

She has developed shortness of breath, which was new and more worse then her usal sthma symtoms. She went to urgent care center, she has D dimer of 7000, She has CT scan doen for pulmonary embolism on 4/6/2021, She right side pulmonary embolism diagnosis as per CT chest.

Hospitalized on 3/31 following episode of unresponsiveness and confusion that started roughly 18hrs after vaccination. Patient had similar presentation requiring hospitalization after first vaccine dose as well Initially presented to Hospital. Workup there included empiric antibiotic therapy, antiviral therapy did not result in improvement, MRI brain and lumbar punctures non-significant, required intubation early in admission for a brief period, then likely developed HAP/VAP and ARDS requiring re-intubation and was transferred to higher level of care our main campus facility from which I am reporting this. Here, rheum/neuro workup largely negative. Her course has been c/b multiple DVTs and Aflutter that has resolved. So far, workup for AMS and fevers have been extensive -- BEM, LP, MRI, thora, bronch w BAL were unremarkable. The patient has been monitored off abx without hemodynamic changes. She did not improve despite various abx administered and did not really respond to seroquel for her delirium. At one point, the husband was considering hospice because nothing had improved her clinical status. Given her rheumatologic hx and declining mental status after the vaccine, the patient was treated with methylpred 1 daily x3 and this dramatically improved her clinical course. She began to wake up and per the ICU, was AOx2-3 at one point, whereas she had not responded even to painful stimuli at one point. She still did have some hypoactive delirium. At this point, she was deemed stable enough to be transferred. Our phsyicians were following her through the admission, was not aware and speaking again until 5/5/21. Currently she is undergoing epilepsy workup and is still hospitalized.

Swollen hands; Heavy periods; chopped her hair since she sweats a lot in her scalp; Body aches; Headache; Fatigue; Bleeding started; Cannot think straight; Hot flashes; Back hurts; Itchy in eyes; Confused; Anxiety increased; Feels depressed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMORRHAGE (Bleeding started) and MENTAL IMPAIRMENT (Cannot think straight) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history reported. Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), LORAZEPAM, MELOXICAM, BLACK COHOSH [CIMICIFUGA RACEMOSA], ESTRADIOL, NORETHISTERONE ACETATE (ESTRADIOL AND NORETHINDRONE), CLOBETASOL PROPIONATE and ESTRADIOL for an unknown indication. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced HAEMORRHAGE (Bleeding started) (seriousness criterion medically significant), MENTAL IMPAIRMENT (Cannot think straight) (seriousness criterion medically significant), HOT FLUSH (Hot flashes), BACK PAIN (Back hurts), EYE PRURITUS (Itchy in eyes), CONFUSIONAL STATE (Confused), ANXIETY (Anxiety increased), DEPRESSED MOOD (Feels depressed), HEAVY MENSTRUAL BLEEDING (Heavy periods), HYPERHIDROSIS (chopped her hair since she sweats a lot in her scalp), PAIN (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue). On 06-May-2021, the patient experienced PERIPHERAL SWELLING (Swollen hands). At the time of the report, HAEMORRHAGE (Bleeding started), MENTAL IMPAIRMENT (Cannot think straight), HOT FLUSH (Hot flashes), BACK PAIN (Back hurts), EYE PRURITUS (Itchy in eyes), CONFUSIONAL STATE (Confused), ANXIETY (Anxiety increased), DEPRESSED MOOD (Feels depressed), PERIPHERAL SWELLING (Swollen hands), HEAVY MENSTRUAL BLEEDING (Heavy periods), HYPERHIDROSIS (chopped her hair since she sweats a lot in her scalp), PAIN (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown. Patient stated that her OBGYN told her she is going thru menopause for which she was prescribed estrogen and she started getting a period. Treatment included Tylenol. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. Very limited information regarding this events has been provided at this time. The events are assessed unlikely related to product. This case was linked to MOD-2021-110270 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: New concomitant drugs (Black Cohosh, Estradiol/norethindrone, Clobetasol propionate, Estradiol cream) were added, New events (Bleeding, back hurts, had period, itchy in eyes, cannot think straight, confused, body aches, heavy period, anxiety increased and feels depressed) were added and Suspect vaccine dosing details were updated.; Sender's Comments: Very limited information regarding this events has been provided at this time. The events are assessed unlikely related to product.

Rhabdomyolysis with associated transaminitis from skeletal muscle breakdown; This spontaneous case was reported by an other health professional (subsequently medically confirmed) and describes the occurrence of RHABDOMYOLYSIS (Rhabdomyolysis with associated transaminitis from skeletal muscle breakdown) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Photopheresis (monthly) since an unknown date. Concurrent medical conditions included Graft versus host disease since 04-Oct-2019 and Weakness (frequently since 2018) since 2010. Concomitant products included RUXOLITINIB from 13-Jan-2021 to an unknown date for Graft versus host disease, PREDNISONE, BUDESONIDE and TACROLIMUS for an unknown indication. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced RHABDOMYOLYSIS (Rhabdomyolysis with associated transaminitis from skeletal muscle breakdown) (seriousness criterion hospitalization). The patient was hospitalized from 05-Mar-2021 to 23-Mar-2021 due to RHABDOMYOLYSIS. On 23-Mar-2021, RHABDOMYOLYSIS (Rhabdomyolysis with associated transaminitis from skeletal muscle breakdown) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Aldolase: elevated (High) elevated levels consistent with myositis. In March 2021, Biopsy muscle: abnormal (abnormal) demonstrated mild myopathy, mitochondrial dysfunction, mild reinnervation and severe type 2 fiber atrophy. Microscopic analysis also demonstrated lymphocytic infiltration, along with apoptotic bodies, providing overall gestalt most consistent with a mixed nonspecific liver injury, along with some findings to support graft-versus-host-disease of the liver. In March 2021, Blood creatinine: elevated (High) elevated levels consistent with myositis. In March 2021, Electromyogram: abnormal (abnormal) consistent with myositis. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered RHABDOMYOLYSIS (Rhabdomyolysis with associated transaminitis from skeletal muscle breakdown) to be possibly related. Extensive serologic workup was done in March 2021 which were grossly negative for new autoimmune processes. No specific treatments were reported. 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.

Before vaccine went for sonogram, no signs of blood clot Vein doctor did more advanced sonogram and was negative again for clots. A few days later clots started appearing on varicose veins. First clot started inside of knee, thought it was a boil, it was a big red figure with a dark center, doctor diagnosed with superficial blood clots (about 10 days after vaccine) On the 10th when seeing doctor blood pressure shot up, had to double lisinopril. Patient reports history of smoking.

This spontaneous case was reported by an other health professional (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cough since an unknown date. Concurrent medical conditions included COPD and Diabetes. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization and life threatening) and BACK PAIN (Back ache). The patient was hospitalized from 07-Apr-2021 to 09-Apr-2021 due to MYOCARDIAL INFARCTION. At the time of the report, MYOCARDIAL INFARCTION (Heart attack) and BACK PAIN (Back ache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDIAL INFARCTION (Heart attack) and BACK PAIN (Back ache) to be possibly related. Treatment includes 3 stents placed to right coronary artery. Blood sugar was over 500 and patient was put on insulin.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

Pt w/hx of COVID positive (5/3) in the setting of an exposure and onset of symptoms including arthralgias, body aches, non-productive cough, loss of taste/smell sensations, shortness of breath upon exertion despite receiving Moderna vaccines (2/12 & 3/12/21). Pt presented to ED w/worsening SOB upon rest and was admitted for management of acute hypoxemic respiratory failure due to COVID-19. Was treated w/dexamethasone, remdesivir. She was ultimately discharged on 5/12 after significant improvement with follow-up.

Dizziness, vision changes. Was hospitalized 4/20 through 4/22. She was having trouble with her vision. Diagnosed with Stroke in the occiput region, was also noted to be in atrial fibrillation. Elevated blood pressure.

Caller stated his wife passed out and hit her head on the floor; hit her head on the floor and split it open; transferred to hospital due to cardiac complications; fall; His wife passed away; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of DEATH (His wife passed away), LOSS OF CONSCIOUSNESS (Caller stated his wife passed out and hit her head on the floor), SKULL FRACTURE (hit her head on the floor and split it open), CARDIAC DISORDER (transferred to hospital due to cardiac complications) and FALL (fall) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Caller stated his wife passed out and hit her head on the floor) (seriousness criteria hospitalization and medically significant), SKULL FRACTURE (hit her head on the floor and split it open) (seriousness criteria hospitalization and medically significant), CARDIAC DISORDER (transferred to hospital due to cardiac complications) (seriousness criterion hospitalization) and FALL (fall) (seriousness criterion hospitalization). On 04-Apr-2021, LOSS OF CONSCIOUSNESS (Caller stated his wife passed out and hit her head on the floor), SKULL FRACTURE (hit her head on the floor and split it open), CARDIAC DISORDER (transferred to hospital due to cardiac complications) and FALL (fall) outcome was unknown. The patient died on 04-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant product use was not provided by the reporter. Treatment information was not provided. On 03 Apr 2021, the reporter stated approximately 45 minutes after receiving the COVID-19 vaccine, the patient passed out in the parking lot and hit her head on the floor which caused it to split open. The patient was taken to a hospital but had to be transferred to another hospital after experiencing cardiac complications. On 04 Apr 2021 at 4:00 am, the patient passed away. Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death

Patient called our pharmacy and stated she had a ?heart attack? after she received her first COVID 19 vaccination. She stated she was otherwise healthy before the vaccination and a subsequent heart cath showed no blockages. Her cardiologist recommended to report this incident and for her receive her second COVID-19 vaccine.

Patient suddenly fainted and fell, striking and lacerating the back of her head on a table leg. The laceration resulted in copious bleeding. After regaining consciousness, patient telephoned for help, and was transported by ambulance to Emergency Dept. After tests verifying no internal bleeding, the laceration was closed with four staples. Patient had no prior history of fainting, nor subsequent fainting. Fainting incident was sudden onset and not preceded by significant episode of faintness. During this day after vaccination, patient also suffered more typical second-dose side effects, including soreness of shoulder, rash, malaise and low-grade fever (100.2°F).

It woke me up about 2 am I had a severe headache and some shortness of breath. I checked my blood pressure and it was 80/40 with pulse of 42. So I went to get something to drink and went back to bed, I thought I was dehydrated. Over the next few days I felt real tired and washed out and with more shortness of breath. They did an EKG and went to a Cardiologist and he thought my thyroid was off, he wanted to watch and change medication to see if it will help. I started to get worse and they CT Scan of my chest with my PCP and they found bilateral PE. I was hospitalized for a day and sent home with medication and right now I'm still out of work. I go back to the Dr. on the 23rd to see if they will let me go back to work.

Pt was admitted from 4/7-4/8 for c/o bloody diarrhea and nausea for 1 week associated with fevers. Her hgb remained stable and she was discharged to follow up with GI on 4/8 with diarrhea resoled. CT scan at that time showed no acute abnl and minor sigmoid diverticulosis. She returned on 6/9 with 4 days of bloody stool. she was discharged on 6/16/21 after a protracted hospital course . Patient is a 67-year-old female with a past medical history significant for wheelchair-bound status secondary to MS and multiple left lower extremity surgeries, type 2 diabetes, CHF, hypertension, hyperlipidemia, depression, GERD who presented to the emergency room on 6/9/2021 for evaluation of bright red blood per rectum x4 days. She was recently admitted in April for a day and a half for diarrhea that was bloody but symptoms resolved. In the ER she was tachycardic and hypotensive she also had lactic acidosis. She was ultimately admitted for anemia of acute blood loss, symptomatic hypotension and lower GI bleed as well as SIRS without sepsis. She was seen in consultation by Gastroenterology and ultimately underwent a colonoscopy on 6/11/2021 which revealed no source for the bleeding and there was no evidence of malignancy she did have diverticulosis seen. She had red-tinged stool throughout the ascending transverse descending and sigmoid colon as well as red bloody stool in the rectum. She was on no blood thinners prior to arrival it stated in her med rec that she was on aspirin but she was not taking aspirin. She remained in the hospital for close monitoring she did receive 2 units of blood. We were hoping to advance her diet and plan discharge home but unfortunately patient began bleeding again and underwent a second colonoscopy on 6/14/2021 which again revealed the same bloody stool in the transverse, descending, sigmoid and rectum. Patient did have a tagged bleeding scan which revealed evidence of bleeding with the tracer becoming visible in the region of the splenic flexure of the colon passing proximally and distally within the lumen of the colon. Despite the second colonoscopy the bleeding source could not be found. Patient was given an additional unit of blood. She was monitored further. She had a period of time after the colonoscopy where she had severe generalized abdominal pain but this resolved by the following day where she then began to have diarrhea but no further hematochezia or bleeding was noted. she was discharged on 6/16/21 home. Of note this is the patient's fourth ER visit and or hospitalization since receiving her COVID-19 vaccinations. CT showing no acute abnl and again diverticulosis. She received her 1st moderna covid 19 vaccine on 3/9 and her second on 4/9/21. she has had 2 hospitalizations since her vaccinations and 2 er visits 3/13 at another er noting increased blood sugars, blurred vision and a headache since her covid vaccine on 3/9 and 3/18 for fatigue, high blood sugars

pulmonary embolism, treated with blood thinners (heparin for first week and eliquis thereafter). Must continue eliquis for six months and then have another CT scan to determine if it has dissolved

pneumonia; I have experienced my heart pumping; severe pain; coughing; chills; continuous fever.; This spontaneous case was reported by a patient and describes the occurrence of PNEUMONIA (pneumonia) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, 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 experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant), PALPITATIONS (I have experienced my heart pumping), PAIN (severe pain), COUGH (coughing), CHILLS (chills) and PYREXIA (continuous fever.). At the time of the report, PNEUMONIA (pneumonia), PALPITATIONS (I have experienced my heart pumping), PAIN (severe pain), COUGH (coughing), CHILLS (chills) and PYREXIA (continuous fever.) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. 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.

New 5 and 7 mm ill-defined nodular densities are seen in the left upper\ increased calcification; Difficulty breathing; Feeling hot; Increased thoracic kyphosis noted; Anterior spondylosis is seen in the upper lumbar; likely infectious or inflammatory in etiology; patient has increased mucus production; very dry cough with just little tiny specs of mucus; felt slightly crappy; Fever; back muscle spasms; little sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PNEUMONIA (likely infectious or inflammatory in etiology), PULMONARY CALCIFICATION (New 5 and 7 mm ill-defined nodular densities are seen in the left upper\ increased calcification), DYSPNOEA (Difficulty breathing) and COUGH (very dry cough with just little tiny specs of mucus) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Chronic bronchitis (given gamma globulin shots, took up swimming and gradually the frequency for illness decreased (over a decade or so).), Pneumonia, Watering eyes, Runny nose and Hormone replacement therapy. Previously administered products included for an unreported indication: PNEUMOCOCCAL CONJUGATE VACCINE in October 2019. Concurrent medical conditions included Allergy to animal dander (Cat hair caused watery eyes, runny nose & stuffed head.) since 18-Dec-1972, Allergy to animal dander (dog hair caused watery eyes, runny nose & stuffed head.) since 18-Dec-1972, Allergy to animals (cattle caused watery eyes, runny nose & stuffed head.) since 18-Dec-1972 and Smoke inhalation (tobacco mix caused watery eyes, runny nose & stuffed head.) since 18-Dec-1972. Concomitant products included TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE (GLUCOCORTICOID)) from 05-Jan-2018 to an unknown date for Contact dermatitis, PREGNENOLONE from 09-Jan-2007 to an unknown date and PROGESTERONE from 09-Jan-2007 to an unknown date for HRT, KRILL OIL, UBIDECARENONE (COQ10 [UBIDECARENONE]) and CRANBERRY [VACCINIUM MACROCARPON] for Supplementation therapy, CYANOCOBALAMIN (VIT B12) and COLECALCIFEROL (VIT D3) for Vitamin supplementation. On 28-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced MUSCLE SPASMS (back muscle spasms) and PAIN IN EXTREMITY (little sore arm). On 29-Jan-2021, the patient experienced PYREXIA (Fever). On 31-Jan-2021, the patient experienced DEPRESSED MOOD (felt slightly crappy). On 01-Feb-2021, the patient experienced PRODUCTIVE COUGH (patient has increased mucus production) and COUGH (very dry cough with just little tiny specs of mucus) (seriousness criterion medically significant). On an unknown date, the patient experienced PNEUMONIA (likely infectious or inflammatory in etiology) (seriousness criterion medically significant), PULMONARY CALCIFICATION (New 5 and 7 mm ill-defined nodular densities are seen in the left upper\ increased calcification) (seriousness criterion medically significant), DYSPNOEA (Difficulty breathing) (seriousness criterion medically significant), FEELING HOT (Feeling hot), KYPHOSIS (Increased thoracic kyphosis noted) and SPINAL OSTEOARTHRITIS (Anterior spondylosis is seen in the upper lumbar). The patient was treated with IBUPROFEN ongoing since an unknown date for Adverse event, at a dose of UNK dosage form; BENZONATATE (oral) ongoing since an unknown date for Cough, at a dose of 200 mg; AZITHROMYCIN (oral) ongoing since an unknown date for Mucus discharge, at a dose of 250 mg and FLUTICASONE PROPIONATE (FLOVENT HFA) (oral) ongoing from 25-Feb-2021 for Adverse event, at a dose of 200mcg/act aer glax. On 29-Jan-2021, PAIN IN EXTREMITY (little sore arm) and PYREXIA (Fever) had resolved. On 30-Jan-2021, MUSCLE SPASMS (back muscle spasms) had resolved. On 31-Jan-2021, DEPRESSED MOOD (felt slightly crappy) had resolved. On 28-Apr-2021, PNEUMONIA (likely infectious or inflammatory in etiology), PRODUCTIVE COUGH (patient has increased mucus production), PULMONARY CALCIFICATION (New 5 and 7 mm ill-defined nodular densities are seen in the left upper\ increased calcification), DYSPNOEA (Difficulty breathing), COUGH (very dry cough with just little tiny specs of mucus), FEELING HOT (Feeling hot), KYPHOSIS (Increased thoracic kyphosis noted) and SPINAL OSTEOARTHRITIS (Anterior spondylosis is seen in the upper lumbar) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, COVID-19: negative (Negative) negative. On 11-Feb-2021, Chest X-ray: inconclusive (Inconclusive) New 5 and 7 mm ill-defined nodular densities are seen in the left upper lobe compared with 2007. On 15-Feb-2021, Computerised tomogram thorax: inconclusive (Inconclusive) Chest x-ray findings correspond with mild left upper lobe ground-glass opacities, likely infectious or inflammatory in etiology. Lungs, Pleura and Airways: Mild left upper lobe stellate peribronchovascular and subpleural ground-glass opacities. No airway narrowing or obstruction. No pleural effusion or pneumothorax.. 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. Patient started taking flu shots in her 50s which did help. On Monday 08 Feb 2021, patient called her PCP, and had a zoom call. She prescribed a cough med and suggested I get a chest xray and Ct scan. The medication helped a bit with the cough (especially at night) but she still had mucus production. Patient had another call with PCP on 16Feb 2021, where she prescribed a five day course of antibiotic, but that didn't result in clearing up the mucus production either. Patient was but on an inhaler to help clear up the likely infection/mucus. Patient had little to no (new) symtoms as a result of the 2nd shot. Patient used the inhaler for about two months and gradually the mucus production and cough went away. Patient weaned myself off the inhaler over the course of the first 2-3 weeks in May and was perfectly fine until she went in to have the pneumonia vaccine (PPSV-23) on 13 Jun 2021. After the shot patient's mucus production started up again and patient started back on the inhaler but only once a day, which seems to keep my symptoms in check. Patient met PCP on 29 Feb 2021, to talk about this on-going lung issue. Patient was going to take a pulmonary Function Test some time this month (July). 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. Further information has been requested. This case was linked to MOD-2021-246799 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: No new information. On 05-Jul-2021: Follow-up case - Second dose, height, weight, ethnic group, race, previous allergies, concomitant medications, treatment medications, new labs added. Action taken event outcome and inarrative updated.; 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. Further information has been requested.

Pneumonia NOS; something was swollen; Cough; feeling very bad right now; shivering; fever; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia NOS) in a 67-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 PNEUMONIA (Pneumonia NOS) (seriousness criterion medically significant), SWELLING (something was swollen), CHILLS (shivering), COUGH (Cough), PYREXIA (fever) and MALAISE (feeling very bad right now). At the time of the report, PNEUMONIA (Pneumonia NOS), SWELLING (something was swollen), CHILLS (shivering), COUGH (Cough), PYREXIA (fever) and MALAISE (feeling very bad right now) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. 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. Events Pneumonia NOS and Cough were added as per narrative. This case was linked to MOD-2021-244433 (Patient Link).; 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. Events Pneumonia NOS and Cough were added as per narrative.

The day following the first injection, I started experiencing a series of adverse events that have not subsided. Initially, my left arm was swollen and painful, I was nauseated, feverish and had chills, in addition to a persistent productive cough. I went to the ER on 6/24 after symptoms worsened and was diagnosed with pneumonia. I was given a course of Azithromycin and Cefdinir, which I completed. The fever subsided but even weeks after the second dose, I am still experiencing persistent coughing. The pain in my left arm has also persisted and is accompanied with occasional numbness. I am unable to comfortably lay on my left side or firmly grip objects with my left hand because of the pain.

Developed SOB and fatigue 1 day after vaccine, went to urgent care and tested positive for COVID at urgent care. Returned to our ED after going to urgent care again on 1/7/21, had o2 sat of 84% on room air, impoved to 98 on 3 liters. Was transferred to another facility for admission.

Patient received COVID-19 (Moderna) vaccine from the Health Department on afternoon of January 8, 2021 and went to sleep approximately 2300 that night. Was found unresponsive in bed the following morning and pronounced dead at 1336 on January 9, 2021

Experienced shortness of breath upon minimal exertion 24 hours after having receieved the vaccine. Called MD 72 hours vaccine received - MD advised hospital ER. Admitted with pulmonary embolism and deep vein thrombosis. Remains short of breath and is on 4L of oxygen. Receiving anti-coagulants.

Pt. was admitted to hospital on 1/6/21 with fatigue, weakness. Pt. was Covid positive in November of 2020. Impression upon admission was fatigue may be due to her aortic stenosis and some hypertensive issues with blood pressure changes. She was anemic. WBC was elevated to 19.2, HBG 10.5, NA-131, K+ - 3.1, Rule out bacterial infection. Potential source could be her heart valve. Also noted to have acute renal failure with BUN of 47 and Creatinine of 2.2 noted. Pt. was transferred to Hospital on 1/8/2021 with dx of aortic stenosis, bacteremia, ARF, Dehydration and anemia. Discharged with dx. of sepsis. Pt. expired on 1/18/21 with dx. of severe sepsis, complete heart block, staphylococcus epidermidis bacteremia.

Nine days after the injection was received an area 2 inches wide and 3 inches long around the injection site became raised, red, hard and very itchy. Patient used Benadryl to treat it. 2 days later the raised effect and hardness had gone away, however the redness spread over most of the shoulder area, and 2 days after that had spread halfway down her upper arm. The itch remained. Patient went to a previously scheduled appointment with our primary care physician who said that she had had a DAR (delayed anaphylactic reaction) and should not get the second dose of the vaccine.

Within 24 hours, the inoculation site became red, swollen and itchy which I expected. After a couple of days it calmed down. I am reporting the symptoms that began a week - 10 days later . On January 19 or 20 my joints and muscles began to feel more painful that usual. By Friday the 22nd I felt a deep dizziness momentarily and shook it off. By that evening, I developed a fever, with shakes and chills which continued into the next morning. My throat was sore. I was completely exhausted. My joints and muscles felt as though there were little bonfires burning. I decided to go to a walk in ER to at least receive a Covid 19 test to see if I could have become infected . The test was negative as well as the flu test, strep culture and multi-bacterial screening test. My blood work indicated a heightened inflammatory response. I have gradually gotten better over the course of the last 10 days. I am reporting this as the vaccine is experimental and although the symptoms that I exhibited are outside of the normal period that a reaction would be expected to occur, perhaps there are outlier cases on the curve

Moderna COVID-a9 Vaccine EUA - Woke from sleep about 15-16 hours after vaccination with continuous sharp cutting sensations in arm pit of arm which received the vaccination. Upper portion of breast also was just tender to touch. The cutting sensation continued for about 24 hours with improvement continuing but 2.5 days later the upper portion of the breast presented bruising/bleeding signs. Picture was taken. Some tenderness.

6 days following vaccination patient had a left sided stroke-numbness in face arm and hand. went to ER. and stroke was confirmed

UNCLEAR TIME FRAME BUT DAY OF VACCINATION SHE WAS OBSERVED FOR 25 MINUTES WITH NO REACTION, REPORTS HOURS LATER SHE HAD DIZZINESS AND PAIN INTO HER NECK AND A MILD HA. SHE BEGAN TO FEEL PALPATATIONS. WENT TO URGENT CARE AND WAS IN AFIB.NOW ON OBSERVATION STATUS ON TELEMETRY UNIT. HAS H/O OF AFIB AND DIABETES

Moderna COVID-19 Vaccine EUA. Monday, 2-15-21. 11:45 am. ? Received first dose of Moderna Covid-19 vaccine. 12:30 pm. ? Headache developed. 8:00 pm. ? Watching TV noted irregular heartbeat, and a minute later, increase in respiration rate. That lasted 20 minutes at the most, and then went away. Went to bed at 10 pm and slept well. Tuesday, 2-16-21. 7:00 am. ? In kitchen. Lightheaded, increased respiration, feeling like I?m going to pass out, so I quickly sit down. Two minutes later feel fine. Went about making breakfast. This happened two more times. Realizing this might be a reaction to the vaccination, went to urgent care. Doctor listened to my heart, ordered EKG and result showed that I was in atrial fibrillation (A-Fib). NO previous cardiac issues, no high blook pressure, no diabetes, never a smoker, not obese. Ambulance was called to take me to Hospital. Another EKG confirmed still in A-Fib. Blood drawn. Hooked me up to a wireless/remote heart monitor. Still in A-Fib, elevated heart rate, higher than normal blood pressure. Kept overnight in hospital awaiting more test results, continuous monitoring, and with ECG ordered for Wednesday morning and then consultation with cardiologist. Wednesday, 2-17-21. 11:45 am., ECG done. Still in A-Fib. ECG shows no signs of blood pooling or clotting. Cardiologist proposed courses of action, starting with what makes sense based on current conditions: A cardioversion. Having done thousands (his words) and given my great state of health otherwise, and very low risk for complications, a cardioversion is agreed to. That would happen immediately after first doing a Tee (transesophageal echocardiography) to look at the back of my heart. Then if all looks clear, no clotting, proceed with the cardioversion procedure. 3:00 pm., anesthesiologist asks if I have any further questions. I didn?t. He sedates me. At 3:17 pm. I open my eyes, see the cardiologist standing at the foot of the gurney giving me thumbs up. I returned the thumbs up and said to him, ?good job.? Heartbeat successfully restored to normal rhythm by the cardioversion procedure. 6:00 pm. (approximately) - Discharged from hospital with prescription for Eliquis and Lopressor, and instructions for follow up appointments with primary care physician, and with cardiologist.

I did experience some headache and lethargy on Sat. so laid low. I did go for a walk about 3:30 walking up hill at times as is usual. I did have an appetite and prepared dinner. I did not go to work (child play therapist). Sunday I felt more myself and did notice the soreness in my arm was surely not as bothersome as with the first shot. Had a very active day, no walk but yoga class. Prepared a nice dinner for VD and settled in to view television later in the evening. Strangely, the memory of the exact nature of how this started eludes me, but I do recall experiencing discomfort in the very upper extremities of my chest. Sharing this with my husband he wondered if it may have had something to do with sleeping on my right side cramping the rib area due to not sleeping on my left side because of the shot. I also pondered if it might be related to my gym workout on Thursday ? I recall feeling tired and headed to bed. I recall awakening to use the bathroom and feeling a slight brief bout of dizziness. When I did awaken the next morning the chest discomfort was still present to I called the Health Center and was advised to go to the ER. The EKG was fine. The troponin level was elevated to 0.19 so I was told I had suffered a mild myocardial infarction and I was going to the ICU.

Patient was diagnosed with Immune Thrombocytopenic Purpura on 2/21/2021. -petechial rash, bruising -Platelets 4 thousand at hospital admission -Patient is receiving prednisone and IVIG with improvements in platelet count currently

I started seeing stars after showering the morning after receiving my shot and eventually blacked out, fell, and struck my head. When I came to, my head was bleeding where it struck the floor and I was in a cold sweat. I crawled to my phone and called 911. They arrived and checked me out, settled me on the couch and gave me tylenol, spoke with a doctor on the phone, and eventually told me that I could get a friend to take me to the ER if I wished. However, my husband is disabled and could not be left alone, so I'd have had to find another friend to stay with him. Although I might have a concussion, my condition seemed OK and I have not had any other severe symptoms so I have not sought further medical attention.

about 24 hours after my shot I was in AFIB. I haven't had this problem since my ablation about 5 years ago. I do not know if the vaccine had anything to do with it or if a coincidence, but pharmacist said I should report it. I am still in AFIB and very short of breath.

acute ITP, platelet count 2,000 with petechial rash, bruising, fatigue, herpes labialis simplex one - petechia occurred 7 days post vaccine; hospitalization 9 days post vaccine. responded to steroids and normalized platelet count 180,000 14 days post vaccine

Started dry cough for three day, pain across the lower back began two days after cough. Began intense pain with nausea and cold and clammy sweats. Called the nurse on my insurance who advised to get to the ER.

Pt found down and pulseless in home by husband. EMS called, Pt found to be in PEA arrest. Pt achieved ROSC with CPR and Epinephrin. Pt Passed away on 09/07/2021 at 1330. Pt was in multisystem organ failure.

patient developed coughing, shortness of breath, lip swelling, hoarse voice, and tightness in throat. She became diaphoretic and pale. Symptoms worsened and progressed to anaphylaxis without shock. EpiPen was given and placed immediately on oxygen. EMS/911 called. Patient was given nebulized albuterol and placed on exam table. Normal saline drip via IV given. Patient stated allergy to Benadryl so not given. Within 5 minutes color improved, diaphoresis resolved, and hoarseness/shortness of breath resolved. Lips swelling improved. Patient transported in guarded condition by ambulance by to Clinic.

On March 5th I experienced shortness of breath around 1:30 that lasted for 10 minutes. I had no other symptoms and it subsided. On 3/9 around 2:30 am I had another episode of shortness of breath that lasted about 5 minutes. I was able to return to sleep. I went to work that morning and had shortness of breath, sweating, and dizziness. I drove myself to the ER where I was diagnosed with an acute saddle pulmonary embolism. I was admitted and started on IV heparin. On 3/10, I was also found to have a DVT in my right leg.

started vaginally bleeding Sunday Feb. 28th and has continued until present Saw Dr. and had blood work done and am going next week for Trans Vaginal ultrasound

3/2/2021 go vaccine - 3/5/2021 had visual issue, bright spinning colorful lights, dizzy. 3/12 had grand mal seizure after same issue. taken away in ambulance. 1st time in my life having a seizure.

Passed away 4 days after second dose, complained of not being able to breathe in the middle of the night, and passed minutes later.

I did not administer vaccine in my office, I was the provider she saw after seeing her PCP who wrote the adverse event off and was not worried about vaginal bleeding in a 68 woman.

Developed right lower extremity DVT and pulmonary emboli after travel out of state where vaccine was administered. Presented to ED and diagnosed with VTE, placed on rivaroxaban and referred to hematologist.

I went into DKA, my left eye bled, my left arm has a blood clot I was in hospital 9 days and a rehabilitation place for 11 days.

Having no previous history of ANY indigestion, or GI problems, I had a sudden onset of acute epigastric pain beginning March 15th, 2021, followed by frequent, unrelenting vomiting, eventual fever, and White Blood Cell count of 20,000. Saw internist, she sent me to an emergency room and then had a subsequent admission to a hospital on March 16. Cholecystectomy was done on March 17, 2021 after 24 hours IV antibiotics to control sepsis prior to surgery.

Three days after vaccination my sister, suffered 2 Mini-strokes. She was taken to the hospital and is now in an Acute Rehabilitation Facility for one more week. She is unable to walk without assistance and has some speech and vision problems. Not sure is there is any connection with this and the vaccination, but just wanted to give the information in case.....

Skin inflamed at injection site. Approximately 7 days after injection, the skin rash became itchy and red.

Pt reports having her 2nd covid vaccine on 3/5, and on 3/17 began to have significant lower leg pain, tenderness, and purpura. Pt was diagnosed with erythema nodosum.

Woke up in the middle of the night; Pain in the legs; Blood on toilet paper when wiped; Fever; Joint pain; Muscle pain; Uncomfortable; Chills/Shivering; Pain on the Injection Site; A spontaneous report was received from a consumer concerning a 68-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, discomfort, injection site pain, fever/pyrexia, sleep disturbance/sleep disorder ,bleeding/haemorrhage, joint pain/arthralgia, myalgia/muscle pain, pain in extremity/pain in leg. The patient's medical history was as cloudy urine prior to vaccination .No Concomitant medications were reported. On 04 Feb 2021,the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in an unknown location for prophylaxis of COVID-19 infection. On 04 Feb 2021 ,night after receiving the vaccine the patient developed chills, was uncomfortable and had little pain in the injection site. On 06 Feb 2021 in the middle of night the patient started shivering, chills and fever to a temperature of 101.4.The patient also noticed bleeding when she went to bathroom. But there was no pain or burning sensation on urination. The patient also experienced muscle pain, joint pain and leg pain as well. Event Blood on toilet paper when wiped was considered medically significant. Action taken with mRNA-1273 in response to the events was not reported. The events, chill, uncomfortable and little pain on injection site were considered recovered on the days 05 Feb 2021.And the events fever bleeding ,muscle pain, joint pain and leg pain were considered unknown; Reporter's Comments: This case concerns a 45 Y/O F with a serious unexpected hemorrhage and nonserious unexpected discomfort, sleep disorder, pain in extremity, and expected vaccination site pain, pyrexia, chills, arthralgia, myalgia. Event onset the same days as first dose mRNA-1273. 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.

Patient admitted for observation to Hospital ER after presenting with A. fib with RVR and tachycardia. Patient monitored for less than 24 hours, rate control and discharged home with medication updates and to follow up in clinic.

Heart attack; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported). On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion hospitalization). The patient was hospitalized for 3 days due to MYOCARDIAL INFARCTION. At the time of the report, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication were reported. No treatment information was provided

On the morning February 22nd I was outside with my family in our backyard. I was checking our plant when I started to feel that I needed to sit down. By the time I sat down, I realized I had no feeling or use from the left side of my body including my face. I also had trouble communicating. Could not form complete sentences. The entire left side of my face was drooping. At that moment my husband immediately called 911. I was taken to the hospital by ambulance where i was immediately treated and diagnosed with a stroke. They administered TPA. I spent 3 days in the ICU. I have since been treated with blood pressure medication, blood thinners and statins.

Resident with nausea, vomiting, confusion, increased blood sugars, falling, tremor. Out to ED and transferred to hospital. Found to have an MI and a brain abscess.

Bad chest pains, palpitations and high blood pressure. Ct scan found two small clots (pulmonary embolism)

68YF Small bowel obstruction within 1 week of vaccine Patient had incarcerated incisional hernia with SBO, preserved bowel on March 19 2021. Patient with alcoholic cirrhosis who presented with abdominal pain, nausea, and vomiting. She was found to have a small bowel obstruction and an umbilical hernia. She had electrolyte derangements including hypokalemia and AKI and was admitted to hospitalist service with surgery consulting. She improved with NG tube decompression, IV fluid resuscitation, and electrolyte repletion. On 3/19 she underwent umbilical hernia repair and was found to have an incarcerated umbilical hernia. On day of discharge she tolerated advancement to regular diet. Her AKI and hypokalemia resolved. She does have chronic thrombocytopenia due to her cirrhosis, with last available baseline platelet count in the 50s. She did not have any significant bleeding postoperatively. She did not have any signs of decompensation of her cirrhosis. MELD Na is 13, with less than 2% 90-day mortality. Patient drinks 1-2 times a month now and did not have any signs of alcohol withdrawal. CT abdomen and pelvis showed a right lower lung nodule at the base. This should be monitored as an outpatient. She was discharged to home in stable condition. Upon 4/13/21 Ambulatory Clinic visit: Patient is recovering well from surgery.

Patient received second Modern COVID vaccine on 3/13. On 3/27 she developed shortness of breath. She presented to her local ED and was found to have a large saddle pulmonary embolism. She underwent thrombectomy with IR x2 and was transferred to Medical Center for surgical pulmonary thromboendarterectomy.

Admitted on 2/16/2021 with ascending weakness/ possible Guillain Barre. Patient was readmitted a month later with severe dehydration, colitis, sepsis and metabolic acidosis

PATIENT RECEIVED THE WND INJECTION APPROX 4:00PM. DAY OF - INITIAL COMPLAINT CHRONIC FATIGUE AND REDNESS & TENDERNESS AT THE INJECTION SITE. NEXT DAY CHRONIC FATIGUE, REDNESS AND TENDERNESS AT THE INJECTION SITE. APPROX 9:30 PM PATIENT COMPLAINED OF A POUNDING HEADACHE AND FATIGUE. SHE DIED A FEW HOURS LATER. CORONER'S OFFICE PROCLAIMED TIME OF DEATH APPROX MIDNIGHT THURSDAY NIGHT/FRIDAY MORNING.

Pt tested COVID positive on 3/24, less than 24 hrs post-vaccination #1. Pt reported no associated COVID symptoms. Presented to hospital w/ weakness r/t Afib (longtime diagnoses).

Patient had lap chole 6 weeks after second Moderna shot and developed multisegmental PE 2 days afterwards. No known clotting issues.

Vaccine 3/15 (2nd dose) By 3/19 Began having significant shortness of breath, which progressed to being unable to walk even short distances . Multiple telehealth visits and message exchanges with primary care. Diagnosed with dyspnea and fatigue. Blood tests: 3/30 by 4/1 was sent for echocardiogram and chest xray from which initial diagnosis of pulmonary hypertension and right ventricle failure, and anemia. 4/6 could not move myself from house to car, had to get wheelchair to get to a doctor appointment (primary care wanted me to see a cardiologist). Cardiologist sent me straight to a hospital. Cat Scan showed mulitple pulmonary emboli in both lungs. Procedure was done (cath sent up through lungs, u

Moderna COVID-19 Vaccine EUA: patient with relapsed AML and right upper extremity deep vein thrombosis (DVT) presented to clinic with headache and found to have subdural hematomas and a cerebral venous sinus thrombosis of unclear acuity. Patient admitted for management of AML, subdural hematomas, and upper extremity DVT. Discharged home improved and medically stable.

Within a few weeks after receiving first COVID injection patient became experiencing memory issues. Workup has led to showing a temporal lobe stroke. Her symptoms include difficulty with memory. Impaired speech, knowing what she wants to say but words coming out wrong. Mild emotional issues. Mild aggression. Physically intact.

multiple pulmonary emboli; could barely breath; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (multiple pulmonary emboli) and DYSPNOEA (could barely breath) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062G20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Gallbladder removal on 25-Mar-2021. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced FATIGUE (fatigue). On 27-Mar-2021, the patient experienced PULMONARY EMBOLISM (multiple pulmonary emboli) (seriousness criteria hospitalization prolonged, medically significant and life threatening) and DYSPNOEA (could barely breath) (seriousness criteria hospitalization prolonged, medically significant and life threatening). The patient was hospitalized for 3 days due to DYSPNOEA and PULMONARY EMBOLISM. On 13-Feb-2021, FATIGUE (fatigue) had resolved. At the time of the report, PULMONARY EMBOLISM (multiple pulmonary emboli) and DYSPNOEA (could barely breath) outcome was unknown. The doctors believed that her diagnosis was not a common side effect from the surgery and believed that the vaccine contributed to the diagnosis. She was treated with apixaban, omeprazole and aspirin 81mg (once daily). The patient is scheduled to visit a hematologist after 6 months. 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. Further information has been requested This case was linked to MOD-2021-081407 (E2B Linked Report).; 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. Further information has been requested MOD-2021-081407:Crosslinked case; Dose 1

cellulitis; Sepsis; Elevated heart rate; Rash from the waist down on left side of body; chills; Fever; This spontaneous case was reported by a physician assistant (subsequently medically confirmed) and describes the occurrence of CELLULITIS (cellulitis) and SEPSIS (Sepsis) in a 68-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. The patient's past medical history included Heart rate increased (elevated heartrate). On 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced CHILLS (chills) and PYREXIA (Fever). On 15-Apr-2021, the patient experienced CELLULITIS (cellulitis) (seriousness criterion hospitalization), SEPSIS (Sepsis) (seriousness criterion hospitalization) and RASH (Rash from the waist down on left side of body). On an unknown date, the patient experienced HEART RATE INCREASED (Elevated heart rate). The patient was hospitalized from sometime in April 2021 to sometime in April 2021 due to CELLULITIS and SEPSIS. At the time of the report, CELLULITIS (cellulitis), SEPSIS (Sepsis), HEART RATE INCREASED (Elevated heart rate), RASH (Rash from the waist down on left side of body), CHILLS (chills) and PYREXIA (Fever) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Heart rate: 132 (High) 132 beats per minute. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. She was admitted to the hospital and hospitalized for four days. She was diagnosed with cellulitis and sepsis. She was discharged home from the hospital with Augmentin (Amoxicillin / Clavulanic acid) for 10 days. Based on the current available information and temporal association between the use of the product and the start date of the event,s a causal relationship cannot be excluded. However, Further information has been requested This case was linked to MODERNATX, INC.-MOD-2021-081503~, MODERNATX, INC.-MOD-2021-081439, MODERNATX, INC.-MOD-2021-081647 (E2B Linked Report).; 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,s a causal relationship cannot be excluded. However, Further information has been requested MODERNATX, INC.-MOD-2021-081503 :Fourth patient-Same reporter MODERNATX, INC.-MOD-2021-081439:First patient-Same reporter US-MODERNATX, INC.-MOD-2021-081647:Third patient-Same reporter

She received her Moderna COVID vaccine on 02/26/201 which was a Friday, then on Monday and Tuesday patient had decreased appetite and felt miserable. Then on 03/08/2021 she started having chest pain that made her go to the ER. She was then found to have a multisegmental pulmonary embolism

Blood clots; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 038K20A) for COVID-19 vaccination. No Medical History information was reported. On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clots) outcome was unknown. Not Provided No concomitant medications were reported. The patient had no problems after her second dose. Treatment information was not provided. Action taken with mRNA-1273 in response to events was not applicable. Company comment: 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.

This 68 year old white female received the Covid shot on 3/3/21 and went to the ED on 3/22/21 and was admitted on 3/22/21 with shortness of breath, pneumonia and died on 4/10/21 . Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.

patient suffered from a massive right ICA stroke on 4/22 (2 days after vaccine). stroke progressed to cerebral edema with evidence of herniation. she was intubated and unfortunately expired. not a neurosurgery candidate due to her age and signs of herniation.

symptoms lasting for over 25 days: Major Headache , extreme exhaustion, trouble breathing (SOB), loss of taste/smell, worsening arthritis, congestion in lungs and head, diarrhea, blood clot in finger (just was seen in the ER for confirmed blood clot in finger)

Lower extremity swelling, persistent shortness of breath and chest pressure for about a month. Received 2nd Covid vaccine on 4/1/2021 and a couple of days later started to have this chest pressure and shortness of breath. Was seen in the clinic on 4/9/2021 with upper respiratory symptoms and cough along with chest pressure. Covid/Flu/RSV PCR test was negative on 4/9/2021. Chest heaviness and shortness of breath persisted, though slowly improving. CTA on 5/7/2021- Showed large burden of pulmonary emboli extending from the lobar to the subsegmental pulmonary arteries and consolidation in the lateral right lower lobe is likely pulmonary infarct. Patient is being treated with Eliquis. Placed in Observation overnight 5/7/2021-5/8/2021.

Patient received first dose of Moderna COVID vaccine on 3/27/21. Patient tested positive for COVID on 4/23/21. Patient received Casirivimab+ Imdevimab on 4/24/21, and was hospitalized for COVID on 4/25/21. Currently in hospital (5/14/21) recovering from acute respiratory failure.

Witnessed Cardiac arrest at home. No bystander CPR; +30 min transport time, unsuccessful resuscitation. Code called upon arrival to hospital

Health district notified by Police Dept. that a homebound resident who received first dose of Moderna on 4/26/21 and was due for second dose moderna on 5/24/21 was found deceased at home on 5/21/21.

Sore Throat in Neck Area; Diagnosed with ITP; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Diagnosed with ITP) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M2EA and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat in Neck Area). On an unknown date, the patient experienced IMMUNE THROMBOCYTOPENIA (Diagnosed with ITP) (seriousness criterion medically significant). At the time of the report, IMMUNE THROMBOCYTOPENIA (Diagnosed with ITP) and OROPHARYNGEAL PAIN (Sore Throat in Neck Area) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: 10,000 (Low) Platelets had dropped to 10,000 and 47,000 (Low) Decreased. Concomitant medications were not reported. Patient went to urgent care and blood work revealed that her platelets had dropped to 10,000 and she was directed to the emergency room and was treated with steroids and gamma globulin. She was diagnosed with ITP and treated with 4 infusions of Rituxan and her platelets are still low at 47,000. Treatment information were included gamma globulin, steroids, 4 infusions of Rituxan at hospital. Action taken with mRNA-1273 in response to the event was not applicable.; 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.

feeling miserable; did not take the second dose; feeling unwell; Vaccine attacked the ankles; Vaccine attacked immune system; Throat was falling short; Anaphylactic shock; Vaccine attack on ankle; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock) and IMMUNOSUPPRESSION (Vaccine attacked immune system) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) 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 CALCIUM and FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA D) for an unknown indication. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criterion medically significant) and DYSPHAGIA (Throat was falling short). 14-Jan-2021, the patient experienced JOINT INSTABILITY (Vaccine attack on ankle). On an unknown date, the patient experienced IMMUNOSUPPRESSION (Vaccine attacked immune system) (seriousness criterion medically significant), FEELING ABNORMAL (feeling miserable), PRODUCT DOSE OMISSION ISSUE (did not take the second dose), MALAISE (feeling unwell) and ARTHRALGIA (Vaccine attacked the ankles). At the time of the report, ANAPHYLACTIC SHOCK (Anaphylactic shock), IMMUNOSUPPRESSION (Vaccine attacked immune system), DYSPHAGIA (Throat was falling short), FEELING ABNORMAL (feeling miserable), MALAISE (feeling unwell), ARTHRALGIA (Vaccine attacked the ankles) and JOINT INSTABILITY (Vaccine attack on ankle) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (did not take the second dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. 15 minutes after vaccination patient had anaphylactic shock with allergies and chronic hives. The patient was taken to emergency room for 6 hours. The patient was treated with unspecified intravenous medication. Company comment: 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.

Shortness of breath leading to new diagnosis of congestive heart failure; prior excellent aerobic capacity

Patient presented to the ED for atrial fibrillation on 4/9/21 and 4/20/21. Patient was hospitalized for atrial fibrillation .

5/15 sustained syncope, fall hypoxic respiratory failure COPD pneumonia vomiting/diarrhea admitted to the hospital acute kidney injury 5/15--ED--cervical fracture, acute MI, elevated troponin multiple cardiology appointments, follow up appointments since then another emergency room visit on 6/10/21.

Pt had her 2nd covid 19 vaccine on 5/4/21 and was admitted to the hospital with an acute cryptogenic stroke on 5/28/21 with sudden R sided facial droop with NIHSS of 6, R sided weakness, expressive aphasia and was given TPA as ct head was neg for hemorrhage. CTA head and neck negative for any stenosis, ldl was 74, follow up mri brain post TPA was negative. Pt also had hyponatremia on admit of which was corrected by discharge. She also fell pta and was admitted with a colles fracture which was reduced at the bedside by orthopedics and casted. She was admitted from 5/28-5/31 and discharged home with her family.

On February 23, 2021, exactly 5 days after my 2nd moderna vaccine, I experienced innapropriate bleeding from my vagina, extreme pain and stiffness in both of my hands and wrists and the heels of both hands became red. The bleeding came every 2 weeks for 3 months. The pain in my hands is still ongoing as are the red palms.

Presenting symptom: dysartrhia and aphasia without evidence of underlying cause. Patient has been having continued TIA type symptoms with chest pressure & pain. Difficulty in walking, speaking, arm drift. This has happened on 3 different hospital occasions. Negative cardiac workup, negative brain scan. Presumptive dx TIA. No prior history, no family history, no underlying medical reason.

chest pains March 19 went to hospital admitted was given potassium for chest pains. May 24 in the evening had a stroke on left side . called 911 . was admitted . stayed 3 days .3 days in rehahab

Next day legs "felt wobbly" and SOB upon activity. Felt burning in chest within the next few days which is still experienced- worsened when fatigued. SOB continues with activity as well. Continues to feel fatigued with no activity. Has reported to HCP and is undergoing testing. Patient also had developed cellulitis in her right foot without any previous injury in the end of May. Has had increased episodes of atrial fibrillation- last episode had been in August of 2020, now under control. Currently still experiencing SOB, fatigue and burning sensation in chest.

I had a stroke on April 3, 2021. Affected right side of body. arm, leg and dominant hand and speech.

Patient had Moderna Vaccines on 1/4/2021 and 2/1/2021. No reactions developed after both vaccinations. Patient came into the ED on 7/15/2021 with complaints increasing dyspnea and a cough that started 9 days ago. She tested positive for COVID 19 and was admitted to ICU for hypoxemic respiratory failure on BIPAP. She is now on heated high flow NC at 100% FIO2 40L oxygen. Patient was started on ceftriaxone, doxycycline and remdesivir. 7.23.21 - patient is still admitted at the time of this form submission.

Almost immediately after receiving the second dose, she experienced having no strength or energy/her weakness is severe/ after taking a shower she must lay down to regain her strength/doesn't have the energy to hardly do anything now; Hard for her to complete a shower; Can't hardly stand by the stove to cook/she can hardly keep herself standing up; ongoing cough; Left foot started to swell; Has been going downhill; Blood clot in her left leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot in her left leg) in a 68-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. The patient's past medical history included Breast cancer (Breast cancer under arm; left side, at the age of 62) in 2015 and Chemotherapy (Stopped chemotherapy treatment during Moderna vaccination series. Restarted after 2 weeks before the time of reporting.) since an unknown date. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced THROMBOSIS (Blood clot in her left leg) (seriousness criterion medically significant). On an unknown date, the patient experienced ASTHENIA (Almost immediately after receiving the second dose, she experienced having no strength or energy/her weakness is severe/ after taking a shower she must lay down to regain her strength/doesn't have the energy to hardly do anything now), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Hard for her to complete a shower), DYSSTASIA (Can't hardly stand by the stove to cook/she can hardly keep herself standing up), COUGH (ongoing cough), PERIPHERAL SWELLING (Left foot started to swell) and GENERAL PHYSICAL HEALTH DETERIORATION (Has been going downhill). The patient was treated with RIVAROXABAN (XARELTO) for Anticoagulant therapy, at an unspecified dose and frequency and BENZONATATE for Cough, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (Blood clot in her left leg), ASTHENIA (Almost immediately after receiving the second dose, she experienced having no strength or energy/her weakness is severe/ after taking a shower she must lay down to regain her strength/doesn't have the energy to hardly do anything now), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Hard for her to complete a shower), DYSSTASIA (Can't hardly stand by the stove to cook/she can hardly keep herself standing up), COUGH (ongoing cough), PERIPHERAL SWELLING (Left foot started to swell) and GENERAL PHYSICAL HEALTH DETERIORATION (Has been going downhill) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Ultrasound scan: abnormal (abnormal) Diagnosed with a blood clot in her left leg.. Patient was given iron injection to regain her energy levels that she lost after the vaccination. It helped her initially but at the time of reporting it was not helping her much. She was prescribed Xarelto for 3 months to treat the blood clot. Patient states that she has no drug or food allergies. 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. Very limited information has been reported at this time. Further information is not expected. This case was linked to MOD-2021-264079 (Patient Link).; 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. Very limited information has been reported at this time. Further information is not expected.

My arm was a little sore after the vaccination but no other symptoms. And on 12/30 I woke up with a sever fever, vomiting and diarreah. Went to the ER and was diagnosed with CHF because my feet were so swollen and was given lasix and released. I continued to feel bad so on that Sunday 1/3 I went back to the hospital and was admitted and tested positive for COVID-19. I spent from Sun-Wed in the hospital

Anaphylactic shock; Potassium "dropped to 1%"; Cold and numb sensation; Sweating; Chest pressure; Blood pressure was 223/105-110; Neck swelling; Numb lips; Throat swelling; Disability NOS; A spontaneous report was received from a 69-year-old, female, patient who received Moderna's COVID-19 Vaccine (mRNA-1273), and experienced anaphylactic shock, potassium dropped to 1%, cold and numb sensation, sweating, chest pressure, blood pressure was 223/105-110,Neck swelling, Throat swelling, Numb lips and disability. The patient's medical history, as provided by the reporter, included allergies to yellow 5 (tartrazine), shellfish, and bee stings. Concomitant product use was not provided by the reporter. On 19 Jan 2021 at 11:42 AM, approximately two minutes 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 19 Jan 2021, minutes after receiving the vaccine, the patient experienced a cold and numb sensation on the upper right part of her back. The sensation extended around her shoulder and into her clavicle region. Approximately 30 minutes after vaccination she started sweating and felt like she was going into anaphylactic shock, which she had experienced in the past. The patient felt like her throat was swelling and her neck started to visibly swell. One hour after vaccination, the patients lips went numb, the clavicular numbness continued, and she started to experience chest pressure. A paramedic then evaluated the patient, her blood pressure was 223/105-110 mmHg, she was placed in an ambulance, given diphenhydramine and solumedrol, then taken to the emergency room. At the emergency room, the patient received a chest x-ray, computed tomography scan, blood tests, and an electrocardiogram. Previously, the patient had a blood test which showed a potassium of 4.3 to 3.9 "or something." At the emergency room, her potassium had "dropped to 1%." The patient was administered potassium in the hospital and was held for observation until approximately 10:00 PM, then discharged. On 20 Jan 2021, the patient continued to experience chest tightness. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events anaphylactic shock, potassium dropped to 1%, cold and numb sensation, sweating,blood pressure was 223/105-110 ,Neck swelling, Throat swelling, Numb lips and disability was unknown. The event, chest pressure was considered not resolved.; Reporter's Comments: This case concerns a 69-year-old, female patient with medical history of allergies to yellow 5 (tartrazine), shellfish, and bee stings, who experienced a serious, unexpected event of anaphylactic shock, sweating, hypoaesthesia, pharyngeal swelling, neck swelling, numb lips, chest discomfort, hypertension, hypokalemia and disability NOS. The event occurred the day the first dose of mRNA-1273 was administered. 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.

Pt presented to the emergency department with complaints of myalgias after receiving the vaccine. She noted that she had vomiting the night prior. She denied any chest pain, shortness of breath, abdominal pain, headaches, fever at that time. Pt was left in room by herself for approximately 5 minutes and was found unresponsive. Code Blue was called. Pt was found in asystole. ACLS was initiated. Return of circulation occurred after 7 minutes of resuscitation. Pt is currently intubated and sedated.

Brain aneurysm; Anaphylactic reaction; Collapsed; BP sky rocketed; Shortness of breath; A spontaneous report was received from a consumer concerning a 69-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced blood pressure skyrocketed, shortness of breath, loss of consciousness, massive anaphylactic reaction, and brain aneurysm. The patient's medical history, as provided by the reporter, included high blood pressure and arthritis. Products known to have been used by the patient, within two weeks prior to the event, included an antihypertensive. On 04 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. Twenty-two minutes later she had a massive anaphylactic reaction. She experienced shortness of breath, blood pressure skyrocketed, and loss of consciousness. She was taken to the emergency room. The patient had a brain aneurysm and never recovered. No treatment information was provided. The patient died on 04 Jan 2021. The cause of death was reported as brain aneurysm. Plans for an autopsy were not provided.; Reporter's Comments: This case concerns a 69-year-old, female patient with a medical history of hypertension, who experienced fatal, serious, unexpected events of Anaphylactic reaction, hypertension, dyspnea, loss of consciousness and brain aneurysm. The events occurred 22 minutes after the first dose of mRNA-1273 was administered. No treatment information was provided. The patient never recovered and died. The cause of death was reported as brain aneurysm. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Additional information has been requested.; Reported Cause(s) of Death: Brain aneurysm

According to her husband, approximately 3 hours after vaccine, patients clasped and was instantly unconscious. She was pronounced dead upon arrival to hospital and physician told husband that she had suffered a burst abdominal aneurysm and passed immediately. Nothing was out of ordinary during vaccination and during 15 minute wait time after.

The next day after vaccine was given, I got vaginal spotting/breakthrough bleeding. I am postmenopausal and on HRT and have been for 14 years and have not had any spotting after menopause and HRT was started. This highly unusual. Today, I also got a little spotting in the afternoon, like yesterday. So this is the second day in a row. I do not have any discomfort. I contacted my doctor late today and left a message for her. I do hope she will contact me tomorrow. I have heard that there are some new symptoms reported in the UK regarding female gynecological side effects like changes in menstrual cycle, which would not apply directly to me, but maybe similar symptoms? I am hoping the spotting will stop soon. The question is, would a 2nd dose be advised or not?

Had Moderna COVID vaccine approximately 1pm on 2/17. Developed headache and right visual field loss approximately 8pm on 2/18. Presented to our hospital at 5pm on 2/19 with progression of aforementioned symptoms and found to have left intraparenchymal hemorrhage with midline shift. Her symptoms are currently stable. Our neurosurgical team is not planning any surgical intervention. MRI of her brain demonstrates potential amyloid deposits, which are likely causative.

about 10 days after receiving the vaccine started with new onset A. Fib and shortness of breath especially on exertion. I am in work up for same Holter monitor, ECHO, ETT and f/u with cardiology

Without showing any side effect symtoms, patient suddenly fell unconscious and passed away within an hour. Though 911 was called and Paramedic was trying to revive the patient.

Pt states she couldn't breathe and was completely out of whack. Was taken to health center and then transferred to hospital in Wichita, KS. States they diagnosed her with pneumonia.

Heart went into fast BPM and irregular rhythm on2/07/2021. Stayed in Afib Until 02/18/2021 with spontaneous conversion.

2nd dose of Moderna at 9:00am. No side effect (except pinch at injection site) throughout the day and evening. At ~9:45pm, my wife suddenly fell unconscious. Immediate CPR & with Paramedic were not able to revive her. SHE PASSED AWAY at home. We believe it may be triggered by the vaccine. Did not have a chance to go to hospital or emergency room - it was too sudden. A sad day for us.

Developed tachycardia and shortness of breath on 3/1/21 which was significantly worse on 3/2/2021. Went to ER and CT angio showed diffuse bilateral pulmonary embolism. Spent the night for heparin, telemetry monitoring and lab work.

Symptoms= extreme short of breath and elevated heart rate. Time = 13 days after 1sr dose vaccine symptoms started. Went to ER on January 30th. CT scan showed bilateral pulmonary emboli. Doppler showed no sign of DVT. Negative COVID and chest X-ray was clear. ECHO cardiogram showed right heart distress. Treatment= IV Heparin followed by IM Lovenox. ICU X 2days and released to home on Eliquis BID. Follow up with Hematologist and cardiologist.

Severe COVID-19 pneumonia with acute hypoxemic respiratory failure diagnosed 3/12/2021, per hospital discharge summary: On admission patient requiring 10 L nasal pendant to maintain adequate oxygenation. She was admitted to the facility. Chest x-ray showed diffuse interstitial thickening and mild bilateral patchy airspace opacity. Inflammatory markers for notable for CRP of 120, D-dimer 805, ferritin 276. She was treated with dexamethasone (and prophylactic ivermectin) and Lovenox 1 mg/kg twice daily. Remdesivir was deferred given the onset of symptoms > 5 days PTA. She had good response to treatment and over the next 3 days her oxygen was tapered off and she had very good symptomatic improvement. At time of discharge she had minimal symptoms and had an ambulatory O2 sat greater than 94% on room air."

Patient developed pneumonia exactly 1 week after second dose. She had no issues before the shot, but had a high fever and breathing issues 1 week afterwards which was found to be pneumonia. While she is unsure if it is a result of the vaccination, she reported to the pharmacy and asked us to report to the manufacturer.

Patient got vaccine dose #2 on 3/23/21 (Tues) approx 10am. Per family reports patient went to hospital 3/24/21 (Wed) for unspecified pain and temp of 102f. Family states a "scan" was done and came back with nothing. P was treated for UTI and sent home. Patient was reportedly laying down at home about 8:15 or 8:30am complaining of a bad headache. Patient was found later that am deceased in her bed.

spontaneous bleed; bruise on the shin; sore arm; hives; nose bleed; A spontaneous report was received from a consumer, concerning a 69 years-old female patient, who received Moderna's COVID-19 vaccine and experienced sore arm, hives, nose bleed, spontaneous bleed, and bruise on the shin. The patient's medical history included Von Willebrand Disease and breast cancer. Concomitant product use was not provided by the reporter. On 19 JAN 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number 012L20A) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date post-vaccination, the patient experienced a sore arm and some hives. Approximately two weeks after the first dose, the patient experienced a spontaneous bleed resulting in a huge bruise on the shin the size of the palm of their hand. The patient consulted their Hematologist who performed blood work which was perfect. There were no abnormal results. The physician administered DDAVP. On 09 Feb 2021, the patient experienced their first nose bleed described as "horrific". The patient reported they had blood gushing out of their nose and that they bled for four hours. The patient ended up in the hospital emergency department where they were sprayed with DDAVP to stop the bleeding. Treatment details included DDAVP. There was no change planned to the dosing schedule of mRNA-1273 in response to the events. The events, nose bleed and spontaneous bleed were considered not recovered / not resolved. The outcome of the events sore arm, hives, and bruise on the shin was unknown.; Reporter's Comments: Based on the information provided and the patient's history of Von Willebrand Disease, a causal association between the events nose bleed, spontaneous bleed, and bruise on the shin with mRNA-1273 use is assessed as unlikely. However, based on temporal association, causality for the events of sore arm and hives cannot be excluded.

bleed on her stomach; blood clot on her leg; A spontaneous report was received from a consumer concerning a 69-year-old female patient who received Moderna (mRNA-1273) vaccine and experienced blood clot on their leg/Deep vein thrombosis and bleed on their stomach/Gastric hemorrhage. The patient's medical history was not provided. No Relevant concomitant medications were reported. On 4 Feb 2021, prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013M20A) in the left arm for prophylaxis of COVID-19 infection. On 14 Feb 2021, the patient had a blood clot on their leg for which the patient was hospitalized. While on treatment the patient had a bleed on their stomach. The patient was in ICU for 2 weeks and another week on a regular room. The event, bleed on their stomach, was considered life-threatening. On 4 Mar 2021, the patient was sent to a rehabilitation facility and on 16 Mar 2021, the patient was sent to their home. No Treatment information was provided. Action taken with mRNA-1273 in response to the event(s) was unknown. On an unknown date, the outcome of the events, blood clot on their leg and bleed on their stomach were considered unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Critical details such as the patient's medical history, list of concomitant medications, diagnostic findings and hospitalization details are lacking. Further information has been requested.

Patient began having symptoms 7 days after vaccination: chest pain, shortness of breath, feeling like a lump in the throat. Over several days symptoms worsened, and included upper back pain and some pain in the upper left arm. Patient went to urgent care clinic on the morning of March 15, where staff decided to send patient by ambulance to the hospital. She was admitted to the hospital and diagnosed with having 5 blood clots in her lungs. She was discharged March 16 in the evening on Eliquis 5mg twice a day. She states the hospital did not know what caused the blood clots, and were aware she had been vaccinated recently. She has not had a doctor visit in years, but is now established with a primary care physician for follow-up care. The second Moderna dose was given today 3/31/21.

Pain in abd and side started on Saturday, patient reported to hospital on 4/6 found on CT scan to have: Multifocal patchy occlusive and nonocclusive PE involving the bilateral lower lobe and right upper lobe segmental and subsegmental pulmonary arteries. Suggestion of flattening of the interventricular septum raising the possibility of right heart strain. Peripheral airspace opacities in the bilateral lower lobes, left more than right, which could relate to a combination of evolving pulmonary infarcts and/or hypoventilatory changes. Small left pleural effusion.

04/07/2021 cold hands, alternating hot and cold sweats, arm stiffness, shaking, aphasic and blank stare. Date of death 04/07/2021.

Started with intense headaches right after the 2nd dose of the Moderna vaccine on 03/06/2021. Had the headache for over two weeks, and eventually went to the hospital with loss of speech and movement on her left side of her body. They at first said it was strokes, then after the CT scan results came back they found multiple abscess in her brain. She does not have a history of strokes or brain abscess. Speech and motor functions never returned, and one abscess was so large that it caused a brain shift ( the two hemispheres separated) they performed brain surgery and it was not successful. She passed away on 3/31/2021 at 431 am.

Eight days following the first vaccine I was admitted with massive blood clots to my lets and lungs. I was hospitalized for 8 days. Four days were in ICU.

Onset of sustained atrial fibulation beginning approximately 22 hours post vaccination (second shot) pulse running between 110-145

1. Bilateral acute pulmonary emboli noted. No evidence of right ventricular strain. 2. Prominence of the pulmonary interstitium and ground-glass density throughout both lungs. This is suggestive of bilateral pulmonary edema. Bilateral pneumonia can give a similar appearance. 3. Small bilateral pleural effusions, right larger than left.

I developed a pulmonary embolus after my second Moderna covid-19 shot. My PSO2 dropped to 86% and Doppler found that i had an extensive DVT in my right leg, of which I was unaware. I have had no cardiovascular issues prior to this - I'm average weight, don't smoke and had no know risk factors at the time. I'm undergoing extensive testing now to see if there was a reason for my DVT and PE>

Started with odd pain in back shoulder bladearea on March 19, 2021,Got diarrhea with bloating 03/20/21 with I thiught was cause of shortness of breath. Shortness of breath got worse till I took some prednosone I had, on April 4, 2021 thinking I was having an asthma attack. Helped a few days. Shortness of breath returned on April 9, 2021. On April 10 we went to critical care thinking I was having asthma attack as extremely short of breath! They said it wasnt asthma but sent me to ER as my oxygen levels were low. In ER they took many tests including CAT scan and ultrasound, which resulted in diagnosis of several large bloodclots in both lungs

Jan 11, 2021?.First Mederna COVID-19 Vaccine Jan 21, 2021?.Had episode of head feeling like it was whirling around. BP was extremely high. ER was running over with COVID patients and no rooms. I took her to see. Not having classic signs of stoke and EKG was done it was fine. Caroitid us and ECHO was ordered. All were NEG. Referred to Dr. for a Heart Cath. Feb 25, 2021 Heart Cath was NEG. Followed up with Dr. and he ordered a Ct Scan of her head with and without contrast. He Also wanted her to see Dr. or Dr. to have her eyes fully examined. Dr. couldn't find anything wrong with her eyes. He said they looked healthy. Mar 12, 2021?.CT of head was done this was a Friday. Mar 15,2021?. Dr called me at work and told me Mama had had a stroke. A Rt Frontal Lobe Infarction She continued having these episodes throughout the weekend with her eyes not being able to focus and feeling. like her eyes where getting hung in their socket. Mar 16, 2021 Seen Dr and he ordered a MRI to see what It would show. Mar 18, 2021 MRI done and the results were NEG? (That?s complete BULLCRAP if you ask me)! April 14, 2nd reading was requested by FNP 2nd IMPRESSION read by Dr. although there are no acute intracranial abnormalities detected, there is a small area of encephalomalacia in the right lentiform nucleus extending to the right caudate head with ex vacuole dilation of the anterior horn of the right lateral ventricle. Ekg- Jan 21,2021 Echo- a week after the EKG Carotid Ultrasound- same as ECHO Heart Cath- Feb. 25, 2021 Cardiologist- Dr. - had to follow up with him due to having a heart cath and BP continuing to spike at random times Optometrist Dr. - twice to rule out anything going wrong with eyes- NEG both visits Now we are waiting to follow up with Dr Neurologist

PATIENT EXPERIENCED RESPIRATORY ARREST REQUIRING BIPAP AND ADMISSION TO ICU AT LOCAL HOSPITAL ONE DAY FOLLOWING VACCINE ADMINISTRATION. PATIENT LOST PULSE UPON ARRIVAL TO HOSPITAL AND REQUIRED ACLS ALGORITHM TO BE INITIATED WITH INTUBATION.

Patient presented for the outpatient procedure of a cataract extraction. Found to be hypertensive and very short of breath. Sent to primary care physicians office who in turn ordered a CT scan. Found to have Pulmonary Embolism and Deep Vein Thrombosis

On 4/3 patient developed neck pain and headache. She had reportedly received her second dose of Moderna COVID vaccine within 1 week prior, but exact date unknown. She became acutely confused and reported tingling in her left fingers on 4/9 prompting presentation to Medical Center. MRI was performed 4/10 reportedly showing an acute focal right corona radiata lacunar infarct. On 4/11 patient became more agitated and 4/12 developed worsening headache and global aphasia. Non-contrast head CT showed multiple areas of subarachnoid hemorrhage bilaterally. MRI brain felt to also have small areas of bilateral diffusion restriction throughout right more than left cerebral hemispheres with concern for leptomeningeal involvement. She was transferred to another facility for higher level of care on 4/14. LP on 4/16 with TNC 33 (95% lymphs, 3% monos, 2% macrophages), RBC 1425, Protein 521, glucose 68. CSF gram stain/culture negative fungal culture and cryptococcal antigen negative, VZV PCR negative, HSV PCR negative, PCR meningitis/encephalitis panel negative, enterovirus culture negative. Serum VZV IgG positive but PCR negative, Lyme and treponemal antibodies negative, HIV Ab negative, ANA/ANCA/Sjogren's antibodies negative. Repeat LP 4/21 with TNC 43 (52% PMN, 35% lymphs, 11% monos, 1% baso, 1% myelos), protein 745, glucose 76). However, given high suspicion for viral encephalitis patient was recommended to complete a 10-14 day course of IV acyclovir by inpatient ID consult service (start date 4/16). She was also treated with empiric steroids. The neurology team is concerned for a possible vasculitis vs reversible cerebral vasoconstriction syndrome as potential etiologies. Brain biopsy performed 4/23 to help clarify diagnosis, results pending.

I had a marked increase in number and severity of heart palpitations starting 1 week after my first dose (above info) and continuing for 2 1/2 weeks after my second Moderna shot on 2/18/2021. In other words an increase in my symptoms of AFib.

Immediate headache & sore arm. by Friday. March 18, I was in severe pain of left side, going through me and coming out the front. so we went to the hospital Another XRay revealed ground class pnuemonia, but no heart problems. After 4 days in the hospital, They dishcharged me. I took and shower and it revealed that I had shinges breaking out from my back areound my left side. The doc dischared me on Monday morning, March 19. I have been taking Gabapentin & Varacyclovir. the Varacyclovir make my heart race, and pound with the least amount of exercise. It is now April 30 and I am still in dreadful pain

Patient received 1st dose of moderna vaccine on 3/31/21. Patient went to the ED on 4/18/21 complaining of 2 weeks of worsening shortness of breath, fatigue, weakness, and new onset chest heaviness which ultimately was a pulmonary embolism (PE). Patient did not have any prior health/risk factors to PE. Patient did test positive for COVID-19 on 4/18

She did not get much sleep one night; Bleeding profusely; Horrible cramping; Blood red, vampire red eye; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bleeding profusely) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included LOSARTAN and MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced HAEMORRHAGE (Bleeding profusely) (seriousness criterion medically significant), MUSCLE SPASMS (Horrible cramping) and OCULAR HYPERAEMIA (Blood red, vampire red eye). On an unknown date, the patient experienced SLEEP DISORDER (She did not get much sleep one night). At the time of the report, HAEMORRHAGE (Bleeding profusely), MUSCLE SPASMS (Horrible cramping) and SLEEP DISORDER (She did not get much sleep one night) outcome was unknown and OCULAR HYPERAEMIA (Blood red, vampire red eye) had not resolved. She is on HRT implant called BioTe and is scheduled for a Pap Smear After the first dose apart from fever she got all the flu like symptoms which lasted 6 days. 2 weeks after the second dose, she got horrible cramping and bled profusely for 7 days. She adds that her husband snores and she did not get much sleep one night and woke up the next day with some redness in her left eye which turned blood red, vampire red in the next few days. The eye is still red so she went to her retinologist to get her eye checked and he said there is no issue with the eye. She is concerned about her upcoming cataract surgery on Monday. Treatment information was not provided. 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.

Patient returned for 2nd dose on 3/26/2021, at that time, she reported to nurse that she was hospitalized at a Medical Center around 9-10 days after first dose of vaccine due to a pulmonary embolism. Attempts made to the hospital to obtain records but did not receive any.

Stroke. Foci of acute/subacute infarction in the right putamen/corona radiata, right insular cortex, right superior frontal gyrus, and left occipital periventricular white matter. No evidence of hemorrhagic transformation or petechial microhemorrhage. No associated mass effect, midline shift, or herniation. Generalized cerebral volume loss on a background of chronic microvascular ischemic changes.

Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremities)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremities)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Additional Details: symptoms started 2 hours after the 2nd Covid a injection. Lower lip was protruding and severely swollen, spasms in left ear, itching and tingling of the face and throat, hived around eyes and on back. Pt tried Benadryl at home but did not help and was rushed to emergency room where was started immediately on an IV. Was also given epinephrine, Benadryl and Pepcid. Pt stayed at emergency room for 5 hours.

Pt contacted our officeat approx 12:30PM on 5/10/21 stating that she thought she was having a reaction to the second vaccine. We received a call from the Deputy Sheriff at approx 4:50 PM to inform us that this pt has passed away apox. 4 hours prior. COD: pending. We have not other information at this stime

minimal pericardial effusion; my oxygen saturation again plummeted/getting difficult to maintain my oxygen level during the day; mild arm pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (my oxygen saturation again plummeted/getting difficult to maintain my oxygen level during the day) and PERICARDIAL EFFUSION (minimal pericardial effusion) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 03IL20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hypoxia. Concurrent medical conditions included Pulmonary hypertension (Reporter states: Pulmonologists disagree about this diagnosis) since May 2019 and Sleep apnea since March 2019. Concomitant products included LORATADINE for Allergy, VITAMIN D3 and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for Deficiency vitamin. On 05-Feb-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (mild arm pain). On 07-Mar-2021, the patient experienced HYPOXIA (my oxygen saturation again plummeted/getting difficult to maintain my oxygen level during the day) (seriousness criterion medically significant). On an unknown date, the patient experienced PERICARDIAL EFFUSION (minimal pericardial effusion) (seriousness criterion medically significant). At the time of the report, HYPOXIA (my oxygen saturation again plummeted/getting difficult to maintain my oxygen level during the day) and PERICARDIAL EFFUSION (minimal pericardial effusion) had not resolved and PAIN IN EXTREMITY (mild arm pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, Oxygen saturation: low (Low) Low. On 17-Apr-2021, Brain natriuretic peptide: 1064 (High) "nearly 10 times the normal limit and is a strong indicator of heart failure". On 29-Apr-2021, Computerised tomogram thorax: abnormal (abnormal) minimal pericardial effusion. Reporter states: I was diagnosed two years ago with sleep apnea and nocturnal hypoxia and have used a CPAP device with oxygen every night since. Following the first dose of the vaccine, my oxygen level was so low that I had to go onto daytime supplemental oxygen for the first time. After the second dose of the vaccine, my oxygen saturation again plummeted. I have been on 3-4 L of daytime supplemental oxygen ever since. It is getting difficult to maintain my oxygen level during the day even with supplemental oxygen. The cardiologist has ordered an echocardiogram for May 7, 2021. That should help determine if my breathing difficulties are due to a sudden worsening of pulmonary hypertension, or if this could be related to the vaccines. Company Comment: 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. This case was linked to MOD-2021-029767 (E2B Linked Report). This case was linked to MOD-2021-029686, MOD-2021-029686 (Patient Link).; 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. MOD-2021-029767:Reporter's friend's case

The decedent experience nausea, headache, and chest pain approximately 72 hours after receieving her second shot. She was found deceased later that day.

Patient received Moderna vaccine 3/2/2021 0.5 ml LD IM Lot: 029L20A and Moderna vaccine 3/30/2021 0.5 ml LD IM Lot: 019B21A. The patient was exposed to an infected person with Covid about 1 week after her second vaccine. She was admitted to the ICU with severe covid on 4/13/21. She was eventually transitioned to comfort care and died on 5/6/2021.

Patient DOD 4/19/21 Death Certificate Line A ?Adverse effect of Covid19 vaccine-5 day interval onset and death? Line B ?Anorexia nervosa? Line C ?Recurrent Major Depressive Disorder? Received her second Moderna dose from our Mobile team on 4/14/21 Since then I spoke with Dr. (Mobile); clients PCP, several times regarding this event. His nurse got an email from client on 4-12-21 that client had vaccination planned on 414 and may need to reschedule medical appointment planned 4-16 if she felt bad. The client was encourage to get vaccine and to keep appointment for Friday April 16th. The client emailed the office at approx 0300 Friday morning April 16 to cancel appointment because she felt to poorly from vaccination shot to come in (fevers; body aches). Dr next heard from police officer on Monday April 19th that she was found dead in her home. He requested the Medical Examiner (ME) evaluate but this request was denied. The client lived alone. Dr contacted family members but they did not have much interaction with the client and had no significant information to contribute. Dr said he speculates that the patients underlying anorexia nervosa likely put the client in a critical nutritional deficiencies / electrolyte imbalance condition and the side effects of vaccination were too much. He felt compelled to complete the death certificate as he did because the ME declined the case. From vaccine mobile team notes: team was there2-3:30pm. All the answers to the health screening questions for the patient were "no" except for "have you ever had a severe allergic reaction to something?" To that question the answer was "yes. Immunization Information System record - lot # is underlined: Coronavirus COVID-19, mRNA,LNP-S,PF, 03/17/2021 1 of 2 100 mcg/0.5mL Full 022M20A IM LA Coronavirus COVID-19, mRNA,LNP-S,PF, 04/14/2021 2 of 2 100 mcg/0.5mL Full 006B21A IM LA

Unknown date of vaccination, physician asked for this to be reported, possibly related to Covid vaccine. Patient admitted to hospital with syncope and bilateral pulmonary embolism. Patient treated and discharged home after after 2 days

A large blood clot developed in my right leg. From the top of the thigh/groin area to my ankle. Went to the emergency room. I was admitted and over 3days, approximately 7 hours the clot was busted with stents and balloons put in. My hospital stay was from April 19, 2021 to April 24, 2021. I didn?t realize what was happening as my leg just keep swelling. I have never had a clotting problem. I have had major surgery (gall bladder removal), a left hip and knee replacement and bunions removed from both feet. Never have had a blood clot problem.

Late in the evening on May 12, my mother started having pain on her right side. She also could not take a deep breath without having a stabbing-like pain. The pain level was severe and kept her awake all night. On May 13, she went to the urgent care department at the medical center. An xray of her chest cavity was taken. It showed fluid in her right lung, but the results were inconclusive because of her limited able to take a deep breath. Extensive blood work was also performed. The urgent care doctor suspected that she has a blood clot in her lung, and she was sent to the hospital for further testing. She is still in the ER of the Medical Center. They are still doing tests and have not officially confirmed that she has a blood clot yet.

2/12/21 2nd round; 2/13/21: Woke up with chills, then sweats, fever of 102 fluctuated, aches and pains, stayed in bed for 4 days. It took a week to become active again. Called my doctor's office several times. I was told it was normal, part of the vaccine reaction. Worse reaction was my leg bones feeling like metal strips of a toy erector set. The taste of metal in my mouth lasted 4 days. Difficulty walking because of leg weakness and dizziness. Loss of appetite. 5/1/21 - 5/3/21 Hospitalization for diagnosis of Acute Pulmonary Embolism and Deep Vein Thrombosis

Chief Complaint Fever History of Present Illness This is a 69 year old female with breast cancer status post left mastectomy, diabetes mellitus, hypertension, and past transient ischemic attack who presented to ED for fever. The patient reports that she began experiencing sudden onset of fever and chills last night (05/15/2021), and she additionally complains of persistent sore throat and cough beginning the previous week. She has undergone radiation and chemotherapy treatment for breast cancer in the past but these treatments have been suspended for several months with mammography performed on 03/10/2021 failing to identify any malignant growths. In the ED, the patient was found to have acute bronchitis due to COVID-19, fevers and systemic inflammatory response syndrome. Review of Systems Constitutional: Positive for chills and fever. HENT: Positive for sore throat. Respiratory: Positive for cough. Negative for shortness of breath. Cardiovascular: Negative for chest pain and leg swelling. Gastrointestinal: Negative for abdominal pain, diarrhea, nausea and vomiting. Genitourinary: Negative for dysuria. Musculoskeletal: Negative for gait problem. Neurological: Negative for syncope. All other systems reviewed and are negative. Vitals Blood pressure 123/75, pulse 95, temperature 37.1 °C (98.7 °F), temperature source Oral, resp. rate 29, height 1.651 m (5' 5"), weight 106.6 kg, SpO2 95 %. Physical Exam Vitals reviewed. Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is morbidly obese. She is not ill-appearing. HENT: Head: Normocephalic and atraumatic. Nose: Congestion present. Mouth/Throat: Mouth: Mucous membranes are dry. Dentition: Abnormal dentition. Pharynx: Oropharynx is clear. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Chest: Comments: Port in place to the upper right chest. Abdominal: General: Bowel sounds are normal. There is no distension. Palpations: Abdomen is soft. Tenderness: There is no abdominal tenderness. Musculoskeletal: General: Normal range of motion. Cervical back: Normal range of motion and neck supple. Skin: General: Skin is warm and dry. Comments: Chronic venous stasis changes to the bilateral lower extremities. Decreased skin turgor throughout. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Plan Admit to hospital ? cardiac telemetry unit Continuous pulse oximetry and telemetry monitoring Control pain, nausea and vomiting as needed Respiratory treatments (MDI) and supplemental oxygen prn IVF hydration; serial neurological checks every four hours Initiate dexamethasone therapy 6 mg IV once daily Ascorbic acid, zinc sulfate, and vitamin D3 supplementation Serial BMP, Mag, CBC, hepatic panel; ESR/CRP, PT/INR Serial lactic acid and procalcitonin; check respiratory PCR Follow up on blood cultures as available; check urinalysis Electrolyte correction/replacement as indicated Fall precautions; PT/OT evaluations during this visit FSBS and SSI every AC/HS for glycemic control Resume selected home medications with hold parameters DVT prophylaxis ? SCDs only GI prophylaxis ? Famotidine

Clinic contacted patient date of death: 05/09/2021. No other information on symptoms, signs experienced prior to time of death.

Shortness of breath with sudden onset. Seen at physican office . Chest CT, Echo, PFT ordered. Bilateral pulmonary emboli discovered . Eloquis started. Improvement seen. Sats and increased HR improved. Persistent coughing still remains. Patient to remain on Eloquis for 6 mon minimum .

patient with bilateral PEs with right heart strain - reported SOB since the time of the second COVID vaccination - plan for EKOS catheter tomorrow and treatment with Eliquis

Atrial fibrilation, new onset, 4 hours in ER with IV and multiple meds to regulate . Follow up with Echo, 2 weeks heart monitor, see cardiologist, blood thinner medication

My sister got her first covid shot on 1/25/21. On 1/27/21 she started a prescription for a diuretic for swelling from DVT in left leg. On 1/29/21 she called me early in the morning to say she couldn't stand or walk. She hasn't walked since. No idea if this was natural progression of dementia. She did walk into and out of cardiology appointment on 1/7/2021, and was weak at that time.

Shortness of breath and calf pains that began about 3 weeks after the second Covid vaccine that turned out to be a DVT and Pulmonary Embolism

Approximately 24 hours after receiving second Moderna vaccine patient developed right sided weakness which prompted a trip to the emergency room. There a head CT was performed and was negative. Patient was then admitted for further testing and a MRI of the brain performed the following day reveled a acute ischemic stroke. Patient was discharged to acute patient rehab and symptoms improved but have not resolved.

patient reported a couple weeks after 1st moderna vaccine (she was unsure of date, I guessed on the first page of the report because I had to put an exact date). she began to feel short of breath. eventually went to hospital where she was diagnosed with blood clots in both the legs and lungs. she said dr is saying it was due to the vaccine and told her not to get the second dose. she stayed 5 days in the hospital according to her. had surgery to place a filter for the clots and is now home on oxygen around the clock.

On 5/28/21, patient presented to the ED for SOB and np cough which started 5/24. Patient states chills, subjective fevers, cough, SOB/DOE worsened over th eweek. She is on 2L O2 at home and with exertion her O2 sat would drop into the 70s. Rapid COVID-19 is positive. Admitted with acute on chronic hypoxemic respiratory failure secondary to SARS-CoV-2 pneumonia. Completed remdesivir, cefepime, Zosyn, and azitrhomycin, receiving dexamethasone, intubated 6/1/21 for persistent respiratory failure.

Only reporting to VAERS as patient received covid-19 vaccination under EUA and was hospitalized and is now deceased from illness deemed UNRELATED to prior covid-19 vaccination. She was a 69 yr old female who was transferred to hospital on 6/8 at 0141 from outside hospital with severe shock, acute hypoxemic respiratory failure, who had a cardiac arrest on arrival here for 5 mins, during arrest CPR was done and 2 doses of epinephrine were administered prior to ROSC and targeted temperature management was initiated. She was found to have a massive PE, alteplase was given and a heparin continuous infusion was started on 6/8 at 0154 and 0345, respectively. She later underwent a thrombectomy on 6/8 at 1640. She showed signs of poor neurological status. Went into MSOF despite aggressive supportive care. Family requested to make her comfortable and the patient expired on 6/10 at 0449.

Deep venous thrombosis and bilateral pulmonary embolism approximately one week after administration of vaccine leading to hospitalization on 4/24/21

blood clots from the knee to top of her leg.; feeling uncomfortable; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clots from the knee to top of her leg.) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hypercholesterolemia. Concurrent medical conditions included Diabetes and Hypertension. On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced THROMBOSIS (blood clots from the knee to top of her leg.) (seriousness criterion medically significant) and MALAISE (feeling uncomfortable). At the time of the report, THROMBOSIS (blood clots from the knee to top of her leg.) and MALAISE (feeling uncomfortable) outcome was unknown. Very limited information regarding this event/s has been provided at this time. Further information is not expected. Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information is not expected.

Signs/symptoms of community acquired pneumonia. COVID negative. Bacterial pneumonia based on chest x-ray.

large blood clot in the right lung/smaller blood clot in the left lung; blood clot in the calf of the left leg; Baker's cyst behind the left knee; "I still didn't feel right or good"; "problems with my kidneys"; dull pain; "really bad chest pains"; "knee got swollen up"; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY EMBOLISM (large blood clot in the right lung/smaller blood clot in the left lung) and THROMBOSIS (blood clot in the calf of the left leg) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included LOSARTAN, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), OMEPRAZOLE, EZETIMIBE, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), VITAMIN D [VITAMIN D NOS], CALCIUM, MULTIVITAMINS [VITAMINS NOS] and APIXABAN (ELIQUIS) for an unknown indication. On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced JOINT SWELLING ("knee got swollen up"). On 26-Apr-2021, the patient experienced PULMONARY EMBOLISM (large blood clot in the right lung/smaller blood clot in the left lung) (seriousness criteria hospitalization and medically significant) and CHEST PAIN ("really bad chest pains"). On an unknown date, the patient experienced THROMBOSIS (blood clot in the calf of the left leg) (seriousness criterion medically significant), SYNOVIAL CYST (Baker's cyst behind the left knee), MALAISE ("I still didn't feel right or good"), RENAL PAIN ("problems with my kidneys") and PAIN (dull pain). At the time of the report, PULMONARY EMBOLISM (large blood clot in the right lung/smaller blood clot in the left lung), THROMBOSIS (blood clot in the calf of the left leg), JOINT SWELLING ("knee got swollen up"), SYNOVIAL CYST (Baker's cyst behind the left knee), MALAISE ("I still didn't feel right or good"), CHEST PAIN ("really bad chest pains"), RENAL PAIN ("problems with my kidneys") and PAIN (dull pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Company comment: Very limited information regarding this events has been provided at this time. 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. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. 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. Further information has been requested.

Rapid onset vision loss in left eye with concurrent rapid onset high blood pressure and rapid pulse. Testing showed existing crowded optic nerve (previously undiagnosed), swelling of the optic nerve, delayed blood flow to optic nerve, and leakage around optic nerve head. Vision loss progressed over about five days, stabilized, and may now be somewhat improved. Diagnosis is Non-Arteric Ischemic Optic Neuritis (NAION), for which there is no treatment and uncertain prognosis. Some extent of permanent vision loss tis epected. Concurrent rapid onset of hypertension (systolic 150s-170s; diastolic low 100s at times) and fluctuating rapid pulse (80s-110). Currently being treated for hypertension but not yet fully controlled. Blood tests revealed elevated inflammatory markers (high C-reactive protein and sedimentation rate and positive ANA. Follow-up tests to determine cause of hypertension are underway. Thus far, no heart abnormalities, no carotid artery blockage, and negative for a number of autoimmune disorders and other possible causes. Prior to this event, blood pressure and pulse were normal and eye exams showed no vision or retina problems, glaucoma, or macular degeneration. Cardiologist and rheumatologist have not ruled out inflammatory response to Covid vaccine, have encouraged reporting of this event to VAERS, and have advised against taking any other Covid booster. Note that the optometrist who first saw me when the vision loss began has since told me that he saw only two cases of NAION in 38 years of practice before mine, but has seen two more besides me in the last couple of months. Both were patients of similar age with similar rapid onset of vision loss, and both had taken the Covid vaccine about four weeks before.

Went to the ER the evening of March 25 with Rapid AFib. Had pulse rate ranging from 160 - 205. Heart was ?flopping?. Treated with medications and sent home.

Patient is a 69-year-old female with a past medical history significant for type 2 diabetes, hypertension, RA, GERD who presented from a rehab facility with fevers, hypotension, tachycardia and diarrhea. This is the patient's third hospitalization in the last month. She was initially admitted on 5/4/2021 for she suffered to syncopal episodes resulting in a motor vehicle accident x 2. From 5/4-5/6. During that admission her gabapentin dose was decreased and she was given 5 days of Macrobid on discharge for a possible urinary tract infection. We also arrange follow-up with cardiology for loop recorder and to see orthopedics as an outpatient the etiology for her syncopal episode was unclear. It was not felt to be seizure related. She went home with home health care. She unfortunately was readmitted on 5/29-6/3 new onset acute pancreatitis with an unknown etiology and was ultimately discharged to rehab. During that hospitalization patient reported that she was seen by cardiology for her 2 syncopal episodes that occurred earlier in the month and a cardiac cause of her syncope was ruled out and they recommended she be referred to neurology. She returns back again for admission on 6/8 for encephalopathy, hypotensive, septic shock, NSTEMI and was subsequently admitted to the intensive care unit on pressor support. She was given Cipro, Flagyl, Vanco and Levophed and IV fluids. Her septic shock was felt secondary to urinary tract infection. The urine culture that was resulted on 5/30 grew Klebsiella pneumonia that was resistant to Macrobid. She was not sent out on any antibiotic therapy as she was not felt to be symptomatic during her last hospital course. She also had a CAT scan during this hospital course which showed colitis. Urine culture from this admission was of mixed flora Greater than 100,000 colony-forming units no organisms were grown out however. She was treated with 7 days of Cipro. Again patient's CAT scan of the abdomen and pelvis done on admission showed colitis she was seen by gastroenterology during her hospital stay and underwent an endoscopy. It was ultimately felt that the patient's colitis was likely ischemic in nature. Patient was also noted to be thrombocytopenic on admission which was felt to be possibly from sepsis or dilution was ultimately resolved at the point of discharge. She also again was found to have acute blood loss anemia with no source found. she had hematochezia noted on admission but resolved by the point of discharge. EGD did not reveal any source of bleeding other than a tiny esophageal ulcer. Aspirin therapy was discontinued. She did not need transfusion during her hospital stay. The lowest her hemoglobin went was to 7.3. Patient's acute tubular necrosis resolved her metabolic acidosis and metabolic encephalopathy resolved and at this point she is stable for discharge to rehab. Patient's lisinopril aspirin, hydrochlorothiazide have been discontinued at this point. Her blood pressure is 121/61 she is afebrile respirations are normal O2 sat is 95% on room air. Patient's hemoglobin is 8.1. She is no longer having an abdominal pain and is tolerating p.o. She is not having any diarrhea. the cause for the patient's colitis is likely ischemic in nature. she was discharged to rehab on 6/15

03-29-2021 at 8:30am awoke with severe headache, left jaw pain and vision problem. Made appointment with eye doctor (April 1) . 03-30-2021, while shopping had a major stroke at 1:00pm. EMS took me to the Hospital. Admitted to ER, acute ischemic stroke, basilar artery thrombosis, atrial fibrillation. Blood clot removal by Neurological Radiologist. Discharged from Hospital April 2,2021. Still am being treated for atrial fibrillation and vision problems.

About 2 months after the 2nd dose vaccine, I started getting shortness of breath and tightness in my chest. Around end of May, the pressure started getting heavier. By June 5, 2021 I thought I was having a possible heart attack, so I decided to go to the Hospital. They did a bunch of tests and an ECHO and detected pericarditis, pericardio effusion and blood clots. I was on a heparin drip for 7 days for the blood clot and they started me on colchicine for the pericarditis which has now resolved. I was discharged with RX for Lovenox to prevent blood clots and to continue to take colchicine. I was in the hospital for 8 days total.

Patient stated that she received her 2nd COVID vaccine on April 23rd and since then has had progressive shortness of breath with exertion. She said that the shortness of breath was so bad she had to come to ED for further evaluation. Found to have pulmonary embolisms. Treated with heparin drip at outside ER and then transitioned to enoxaparin 1 mg/kg BID. On day 2 of admission, patient transferred to a tertiary center for possible catheter directed TPA/Thrombectomy due to her right heart strain and patient feeling dizzy when she moves.

a month later she had thrombotic event- she had a central artery embolism to her right eye and multiple small ischemic strokes in multiple areas of her brain. she lost vision in her eye,

COVID-19 symptom onset 5/3, hospital admission 5/11, and death on 5/18/2021. Primary cause of death acute hypoxic respiratory failure, underlying cause COVID-19 viral pneumonia

The day she received the second dose she started with flu like symptoms. She also had tingling hands and feet her condition did not get better and was rushed to the ER. She was there for 4 days and sent to a long term facility where her condition worsen. She started having breathing issues went back to the ER with chronic breathing complications. At the hospital she had low oxygen level, lung complications, kidney failure and went into cardiac arrest. She was resuscitate and put on a ventilator for 3 days. She started breathing on her own and was taken off the machines. She was sent home a few days later and nine days later went into cardiac arrest again and this time did not make it.

wheezing same day as vaccine- albuterol hfa and prednisone dyspnea exacerbated over next several days leg deep venous thrombosis developed/diagnosed 11 days later

6-14-2021 left arm pain and numbness 6-18-2021 massive stroke (right hemi) 6-22-2021 heart attack 6-26-2021 unspecified seizure 6-27-2021 severe chest pain 6-28-2021 shingles outbreak 6-29-2021 salmonella & staph infections detected 7-1-2021 unspecified blood in stool Extreme confusion throughout this time

7/12/21 er @ hospital: 69 y.o. female who presents with increasing shortness of breath. Patient reports increasing shortness of breath for the past 3 days. She denies any runny nose or sinus congestion. Patient does report a dry cough but states it is no different from her typical COPD cough. Patient denies any chest pain or palpitations. However, patient on bedside monitor is in AFib with RVR. Patient does voice a history of intermittent atrial fibrillation. Patient denies any current palpitations, chest pain, or edema. Of note, patient reports she sustained a stroke approximately 6 weeks ago. Patient reports she experienced left-sided weakness. She reports that left-sided weakness has since returned to completely normal. She did not seek medical care for her stroke at the time of the stroke. (pt is a retired nurse) Transferred to another healthcare facility where she remains admitted as of 7/13/21

stroke; Flashers in her eyes that continue; Woke up in the middle of the night several times; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included ATENOLOL, LEVOTHYROXINE, CHLORTHALIDONE, SIMVASTATIN, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and ACETYLSALICYLIC ACID, CAFFEINE, CHLORPHENAMINE MALEATE (CORICIDIN [ACETYLSALICYLIC ACID;CAFFEINE;CHLORPHENAMINE MALEATE]) for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PHOTOPSIA (Flashers in her eyes that continue) and INSOMNIA (Woke up in the middle of the night several times). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Migraine and Headache, at a dose of 1 dosage form four times per day. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), PHOTOPSIA (Flashers in her eyes that continue) and INSOMNIA (Woke up in the middle of the night several times) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered CEREBROVASCULAR ACCIDENT (stroke) to be not related. No further causality assessments were provided for PHOTOPSIA (Flashers in her eyes that continue) and INSOMNIA (Woke up in the middle of the night several times). Based on the current available information and temporal association between the use of the product and the start date of the events of photopsia and insomnia, a causal relationship cannot be excluded. Based on reporter's causality the event of cerebrovascular accident is assessed as unlikely related to mRNA-1273. Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Significant follow received and the initial diagnosis of ocular migraine was wrong and is confirmed to be a stroke. Reporter causality was updated to unrelated.; 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 of photopsia and insomnia, a causal relationship cannot be excluded. Based on reporter's causality the event of cerebrovascular accident is assessed as unlikely related to mRNA-1273.

After the first dose I had joint pain and stiffness of movement; after the 2nd dose, I had a moderate fever, headache, and extreme joint pain and difficulty in walking especially going up and down the stairs in our home. The discomfort in my joints, especially my hips and knees, was so severe I made an appointment with a rheumatologist who ruled out RA and with an x-ray confirmed bursitis in right hip, which was the very first time I ever had bursitis. Since then my hip pain and stiffness became even more severe and I am now scheduled for a hip replacement in late October. My concern is that the vaccine spiked an inflammatory response with my arthritis and I have been in chronic pain since that second dose...

After the initial side effects of chills, fever, and body aches subsided I had hot flashes and night sweats every night for 5 weeks. Then breast pain and swelling began and breast tissue changes were confirmed on May 28 via ultrasound. Two weeks later I developed a blood clot in my left calf as confirmed by an ultrasound on June 11, 2021. I believe this blood clot was provoked my the Moderna vaccine, as there were no other factors that could have provoked the blood clot.

Early in the morning Saturday, the day after the injection, patient became very nauseaus with a bad headache. She was sick all day on Saturday with nausea and headache. She could not sleep. On Sunday, she felt worse and called ambulance. They came and checked her out. Said Oxygen level was normal and all her symptoms were normal side effects. They did not take her to the hospital. All day Sunday, she continued to be agitated and not able to get comfortable. She was hot and cold, back and forth. Her headache was very bad and she felt like she would throw up, but only threw up a little that day. By Monday, she started not making sense and slurred her words. We thought this was due to lack of sleep (exhaustion). Her sugar was high, so we gave her an insulin shot. She continued to make less and less sense so we called 911 approximately 7 PM on Monday night. She was hallucinating. At the hospital, they looked for infection, but could not find any source of infection. They intubated her and soon after this, her heart stopped breathing. They performed CPR 3 times, but not successful. She died at 5 AM Tuesday morning.

mini stroke; high blood pressure; difficulty recalling word; dizziness; no control over body; Shaking Arms; weakness; right side jaw pain; soreness; exhaustion; throbbing; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Feb-2021. The most recent information was received on 12-Jul-2021 and was forwarded to Moderna on 12-Jul-2021. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (mini stroke) and HYPERTENSION (high blood pressure) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016ZMOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced HYPERTENSION (high blood pressure) (seriousness criterion medically significant), MEMORY IMPAIRMENT (difficulty recalling word), DIZZINESS (dizziness), DYSKINESIA (no control over body), TREMOR (Shaking Arms), ASTHENIA (weakness), PAIN IN JAW (right side jaw pain), PAIN (soreness), FATIGUE (exhaustion) and HEADACHE (throbbing). On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (mini stroke) (seriousness criterion medically significant). The patient was treated with ALPRAZOLAM (XANAX) at a dose of UNK, qd. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (mini stroke), HYPERTENSION (high blood pressure), MEMORY IMPAIRMENT (difficulty recalling word), DIZZINESS (dizziness), DYSKINESIA (no control over body), TREMOR (Shaking Arms), ASTHENIA (weakness), PAIN IN JAW (right side jaw pain), PAIN (soreness), FATIGUE (exhaustion) and HEADACHE (throbbing) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication detail 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. Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: follow up received and Updated reporter contact information. On 01-Jul-2021: The follow up document contain no new information. On 12-Jul-2021: Added newserious event (transient ischaemic attack).; 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.

May 11, 2021 SOB began at am upon waking. May 13th doctor was contacted and a chest x-ray and blood draw was obtained. Results of the D-dimer were elevated and the doctor ordered a CT scan for the morning of May 14th, 1 hour later doctor called and wanted patient to go to ER as a large blood clot was noted on the CT in the pulmonary artery. Patient went to ER and started IV Heparin and was sent to Hospital for admit over night there obtained and ECHO and more blood work which was inconclusive in determining why she got the clot.

04/21/2021- First thing in the morning, walked to the bathroom, a few feet from bed, and passed out, hitting my head, lips cut, head cut, bruises on the side of my face, not sure what I hit when I landed. I did not call 911, I called for help and went downstairs and stayed downstairs for 3 days, I had fatigue and pain from injuries, I remained in a state of lethargy and pain for a week following this event. I let my Doctor know the day after I passed out 04/22/2021. May 9th, 2021, I passed out again and went to ER. May 11th, went to doctor she told me to have someone with me all the time . May 12th, 2021 I went into hospital at 10:00AM and I was hospitalized for observance until May 14th, 2021. My heart was stopping for a few seconds and then on May 14th, 2021, it stopped for 21 seconds. On Friday May 14th, 2021 they put a pace maker in me but I had no prior heart issues. I was released on May 15th, 2021. I have had 5 different appointments including a stress test since the pace maker implant. On Friday July 23rd, 2021 I had thyroid lab work and it is finally starting to stabilize.

Vaccine Candidate received vaccine approxat 2:30pm, was monitored for 15 min no complications at the time, went home. Around 5:30pm while walking into her home she became unresponsive, was assisted in a siting position, became incoherent, mumbling and started to convulse to the right side of her r upper extremity. Foaming at the mouth and stopped breathing, CPR was initiated for 1-2 min, EMS arrived was transported to Medical Center. She was admitted and is currently hospitalized. MD reports this event is highly unlikely related to the vaccine given her medical history but suggested to report being its a new vaccine. Current status: stable.

Patient received her first dose of the Moderna COVID-19 Vaccination on Saturday January 16th 2021 at approximately 12pm. She completed all necessary screening forms and was deemed to be at low risk for serious allergic reactions. She tolerated the vaccination well, and no complications or immediate adverse events occurred. She was observed for a full 15 mins per CDPHE/CDC guidelines and left the Clinic in stable condition after her observation period was complete. On the morning of Tuesday, January 19th, 2021, the patient was found unconscious and unresponsive by her husband. She was transferred by Ambulance to Hospital shortly thereafter. She was diagnosed with a brain bleed that was determined to be inoperable. She was transferred to other Hospital for higher level care. She was seen by neurosurgery and diagnosed with a ruptured aneurysm. She was treated in the ICU for 24 hours, at which point her team determined that the severity of her brain bleed would not respond to treatment. Supportive cares were withdrawn on Wednesday Jan 20th, and she passed away shortly thereafter.

2ND ACHY. DAY AFTER INJECTION. RAN FEVER 101.6. BECAME CONFUSED. GROUND GLASS COUGH, VENTRICULAR TACHYCARDIA. ADMITTED TO HOSPITAL. IV STEROIDS,AND ANTIBIOTIC STARTED. CHANGED TO PO AFTER 3 DAYS. PT IMPROVED. COUGH RESOLVED PT SENT HOME WITH ORAL STEROIDS AND ANTIBIOTICS FOR 3 DAYS.

anaphylactic shock 30 minutes after receiving shot with tongue swelling, air passage swollen shut, and unable to breathe. received 2 epi pens shots and large shot of Benadryl from paramedics. I am still having AFTER EFFECTS 1 week later. Heart still races and blood pressure drops.

Pt with h/o myasthenia gravis presents to ED with 3 week h/o worsening weakness. Unclear exact timing on onset relative to vaccine administration but appears to have been a few days later. During these 3 weeks, patient also diagnosed and treated for a UTI but patient had worsening of weakness leading to falls x2 a few days before presenting to hospital ED. On admission to hospital, pt diagnosed with myasthenic crisis treated initially with non-invasive mechanical ventilation and plasmapheresis. DDx included UTI with encephalopathy and confusion related to it.

On 3/4/21, @ 2:pm, I had a very severe pain between my shoulder blades that took my breath away, that radiating to the front of my check. I put an aspirin under my tongue, walked around and had some water. Pain kept getting worse. My husband drove me to the ED got there at 4pm. They took blood, did chest x-ray, ekgs. Blood work showed my Troponin level @ .11 and later elevated to 2.1. My blood pressure was 215/99, temp 97. I started having pain in my right shoulder & right wrist. I was diagnosed with a slight heart attack. On Friday, 3/5/21, facility did an angiogram, which showed my arteries were clear, no blockage or plaque, no heart damage. Did show it appeared the arteries had gone into a spasm which may have caused the heart attack. I saw my primary Dr on Monday, 3/8/21, and she said I have no history of heart problems, no high cholesterol, etc. I asked her if this could be a side effect of my vaccine. Dr. said it was a good question & she didn't know the answer, since not all the research has been done. She suggested I submit my question to VAERS! I'm now taking Aspirin 81 mg, daily, Bisoprolol 5 mg Tab, Losartan 25 mg Tab, DOK 100 mg Cap.

The patient presented to the off complaining of feeling weak in the legs on Monday, March 1, 2021. She had been moving over the weekend and was over-exerting herself and stated she had fallen on a rug at the old house and then had lain down on the floor to sleep with her dog in the new home, had difficulty getting up and needed help. No symptoms of fever, chills, sweats, headache, myalgias. The next day she passed away at her home, sitting in her chair.

A high risk employee received 1st vaccine dose of Moderna through the Health Center (HC) on 2/1/2021. This patient was seen as an employee only and was not established patient of the HC. The patient reported "having symptoms of Bronchititis" on 2/5/2021 prior to being hospitalized for 7 days (2/5/21 to 2/12/21). On 2/12/2021, an ER visit at Medical Center & transported to General Hospital on 2/13/21. On 3/11/2021, we were notified that the patient died on 3/10/21.

Note: after giving shot nurse said WOOPS - blood dripping down my arm. 4 hours later arm VERY sore. 6 hours later arm VERY VERY sore. No sleep, hot and cold flashes, significant aches esp. in legs (even my eyeballs hurt!). Pain resolved by AM. Next day arm got a bit itchy. 3 days later arm itched like I had poison ivy and fingers / hands had pain and joint swelling. Used a prescription steroid cream on arm and that resolved itching. Hands, fingers took 10 days to return to normal. All in all 14 days to recover completely from 2nd Moderna Covid shot.

Patient is a 70 year old female that is post-menopausal. Her first Moderna vaccine dose was given on 2/4/21. Exactly one week later on 2/9/21, the patient had vaginal bleeding that lasted one day. There were small clots in the blood that was discharged. The patient went to the doctor where a urinalysis was performed. The patient had a positive urinalysis and was started on antibiotics. The patient's second dose was on 3/4/21. Exactly one week later on 3/11/21, the patient had vaginal bleeding that lasted a day. Patient usually takes aspirin 81mg daily, however she stopped this medication prior to both doses being administered. She restarted the aspirin after each Moderna dose.

Two week after receiving the Moderna vaccine, patient started to have a high fever, body aches all over, coughing, congestion, and oxygen levels would not remain stable. On 3/15 she was admitted the hospital. She is still currently in the hospital and her blood oxygen levels remain around 80. She has fluid in her lungs and around her heart. Her liver enzymes remain highly elevated.

The next day, I had short term memory loss. I went to the hospital, and they said I had some type of heart episode. I was taken by ambulance to the hospital and was told I had a blood clot in my brain and had suffered a mini stroke. I was hospitalized for 4 nights. I was given blood thinner and I improved.

Symptoms began 2 hours after dose, including headaches, myalgias, and lower extremity weakness. Tried Tylenol with no relief. Symptoms progressively worsening. Fell and hit head the following day, denied loss of consciousness. Never had a reaction to vaccine before. No response to first dose. No lightheadedness/presyncope prior to falls. Came to ED after fall (evening of the day after receiving the vaccine). Found to have elevated troponin. CK elevated, aggressive fluid repletion initiated, determined to be in rhabdomyolysis. Hypokalemic. Patient improved with fluids and electrolytes, determined to be stable for discharge after 2 days.

Vibrating from my waist to my neck; Atrial fibrillation; Really tired; Felt lousy; Extreme thirst; I've lost 8 lbs from the last month or two; A spontaneous report was received from an consumer concerning a 70 years old, female patient who experienced atrial fibrillation, tired out, vibrating from waist to neck, felt lousy, extreme thirst and lost 8 lbs last month. The patient's medical history was not provided. Concomitant product use was none by the reporter. On 01 Feb 2021, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: 027L20A) in left arm for prophylaxis of COVID-19 infection. On 01 Mar 2021, prior to the onset of the symptoms, the patient received the second of two planned doses of mRNA-1273 (Batch number not provided) in left arm for prophylaxis of COVID-19 infection. The patient experienced the events tired since an unknown date in Feb 2021; vibrating from my waist to my neck, atrial fibrillation, felt lousy, extreme thirst and lost 8 lbs last month all since 06 Feb 2021. The patient was hospitalized on 06 Feb 2021 and was discharged on 07 Feb 2021. Laboratory investigations included echocardiogram which "turned out ok" and EKG "was ok" both performed on an unknown date in Feb 2021. Treatment for the event included diltiazem and Eliquis both since an unknown date for an unknown indication. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable. The outcome of the events felt very tired, vibrating from my waist to my neck, atrial fibrillation, felt lousy, extreme thirst and lost 8 lbs last month were 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.

R subclavian occlusive DVT, currently on oral anticoagulation with xarelto Symptoms: discoloration/swelling of R arm Symptom with vague onset, starting ~3/8/21

illness and very very sick; Death; A spontaneous report was received from a lawyer concerning a 70 or 71-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who died following illness. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on an unspecified date. On an unknown date, approximately 24 hours prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) via an unknown route for prophylaxis of COVID-19 infection. Within 24 hours, of vaccination the patient got very ill and sick and on the 4th day patient went to have a shower and found dead by patient's husband. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the event, illness and very sick was unknown. The patient died on 13 Mar 2021. The cause of death was unknown. Plans for an autopsy were denied due to COVID-19 relation and are reporting to Moderna. Autopsy was not performed.; Reporter's Comments: This is a case of death in an 70/71-year-old male subject with unknown medical history, who was sick from day 1 and died on day 4 after receiving first dose of vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death

2/10/21- RECEIVED MODERNA; 2/11/2021- FEVER AND FATIGUE; 2/19/2021- CHEST PAIN AND SHORTNESS OF BREATH; 2/20/2021- CONTINUED CHEST PAIN AND SHORTNESS OF BREATH- ER VISIT (ADMITTED FOR PULMONARY EMBOLISM); 2/23/2021- DISCHARGED FROM HOSPITAL TO HOME

Atrial fibrillation; A spontaneous report was received from a consumer concerning a 70 years old female patient who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced Atrial fibrillation. The patient's medical history was not provided. Concomitant medications reported included LEVOTHYROXINE(75mcg daily), HYDROCHLOROTHIAZIDE(25mg daily), CO Q10(200mg daily), VITAMIN D (2000iu daily), VITAMIN, RESTORE VITAMIN, BIOTIN (5000mcg daily), NEXIUM(daily), ATIVAN(0.5mg as needed for sleep), METFORMIN (500mg three times daily), METOPROLOL ER (25mg daily), ELIQUIS( 5mg twice daily), POTASSIUM CHLORIDE ER (10meq twice daily). On 05 Feb 2021, prior to the onset of the event, the patient received the first of two planned doses of mRNA-1273(Lot number: 010MZ0A ) vaccine intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 05 Feb 2021, patient reported that 3-4 hrs later she had Atrial fibrillation where her heart rate reached 170. She went to the ER and they were able to convert within a couple of hours. Patient reported that she had no prior history. The event was considered to be medically significant. Treatment for the event included Metoprolol ER 25mg daily. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the event Atrial fibrillation is 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.

Patient tested positive for Covid on 3/12/21 per hospital admission notes. Patient was admitted to the hospital on 3/16/2021 with Covid pneumonia. She passed away on 3/22/21.

Blood Clot in Leg; A spontaneous report was received from consumer concerning a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood clot in leg. The patient's medical history was not reported by the reporter. Concomitant medications taken by the patient included blood thinners for blood clot. On 21-Jan-2021, the patient received her first of two planned doses of mRNA-1273 (Lot number: 013L20A) through intramuscular route on left upper arm for prophylaxis of COVID-19 infection. On 18-Feb-2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Lot number: 013M20A) through intramuscular route at right upper arm for prophylaxis of COVID-19 infection. On 23-Jan-2021, after the first dose patient developed leg pain. The patient reported of having the leg pain linger for about 2 weeks before seeing a healthcare professional. The healthcare professional had later found that the leg pain was related to the development of a blood clot. Relevant Treatment for the event was with blood thinner. The patient received both scheduled dose of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable. The outcome of event, blood clot in leg 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 events, a causal relationship cannot be excluded.

Post-Vaccine onset of 30 minutes. Difficulty breathing, mild tongue swelling, coughing, wheezing, difficulty speaking, flushing. Self-Injected EpiPen Xopenex 1.25mg/3mL solution Famotidine 20mg tablet Diphenhydramine 50mg Adrenalin 1mg/ml (0.5mg)

On 3/15/2021 pt was trying to use her computer when she started having problems with her vision. She noticed her left hand was clumsy and awkward. Her left leg would not operate properly. She could not swallow pills with water and her speech was slowed and slurred. She went to the Hospital ER. They did MRI, CT, blood test that showed she had a small stroke. She was released to go home to do physical therapy and speech therapies. She has both of these scheduled and will follow up w/ PCP on 4/23/2021.

Her leg started bothering her, the pain was quite heavy and consistent; pain under her left arm; blood cloth in her leg; a little nauseous; headache; tired; pins; A spontaneous report was received from a consumer concerning a female patient of 70-years-old, who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced Pins/ Paraesthesia,nausea,tiredness,headache,pain in leg was quite heavy and consistent, blood cloth in leg, pain under left arm. The patients medical history was not provided .Concomitant medications reported included Eliquis starter pack twice a day,Latanoprost for Glaucoma,Omeprazole for heart burn. On 15 Jan 2021,prior to the onset of events, the Patient received their first of two planned dose of mRNA-1273(Lot number: 037K20A) vaccine via unknown route for prophylaxis of COVID-19 infection. On 12 Feb 2021,prior to the onset of events, the Patient received their second of two planned dose of mRNA-1273(Lot number: 024M20A) vaccine via unknown route for prophylaxis of COVID-19 infection On 12 feb 2021,That evening she got pins again.The next day she was a little nauseous, tired and had a headache. Her leg started bothering her 3 days to a week after the second dose.And the pain in her leg was quite heavy and consistent, she thought it might be her sciatica. She went to the doctor and ended up getting a doppler and they discovered a blood clott there. She had never had a blood clott before in her life.she was feeling pain under her left arm as well. No Treatment for the event was provided. Action taken with the mRNA-1273 in response to the event was not applicable. the event pins were considered resolved on 13 Feb 2021. The events nauseous,tiredness,headache were considered resolved on 14 Feb 2021. The outcome of the events pain in leg was quite heavy and consistent, blood cloth in leg, pain under left arm 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 these events, a causal relationship cannot be excluded.

She bled down her arm like she never bled before; Warm to touch; Tender to touch; Red warm 3inches round under the skin; Rash; Pain in arm; This spontaneous case was reported by a 70-years-old female consumer who received first dose of mRNA-1273 and experienced event rash. The consumer's medical history was not provided. Relevant concomitant medication was reported as acetylsalicylic acid (aspirin) for an unknown indication. On 14-JAN-2021, prior to the onset of the events the consumer received first of two planned doses of mRNA-1273 (batch number: 041L20A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 23-Jan-2021, the consumer experienced the event rash. Treatment information was not provided. The action taken with mRNA-1273 in response to the event was unknown. The outcome of event was unknown. The follow-up was received on 27-Jan-2021 and it included that the consumer had experienced events she bled down her arm like she never bled before, pain in arm, red warm 3inches round under the skin, warm to touch and tender to touch. On an unknown date, the consumer experienced the event she bled down her arm like she never bled before. On 14-JAN-2021, the consumer experienced the event pain in arm. On 23-Jan-2021, the consumer experienced the events red warm 3inches round under the skin, warm to touch and tender to touch. Treatment information was not provided. The action taken with mRNA-1273 in response to the events was unknown. The outcome of events was unknown. The follow up information was received on 27 Jan 2021. The outcome of rash (unknown), erythema and pain (recovered) of extremity was updated.; Reporter's Comments: This case concerns a 70 Y/O F with a serious unexpected event of hemorrhage, and nonserious unexpected pain in extremity, feeling hot, tenderness, and expected erythema, rash. Event onset on Day 1 after first dose mRNA-1273. Event outcomes unknown. 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.

Blood clot in the lung; A spontaneous report was received from a consumer concerning a 70-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood clot in the lung/ Pulmonary thrombosis. The patient's medical history included hyperthyroidism. Products known to have been used by the patient, within two weeks prior to the event, included levothyroxine for hyperthyroidism. On 10 Mar 2021, approximately five days prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Batch number not provided) via unknown route for prophylaxis of COVID-19 infection. On 15 Mar 2021, the patient developed a medically significant event of blood clot in her lung and was hospitalized for 2 days followed by short of breath and cannot walk very far. Treatment for the event included blood thinner. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event, blood clot in the lung/t Pulmonary thrombosis was not provided.; 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.

Pt. states she started to spit blood approximately 12 hours after Covid 19 vaccines. It happened both times. 1st dose given on 2/25/21, reporting second dose from 3/25/21 because pt. sought ER care at . She states the blood was coming from throat area, not vomiting. She just spit out blood and blood clots. Dr. will send her to ENT to rule out lesion.

Death; had vomited and was found unresponsive and covered in stool, intubated and then went in to PEA in the field and passed despite lengthy resuscitation.

Patient admitted with encephalopathy, rhabdomyolysis, lactic acidosis, troponin elevation. Note the presence of other medications, ie ambien and neurontin that may have contributed to her illness

Community Acquired Pneumonia in left lower lobe with no evidence of plural effusion, negative for pneumothorax; got really run down; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Community Acquired Pneumonia in left lower lobe with no evidence of plural effusion, negative for pneumothorax) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Pneumonia. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PNEUMONIA (Community Acquired Pneumonia in left lower lobe with no evidence of plural effusion, negative for pneumothorax) (seriousness criterion medically significant) and FATIGUE (got really run down). At the time of the report, PNEUMONIA (Community Acquired Pneumonia in left lower lobe with no evidence of plural effusion, negative for pneumothorax) had not resolved and FATIGUE (got really run down) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Chest X-ray: abnormal (abnormal) Community Acquired Pneumonia in left lower lobe with no evidence of plural effusion, negative for pneumothorax. On 26-Mar-2021, SARS-CoV-2 test negative: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Based in the current information and the 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 in the current information and the temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.

She was admitted at hospital on 3/9/21-3/11/21 due to ischemic stroke which she received TPA and mechanical thrombectomy for L MCA M1 occlusion. Her symptoms include aphasia, R facial droop, R side weakness. Patient report no residual deficits.