Moderna

I woke up at approximately 4:00 am with an extremely dry mouth. I went into the bathroom and took a drink of water. I returned to bed. I noticed that my breathing was becoming more rapid. I had trouble catching my breath. I sat up on the side of the bed. My heart was pounding and quick. My breathing was difficult. I woke up my wife. After about 5 minutes my symptoms improved. She took my pulse which was now at 62ppm. I laid back down in a reclined position. My symptoms of difficulty breathing and elevated heart rate quickly returned. My pulse was now up to 98 ppm. I sat up again. My symptoms gradually improved. Being unsure of what was going on my wife called 911. The ambulance arrived in about 8 minutes. I was about 60% better. Vitals were improving other than my blood pressure which was 180/100 Being unsure of what was happening, I was transported to Hospital. I had a chest x-ray, a chest CT scan with contrast to rule out a blood clot, blood work including tests to rule out MI x2. All test were negative. By about 6:30 am I was feeling at least 80% better. My breathing I felt had returned to normal. My pulse was down into the 50"s which is my normal range.

1305: vaccine administered 1312: Client reports facial numbness, feeling faint, short episode of shortness of breath x 1 min that resolved already, O2: 97%, P: 74 1315: Given life savers candy, BP 142/82 LA, Temp 98.1, Lungs CTAB 1317: States that he is no longer feeling faint but still has lip numbness, capri sun given 1325: Client states he is feeling better 1335: Client feels ok to drive. Released from clinic

1. Incontrollable Shaking of body and limbs-- for 2 days, 2. Migraine, Body aches, Stomach Cramps, Cough, Shortness of breath, Chills, Heavy chest, Hives, Soreness at injection site --all for 9 days

Back and neck stiffness, trouble swallowing, tongue thickness, facial twitch, and shortness of breathe.

Low grade fever (99...typical is 96-97 for me), intense lower back pain and headache. Also, lethargy and a heaviness to my breathing when exercising.

Pain in wrist immediately after injection blurry vision an hour and half after injection brain fog, flushed face, feeling of swollen face, shortness of breath about throughout the night and into the next morning along with elevated blood pressure.

Approximately 5 hours after my injection, I started to feel fatigue. Went to bed, awoke around 0039 1/26/2021 with mild shortness of breath and slight chest pressure. Around 0500 I started with chills, muscle, joint, bone pain. I went back to bed and awoke around 1200 with throat tightness, SOB, chest pressure and diaphoretic accompanied by the other symptoms. I went to my local ER.

Early the next morning I had a red rash on my chest and the back of my shoulders. It really itched and I went to the Doctor. They gave me anti-itch stuff from the injection. Then my Lymph nodes swelled up in my throat. I went home and took my medicine and the itching stopped in about two days.

On evening of vaccine, patient developed arthralgias,right eye felt irritated, 30% vision loss with blurring . During the night, developed fevers, chills, substernal chest pain with radiation towards his back and bilateral arms. mild SOB. Next day, continued chest pain/angina, worsened with climbing a flight of stairs. Admitted to ED/ICU 2/16, general myalgias, Temp 100.7, CP 1/10 on arrival to ED. Small abrasion to right eye noted after flouroscein stain.

"I can't breathe." Removed face mask. Pulse 120. BP 140/80. 100% pulse ox. Underlying cardiac issue, so medics transported to hospital.

Heart palpitations; shortness of breath; dizziness; hands shaken. Events lasted about 3 minutes. Then disappeared. They checked my blood pressure and it was elevated 155/110. High blood pressure remained for 2 days.

Patient had vaccine and waited the 15 minute waiting period. He felt well after 15 minutes and left the observation waiting area. He went up front to purchase something 5 minutes later and collapsed face first on the floor as observed by a nearby customer. The customer said he started having convulsing seizures and the customer went to aid in keeping the patient safe. the pharmacy manager (myself) was alerted and I immediately ran upfront to the patient with the emergency bag. 911 was already on the cashiers phone. They dispatched an ambulance. The only treatment was keeping the patient on his side and safe. He was having some labored breathing initially which quickly calmed down. The EMT arrived and they called his Dr office off the VAR. They said he had some hx of seizure. He had selected no to question #6 on VAR (Have you had History of seizure for which you are on medication for). He became conscious before transport to the hospital. The EMT stated that he seemed to be covering as expected from seizure. He was then transported to Hospital Center.

Vomiting, diarrhea, shaking, difficulty breathing, OSat down to 90, whole body sensitive to touch, pain in left arm

pt states he felt fine until about the 10th day 3/8/2021 he started getting flu like symptoms. He has SOB, diarrhea, headache, sweats, muscle pain, cough, chills, and fever. On 3/11/2021 pt is still having these symptoms but is feeling a little better. Pt is taking Robitussin, Aleve, Vicks Av.

At clinic, patient complained of nausea to RN at Obs station #1. She was walking him to bathroom outside Obs station #2. Pt complained of lightheadedness. Supervisor, grabbed chair out of Obs #2 and asked us for help. I came on seen found pt diaphoretic, pale, shaking. Said he was nausea. given trashcan. Asked his history.Said he had a similar rx after having a flu vaccine in the past and Gallium Injections for cardiac condition. Asked meds. Told me he takes Propanlol for Afib and SVT. Has a low heart rate normally. Heart was very week. HR52. Asked supervisor to call 911. BP tried by one nurse and unsuccessful. I tried and got a 90/52. Pt then stated he was SOB and felt difficultly breathing. Attempted pulse ox. Unable to get reading. Place him on o2 at 10l fase mask. Ask to prep benedryl. Pt said he had benedryl in past and it made symptoms worse. He said breathing was improving. Still very cold with chills. BP rechecked 102/60 Hr 68. Wife was standing by. Patient was slowing improving. Color in face improving, reported nausea was gone. Still unable to get a pulse ox. Heart rate at wrist very hard to palpate.Increased O2 to 15L with face mask. No medication was given, only O2. EMS on seen, reported & assisted him to gurney. Gave his wife his apple watch.

Date & Time started: 3/09/2021 2300 Itchy 3/09/2021 2300 dizzy 3/10/2021 0100 headache 3/10/2021 0100 eye pain 3/10/2021 0130 Fast heartbeat 3/10/2021 0130 Difficulty breathing; Shallow breathing 3/10/2021 0130 Severe Chest pain pulsing to left arm 3/10/2021 0130 Tremors 3/10/2021 0130 weakness 3/10/2021 0130 blurred vision right eye 3/10/2021 0130 joint and muscle pain whole body 3/10/2021 0130 cramping 3/10/2021 0130 nausea all continued through the 10th; Dizziness, headache, eye pain, tremors, weakness, blurred vision right eye, joint pain, and nausea continued through the 11th but got better by the evening. Weakness and blurred vision still present on the 12th.

Muscle neck and right arm became very tight and knee joints hurt started at 8 pm one day after .. My wife systems much worse fever, breathing Nausea headache. this lasted for two days no energy confusion sweats

about ten hours after injection chills then fever then difficulty breathing sinuses draining couldn't slrrp took benadryl called 911 they came and took my vitals highblood pressure a fever of 101 it wasn't to bad so they left i stayed awake all night and started to feel better the next day

3/4/21 out of breath , peaked 3/08/21. 3/09 pain in right lower leg Hospitalized 4 days - 5 hour procedure for Acute DVT and Acute Saddle pulmonary Embolus

patient stated experienced "labored" breathing and he took himself to the ER. did not experience rash, itching, hives, swelling of mouth, lips, or throat. Pt is also experiencing severe nausea and headache. Patient was instructed if continued to experience labored breathing to reach out to his primary care provider or seek medical attention. Patient did not have any reaction to first dose in series.

Before administration patient was given handout regarding Moderna information and read through handout patient denied any previous adverse reactions to vaccines and consent was signed. Patient received vaccine at 1407. Around 5 minutes after administration the nurse was notified that patient was "not ok". RN quickly assessed patient and called for help. At first assessment, patient was having involuntary movements and delayed verbal response to questions. Shortly after he began labored breathing and became unresponsive. He continued having involuntary movements in bilateral upper extremities. He did not respond to sternal rub. At that time EMS was called. BP was 50/32 in right arm with HR of 52 and O2 saturation of 93% on room air. EMS arrived to the clinic approximately 5-6 min after patient began having adverse reaction. EMS took over care at that time. He was then transferred to ED by ambulance for further evaluation.

The day after the shot 3/9/2021 pt had 104 degree fever and shortness of breath and chest pain. This continued for a couple days. By 3/13/2021 pt went the hospital and he was confirmed to be having an active heart attack.

This is a 60-year-old male who comes in today (3/22). Patient states that he received a Covid shot 11 days ago since then he has had mild fevers. However 6 days after he received his Covid vaccine he developed a fever of 102 he has been alternating between Advil and Tylenol without any improvement of his symptoms. Patient states that he now is having a difficult time breathing he has some nausea without any vomiting but has had a difficult time eating without any abdominal pain no diarrhea. Has had generalized myalgias as well. He denies any large cough states that he is coughing a little bit. No chest pain. Patient tested positive for Covid 19. Is now admitted and on oxygen.

PATIENT EXPERIENCED EXACERBATION OF ASTHMA SYMPTOMS. HE NEEDED TO USE HIS INHALER MORE OFTEN, AND WAS WOKEN UP FROM SLEEP WHEEZING (WHICH IS NOT NORMAL FOR HIM). HE WAS ABLE TO CONTROL HIS SYMPTOMS WITH HIS INHALER, AND HE STILL WANTS TO RECEIVE HIS SECOND DOSE.

Moderna COVID-19 Vaccine EUA The day of the shot I started having difficulty breathing and fatigued. As time went on, it got worse and I had to go to hospital on 03/25.

4 days after the vaccination I started having breathing problems and a racing heart. I first went to Urgent Care and they sent me to the E.R. immediately. They x-rayed my chest and ran 3 EKG's which all came out normal. However, they wanted to check my into the hospital to run a heart stress test the next day. I chose to go see and cardiologist and a pulmonary specialist. Those are appointments are being scheduled.

1- On Day one few ours after the 2nd shot, I had my heart flutter and lost by breath few times, next day was gone. 2- Knee joint pain and tendons pain still ongoing was very hard to walk. Improving very slowly. 3-Felt like I had the flue the next day with a headache, flue like symptoms gone within 2 days, however I am on week 3 with a non stop headache. I usually never have a headaches, and now I have it every day and night since the 2nd shot.

Opposite arm pain. Then chills and pain in all joints and muscles. It lasted all night following injection. The next few days I felt tired and easily out of breath.

Vaccine administered at 11:00 am at 11:10 client reported throat and tongue tingling, dizziness and difficulty breathing. Administered 1 mg epinephrine. EMS was called and transported client to the hospital where he was admitted under observation.

At 10:40pm, i was awakened by a high heart beat, approx 86 while sleeping, then had very short breath which i had to deep breath for about 2.5 hours , plus shakes, headache , and body aches, after about 3-4 hours i fell back to sleep and the next day at 12 noon, Everything was back to normal and totally fine.

Patient with prior Covid infection Nov 2020, fully recovered, received first dose Moderna vaccine on 3/13/21 and next day developed body aches, fevers, chills, shortness of breath. Admitted 3/17/21 due to hypoxia, had ground glass opacities on CT. SARS-CoV-2 PCR negative x 2. Vigorous immune response could have caused lung inflammation and hypoxia, similar to a covid infection, but from the vaccine. 60YM with a history of a chronic inflammatory arthritis on methotrexate, hospitalization in November 2020 with Covid pneumonia, he was discharged on 1 to 2 L of home oxygen, and reports that he was told by his PCP about a month after discharge that he was able to come off the oxygen as his oxygen saturations had normalized. He returned to his usual state of health and activity with no issues until he received the first dose of his Moderna covid-19 vaccine through his primary care office on 3/13. The next day he developed arm pain and then progressive body aches, headaches, fevers, chills, and shortness of breath. He presented to the ER and was found to be febrile with hypoxia and admitted for treatment and evaluation. Acute hypoxemic respiratory failure with ground glass opacities on CT : oxygen 87% on RA in ER, 84% on room air 3/19, resolves with oxygen support of 2lpm. CTA was negative for pulmonary embolism. SARS-CoV-2 PCR negative x2 as well as respiratory virus panel, CT shows ground glass opacities, patient was started on ceftriaxone and doxycycline for empiric treatment for possible community-acquired pneumonia, although procalcitonin was negative. BNP was elevated at 458, so an echocardiogram was performed which showed a normal EF, and grade 1 diastolic dysfunction. Patient was given 2 doses of furosemide during the hospitalization and BNP normalized. Patient was started on prednisone to calm down a possible inflammatory response triggered by the COVID-19 vaccine in a person who likely already has antibodies, causing hypoxia. With this patient significantly improved and at discharge is on room air at rest, but still requires 2 L/min with exertion. CRP was markedly elevated, supporting an inflammatory process. Autoimmune lung disease panel was sent and is in process at time of discharge. Patient requested discharge home, Discharged on a slow prednisone taper to avoid rebound with abrupt discontinuation of steroids. Patient will complete 2 additional days of Augmentin and doxycycline at discharge.

Woke up and walked down stairs 12:30 pm Wednesday with shortness of breath, walked back upstairs 1:00 pm, slept 45 minutes, waled back down stairs, watched TV from sofa in family rm, at 4:00 pm attempted to get up to go to the bathroom and fell. Help from partner to get to bathroom and back to sofa. It was getting more difficult to shift body on sofa, no strength in arms or legs. Spent night on sofa, slept from 2:00 am until 2:00 pm Thursday. Getting up 11:00 am with help to go to bathroom. During the rest of the afternoon and evening slowly regained strength and improved breathing. Went to bed upstairs 2:00 am Friday. Woke up Friday 2:00 pm and felling much better.

Received vaccine, and hour later felt nauseous and dizzy, went home, laid down and had shallow breathing, next day(3/24/21) couldn't do much, fatigued, legs felt like giving out, midnight on 25th he jumped out of bed to check on animals before he made it to the door he felt really bad and had to sit down, wife checks him and speech was slurred, face was droopy, 40m later went to emergency room, emergency room said he was fine in grants. Hospital said he had a stroke possible bell's palsy. Still not doing well headaches, right side of body weak, blurry vision which is getting worse, one day doing well next moment he's not.

Got the shot Thursday. On Friday I had no energy, and was finding it hard to breath. My upper chest became very congested Saturday night I was very crackly in my chest and could not take a deep breath. On Saturday it was so bad, I thought I had Pneumonia bad. I called my doctor and they require a Covid test before I could get an X-ray. Of course I live in Oregon where there are plenty of providers near by giving FREE RAPID COVID TESTS, Every single damn one required a Doctor's consultation and APPROVAL before I could get the free test. So I waited until Monday to take the test, I got the results on Thursday. By Monday all symptoms including my chest congestion.

Patient presented to hospital on 4/9 with worsening dyspnea on exertion and fatigue and brown colored urine. Patient was diagnosed by hematology service with warm autoimmune hemolytic anemia (Evan's disease). It was refractory to high dose steroids, rituximab, cyclophosphamide and required splenectomy. He has required multiple blood transfusions.

Throat tightness, metal taste in mouth. Patients blood pressure and pulse ox remained normal throughout and there were no signs of oral or facial edema and no signs of accesory breathing. Given epinephrine and benadryl on site

Afib and now an irregular heart rhythm, a never before heart arrhythmia.. Also newly diagnosed PVC.. And constantly breaking out in cool clammy sweats and shortness of breath. Never had this issue until 2 weeks after my first moderna vaccination

Difficulty breathing due to heart pounding and could not walk more than 50 feet. Had ECHO yesterday 4/26/21, which revealed inflammation. Provider recommended waiting to do second dose for now.

After second dose 3/10/21 started having chills, myalgia. On 3/24/21 hospitalized with respiratory failure, kidney failure, heart attack, sepsis and liver malfunction. Had subsequent GI bleed

Asthma symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Asthma symptoms) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. medical history of patient was not provided by the reporter. On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced ASTHMA (Asthma symptoms) (seriousness criterion hospitalization). On 23-Apr-2021, ASTHMA (Asthma symptoms) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing was delayed on an unknown date. No treatment information was 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.

I haven?t had the chills like that in forever! It came in waves. You just lie there, hot, and ache all over, then this wave of chills hits for maybe 5 seconds then dissipates. The 2 mins later, it happens again! And this goes on for an hour or more! I had to pee but was worried I?d be too cold to stand still. So I waited until I could not wait anymore. OMG! Trying to stand up! It?s as if my joints no longer worked! And when I did stand up I was dizzy as hell! The next day, utter exhaustion. I am so weak, it takes effort to move. Even breathing took work! I didn?t sleep all night as every position I lay in was uncomfortable and had twinges of chills. The amount of energy it takes to physically get up and walk to the bathroom is dumbfounding! This morning I am achy, hot and cold, exhausted, and just had a bout of dry heaves. I?m hoping to be able to get some sleep today.

Patient stopped breathing five days after the vaccine (5/29/21) He was taken to Hospital by paramedics and was put on ventilator in Intensive Care. They took him off the ventilator and he died 6 days after (5/5/21).

presented with chest pressure and difficulty breathing 4/15/21, eventually admitted 5/6/21 for pericarditis with atrial flutter. No PE on CT chest

The morning of April 13,2021, I was taken to the emergency room with heart attack like symtems. After blood test a CT was done and multipul blood colts were found in both my lungs. I was then placed on blood thinners a low salt diet. I remained in the hospital until the April 16,2021.

Patient said had covid19 last august. He said that he was hospitalized. He said he was followed up for cardiac issues, now they are follow up with his lungs, because he said he is winded. He said after the vaccine he had a rash on his arm that had cleared up. He said he was fatigued and winded. He said that the symptoms are still off and on.

Several days after vaccine administration patient developed shortness of breath, orthopnea, tachycardia, leg swelling, cough. Seen by Cardiology outpatient, had Echo which showed EF 15%. Admitted to medical center. Patient diagnosed with myocarditis post vaccine administration by ID.

5/16- symptoms started- cough, fever body aches. admitted 5/19 with SOB in addition. COVID pnuemonitis, 5/23-sudden decrease in saturation - placed on BiPAP and transferred to the ICU. further decline and arrested on 5/27. PEA and agonal breathing. intubated and ACLS meds given. Coded a second time and family elected to halt heroic measures.

Two weeks after the shot, light dry cough. cough turned into shortness of breath. Left foot started to burn. Ringing in both ears. Breathing is better now, but not normal. Left foot still burns and ringing in both ears. Sparkles in eyes/may not be related. Hospital said could not say if symptoms were vaccine related. I have a kidney problem, the Doctor at hosptial said to follow up with primary care physician

Patient is a 60-year-old gentleman with a history of tonsillar and skin cancer with mets to the lymph nodes status post chemotherapy and radiation, BPH, hypertension, hyperlipidemia, and CKD stage 4. Patient presented to the emergency department for complaint of dizziness x4-5 days with diarrhea x3 days and syncope today , pt noted hypotensive in ER but per ER physician not orthostatic, Dr spoke with pt oncologist and seems his Blood cell count close to his baseline, but his baseline creat 2.1 so does have acute on CKD and dehydration. pt noted COVID 19 positive and cxr suggestive covid pneumonia, his cxr was better couple of days ago when pt wasin ER as well. pt did recived his covid vacine 1st dose on Saturday. He finished his chemo on May 13th.

1st dose vaccine, I had very typical reactions- redness and soreness at the injection site, muscle aches and low grade fever. It went away a couple of days and I am fully recovered. The 2nd dose vaccine (IM RA)-I had the same reactions as the 1st dose. About 8-10 days after, I started having SOB, coughing and chest congestion. I went to urgent care and got a covid test (negative) and got a Chest x-ray which came back positive for viral pneumonia. I was prescribe amoxicillin, albuterol inhaler, Codeine base cough medicine, and prednisone. I am fully recovered from my viral pneumonia.

Within 20 minutes of receiving the vaccine, I was experiencing extreme shortness of breath, my entire body hurt and I was dizzy to the point that I could not stand up without holding onto something. Since the injection, I have felt nauseous everyday, I cannot concentrate, I become fatigued just standing up. It's been almost six weeks since the injection & I still do not feel right. I fall asleep whenever I sit down and I've fallen asleep while driving.

Had a seizure, 2 other reactions like seizures; Could not breathe, has breathing problems; Was really sick; could not get out of bed for 4 days; shoulder pain; muscle pain; Felt a little nauseated; Is really fatigued, tired; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Had a seizure, 2 other reactions like seizures) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure high, Diverticulitis, Narcolepsy and Vertigo. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-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 SEIZURE (Had a seizure, 2 other reactions like seizures) (seriousness criterion medically significant), DYSPNOEA (Could not breathe, has breathing problems), ILLNESS (Was really sick), MOBILITY DECREASED (could not get out of bed for 4 days), ARTHRALGIA (shoulder pain), MYALGIA (muscle pain), NAUSEA (Felt a little nauseated) and FATIGUE (Is really fatigued, tired). At the time of the report, SEIZURE (Had a seizure, 2 other reactions like seizures), DYSPNOEA (Could not breathe, has breathing problems), ILLNESS (Was really sick), MOBILITY DECREASED (could not get out of bed for 4 days), ARTHRALGIA (shoulder pain), MYALGIA (muscle pain), NAUSEA (Felt a little nauseated) and FATIGUE (Is really fatigued, tired) outcome was unknown. The patient's medical history also included an unknown syndrome (could not understand the name). Concomitant product was not reported. The patient had experienced shoulder pain, muscle pain, fannnnd had elt a little nauseated. Three and a half weeks after having the second shot , he had a seizure, was really sick, could not breathe (started after he got the seizure), and it was horrible. At the time of the report, the patient continued to have muscle pain and everything, predominantly in his upper chest, and has breathing problems; he had never smoked or anything. He also had 2 other seizures like reactions. He was really fatigued and tired. He could not get out of bed for 4 days. He went to doctor but was given no aditional treatment. At some point after he had the seizure, the patient saw his doctor. Treatment was not reported. Very limited information regarding this event (seizure) 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 all other events, a causal relationship cannot be excluded. Details regarding diagnostics, doctor's notes from the clinic visit/ treatment are required for further assessment.; Sender's Comments: Very limited information regarding this event (seizure) 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 all other events, a causal relationship cannot be excluded. Details regarding diagnostics, doctor's notes from the clinic visit/ treatment are required for further assessment.

I woke up with a sore throat on 06/11/2021 at 6:00AM. I woke up coughing and it felt like a burning sensation in bronchial tubes and a tightness and I thought I had Covid. and I thought I was getting sick and it went into my sinuses. I had a really bad pressure in sinuses and mucous. I waited 20 days bc I thought I had a cold. I felt tired. I went to urgent care and they did rapid Covid test that was negative and they put me on Dicloxacillin and I was feeling better within 3 days.

60-year-old male with complaint of palpitations and shortness of breath since 3 days ago after getting his 1st Moderna COVID vaccine. He states that the palpitations started right when they put the needle in his arm. He states that he does have some history of anxiety and depression but that this feels different.

Delayed anaphylactic reaction. Evening of receiving injection he didn't feel well, oxygen dropped to 80s on pulse ox and patient self administered epi pen at home and went back to sleep. Later this happened again and he developed throat closing and gave himself a second shot. He went to the ER the following day 7/26/21 where he received treatment with dexamethasone, pepcid, and benadryl. He also had labwork completed, EKG, and Chest xray. He did well with treatment and was discharged home.

Next day. 12/31/20 - severe muscle pain myalgia, could not ambulate well 1/1/21 - chills severe shaking chills N/V & diarrhea severe shivering, freezing causing difficulty breathing lasted 1/2 hour

Tightness in chest several times about 1 week and 2 weeks after 1st round. Difficulty sleeping on left side 20 and 21 days following 1st round. Severe pain with inhaling AM of 22 day. Diagnosed at ER Hospital, with DVT left calf and PE both lungs. On Heparin IV for 4 days inpatient. Now on Eloquis 10mg BID for a week, 5mg BID thereafter.

5 minutes after injection, patient started complaining of sever chest pressure, shortness of breath. EKG was done and EMS was called. Patient was transported to ED since he continues to exhibit shortness of breath and still complaining of chest pain/pressure.

Pt started to have restless leg symptoms (which he only feels at night) 15 minutes after vaccination. He also started to have muscle twitching and a visible tremor. He developed some subjective SOB, RR30. Lung sounds clear. His BP was 179/80. He was given water and monitored for 45 minutes, at which point his RR was 16 and BP dropped to 160 systolic. Tremor cleared up. RLS symptoms resolved. He was sent home with education to go to ED with worsening symptoms.

2/20/21-61 year old male with decreased level of consciousness and hypoxia. I received a call from nursing staff indicating that patient was having low oxygen saturations this AM and required oxygen. He needed only 1.5-2L by NC but was mouth breathing so mask was used and 4L due to mask. This brought his saturations back up. He has been quite drowsy since receiving his second COVID vaccine on 2/17/21 and has not been eating and drinking much. Today he is not responding to nursing staff in a coherent fashion. I met with him in his room along, RN. He did not wake to my voice or touch. On examination he is sleeping and using accessory muscles to breath, especially his abdomen. NC/AT, face symmetric. Lungs are clear to auscultation bilaterally anteriorly with no wheeze heard. No pretibial edema. 61 year old male with decreased level of consciousness. I will send patient to the ER due to his decreased level of consciousness and difficulty with breathing causing accessory muscle use despite normal respiratory rate of 17 but with hypoxia. I do believe his fever of 103 this AM was due to the COVID vaccine. I am concerned that he could be having a COPD exacerbation on top COVID vaccine symptoms and his bladder cancer is dragging him down along with dehydration from poor intake the past few days. I did call and speak with the ER provider and the EMS crew. They reported seeing a lot of this with the second COVID vaccine. 2/21/21-I received a call from nursing staff indicating that patient had worsening hypoxia with need for 8L of oxygen by mask. He was very restless and not making a lot of sense. He had receive Tylenol PR for a fever of 103 that was now only down to 101 and not budging. He was in the ER yesterday and diagnosed with possible Right middle lobe pneumonia on CT. He is already taking Levaquin. Due to his Oxygen need I did call to see about possible direct admission as he had a full work up the day before. The hospitalist was concerned that he might need BiPAP and so I did call and speak with the ER provider and she agreed that due to his new oxygen requirements he should be sent to the ER there and likely would need ICU. She was advised of the work up from yesterday so as not to repeat what wasn't needed. He was sent by ambulance due to his inability to sit up well. I received a call later that night from the intensivist in the ICU indicating that patient was reacting to the COVID vaccine most likely. He felt that there really was not much in the way of a pneumonia diagnosis as that has really not shown up on their imaging and all labs are normal including white count, CMP and blood gases. He is still requiring oxygen and is able to answer in sentences but is very drowsy and may be a bit confused. He has a minimal UTI and they will keep him given his low level of consciousness and hypoxia.

Fever, extreme aches, shallow breathing, dark urine, fatigue, joint pain. Patient had had Covid three months prior (mid-November). Vaccine side effects were the same as when he had Covid and lasted 36 hours.

Patient was unable to get out of bed the whole day and missed all three meals. Patient had a fever of 100.6 and had generalized weakness and malaise. Patient was also confused. Patient was experiencing tachypnea and shallow breathing.

Had COVID vaccine on 02.11.21. States the next morning his anxiety was very high. States he did not know who he was. Still experiencing a lot of anxiety at night. Admits to heart palpitations and hard time breathing. Can't sit still. Reports manic episodes and cycles of depression over the course of hours. Patient states it has gotten a tiny bit better. Tried trazodone which helps temporarily. Denies chest pain. Patient states he has no appetite. Palpitations resolved pretty quickly. Shortness of breath is described as tightness that comes with anxiety feeling. Resolves with shoulder massage. Occurring three times per day. Also admits to dry mouth. Patient admits to needing to sleep with multiple pillows or feeling like he had to sit up and couldn't lay down as shortness of breath would get worse. EKG in office on 2/24/21 showed ST-T changes and given symptoms patient was transferred to emergency room via ambulance. Work up in hospital was unremarkable and patient was diagnosed with pericarditis (unknown etiology) and prescribed NSAIDS from ER and discharged. Admission not required. Patient followed up to us as outpatient on 03.02.21. Patient felt much better and had not take motrin for 1 day. COVID testing obtained at this point (unclear why ER did not send it). Patient referred to outpatient cardiology given risk of cardiovascular disease, stress echo, and event monitor.

EMS reported sudden onset of shortness of breath, patient grabbed his chest and collapsed. He stopped breathing. Wife began CPR with chest compressions at 5:00. Fire dept. arrived resumed CPR and attached AED but there was no shock advise. They placed an OPA as well (inserted an airway) and started ventilation. Asystole was confirmed, they continued CPR. After 5:25 they gave 3 rounds Epineferin and ended CPR at 5:46. They also checked his blood sugar and it was 136. Possible reaction to covid vaccine. Possible death due to history of cardiac issues. His PCP is requesting an autopsy

Client phoned; C/o face swelling; trouble breathing; dizziness and weakness. 911 phoned for client home address; client refused medical care/ambulance service.

A few minutes after client received the vaccination he felt light headed, dizzy, chest pain, disoriented, throat discomfort, and difficulty breathing. Was transported to Medical Center for further evaluation.

Patient complained of tightening of throat and tingling of the lips, stated it feels "similar to a reaction to a bee sting". A doctor was notified, and ordered sublingual Zyrtec be given, 10mg of Zyrtec given sublingually. Symptoms resolved and patient was discharged from clinic.

After first shot in series, I developed slight headache, minor weakness, minor shoulder pain. After second shot in series, 8 hours post-injection, I developed headache, moderate to severe joint pain throughout, fever around 100, extreme fatigue and weakness, slight difficulty breathing. Went to bed for 19 hours and began to feel better with recovery in two days. 14 days post-injection, I developed a systemic rash throughout my body. Consulted with my PC physician. Was prescribed Medrol Dose Pack. This had very minor effect on rash. Returned to physician for consult upon completion of steroid series. I then received a steroid shot intramuscular in right hip and one week oral steroid protocol. This achieved a more positive result, almost clearing up the rash. I had a consult with a dermatologist on 03/02/2021 who confirmed the opinion that the rash was probably a side effect of the Moderna vaccine. The rash has returned fully as of 3/14/2021.

The night of my vaccination I went to bed early. I was tired and a little achey. I woke up about 2:00 AM with significant discomfort in my chest. My chest felt heavy and when I inhaled it felt like someone was squeezing both lobes of my lungs. I got out of bed and went to the bathroom to urinate. I went back to bed and tried to get back to sleep. The discomfort in my chest continued and seemed to get worse. I got back out of bed at about 2:45 AM and went downstairs where I walked around my living room to see if that would help me feel better. I continued to feel severe discomfort in my chest and lungs. I did not otherwise feel bad. I was not congested. I could still take a deep breath but it hurt to do so. I took my temperature and I did not have a fever. At about 3:00 AM I woke up my wife and she drove me to the emergency room at Medical Center. On the car ride to the hospital I started to feel much better. By the time I checked into the emergency room most of my discomfort had dissipated and only a very slight feeling of heaviness remained in my chest.

I had Covid in November and was told that there was a high probability that I would get sick but was not prepared for this. It is like I am sick all over. Fever, no taste (It all reminds me of cardboard), exhausted, sleeping, no appetite, mild nausea, headache, winded easily

Woke from sleep at 12:45 a.m. on 3/19 with severe pain at injection site. Got up to urinate and take Tylenol. While in bathroom, became dizzy, broke into sweats, and felt I was about to faint. I went to my knees holding onto counter. My wife came in to help me in bathroom. She observed I was incoherent but uttering moaning sounds and breathing heavily. She called 911. While on phone I came to and vomited into sink. It appeared I had not digested anything from dinner that night. After vomiting (1x) I felt much better. First responders reported normal vital signs. I did not go to E.R. that night but went to Urgent Care later that morning and all seemed fine.

experienced extreme shortness of breath a day or two after receiving 2nd COVID-19 vaccine. Breathing became worse at night, more so in reclined position than upright. Thinking it was a vaccine side effect waited for it to subside, when it did not sought medical attention. Doctors determined to be acute congestive heart failure exacerbation. Treated with diuretics and blood pressure medications. Hospitalized from 3/14/2021 to 3/19/2021.

Rapid heartbeat that lasted one (1) minute +/-. Slight swelling in throat for maybe 45 minutes +/-. Was able to breathe fine.

Foggy headed, sometimes a little dizzy, off balance Fatigue More aches and pains than usual sometimes a feeling of shortness of breath

Pt was treated in the emergency department for pleuritic chest pain, pneumonia, and nonspecific left greater than right lower lobe ground glass opacities found on CT scan on February 27, 2021 beginning at 1826.

Lungs filling up with fluid; Cannot move; Uncontrolled diarrhea and uncontrolled bowel movements; Vomiting; A spontaneous report was received from a consumer concerning a 61-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lungs filling up with fluid/pulmonary edema, uncontrolled diarrhea/diarrhea, vomiting, cannot move/mobility decreased, uncontrolled bowel movements/bowel movement irregularity. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 16 Mar 2021, prior to the onset of the events, the patient received their doses of mRNA-1273 (Batch number:unknown) for prophylaxis of COVID-19 infection. On 16 Mar 2021, within 12 hours of vaccination, the patient experienced lungs filling up with fluid, uncontrolled diarrhea, vomiting, cannot move and uncontrolled bowel movements. Treatment information was not provided. Action taken with mRNA-1273 in response to the events were not reported. The outcome of events, lungs filling up with fluid, uncontrolled diarrhea, vomiting, cannot move and uncontrolled bowel movements, were 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.

Pt presented to clinic today for his 2nd dose Moderna vaccine at approx 1033. Pt was brought back to conference room and was given his 2nd dose Moderna vaccine at approx 1040. Pt reported no allergies to medications, no severe allergic reaction in the past. Pt states doing fine with the 1st dose of the Moderna vaccine. Pt was waiting his observation time of 15 min and began itching face, arms, and legs. Nurse questioned pt if he was feeling ok? If he is itching? Pt reports that he is itching but he has some anxiety but that he is hanging in there. Nurse offered pt some water. Pt declined. Pt started clearing throat and coughing. Nurse questioned pt if he was still feeling ok and again offered pt some water. Pt declined. Pt reports that he is feeling ok. Pt's timer alarmed and pt got up ready to leave. When asked if he is doing ok, pt reports that he is. Nurse questioned pt if his cough is normal for him and pt reports that he has asthma and proceeded to walk out. Pt was escorted by nurse. Nurse questioned pt again if he is feeling ok. Pt states that he is. Nurse notifies pt that if he not feeling ok then he should come back. Pt states understanding and exits building. Nurse seen pt returning back to clinic from window. Nurse meets pt upon entering building. Pt reports trouble breathing. Nurse observes that pt has voice change, trouble completing sentences, cough is worsening, and itching is intensified. Pt grabs the wall while ambulating. Nurse provided stand by assist. Nurse immediately escorts pt back to exam room and gets assistance from nursing staff and provider presents to exam room immediately. Crash cart arrives. Epi 0.3mg autoinjector administered IM to LT at approx 1100. IV NS ordered. At approx 1104 pt O2 sat of 98% on RA, HR 96. Approx 1105 Duo Neb administered via nebulizer mask as ordered. Approx 1107 IV inserted to RAC with 18g on 2nd attempt. Approx 1108 Diphenhydramine 25mg/0.5ml administered IV as ordered. SoluMedrol 125mg/2ml administered IV as ordered. Pt O2 sat 97% on RA, HR 102. Approx 1110 pt BP 140/85, O2 sat of 93% on RA. Pt has coughing spell. EMS was called. Approx 1113 pt O2 sat 90% on RA. Ongoing coughing spell. Approx 1114 O2 2L administered via mask as orderd by provider. Pt's wife contacted via pt's cell phone. Approx 1116 Epi 0.3mg administered IM to LT as ordered. Pt O2 sat 97% on 2L O2, HR 87. Pt reports itching getting worse. Approx 1121 Diphendydramine 25mg/0.5ml administered IV as ordered. Approx 1123 pt O2 sat 97% on 2L O2, HR 119. Approx 1125 EMS arrived. Approx 1127 BP 183/75. Pt taken by ambulance with EMS to ER at approx 1135. Report called to ER by provider. ER transfer form faxed to ER.

On 3/1/2021 patient came to hospital as an outpatient for labs and CT chest after being seen in local clinic with dyspnea. Pt had received first Moderna vaccine 1/14/2021 Lot # 141L20A and second Moderna vaccine 2/11/2021 Lot # 010M20A

61-year-old white male received his second Moderna COVID-19 vaccine at 0910 and at 0945 he became slightly vertiginous and noticed poor balance and on both sides of his face and both sides of his upper neck became. He felt like there was some swelling of his lips and tongue and he notes some trouble swallowing and states his throat feels "tight". He denies lateralizing neurological signs, specifically denying tingling or numbness or weakness of extremities. He had no trouble with his vision or cognition. He had no trouble with the previous vaccine. Presently the symptoms are resolving. Feeling better with less sensation of neck and facial swelling and numbness as well as decreased vertigo after 1 dose of Benadryl. Time: 11:23

4/1/2021 Shivers/Shakes at about 10pm, Fever was high 102+, after midnight began vomiting for along period and until empty. Chills continued with fever thru the night. 04/02/2021: The next day had severe headache and fever all day. Went to bed at 10pm and woke the next day feeling much better. 04/03/2021 Weak all day but headach was gone. Had some shortness of breath for almost a week.

He was given the Covid vaccine at a pharmacy and not at my office. 4 days after the vaccine he noticed discomfort in the right calf. Initially he dismissed it but then gradually the calf started to swell. Once he noticed some shortness of breath he decided to come into the office. He was seen on 4/12/21 and diagnosed with a pulmonary embolism. He was then admitted to Hospital for IV therapy and monitoring.

During the middle of the night after receiving the vaccine, woke with chills and other flu-like symptoms such as fatigue and body aches into the next day. Had some chest congestion into the next day. Advil tylenol and allegra to get through the symptoms. Slept for most of the day the following day.

I was taken to emergency room following day for complications from vaccine, symptoms included shortness of breath, extreme joint pain. I was given a course of steroids antiflamitories and was released next morning. I have full report from Hospital ER. I can provide report if requested.

Received Moderna Covid Vaccine on 3/3/21 and 4/8/2021. Nted onset 4/24 of right calf discomfort, swelling and firmess and at same time began to have exertional dyspnea with chest heaviness. U/S RLE - extensive DVT. CTA - multiple segmental vessels with clot, dilated right ventricle

after 15 min observation period the patient began to feel tightness in his throat and lightheadedness. Initial vitals- BP- 160/85 HR-65 RR- 20 T-97.3 O2Sat 100% on room air. lungs clear to auscultation. patient in no respiratory distress, postenior pharynx/ Uvula without swelling vital signs prior to being transferred to ER: BP-147/72 P-65 02SAT- 100% on room air RR-20

Covid-19 J96.90 - Respiratory failure (CMS/HCC) N39.0 - Urinary tract infection A41.9 - Sepsis (CMS/HCC) U07.1, J12.82 - Pneumonia due to COVID-19 virus

right leg DVT and bilateral pulmonary embolisms. Symptoms of cough, chest pain and dyspnea on exertion started on (about) 4/19/21. Patient presented to urgent care on 4/26/21 and again on 4/30/21 at which time the diagnosis was made.

This 61 year old male received the Covid shot on 4/08/21 and went to the ED on 4/24/21 with shortness of breath and was admitted on 4/25/21 with the diagnoses listed below. U07.1, J12.82 - Pneumonia due to COVID-19 virus

32 hours after the vaccine, he suffered a massive heart attack due to a blood clot and a massive clot in the right arm. He went to the hospital and under went surgery at 12 am on Saturday. The coronary surgeon mentioned that this was not from heart disease as all vessels were clear. Rather, this was due to an embolism due to an unknown origin. A further work up concluded that he also had blood clots throughout his body (both lungs, one kidney, heart, liver, legs, arms, and possibly brain). By 12 p.m. we were asked back to the hospital as he was worsening. Treatment options included a heparin drip, which caused a brain hemorrhage. He was just at the doctors two times this week, on Tuesday and Wednesday and was fine no issues found. They went through with the 2nd dose and came to our home on Thursday.

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was respiratory failure with hypoxia due to COVID-19 infection.

This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), ASTHMA (Asthma) and DYSPNOEA (Difficulty breathing which started in the morning and got worst by evening / Barely catch his breath) in a 61-year-old male 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. The patient's past medical history included Heavy smoker in 2020. On 01-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) (unknown route) 1 dosage form. On 02-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). On 03-May-2021, the patient experienced PRURITUS (Feeling scratchy). On 04-May-2021, the patient experienced CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) (seriousness criterion medically significant), ASTHMA (Asthma) (seriousness criterion medically significant), DYSPNOEA (Difficulty breathing which started in the morning and got worst by evening / Barely catch his breath) (seriousness criterion medically significant) and WHEEZING (Wheezing sounds). On 02-May-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) had resolved. On 03-May-2021, PRURITUS (Feeling scratchy) had resolved. On 06-May-2021, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), ASTHMA (Asthma), DYSPNOEA (Difficulty breathing which started in the morning and got worst by evening / Barely catch his breath) and WHEEZING (Wheezing sounds) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, Oxygen saturation: 91 Low. On 03-May-2021, the patient was feeling scratchy and mentioned it could be due to pollen. On 04-May-2021, he was experiencing difficulty breathing, which began in the morning and exacerbated by the evening. He had wheezing sound and by 6 PM he could barely catch his breath. He got breathing treatment using nebulizer and his oxygen level was 91. By 8 PM he went to the ER and underwent tests. He was diagnosed to have Asthma and COPD. Treatment: Inhaler, nebulizer and steroid. 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.

APPROX 12 HOURS AFTER 2ND SHOT, AT 1 IN THE MORNING, WOKE UP GASPING, THEN WENT FOR APPROX 8 HOURS CONTINUOUSLY GASPING AT EVERY BREATH, SHORT AND QUICK BREATHS. SEEMED LIKE I NEVER FEEL ASLEEP UNTIL GASPING SUBSIDED AT BOUT 7 THE NEXT MORNING. TWO DAYS LATER STILL ACHY AND LIGHT HEADED.

patient was not concentrating well and asks not to be asked too many questions; it does not let him walk almost; he can walk indoors and he runs out of oxygen, he use oxygen all the time; lot of back pain; sweats a lot, when he is not cold he sweats a lot; arm pain; tired/exhausted; lost consciousness/couldn't even remember the days; woke up all the time, he could not breathe/breathing like panting; woke up very bad; patient had no balance; did not feel well; got very hungry; got very thirsty; sneezing; started to feel silly; running nose/running nose was getting stronger and stronger; patient has been dead for two or three days day and night; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (lost consciousness/couldn't even remember the days) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Emphysema and COPD. On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced HUNGER (got very hungry), THIRST (got very thirsty), SNEEZING (sneezing), FEELING ABNORMAL (started to feel silly), RHINORRHOEA (running nose/running nose was getting stronger and stronger) and UNEVALUABLE EVENT (patient has been dead for two or three days day and night). On 27-Apr-2021, the patient experienced DYSPNOEA (woke up all the time, he could not breathe/breathing like panting), MOOD ALTERED (woke up very bad), BALANCE DISORDER (patient had no balance) and MALAISE (did not feel well). On 28-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (lost consciousness/couldn't even remember the days) (seriousness criterion medically significant). On an unknown date, the patient experienced DISTURBANCE IN ATTENTION (patient was not concentrating well and asks not to be asked too many questions), GAIT DISTURBANCE (it does not let him walk almost), OXYGEN CONSUMPTION DECREASED (he can walk indoors and he runs out of oxygen, he use oxygen all the time), BACK PAIN (lot of back pain), HYPERHIDROSIS (sweats a lot, when he is not cold he sweats a lot), VACCINATION SITE PAIN (arm pain) and FATIGUE (tired/exhausted). At the time of the report, LOSS OF CONSCIOUSNESS (lost consciousness/couldn't even remember the days), HUNGER (got very hungry), THIRST (got very thirsty), SNEEZING (sneezing), FEELING ABNORMAL (started to feel silly), RHINORRHOEA (running nose/running nose was getting stronger and stronger), MOOD ALTERED (woke up very bad), BALANCE DISORDER (patient had no balance), MALAISE (did not feel well), DISTURBANCE IN ATTENTION (patient was not concentrating well and asks not to be asked too many questions), GAIT DISTURBANCE (it does not let him walk almost), OXYGEN CONSUMPTION DECREASED (he can walk indoors and he runs out of oxygen, he use oxygen all the time), BACK PAIN (lot of back pain), UNEVALUABLE EVENT (patient has been dead for two or three days day and night) and VACCINATION SITE PAIN (arm pain) outcome was unknown and DYSPNOEA (woke up all the time, he could not breathe/breathing like panting), HYPERHIDROSIS (sweats a lot, when he is not cold he sweats a lot) and FATIGUE (tired/exhausted) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. Treatment medication included acetaminophen for arm pain and a lot of back pain and other medications included Steroids and oxygen. Concomitant medications included High blood pressure medicines, high blood sugar medicines ("under control"), cholesterol medicines and medicines for his lung disease. 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.

Went in to physician due to shortness of breath. Found pericarditis. The physician went in to do a pericardial window and the patient experienced bleeding so the surgeon had to perform a sternotomy to determine where the bleeding originated. Once the chest was opened the surgeon noted a mass that appeared to look like a fungus on the heart. Biopsy of the heart mass, pericardial fluid and a mass on the liver were performed. The biopsy results originally came back as adenocarcinoma of the urinary (bladder, kidneys) origin. The physicians noted that that would be highly unlikely since there were no tumors noted in the urinary area. Pathology was sent off again from the pericardial fluid that was obtained by "extracting RNA from tumor enriched sections. This pathology showed the cells to be squamous cell carcinoma with 90% probability of coming from the lung. The doctors are finding this very unusual . My husband was very healthy prior to this with no symptoms. Could this be caused by the vaccine?

Losing breathe; Paralysis of face; Bells Palsy; Guillain-Baire syndrome,; Numbness in hands; Could not swallow; Tingly in hands; Impaired vision; Speech impairment; Could not walk; Paralysis in his head from neck up.; Pneumonia; Totally impaired; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (Paralysis in his head from neck up.), PNEUMONIA (Pneumonia), DYSPNOEA (Losing breathe), FACIAL PARALYSIS (Paralysis of face), BELL'S PALSY (Bells Palsy), GUILLAIN-BARRE SYNDROME (Guillain-Baire syndrome,), HYPOAESTHESIA (Numbness in hands), DYSPHAGIA (Could not swallow), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Totally impaired), PARAESTHESIA (Tingly in hands), VISUAL IMPAIRMENT (Impaired vision), SPEECH DISORDER (Speech impairment) and GAIT DISTURBANCE (Could not walk) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Plasmapheresis in April 2021, Feeding tube insertion in April 2021, Tracheostomy tube insertion in April 2021 and Mechanical ventilation in April 2021. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PARALYSIS (Paralysis in his head from neck up.) (seriousness criteria hospitalization, disability, medically significant and intervention required), PNEUMONIA (Pneumonia) (seriousness criterion medically significant), DYSPNOEA (Losing breathe) (seriousness criteria hospitalization, medically significant, life threatening and intervention required), FACIAL PARALYSIS (Paralysis of face) (seriousness criterion hospitalization), BELL'S PALSY (Bells Palsy) (seriousness criterion hospitalization), GUILLAIN-BARRE SYNDROME (Guillain-Baire syndrome,) (seriousness criteria hospitalization, disability, medically significant, life threatening and intervention required), HYPOAESTHESIA (Numbness in hands) (seriousness criteria hospitalization and medically significant), DYSPHAGIA (Could not swallow) (seriousness criteria hospitalization and medically significant), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Totally impaired) (seriousness criterion disability), PARAESTHESIA (Tingly in hands) (seriousness criterion hospitalization), VISUAL IMPAIRMENT (Impaired vision) (seriousness criterion hospitalization), SPEECH DISORDER (Speech impairment) (seriousness criterion hospitalization) and GAIT DISTURBANCE (Could not walk) (seriousness criterion hospitalization). At the time of the report, PARALYSIS (Paralysis in his head from neck up.) had not resolved and PNEUMONIA (Pneumonia), DYSPNOEA (Losing breathe), FACIAL PARALYSIS (Paralysis of face), BELL'S PALSY (Bells Palsy), GUILLAIN-BARRE SYNDROME (Guillain-Baire syndrome,), HYPOAESTHESIA (Numbness in hands), DYSPHAGIA (Could not swallow), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Totally impaired), PARAESTHESIA (Tingly in hands), VISUAL IMPAIRMENT (Impaired vision), SPEECH DISORDER (Speech impairment) and GAIT DISTURBANCE (Could not walk) outcome was unknown. Non-drug therapy included: The patient had 7 plasmapheresis, trachea to breathe, feeding tube and put on a ventilator. 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-2021-141559 (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.

Within 3 minutes of vaccination, pt began to feel lightheaded and was assisted to lie down on a cot. He c/o a "scratchy throat" and a little trouble breathing; he developed a rash on his neck. VSS were stable throughout episode with SpO2 95-99%. Pt was administered Benadryl 50mg po x once w/good effect. The reaction resolved and patient left for home after an hour.

Had shortness of breath and admitted to hospital for blood clot/pulmonary embolism on 4/28/21 * Hematologist suggested I should report for information purposes. Not stating this is believed to be the cause of the event - just reporting as requested

Moderna Dose 1 3/5/21 (029A21A) Moderna Dose 2 4/16/21 (027B21A) COVID Positive 5/20/21 5/20/21: Presented to ED. The patient presents with fever. 61 year old male presents to the emergency department for a fever with an onset of 1 day. Patient was diagnosed with pancreatic cancer in April 2021. Patient states he has had 2 rounds of chemotherapy but states he could not have his 3 round last week because his white count was too low. Patient is also complaining of dull chest pain that is exacerbated with deep breathing, cough, and a headache but denies vomiting, diarrhea, neck pain, dysuria, hematuria, and nausea. Patient was diagnosed with blood clots on 05/09/2021 but states that he is not having similar symptoms to when he was diagnosed with blood clots. Patient is taking Xarelto. He has never had COVID but is vaccinated. Patient sees Dr. (Name) at the UI Oncology clinic. 5/25/21: 61-year-old male on chemotherapy for pancreatic cancer, also recently diagnosed pulmonary embolism on rivaroxaban, presents with 1 day of fever. Initially, did not have any cough or shortness of breath, was admitted to the hospital, where a chest x-ray, urinalysis and examination failed to reveal an exact source of the fever. His absolute neutrophil count was less than 500, so he was admitted for neutropenic fever. Cultures were obtained. IV antibiotics started. COVID-19 was tested and, surprisingly, came back positive. The patient has actually had both of his COVID-19 vaccines and basically, does not have pneumonia, shortness of breath, or hypoxemia. We did not use any medications for COVID while in the hospital, watching for any signs of respiratory compromise, but none developed. Blood cultures were negative. He was switched from ceftazidime to doxycycline at time of discharge. Will follow up with Dr. (Name) for his next cycle of chemotherapy. Because of his COVID-19 positivity, we will not schedule any immediate followup appointments, although the patient will call if he has persistent fever, dyspnea, or signs of hypoxemia. For the past 2 days, the T- max has been 99.9, and most the time 98.6. He was seen the day of discharge, doing quite well. Blood pressure 153/80, pulse 90, regular, oximetry 95% on room air. Glucose was 210. Discharged on Rivaroxaban 15 mg b.i.d., doxycycline 100 mg b.i.d., Robitussin AC as needed for cough, Lantus 28 units at bedtime, atorvastatin 80 mg daily, aspirin 81 mg daily. The patient did get 1 dose of Neupogen 480 mcg subcu while in the hospital.

Shortness of breath, injection site soreness, fever, weakness, night sweats first night following injection and progressively worsened.

10 days post-injection, became very lethargic with discomfort in chest and shortness of breath. Reported to emergency room two days later, and admitted for cardiac tests, including echo and stress tests. Found to have high blood pressure, slight thickening of heart wall. Given prescription for high blood pressure and discharged next day. Subsequent follow up with PCP and cardiologist has focused on high heart rate and continued shortness of breath as of 6/11/2021. Condition seems to be improving, but slowly.

I had server chest pain. Slight SOB called 911 because of previous heart attack. They took me to the hospital. They did blood test, Chest x-ray, CT scan, Covid-19 (nasal and blood) and MRI. Covid-19 test came back negative. They told me it was not a heart attack. They said it might have been anxiety or tissue got stuck under rib. They did keep me overnight for observation.

My husband passed away June 3, 2021 resulting from complications which began a few hours after receiving his 2nd Moderna shot on April 29, 2021. He never tested positive for Covid19, however his first symptoms were the typical fever, muscle aches, rash. He declined daily from a host of mysterious symptoms including full body rash, blood clots, muscle spasms, atrial fibrillation, ulcers lining his esophagus and colon, and exorbitant WBC (157K) with extremely high eosinophils (90%). He was treated with a host of drugs including antibiotics, steroids, blood thinners, ivermectin and finally chemotherpay (Campath). His ICU team included hematology, pulmonology, ... oncology and infectious disease. After an incredible amount of diagnostic testing ( daily routine blood work, EKGs, chest x-rays, CT scans, MRI, bone marrow biopsy, endoscopy, colonoscopy, skin biopsy, genetic testing) no definitive diagnosis could be made, however, he was given the possible diagnosis of chronic eosinophilia leukemia in late May. The big question among the medical staff was, "Did the shot trigger something?" He was eventually treated with the chemotherapy drug Campath, which reduced the WBC and EOs some, but his organs, especially, lungs had been very compromised by the high WBC and eosinophils. Several days after being placed on a ventilator and given a feeding tube at the end of May, a CT scan and MRI confirmed patient had suffered multiple strokes. He passed away a half hour after being taken off the ventilator the morning of June 3, 2021. His death certificate read: A. cardiopulmonary arrest B. acute hypoxic respiratory failure C. hypereosinophila

rapid heart beat; Palpitations; Shortness of breath; Chest pain; Chest heaviness; Dizziness; Weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (rapid heart beat) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Liver transplant in 2011 and Cardiac ablation on 16-Jun-2021. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced ATRIAL FIBRILLATION (rapid heart beat) (seriousness criteria hospitalization and medically significant), PALPITATIONS (Palpitations), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain), CHEST DISCOMFORT (Chest heaviness), DIZZINESS (Dizziness), ASTHENIA (Weakness) and FATIGUE (Fatigue). At the time of the report, ATRIAL FIBRILLATION (rapid heart beat), PALPITATIONS (Palpitations), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain), CHEST DISCOMFORT (Chest heaviness), DIZZINESS (Dizziness), ASTHENIA (Weakness) and FATIGUE (Fatigue) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, Heart rate: high. On 15-Jun-2021, SARS-CoV-2 test: negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient had heart Ablation Surgery on 16/Jun/2021 at (Hospital name) as a treatment for atrial fibrillation. The patient had been tested for COVID-19 on 27/Jun.2021. No concomitant medication information was 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. However, very limited information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been request.; 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 is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been request.

Patient came to the ED with SOB, kidney pain, weight loss, and disoriented. CT scan and MRI showed portal vein thrombosis. Patient is still inpatient at Hospital. Patient unable to give lot number or date of vaccination.

Diagnosed with AFIB; rapid heart beat; Palpitations; Shortness of breath; chest pain; chest heaviness; Dizziness; weakness; ftigue; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Diagnosed with AFIB), HEART RATE INCREASED (rapid heart beat), PALPITATIONS (Palpitations), DYSPNOEA (Shortness of breath), CHEST PAIN (chest pain), CHEST DISCOMFORT (chest heaviness), DIZZINESS (Dizziness), ASTHENIA (weakness) and FATIGUE (ftigue) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Liver transplant and Cardiac ablation (Patient had heart Ablation Surgery on 16-06-2021) on 16-Jun-2021. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 14-Feb-2021, the patient experienced ATRIAL FIBRILLATION (Diagnosed with AFIB) (seriousness criteria hospitalization, disability, medically significant and life threatening), HEART RATE INCREASED (rapid heart beat) (seriousness criteria hospitalization, disability and life threatening), PALPITATIONS (Palpitations) (seriousness criteria hospitalization, disability and life threatening), DYSPNOEA (Shortness of breath) (seriousness criteria hospitalization, disability and life threatening), CHEST PAIN (chest pain) (seriousness criteria hospitalization, disability and life threatening), CHEST DISCOMFORT (chest heaviness) (seriousness criteria hospitalization, disability and life threatening), DIZZINESS (Dizziness) (seriousness criteria hospitalization, disability and life threatening), ASTHENIA (weakness) (seriousness criteria hospitalization, disability and life threatening) and FATIGUE (ftigue) (seriousness criteria hospitalization, disability and life threatening). At the time of the report, ATRIAL FIBRILLATION (Diagnosed with AFIB), HEART RATE INCREASED (rapid heart beat), PALPITATIONS (Palpitations), DYSPNOEA (Shortness of breath), CHEST PAIN (chest pain), CHEST DISCOMFORT (chest heaviness), DIZZINESS (Dizziness), ASTHENIA (weakness) and FATIGUE (ftigue) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Heart rate: high (High) High. Concomitant medication and Treatment medication use was not provided by reporter. Company Comment: Very limited information regarding this events has been provided at this time. Further information has been requested. This case was linked to MOD-2021-238357 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.

rib pain/shortness breath/Pulmonary Embolus and viral pneumonia Narrative: Development of symptoms beyond the 48-72 window. Tested at time of ER visit Negative for Covid. Repeated Covid NP swab on 01/05/2021. Was not hospitalized overnight discharge home on oral anticoagulant medications.

Headache, Myalgia, reports redness running down arm the afternoon of and today is feeling flush, and mild shortness of breath Narrative:

Systemic: Fainting-Medium, Systemic: Other- Pt felt sob and went to go get help, he fainted a while after. When EMS arrived he was feeling better, and was left at the facillity. Pt awaiting pacemaker, may have underlying condition. Symptoms lasted 1 day

High temperature, difficulty breathing pain in abdomen and ribs. Shallow breathing to try and avoid cough as it hurts so much. Temp in the middle of the night reached 102.4F Chills and uncontrollable shaking.

Narrative: Respiratory failure / respiratory depression went to ED / ICU 2/1/2021. Frail patient. 1st vaccine 12/23/2020 Moderna Lot 039K20A exp 6/20/2021, 2nd vaccine 1/20/2020 Moderna Lot 013L20A exp 7/8/2021

Almost immediate headache per wife. Developed fever around 4 pm. Headache all day. Took Tylenol at 4 and 10 pm. Gradual development of SOB and cough. Temp of 101.4 at 10 pm. pulse ox 92% at 10 pm. Went to sleep, woke up at 0050 with increasing SOB. Pulse ox 82%. Used albuterol inhaler, wife called emergency services at 0113. EMS arrived around 0130 to patient's home. pulse ox 86%, coughing, sob, hard time breathing. Walked to stretcher. Became unresponsive. Found to have no pulse, stopped breathing. CPR initiated at about 0140. King airway placed in field, I/O in left tibia. Patient from PEA to asystole, to vfib, to asystole. ACLS followed. Unrecoverable asystole and patient time of death 0213.

Body Aches and sore arm started 12 hours after vaccine was administered and still continues High Fever of 103 started 24 hours after vaccine was administered and still continues. Sweating profusely and confusion and chills Difficulty urinating started 12 hours after vaccine was administered and still continues Loss of appetite and fatigue SOB started 24 hours after and continues slightly

Approximately 18 hours after taking the vaccine I woke up with body aches and chills. I was also short of breath. The chills lasted approximately 3 hours. The body aches were not severe but lasted 24 hours, as did the shortness of breath. I did go to work on the the 18th (the morning after the shot), but had to leave work early because I was too short of breath to stand up for very long and I also had trouble focusing on my work.

Moderna COVID-19 Vaccine EUA 5-10 minutes after receiving the vaccine the following symptoms were experienced: Dizziness, weakness, brain fog, breathing difficulties, lowered O2 saturation, nausea, elevated BP and elevated / thready pulse. O2 was administered, I was placed in a response room and monitored by staff nurses (RN and LPN's) MD checked on progress. O2 saturation returned to 100% after 15 minutes and an EPI pen was determined to be not required. Walked out of the hospital 2 hours after administration of the vaccine.

After receiving the vaccine patient stated he felt really hot and felt he was going to pass out. Patient states he thinks it's because he is trying to breathe through to mask and a face shield. Patient also had gloves on and a heavy jacket. Patient started to become diaphoretic and appear to be hyperventilating. Once pt was removed from the area and masked and jacket was removed he immediately started to feel better. Patient breathing improved and skin became dry. Patient did says he was nervous because this is the first public event he has done since before COVID. Patient was observed for 30 minutes and then released.

The morning after the vaccine, the symptoms started with a stiff neck and headache on the left side including soreness at the injection site. As the symptoms progressed, I felt aching in my lungs on the backside, and flu-like symptoms with no fever, and spasms in my feet and stomach region. Other symptoms have been dizziness, facial puffiness and tingling, with continued aching and tingling in the left arm. The stiff neck and headaches and general malaise has persisted throughout even until now. As a school teacher, I have taken the appropriate precautions and received a Covid19 test: Results negative.

sudden death, while sleeping 2 days after injection Vaccine 3/12/21 last seen conversant and comfortable at 3a 3/14/21 Found nonresponsive and not breathing at 8:30a 3/14/21

,body aches,shortness of breath,pain and fog in brain, entire bone and joints shooting with pain couldn't sleep for,2 days, dizziness,etc etc

Pt developed a RT Leg DVT Deep Vein Thrombosis and Pulmonary emobolus. Started haveing symptoms of dyspnea. , low oxygen saturations in the 80s and RT pleuritic chest pains one week after getting the shot. He had never had a DVT or PE before. Was seen in Emergency on 03-23-2021 . He was admited on 02-23-2021. Started on anticoagulation and went to the cath lab to have intraarterial administration of TPA in pulmonary arteries.

Itching in 10 minutes followed by reddening of skin and red splotches, extreme headaches, body aches, fever, sweats, chills, cough, nausau, swelling of lymphs nodes in chest and groin, shortness of breath, and light sensitivity.

patient experienced shallow breathing, hives, sweating and low systolic blood pressure 85 within 5-10 minutes of receiving first moderna covid vaccine. Had pt lie down on his back and administered epinephrine 0.3mg on thigh within 5-10 minutes of monitoring pt. Patient became more alert and sbp came up to 110. EMT came and took him to er

About 10 minutes after I received the shot I was sitting in a chair and I started getting very hot, sweaty, and found like I was going to throw up. Started seeing stars, vision narrowing. I laid down on the floor, and it seemed like I was having a hard time breathing. The pharmacist came out and started talking to me. My wife happened to be there and was trying to calm me down. I felt like I was passing out. The pharmacist checked my BP and it was like 80 something. He felt I was having an allergic reaction so gave me a show with an Eppy pen. They called paramedics. I started feeling better but paramedics said I should still go to ER so ambulance took me to ER. They ran blood tests, EKG, and chest Xray. After a few hours they released me. They basically said that it was ok for me to get second shot, but obviously I am now extremely concerned out about getting it

Patient reported difficulty swallowing and stated he felt throat closing within 10 minutes of receiving vaccine.

Chest pains, shortness of breath, started 24 hours after 2nd injection, has continued for past 5 days

Day 1-body aches. Day 1/2-middle of night- high fever 101-102, extreme chills, labored breathing during night lasting approx 30 min,. Day 2 -High fever102 continued, extreme chills next day, body aches, SOB, cough Day 3 - 9am, fever broke, body aches, cough, headache, dizziness

Right hip pain lead to sciatica like nerve pain. Using ice and lidocaine to reduce pain. Severe, recurring nasal discharge and minor amount of sneezing first night after shot. After the discharge ended after a few hours I felt that my (prevaccine) sinus infection congestion in upper sinuses actually got better. I have taken a lot of prednisone for chronic sinusitis and asthma and after the vaccine (espec first night and second day) I felt similar (unable to sleep--jittery--flushed). Slight fever that never exceeded 100 degrees first night and second day. Normal temperature 48 hours later.

63-year-old male who complains of sudden mid upper back sharp tightness pain sensation worse with inspiration unlike pain ever felt before that occurred while he was exercising on the rowing machine earlier today. The patient denies any injury or fall and he does not take any anticoagulation therapy.

Throat infection swollen lymph glands neck Shingles outbreak right ear Difficulty breathing and swallowing

On day 4 following dose 2 of Moderna series, pt developed fever, chills, fatigue, malaise and self-medicated with ibuprofen and acetaminophen. After a "few" days of feeling unwell despite treatment, presented to ER and was found to have AKI, hyponatremia, and thrombocytopenia. Over the course of several days rapidly deteriorated and developed MSOF, including liver failure, DIC, respiratory failure requiring intubation, and shock requiring pressors. Workup for VTE, including V/Q scan, LE dopplers, and head CT negative for thrombosis. Ferritin was found to be highly elevated (12,000) suggestive of hemophagocytic lymphohistiocytosis (HLH). Per ER report, marrow positive for hemophagocytosis on smear. At time of report, transferred to Cancer Center for HLH treatment, currently in ICU, intubated, sedated, and on pressors. PF4 antibody pending.

Bleeding Gums, Rash, fatigued, shortness of breath, random joint pain, fever, chills, brain fog, electric shock in arms, left arm weakness. 2 emergency rooms, 1 walk in medical center, 1 doctor visit, cardiologist, rheumatologist. Extensive blood work at both ER's and Doctors, x-rays, EXG, cat scan. Yesterday received cortisone shot left arm. Presently on prednisone 2o mg 2x, hydroxyzine 25mg 2x bed, gabapentin 100 mgg 3x.

On 4-15-21, patient started having breathing problems and shortness of breath. He had a cough that he had productive phlegm. He continued to get worse. On 4-18-21, he fell getting out of the shower and slumped onto the floor, stating that he couldn't breathe. His wife and neighbor took him to the local ER. His condition improved with oxygen. He was admitted on 4-18-21 and then was transported by Air Evac to ICU. He was placed on the ventilator prior to leaving on 4-21-21 and transferred to hospital. His condition continued to deteriorate and he passed away on 4-25-21.

swelling of throat on both sides of lower neck base and slightly to the side on right and left side -- swollen and puffy -- does not go away , stays about the same in size .... and bad rash all over body that does not go away - sever itch ... doctors have no idea about swelling on base of neck and suggested we watch it ,,, so I have no confidence in what they say -- the same is true of the persistent rash that will not go away -- they prescribed some sort of cortizone cream and zyrtek ... another wrong diagnosis and treatment -- and my insurance does not cover these doctors visits because I have a high deductible and my employer does not offer health insurance -- Looking back , I wish I had never taken the vaccine .

Hospitalized twice 4/18-4/21 and 4/24-28: Flu-like systems for 6 weeks. Nausea, headache, dizziness, muscle ache, inflammatory markers CRP 23.6, ESR 97, Chest pain, shortness of breath, pericardial effusion, pleural effusion, A-Fib. Manually drained right pleural cavity 400 cc. Fluid came back. Was put on prednisone for 10 days. Fluid was reduced.

Patient received vaccination at 8:00 am and returned to work after finishing the 15 minute monitoring period. At approximately 0845 am the patient began to feel nauseas, tightness in throat, diaphoretic, short of breath. In the Emergency Department patient was given Epinephrine 0.3 mg intramuscularly and methylprednisolone 125 mg intramuscularly.

Respiratory Symptom - Patient had a hard time breathing one hour after his 1st dose of the Moderna Vaccine. Patient expressed he was feeling some anxiety/panicky also. Patient stated he was short of breath at this time.

fatigue, slight shortness of breathe for couple hours, especially if i went for a walk, sore arm that got worse a day after shot then started to subside 36 hours after shot.

Began as low grade fever and night sweats on 4/5/21. After two weeks began having difficulty breathing, and fever reached 102°F and was more constant. Pulse rate increased by almost 50% over 2-1/2 weeks. On 4/23/21, after 2-1/2 weeks of increasing fever, pulse rate, and breathing difficulty, pulse rate shot up past 200 so I went to the ER. Kept in ER for 4 days, was on oxygen for first 3 days. Diagnosed with Pericardial Effusion caused by Viral Pericarditis. Treated with anti-inflammatory medications. Have had two more SVT (SupraVentricular Tachycardia) episodes since; had to go back to ER for one of them Slowly recovering over several weeks.

Patient c/o sudden onset of lightheadedness f/b syncopal episode 15 min pta. Rec'd Moderna COVID-19 vacc yesterday. Has h/o HTN but has been refusing meds and chronic clinics since 2018. C/o SOB and upper back tightness. Responding nurse indicates pt's HR was initally irregular. Peripheral pulses thready. Unable to obtain BP. 18g IVs were placed in bilat ACs w/NS running wide open. EMS was called. On arrival they attempted adenosine 16mg then 8 mg. Then patient was successfully cardioverted and taken to the hospital.

Patient was provided with the COVID-19 vaccine outside of the hospital and begain having shortness of breath approximately 15-20 minutes after receiving the vaccination. In route home, the patient could not catch his breath. The patient was found slumped over at home. EMS arrived and the patient received ACLS and ROSC was achieved. Days later, the patient arrested again and passed away on 5/13/21.

Patient reported fatigue and progressive weakness since given vaccination. Now admitted to ICU in hypercarbic and hypoxemic respiratory failure on invasive vent support.

@1/31/2021 Pain started in left ankle Lasted @10 Days. Swollen joints and pain. Swollen joints continued and pain moved throughout different parts of the body. (Right knee, right ankle, etc..) Pain increased every day until he couldn't stand it anymore so on 2/23/2021 went to emergency room for the first time in his life as the patient. Doctor gave him predniSONE 10 mg Discharge Diagnosis: Inflammatory arthropathy; Left arm pain; Tendinitis. 2/26/21 went to PC doctor Diagnosis New onset Polyarthropathy Prescribed PredniSONE 10 mg for 5 days. 3/2/21 Received 2nd Covid Vaccine shot. 3/8/21 called PC doctor still in extreme pain. Doctor prescribed Diclofenac Sodium 50 mg. 1 tablet every 8 hours. 3/9-3/10 started slurred speech. 3/10/21 Emergency room. Discharged Diagnosis Polyarthralgia (Joint pain) Prescribed methLPREDNIsolone 10 mg for 5 days. 3/11/21 Dr. called telling him to stop taking the Diclofenac Sodium immediately. Continued taking PredniSONE until 3/18/21. 3/22/21 sent to Gastrologist noted to have progressive microcytic anemia without GI bleeding, B12, folate, iron panel, EGD and Colonoscopy ASAP, Joint Swelling, Rheumatology evaluation pending, slurred speech, consider neurology evaluation. 3/31/21 Colonoscopy and Endoscopy performed. 4/1/21 Rheumatologist Appointment - First Appointment with this doctor. 4/5/21 Gasterology doctor diagnosed him having H-Pylori infection. All of his biopsies came back negative."H-Pylori Diagnosis - Amoxicillin 500 MG 2 Capsules twice daily for 14 Days /Omeprazole 20 MG 1 capsule twice daily for 14 days/Clarithromycin 500 MG 1 tablet twice daily for 14 Days. 4/8/21-4/10/21 Hands started shaking. 4/29/21 PC doctor appointment. Still experiencing fatigue and very pale. Can't catch his breath and gets tired very easily. Doctor took him off of his blood pressure medicine. 4/30/2021-5/2/2021 Had a horrible weekend. Pain/Fatigue/Absolutely No Energy 5/3/2021 stopped at PC office to see doctor. Took blood for more tests. Still experiencing pain in his body and swollen joints. "Prescription for Iron Tablets Take 1 pill in the am and 1 pill in the pm for 1 month Ferrous Sulfate 325mg (5gr) 5/7/2021 patient looks horrible today. He looks almost yellow to me and 1 of his eyes is bloodshot He has no energy (ZERO) and is very tired. He has lost over 15 pounds. 5/7/2021 patient called PC Doctor and asked him to look at his lab work. Dr. called and told him he made arrangements for him to go and see Neuropathist ASAP. Patient met Dr that same day. Dr. sent patient over to Hospital. In the ER they took blood, EKG test, CT scan of his lower abdomen and pelvis. They took a Chest X-Ray. He was given 60 mg of Steriods and started on IV fluid. They also scanned his head. Acute renal failure. Transabdominal ultrasound of the kidneys obtained. Ultrasound retroperitoneal kidneys. Findings: The right kidney measures 10.8 x 6.8 X 7.1 cm The left kidney measures 11.8 X 7.3 x 6.2 cm. There is mild bilateral renal cortical atrophy. There is increased renal cortical echogenicity of both kidneys. There is no hydronephrosis or shadowing renal calcui. The bladder is partically distended and unremarkable. Medical renal disease. No hydronophrosis or shadowing renal calculi. Clincial Indication: ARF-Other Acute renal failure. 5/10/21 Kidney Biopsy. Prednisone 20 MG Tablets Take 3 Tablets by Mouth Daily for 10 Days. 5/13/2021 Dr. visit diagnosis Focal Necrotizing and Crescentic Glomerulonephritis, Pauci-Immune Nine 0f 25 (36%) nonglobally sclerotic glomeruli show necrosis and/or cellular/fibrocellular crescent formation. Correlation with ANCA serologies is recommended. 05/17/2021 Prednisone 20mg. Next doctor appointment scheduled Monday, May 24, 2021. I also have 9 different Blood Lab Test Reports if you need to see them. My husband went from running 3 miles a day with nothing wrong with him except reflex condition to not being able to move at all. I'm not sure if it is related to the vaccine or not but I wanted to submit this report just in case. Please let us know if you have any further questions or need any additional information. Thank you.

C/o chest pain with radiation up posterior neck and thoracic area. Mild SOB Sent to CTH 5/19/21 and returned 5/23/21 TTE shows reduced LV function with large apical aneurysm and a layered non-mobile LV thrombus. Additional medications added upon return- Coumadin 7.5mg, Losartan 25mg, Lasix 40mg, Lovenox 150 mc/ml, coreg 6.25mg, Lipitor 80mg, D/c'd amlodipine, ASA

Blood clot in his lung; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY THROMBOSIS (Blood clot in his lung) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012a21a) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). Concomitant products included BRINZOLAMIDE (AZOPT) for an unknown indication. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-May-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PULMONARY THROMBOSIS (Blood clot in his lung) (seriousness criterion medically significant). At the time of the report, PULMONARY THROMBOSIS (Blood clot in his lung) outcome was unknown. No treatment information was 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 event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded

Pt initially contacted clinic describing shortness of breath present the night before, and no other symptoms. Pt advised to go to ED or call 911. Pt contacted today and he described his symptoms differently, specifically as: aprox 5 hours after COVID immunization, developed fever 102, sweating, loss of small and taste, diarrhea, fatigue beginning noc of immunization and gradually fading over ~3.5 days. Only residual Sx pt endorses at this time are diarrhea and fatigue. Pt given advice directly from Provider to go to emergency dept/call 911. Pt cont. to decline to attend emergency dept /urgent care of get COVID test, saying "I'll ride it out."

Upon arrival to the ED, the patient reported symptoms starting on Sunday with exertional SOB. SOB was significant while laying flat and awakening at night SOB. Patient was admitted to the hospital and stayed in the ICU for a few days. Medications received during the patients stay included: APAP 650 mg, ASA 81 mg, Atorvastatin 40 mg, Colchicine 0.6 mg, diphenhydramine, enoxaparin 40 mg, fentanyl citrate, heparin. lidocaine hcl, metoprolol tartrate, midazolam hcl, ondansetron, miralax and NS. The patient was admitted 6/4/21 and discharged 6/10/21.

62-year-old male with history of hypertension presented to the hospital with chest pain. Chest pain centrally located, pressure-like sensation radiating to the left upper extremity and left side of the jaw. Associated with sweating. He had difficulty breathing when he had the chest pain. Patient was nauseous. NSTEMI. Cardiac Catheterization performed.

March/April 2021 began having palpitations and shortness of breath. EKG at PCP office confirmed new onset atrial fibrillation. Stress ECHO and Holter monitor confirmed a reduced ejection fraction and mild cardiomyopathy. Cardiac angiography confirmed suboptimal ejection fraction

I had a pulmonary embolism that required hospitalization. I had blood clots in my lungs which traveled from my left calf. I noticed a shortness of breath when running 4 days after my first vaccination. Subsequent runs featured extremely elevated pulse rates, too high in my opinion given I was only running at a moderate pace. That led me to think there was something wrong. I went to the doctor who ordered tests for me. The tests confirmed that I had blood clots and I was told to go to the emergency room immediately. I was hospitalized for 2 days, and was prescribed Eliquis. I have to take Eliquis for 6 months. Bloodwork confirmed that I was not genetically predisposed to blood clotting. If I was not active, I would never had known a problem existed. I was told that I could have died if I did not go to the doctor to check this out.

I had a slight sore throat on night of getting vaccine. On the day after, I had chills, body aches, chest tightness and pain, shortness of breath and Wheezing.

On 1/15/2021 at 1800, resident noted to be lethargic and shaking, stating "I don't care." repeatedly. C/O head and neck pain. T100.6. Given Tylenol with no relief of pain. Order received for Aleve and administered.. Assisted to bed as usual in evening. Monitored during night shift and noted to be resting comfortably/sleeping.. Noted agonal breathing at 4:10 AM 1/16/2021 , T 99.4, Absence of vital signs at 4:15AM 1/16/21 and death pronounced at 4:40AM 1/16/21.

Thursday Nite starting at 11 PM: A warm feeling at the top of my head like a heat lamp. Lasted 15 Minutes. Then Left Leg, Two Toes start pulsating/shaking uncontrollably. I rubbed with the right foot...it would stop...then start back up. Lasted 30 Minutes. Then my chest started feeling like I had a bad sunburn on my skin. Lasted 30 Minutes...all the while these strange things were going on, I noticed I had asthma. I ONLY get asthma if I have a cold or flu. I thought to get up and take an inhaler but decided against it worried about an adverse reaction to the vaccination. I fell back to sleep and awoke with no asthma and all strange symptoms gone. Then Friday afternoon I developed chills and a queasy stomach (belching and gas and loose stools.) I checked my temperature (on multiple occasions) and it was normal. These two conditions lasted until Saturday. Also on Saturday, I developed aches in my neck. Then very late Saturday Night, I awoke to a sweat drenched tee shirt but chills were gone. Sunday...today....I feel perfect.

Saturday, headaches and tiredness. Sunday morning still had headache, later developed SOB, difficulty breathing, feeling sick, and diarrhea. Monday, headache and SOB throughout the day. Tuesday, SOB had gone away but still had headache.

Headaches, tiredness. Sunday still had headaches but worse after waking up. Started developing severe SOB, stomach ache. Early evening, had diarrhea until the next morning. Monday still had SOB, and headache. By Tuesday, SOB had kind of went away but still had headaches.

Bronchitis; COVID-19; A spontaneous report was received from a consumer concerning a 63-year-old, male, patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed COVID-19 and bronchitis. The patient's medical history, as provided by the reporter, included asthma and unspecified allergies. Concomitant product use included unspecified allergy medication and asthma/bronchitis inhalers. On 02 Jan 2021, the same day as 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 02 Jan 2021, the patient experienced coughing, wheezing, shortness of breath, headache, and sinus congestion. The patient tested positive for COVID-19. The patient was taken to the hospital where he was treated with an infusion. On an unspecified date, a computed tomography scan showed bronchitis. Additional treatment for the events included unspecified antibiotics and steroids. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events COVID-19 and bronchitis was unknown.; Reporter's Comments: This spontaneous report concerns a 63-year-old male patient who experienced the serious events of COVID-19 and bronchitis. The event occurred on the same day after the administration of the first dose of the vaccine mRNA-1273 vaccine (Lot #: Unknown, expiration date-Unknown). Treatment administered included antibiotics and steroids. Outcome was unknown. Although a temporal association exist, there is not enough information to adequately assess the causal association between the reported events and mRNA-1273 vaccine administration. Critical details such as diagnostic test for COVID infection prior to vaccination was not ascertained. Causality is also confounded by the patient's advanced age. Main field defaults to ‘possibly related'

1/31 - received 2nd dose of Moderna vaccine at MD (where I work as M.D.) Approximately 8 hours later, experienced severe chills, fever 102, chest pain, and shortness of breath. Fever lasted two days, however ,still not feeling well then experienced palpitations, irregular heartbeat. Went to cardiologist on 2/8. Tests revealed pericardial effusion and pleural effusion.

high fever unresponsive to tylenol, muscle pain and weakness, sore arm, joint pain, mild shortness of breath, headache

2/9/21 - pain/soreness injection sight afternoon, from 9 pm on flatulence 2/10/21 - in bed around 12am chills on and off, woke up with headache, body aches and general malaise, cramps and diarrhea around 4pm, 6 pm severe chills, could not stop and started hyperventilating, used paper bag and after about 15 minutes got breathing under control and got in bed fully clothed with 2 blankets and with heat turned up finally stopped shaking. 2/11/21 - fatigue, cough 2/12/21 - fatigue, cough 2/13/21 - better, normal bowel movement

Passed away; tired; nonresponsive; cold; difficulty breathing; swelling; sore arm; feeling weird and funny; A spontaneous report (United States) was received from a consumer concerning a 63 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the patient experienced limb discomfort, feeling abnormal, dyspnea, fatigue, swelling, unresponsive to stimuli, body temperature abnormal and the patient passed away . Medical history included treatment for tuberculosis and dialysis. Concomitant medication included calcium acetate, Renvela, glipizide, omeprazole, aspirin, vitamin D, losartan, furosemide, rifampin, and Sensipar. On 14 Jan 2021, the patient received the first of their first planned doses of mRNA-1273 (lot number 030L20A) for prophylaxis of COVID-19 infection. On 13 Jan2021, the patient tested negative for COVID-19). On 16 Jan 2021, the patient experienced a sore arm, and feeling weird/funny. On 17Jan2021, the patient experienced difficulty breathing and swelling. On 18 Jan 2021, the patient declined dialysis, was tired and wanted to lay down. At 8 am, the patient was found nonresponsive and cold and is believed to have passed away around 4 am. The coroner tested the deceased for COVID-19 and the test was positive. No autopsy was reported. No death certificate was issued at the time of the report but the reporter believes it will list cause of death as COVID complications. Action taken with the mRNA-1273 was not applicable. The outcome of the events of limb discomfort, feeling abnormal, dyspnea, fatigue, swelling, unresponsive to stimuli, body temperature abnormal, was fatal. On 18 Jan 2021, the patient was died. Cause of death was COVID-19. Autopsy details were not provided.; Reporter's Comments: The events developed on four days after first dose of mRNA-1372. Dyspnea, unresponsive to stimuli, and death were consistent with infection in pandemic set up confounded by age of patient and refusal of dialysis Cause of death was reported as COVID-19. Autopsy details were not provided. Based on reporter's causality the events are assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: COVID-19

Difficulty breathing upon going to bed/ shortness of breath had to sleep flat on my stomach constantly blowing for 3-5 hours until I fell asleep from exhaustion of standing in line for five hours to get vaccinated. Awoke with rash on both forearms. I awoke this morning and breathing was "normal". I drank lots of water this morning to combat rash and it seems to be going away.

I had a nasty reaction to 2nd dose of Moderna 8-12 hours after. Began with body aches and chills so severe it was hard to breath. No fever. When I got under covers and warmed up so chills subsided and breathing returned to normal it felt like I was being squashed in a Panini press. Every cell in my body felt like it was vibrating in pain. I had to get up ever hour or so to urinate. I would be back in sever chill mode before i made it to the bathroom and it took about 5 minutes back in bed for chills to stop and breathing back to normal. I was also nauseous the whole time but did not vomit Then. The room temperature was 72F. This continued for 12-14 hrs. I then tried to drink cranberry juice and eat 3 bites of a banana which I immediately regurgitated. The rest of the day I was drained of energy. No sleep 48hrs. 3 days

Cardiac arrest just stopped breathing fortunately at home wife called 911 within five minutes of noticing not breathing responders there in 3-5 minutes worked on him for 15 minutes at home before transporting to ER hospital. No heart beat pulse etc... used CPR machines and paddles Patient had walked 6 1/2 miles that morning no problems did about 50-60 miles weekly outside. This was sudden and me, his wife, say it was a reaction to something in shot that contributed to this event- there is absolutely nothing you could say to make believe differently. This happened 1 1/2 hours after getting shot.

About 24 hours later I felt weak and had a fever and had little shivers that went thru my joints to the top of my head. It almost like little shocks going thru my body. I had a video appointment with my Dr. and he prescribes doxycycline and prednisone. The next day the fever went away and started to feel better (48 hours later). I also tested positive for Covid on 12/24/20, I didn't wait 90 days before I got my vaccine. I felt awful with the second dose, almost worse than being in the midst of Covid. I'm currently on Workman's Comp. I'm constantly out of breathe and have no energy, I use to have tons of energy. From my atoms apple to my sternum I have tons of pain. My lungs feel like I'm smoking and have tons of pressure. My Dr. ran test because I have the worst head aches. I'm like slow motion.

Patient woke up at 4am with shortness of breath, pulse ox 75 on 3.5L oxygen. No improvement with increased oxygen so patient was transported by ambulance to the hospital. When patient arrived to hospital heart rate was over 200.

throat was swollen, difficult to swallow, no compromised airway, uvula swollen, TX: Patient given decadron IM and oral prednisone taper, patient responded to treatment and doing better

3/17/21 63 y.o. male who presents with sudden onset of chest pain and palpitations, which occurred while patient was exerting himself. Pain is substernal, radiated to the left arm, associated with lightheadedness. Denies diaphoresis or nausea. Per EMS there were short runs of nonsustained ventricular tachycardia 3/18: - remains inpatient admission as of 3/18/21 @ 0900 63 y.o. male with a past medical history of nonsustained ventricular tachycardia. He states he was lifting a couch yesterday and his heart started beating fast. He did not really have any chest pain, but felt a little bit lightheaded. He called an ambulance and they brought into the ER. In the emergency room his EKG did show some frequent PVCs. However, he did not really require any intervention. He was given 3 nitro, but it really did not make any difference in the way he was feeling. The patient denies multiple times that he actually had chest pain. He states he just felt like his heart was beating funny. The patient's most recent stress test was a nuclear stress test in May of 2019. Overnight, the patient has felt very well. He denies any significant chest pain. He denies any further heart palpitations. On the monitor he would occasionally going to bigeminy, which is not abnormal for him. EKG this morning was unremarkable. After speaking with the patient's wife, she told me that he has had a several month history of very limited exertion. She states every time he exerts he becomes extremely dyspneic and has heart palpitations and sometimes almost passes out. She states last night he was extremely diaphoretic and very nearly passed out.

ARM was hurting for 3 weeks, blisters on the upper arm vaccine area, rash on the entire right arm, full torso and and both legs, short of breath, shivers, fever and body ache for 2 weeks. This lasted from March 10th through March 20th

A mild itching and swelling of my throat that lasted about an hour. This reaction happened within five minutes of getting the shot.

Pt received 1st moderna vaccine on 3/15/2021 and was admitted with sudden hypoxia , sob , low grade fever and pleuritic chest pain 10 days later. Pt is lifelong non smoker. no recent travel or recent illness. no new medications.

rash in his throat; boils in his tongue; swelling in his face and throat; swelling in his face and throat; headache; joint pain; A Spontaneous report was received from a consumer(patient) concerning himself a 63 year old male patient, who received dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache, joint pain/arthralgia, swelling in face and throat, rash in the throat/oropharyngeal blister and boils in tongue/tongue blistering. The patient's medical history was not provided. Concomitant medications included blood thinner and meloxicam. On 25 Feb 2021 prior to the onset of events the patients received first dose of their two planned doses of mRNA-1273 (Batch N0:001A21A) intramuscularly in the left arm for prophylaxis of covid 19 infection. On 25 Feb 2021, within the first 24 hours he had a headache and joint pain. Then, a couple of days after he experienced swelling in his face and throat, a rash in his throat, and boils on his tongue. Rash in the throat/oropharyngeal blister was considered medically significant and serious. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, headache, joint pain/arthralgia, swelling in face and throat, rash in the throat/oropharyngeal blister were unknown. The outcome of the event boils in tongue/tongue blistering was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

03/29/2021 Patient 63-year-old male Reporting patient reaction to Covid-19 vaccination. 8:32 AM patient received 0.5ml Moderna vaccine IM in left deltoid 8:38 AM Patient experienced tightening of airway 8:39 AM EMS contacted 8:39 AM received 0.3 Epinephrine IM left arm 8:39 oxygen at 2 liters per minute applied nasal canula 8:42 vital signs BP 160/110 HR 70 oxygen 97% 8:47 Epinephrine 0.3 ml IM left arm 8:48 vital signs BP 164/104 HR 68 O2 99% 8:48 EMS arrived Patient left with EMS 8:56 AM of own power and was transported to local hospital for evaluation. 03/30/2021 9:45 AM contacted patient to check condition. Patient reports that he was monitored for approximately 2 hours and released. Patient denies any further reactions or side effects.

Patient had the COVID vaccine 5 days prior to admission, this was followed by diarrhea, body aches, intermittent shortness of breath and general feeling unwell. Most resolved but the diarrhea and intermittent respiratory distress, this worsened on day of admission (4/11/21) with decline in mental status. Nausea with no vomiting, no fever, no cough. Patient was admitted to the ICU with acute respiratory failure with hypoxia and pneumonia. Placed on BiPAP, IV fluids. Patient is currently in the ICU with diagnosis encephalopathy, bilateral aspiration pneumonia, right pleural effusion and UTI. Discussed patient with Health Department who requested patient be reported to VEARS for review.

Blood clots in left leg, hip, bilateral lungs; treated with blood thinners; was admitted to hospital from 4/1-4/3; discharged to home, stable

Patient reported after 1st vaccine experiencing some itching. Patient also reported an increase in his BS after vaccine 1. Provider prescribed Atarax to patient for this, patient had previously been prescribed this as he has had a similar reaction to other vaccines and medication changes. Patient was seen by provider for high BS, patients insurance stopped paying for his insulin and they were transitioning him to Trulicity. Patient came to vaccine clinic on 4/13/2021. Patient was given 2nd dose of vaccine and monitored for appropriate period of time post vaccination. Patients family reports that patient had been feeling SOB for the past several weeks and more fatigue than usual. 4/14/2021, patient triggered an alert thru the monitoring system, nurse reached out to patient to discuss and schedule appointment for further DM education and appt with provider. Nurse had difficult time reaching patient, but patient did call back same day and scheduled appt on 4/23/21. Family reports they went to bed on 4/14/2021, brother went upstairs for bed checked on patient and he was unresponsive. 911 called, paramedics and fire department responded, but CPR was unsuccessful. Patient pronounced dea 4/15/2021 @ 12:26am.

woke up with trouble breathin like couldn't get enough air into lungs, happened when sleeping for several nights

later that night patient began to have extreme back pain, legs hurt even to touch (lasted for days), knees rubbery ...patient had pain for 11 days...patient had dizziness and his balance was off...patient had difficulty breathing ...patient stayed in the er all day underwent a battery of tests "all day" ...in the end didnt have answers ....still having problems breathing and coughing ...patient was zapped of all energy and had difficulty even dressing self

On second day pt experienced overt fatigue. He had to increase breathing treatments because he if has extreme SOB. Describes symptoms of being "wiped-out". Unable to function. I referred him to the Emergency Dept.

Vaccine on 04/10/21.Shortness of breath, dizziness, nausea 04/13/2021. Death on at hospital on 04/14/2021 Autopsy found Bilateral pulmonary thromboemnbolus

Patient received first dose of Moderna COVID-19 vaccine on 3/31/2021. Vaccine given at 0857. Patient complained of dizziness, confusion, fatigue, and mild SOB. He was evaluated by PCP and PA-C. BP 150/100 and glucose 156. EMS evaluated the patient and did not send to ED. Patient was observed for 30 min.

In order of progression: - numbness/tingling in hands - double/blurry vision - affected speech, loss of some tongue/pallet mobility - partial paralysis of face - headache - loss of functioning in throat (unable to swallow) - loss of bowel control - loss of reflex (especially in upper body) - not able to open eyes - respiratory arrest

Patient received the moderna vaccine (1st dose). Shortly after was hospitalized for a potential MS flare and was treated with pulse dose steroids, discharged home. He then started to feel progressively fatigued and was readmitted to the hospital on 4/19/21 with a diffuse pneumonitis complicated by hypoxemic respiratory failure. He is currently being treated with IV steroids.

Anaphylaxis reaction; fast heartbeats; stomach ache; shortness of breath; orthostatic hypotension; sore shoulder; headache; minor nausea which increased the third day; dizziness; body ache; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis reaction) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PAIN (body ache). On 16-Apr-2021, the patient experienced DIZZINESS (dizziness) and NAUSEA (minor nausea which increased the third day). On 21-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis reaction) (seriousness criterion medically significant), HEART RATE IRREGULAR (fast heartbeats), ABDOMINAL PAIN UPPER (stomach ache), DYSPNOEA (shortness of breath), ORTHOSTATIC HYPOTENSION (orthostatic hypotension), ARTHRALGIA (sore shoulder) and HEADACHE (headache). At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis reaction), HEART RATE IRREGULAR (fast heartbeats), ABDOMINAL PAIN UPPER (stomach ache), DYSPNOEA (shortness of breath), DIZZINESS (dizziness), ORTHOSTATIC HYPOTENSION (orthostatic hypotension), PAIN (body ache), ARTHRALGIA (sore shoulder), NAUSEA (minor nausea which increased the third day) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant meds were reported. No treatment information was provided. 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, and excluding other etiologies, a causal relationship with the product use cannot be excluded. Arthralgia, myalgia, nausea and headache are consistent with the product known safety profile.; 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, and excluding other etiologies, a causal relationship with the product use cannot be excluded. Arthralgia, myalgia, nausea and headache are consistent with the product known safety profile.

Within 12 hours of vaccine patient complained of being short of breath and asked his wife to call 911, he then stopped breathing and she did CPR until rescue squad arrived. Pt was unable to be revived and died.

Moderna COVID?19 Vaccine. While I was sitting, suddenly I had light-headedness for a second and then chest pain and rapid heart rate. Cold sweat started running over my face and wet my shirt. I went to the Emergency Department at the hospital. While I was waiting in the Emergency Room, all symptoms were gone after 1hr except rapid heart rate. Discharged around 11 pm after signing

4 days later (5/1/2021) anaphylactic shock after a bee sting. No allergy to bee stings before. Whole body rash with severe itching, swelling in mouth and throat, extreme weakness, close to fainting within minutes. Emergency room visit, EPI pen injection, steroid injection, EKG, chest x-ray, blood work. 4 hours of observation in hospital. Still weak today, voice weak, and can't seem to take in enough oxygen to go on a walk or do simple yoga stretches.

A Week after my first dose ~ I had a rash all over my body 14 hours after my second dose. I awoke to a very painful cramp about an inch below my left rib on my left side that lasted for almost 2 hours. The more I moved, the worse it became. I could not go to the bath room and when I drank water, the cramp intensified. Worse pain that I had ever experienced. I sweated profusely. Felt like I got kicked in the side. I was not nauseous, a little dizzy for a moment. My mouth was dry only because of my heavy breathing. My second episode happened the following Saturday morning, I don't think that it was as intense, but it felt like it was only because my left side was sour from Friday mornings episode. My third and final episode happened again early Sunday morning. This one was not as intense, but still woke me up and made me struggle. I did not experience another episode on the 4 the night from my second dose. At this time, my left side feels bruised internally and I have to change the speed of my walk. It hurts to walk fast

CHF (congestive heart failure) Pneumonia Respiratory distress Hypoxia Suspected COVID-19 virus infection

COVID -19; high fever (for over two weeks); pneumonia; difficulty breathing; headache/similar to sinus headache; achy; tired; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Mar-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. On 28-Mar-2021, the patient experienced DYSPNOEA (difficulty breathing), SINUS HEADACHE (headache/similar to sinus headache), MYALGIA (achy) and FATIGUE (tired). On 12-Apr-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant). On an unknown date, the patient experienced COVID-19 (COVID -19) and PYREXIA (high fever (for over two weeks)). At the time of the report, PNEUMONIA (pneumonia), DYSPNOEA (difficulty breathing), COVID-19 (COVID -19), SINUS HEADACHE (headache/similar to sinus headache), PYREXIA (high fever (for over two weeks)), MYALGIA (achy) and FATIGUE (tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Computerised tomogram: she had pneumonia. On 12-Apr-2021, Drug specific antibody: Positive. No concomitant medications reported by investigator. Treatment included Levofloxacin, inhaler (albuterol) and steroid dexamethasone. Based on the information provided, a causal association between the administration of mRNA-1273 and the event of Covid-19, pneumonia is assessed as unlikely as pneumonia is of an infective etiology. Although the other events are consistent with, the known safety profile for mRNA-1273, based on onset of the events, they are more likely symptoms of pneumonia, This case was linked to US-MODERNATX, INC.-MOD-2021-095621 (Linked Report).; Sender's Comments: Based on the information provided, a causal association between the administration of mRNA-1273 and the event of Covid-19, pneumonia is assessed as unlikely as pneumonia is of an infective etiology. Although the other events are consistent with, the known safety profile for mRNA-1273, based on onset of the events, they are more likely symptoms of pneumonia, US-MODERNATX, INC.-MOD-2021-095621:1st dose

headache; Pneumonia; covid-19; difficulty breathing from copd; Achey; tired; high fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Pneumonia) and COVID-19 (covid-19) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-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 CHRONIC OBSTRUCTIVE PULMONARY DISEASE (difficulty breathing from copd), MYALGIA (Achey), FATIGUE (tired) and PYREXIA (high fever). On 12-Apr-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant) and COVID-19 (covid-19) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, PNEUMONIA (Pneumonia), COVID-19 (covid-19), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (difficulty breathing from copd), MYALGIA (Achey), FATIGUE (tired), HEADACHE (headache) and PYREXIA (high fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, SARS-CoV-2 test positive: positive (Positive) positive. On 12-Apr-2021, Computerised tomogram: positive (Positive) positive for pneumonia.. On 12-Apr-2021, SARS-CoV-2 antibody test: positive (Positive) positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient finished treatment with antibiotics and was tested positive for antibodies. Patient took Levofloxacin, inhaler (albuterol) and steroid dexamethasone medications as a treatment. There are no concomitant medication 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. Based on reporter's causality history a positive SARS-CoV-2 viral test event is assessed as unlikely related to mRNA-1273 This case was linked to MOD-2021-095577 (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. Based on reporter's causality history a positive SARS-CoV-2 viral test event is assessed as unlikely related to mRNA-1273 MOD-2021-095577:

63 yo male received 1st dose of Moderna Vaccine on 3/31/21. Admitted to hospital on 4/6/21 then transferred to another Hospital on 4/12/21 for idiopathic pericardial effusion, acute kidney injury then released home on 4/23/21. He presented to hospital on 4/25/21 with acute respiratory failure, septic shock, cardiogenic shock, acute myocarditis and acute on chronic kidney injury. Transferred to different Hospital on 4/30/21

One day after the 2nd shot, I had severe asthma. I have had it every single day since today, May 14, 2021. I went to my doctor and have been on inhalers (Albuterol and Flonase daily) with no change in symptoms.

1.) 5/13 Sore Arm....no concerns 2.) 5/14 Minor enlargement of glands in neck 3.) 5/15 Increased enlargement of glands in neck....felt minor constriction of throat by 11:00 PM 4.) 5/16 Glands in neck swollen....breathing constriction is increasing. Will take Benadryl and monitor .....if no better by afternoon then I will head to emergency room

Pt states that he woke up the next morning and his entire left arm was swollen and numb. The following day, two days after the vaccination, the entire left side of his body was swollen and numb. The patient went to the hospital on April 6, 2021, and was hospitalized for ten days. Upon admission, he had bloody urine, swelling and numbness on the left side of his body, and was short of breath and coughing up blood. Pt was diagnosed with pneumonia while admitted to hospital.

5-19-21 Patient self-reported to that 8 days after receiving his first dose of Moderna (3/18/21), he began coughing up blood, was taken to the hospital, transferred to the ICU with thrombosis. He states he was in the ICU for 6 days. He then received second dose on 04/09/21 and was ill for 5 days again. States he currently remains fatigued, short of breath and "just not himself." Patient is concerned that the blood clots were related to his COVID Vaccines.

Within 2-3 hours of vaccine developed swelling of tongue and throat with difficulty breathing. Patient applied ice and took Aspirin. Episode lasted 6 hours. Patient did not seek medical attention. This was revealed at the time of the second dose assessment.

onset of respiratory failure on 05/14/2021 to be eventually diagnosed with pulmonary embolism. hospitalized at facility .

Hospitalized 4/28/2021 - 4/30/2021 with cough, dyspnea, sputum production Pt. is on immunosuppressive therapy for Sarcoidosis Pt. has chronic kidney disease stage III

He got his vaccine, he had no reactions. The next morning he woke up his arm was sore, and it was that was for 2 days. Then his breathing starting getting worse. He started coughing, couldn't lay down, could not sleep due to that. He went to the ER and they told him that there was nothing wrong and that it was just allergies. They told him to go home and take some OTC cold medicine and that everything would be okay. A week later he went to another ER for the same thing as he continued not to be able to breath, they did a bunch of tests and said that nothing was wrong and that it was just a call. He then went to Hospital ER and they released him stating it had just a cold. He then called his cardiologist and they told him to go back to Hospital, was admitted on 5/11/21 and they did more tests and said that he had a blood clot in his left lung and said that it had nothing to do with the vaccine. He was discharged on 5/13/21. They put him on Heparin while in the hospital and sent him home as a disgruntled patient. They also told him that he had fluid around his heart and gave him medicine to get that taken away. They sent him home on Lasix and Eliquis. He then went to another hospital on Friday 5/14/21 as he was going crazy about the blood clot and went there and was kept there for 3 days and discharged on 5/16/21 with the same medications, Lasix and Eliquis. He was also told that he had fluid around his heart again. Before the vaccine he was very healthy, and was able to jog around his neighborhood and now he's not able to do so, and they told him that he was now having heart failure and is having trouble breathing because his heart is swelling up. He went to see his cardiologist last Friday and that's when she told him about his heart failure. ADMISSIONS: ADMITTED 5/11/21 TO 5/13/21; 5/14/21 to 5/16/21.

2/19/21- Patient presented with shortness of breath that appears to be chronic, but potentially worse (this was 5 days after 2nd Covid vaccine). Lab tests showed thrombocytopenia (unknown if this is new or old) as well as mild transaminitis (again, not known if new) 3/23/21- Patient presented with a stroke involving the R frontal and parietal lobe. Echo normal at that time 4/22/21- presented to urgent care again and was found to have elevated troponin (without associated chest pain or EKG changes). Echo was normal, but cardiac MRI showed evidence of myocarditis

Patient presented to the ED on 4/28/2021for COPD exacerbation. Patient presented to the ED on 5/11/2021 and was subsequently hospitalized for 3 days. These visits are within 6 weeks of receiving COVID vaccination.

per patient: "On 5/26/21 received the 2nd dose of Moderna Vaccine. Around noon experienced headache, left earche and tingling to left foot. Around 1pm started having trouble breathing and later that evening felt like someone was standing on my chest. Took Excedrin EC for headaches. Headache lasted for a day or two. Felt like i was forcing myself to breathe instead of coming naturally".

Dizziness Weakness Face dropped. Right side Breathing labored 30 mins. Benadryl given Happened again that night. Right side face droop and right side motor function affected. Still can't lift right leg correctly

5 DAYS AFTER SHOT 1 BECAME FEVERISH (102.4), EVERYTHING TASTED SALTY, TIED, DIFFICULTY BREATHING, PHYSICALLY WEAK

Mouth went numb and throat tightened up within 5 min of injection. Was administered epipedrine and Benadryl and taken to emergency room by ambulance and observed until noon and released.

Pt received 2nd dose of Moderna COVID-19 vaccine 5/5/21. In mid June patient developed SOB symptoms, dyspnea on exertion, and upon CT imagining in ER found to have bilateral pulmonary emboli with evidence of right heart strain on CT and EKG.

Dizzynies, loss of balance, loss of apitite, chils, redness, swelling, mild fever, altered sense of smell and taste, headache, joint pain, muscle aches and pain, cough, "brain fog", extreem fatigue, body aches, shortness of breath, difficulty concentrating, loss of taste or smell.

The patient began having body pain, diaphoresis, dyspnea, abdominal pain, and fatigue approx 14d post-COVID vaccine (2nd dose, Pfizer). He presented to our hospital on 6/18 with these complaints and was found to have significantly altered mentation, acute kidney injury, and profound thrombocytopenia. Workup was positive for TTP and he was started on PLEX therapy x 5d. Hematologic parameters, renal function, and mentation have improved with PLEX therapy. ADAMTS-13 activity <5% c/w acquired TTP.

short of breath; Missed dose 2; heart rate dropped below 40; dizziness; "hit by a bus" and had a "bad flu"/Covid-19 like symptoms (not positive); Pea Sized Nodes/nodes were tender; Sore Muscles; fatigue; fever; sore bones; patient felt like he was "hit by a bus"; This spontaneous case was reported by a consumer and describes the occurrence of BRADYCARDIA (heart rate dropped below 40) in a 63-year-old male 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. 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 15-Feb-2021, the patient experienced BONE PAIN (sore bones), MALAISE (patient felt like he was "hit by a bus"), MYALGIA (Sore Muscles), FATIGUE (fatigue) and PYREXIA (fever). On 16-Feb-2021, the patient experienced INJECTION SITE LYMPHADENOPATHY (Pea Sized Nodes/nodes were tender). On 18-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS ("hit by a bus" and had a "bad flu"/Covid-19 like symptoms (not positive)). On 25-Feb-2021, the patient experienced DIZZINESS (dizziness). On 26-Feb-2021, the patient experienced BRADYCARDIA (heart rate dropped below 40) (seriousness criterion medically significant). On 26-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose 2). On an unknown date, the patient experienced DYSPNOEA (short of breath). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and Surgery (Pacemaker) for Bradycardia. On 19-Feb-2021, INJECTION SITE LYMPHADENOPATHY (Pea Sized Nodes/nodes were tender) had resolved. On 21-Feb-2021, INFLUENZA LIKE ILLNESS ("hit by a bus" and had a "bad flu"/Covid-19 like symptoms (not positive)) had resolved. At the time of the report, BRADYCARDIA (heart rate dropped below 40) was resolving and DIZZINESS (dizziness), DYSPNOEA (short of breath), BONE PAIN (sore bones), MALAISE (patient felt like he was "hit by a bus"), PRODUCT DOSE OMISSION ISSUE (Missed dose 2), MYALGIA (Sore Muscles), FATIGUE (fatigue) and PYREXIA (fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: negative (Negative) Negative. On an unknown date, Heart rate: 40 bpm (Low) 40 BPM. It was reported that, in total the patient recorded 3 negative COVID tests. There was no history of cardiovascular disease in patient's family. The patient was advised by his doctor to not receive the second dose of the vaccine. Treatment medication include Advil. Company Comment : This case concerns a 63-year-old male patient who was advised by physician not to receive the second dose (product dose omission) due to adverse events. The remaining events are temporarily associated with the product use and hence, a causal relationship cannot be excluded. Injection site lymphadenopathy, myalgia, fatigue and fever are consistent with the product known safety profile. Product dose omission is not applicable. Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Additional information received and case was upgraded to serious, Height, age, race and Ethnicity updated in patient tab, Suspect product Batch number and route of administration updated in products tab, Updated events and event outcome in events tab.; Sender's Comments: This case concerns a 63-year-old male patient who was advised by physician not to receive the second dose (product dose omission) due to adverse events. The remaining events are temporarily associated with the product use and hence, a causal relationship cannot be excluded. Injection site lymphadenopathy, myalgia, fatigue and fever are consistent with the product known safety profile. Product dose omission is not applicable.

I started feeling cold and shaking and very bad headache and discomfort all over. I was bedridden for a couple of days, then it got a little bit better and then it got worse again. Then it got hard to breath. So I lost over 30 pounds in the matter of a month and that is unlike me, I have always been overweight and a food addict and so I called the DR and they told me to get a covid test because the symptoms were similar. I got the test and it was negative. I went to the ER and they said I got pneumonia, which I do not know is related or not but it did happen after the shot and seemed pretty odd. I tend to be the person to just tough things out. At the ER they told me pneumonia in my right light and gave me antibiotics. I called my pulmonologist when home because it was getting worse and he prescribed more antibiotics. I went to see him and he took another x-ray of my lungs. I still had stuff in my lungs so he gave even more antibiotics. He took another x-ray and CT scan recently that I do not have the results of yet. I have vertigo which just started about two weeks ago as well, I read about exercises to do for that and it helped a bit but it came back and now cannot get rid of it. It still is kind of hard to breath as well. I have no appetite which is weird for me and I am cold which is also very strange. I usually could go in a cold place of like 35 degrees and be fine and now I am just always cold. Even when I know I'm hot and know it's hot, I am cold and using a blanket. I shiver and shake so much from being so cold but my bed is soaking wet from sweating, it just doesn't make sense. I have a hard time going to sleep because I am cold and uncomfortable. Even today I am still very tired and now with the vertigo it is hard to do anything today, just talking a lot like right now I am out of breath.

Recurring bouts of fever, aches. Pain when taking deep breath. eventually shortness of breath and pressure high in chest. Diagnosis : Pericardial Effusion. Treatment : Surgery to drain fluid. install drain. install pericardial window. 5 days in hospital.

4/15/21 At local Hospital with double vision, neuropathy, Bells Palsy type face with droopy eye, altered gate, swallowing issues. Hospital tested for stroke but could not find evidence ( CT, EEG, Xray Bloodwork) History did not include that he had neurological side effects for the first Moderna vaccination. He was rushed by ambulance to a much larger hospital. I realized the error of not telling the history of the Moderna neurological adverse event from the hospital and called the hospital. The hospital had already sent him on to a larger hospital. I then contected his spouse regarding the adverse event from the first dose of Moderna. 4/15/21 at secondary Hospital, MRI, CT, EEG, Xray, Bloodwork still found no evidence of stroke. Precious time was lost. I called the nurses station to relay the information regarding the neurological adverse event from the first vaccination and told them that he had just taken his second dose. Soon they had their diagnosis and a path to treatment. He was diagnosed with Guillaine-Barre Syndrome with Variant caused by the Moderna Vaccination. Ventilator inserted, causing pneumonia 04/17/21 Feeding tube inserted 4/17/21 Treatment started plasmapheresis plasma exchanges done 4/17, 4/18, 4/20, 4/22. 4/24, 4/26, 4/28 4/20/21 No infection of brain 4/24/21 patient suffered a respiratory arrest when left unattended. Died temporarily. 4/25/21 starting to respond to commands 4/29/21 trach inserted 5/10/21 Patient breathing on own, Trach sealed with red cap 5/16/21 getting physical therapy sessions Released to spouse and sent home. Hospital records may be obtained by going directly to the patient if he has recovered enough to help.

Within hours of vaccine became somnolent. Trouble staying awake for first 3 days, then somnolence slowly faded over 2-3 weeks. 4 weeks out fatigue a miner issue but not resolved. By mid June began having exacerbation of reactive airway disease (irritable larynx/cough variant asthma) marked by increase in cough with bouts of shortness of breath. Usual triggers for such exacerbation not present. Bouts of hot flashes/sweats but no fever. By late June high barometric pressure weather system (a known trigger) settled in for 5 days causing increased symptoms. Saw Primary Dr. 6/29, prescribed Doxycycline. Today is day 7 of antibiotic, exacerbation is milder, but it remains.

Patient was experiencing a high fever and was diagnosed with a urinary tract infection and COVID-19 at an outside facility on 7/18/2021. He was instructed to go to emergency department for further management on 7/21/2021. He presented with a cough and mild shortness of breath. He was treated with supplemental oxygen, dexamethasone, and remdesivir. His symptoms improved and he was discharged from hospital on 7/27/2021.

Patient began having headache and fatigue 12/29. Early morning of 12/30 patient reported severe chills. Felt better during the day of 12/30 with only a headache. Night of 12/30 patient reported severe chills again and wanted to call the doctor in the morning, but the felt better on 12/31. The night of 12/31 patient again had chills, but less severe (rated 3/10 on scale). Night of 1/1 patient reported slight hive like rash that went away with warm Epsom salt bath. 1/3 0100 patient woke up with severe hives down back of legs and lower back. Got into a hot tub to soak and once the patient got out he was standing at the sink and passed out. His wife got him back to bed. Around 0700 on 1/3 patient woke up to urinate and he passed out again. He states both times he passed out felt the same stating "I felt like I was going to vomit and then all of a sudden I couldn?t breath, almost like I was choked out."

CoughWheeze some mild congestion, scratchy throat post nasal drip Narrative: 12/29 Tested positive COVID

On 12/31/2020, at approximately 00:15, pt developed a fever of 102.9 F and tachycardia with rate of 120. He was treated with acetaminophen. Later in the morning, he complained of nausea, generalized muscle aches, intermittent increase in confusion. At approximately 14:00, he had a fall out of bed and at that time noted to be short of breath, tachypneic. He was taken via ambulance to Emergency Department. From there he was transferred to Hospital for admission with acute respiratory distress, suspected sepsis with lactic acid 7.4 and Bilateral Pulmonary Emboli. He was started on heparin and broad spectrum antibiotics and transitioned to ELIQUIS on 1/3/2021. Infectious etiology of sepsis was unclear. He continued broad spectrum antibiotics with clinical improvement. Abdominal CT scan was obtained due to intermittent nausea, vomiting, abdominal pain, loose stools. His heart rhythm flipped to Atrial Fibrillation with RVR on 1/2 and his rate improved with titration of metoprolol. He was also treated with prednisone for suspected underlying undiagnosed COPD. It is noted in his hospital summary that PEs presumed provoked in the setting of his recent COVID 19 infection. He was discharged from the hospital on 1/8/2021 and readmitted to the Veterans Home. He has been stable.

patient states he felt fine the day he received the vaccine, but at 0500 on 1/15/2021 he was woken out of his sleep having difficulty breathing. He estimates this episode lasted 30 seconds- 1 minute. he drank a sip of water thinking that would help. He then had a second more severe episode that lasted about 2 minutes. "I could not breathe, it felt like I was under water". H stated that after the episodes he felt jittery and very fatigued the rest of the day. He stated that the second episode was the worst he had ever had and thought he was going to pass out. He is a nonsmoker with NKDA. He does have asthma. He is on an inhaler and has a rescue inhaler. He stated that his last episode was 3-4 months ago, but these episodes were different. " It was a bigger fight to breathe". On 1/18/2021 at 2100 He had another episode that lasted 1-2 minutes. He used his inhaler, and improved. He was weak and dizzy after this episode and was unable to go to work.

Pt and other foster home residents and CGs received COVID shot #1 at 11:30 am within the foster home after POA consented to pt's vax. At ~9p, CG heard pt vocalize a loud sound, CG checked on him and entire body and stomach so rigid, lips were pressed together/pale and pale throughout. Stopped breathing for a few seconds. CG couldn't get BP or pulse initially. Say tears rolling down face. 87/45, 56, 97.2F, 91% on RA. After 10 mins was 129/53, 48, 91%. Called 911, 79/47, couldn't get pulse. Due to POLST comfort measures, EMS did not transfer pt to ER. After EMS left, pt "came to" again, pt signed EMS consent NOT to be transferred to ER. Pt's POA didn't pick up the phone. Current VS: 111/64, 69, afebrile. POA does not want pt to receive the second COVID shot.

Positive COVID -19 Lab result on 01/08/2021. Employee hospitalized due to COVID weakness, cough and shortness of breath. Admitted for 5 days.

Complaint of headache upon waking next day after receiving vaccine. Heachache accompanied by loss of appetite, chills, generalized discomfort, chest pain, difficulty breathing, and difficulty sleeping. All symptoms resolved with the exception of headache and difficulty sleeping until day 2 after receiving vaccination. Day 2 without symptoms

Patient is currently hospitalized in Hospital with Covid. His Wife reported admission with O2 Sat at 48. He has Pneumonia, Ketones of 4, borderline ketoacidosis, and Fluid on his lungs,.

On day after receiving 2nd Covid vaccine, experienced chills, congestion, diarrhea and pain of right arm., Unable to work. Seen by Concentra provider on 2/26/21. On 3/1/21, still feeling ill, unable to come to work.

1-25-2021- Phone call: pt had cold and cough prior to vaccine. cough worsened 1-28-2021 Phone call: pt requesting provider visit, cough is same and taking tessalon pearls 1-29-2021 Provider in office visit: pt complain of cough and SOB for 6 days. Getting worse. Temp 101.2, pulse ox 87%, BP 128/70. level of distress- leaning forward to breath. appeared ill. diffuse rales throughout both lung fields, more at bases. Diagnosis Pneumonia due to COVID 19 virus. Sent to ER

pt stated that evening after getting the covid vax he started getting a pain like a cramp that started in the left buttock and hip that went all of the way down the outside of his leg. Pt went to ER on 3/5/2021 in early am since was having problems breathing and very nauseated. His back and legs were still hurting. He was given something for pain and nausea. Blood Pressure was elevated. They did blood work and chest X-ray with normal results. He was observed for about an hour and then discharged since nothing was found and told him he had a reaction to the vaccine. Pt still has constant pain in left leg and has not been able to work. Pt has an appt w/ PCP on 3/12 for FU.

Severe shortness of breath. RR 50. Severe chest pain unable to take deep breath severe back pain unable to move.

Patient received 1st COVID vaccine on 2.12.21. Reported to local ER with chest pain and increased ShOB on 2.22.21. Found to be positive for COVID, elevated troponin. Transferred to medical center. Patient was mildly hypoxic on the floor but never required more than 2L nasal prongs. Patient is currently on dialysis. Patient received dexamethasone therapy only while on the floor. Discharged home on 3.4.2021.

Heavy chest pain, trouble breathing, fatigue on day following vaccine. Symptoms of chest pain remain but have lessened.

I was awakened with severe chills,runny nose,hot head,nausea,short of breath,unable to walk because of severe shaking,blurred vision,slight headache,exhaustion

ADVERSE EVENT REPORT: MODERNA VACCINE 1 of 2 Dates: Feb. 17 to March 16, 2021 1. I received the first dose of the Moderna Anti-COVID19 vaccine at the Outpatient Clinic on Feb. 17, 2021 at 1:31PM. I have been suffering from Gulf War Illness (GWI) for over four years. a. My condition is a combination of ME/CFS and Fibromyalgia. Please review these CDC pages for details: https://www.cdc.gov/me-cfs/index.html and https://www.cdc.gov/arthritis/basics/fibromyalgia.htm. b. GWI a neuro-immunologic disease that is still not well understood by the medical community. 2. Feb. 17, 2021. I received the FIRST MODERNA VACCINE SHOT on my right arm on Wednesday, Feb. 17, 2021. The injection site hurt for two days (Feb. 17 & 18, 2021). I had the following side effects on Feb.17, 2021: chills, headache, joint pain (arthralgia), muscle pain (myalgia), fatigue, nausea, and swollen glands. 3. Feb 18, 2021. I had no side effects. 4. Feb. 19, 2021. I had a headache. 5. Feb. 20, 2021. On Saturday, Feb. 20, 2021, I walked one mile in 29 minutes. I felt tired, weak, short of breath, and I had to stop walking on 4 separate occasions. I produced phlegm. The phlegm secretions were white, very thick, and extremely sticky. I started Mucinex 1200MG (guaifenesin) and Neil-Med Saline Solution nose irrigations this day. 6. Feb. 21, 2021. On Monday, Feb. 21, 2021 between 1AM to 7AM, I had itching at the injection site (right arm), chills, headache, arthralgia, myalgia, fatigue, nausea, and swollen neck glands. 7. Feb. 22, 2021. From 8AM to 4PM my side effects were itching at the injection site (right arm), chills, headache, arthralgia, myalgia, fatigue, nausea, swollen neck glands, coughing, and stomachache. At 5PM I had difficulty breathing. It lasted until 8PM. I took albuterol via nebulizer and was observed by my wife and son to ensure that I did not get worse. 8. Feb. 23, 2021. No side effects. 9. Feb. 24, 2021. I had a headache and a runny nose. 10. Feb. 25, 2021. It has been 8 days since I received the first dose of the Moderna COVID19 EUA. The side effects have been chills, cough, shortness of breath (oxygen saturation of 95%), and thick white and sticky phlegm. Today my neck glands and tongue are swollen. My throat, and the inside of my ears hurt. My nose is runny, like if I had a cold, and I sneezing often. My chest congestion has moved from my chest to my nose sinuses. I have no nausea today. I have no fever. My injection site does not hurt. My Rosacea became active today. Today, I wore an N95 mask to ensure that I did get anyone in my family sick. They all wore their N95 masks. At 6:35 PM, I had a Gulf War Illness ?crash? and was bedridden until 9:06 PM. At 9PM both my malaise and nausea were back. 11. Feb 26 to Mar 2, 2021. I had no Moderna vaccine side effects. 12. Mar 3, 2021. I had four explosive vomiting episodes starting at 10AM. Initially, I thought that the vomiting had nothing to do with the Moderna vaccine. However, my son ate the same food that I did and he did not vomit. I vomited so hard that my son wanted to take me to the Emergency Department, but I refused. I vomited four times today Saturday, March 3, 2021. Every time I vomited it sounded horrible to my family members. The vomit had an extraordinarily strong nasty smell. 13. March 4, 2021 to the present. I have not experienced any Moderna vaccine side effects side March 3, 2021. In conclusion, for any questions regarding this Adverse Event Report please email me. Thank you. Very respectfully,

Chills started within five minutes then within an hour fever of 104. Patient taken by ambulance to Hospital and patient diagnosed with sepsis and cellulitis and shortness of breath

6 hours after injection had severe flushing of skin. Moderate to severe itching minor swelling of face and throat. Started to subside in 30 minutes or so. Went home took a Benadryl and slept for two hours. Had severe tiredness and some minor nausea.

Patient expericed slight tightening of throat/tingling. But was able to swallow. He was asked to take Benadryl but he refused and was given loratadine 10mg tab (1) by mouth. He was observed for 30 minutes and a was driven home. A follow up was conducted 4 hours later he was fine.

Moderna COVID- 19 Vaccine EUA: patient presents to the emergency department (ED) with shortness of breath, dizziness, abdominal pain, nausea, cough, malaise, and headaches. Symptoms started four days prior to arriving in the ED when shoveling snow. Three days prior to arriving in the ED patient received vaccination and reports fever and persistent shortness of breath ever since. Seen by primary care provider one day before presenting to the ED and prescribed prednisone but did not take it. Initial vital signs showed tachycardia, fever, tachypnea, and decreased oxygen saturations on room air. Physical exam noted faint wheezing. Patient placed on oxygen, received albuterol, ipratropium, and steroids with improvement. Patient discharged to home with steroids, inhalers, and oxygen.

Chills and feeling freezing; Vomitting; Abdominal pain; Difficulty breathing; Fever; A spontaneous report, was received from a consumer (patient's wife), concerning her husband, a 64 years-old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced chills and feeling freezing (chills), vomiting, abdominal pain, difficulty breathing (dyspnoea) and fever (pyrexia). The patient's medical history included history of congestive heart failure; triple bypass surgery done in 2017. The patient received dialysis on (Mon, Wed, & Fri), and was on oxygen 24 hours a day. The patient has allergy to valsartan and morphine. No Relevant concomitant medications were reported. On 11 Mar 2021, approximately within one hour prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 11 Mar 2021, while at home, within an hour of receiving the vaccine, the patient started to experience chills and feeling freezing. The patient was taken to the hospital. The patient also experienced vomiting, complained of chills, developed abdominal pain, and had difficulty in breathing. The patient was currently in the intensive care unit. The patient's carbon level was high, needed a pit line and under bypap. The patient also had developed fever. Treatment medications included unspecified antibiotics and bilevel positive airway pressure (BiPAP) given to the patient at the hospital. Action taken with second dose of mRNA-1273 in response to the events was unknown. The outcome of the events, chills and feeling freezing, vomiting, abdominal pain, difficulty breathing, fever were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

More recently (around 2/1) he started having intermittent chest pressure again, then developed dyspnea, cough, intermittent mild fever ~ 101, and hypoxia noted on home monitor. Felt to have pneumonia and was placed on antibiotics 2/4/21 without improvement of symptoms. Seen by his PCP on the day of admission, he was much more dyspeptic and tachycardic with heart rates in the 150s. He was sent to the ER for further w/u and management.

Pressure in chest, rapid heart beat, skipping heart beat. shortness of breath, headache. Took Tylenol after 3 days which helped with headache, felt better after 1 week. heart skipping still although not nearly as often

At 6:00 pm start to cough real bad, then around 8:30 start having a problem breathing until 11:00 pm was real difficult, that's when we call 911.

Extremely sore at injection site. Fever, chills, all body joints extremely sore, heavy breathing with flu-like symptoms.

Day after the shot (March 3) he started having shortness of breath and then continued up until March 16 started running fever of 102.9 and still having difficulty breathing-went to ER and then diagnosed with blood clots in lung "acute pulmonary emboli" and pulmonary infarct and his heart was enlarged-by CAT scan. In ICU for 3 days and discharged at that time out of ICU to home.

14 days after 2nd dose severe shortness of breath, fatigue, lightheaded, near syncope. Diagnosed with bilateral DVT and bilateral PE

patient experienced onset of subjective and eventually objective fevers 4 days after receiving the second Moderna vaccination. He experienced malaise, and fatigue as well and some shortness of breath with chest tightness and was ultimately diagnosed with pericardial effusion and pericarditis.

Anaphylaxis (SOB, throat closing, wheezing, tachycardia, change in mentation over 10 minutes) Given Epi-Pen and Benadryl, Transported via EMT to ER

Adverse Flu-Like symptoms occured the following afternoon after recieving Dose 2 of the Moderna vaccine. Symptons include chills, severe muscle and joint aches, mild grade fever. Symptoms have lessen on the morning of 4/23/2021, but I still feel winded.

Please note the patient did not receive the vaccine at this hospital so lot # is not available. Submitting to VAERS since patient had an anaphylactic reaction and unsure if vaccination site submitted. 64 y.o. male who arrived to the emergency department for Allergic reaction. Patient developed airway, tongue, lip swelling 5-10 minutes after receiving his second Moderna COVID vaccination today. He was given 2 IM Epipens at site where the vaccine was administered then transferred to ED by EMS. EMS gave him Benadryl and a DuoNeb treatment. Patient reported mild relief. He still reported tongue, oral floor, and throat swelling. Discharged from ED in stable condition after 4 hours of observation

24 hours after injection, I began having severe breathing problems. My wife took me to the ER department. I spent 4 hours on a gurney and given these treatments: Breathing treatment 2 IV's EKG Chest X-ray Multiple blood draws

Severe pain to lower left leg without injury hx. Went to doctor on 3/17/21 and was examined and doppler to left leg showing no blockage. Dr prescribed nsaid as needed for pain and monitor. Monitored and pain continued until approx 4/9 and noticed swelling starting and some redness to skin slightly warm. Returned to dr on 4/13 and was placed on antibiotics. On 4/14 noticed slight shortness of breath on exertion and on 4/15 shortness of breath worsened and some irregular heartrate. I went to hospital. Bloodwork, EKG, Chest xray and CT showed multiple pulmonary embolisms and several DVTs in left leg. Admitted to hospital and placed on Heparin drip and monitored for three days. Released from hospital on 4/19 on Eliquis and advised to follow up with personal physician and report severe breathing problems or CP.

Sore arm for three days after shot. Cough increasingly more frequent w/ rib soreness at the intercostal anterior of primarily right side but occasionally left side as well. Increasing difficulty breathing on exertion, increase in altitudes over 8,000 feet, entering cold environments. Severity increased to point where entered ER on APR 26th. Massive PEs found in both lungs. D-Dimer score of 10,000.0 ng/mL. CTA Chest w/ contrast found multiple PEs. ALS transport transferred to Hospital for treatment. Released from the hospital APR 29.

My Father received the first dose of CV19 on 03/02/21 and the second dose on 03/03/2021 in the morning, and at night he had a stroke, we called 911 they hospitalized him within a week he was out of danger and had physical therapies for a month at facility he got out on the 31st of March 2021 and on April 4th he once again went into the hospital for lack of oxygen, they detected blood clots in his legs and his lungs and also an aneurysm in his heart.

20% overall energy reduction, abnormal sweating while walking in 60 degree weather, Abnormal Shortness of breath upon exertion , Tinnitus tone change, Intermittent occasional chest wall cramping that goes away

The next morning (exact time was estimated) patient complained he didn't feel good. His symptoms increased to the point of his believing he has Covid again (with the exception of taste and smell); ie: restlessness; fever (off and on); extreme fatigue; coughing; labored breathing; loss of appetite; and difficulty sleeping. He already had Covid-19 and was hospilized over a week and returned home with oxygen and at-home treatment.

increase shortness of breath and pt tried putting on trilegy machine. He tried doing this two days in a row and didn't relieve his SOB, so pt went to ER and they diagnosed him with influenza B. Pt had increased weakness and had trouble with ambulation.

confusion, didnt know where i was driving home. fever, headaches and body aches feet and hands numb brain fog memory issues. very very tired super weak ... second shot, same but with added lower back pain and leg cramps. massive headache, went to the doc, he told me that first event was a stroke. now i have a blockage carotid left side in my neck. sent me for ultra sound them ct scan. waiting to see vascular doc after discovery 80% blockage. sill very tired very weak. brain fog, hands going numb eye sight weaker. bad smell in my nose sometimes., not sleeping well. short of breathe.

The second day I woke up and my arm was on fire. That night I started with a fever. for 10 days I had a fever of 102-103. I had blood in my urine. I had a lung infection where I could not inhale.

Right off the back with fever and super tried. Started having swelling in my throat. Went to my cancer doctor an had a CAT SCAN and it came back abnormal with enlarged lump nose. So, we understood with the cancer and went back the next month an did another CAT Scan and it came by with other things in my lungs. He don't know if it's from the vaccine. I go back to my cancer doctor on 06/09/2021. He also did a PET Scan on 06/04/2021 to see some other things. Hopefully, tomorrow's test will tell the outcome. I had a total of three CAT Scan's and One PET Scan done. A lot of different things is starting to happen to my body since the vaccine. I will know more on tomorrow 06/09/2021 to be able to report more finding, if any by my PCP.

Arrived to ED complaining of increased work of breathing, black stool and chest pain. Vaccination prior day incidental to medical findings not suspected to be caused by vaccine. 64 years male with PMH of multiple upper GI bleed secondary, atrial fibrillation, CAD, HTN, HLD, COPD on 2L, morbid obesity, OSA on CPAP who presented to the ED with black stools. Has had multiple endoscopic clips and coils placed in the past. VSS; H/H 7.5/21 on admission. His troponin was elevated and peaked at 1.68. Cath in July 2019 showed 80% proximal LAD, difficult to image secondary to an obese patient, occluded nondominant RCA, moderate disease in a large OM (40% stenosis), large anterior apical wall motion. motion abnormality, EF of 45%. GI and cardiology were consulted in the ED. He was admitted for acute blood loss anemia secondary to GI bleed, likely AVM. While inpatient, he remained afebrile and hemodynamically stable. He required 6u RBC transfusion total during his admission (transfused for <8.0 given ischemic heart disease). GI performed upper endoscopy x2 and removed large amounts of blood clots and placed 4 additional hemoclips to stop the bleeding. Cardiology was also consulted due to elevated troponin in the setting of ischemia heart disease, and inability to have stent placement/antiplatelet therapy due to GI bleeds - recommended conservative treatment, likely type II demand ischemia. He received IV octreotide 50mcg/hr for 4 days, as well as IV PPI 40mg BID.

Had 1st vaccine on 3/30/21started feeling ill on 4/2 on 4/5 went to hospital for fever, aches & pains, loss appetite shortness of breath, etc. Was back in hospital 4/9 ? 4/14 for weight loss, fever, aches & pains, headache high white count

6/14/21, admitted for shortness of breath, initially thought to be CHF exacerbation, persistent hypoxia, underwent V/Q scan 6/16, showing bilateral pulmonary embolism, starte don heparin and then lovenox, still with persistent hypoxemia

I went swimming and I go swimming 3 to 4 times a week. After getting the vaccine, I had a terrible problem with shortness of breath. I was swimming in a 25 meter pool. After swimming a couple laps, I noticed I had shortness of breath that I couldn't take air in easily and I had a lot of pressure in my body trying to breath while standing up. I waited and tried again then got out of breath and started to turn a little purple. I got out tried again a few days later and the same thing happened. I called my doctor and he did 7 different tests on me. They did blood work, x ray on lungs, scans of heart, stress test, and injected dye into my system to check out lungs and heart. I passed all test with flying colors. After I was through with the tests, I tried to go back swimming again after I had stopped after 4 weeks. At that time I had my second dose. When I went back swimming I didn't have anymore issues. I went back to my doctor and he was stunned. When I had a test for covid it came back positive. My doctor thought it was positive because I received the vaccine.

patient started to experience pain and discomfort by the rib cage starting 06/01/2021 it progressively got worse after the 2nd dose 06/15/2021.Pt was seen by urgent care physician and was diagnosed with pleuritis and was give a steroid shot and tablets.

First shot resulted in joint soreness, headache and fatigue. Second shot in March resulted in same, more severe, with redness and extreme swelling of arm from shoulder to elbow. Since that time I have inflammation and pain between ribs and lungs front and back, both sides of body.

passed away; short of breath; unwell & very unwell; extremely thirsty; dry mouth; This spontaneous case was reported by a pharmacist and describes the occurrence of DEATH (passed away) in a 64-year-old male 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 Oxygen therapy (Required Oxygen Assistance in the office). Concurrent medical conditions included Diabetes and Brain tumor. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced DYSPNOEA (short of breath), MALAISE (unwell & very unwell), THIRST (extremely thirsty) and DRY MOUTH (dry mouth). The patient died on 16-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, DYSPNOEA (short of breath), MALAISE (unwell & very unwell), THIRST (extremely thirsty) and DRY MOUTH (dry mouth) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information is not provided. Concomitant medication is not provided. Reporter states that the friend stated that the patient had other underlining conditions, patient needed oxygen assistance in the office,friend advised patient to go to the ER and Patient refused Action taken with mRNA-1273 in response to the events was not Applicable. Company Comment: 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

4-13,14,15,16 : Fever and sweats while sleeping. Palpitations / rapid heart rate prior to sleep. Upset stomach.

Symptoms: Fatigue, dizziness, and shortness of breath Diagnosis: small blood clots in right upper lung Treatment: Eliquis

Unable to Breath, Excessive pain, Pulmonary Embolism. Resulted in Hospitalization. No prior history of PE's.

Trouble breathing/Hard for me to walk 2 to 3 steps before I am out of breath.; Trouble breathing/Hard for me to walk 2 to 3 steps before I am out of breath.; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Trouble breathing/Hard for me to walk 2 to 3 steps before I am out of breath.) and GAIT DISTURBANCE (Trouble breathing/Hard for me to walk 2 to 3 steps before I am out of breath.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 028A21A) 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 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-May-2021, the patient experienced DYSPNOEA (Trouble breathing/Hard for me to walk 2 to 3 steps before I am out of breath.) (seriousness criterion medically significant) and GAIT DISTURBANCE (Trouble breathing/Hard for me to walk 2 to 3 steps before I am out of breath.) (seriousness criterion medically significant). At the time of the report, DYSPNOEA (Trouble breathing/Hard for me to walk 2 to 3 steps before I am out of breath.) and GAIT DISTURBANCE (Trouble breathing/Hard for me to walk 2 to 3 steps before I am out of breath.) outcome was unknown. No concomitant medications were reported. The patient reports that his doctor prescribed an inhaler for his breathing issues but the medication name is unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant follow up: Date and batch no added for dose 1 and dose 2; 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.

The next day I was pretty much wiped out. I was having trouble breathing. 2 weeks after getting the shot I went to see the doctor I was prescribed ventalin because they thought it was seasonal allergies. It didn't get any better so I went back to the doctor and I was referred to a cardiologist. It continued to get worse. The cardiologist has now taken over and have ran stress test.

Lightheaded (in a fog) jitters, difficultly breathing (Asthma attacks) , Anxiety (had several panic attacks), headaches . The side effects lasted several weeks but have tapered off I continue to deal with difficultly breathing and anxiety. I did get a second vaccination (Moderna OU7B21A) on 5/24/21. with the same but more intense side effects, which caused me to visit my general practitioner.

Temperature increased to 100.1 F, blood pressure elevated 148/92, dizziness with fall, radial pulse rate increased to 120/min, shortness of breath, rash

Flushing and pressure feeling in my head/face and ringing in my ears increased immediately after injection. Then proceeded to get a slight noticeable increase in heart rate. After setting for approximately 15 minutes I was released to leave. I mentioned to them that I just lived down the street and told them if I had any further issues or symptoms I would call them. Approximately 30 minutes later I was having a slight lightning of the throat or airway and some slight tightness in breathing. This tightness continued for approximately 2 hrs. I called the clinic and was attempting to get there recommendations but the nurse had left. I was told to get the ambulance personnel. As a prior EMT I felt that an ambulance was not needed at this time. I took 2 ea Benadryl tablets and those symptoms lessened. Some numbness in lips and face, and felt heart beating in lips. That all subsided as well after taking Benadryl. Still trying to get with a provider that could give me advise moving forward. The doctor was busy with an Emergency.

I awoke at 3:00 a.m. this morning (Feb 16) with itching in my skin beginning to be felt. By 3:30 am it was widespread and developing a rash over much of my torso and arms. This appears now to have run its course. My nose and lips swelled. My nose became hard and numb. Both now less swollen than early on. My body temperature was 95.4 degrees. I felt dizzy when standing, and there were waves of mild nausea. I had major nasal congestion and could breathe only through my mouth. My CPAP machine (which I use all night every night) was on before the 3 am wakeup, and I donned it again when I returned to bed at around 4 am. Nasal congestion now has improved a lot. On two occasions (maybe around 4 am) I noticed a minor wheeze. On a couple of occasions I coughed lightly, and it was a sore one from the chest. I still have some dizziness, and now an intermittent headache. Before going to bed last night I took two Naproxen Sodium PM tablets for some neck pain.

unconscious, near death experience; extreme headache while at work; felt like he was walking on water; couldn't eat; couldn't sleep; doesn't remember any of it; couldn't talk; speech was garbled; wasn't understanding or comprehending anything; difficulty breathing; fatigue; muscle pain all over his body; joint pain; chills; nausea; vomiting; he couldn't control his bladder; fever that went up really high; dizziness; Weakness; Two spontaneous cases were received on 02Feb2021 concerning a male patient, 65 years of age. The cases are cross-linked. The reporter stated the patient is their nephew. According to one report, the patient experienced the following symptoms: "extreme headache while at work", "felt like he was walking on water", "couldn't eat", "couldn't sleep", "doesn't remember any of it", "unconscious", "near death experience", "he couldn't talk and speech was garbled", "he wasn't understanding or comprehending anything". According to the other report, her nephew experienced symptoms immediately upon receiving the vaccine. She reported the following symptoms not already mentioned by the first reporter; "difficulty breathing", "chronic headache:, "fatigue", "muscle pain all over his body", "joint pain", "chills", "nausea", "some vomiting", "couldn't control his bladder", "fever that went up really high", " lost ability to breathe", "dizziness", "weakness", "Moderna shot is killing him", and "he is dying". The patient's prior medical history include an allergy to Shellfish, previously reported as fish allergy. No other medical history was provided and concomitant product use was not provided by either reports. Prior to the onset of events, the patient received his first of two planned doses of mRNA-1273, (date and batch number not provided), (injection site not provided), for prophylaxis of Covid-19 infection. On ??Jan-2021, shortly after receiving mRNA-1273 immunization, the patient began experiencing the following symptoms: "extreme headache while at work", "felt like he was walking on water", "couldn't eat", "couldn't sleep", "he couldn't talk and speech was garbled", "he wasn't understanding or comprehending anything". At an unknown time later he experienced "difficulty breathing", "lost consciousness" and was admitted to the hospital ICU on 22Jan-2021. Transport to hospital and name of hospital was not reported. According to the reporters the patient remained in the ICU for eleven days. The following symptoms were reported as occurring during his hospitalization either in the ICU or after transfer to a less acute unit on or about 01-Feb-2021: "chronic headache:, "fatigue", "muscle pain all over his body", "joint pain", "chills", "nausea", "some vomiting", "couldn't control his bladder", "fever that went up really high", " lost ability to breathe", "dizziness", "weakness", "dying", unconscious for almost a week". According to the reporters he had CT exams of spine and brain, and heart exams twice on different days while hospitalized but results "didn't find anything". No other significant results or details of his hospital stay were reported. As of the report date 02-Feb-2021 the patient remained hospitalized. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events were unknown. Company comment: The reported events, "loss of consciousness", "headache", "feeling abnormal", "weakness" "decreased appetite", "insomnia", "amnesia", " aphasia", "dysarthria", "confusional state", "dyspnea", "fatigue", " myalgia", "arthralgia", "chills", "nausea", "vomiting", " pyrexia", "urinary incontinence", and "dizziness" were possibly related to mRNA-1273.

Patient wife called store stating that patient has been experience shortness of breath, fever since he received vaccination. Approximately, 4 days now

within 10 minutes of vaccination (administered 11:50 AM) felt weak and tired, became pale and diaphoretic. Pulse weak, irregular. EMS promptly arrive (1 block away) and transported to Emergency Department (within 1 mile). Found to have new onset atrial flutter with rapid ventricular response and BP systolic 86. Improved with diltiazem. Also treated with diphenhydramine and methlyprednisolone

Patient with h/o afib presented to ED on the next day with shortness of breath after having with full-body chills, associated diaphoresis, fever temp 100.6, HR 120 and palpitations after receiving the 1st dose of the Moderna Covid vaccine. Patient had Covid+ back on 12/21. Patient was given IV fluid bolus and Tylenol. Discharged after reassuring labs and imaging. Fever has resolved.

Patient woke up on 2/28/21 extremely fatigued. Fatigue continued through 3/1/21. On 3/2/21 patient woke up in the morning with shortness of breath, wheezing, headache, joint pain, muscle pain, and a fever of 104. He was admitted to the hospital on this day. He left hospital on that same day against physician's orders. He talked to his primary care doctor on 3/3/21 and she told him to return to hospital, which he did. Patient stated he still had same symptoms as on 3/2/21. After patient's fever was resolved in the hospital he left again against physician's orders. Patient stated most of his symptoms resolved on 3/3/21 except for some muscle pain and shortness of breath. Patient followed up with his primary care provider, on 3/5/21 and said he is feeling better other than being a little short of breath.

After the initial 3 days of post injection recovery, started feeling that my lung capacity was sub-normal when walking. Stated running a low grade fever. ON about Feb 24, symptoms included chills, fever reaching 101. Ran several tests at the clinic, and finally got admitted in hospital for more tests on March 04, released on March 05

Possible PEA arrest unclear etiology ~1 hour after receiving first dose COVID-19 moderna vaccine, s/p ROSC in field after 3 minutes CPR, no meds given. Intubated in field, extubated after 2 days.

2/10/21 patient had been given COVID vaccine. Later in the evening he had cough and headache and felt run down. He then started with some shortness of breath and wheezing the next day. He then used his inhaler to get through the symptoms quicker and it did help. Patient notes that within 22 hours of having the shot his symptoms then resolved. He is not having any further issues or symptoms from the COVID vaccine at this time.

Day 1: Within hours of vaccination symptoms of fatigue and muscle pain and achiness began to appear. Also, a slight perception of tightness in the throat that was alleviated by taking a claritin pill. Day 2: The next day produced significant fatigue, muscle pain and achiness throughout the whole day that began to decrease in the later evening. A fever of 99.9 started in mid-afternoon and continued through about 9PM. Day 3: The following day all symptoms disappeared.

On 03/11 I received 1st shot of Moderna COVID-19 Vaccine EUA, after about 8 mins I became very light headed and short of breath after about 10 mins. I felt a rush come over my body followed by rapid heart beat. These symptoms lasted about 2 mins then subsided. I really didn`t want panic everyone or go to the hospital all I wanted was fresh air so I left, admittedly not my smartest move but I knew my doctors office was right across the street. After 24 Hrs. still Light Headed, no breathing issues, heart rate normal sore arm no rash.

I was having difficulty breathing, a horrible migraine like headache, my calves were aching, nausea and barely able to stand and walk. All started 2:00 am. Spent next day in bed until 3:00pm Sunday 3/14. Just now starting to feel a little better at 3:30.

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Additional Details: patient was very anxious prior to shot.

felt like he had something in his throat, dizzy and wheezing BG was 54 Provided OJ, Benadryl, Epi pen , albuterol and dexamethasone 4mg Symptoms continued called 911 to sent to ED BG improved to 120

Mild 1st 24 hours: sore arm, mild fatigue Sat 27 Feb; afternoon/evening 28 Feb fever, chills, muscle aches; continuing and increasing thru week; mild cough and discharge of very bad tasting and smelling mucuous by Wed (3 Mar) No sinus issues; no decline in O2 sat (pulse ox test) Measurable fever - usually around 100 F (normal 97.5) Covid test Fri 5 Mar - negative Dr visit - Mon 8 Mar - chest X-Ray and 5 - day azithro prescription Note: this was a Zoom viisit followed by a clinic visit for X-Ray Fever and most discharge subsided in 3-4 days Normal temperature and no discharge now (9 days from start of treatment)

65 Y male who is referred for c/f dyspnea and chest pain. Per clinic notes: "Brief summary covid vaccine 1/21 with side effect within 12 hr lasting 3 d By around 1/26-1/29 had cp w/ exertion and sob TST 2/2 w/ Minor ekg changes and min workload per pt (mod workload per note) nuc study pending. Cough and sob worse over the last 5 d or so, sleeping in recliner, and having trouble sleeping. Though no desat on march test, he has freq intermittent coughing and he was tachycardic to 110 on exam this am." Pt states symptoms worsening over past week. No symptoms at rest. With exertion has anterior chest tightness and dyspnea. No radiation of pain or migration. He can walk usual distances but much slower. Improved at rest. Cannot lay flat at night. Cannot sleep much at night. Dry cough. No wt changes or LE pain/swelling. No f/c. No ill contacts. No chest pain currently. Pt underwent exercise treadmill stress test on 2/2/21 that showed borderline ischemic changes (so a myocardial perfusion study was planned) but patient's dyspnea on exertion worsened so he was seen in clinic on 2/10/21 where he was noted to have elevated BNP and D-dimer, was sent to the emergency department where CT angiography was negative for pulmonary embolism but it revealed pulmonary edema with bilateral pleural effusions. Patient was admitted, noted to have elevated troponin, anterolateral ST depressions on EKG, noted to have rapid atrial fibrillation, had NSTEMI so he underwent cardiac cath on 2/10/21 that revealed multivessel coronary artery disease, was hypotensive so IABP was placed, percutaneous coronary intervention of left main, LAD and RCA were done and admitted to the ICU. TTE on 2/11/21 showed LVEF 45% with moderate posteriorly directed MR, was diuresed, started IV amiodarone for SVT and atrial fibrillation, IABP was removed on 2/12/21, dopamine IV drip was weaned and patient was transferred to telemetry on 2/13/21 for further care. Heparin was transitioned to Pradaxa on 2/14/21 and dopamine drip was weaned off on 2/16/21. Patient then had an episode of epistaxis on 2/18/21 (resolved with pressure and Afrin spray), had cough on 2/18/21 and chest x-ray showed mild worsening bilateral central patchy parenchymal opacification so IV Zosyn was started (2/18-2/21/21) then changed to Augmentin (with plans to complete course on 2/24/21), Lasix give for diuresis, CT chest and abdomen was done on 2/20/21 for anemia that showed no obvious hematoma or soft tissue collections. Patient continued diuresis and cardiac medications adjusted. Coronary artery disease, paroxysmal atrial fibrillation, NSTEMI status post percutaneous coronary intervention, cardiogenic shock, systolic dysfunction congestive heart failure, moderate MR: Patient was continued on current cardiac medications including aspirin (for 1 month post cath until 3/10/21), clopidogrel, atorvastatin, Pradaxa, losartan, spironolactone. Continued lasix 80mg PO daily as maintenance diuretic regimen per cardiology recommendations. Patient's current weight is 178 lbs (admission weight was around 189 lbs). Patient was not started on beta blockers given recent cardiogenic shock. Acute kidney injury: Seems to have resolved with current creatinine of 1.2. Leukocytosis: Resolved. Will complete about 7 day course of antibiotics with Augmentin until last dose on 2/23/2021. Tobacco smoker: Patient was counseled on smoking. Patient was advised to quit. Discussed smoking cessation classes. Continued nicotine patch. Anemia: No evidence of active bleeding. Will repeat CBC on 2/26/21 as patient is on dual antiplatelet therapy as well as anticoagulation. Patient was also placed on pantoprazole for GI ulcer prophylaxis. Patient got 2nd COVID19 Moderna vaccine as outpatient on 2/27/21.

Prior to the vaccine on 2/13/21, He was a healthy 65 year old active college professor. 32 hours after the vaccination on 2/14/21, He had acute pancreatitis, which led to septic shock and respiratory failure, and he was placed on a ventilator at Hospital. On 2/24/21, he was transferred to Hospital and continued to have additional diagnoses, including polyneuropathy critical illness, acute gangrenous cholecystitis, abdominal pain, anemia, impaired mobility, oropharyngeal dysphagia, pulmonary embolism, and assistance with ADL. On 3/19/21, he was transferred from Hospital to Acute Rehab Unit for acute physical, occupational, and speech therapy. He remains there today. We do not know if this sequence of events is related to the vaccine, but because it occurred one day after the vaccine, we thought it should be reported.

Sudden onset of shortness of breath, chest tightness and coughing. His usual rescue inhaler didn't help symptoms. Up all night long. Unable to lay down as it made his breathing worse. The next day, he did a nebulizer treatment and that helped his symptoms. Unfortunately, he has had an acute asthma attacks nearly every day since. Starting 1 week ago, symptoms have gradually improved. He is still having to use his nebulizer, but not as often, as his usual inhalers have not been ineffective.

Increased intense Asthma events, new inhaler (Albuterol) prescribed and used for 3 days, Some vertigo, occasional body temperature fluctuation & SEVERE CHRONIC BRONCHITIS & intense coughing for over a week! - Tessalon Perles, NettiPot rinse routine 3x's/day, Flonase 3-4X's/day, Salt Solution oral & throat rinse, Tylenol & inhaler as needed. Very stressful & scary/unpleasant. I have very minimal confidence in injection repercussions now.

65 yr old male who took his meds this morning, Moderna vax given @ 0840; had reaction to vaccine with HA, change in mentation, and diaphoresis, EMS called and pt transferred to ER; pt has SOB with POX down to 94 percent; went to 91 percent; with epi pen given at 08:51 pt went to 100%; due to his symptoms, pt sent to ER;

Much energy on first day. Then severe spasms in legs and hands, unable to flex. Breathing labored. I believe it was injected into my left arm muscle.

I had moderate aches and pain. I had moderate to severe diarrhrea for 3 straight day. I had shortness of breath for 1 week.

Patient said he was feeling unwell. Started to feel dizzy and felt like he could possible faint. Had slight trouble breathing. Had patient lay down and elevate legs. Patient started to feel better. Sat back down on chair but started to feel faint. Laid back down until EMS arrived. No loss of conscience. Patient was able to communicate without issue. EMS checked patient out and there was no issues found. Patient called and said he is feeling well.

Vaccine reaction and Uvular swelling. Shot site remained sore, swelling on left side of throat and tongue. Treated with Diphenhydramine and Methylpredisolone sodium succinate injections at 5:27 p.m., March 26th. Prescribed famotidine, 20 mg and methylpredisolone, 4 mg. Recommended benedryl, 25 mg, every 6 hrs. Recommended follow up with primary doctor. Doctor did not want second covid shot administered. Relief immediate from treatment.

Patient was fully vaccinated (dose 1: 1/19 dose 2: 2/16). Patient developed fatigue on 3/1 then tested positive for COVID the following day (3/2). Was self-isolating at home and did not receive any COVID therapies. He reports progressively worsening fatigue, productive cough (white sputum), loss of taste, disorientation, and poor PO intake. Patient arrived to the ED for COVID-19 symptoms (3/13), tested positive and was admitted for severe hypoxic respiratory failure due to COVID-19. Patient with AKI (creatinine =2.48) Patient escalated to HFNC then down to 6L NC to 4L then slowly weaned to RA. Received dexamethasone 6 mg daily x 10 days. Patient was admitted from 3/13 to 3/18 for COVID-19. Creatinine on discharge was 1.29

Got the shot Saturday patients arm was hurting Saturday and the people at shot clinic told the patient to take Tylenol for pain, Sunday the patient was extremely tired and clammy told the daughter his joints and body was hurting so badly. Sunday the patient woke up with allergy symptoms so patient was waiting it out to see dr until his appointment. The patient finally woke up on 3-31-21 around 5 am and the patient had cold chills and clammy the patient put on his robe then told his wife that he was too hot shortly after. The wife was leaving for work at 6am and the patient was curled around toilet stating he felt nauseous, wife left for work around 6am and then she stated about 15-20 minutes later the husband called her asking her to come back home she stated he sounded very short of breath and just not right, she turned around and got home around 645am and found her husband pale and in his recliner with his mouth open and unresponsive. The wife called 911 and she stated the told her pull him into floor and EMS arrived as soon as she got in the floor to start CPR.

Extreme body aches and inflammation. Shortness of breath. Lasted for 48 hours until I went to the Emergency Department at the local hospital.

Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Flushed / Sweating-Medium

6 hours after shot my throat closed a bit and had trouble swallowing. . . I took 2 benedryl and drove to ER at Hosp. . . They said it wasn't too bad. Observed me for 2 hours . . I went home . . I asked for Epipen script.

Patient had covid vaccine and then 1 day later, developed worsening PVCs. Patient has a history of PVCs and Vtach for which he has a pacemaker. Patient is historically very symptomatic with his PVCs. These worsened over the course of a week which lead to worsening substernal chest pain and he presented to the ER on 3/15/2021 and due to his history of CAD, was hospitalized for observation, discharged on 3/16/2021. He had labs, echocardiogram while in the hospital. His metoprolol was increased to help decrease symptomatic PVCs. On 3/9/2021, patient developed chills, difficulty swallowing and the sensation of his throat and tongue being swollen, along with some generalized itching. He presented to the ER 3/9/2021 due to these symptoms and these symptoms resolved without interventions and he was discharged home. He then developed lower lip swelling on 3/15/2021.

Three days after dose one on 1/14/2021, the patient became very out of breathe and extremely fatigued. He knew something was wrong when he could not stand taking a shower. He literally had to lie down in the shower. They started a number of doctors visits and he had an abnormal chest x-ray, he got a CT scan, and started to see a pulmonologist. He is on oxygen 24/7, without it, his oxygen stats are in the 70s and 80s. He got his 2nd shot on 02/23/21.

Patient presented to ED on 3/16/21 with cough and shortness of breath. He was found to be COVID-19 positive on 3/16/21 at PCP office. Was treated and admitted from 3/16/21 to 3/20/21. Returned to ED on 3/21/21 following a syncope and collapse episode at home that results in a head wound and suturing. Presented to ED on 3/24/21 with hypoxia and was transferred to medical facility where he was admitted from 3/24/21 to 4/1/21.

blurred vision and sweats within 5 minutes of injection. +throat tightness. stomach cramping started several hours later.

On March 30th started with headaches then progressed to shortness of breath while moving. Then on April 4th transport to hospital via EMT was tested for Covid 19 results was negative. It was determined that blood clots where found in Right leg & Left leg and both lungs and now blood clot was found in heart. PT has low platelets, low blood pressure. While in the hospital pt was given herapin . Patient has remained in ICU since the 4th to present time.

Diagnosed with pericarditis; Severe breathing problems; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PERICARDITIS (Diagnosed with pericarditis) and DYSPNOEA (Severe breathing problems) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The patient's past medical history included Pericarditis (He also had history of pericarditis when he was 21 years of age (which is from bacteria).), Pacemaker insertion (cardiac) (Patient has 2 pacemakers) and Sepsis. 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PERICARDITIS (Diagnosed with pericarditis) (seriousness criteria hospitalization and medically significant) and DYSPNOEA (Severe breathing problems) (seriousness criterion hospitalization). The patient was hospitalized from 30-Mar-2021 to 31-Mar-2021 due to DYSPNOEA and PERICARDITIS. At the time of the report, PERICARDITIS (Diagnosed with pericarditis) and DYSPNOEA (Severe breathing problems) outcome was unknown. Concomitant medications were not reported. The patient was under doctor's care. Pericarditis came back after he took the second shot of the vaccine. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Extremely bad headaches, severe dizziness, shortness of breath, sharp, shooting pain in the middle of the back of the head

Pt presented with lingering mild cough and dyspnea after his home diagnosed COVID-19 from 2 mos prior, that seemed to improve with his Moderna vaccine series 2/23/21 and 3/23/21. But he also had new LUQ abdominal pain and painful breathing. On exam he had a firm tender enlarged spleen versus several cm abdominal mass. WBC was > 185, 000, peripheral smear (by lab director) was "full of blasts". I sent patient same day to ER, he was admitted, prelim diagnosis: CML, awaiting pathology results but has started chemortherap as of today (4/19/21).

Moderna COVID19 EUA chest tightness and shortness of breath, covid negative per rapid test, tachycardia and HR in 180s-190s. elevated BP and hypoxic, narrow SVT found through EKG, adenosine ineffective, admitted for pneumonia later developed chest pain and transferred to Hospital

Moderna COVID-19 Vaccine EUA: patient presents to emergency department one day after vaccination reporting shortness of breath and left flank radicular pain. Found to have widely metastatic urothelial cancer involing the chest, abdomen, and pelvis. Patient admitted to the hospital for medical management. Discharged to hospice care.

Shortness of breathe with reduced pulse Ox of 93, trouble breathing, body aches, arm soreness, chills, fever, headache, excessive burping, weakness, unable to care for self

3/18 Initially aches and chills. 3/20-29 Progressed on to more severe pain in muscles, joints, tendons and ligaments. 3/30-4/3 pain became debilitating, difficult to get out of bed without using arms to move legs, sitting and rising from a sitting position required extensive use of arms. 4/4-4-26 pain gradually diminished but was not eliminated. Remaining pain is mainly in shoulders, hamstrings, buttocks and hips. 4/23- some breathing difficultly started, only when taking deep breaths. Appt with PCP tomorrow to diagnose and for potential EKG.

Patient with a history of well-controlled asthma/COPD presented with asthma exacerbation 24 hours after 2nd dose of Moderna COVID vaccine,(lot 038B21A) on 4/11. Patient also had similar symptoms following the 1st COVID vaccine dose. On 4/13 ED visit, patient was on 3L nasal canula with 98% O2sat. Patient was initially treated with prednisone, continuous albuterol neb, ipartropium, pepcid, and solumedrol, which continued during 3 days of admission. Respiratory symptoms improved. Patient was discharged home on tapered prednisone, tiotropium and albuterol inhalers.

Patient presents to a hospital with a complaint of weight loss with diarrhea. Onset was roughly 10 days prior to admission. Patient also reported shortness of breath with fatigue. In the ED, patient was found to be COVID positive.

2 weeks after vaccination, patient developed swelling in legs and feet, shortness of breath, left pleural effusion, ground glass opacity on imaging of lung

The patient presented to the Emergency Department with shortness of breath, mild cough, fatigue, diarrhea, and weight loss. Upon presentation to the ED, the patient tested positive for COVID-19 (04/28/21). The patient is currently being treated with dexamethasone and remdesivir.

Arthralgia; Chills; Cold sweat; Dyspnoea; Fatigue; Feeling of body temperature change; Nausea; Pain; Pain in extremity; Pallor; Unresponsive to stimuli; This case was received via FDA VAERS (Reference number: 1150577) on 27-Apr-2021 and was forwarded to Moderna on 27-Apr-2021. This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of ARTHRALGIA (Arthralgia), CHILLS (Chills), COLD SWEAT (Cold sweat), DYSPNOEA (Dyspnoea), FATIGUE (Fatigue), FEELING OF BODY TEMPERATURE CHANGE (Feeling of body temperature change), NAUSEA (Nausea), PAIN (Pain), PAIN IN EXTREMITY (Pain in extremity), PALLOR (Pallor) and UNRESPONSIVE TO STIMULI (Unresponsive to stimuli) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 014M20A) for COVID-19 vaccination. Concurrent medical conditions included Lactose intolerance. Concomitant products included DIPHENHYDRAMINE, VITAMIN D3 and ZINC. On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced ARTHRALGIA (Arthralgia) (seriousness criterion death), CHILLS (Chills) (seriousness criterion death), COLD SWEAT (Cold sweat) (seriousness criterion death), DYSPNOEA (Dyspnoea) (seriousness criterion death), FATIGUE (Fatigue) (seriousness criterion death), NAUSEA (Nausea) (seriousness criterion death), PAIN (Pain) (seriousness criterion death), PAIN IN EXTREMITY (Pain in extremity) (seriousness criterion death), PALLOR (Pallor) (seriousness criterion death) and UNRESPONSIVE TO STIMULI (Unresponsive to stimuli) (seriousness criterion death). 27-Mar-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Feeling of body temperature change) (seriousness criterion death). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. The patient died on 31-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood chloride: 104 (Inconclusive) 104. On an unknown date, Blood creatinine: 1.4 (Inconclusive) 1.4. On an unknown date, Blood glucose: 421 (Inconclusive) 421. On an unknown date, Blood lactic acid: 9.7 (Inconclusive) 9.7. On an unknown date, Blood potassium: 4.1 (Inconclusive) 4.1. On an unknown date, Blood sodium: 139 (Inconclusive) 139. On an unknown date, Blood urea: 13 (Inconclusive) 13. On an unknown date, Calcium ionised: 1.18 (Inconclusive) 1.18. On an unknown date, Haematocrit: 42 (Inconclusive) 42. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Paracetamol was taken for the treatment of pain. Patient's wife called 911 and she stated the told her pull him into floor and EMS arrived as soon as she got in the floor to start CPR. Action taken with the mRNA-1273 in response to the event is not applicable.; Sender's Comments: Very limited information regarding these events has been provided at this time. The fatal outcome may be related to the patient's pre-existing comorbidities. Further information required.; Reported Cause(s) of Death: Death

His oxygen dropped to 88%; Bronchitis, upper bronchitis infection; Meory issues, words wouldn't go together; Sleep apnea, snoring a lot; COPD; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OXYGEN SATURATION DECREASED (His oxygen dropped to 88%) in a 68-year-old male 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 AMANTADINE for an unknown indication. The patient's past medical history included Dyskinesia. Concurrent medical conditions included Parkinson's disease. Concomitant products included RASAGILINE MESYLATE, PARACETAMOL (TYLENOL), CARBIDOPA, LEVODOPA (SINEMET), MIRABEGRON (MYRBETRIQ) and DESMOPRESSIN for an unknown indication. On 10-Jan-2018, the patient started AMANTADINE (unknown route) 68.5 mg once a day. On 17-Jan-2018, AMANTADINE (unknown route) dosage was changed to 137 mg once a day. On 26-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 30-Mar-2021, the patient experienced OXYGEN SATURATION DECREASED (His oxygen dropped to 88%) (seriousness criterion hospitalization). On an unknown date, the patient experienced BRONCHITIS (Bronchitis, upper bronchitis infection), DISORGANISED SPEECH (Meory issues, words wouldn't go together), SLEEP APNOEA SYNDROME (Sleep apnea, snoring a lot) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). The patient was hospitalized from 30-Mar-2021 to 04-Apr-2021 due to OXYGEN SATURATION DECREASED. At the time of the report, OXYGEN SATURATION DECREASED (His oxygen dropped to 88%) and BRONCHITIS (Bronchitis, upper bronchitis infection) had resolved and DISORGANISED SPEECH (Meory issues, words wouldn't go together), SLEEP APNOEA SYNDROME (Sleep apnea, snoring a lot) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Dec-2020, SARS-CoV-2 test: Negative. On 24-Dec-2020, X-ray: (Inconclusive) Chest x-ray continued. On 31-Dec-2020, SARS-CoV-2 test: Negative. On 30-Mar-2021, SARS-CoV-2 test: Negative. On 30-Mar-2021, X-ray: Result not provided. On an unknown date, Oxygen saturation: 98%. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Concomitant medication also includes RYTARY (CARBIDOPA; LEVODOPA) Capsule, 95 mg. The patient was treated each time with unspecified steroids and antibiotics.The infection would seem to resolve then came right back. On a subsequent unspecified date, the patient visited a pulmonologist and was put on a different round of unspecified steroids, nebulizers and antibiotics and finally the bronchitis infection resolved 100%. 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

Patient called to report that he has difficulty breathing and suspects it may be related to the Moderna covid vaccine he received 4 days ago. He has been advised to call 911 for help and this will be reported to VIS

Patient became suddenly short of breath, unresponsive, attempted CPR unsuccessfully and patient expired.

NAUSEA, DIARRHEA, SEVERE COUGHING, MUSCLE/ BODY ACHES, SEVERE SHORTNESS OF BREATH, PAIN WHEN BREATHING, HEADACHE MY HUSBAND WAS PUT ON FULLTIME OXYGEN TODAY

Patient positive for COVID-19 on 3/26/21 after completing vaccination. Admitted for SOB. Treatment with Remdesivir.

Pt presented to our facility on 5/11/21 with altered mental status and tachypnea, ultimately diagnosed with Bickerstaff Brainstem Encephalitis (Guillain-Barre variant) by neurology. Currently intubated and receiving IVIG.

Heart pain/ chest pain. Hard to breathe Lack of energy Swollen legs Erratic heart rate Outcome: death 3 days after. Heart failure

Wife reporting this information, her husband is in prison. He informed her that he did not have a choice to take the vaccines. He does have a heart condition. He feels that he was coerced to get the vaccine, and informed that if he did not take it that he would be moved to an area where he would not have privileges for visitors, etc., and then found out a week later that was not the truth. He got his vaccine, he has more shortness of breath, bad pain in his joints, lots of confusion with his brain, blood blisters on his hands that are oozing on his fingers. Sick for 2 days on the 2nd vaccine, but he continues with joint pain, oozing, and brain fog. He has an injury to his knee and he cannot get to the infirmary and cannot buy Tylenol in the canteen.

A few hours after my second shot I got a mild headache, tired, and a bit blurry vision. The next day things got worse with high fever, bad headache, and very tired. The bad side effects went away after 4 days but since then I often feel tired with a mild headache and a little chest pain now and then. Before my vaccination, I played tennis 3 times a week, each time I played about 2 to 3 hours continuously without feeling tired. But after the vaccination, it takes only 15 to 30 minutes for me to run out of breath so I have to slow down to catch my breaths. My stamina is adversely effected after my vaccination . I'm afraid that I have a case of Myocarditis, a condition similar to Pericarditis, which is an inflammation of tissue surrounding the heart, that caused by the vaccine.

Patient developed an acute hepatitis with significant rise in ALT and AST as well as alkaline phosphatase. It isn't clear when began exactly but labs 1/14 were essentially his baseline then next routine check on 2/18 significant elevation that continued until peak around first week May. Patient admitted for this and ultimately underwent a liver biopsy. This did NOT suggest CLL, autoimmune hepatitis. He also had neg HBV DNA and other lab work up negative. Lab abnormalities started to decrease May 17th. He is still currently being followed in Hepatology clinic. At time admitted, also had a COPD/asthma flare so that kept him in hospital longer than the work up of acute liver injury.

Suffocating; Vaccine went into my lungs and couldnt breathe; Weakness; Fever; Severe headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASPHYXIA (Suffocating), DYSPNOEA (Vaccine went into my lungs and couldnt breathe), ASTHENIA (Weakness), PYREXIA (Fever) and HEADACHE (Severe headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. No Medical History information was reported. On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced ASPHYXIA (Suffocating) (seriousness criteria medically significant and intervention required), DYSPNOEA (Vaccine went into my lungs and couldnt breathe) (seriousness criterion intervention required), ASTHENIA (Weakness) (seriousness criterion intervention required), PYREXIA (Fever) (seriousness criterion intervention required) and HEADACHE (Severe headache) (seriousness criterion intervention required). On 03-May-2021, ASTHENIA (Weakness), PYREXIA (Fever) and HEADACHE (Severe headache) had resolved. At the time of the report, ASPHYXIA (Suffocating) and DYSPNOEA (Vaccine went into my lungs and couldnt breathe) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided. Treatment information was not provided. Patient stated that the shot went into his lungs almost immediately and affected his breathing. It was like he was suffocating for 4 days. He went to the emergency room and they checked him out. The emergency room ran some tests and wanted to admit him to the hospital, but he refused and left. His primary care physician told him to get the vaccine even though he had COVID-19 in January. He also had a fever, severe headache, and weakness after the vaccine. He was not on any concomitant medication. He had a pulmonary doctors appointment 14-Jun-2021 for this issue. 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.

Had problems with throat getting stuck/Heimlich to get food out; Sweating; Would drink water and have problems getting it down throat/Heimlich to get food out; Had problems breathing; can't think straight; Fever; Chills; Muscle soreness in back/Muscle soreness in legs; Muscle soreness in ankle; This spontaneous case was reported by a consumer and describes the occurrence of CHOKING (Had problems with throat getting stuck/Heimlich to get food out) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037b21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Cancer. On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced HYPERHIDROSIS (Sweating), DYSPHAGIA (Would drink water and have problems getting it down throat/Heimlich to get food out), DYSPNOEA (Had problems breathing), THINKING ABNORMAL (can't think straight), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle soreness in back/Muscle soreness in legs) and ARTHRALGIA (Muscle soreness in ankle). On an unknown date, the patient experienced CHOKING (Had problems with throat getting stuck/Heimlich to get food out) (seriousness criterion medically significant). At the time of the report, CHOKING (Had problems with throat getting stuck/Heimlich to get food out), HYPERHIDROSIS (Sweating), DYSPHAGIA (Would drink water and have problems getting it down throat/Heimlich to get food out), DYSPNOEA (Had problems breathing), THINKING ABNORMAL (can't think straight), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle soreness in back/Muscle soreness in legs) and ARTHRALGIA (Muscle soreness in ankle) outcome was unknown. Concominant medications included unknown cancer medications. On an unknown date, treatment included the Heimlich maneuver. 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. 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.

With in 10 min. after receiving the vaccination I started to wheeze, cough and itch my eyes. I immediately had trouble breathing with the feeling that my throat was closing. That's when the EMT's took me to the ambulance and gave me an injection and other treatment that I can not remember and then I was transferred to the hospital. At the hospital I received more meds and within a short time other then being tired I felt better. I went home and went to bed a slept to the next morning.

This is a Physician reporter who is willing to provide further information if needed. The day of the vaccine I started to have tightness like a Broncho Spasm in my chest 30 minutes after the vaccine.. My co-workers told me I was flushed. I was a little short of breath and my pulse was elevated. It seemed to improve after a little time. I started to feel worse on 01/12/2021. Ten days after the vaccine I tested positive on 01/14/2021for Covid-19. I had serious symptoms with the Covid-19. After five months I have been unable to work as a Physician and I am still having. I recently got tested for Polyethylene Glycol and I tested positive on a skin test. I am unsure whether to get the second dose. I also have headaches and memory defects muscle aches weakness and a weak left arm. My headaches happen daily and they vary in severity. I am scheduled to have a Bifrontal MRI tomorrow. I started to have problems with concentration within a week of the vaccine and I am still having problems with that. I experience muscle and body aches as well as neck and shoulder problems. My energy level is improved but still very low. I am scheduled to see a Neurologist. My left arm is very weak from the shoulder to the forearm since that time Radiculopathy.

May 28, 2021, about 28 hours after receiving the second Moderna shot, began to feel light headed and almost passing out. Breathing became labored. 911 was called and the EMTS arrived. Blood pressure was very low below normal readings. Also did an EKG on site. Was transported via Ambulance to Hospital. IV fluids administered in the ambulance. More fluids were given by IV in Emergency room. Blood Pressure monitored at 152/82 in Emergency room, about 2 hours after admitted. EKG, Chest and Lung Xray, full blood work. Emergency Dr gave 2 mg of Doxazosin scheduled meds and was released. Blood pressure continued to elevate after released. BP meds were still taken as scheduled.

First symptoms were severe back pain bent over when walking. Later pain in left shoulder and shortness of breath climbing stairs with heartbeat racing. Later developed pain in right thigh and calf. On May 30 emergency room determine blood clots in right leg and both lungs. First Symptoms appeared about one week after second dose on April 19

I have had mild AFIB for years, minor short term less than 4 days perhaps once a year. On February 28th I started a very symptomatic AFIB, breathless with little energy and stamina , it lasted 8 days which is double previous events. It then subsided and recurred about 2 weeks later for 11 days. Again a severe episode which prompted me to seek out medical help. I just finished a cardiac ablation because of these episodes. They were far more severe and persistent than previous events.

2-3 days of swelling of throat/neck with a sensation of a foreign body in throat then lost voice or raspy voice for weeks.

1 week history of shortness of breath and nonproductive cough beginning shortly after receipt of second dose. Patient became hypoxic and had diffuse consolidation through left lung with wedge-shapes consolidation involving the right upper and midlateral lungs. Leukocytosis and bandemia noted and acute renal failure. Developed atrial fibrillation and rapid ventricular response. Multilobal pneumonia, septic shock, non-q-wave myocardial infarction, acute renal failure. Patient expired.

Patient presented to the ED on 2/21/2021 and was subsequently hospitalized for atypical chest pain and shortness of breath. Patient presented to the ED on 04/12/2021 with Hypotension due to hypovolemia and was subsequently hospitalized. Both visits are within 6 weeks of receiving COVID vaccination.

After my shot I thought I did really good. I did have soreness and sensitivity but if I touched my arm it was sore. No fever, aches, or pains. I didn't think anything of it. I've had breathing issues for 5 years and I kept telling the Doctor I cant breath and I can't mow my yard. I did a medical stress test and a nuclear imagining afterwards and I assumed everything was OK because they weren't worried about anything. I still had the problems though. 05/13/2021 after lunch my chest felt heavy and that afternoon I had a heart attack and went to ER and it turned out that I had a blockage and the next day on 05/14/2021 Dr. put in 2 stents. I have to carry a card now. First stents in the OM, second stent in RCA. I don't feel the shot caused this but you never know. Now I'm feeling really good. Dose 2 Lot # could be 00821A or 008Z1A

Site: Bruising at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium

June 16, 2021 Heart Ablation - because I had been in A-Fib and in order to get me off the medicine, I had to have the ablation. So that it would get me to stay out of A-Fib. Also I gained a bunch of weight very fast - after the second vaccine. I had been on a bunch of steroids from January hospitalization when I had COVID pneumonia. I waited until March to have the COVID vaccine - on the 10th (the first one). I got the second one on the 9th of April. I had tiredness and flu like symptoms - body aches and slight fever (99.1) the first day after the 2nd vaccine and all the other symptoms went on another day. I felt good enough to try to play 9 holes of golf on the Saturday after - although I was pretty wiped out after. So I was fine - until lately when I had shortness of breath after the ablation. The weight gain had been coming on - I was pretty active until that Ablation of time - I go to the gym and was getting rehab for my shoulder. But now with having the Ablation and then after having shortness of breath after the Ablation, I haven't been able to do that. I just tried to start a little walking again yesterday for the first time. I think the shortness of breath is getting better - it's better today than it was last week. Note: I got a Pneumonia vaccine at doctor's office in February; I got a 1st Shingles shot after I had both COVID vaccines - in the latter part of May probably; I haven't had the second shingles shot yet - should probably get that next month.

Rapid heart rate (atrial flutter), chest pain with elevated troponin, fever, fatigue, shortness of breath, lightheadedness

Patient complains of fatigue since the completion of the Moderna series. He has experienced a 5 pound weight gain. Pt has felt tired and fatigue that prevents him from working. Some days he experiences extreme fatigue and has difficulty speaking without getting shortness of breath. He has also developed anxiety and has difficulty falling asleep and wakes up throughout the night.

5:30 am. -Mind "cloudy", tightness in lower esophageal area, minor swallowing difficulty, fatigue. 9:00 am. - progression of previous symptoms with addition of discomfort on chest area, severe acid reflux. 1:00 pm. - further progression of previous symptoms with addition of pain in neck and jaw area and headache, occasional feeling of shortness of breath. 7:00 pm - all symptoms began to progressively decrease in mostly the same order of onset. 11:00 pm - Continued decrease in symptom severity. 1/24 @ 8:00 am - Symptoms subsided with exception of minor degree of swallowing difficulty and reflux.

Lightheaded, high pulse rate of 116 bpm, breathless, fatigue. I sat in the facility for 40 minutes after receiving the injection. Started an hour + after I departed the facility, (an hour and 40 minutes after injection). Laid down and sleep overnight. Pluse dropped to 88. My average resting pulse rate is 68-72. Current resting pulse rate is 88-94. Still feel lightheaded. I feel like my heart is fatigued. My oxigenation is 95-96. Meds Cont: Atorvastatin, Aspirin (81), CoQ10 (200mg), Albuterol, Flovent, Vit C, Vit B-12

Caused my breathing to be erratic, heart rate increased about 15% and Glucometer readings increased 50-70 points each reading. Breathing/heartrate has gotten better and sugars are almost back to my normal readings.

syncope, c/o itchy throat Narrative: Patient was seen prior to administration of the Moderna COVID-19 vaccination. He has allergies to bees/egg and a h/o anaphylaxis 2/2 receiving an injection of penicillin in the past. Discussed that prior h/o anaphylaxis to PCN injection was not a contraindication to this vaccination, but is a precaution. Discussed risks of receiving the vaccination vs benefits of the vaccine, which patient states "I already had this discussion with Dr.!" He has multiple comorbidities which place him at a higher risk for more severe illness from COVID-19. Again received the risk vs benefit discussion. Patient stated understanding and desire to proceed with the vaccination. He will be monitored for at least 30 minutes in area where staff can directly observe him. Patient received the COVID vaccination at 13:00. At 45 minutes later, staff alerted that he was c/o palpitations. Due to confusion and weakness, we were unable to transport him to an examination room. Oxygen, water, and vitals machine were brought to him. He presented with SOB, confusion, lightheadedness. Exam demonstrated acute distress, speaking in staccato sentences. HR in 80s, with lungs CTAB and no stridor - despite increased RR to 20s. Vitals with HR in 70s, SpO2 remained 97% or greater on RA. BP was initially 140/72. A code blue was called and Drs. presented to the area. Patient c/o itchy throat and still p/w confusion/combativeness, loss of orientation, and SOB. No visible swelling noticed. At around 13:58, patient syncopized. HR and SpO2 remained 70-80s and >98% on room air respectively. Pulse remained palpable. At that time, an epipen was administered. Patient woke up. During the entire episode, he was able to recognize a staff member with whom he was previously familiar. EMS arrived, vitals remained stable. EMS transported patient to the ER for further monitoring and f/u. Concern for immediate allergic reaction 2/2 vaccination. After event, patient in need of referral to allergy provider for evaluation prior to consideration of 2nd dosage.

02/13/21 Headache, fatgue, shortness of breath, pain at injection site 02/14/21 Same 02/15/21 Fatigue, shortness of breath increased and dizziness

-Approximately 5 hours after injection, developed 12 hours of chills (no fever), diffuse aching, fatigue, and very low energy. -Approximately 3 days after vaccine noted difficulty completing usual daily exercise routine-stamina appeared low. -Approximately 3-5 days after vaccine noted difficulty completely taking in deep breath, with "catch" or discomfort in substernal area. -During early morning hours of day 7 after vaccine, was awakened with sharp, intense toothache pain right flank. With change of position was able to get comfortable after which pain resolved. This reoccurred the next two nights prompting ED visit. -First ED visit focused on right flank pain and CT Abdomen and pelvis was negative except for "atelectasis" right lung base -Due to more pleuritic symptoms, second ED visit occurred, and CT chest with contrast demonstrated bilateral PEs (approximately 5 on right and 2 on left) with evidence for RV strain -Hospitalized and started on anticoagulation (Lovenox SQ for one dose and then Eloquis). Echocariogram confirmed mild RV dilatation. Interventional Radiology did not feel removal/lysis of clots necessary. -Completed exhaustive evaluation with Hematology--no underlying clotting disorder identified to date -Have returned to 100% activity without significant symptoms at present

About 60-90 minutes post injection he began to feel bad. Voice became very raspy, felt weak, felt like someone was chocking him. Extremely diaphoretic, felt very hot, had to remove shirt. Felt SOB, Called 911 with EMT response. BP 220/160, declined transport to ED, went home with family. BL more stable by 2100 that day. Day after shot blood sugar elevated at 220, normally 150/180.ALso vomiting clear fluids. Still not feeling well 4 days later, feels like "in another world", feels weak at times. Feels dizzy. Has and "eerie" feeling. Feels "equilibrium is off". Took Benadryl on 2/20. Has some disorientation "forgot what he was doing" at one point. Cramps in bilateral legs, both thighs and calves. Has headaches, migraine like at 3am without an elevated BP. Encouraged to see PCP, has appointment with physician on 3/2

My first vaccination was given at Medical Center, on 1/27/21. Medication was Pfizer, Lot # EL3302. At time of scheduling I was told that I could get my second vaccination at facility, which was about 50 miles closer to my home. The scheduler verified that facility administered both Pfizer and Moderna vaccines. On 2/16, when I reported to facility for my second shot, I reminded the intake person and the one who escorted me to the vaccination station that I needed the Pfizer vaccine, and was told by both people that Pfizer was in the record and that I would receive that vaccine. The person who escorted me to the vaccination station brought the syringe to the vaccinator, who asked me my name and date of birth, administered the shot, and handed me the post-administration paperwork. While seated in the waiting area I read over my paperwork and reviewed my dosage record card and discovered, that I had been given the Moderna vaccine., against the CDC guidance and without prior notification to or authorization by me. I have subsequently experienced shortness of breath, an unusually high level of nasal congestion, nad a serious lack of energy. These symptoms began about 72 hours after the second vaccination.

High fever up to 103 degrees Fahrenheit, body aches, shortness of breath, shivering. He took Tylenol every 2-3 hours, felt better by next morning.

Patient felt mildly short of breath and fatigued about 30 minutes after receiving the vaccine. Patient had returned to immunization area after walking around the store and was given 25mg diphenhydramine liquid. Patient rested another 10 minutes and said he felt better.

Presented to the ER 1 day after receiving the second dose of Moderna vaccine with truncal ataxia, vertigo, and dizziness. Patient later became aphasic in the ER. Patient also noted to be febrile, hypotensive, with elevated lactic acid. Patient discharged on day 3 of admission per neurology clearance.

Presented to the ED on 3/1/21 with progressively worsening SOB with cough for past 1.5 weeks. He also reported having bright red blood per rectum for the past 6 months. He denied fever, N/V, abdominal pain, etc. He reports that he stopped smoking ~2 weeks ago and this is when his symptoms started. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine

2-19-2021 Received 1st Covid Injection 2-20-2021 Gasping for Air , LBP, EKG, transported via ambulance 2-21-2021 Admitted to Hospital LBP, EKG 2-22-2021 Surgery in which a pacemaker was installed

Approximately 5 hours after receiving my first Moderna vaccine I developed a cough, fever, chills, runny nose. I assumed these were some of the symptoms as a result of the vaccine. I monitored my fever for several hours. The cough persisted for the next 9 plus days and I didn't have any desire to eat or drink liquids. I lost my taste and smell during this 9 day period. On February 25 my wife and I took a Covid-19 self test at pharmacy. Also on this same date I went to urgent care My wife was concerned about my labored breathing. My vitals were checked and I requested a chest xray. I was given 2 prescriptions. 1 for Prednisone 20mg and Ventolin.

Chocking sensation, tightness in throat and chest severe enough to make me go to the emergency room of Hospital. I spent the entire weekend in Hospital. I had gotten the vaccine in that same hospital earlier that afternoon. I had a similar reaction with the first dose also given at hospital one month before on Feb 5 ,2021. It was not severe enough to make me go the emergency room. It happened approximately the same amount of time after the vaccination. approximately 12 hours after the shot.

Symptoms very similar to my shellfish allergy. Throat started to close up, hard to swallow. Note this was a mild reaction but a reaction all the same. A single dose of Benadryl was all that was required.

Kidney Stones/pyelonephritis; Severe Pain; Couldn't Stand; Difficulty Breathing; Joint Pain; Severe Fever 102.9; A spontaneous report was received from a consumer who was also a 66-years-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced with kidney stones or pyelonephritis/ nephrolithiasis, severe fever 102.9/ pyrexia, severe pain/ pain, couldn't stand/ dysstasia, joint pain/ arthralgia and difficulty breathing/ dyspnoea. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 12 Feb 2021, approximately one day prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On 13 Feb 2021, morning at 2-3am patient had a severe fever of 102.9 and joint pain. Later patient developed severe pain and couldn't stand up. On same patient went to emergency room and was diagnosed with pyelonephritis (kidney stones). Patient also reported that patient was having a difficult time breathing. Treatment for the event included receiving oxygen. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events was not reported.; 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.

Moderna COVID-19 Vaccine EUA. At approximately 4:30 p.m. while at home, I felt pressure in my chest, shortness of breath. After the symptoms became worse, I was driven to the Emergency Department for treatment. My initial blood pressure was 247/114. I was administered aspirin iohexol (OMNIPAQUE) and nitroglycerin (NITROSTAT). I was given oxygen. Blood was drawn, an EKG standard was taken, a CTA Chest scan was done and a XR Chest 2 View PA and Lateral were taken. I was released from the hospital at approximately 11:30 p.m. My blood pressure at the time was 187/107. My breathing was easier and my chest pain was low.

ON 03/11/2021, PRIOR TO RECEIVING HIS 2ND MODERNA VACCINE, CLIENT REPORTED TO NURSE HE EXPERIENCED SWELLING AND SCRATCHINESS TO LEFT SIDE OF THROAT AS WELL AS A FLUSHED FEELING IN FACE APPROXIMATELY 20-30 MINUTES AFTER RECEIVING 1ST INJECTION OF MODERNA VACCINE, 02/11/2021. ACCORDING TO CLIENT, SYMPTOMS SUBSIDED AND HE DID NOT SEEK MEDICAL ATTENTION.

Narrative: ON 3/9/21--RECEIVED VACCINE DOSE#1 OF THE MODERNA,APPROX. 0915AM PT STATED HE WENT STRAIGHTHOME--THAT EVENINGPATIENT STATED HAD COLD CHILLS--PT STATED HE THOUGHT IT WAS THE BEGINNING OF THE FLU, BODY WAS HOT. ON 3/10/21-- IN THE AM FEELING SLLUGGISH/WEAK/NO ENERGY, WAS BABYSITTING GRANDSON, IN THE AFTERNOON WENT TO LAY DOWN. (PATIENT DOES NOT REMEMBER THE REST OF THE EVENTS--REPORTED TO HIM LATER BY SPOUSE OF WHAT HAPPENED) PT FOUND GURGLING BY SPOUSE, WIFE CALLED SON-IN-LAW, HE CAME IN BUT AT THE TIME PATIENT HAD STOPPED BREATHING, HE STARTED CPR ON THE PATIENT, AND SOMEONE CALLED 911. PATIENT WOKE UP IN THE AMBULANCE.

03/13/2021: Presented to the emergency department for profuse diarrhea, tachycardia, and diffuse wheezing. Patient hypoxia was most likely secondary COPD exacerbation was started on IV steroids and transition to p.o. prednisone. Medication changes led to better heart rate control.

gasping air issues/ severe breathing issues; A spontaneous report was received from a consumer concerning a 66-year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced gasping air issues or severe breathing issues (gasping). The patient's medical history was not reported. Concomitant product use was not reported. On 19 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011M20A) intramuscularly for prophylaxis of COVID-19 infection. On 20 Feb 2021, next day of receiving vaccine, patient experienced gasping air issues and had went to the emergency room because of severe breathing issues. He was admitted into the hospital and on 22 Feb 2021, they had put him on a pacemaker. He also had a little bump on electrocardiogram (EKG). His second shot was scheduled on 16 Mar 2021. Action taken with mRNA-1273 in response to the event was not reported. The outcome of event, gasping was recovered.; 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.

On Friday night, 3/19/21, patient spiked a fever, had shortness of breath, and had blood coming out of his nose and mouth per patient's daughter-in law. 9-1-1 was called, paramedics arrived at the home at 5AM on Saturday, 3/20/21 per patient's daughter. Patient died.

Nosebleeds began 2/21. Presented to Community Hospital on 3/9/21 with nose bleeds, spontaneous bleeding from mouth, and severe dyspnea. Had bone marrow biopsy done 3/10, then transferred to Community Hospital for further management. Diagnosed with aplastic anemia on 3/12 and discharged with a plan for follow-up. Readmitted to Community Hospital for treatment with ATGAM and cyclosporine. Completed course of ATGAM 3/16. Has yet to be discharged as of 3/23.

Two days after vaccination on 3/3, deep, sharp pain in the upper right portion of the chest and the upper right back, to the point of painful inability to breath beyond shallow breaths. This pain subsided, but returned shortly after contracting and testing positive for Covid-19 on the 3/12, at which point i decided to go to the hospital emergency room, Well I was tested for and found to have a PE (pulmonary embolism ) in the upper right portion of my right lung.

Pt is always stable on dialysis. Pt was 30 min from completing his treatment and he stopped breathing. Fluid was given, oxygen was placed and sternal rub was performed, pt regained consciousness.

Wheezing, tired, fever of 101.4, chills, muscle and joint pain, severe headaches, extreme nausea , swelling, itching and redness at injection site.

I received the second vaccine injection, and in about an hour felt a little warm and clammy, I was having some joint and muscle pain, and stomach upset. I had no appetite and did not eat lunch. At supper I still did not want anything, so ate cereal instead. During the night I was restless, and expelled quite a bit of gas throughout the night. Stomach still uneasy. When I awoke, about 6:00 AM, I was hungry and attempted to pour a bowl of cereal but could not due to shaking. My wife found me in the middle of a grand mal seizure and called the ambulance. The ambulance, police, and fire company all responded. They provided medical care onsite and in route to Hospital. I had a fever of 102 degrees, had been biting my tongue raw, flailing arm and hyperventilating. I was somewhat disoriented and delusional. During my hospitalization the injection site was found to be very swollen and red. Ice was applied. An MRI was performed of the head and found to be normal. Several other blood tests were also completed. I remained inpatient from 3/25/21 through 3/21/21.

Patient received Moderna vaccine dose #1 on 3/3/21 at approximately 0900. In the afternoon of 3/4/21, patient had sudden onset shortness of breath while at home, as well as fatigue and low energy. Patient knew that a potential side effect of vaccine was fatigue, so he assumed this was just a normal side effect to be expected. States that his difficulty breathing and fatigue continued for about a week. After continued urging from wife to seek medical care, patient visited urgent care center on 3/15/21. The urgent care did a D-Dimer lab, and an x-ray of chest. X-ray "showed something abnormal" so they did a CT scan as well, which showed a "huge pulmonary embolism." D-Dimer lab was elevated. Patient was transported to hospital by ambulance and had immediate surgery to remove blood clot from lungs at approximately 2100 on 3/15/21. Per patient, the surgeon said the clot was about the size of his palm. Surgeon reported that there was "100% blockage to left lung from the aortic artery and 90% blockage to right lung from aortic artery." A DVT in popliteal vein was identified, and the surgeon assumes the clot started in the popliteal vein and broke off and traveled to lungs. Patient was admitted and hospitalized until he was discharged home on 3/18/21. During course of hospitalization, genetic testing was done and it was determined that the "genetic marker for clots was negative, so they think the clot is from a one-time event--patient's family does not need to be concerned that they have clotting issues." Patient states that he was started on heparin in the hospital, and was discharged home on Eliquis blood thinner, which is being tapered. Patient states that the doctors think he will be on Eliquis for about 6 months and will not need to be on it for life. Doctors say the DVT in leg will dissolve on its own. During hospitalization, an echogram and cardiac cath was performed, which showed "an old heart attack on the left side, but that collateral vessels have built up already." Right side of heart was weaker from having to work so hard due to blood clots in lung, but prior to discharge from hospital, the right side of heart was already showing improvement. A heart cath was done to check vessels and it was determined no stents were needed, although there was a small clot in left anterior descending artery. Patient was also newly diagnosed during course of hospitalization with Type II Diabetes in a non-obese person, HTN (which patient had never had before), Coronary Artery Disease, Hyperlipidemia, 1st degree AV block. Was discharged home with metformin, losartan, chlorthalidone, atorvastatin, and Aspirin. The chlorthalidone was discontinued, due to "blood pressure dropping too low--they think his high blood pressure was situational" per wife of patient. Medical doctors advised against receiving the 2nd dose of Moderna vaccine. Patient being followed by Internist at hospital. Patient's shortness of breath resolved "immediately after clot was removed" but is continuing to be followed while on new medications and blood thinner dosing. The above information was provided during telephone interview of patient and his wife.

ended up passing out, seemed to black out; couldn't respond/ not responding to his name; falling; achy; very shaky; eyes were glassed over; couldn't hold his head up straight; breathing was labored; soaking with sweat; slight temperature of 99.5-100.9F; A spontaneous report was received from a spouse concerning a 65-year old, male patient who received Moderna's COVID-19 vaccine(mRNA1273) experienced ended up passing out, seemed to black out/ loss of consciousness, couldn't respond, not responding to his name/ unresponsive to stimuli, fall, achy/ pain, shaky/ tremor, eyes were glassed over/ glassy eyes, couldn't hold his head up straight/ balance disorder, labored breathing/ dyspnea, soaking with sweat/ hyperhidrosis, and slight temperature of 99.5-100.9f/ pyrexia. The patient's medical history was not provided. Concomitant medications included medicine for chlolestrol and blood pressure. On 18 Mar 2021, prior to the onset of the events, the patient received second of two planned doses of mRNA-1273 (lot/batch:047A21A) intramuscularly on left arm for prophylaxis of COVID-19 infection. 19 Mar 2021, the patient complained of being achy and had a slight temperature of 99.5 F that went up to 100.9 F. The patient was very shaky, and ending up passing out, and falling. The patient seemed to black out, his eyes were open and glassed over, but he couldn't respond or hold his head up straight. He did not respond to his name and his breathing was labored. The patient was also sweating. Treatment for the events included aspirin and rest. 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 was unknown.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported event, and excluding any other etiology, a causal relationship with the event cannot be excluded.

Swollen lip; Rash over their body (it itches bad); Heartbeat fast; Difficulty breathing; Had all of the symptoms of an allergic reaction; Dizziness; Weakness; Swelliness of their face, hand and feet; A spontaneous report was received from a healthcare professional concerning a 66-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events had all of the symptoms of an allergic reaction, rash over their body, it itches bad (hypersensivity), dizziness, weakness (asthemia), swelliness of their face, difficulty breathing (dyspnea), heart beat fast (heartbeats increased), swollen lip, feet and hand swolle up. The patient's medical history was not provided. Concomitant medications reported were metformin, carvedilol, atorvastatin, aspirin, citalopram. On 4 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011M20A) via unknown route for prophylaxis of COVID-19 infection. On 5 Feb 2021, the patient experienced the event(s) had all of the symptoms of an allergic reaction, rash over their body (it itches bad), dizziness, weakness, swelliness of their face, difficulty breathing, heart beat fast. On 19 Feb 2021, the patient experienced the event(s) swollen lip, feet and hand swolle up. Treatment details included Benadryl. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), had all of the symptoms of an allergic reaction, rash over their body (it itches bad), dizziness, weakness, swelliness of their face, difficulty breathing, heart beat fast, swollen lip, feet and hand swolle up 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

Swelling of throat and tongue. Chewed some Benadryl Tablets, about 20 minutes after taking Benadryl issue went away

3 min after vaccination, pt complained of blurry vision. endorsed tingling down his back and arms. felt he was getting very hot. itching down back of his head into his arms. reported pain in his throat, dificulty swallowing, felt like something was stuck in his throat. felt he had an upset stomach but did not think he was going to vomit. denied trouble breathing in his chest. no lip swelling, no eyelid swelling, no hives. pulse regular. 74. BP 150/70. O2 sat 98%. 0.3mg Epi given to right thigh at 1432. pt complained he still had globus, still had blurry vision, itchiness and was feeling even hotter. BP 180/90 at 1435. reported "hammer to his head" headache at 1437. cotninued blurry vision and globus. BP 172/94 at 1438. 0.3mg Epi given to left thigh at 1438. 1440 pt getting very shaky, handoff given to ambulance.

Moderna COVID-19 Vaccine EUA. Chills, Fever, Aching Joints, Aching Muscles, Runny Nose & Eyes, Shortness of Breath

Patient reported dizziness and throat swelling. He was given epi 1:1000 0.3mg IM, solumedrol 125mg IV, and NS 500 cc bolus in the urgent care. His symptoms improve after treatment; he was monitored for an additional 2 hours and discharged home.

Noticeable increase in chest pain and discomfort as well as noticeable increase in breathing problems.

right leg pain starting 1-2 weeks after first Moderna COVID vaccine (admin 2/24/21). 2-3 days after second COVID vaccine (admin 3/24/21) right leg pain intensified and was followed by right pleuritic chest pain On 3/29/21 ultrasound showed right superficial femoral DVT. CTA showed bilateral pulmonary emboli

deep vein thrombosis, blood clot in left leg and 2 clots in lung, pneumonia, in hospital 3 days, released 2 days and back in for 3 days with gastrointestinal hemorrhage with melena

Not able to leave bed for 3 days after vaccine and very fatigued. Felt mostly back to normal the weekend of 4/3/21 then fatigue returned around 4/6/21 accompanied by generalized weakness, tremor or upper and lower extremities and increased shortness of breathe. Then became dependent on someone else to get up, stand. Was unable to walk due to severity of tremor in upper and lower extremities. Continues to have tremor in rehab facility where he is residing at this time after hospitalization.

The patient presented to our clinic with left calf pain and swelling, shortness of breath without chest pain, low grade fever. He was slightly tachycardic with elevated blood pressures to 160s/90s but had O2 saturation of 99%. DVT US showed extensive thromboembolism of left superficial femoral vein down to popliteal vein and calf veins. CTA chest showed bilateral sub-segmental PE. He was transferred to the the ED for PE workup and treatment.

became hot, clammy, (nausea w/ results for over 15 hours), entire body aches, shortness of breath, it was like doing all over again, has been over 40 hours now better but not quite there

Possible COVID Vaccine Reaction Introduction I am writing this because I think all of the issues described under the ?Current Situation? section may somehow be tied to an adverse reaction to my second COVID shot. Until today, I had thought they were separate incidents with no common thread. I now can see the possibility that they may be related. I am asking for competent and engaged medical help to determine whether this is so, and if not, what the causes are for my issues. I will give a brief medical history to give some current perspective. Health History Current Vital Statistics ? Age: 66, Gender: Male, Height: 6?3?, Weight: 245 Hemorrhoidectomy ? In 1999 I had a hemorrhoidectomy to stop episodes of severe bleeding. Heart Attack ? In August 2000 I had a heart attack, diagnosed as unstable angina, while on vacation. They did further tests, found blockages and inserted stents in two arteries. I was sent home with instructions to contact a cardiologist. AICD ? After returning home, my new cardiologist did further tests and found evidence of ventricular tachycardia. I was sent to a specialist who did an electrophysiology study and immediately implanted an AICD. I have had it replace twice, with the latest one in April 2012. It has never gone off. There are close to five years left on my current battery. Knee Replacement ? In January 2015 I had a total knee replacement of my right knee. That was a result of several injuries and four surgeries, which left the knee without cartilage. The knee replacement has worked flawlessly, and I am able to pursue athletics, especially playing tennis, without limitation. Current Situation February 23 ? Received my first shot of the Moderna vaccine in my right arm. Other than minor soreness around the injection site, I had no other reaction. March 29 ? Received the second shot of the Moderna vaccine in my right arm. Again, there was minor soreness around the injection site. April 2 ? Had major pain in my tightness in my chest and major pain starting in my left shoulder and radiating down my left arm. It caused significant discomfort, and I was awake a large part of the night deciding whether I need to call 911 for a possible heart attack. I decided against that and instead went to urgent care in the morning (April 3). My EKG was normal, my blood pressure was elevated (158/96 sitting, 157/91 standing). Doctor could find nothing to suggest heart attack. Prescribed a course of Prednisone for the shoulder/arm pain. Had blood work ordered, which all came back normal. April 5 ? Played doubles tennis as usual. Noticed some weakness in my left shoulder and arm but played through it successfully. The pain level was very low. April 10 ? Played doubles tennis again. From the first ball I hit I was aware of major weakness in my shoulder and arm. They had no power at all, and I was almost unable to get my serve over the net. I played through it again and played very poorly. The interesting thing was that the pain and weakness did not worsen during the play or afterwards. The pain remained after I had finished playing. April 11 ? Chatted with the athletic trainer while I was officiating their women?s tennis match to look for clues as to what might be wrong. He suggested in may be a shoulder impingement. April 15 ? Had a phone consult with my primary care doctor. I suggested the possibility of the shoulder impingement and he was willing to start there since this was a phone visit. He referred me to orthopedics and physical therapy and prescribed meloxicam for pain. The pain has continued unabated during this time. April 21 ? Pain level was very high to the point where I was unable to work. Went home and slept most of the day. Meloxicam was not having much impact on the pain compared to my usual regimen of both acetaminophen and ibuprofen (which I had stopped using when I was taking the meloxicam). After this I stopped the meloxicam and went back to the other drugs as required. I had an initial visit with the physical therapist that afternoon. She did not find anything which would suggest a rotator cuff or labrum injury. Range of motion was normal. She noted weakness in my left side compared to my right, which is unusual since I am left-handed. She gave me three exercises to do daily. April 23 ? Pain had been back to a more tolerable level. I had a COVID test in the morning for a treadmill test I have next week, and also got an x-ray of my shoulder as requested by my primary care doctor. After I went to bed, I had an incident of severe incident of chills which left me freezing and short of breath even with sweats on under my bed covers. I called my wife in to check my vitals. My blood pressure was a bit higher than normal but not critical. My blood oxygen was 98 and my pulse was 70. My temperature was 99.7 with an oral thermometer. We called the after-hours nurse hotline and spoke with a nurse. By that time, it had been about 30 minutes of chills and they were subsiding. She said she would have a doctor call in the next couple of hours. The doctor called back, and after going over everything, said to come in if the symptoms reoccurred. Thankfully they did not. All the while I am still having the pain in my left shoulder and arm. April 24 ? Again, slept most of the day due to being worn out from the previous night issues and lack of sleep. No change in the pain and discomfort.

PATIENT CALLED TODAY 4/26/21 CONCERNED ABOUT THE SECOND SHOT IN THE MODERNA VACCINE SERIES. HE STATED THAT AFTER THE FIRST DOSE ON 4/20/21 HE EXPERIENCED A FEELING OF BEING OVERWHELMED THAT LASTED ABOUT 3 HOURS. HE FELT A SENSATION OF THROAT AND LIP SWELLING, TINGLING OF THE TONGUE AND FEELING OF DISCOMFORT. PATIENT STATED THAT HE HAS HAD REACTIONS TO POLYETHYLENE GLYCOL IN THE PAST.

Watery eyes rentlsly coughing fatigue vomiting diarrhea dizzy shortness of breath weakness in muscles in arms wheezing head ache. Chils fever it was just like I had covid-19 again

Note: tested positive for virus 12/28/20 & administered monoclonal antibodies a week later. Six hours after having the Moderna vaccine on 4/23/21, I started experiencing fever which rose to over 101 over the next few hours. Also experienced chills, muscle & joint pain, headaches, slight difficulty breathing and fatigue. Took Tylenol every 6 hours after fever started but temp at one point rose to almost 103. Took almost 48 hours for symptoms to subside after waking up the on the morning of the 25th drenched in sweat. The symptoms I experienced were very similar to symptoms I experienced with the virus.

Pt presented to pharmacy to receive his 2nd Covid19 dose. During counseling he stated that he received his first dose of Moderna Covid19 on Monday, 04/05/2021. On Friday, 04/09/2021 he experienced pain on his left side ('pain in lungs). Then, on Saturday, 04/10/2021 he went to the hospital, where an x-ray showed a clot in his lungs, He also experienced a stroke. He we home on Eliquis 5 mg : TAKE 2 TABLETS BY MOUTH 2(TWO) TIMES DAILY FOR 7 DAYS, THEN 1 TABLET 2(TWO) TIMES DAILY FOR 23 DAYS. INDICATIONS VENOUS THOMBOEMBOLISM ('Dr not sure this was related to vaccine'. His doctor 'approved a second dose of Covid19')

Approximately 36 hours after I received the first Moderna vaccine, I developed a high fever 101.5, chills and body aches lasting about 4 days. I went to healthcare facility and had a negative influenza and Covid tests at that time. 2 days later, I started to have difficulty breathing. I had a routine doctor appt scheduled for 3/25. When I arrived, my O2 sats were 80% and I was sent to the ER. There I had another negative Covid test. I was diagnosed with bil PE's and had a 8 days stay in the hospital, 6 days in ICU. I was sent home on long term medications and oxygen.

Next day after 2nd shot: Chills, fatigue, head ache, slight fever. They went away by end of 3rd day. About 1.5 weeks later all those side effects reemerged at a much greater amplitude. Also, I had trouble breathing and was very weak. I went to PCP and had low O2 at 92%. He thought I had COVID, but rapid test came back negative and chest x-ray was normal. Based on his recommendation and my O2 staying low, I went to emergency room 2 days later. The doctor there thought symptoms were consistent with COVID. I got another chest x-ray . It was normal. They performed a lot of blood analysis and found nothing acute and abnormal. They gave me a PCR test and it came back negative. I got diarrhea constantly for about a month. I slowly got better with my O2 returning to normal range and diarrhea over with.

persiseant hypoglycemia, cardiomyopathy with pulmonary edema, encephalopathy, elevated inflammatory markers, (ddimer, crp, esr)

Patient admitted to referring hospital on 5/18/2021 for fatigue and SOB, found to have pulmonary embolism (CT with central pulmonary emboli with right heart strain), alteplase was given at referring hospital and was admitted to ICU for continued monitoring. Venous duplex done also revealed bilateral DVTs. Patient was doing well after fibrinolytic with heparin anticoagulation, but had sudden decompensation on 5/21 (hypotension and respiratory failure requiring intubation). Transferred to current institution for ECMO evaluation due to severe cardiopulmonary compromise. Patient deemed not ECMO candidate based on co-morbid conditions based on CT findings. He underwent mechanical thrombectomy with improvement. He was continued on heparin infusion, then had sudden decrease in platelet on 5/25 with worsening cardiopulmonary status. HITT was suspected and heparin was transitioned to argatroban. Results of heparin induced platelet antibodies (PF4 ELISA assay) and Serotonin Release assay was negative. Repeat imaging revealed increase clot burden and therefore patient underwent catheter directed thrombolysis followed by aspiration suction thrombectomy. Due to high clinical suspicion of HITT, repeat heparin induced platelet and SRA sent and pending at the time of report. Of note, patient still in hospital at the time of this report

sick as a dog; Kidney's almost shut down both times; had 2-3 attacks; Unexplainable pain in lower stomach area; Health declined quickly; Heart issue after first shot of vaccine; Lungs have gotten worse since the first shot; grabbing and pulling at his chest; Unable to sleep; Foul smelling diarrhea; Terrible chest pain; Could not breath/Very difficult to breathe; Could not eat anything; didn't take the second dose of the Moderna COVID-19 vaccine; Sick as a dog; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RENAL IMPAIRMENT (Kidney's almost shut down both times), MYOCARDIAL INFARCTION (had 2-3 attacks) and ILLNESS (sick as a dog) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Peanut allergy, Fruit allergy (citrus allergy was reported.), Milk allergy (Dairy allergy was reported.), Drug allergy (demerol), Kidney disorder (Kidney disease was reported.) since 2008, Chronic pancreatitis since 2012, COPD since 2001, Heart disease, unspecified since 2000, Drug allergy (tramadol), Drug allergy (lorazepam), Food allergy and Food allergy. Concomitant products included ONDANSETRON, PANTOPRAZOLE, BUPRENORPHINE and SALBUTAMOL SULFATE (PROAIR HFA) for Chronic pancreatitis, LOSARTAN POTASSIUM (LOSARTAN [LOSARTAN POTASSIUM]) for Hypertension, FLUOXETINE HYDROCHLORIDE (PROZAC) for Mood depression, AMMONIUM BROMIDE, POTASSIUM BROMIDE, SODIUM BROMIDE (BROMIDES), TIOTROPIUM BROMIDE (SPIRIVA) and DIAZEPAM (VALIUM) for an unknown indication. On 03-Mar-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced RENAL IMPAIRMENT (Kidney's almost shut down both times) (seriousness criteria hospitalization, medically significant and intervention required), MYOCARDIAL INFARCTION (had 2-3 attacks) (seriousness criteria hospitalization, medically significant and intervention required), PRODUCT DOSE OMISSION ISSUE (didn't take the second dose of the Moderna COVID-19 vaccine) and ILLNESS (Sick as a dog). On 06-Mar-2021, the patient experienced ILLNESS (sick as a dog) (seriousness criteria hospitalization, medically significant and intervention required), DYSPNOEA (Could not breath/Very difficult to breathe) and FEEDING DISORDER (Could not eat anything). 06-Mar-2021, the patient experienced CHEST PAIN (Terrible chest pain). On 19-Mar-2021, the patient experienced DIARRHOEA (Foul smelling diarrhea). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Unexplainable pain in lower stomach area), GENERAL PHYSICAL HEALTH DETERIORATION (Health declined quickly), CARDIAC DISORDER (Heart issue after first shot of vaccine), LUNG DISORDER (Lungs have gotten worse since the first shot), CHEST DISCOMFORT (grabbing and pulling at his chest) and INSOMNIA (Unable to sleep). The patient was treated with TIOTROPIUM BROMIDE (oral) on 05-Mar-2021 at an unspecified dose and frequency; SIMETHICONE ongoing since an unknown date at an unspecified dose and frequency; PREDNISONE at a dose of 10 mg and OXYGEN at an unspecified dose and frequency. At the time of the report, RENAL IMPAIRMENT (Kidney's almost shut down both times) had not resolved and MYOCARDIAL INFARCTION (had 2-3 attacks), ILLNESS (sick as a dog), DYSPNOEA (Could not breath/Very difficult to breathe), FEEDING DISORDER (Could not eat anything), DIARRHOEA (Foul smelling diarrhea), ABDOMINAL PAIN UPPER (Unexplainable pain in lower stomach area), GENERAL PHYSICAL HEALTH DETERIORATION (Health declined quickly), CARDIAC DISORDER (Heart issue after first shot of vaccine), LUNG DISORDER (Lungs have gotten worse since the first shot), CHEST PAIN (Terrible chest pain), CHEST DISCOMFORT (grabbing and pulling at his chest), PRODUCT DOSE OMISSION ISSUE (didn't take the second dose of the Moderna COVID-19 vaccine), ILLNESS (Sick as a dog) and INSOMNIA (Unable to sleep) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal other. On an unknown date, SARS-CoV-2 test negative: negative negative. On an unknown date, Troponin: high (High) high. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient is on nebulizer treatment of tiotropium bromide and a lot of simethicone. Patient do not know if using either medication helped or not but that was my immidiate reaction. Now patient is on prednisone and feels like he's taking it just to breathe. Patient has had to go on 24 hr. oxygen since the first shot. Patient was negative for Covid-19 over the past 3 months at three different times. He continued to have terrible chest pain where he was grabbing and pulling at his chest, pain creeping up to his chest, could not breath or eat anything for 1 week after his first shot. Patient was in the ER on 10Mar2021. Caller stated he has chronic pancreatitis and breathing issues for which he was prescribed steroids, his doctor told him to decrease the prednisone to 10mg for 2 days prior and day of vaccination. Caller thinks he had a week long stroke since he had high Troponin level which resulted in visit to the hospital where the doctors thought he had septicemia. Caller stated he has not been able to sleep because he keeps having attacks of chest pains that last approximately 15 minutes in the middle of the sleep which occurs 4+ times per night. Kidney's have gotten worse since 1st shot vaccine. Doctors said "the kidney's took a shot" after the first shot of vaccine. Patient was admitted to the Hosp twice after the first shot because his kidneys almost shut down both times. Unexplainable, excruciating pain in chest and very difficult to breathe for approx. 10-15 minutes each attack. New, unexplainable pain in lower stomach area since 1st shot of vaccine. Doctors cannot explain. Patient is seeking legal action against Moderna. Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up received on 18 May 2021,included patient demography (Ethnicity, race, height, weight), allergy to peanuts, citrus, dairy, Demerol, tramadol, lorazepam. Current medical condition kidney disease was updated. concomitant medications were buprenorphine, pantoprazole, ondansetron, losartan, Prozac with product indications were updated. Laboratory information EKG was updated. Events Kidney's have gotten worse, unexplainable pain in lower stomach area, my health has declined, lungs have gotten worse was updated. On 23-May-2021: follow-up appended, conmeds added, NF added to events, new events added, new allergies coded, generated narrative.; Sender's Comments: This case concerns a male patient of unknown age who missed second dose due other adverse events experienced post first dose of mRNA-1273. The other events show temporal association with the use of mRNA-1273 and a causal relationship cannot be excluded. However, the patient has concurrent history that confounds the reported events to include chronic pancreatitis, COPD, kidney and heart disorder. Missed dose is assessed as not applicable

3/26 temp started of over 100F x3 days, severe ache in every joint, hard to concentrate or remember; on 3/28, started rash all over body so called MD, they did COVID-19 test which was negative; that afternoon, rash went up neck and side of face -went to Urgent Care, had elevated pulse (120 bpm) so did EKG and other tests, got IVs hooked up and provider thought he was having a heart attack so transferred from clinic to ER -received steroids and rash went away almost immediately, determined was not a heart attack, believed instead a side effect from COVID-19 vaccination. lingering effects of fatigue, shortness of breath, ears ringing. now has new diagnosis of asthma and on inhaler.

Outcome: Patient Death CHIEF COMPLAINT in ER: chest pain, SOB History of Present Illness: Patient is a 66 yo with PMH of chronic afib on chronic anticoagulation who presented to the ER with a chief complaint of shortness of breath and increased fatigue over the past several weeks that has progressively become worse. Patient denies orthopnea or PND but does have some palpitations and occasional chest pain associated with increased fatigue with exertion. On evaluation emergency room patient was noted to be tachycardic consistent with chronic atrial fib, also acute renal insufficiency likely secondary to dehydration. Patient is admitted to the medical service for further treatment and evaluation. DEATH SUMMARY Date of Admission: 04/07/2021 Time of Death: 04/10/2021 at 0737 Final Diagnoses: 1. Sudden Cardiac Death 2. Acute Renal Impairment Secondary to Hypovolemia, A TN 3. Chronic Atrial Fibrillation w/ RVR, Resolved 4. Atypical Chest Pain, Resolved 5. Hypokalemia, Resolved 6. Obstructive Sleep Apnea 7. Chronic Diastolic Heart Failure Hospital Course: Patient is a pleasant 66yo admitted for acute renal impairment secondary to significant o hypovolemia resulting in ATN as well as atrial fibrillation w/ RVR after presenting to ER with complaints of chest pain, dyspnea, malaise, and anorexia that began after receiving his second COVID vaccine on 4/01/2021. Please see H&P for full details. Patient reported that on the day after his COVID #2 vaccine, he lost his appetite and was not able to eat or drink. He continued to take his home medications as prescribed including losartan, chlorthalidone, and meloxicam. After experiencing progressive worsening of symptoms for 5 days, patient presented to ER for further evaluation. Upon arrival to ER, patient was noted to be hypotensive and tachycardic. EKG showed atrial fibrillation w/ RVR. Routine labs were obtained and were remarkable for elevated creatinine and mild hypokalemia w/ normal BNP and negative cardiac enzymes. CXR showed enlarged cardiac silhouette, but no evidence of pulmonary edema or other acute abnormalities. Patient was subsequently admitted for further evaluation and medical management. He was staited on aggressive IV hydration for his hypotension and hypovolemia w/ PRN IV metoprolol as needed for HR> l lObpm. He was continued on anticoagulation. Serial cardiac enzymes were obtained and were negative. TIE report from Dr's office that was performed recently was obtained and showed EF of 55-60% with Grade 1 diastolic dysfunction. Patient's wife brought his CPAP from home and patient wore his CPAP while sleeping during his hospital stay. During the course of hospitalization, patient's blood pressure & HR improved, though he remained in atrial fibrillation. His creatinine continued to trend up consistent with ATN, but patient continued to produce adequate urine and he had no signficant electrolyte derangements. IVF were adjusted based on urine output and volume status. Patient had no recurrence in his presenting complaint of chest pain and he overall reported feeling better throughout his course of hospitalization despite reporting that he continued to have little appetite. Patient was monitored closely on telemetry throughout his hospital stay. On the morning of 4/10/2021, lab tech and nurse walked into the patient's room to obtain specimen for AM labs. Patient reportedly tried to get out of the bed independently, grabbed at his chest & pulled off his telemetry, and fell to his knees. Staff called Code 99 and patient was placed back in the bed. He was noted to be in asystole. ACLS was performed and despite maximal efforts, patient subsequently expired at 0737. I personally called the patient's cardiologist & personal friend, to discuss the events leading up to the patient's death. Upon review of the patient's course of hospitalization, it was felt that patient most likely experienced sudden cardiac death. Of note, Dr reports that the patient frequently contacts him via text message with concerns or complaints. He states that the patient did not message him during the hospitalization to report any chest pain or other concerns. Disposition: Patient Expired

Pt was admitted to Medical Center on 4/21/21 from the ED for COPD exacerbation. 11 days after receiving the second dose of vaccine. Per guidelines, all hospitalizations are to be reported.

It felt a little sore for the first day or two. I am semi retired. Everything was good until 5 days later at 3am. I could not breathe and my fever was 103 degrees. My wife called an ambulance and sent me to the hospital after breathing treatment. I was on a-fib and the doctors/nurses trying to send me back to life. I spent 7 days in the hospital. Blood work, Nuclear tests, fluid tests, lung tests, X-rays, biopsy into my lung and got tissue to get an amount (Bronchoscope). I was very scared. I had pneumonia too. Every 6 hours, breathing treatments.

Dehydrated; Collapsed; Cardiac death/the patient woke up and then grab it's chest and collapsed; Started having heart issues; Chest pain; Lose it's appetite; Thirsty; Short of breath/got very winded; Fatigue/ very tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CARDIAC DEATH (Cardiac death/the patient woke up and then grab it's chest and collapsed), DEHYDRATION (Dehydrated) and CIRCULATORY COLLAPSE (Collapsed) in a 66-year-old male 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 CHLORTHALIDONE, LOSARTAN POTASSIUM, MELOXICAM, METOPROLOL SUCCINATE, PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTOPRAZOLE SODIUM), TAMSULOSIN HYDROCHLORIDE (TAMSULOSIN HCL), RIVAROXABAN (XARELTO), AMLODIPINE BESILATE (AMLODIPINE BESYLATE) and TADALAFIL for an unknown indication. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced DEHYDRATION (Dehydrated) (seriousness criterion hospitalization), CARDIAC DISORDER (Started having heart issues), CHEST PAIN (Chest pain), DECREASED APPETITE (Lose it's appetite), THIRST (Thirsty), DYSPNOEA (Short of breath/got very winded) and FATIGUE (Fatigue/ very tired). On an unknown date, the patient experienced CIRCULATORY COLLAPSE (Collapsed) (seriousness criterion medically significant). The patient died on 10-Apr-2021. The reported cause of death was Cardiac death. An autopsy was not performed. At the time of death, DEHYDRATION (Dehydrated), CIRCULATORY COLLAPSE (Collapsed), CARDIAC DISORDER (Started having heart issues), CHEST PAIN (Chest pain), DECREASED APPETITE (Lose it's appetite), THIRST (Thirsty), DYSPNOEA (Short of breath/got very winded) and FATIGUE (Fatigue/ very tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: inconclusive (Inconclusive) Inconclusive and inconclusive (Inconclusive) Inconclusive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Action taken with the mRNA-1273 vaccine due to the events was not applicable. The reporter informed that the patient had received both doses of mRNA-1273 vaccine. He first lost his appetite and started feeling thirsty on the following day after vaccination, which worsened progressively for the next five days. The patient then started having chest pain, was short of breath and experienced fatigue. He got very winded when he went to the bathroom and felt very tired for the next two days, When he went to the hospital, the doctor said that he would need to be admitted if he doesn't feel well. On a Wednesday, the patient went to the hospital and an ECG was done. The reporter informed that when the doctor compared it with an ECG from few days before, he could not believe it was of the same patient's. The patient was taken to the ER (emergency room) and was them transferred to ICU (intensive care unit) as he was dehydrated. Dehydration was treated and at the time the patient started having heart issues. By Friday, the patient started doing better and the doctor discussed discharging him. On Saturday, when the patient woke up he grabbed his chest and collapsed. The reporter informed that they were not able to get an autopsy but the death was assumed to be cardiac death. It was reported that the patient passed away approximately nine days after receiving the second dose of the vaccine. The reporter further informed that the patient was in good health and had a full 'cardiac work' prior to his vaccination. Company comment: Very limited information regarding this event has been provided at this time. Details regarding medical history and course in the hospital is required for further evaluation.; Sender's Comments: Very limited information regarding this event has been provided at this time. Details regarding medical history and course in the hospital is required for further evaluation.; Reported Cause(s) of Death: Cardiac death

Pt with no active medical problems other than diet controlled diabetes had his Moderna COVID vaccines 02/16 and 03/16/2021. He presented to the hospital with c/o 2 mo (since around 4/14) of progressive fatigue and weakness which progressed to dizziness and now shortness of breath the past month and was found to have profound pancytopenia. He had no history of alcohol use, b 12 or folate deficiancy, no recent illness, no medications, HIV and hepatitis testing were negative. He does not smoke. He had no prior history of problems with his white blood cell count, red blood cell count or platelet count. He admitted that shortly after his second vaccine he began to feel fatgiued with symptoms progressing afterwards. Upon admission his hemoglobin was 6.7 and he was given 2 units of blood. His D-dimer was elevated at 1224 and a CTA of the chest was negative for PE. His PT/INR PTT were within normal limits EKG showed no acute ischemia and normal sinus rhythm. Fibrinogen was 246. His iron was 238 saturation of 77 TIBC of 309 and ferritin of 941. His hemoglobin A1c was 6.0. He was seen during his hospital stay by Hematology/oncology . vitamin B12 and folate levels were normal. He has no prior history of malignancy. Patient's ultrasound of the abdomen showed no splenomegaly. Again vitamin B12 and folic acid levels were normal. A peripheral blood smear was done which was concerning per oncology for an underlying bone marrow condition. Ultimately his bone marrow biopsy showed Acute myeloid leukemia with blasts and monocyte features.

After 3 days, chest pain that lasted 6 days, noticeable but not worrisome (grade 3-5 out of 10). More noticeable chest pain after 8 weeks(after 2nd shot) which last a day or two (grade 7-concernable) and some shortness of breath. #2 restless leg syndrome 3 weeks after first shot (related or not?) #3 oozing raw burn mark which occurred 5 days after SECOND SHOT, quarter-sized, shaped like a horseshoe

Reaction noted 2 days after 2nd Moderna vaccine, continuous Oxygen has been ordered ( patient has been seen several times for Sx: COPD exacerbation Fatigue Myalgia Hypoxia

Sudden cardiac death; Acute kidney injury; Atrial fibrillation; Cardiac arrest; Cardio-respiratory arrest; Cardiomegaly; Chest pain; Chronic left ventricular failure; Condition aggravated; Decreased appetite; Dehydration; Diastolic dysfunction; Dyspnoea; Fall; Fatigue; Feeding disorder; Fluid intake reduced; Hypokalaemia; Hypotension; Hypovolaemia; Malaise; Palpitations; Renal impairment; Renal tubular necrosis; Sleep apnoea syndrome; Tachycardia; This case was received via DA VAERS (Reference number: 1391483) on 22-Jun-2021 and was forwarded to Moderna on 22-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of SUDDEN CARDIAC DEATH (Sudden cardiac death), ACUTE KIDNEY INJURY (Acute kidney injury), ATRIAL FIBRILLATION (Atrial fibrillation), CARDIAC ARREST (Cardiac arrest), CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest), CARDIOMEGALY (Cardiomegaly), CHEST PAIN (Chest pain), CHRONIC LEFT VENTRICULAR FAILURE (Chronic left ventricular failure), CONDITION AGGRAVATED (Condition aggravated), DECREASED APPETITE (Decreased appetite), DEHYDRATION (Dehydration), DIASTOLIC DYSFUNCTION (Diastolic dysfunction), DYSPNOEA (Dyspnoea), FALL (Fall), FATIGUE (Fatigue), FEEDING DISORDER (Feeding disorder), FLUID INTAKE REDUCED (Fluid intake reduced), HYPOKALAEMIA (Hypokalaemia), HYPOTENSION (Hypotension), HYPOVOLAEMIA (Hypovolaemia), MALAISE (Malaise), PALPITATIONS (Palpitations), RENAL IMPAIRMENT (Renal impairment), RENAL TUBULAR NECROSIS (Renal tubular necrosis), SLEEP APNOEA SYNDROME (Sleep apnoea syndrome) and TACHYCARDIA (Tachycardia) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The patient's past medical history included Coronary artery disease, Congestive heart failure, Hypertension, Atrial fibrillation (Chronic Afib), Pulmonary hypertension, Cholecystectomy, Hernia repair, Tonsillectomy and Anticoagulant therapy on 02-Apr-2021. Concomitant products included CHLORTHALIDONE, LOSARTAN POTASSIUM (LOSARTAN POTASSIUM ACCORD), MELOXICAM and METOPROLOL SUCCINATE for an unknown indication. On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced ACUTE KIDNEY INJURY (Acute kidney injury) (seriousness criteria hospitalization, medically significant and life threatening), ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criteria hospitalization, medically significant and life threatening), CARDIAC ARREST (Cardiac arrest) (seriousness criteria hospitalization, medically significant and life threatening), CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) (seriousness criteria hospitalization, medically significant and life threatening), CARDIOMEGALY (Cardiomegaly) (seriousness criteria hospitalization and life threatening), CHEST PAIN (Chest pain) (seriousness criteria hospitalization and life threatening), CHRONIC LEFT VENTRICULAR FAILURE (Chronic left ventricular failure) (seriousness criteria hospitalization and life threatening), CONDITION AGGRAVATED (Condition aggravated) (seriousness criteria hospitalization and life threatening), DECREASED APPETITE (Decreased appetite) (seriousness criteria hospitalization and life threatening), DEHYDRATION (Dehydration) (seriousness criteria hospitalization and life threatening), DIASTOLIC DYSFUNCTION (Diastolic dysfunction) (seriousness criteria hospitalization and life threatening), DYSPNOEA (Dyspnoea) (seriousness criteria hospitalization and life threatening), FALL (Fall) (seriousness criteria hospitalization and life threatening), FATIGUE (Fatigue) (seriousness criteria hospitalization and life threatening), FEEDING DISORDER (Feeding disorder) (seriousness criteria hospitalization and life threatening), FLUID INTAKE REDUCED (Fluid intake reduced) (seriousness criteria hospitalization and life threatening), HYPOKALAEMIA (Hypokalaemia) (seriousness criteria hospitalization, medically significant and life threatening), HYPOTENSION (Hypotension) (seriousness criteria hospitalization and life threatening), HYPOVOLAEMIA (Hypovolaemia) (seriousness criteria hospitalization and life threatening), MALAISE (Malaise) (seriousness criteria hospitalization and life threatening), PALPITATIONS (Palpitations) (seriousness criteria hospitalization and life threatening), RENAL IMPAIRMENT (Renal impairment) (seriousness criteria hospitalization, medically significant and life threatening), RENAL TUBULAR NECROSIS (Renal tubular necrosis) (seriousness criteria hospitalization, medically significant and life threatening), SLEEP APNOEA SYNDROME (Sleep apnoea syndrome) (seriousness criteria hospitalization and life threatening) and TACHYCARDIA (Tachycardia) (seriousness criteria hospitalization and life threatening). The patient died on 10-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, ACUTE KIDNEY INJURY (Acute kidney injury), ATRIAL FIBRILLATION (Atrial fibrillation), CARDIAC ARREST (Cardiac arrest), CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest), CARDIOMEGALY (Cardiomegaly), CHEST PAIN (Chest pain), CHRONIC LEFT VENTRICULAR FAILURE (Chronic left ventricular failure), CONDITION AGGRAVATED (Condition aggravated), DECREASED APPETITE (Decreased appetite), DEHYDRATION (Dehydration), DIASTOLIC DYSFUNCTION (Diastolic dysfunction), DYSPNOEA (Dyspnoea), FALL (Fall), FATIGUE (Fatigue), FEEDING DISORDER (Feeding disorder), FLUID INTAKE REDUCED (Fluid intake reduced), HYPOKALAEMIA (Hypokalaemia), HYPOTENSION (Hypotension), HYPOVOLAEMIA (Hypovolaemia), MALAISE (Malaise), PALPITATIONS (Palpitations), RENAL IMPAIRMENT (Renal impairment), RENAL TUBULAR NECROSIS (Renal tubular necrosis), SLEEP APNOEA SYNDROME (Sleep apnoea syndrome) and TACHYCARDIA (Tachycardia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Blood creatinine: increased (Inconclusive) increased. On 02-Apr-2021, Chest X-ray: abnormal (abnormal) CXR showed enlarged cardiac silhouette.. On 02-Apr-2021, Echocardiogram: normal (normal) normal. On 02-Apr-2021, Ejection fraction: normal (normal) 55-60% with Grade 1 diastolic dysfunction. On 02-Apr-2021, Electrocardiogram: abnormal (abnormal) atrial fibrillation. On 02-Apr-2021, Myocardial necrosis marker: normal (Negative) normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Advanced Cardiovascular Life Support (ACLS) was performed and despite maximal effort, the patient subsequently expired at 0737. Company Comment : This is a case of death in a 66-year-old male patient with medical history of Coronary artery disease, Congestive heart failure, Hypertension, Chronic Atrial fibrillation and Pulmonary hypertension, that occurred 10 days after receiving second dose of vaccine (Lot number unknown). The patient experienced sudden cardiac death during hospitalization for worsening dyspnea in the past weeks prior to hospitalization. No further information is expected.; Sender's Comments: This is a case of death in a 66-year-old male patient with medical history of Coronary artery disease, Congestive heart failure, Hypertension, Chronic Atrial fibrillation and Pulmonary hypertension, that occurred 10 days after receiving second dose of vaccine (Lot number unknown). The patient experienced sudden cardiac death during hospitalization for worsening dyspnea in the past weeks prior to hospitalization. No further information is expected.; Reported Cause(s) of Death: unknown cause of death

Heart Failure; troubled breathing; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of CARDIAC FAILURE (Heart Failure) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COPD since an unknown date and Arteriosclerosis since an unknown date. On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced DYSPNOEA (troubled breathing). On an unknown date, the patient experienced CARDIAC FAILURE (Heart Failure) (seriousness criteria death and medically significant). The patient died on 29-May-2021. The reported cause of death was Chronic obstructive pulmonary disease, Heart failure and Atherosclerosis. It is unknown if an autopsy was performed. At the time of death, DYSPNOEA (troubled breathing) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. No concomitant product information was provided. No treatment information was provided. This is a 66-year-old male patient who experienced CARDIAC FAILURE and died 30 days after receiving mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. unknown). Patient had a concurrent CHRONIC OBSTRUCTIVE PULMONARY DISEASE, and ARTERIOSCLEROSIS. It is unlikely, that the events are related to the vaccine based on long standing illness of COPD and Arteriosclerosis. Very limited information has been reported at this time. Further information is expected.; Sender's Comments: This is a 66-year-old male patient who experienced CARDIAC FAILURE and died 30 days after receiving mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. unknown). Patient had a concurrent CHRONIC OBSTRUCTIVE PULMONARY DISEASE, and ARTERIOSCLEROSIS. It is unlikely, that the events are related to the vaccine based on long standing illness of COPD and Arteriosclerosis. Very limited information has been reported at this time. Further information is expected.; Reported Cause(s) of Death: Chronic Obstructive Pulmonary Disease; Heart Failure; Atherosclerosis

?Moderna COVID-19 Vaccine EUA? Patient states that 5 minutes after receiving the vaccination he started to develop HIVES, and SOB and lightheadness. Patient admits he was given Benadryl IM at vaccination drive thru clinic and was transported to ER.

Immediately started getting rapid heart beat, difficulty breathing, dizziness. Half an hour later got chest pain, mental confusion and slurring of speech. Had to sit for over 30 minutes. Is allergic to Epinephrine so not able to give Epi Pen. Just had observation. It lasted a little over an hour, but was still dizzy. On 1/21/21 felt horrible, felt like he was getting sick, but has now recovered fully from the event.

About six minutes after the vaccination, while sitting in the clinic, I experienced a feeling like I was about to lose consciousness, together with salivary gland activation and heavier breathing. This lasted about one minute and I did not pass out. But about 25 minutes later, while driving home (alone), I experienced the same thing but for about 5 or 6 minutes. Fortunately I didn't pass out. About an hour after the shot I felt sort of back to normal.

Fever, body aches, weeknesss,temperature of 100.3, swollen neck, shortness of breath and chest pain.nousea Tylonal, phenergan, Benadryl Waiting to see if this helps

Resident woke up flushed appearing, he had the chills, pale looking. His gait was unsteady, lethargic, confusion, and complaints of shortness of breath.

Patient vaccinated on 1/12/21 at 10:19 and returned to vaccination clinic at 11:55. Appeared short of breath when walking in with respiration rate 24-26. Staff reported he presented with same appearance with first arrival prior to vaccination. Patient stated "I just don't feel good and I'm shaky". He was asked to be seated and within 5 minutes respiratory rate decreased to 20-22. Vital signs taken RR-22, B/P-110/80, HR-70 and regular, Temp-97.1. Pt states his primary care provider office is closed today. I instructed him to go to our Emergency Room for evaluation which he refused stating "I hate hospitals". After 30 minutes of observation patient stated "I'm leaving and going to see my sister who is a nurse". Treatment in our ED offered multiple times with refusal. Patient appeared stable when leaving.

Patient complained shortness of breath/feeling hot and vitals 156/96, 65, 97% RA Patient given Benadryl 1tab with resolution of symptoms.

Systemic: Fainting / Unresponsive-Severe, Systemic: shortness of breath-Severe, Systemic: Seizure-Severe, Systemic: Shakiness-Severe, Additional Details: Patient was sitting in observation when he suddenly had his head and eyes rolled back. Patient's daughter alerted the pharmacist on duty that he felt like he couldn't breathe. Patient went into a possible seizure. His eyes rolled back and his body went stiff. After a few minutes, patient was alert and oriented enough to answer questions coherently before the ambulance arrived. Patient went on the ambulance.

1114 C/O SOB 4 MINUTES AFTER RECEIVENG SECOND MODERNA DOSE 1123 98% ROOM AIR 137/74 BP 72 HR PPT C/O SOB 4 MINUTES AFTER RECEIVING SECOND DOSE OF MODERNA VACCINE VITALS STAABLE, OC SAT 98R/A. PATIENT DOES NOT APPEAR TO BE IN DISTRESS. PATIENT GIVEN WATER TO DRINK. WILL CONTINUE TO MONITOR 1127 PATIENT REPORTS HE FEELS BETTER. INSTRUICTED PATIENT TO STAY IN OBSERVATION FOR AT LEAST 30 MINUTES, WILL FOLLOWUP WITH HIM BEFORE LEAVING. PATIEN ADVISED IF CHANGE IN PHYSICAL CONDITION ONCE LEAVING, NOTIFY PCP, IF LIFE THREATENING CALL 911 OR GO TO NEAREST ER

50 minutes after covid vaccine patient reported coughing up a small amount of blood while at dialysis center. Dialysis was delayed a day. Patient reported low BP, swelling on neck and mild shortness of breath.

Patient got up from the seat where he received his vaccine and was walking to the back to be seated and monitored. He past out once he got to the back. He hit the right side of his head. As he came too he reported mild nausea. He denied any pain or vision changes. He then reported a history of diabetes. He stated he had dialysis this morning and took insulin prior to coming to vaccine clinic but did not eat anything. He took a few sips of juice. He was diaphoretic and clammy. Pulse was 46, SPO2 was 96%. He had a mild audible murmur. Lung sounds: wheezing and crackles. There was a small area of swelling noted to the right side of his head. EMS was called for transport due to hitting his head and history of taking blood thinners.

Felt SOB, little headache. After getting home, felt more fatigued, tiredness, tingling in throat, eyelids appear darker. Biggest complaint is being tired and fatigued.

pt stated the night after he got the vax he had flu like symptoms. He was nauseas, dizzy, breathing heavy, fever. pts left arm started hurting about 3 days later. It was sore, red, and itchy. Pt states he feels better today.

Two hours after receiving the vaccine on 3/4/21, he started feeling very tired and had a 100.2 temp. By evening he was feeling very cold and not eating much. On 3/5/21 he was sleeping alot, had headache, chills and fever, no appetite, diaphoretic. At 8pm he could not get up out of his chair and was disoriented. Wife call an ambulance. He was admitted for altered mental status. Blood cultures showed streptococcus pneumoniae. He was hypoxic at 89%. BP 171/96, pulse 85, temp 37.3C. Chest xray showed bilteral infiltrates and a masslike density in the right lung apex. Encephalopathy, pneumonia and sepsis diagnosed. Ct of head normal.WBC count 19 and amonia 24. Wife told me he had a spinal tap on 3/9/21 and that it showed bacterial meningitis. I do not have the lab reports on that yet. THe infection control doctor told wife he is critical.

March 7: After 3-4 days or worsening dyspnea, pt requested ambulance transport to our ED. Upon arrival, pt was very SOB so full workup ensued. Pt was found to have elevated BTNP at 2240 pg/ml with fluid overload, and Biofire Respiratory Panel showed Coronavirus PCR positive. At that time, his COVID markers were also elevated. CRP 91.4 mg/L, D-Dimer 2340 ng/mL. Patient was admitted, diuresed, and started on inpatient COVID protocol which included Ivermectin. March 9: EKG was performed and patient was found to have a heart block. All labs had improved over the past 48 hrs. BTNP reduced to 1530, D-Dimer reduced to 1700, CRP reduced to 47.9. Due to the heart block, patient was transferred to a care center to a cardiologist. Just prior to transfer, a follow up Biofire respiratory panel showed Coronavirus PCR NEGATIVE. PCR positive and negative results were relayed to accepting facility - facility and they were going to refer to epidemiology for follow up.

started with minor swelling in glands, then tightness of chest, breathing difficulty, then eyes began to swell,

numbness to left side of face approximately 30 minutes after vaccine.. lasted 3 days ( 2/15-2/18) weakness, fatigue , shortness of breath, used my asthma puffer, went out for walk with my dogs as I usually do on a mountain path, elevation 5-6,000 ft and broke out in heavy sweats, and shortness of breath. these symptoms lasted about 3 days.. I was scheduled for the 2nd moderna covid shot today 3/15/21 but after talking to the nurses there they advised me to fill out this report and postpone the 2nd shot until I hear from you,

Headache, Fever, CoughWheeze, Diarrhea, NauseaVomiting, bodyaches Narrative: Reported mild symptoms. Treating at home with OTC meds Other Relevant History:

Several hours after injection I began experiencing severe and extreme muscle and joint pain in head, neck, and left shoulder and arm. Further into the evening and past midnight I started experiencing shortness of breath and extreme headache pain above the eyes. Extremely Sharp pain in the right arm and shoulder, felt like my arm was being aggressively yanked. I then became panicky and decided to call a 24 Hour nurse service and describe what I was experiencing. After spending 20 minute on the phone with the nurse she concluded that an emergency room visit was necessary but that I should contact my doctor at the beginning of the next business day. The pain still exists.

Participant felt flushed, feverish, fatigued with general aches and dry cough over the weekend after receiving injection, took acetaminophen and cough syrup on Monday. He became short of breath on 1/20/2021 and was hypoxic on oximeter check, was sent to the ER. He was intubated in ER and went into respiratory failure with sepsis due to COVID19. He was treated with tocilzumab, became paralyzed and DVT in left lower extremity was found. HE required pressors and diuresis, he developed AKI and hyperkalemia. On 2/21 he was in multi-organ failure. His level of cognition decreased until he was no longer responsive and he died on 2/24/2021.

Congestion; After getting the vaccine the COPD was worse; After getting the vaccine the COPD was worse, but now is better than before; did not feel well; recover appetite; headaches; Had no energy,felt weak for 3-4 days.; Chills; A spontaneous report was received from a consumer who is a 67-year-old male patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced congestion, COPD worsening, not feeling well, lack of energy, feeling weak for 3-4 days, chills and headache. He also reported an improvement of the pre-existing COPD after receiving the vaccine and experiencing the exacerbation. Medical history includes COPD (Chronic Obstructive Pulmonary Disease) and emphysema. Concomitant medications include oxygen, salmeterol xinafoate/fluticasone propionate and Tiotropium bromide. On 27-JAN-2021, this patient received their first of two planned doses of mRNA-1273 (Lot/Batch number: 007M20A) intramuscularly in his left arm for prophylaxis of COVID-19 infection. On 27-JAN-2021, the day of vaccination, the patient felt fine, up until bedtime. When they started to undress for bed the patient experienced chills. He put on sweatpants, socks, and some warm clothes to get warm. The patient managed to get to sleep. The next day, the patient did not feel very well at all. The patient describe as having no energy and felt weak for 3-4 days. He also had headaches, for which he took some Tylenol. Towards the weekend he recovered his appetite and started to feel better. The patient mentioned they used a nebulizer to treat some congestion they experienced. He stated, at first after getting the vaccine, the COPD was worse, but now it was better than before the vaccine. Patient was suppose to get second dose next week and wonders if they should. Event congestion was considered medically significant. Laboratory test were not reported. Action taken with the drug in response to the events is unknown. The outcome for the events, congestion, COPD worsening, not feeling well, lack of energy, feeling weak for 3-4 days, chills and headache, was recovered. The outcome for the event preexisting condition improved 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.

chest congestion; sore arm; A spontaneous report was received from a consumer concerning a 67- year old-male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chest congestion and vaccination site pain. The patient's medical history was not provided.No relevant concomitant medications were reported. On 30-Jan-2021,prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot/batch 007M20A) on left arm for prophylaxis of COVID-19 infection. On an unknown date,the patient experienced chest congestion and sore arm. No laboratory data was provided.Treatment information was not provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events chest congestion and pain in arm was considered as unknown at the time of the 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 event, a causal relationship cannot be excluded.

Patient passed away; Heavy breathing; Shortness of breath; Low temperature; Tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEATH (Patient passed away) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication. On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced BODY TEMPERATURE DECREASED (low temperature) and FATIGUE (tired). On 20-Mar-2021, the patient experienced DEATH (Patient passed away) (seriousness criterion death), DYSPNOEA (heavy breathing) and DYSPNOEA (shortness of breath). The patient died on 20-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, DYSPNOEA (heavy breathing), DYSPNOEA (shortness of breath), BODY TEMPERATURE DECREASED (low temperature) and FATIGUE (tired) outcome was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. The fatal outcome may be related to the patient's pre-existing comorbidities. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death

fever (100.2F), chills, nausea, shortness of breath, tired, headache Nausea was first about 3 hours after shot (Tuesday). Then chills and body aches about 5 hours after shot. Very little sleep that night took Tylenol before bed. In morning (Wednesday) of next day had 100.2F fever and bad headache with body aches. Nausea left during day. Temp was 99.6F just before bed time Wed night. Fever broke around 2am Thursday with night sweats. Thursday - no fever or headache or aches, but still tired and feel feverish with activity. Right arm still sore.

Pain in the chest; Water in lungs; Pain in the neck and left side of sternum; Soreness in arm; Fatigue; A spontaneous report was received from a consumer, concerning a 67 year old male patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced pain in the chest (chest pain), water in lungs (pleural effusion), pain in the neck that went down the left side of sternum (neck pain radiation), soreness in arm (pan in extremity) and fatigue. The patient's medical history was not provided. Concomitant medications reported included warfarin sodium, ezetimibe, fiber, and vitamin D NOS. On 06 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: 011L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 03 Feb 2021, prior to the onset of events, the patient received the second of two planned doses of mRNA-1273 (Lot number: 028L20A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 03 Feb 2021, an unspecified duration after receiving the vaccine, the patient experienced soreness in the arm and fatigue. On 08 Feb 2021, the patient experienced pain in the neck on the left side which radiated to the left side of sternum. On 12 Feb 2021, in the morning, the patient experienced a huge pain in the chest and called 911 for an ambulance. The cardiologist and pulmonologist stated that everything was fine except that there was some water in the lungs. The patient still has pleural effusion. On the same day, the patient underwent electrocardiogram (EKG) and heart CT without significant findings and no abnormalities. The patient was recommended for a computerised tomography (CT) arteriogram. Treatment medications included acetaminophen, codeine, fentanyl, and concomitant medications. Action taken with second dose of mRNA-1273 in response to the events was not applicable. The outcome of the events, pain in the chest, water in lungs, pain in the neck that went to the left side of sternum, soreness in arm, and fatigue were not reported.; 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.

Chills with severe shaking, Fever 101.6, Sweats, Fatigue, Loss of appetite, Malaise, Spo2 on 8 liters of oxygen dropped to 70, coughing increased shortness of breath

04/01/2021 (Same day as vaccination): fatigue 04/02/2021: fatigue, insomnia, muscle aches, joint aches, headache, fever, congestion, shortness of breath, gastrointestinal pain/aches, vertigo, blurry vision, chills, overheating, excessive sweating, slowed thinking, lack of appetite 04/03/2021: same as previous day, but a little less severe 04/04/2021 ~ 04/08/2021 (less severe than previous days): fatigue, muscle aches, headache, congestion, shortness of breath, vertigo, blurry vision, slowed thinking I believe that either the vaccination exacerbated the symptoms of my Lyme disease, or the Lyme disease exacerbated the side effects of the vaccination.

67 y.o. male with past medical history of asthma, prostate cancer, GERD, hyperlipidemia, hypertension who was admitted with chest tightness and sob was found to have b/l PE after moderna vaccine for COVID (3/26) second dose otherwise nothing different in his life and PE could have been caused by COVID 19 vaccine.

Tightness of chest with suppressed breathing abilities. Subsequently, on and off impaired breathing; unknown as to relation(s) to ongoing medical problems or illness in my trunk (torso) area.

Short of breath just walking- wheezing-dizziness- It is now a month later and still short of breath in all that I do Primary care dr. gave 2 series of steroids and bacterial infection meds (no help) chest xray--cta scan- ekg-he couldn't see a major lung problem so he sent me to the hospital for a cardiac stress test. Hospitalized for 5 days-more steroids and antibacterial in saline solution- oxygen blood gas level down so administered-cardiac stress test- respitory stress test-respitory therapy-blood drawn all in normal ranges-blood gases normal-hematology-normal,chemistry-normal,immuno/serology-normal, abdomen ultrasound

Chief Complaint Patient presents with ? Fatigue C/o feeling like he was going to faint since yesterday. Is feeling very weak. C/o still coughing and spitting up some green phlegm. Admitted to hospital

67-year-old male with PMH of asthma history of prostate cancer, GERD, hypertension, hyperlipidemia presents on 4/2/21 from doctor's office for evaluation of shortness of breath with exertion over the prior 3 days associated with some chest pain. He received COVID vaccine on 03/26 with Moderna vaccine (second dose) and was doing well until 3 days PTA. In the doctor's office patient had an EKG that was read as atrial flutter and doctor sent patient to the ED for rule out PE and evaluation of chest pain and shortness of breath. CTA chest showed numerous bilateral pulmonary emboli and evidence of right heart strain. Of note, his father had history of pulmonary embolism as well as rectal cancer. Patient was evaluated by pulmonologist and cardiologist and was started on full-dose anticoagulation for PE treatment. Patient did not report anything different in his life that may have contributed to development of PE (besides COVID vaccine). He denies any prior cardiac history and indicated maintaining an active lifestyle. Patient had symptomatic improvement and was discharged on full-dose rivaroxaban.

3 days after 2nd Moderna vaccine developed fevers, chest pain, shortness of breath. Now found to have probable constrictive pericarditis without clear etiology.

THREE DAYS AFTER GETTING HIS 2ND DOSE OF MODERNA THE PATIENT DEVELOPED SOB AND WAS FOUND TOP HAVE BILATERAL PULMONARY EMBOLISM AND DVT

Patient hospitalized Hospital Admission Diagnoses: Severe sepsis (CMS/HCC) [A41.9, R65.20] Discharge Diagnosis: Patient Active Problem List Diagnosis Date Noted *Elevated troponin 03/30/2021 *B12 deficiency 03/30/2021 *Acute systolic heart failure (CMS/HCC) 03/25/2021 Discharge Diagnoses: Patient Active Problem List Diagnosis Date Noted *Elevated troponin 03/30/2021 *B12 deficiency 03/30/2021 *Acute systolic heart failure (CMS/HCC) 03/25/2021 *Acute respiratory failure with hypoxia (CMS/HCC) 03/24/2021 *Acute pulmonary edema (CMS/HCC) 03/24/2021 *IVH (Intraventricular hemorrhage) (CMS/HCC) 06/06/2018 *Brain edema (CMS/HCC) 06/06/2018 *Brain compression (CMS/HCC) 06/06/2018 *Benign essential HTN *Coronary artery disease * Type 2 diabetes mellitus with hemoglobin A1c goal of less than 7.0% (CMS/HCC) *Nontraumatic right thalamic hemorrhage (HCC) 06/05/2018 Consults: IP CONSULT TO PULMONOLOGY IP CONSULT TO CARDIOLOGY INPATIENT CONSULT TO PHARMACY INPATIENT CONSULT TO PHARMACY IP CONSULT TO NUTRITION SERVICES IP CONSULT TO NUTRITION SERVICES Procedures: Intubation Catheterization Significant Diagnostic Studies: Cardiac Catheterization

pulmonary embolism; shortness of breath, shortness of breath was getting worse; Nausea; migraine; Myalgia; low grade fever; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (pulmonary embolism) and DYSPNOEA (shortness of breath, shortness of breath was getting worse) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047821A and 014M2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Prostate cancer and Proctectomy. Concurrent medical conditions included Asthma, Hypertension (Controlled), Hypercholesterolemia (Controlled), Failed back surgery syndrome, Chronic back pain, Drug allergy (NSAIDs), Drug allergy (Fluconazole (Fluticasone)) and Drug allergy (Zipro). Concomitant products included SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for Migraine, DENOSUMAB (PROLIA), ALBUTEROL [SALBUTAMOL], ALPRAZOLAM (XANAX), CELECOXIB (CELEBREX), RIVAROXABAN (XARELTO), TADALAFIL (CIALIS), CEFIXIME (FLEXERIL [CEFIXIME]), MAGNESIUM, ZONISAMIDE (ZONEGRAN), OXYCODONE, EZETIMIBE (ZETIA), PRAVASTATIN, RAMIPRIL and CARVEDILOL 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-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced MIGRAINE (migraine), MYALGIA (Myalgia) and PYREXIA (low grade fever). On 28-Mar-2021, the patient experienced NAUSEA (Nausea). On 29-Mar-2021, the patient experienced DYSPNOEA (shortness of breath, shortness of breath was getting worse) (seriousness criterion hospitalization). On 02-Apr-2021, the patient experienced PULMONARY EMBOLISM (pulmonary embolism) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 02-Apr-2021 to 05-Apr-2021 due to DYSPNOEA and PULMONARY EMBOLISM. On 28-Mar-2021, PYREXIA (low grade fever) had resolved. At the time of the report, PULMONARY EMBOLISM (pulmonary embolism), DYSPNOEA (shortness of breath, shortness of breath was getting worse), MIGRAINE (migraine), MYALGIA (Myalgia) and NAUSEA (Nausea) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Physical examination: normal (normal) no findings. On 27-Mar-2021, Body temperature: 37.8 degree Celsius (High) Self Test. In April 2021, Computerised tomogram: abnormal (abnormal) pulmonary embolism with CAT scan with dye, multiple pulmonary embolism in the lungs.. In April 2021, Fibrin D dimer: high (High) High. In April 2021, Ultrasound scan: negative (Negative) Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PULMONARY EMBOLISM (pulmonary embolism) and DYSPNOEA (shortness of breath, shortness of breath was getting worse) to be possibly related. No further causality assessments were provided for MIGRAINE (migraine), MYALGIA (Myalgia), PYREXIA (low grade fever) and NAUSEA (Nausea). Treatment medications included sumatriptan (for migraine), and prednisone and home nebulize albuterol (for asthma exacerbation). Company Comment: Very limited information regarding these events has been provided at this time. Further information has been requested. 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 This case was linked to US-MODERNATX, INC.-MOD-2021-070707 (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, a causal relationship cannot be excluded US-MODERNATX, INC.-MOD-2021-070707:Same reporter/Different patient

SHORTNESS OF BREATH; multiple pulmonary embolism; NAUSEA; MIGRAINE; low grade fever / 100 degree Fahrenheit; MYALGIA; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Apr-2021 and was forwarded to Moderna on 06-Apr-2021. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (multiple pulmonary embolism) and DYSPNOEA (SHORTNESS OF BREATH) in a 67-year-old male 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 Drug allergy (allergy to Nonsteroidal anti-inflammatory drug and Salsalate.Fluconazole) since an unknown date, Hives since an unknown date, Rash (patient develops rash with Zipro.) since an unknown date, Hypertension since an unknown date, Hypercholesterolemia since an unknown date, Prostate cancer since an unknown date and Chronic back pain since an unknown date. On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PULMONARY EMBOLISM (multiple pulmonary embolism) (seriousness criteria hospitalization and medically significant). On 27-Mar-2021, the patient experienced PYREXIA (low grade fever / 100 degree Fahrenheit ) and MYALGIA (MYALGIA). On 28-Mar-2021, the patient experienced MIGRAINE (MIGRAINE) and NAUSEA (NAUSEA). On 29-Mar-2021, the patient experienced DYSPNOEA (SHORTNESS OF BREATH) (seriousness criterion hospitalization). At the time of the report, PULMONARY EMBOLISM (multiple pulmonary embolism), DYSPNOEA (SHORTNESS OF BREATH), MIGRAINE (MIGRAINE), PYREXIA (low grade fever / 100 degree Fahrenheit ), MYALGIA (MYALGIA) and NAUSEA (NAUSEA) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: for pulmonary embolism in lungs. On an unknown date, Ultrasound Doppler: Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. Treatment included were Sumatriptan, Prednisone and home nebulize albuterol. Action taken with mRNA-1273 in response to the event was not applicable. There was complete workup done and he was diagnosed with pulmonary embolism with CAT scan with dye, multiple pulmonary embolism in the lungs, Ultrasound in legs which was negative. He reports that his D-dimer were very high. In conclusion his imaging and D-dimer pointed towards the pulmonary embolism diagnosis. Company comment: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded. This case was linked to US-MODERNATX, INC.-MOD-2021-068247 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-068247:Same reporter/Different patient

Patient had trouble breathing. He almost called 911 but took rescue inhalers for his asthma which has been stable since 1/25/2019. He was able to stay conscious and restore breathing and then followed up with his PCP here at Medical Clinic.

About 24 hours after receiving the vaccine I noticed shortness of breath and cardiac arrhythmia as determined by repeated radial pulse checks. This lasted fro 6 to 8 hours, then I seemed to return to normal. the effects were notably more severe while lying down on my side back or stomach. sitting up felt the best.

received vaccine on 3/24/21 at another site. Was admitted to the hospital thru the ED with worsening shortness of breath.

8 days later presents to our ER with decreased energy, fatigue, lethargy, delirium, and shortness of breath with several falls over the past few days. SOB increasing over the last few days and found to be in respiratory distress this morning. 4/28/2021.

Patient developed shortness of breath on 4/6/2021 after getting the Moderna vaccine #2 on 3/26/2021. He saw me (his doctor) on 4/22/2021 for this and had positive D dimer and we did CT angiogram of chest showing pulmonary emboli. He was put on Eliquis and is now feeling better. He has never had DVT or PE in the past.

Patient became short winded a few days after receiving the vaccine. He came to my office and was found to be short of breath and testing was done he was found to have bilateral PEs at our local hospital.

Malaise beginning ~10 hours after injection. Finally able to sleep at 8:00 next morning. Woke at 11:00 disoriented, blurred vision. EMT took me to stroke center. They determined probably not a stroke, sent me to Hospital (cardiac). I was told the MRI there showed no evidence of stroke. I do not know the results of the other scans/tests. Felt better after 24 hours. Mostly recovered after 72 hours. Now (28 days later), have some residual problems with right eye, become out of breath after moderate exertion (%SpO2 95 or above).

Patient is increasingly developing exercise intolerance with muscle weakness, shortness of breath, and fatigue. States he gets so sleepy when he drives, he has nearly fallen asleep. He is afraid he might actually fall asleep and hurt himself or others. States this began 2 weeks after second vaccine.

covid-19 infection; hypoxia; Bilateral lung infiltrate; Cough; weakness; Chills; Covid-19 infection 19 days after COVID-19 vaccine; This literature-non-study case was reported in a literature article and describes the occurrence of COVID-19 (covid-19 infection), HYPOXIA (hypoxia), LUNG INFILTRATION (Bilateral lung infiltrate), COUGH (Cough), ASTHENIA (weakness) and CHILLS (Chills) in a 67-year-old male 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 Heart transplant (0.58 years from treatment for COVID-19) and Cardiomyopathy (Cause for heart transplant was Nonischemic cardiomyopathy). Concomitant products included TACROLIMUS, MYCOPHENOLATE MOFETIL and PREDNISONE for Immunosuppression. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid-19 infection) (seriousness criterion hospitalization prolonged), HYPOXIA (hypoxia) (seriousness criterion hospitalization prolonged), LUNG INFILTRATION (Bilateral lung infiltrate) (seriousness criterion hospitalization prolonged), COUGH (Cough) (seriousness criterion hospitalization prolonged), ASTHENIA (weakness) (seriousness criterion hospitalization prolonged), CHILLS (Chills) (seriousness criterion hospitalization prolonged) and VACCINE BREAKTHROUGH INFECTION (Covid-19 infection 19 days after COVID-19 vaccine). The patient was hospitalized for 5 days due to ASTHENIA, CHILLS, COUGH, COVID-19, HYPOXIA and LUNG INFILTRATION. At the time of the report, COVID-19 (covid-19 infection), HYPOXIA (hypoxia), LUNG INFILTRATION (Bilateral lung infiltrate), COUGH (Cough), ASTHENIA (weakness) and CHILLS (Chills) outcome was unknown and VACCINE BREAKTHROUGH INFECTION (Covid-19 infection 19 days after COVID-19 vaccine) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood creatinine: >0.3 mg/dl milligram per decilitre (abnormal) >0.3 mg/dl. On an unknown date, Lymphopenia: <900/mcl (abnormal) <900/mcL. On an unknown date, Oxygen saturation: <92% (abnormal) Hypoxia. On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patients were comparable to those of solid organ transplant patients (SOTs) who had COVID-19 infection and have not been vaccinated. Antinucleocapside antibody at COVID-19 diagnosis was also negative. Treatment for COVID-19 was with Remdesivir and Convalescent Plasma. Patient was discharged on 2 liters of oxygen. Very limited information regarding this event has been provided at this time. The date of vaccine administration, onset date for the events and the date for the antibody test are required for further evaluation. Based on the mechanism of action of mRNA-1273, the event is assessed as unlikely related to mRNA-1273. However, immunocompromised state in solid organ transplant patients may remain as risk factors for reduced immune response and infection. Very limited information regarding this event has been provided at this time. The date of vaccine administration, onset date for the events and the date for the antibody test are required for further evaluation. Based on the mechanism of action of mRNA-1273, the event is assessed as unlikely related to mRNA-1273. However, immunocompromised state in solid organ transplant patients may remain as risk factors for reduced immune response and infection. This case was linked to MOD-2021-094284, MOD-2021-094289, MOD-2021-094295 (E2B Linked Report). This case was linked to MOD-2021-094316 (Patient Link).; Sender's Comments: Very limited information regarding this event has been provided at this time. The date of vaccine administration, onset date for the events and the date for the antibody test are required for further evaluation. Based on the mechanism of action of mRNA-1273, the event is assessed as unlikely related to mRNA-1273. However, immunocompromised state in solid organ transplant patients may remain as risk factors for reduced immune response and infection. MOD-2021-094284: MOD-2021-094289: MOD-2021-094295:

4/2/21 Vaccination #2 given, 4/3 fatigue, decreased appetite and energy, increased confusion. 4/6/21 PCP ordered CT angiogram of chest-no PE but suspicious infiltrates in upper lung for Covid-19 pneumonia. DVT negative. 4/7/21 Hospital ER CT of head/neck -no stenosis, no intercranial abnormalities, Covid test negative, RIDP positive for rhinovirus and entrovirus. Neuro consult, full admit. Treated with Rocephin, zithro and oxygen, eventually vented then transferred to another location on 4/11/21. Acutely ill and in shock, Extensive workup showed no other identifiable source of infection. Died 4/18/21.

On 3/17/21 15:05 Inmate arrives via ambulance due to SOB, fever and chills and 02 sats at 88% since 9 am per EMS report given to hospital ER. On 3/19/21 pt transferred to a different hospital via EMS. Inmate had 2nd hospitalization on 5/3/21 for SOB again and then was d/c'd on 5/6/21 with dx of mild to moderate Pulmonary Edema, Cardiomegaly, small bilateral effusion.

This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clot in each lung) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included CALCIUM FRUCTOBORATE, CHONDROITIN SULFATE SODIUM, GLUCOSAMINE HYDROCHLORIDE, HYALURONIC ACID (MOVE FREE JOINT HEALTH) for Joint disorder NOS, MINERALS NOS, VITAMINS NOS (ONE A DAY [MINERALS NOS;VITAMINS NOS]) for an unknown indication. On 21-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced THROMBOSIS (blood clot in each lung) (seriousness criteria medically significant and life threatening). On 28-Feb-2021 at 6:00 PM, the patient experienced DYSPNOEA (shortness of breath). At the time of the report, THROMBOSIS (blood clot in each lung) outcome was unknown and DYSPNOEA (shortness of breath) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Feb-2021, Computerised tomogram: blood clot (abnormal) Blood clot in both lung. On 21Jan2021, patient had received the first dose of Moderna Covid-19 vaccine and about 4-5 days later, he began to noticed that his breathing was labored. At the time of the report, the patient did not think much about the labored breathing since he was older in age and thought it was due to exercise. Patient received second dose of Moderna COVID-19 Vaccine on 18-Feb-2021 and he reported that his breathing became more laboring where he needed to stop walking to catch his breath. He had 2 scan which revealed that he have a blood clot at each lung and he was prescribed Xarelto 15 mg twice a day, then he will begin Xarelto 20mg once a day on 20-MAY-2021. Patient is on Kirkland C 500mg as a concomitant medication as well. Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Significant FU- outcome of the event.

PT SAID HE HAS SEVERE MUSCLE ACHES, JOINT PAIN, COUGHING, HAD TROUBLE BREATHING AND WENT BLIND FOR A PERIOD OF TIME. ALSO NOTED HE HAS COUGHED UP STUFF SINCE THEN. DID NOT SEEK MEDICAL ATTENTION .

I experienced a seizure. A family member told me I was "out" for 1 or 2 minutes, got very stiff, breathed very heavy then seemed as though I stopped breathing, involuntarily urinated. When I came to, my speech was slurred for a few minutes and my blood pressure was very low. The EMT's arrived, took my blood pressure, reported it was 85 / 58. After a few minutes, drinking some fluids, I began to feel more normal. I declined to go with the EMT's. That afternoon, I was extremely tired and slept most of the afternoon.

PATIENT REPORTED DIFFICULTY BREATHING UPON EXERTION AND CHEST PAIN STARTING AROUND 05/08/2021. PATIENT WENT TO MD ON 05/12/2021 WHERE MD FOUND EKG ABNORMAL. PATIENT PASSED AWAY THAT EVENING

eosinophilia, cardiac tamponade/ pericarditis. Pericardial fluid was eosinophilic. One month later, he developed patchy pulmonary infiltrates.but biopsy was not obtained and ANCA was negative.

Had 1st Moderna shot on 4/22/21 and the 2nd shot on 5/20/21 (I recorded for #4) and he ends up in hospital with a blood clot, went to ER on 6/6/21 and was diagnosed with a blood clot that is why I reported since it was so close to date of Vaccine on 5/20/21. He got sick on 6/3/21 chilling, getting hot, temperature, coughing-went to Urgent care did x-ray-said had pneumonia-6/6/21 had hurting in side, chest, breathing problems-took ER found a blood clot in his chest, no pneumonia. (not sure of time of vaccine)

After the 2nd injection I experienced flulike symptoms for 36-48 hours. I checked my blood pressure on the second day and the monitor said I had an irregular heartbeat- my bp is usually 120 over 70- it was slightly elevated my pulse was 85- so I called my doctor- I was experiencing shortness of breath and didn't feel right- very tired- my doctor- listened to my heart with his stethescope and immediately ordered an EKG- the EKG was normal- he then ordered a Echocardiogram- that came out normal- but I still had an irregular heartbeat- it lasted for 3 weeks- I am feeling better now- and the problem has not happened again- I think it had something to do with the second maderna shot-

Complete heart block; He feel out of breath; Feeling tired; Weakness in legs; Could not walk 20 steps/Can not climb staircase; This spontaneous case was reported by a consumer and describes the occurrence of ATRIOVENTRICULAR BLOCK COMPLETE (Complete heart block) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M21A and 038K20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Bone marrow disorder and Pacemaker insertion (cardiac) since 03-Mar-2021. Concomitant products included MYCOPHENOLATE MOFETIL (MYCOPHENOLATE) for Bone marrow disorder. On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced ASTHENIA (Weakness in legs) and FATIGUE (Feeling tired). 01-Mar-2021, the patient experienced GAIT DISTURBANCE (Could not walk 20 steps/Can not climb staircase). On 02-Mar-2021, the patient experienced ATRIOVENTRICULAR BLOCK COMPLETE (Complete heart block) (seriousness criteria hospitalization, medically significant and intervention required) and DYSPNOEA (He feel out of breath). The patient was hospitalized on 02-Mar-2021 due to ATRIOVENTRICULAR BLOCK COMPLETE. At the time of the report, ATRIOVENTRICULAR BLOCK COMPLETE (Complete heart block), ASTHENIA (Weakness in legs), GAIT DISTURBANCE (Could not walk 20 steps/Can not climb staircase), DYSPNOEA (He feel out of breath) and FATIGUE (Feeling tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Heart rate: 23-27 (abnormal) heart rate was irregular and went down to 23-27 beats per minute'.. patient of Bone marrow disease and taking Mycophenolate for last 4 years. Treatment medication 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. 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.

Patient presented to the outside hospital on 6/27 due to having congestion and feeling much worse. Patient symptoms started on Friday (6/25) with congestion and cough. This was not able to be remedied by Mucinex. Patient then went to an urgent care clinic on Saturday and after listening to his lungs was sent to the emergency room. While in the emergency patient received a CT scan of his abdomen and pelvis which showed signs of liver cirrhosis and Covid. Patient then had a rapid Covid test that came back positive. They then obtained a confirmatory test but that is still pending. Patient then had agitation while he was in the hospital to the point where he almost struck a nurse. Patient's confusion got a little bit better but was found to have an elevated ammonia which was thought to be the cause of his delirium.

Patient found down at home unresponsive on the floor. EMS was summoned the patient was found to be in asystole. EMS was able to get a heartbeat. Pt intubated and transferred to hospital. Shortly admission to ICU patient began having severe myoclonic jerking and seizures. Patient was extubated and made no respiratory attempts. Patient expired

Blood clots in heart with extremely low blood pressure and shortness of breath. Symptoms suddenly appeared on 04/02/21. Hospitalization and rehabilitation Until discharge of 05/03/2021. Extremely low blood pressure, weakness and shortness of breath continued until he was hospitalized again 06/02/2021 He passed away 06/09/2021. He was labeled as Covid 19

Pt states that the night after the vaccine, he was short of breath and unable to exercise as normal. He is a very active man, exercises daily. He stated that he was weak with body aches.

Acute myocardial injury/ Myocarditis; MIS-A; Hypertensive; Worsening shortness of breath; Orthopnea; Fever; Chills; Nausea; Increasing fatigue; acute exacerbation of CHF; hypoxia; tachycardia; tachypnea; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Acute myocardial injury/ Myocarditis), SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (MIS-A), HYPERTENSION (Hypertensive), DYSPNOEA (Worsening shortness of breath), ORTHOPNOEA (Orthopnea), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Increasing fatigue), CONDITION AGGRAVATED (acute exacerbation of CHF), HYPOXIA (hypoxia), TACHYCARDIA (tachycardia) and TACHYPNOEA (tachypnea) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. LITERATURE REFERENCE: Acute myocardial injury following COVID-19 vaccination: a case report and review of current evidence from vaccine adverse events reporting system database. The patient's past medical history included Stent placement and Coronary artery bypass graft. Concurrent medical conditions included Hypertension, Type 2 diabetes mellitus, Hyperlipidemia, Coronary artery disease, Congestive heart failure (with preserved ejection fraction), Chronic obstructive pulmonary disease (without any home oxygen requirement), Hypothyroidism and Gastroesophageal reflux disease. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), ATORVASTATIN, CLOPIDOGREL, FUROSEMIDE, ISOSORBIDE MONONITRATE, LEVOTHYROXINE, LISINOPRIL, METFORMIN, METOPROLOL TARTRATE, POTASSIUM CHLORIDE, SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) and TIOTROPIUM for an unknown indication. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Acute myocardial injury/ Myocarditis) (seriousness criteria hospitalization prolonged and medically significant), SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (MIS-A) (seriousness criteria hospitalization prolonged and medically significant), HYPERTENSION (Hypertensive) (seriousness criterion hospitalization prolonged), DYSPNOEA (Worsening shortness of breath) (seriousness criterion hospitalization prolonged), ORTHOPNOEA (Orthopnea) (seriousness criterion hospitalization prolonged), PYREXIA (Fever) (seriousness criterion hospitalization prolonged), CHILLS (Chills) (seriousness criterion hospitalization prolonged), NAUSEA (Nausea) (seriousness criterion hospitalization prolonged), FATIGUE (Increasing fatigue) (seriousness criterion hospitalization prolonged), CONDITION AGGRAVATED (acute exacerbation of CHF) (seriousness criterion hospitalization prolonged), HYPOXIA (hypoxia) (seriousness criteria hospitalization prolonged and medically significant), TACHYCARDIA (tachycardia) (seriousness criterion hospitalization prolonged) and TACHYPNOEA (tachypnea) (seriousness criterion hospitalization prolonged). The patient was hospitalized from sometime in 2021 to sometime in 2021 due to CHILLS, CONDITION AGGRAVATED, DYSPNOEA, FATIGUE, HYPERTENSION, HYPOXIA, MYOCARDITIS, NAUSEA, ORTHOPNOEA, PYREXIA, SYSTEMIC INFLAMMATORY RESPONSE SYNDROME, TACHYCARDIA and TACHYPNOEA. The patient was treated with FUROSEMIDE (intravenous) for Adverse event, at an unspecified dose and frequency; HYDRALAZINE for Adverse event, at an unspecified dose and frequency; CEFTRIAXONE for Sepsis, at an unspecified dose and frequency; AZITHROMYCIN for Sepsis, at an unspecified dose and frequency; Physical therapy (BiPAP (12/8 cm H2O setting)) for Dyspnoea and Physical therapy (BiPAP (12/8 cm H2O setting)) for Hypoxia. At the time of the report, MYOCARDITIS (Acute myocardial injury/ Myocarditis), SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (MIS-A), HYPERTENSION (Hypertensive), DYSPNOEA (Worsening shortness of breath), ORTHOPNOEA (Orthopnea), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Increasing fatigue), CONDITION AGGRAVATED (acute exacerbation of CHF), HYPOXIA (hypoxia), TACHYCARDIA (tachycardia) and TACHYPNOEA (tachypnea) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood bilirubin: 1.9 (High) mg/100mL. In 2021, Blood culture: negative (Negative) negative. In 2021, Blood gases: abnormal (abnormal) pH 7.294, HCO3 21 mmole/L, PaCO2 39.9mmHg. In 2021, Blood lactate dehydrogenase (135-225 units/l): 239 (High) units/L. In 2021, Blood lactic acid: 5.7 (High) mmol/L. In 2021, Blood potassium: low (Low) hypokinesis of the ventricular wall in 2 regions on TTE with an acute presentation. In 2021, Brain natriuretic peptide (Unknown-124 pg/ml): elevated (High) 43134 pg/mL, elevated (High) 39813 pg/mL and elevated (High) 4796 pg/mL. In 2021, Breath sounds: abnormal (abnormal) coarse crackles in both lung bases. In 2021, C-reactive protein (0-0.5mg/dl): elevated (High) elevated 15.5 mg/dL and elevated (High) 11.5. In 2021, Chest X-ray: abnormal (abnormal) cardiomegaly and pulmonary edema without any focal conslidation. In 2021, Echocardiogram: abnormal (abnormal) mildly dilated left atrium, a left ventricle ejection fraction of 50%-54%, mild hypokinesia in the mid-septal and mid-anterior walls and grade 2 diastolic dysfunction. In 2021, Electrocardiogram: abnormal (abnormal) sinus tachycardia with non-specific ST/T wave cganges. In 2021, Fibrin degradation products (Unknown-500 ng/ml): 2010 (High) ng/mL. In 2021, Haemoglobin: 18 (High) g/dL. In 2021, Influenza virus test: negative (Negative) negative. In 2021, Oedema peripheral: 1+ (High) pitting edema in his lower extremities. In 2021, Oxygen saturation: 86% (Low) on lL/min of oxygen via nasal canula. In 2021, Red blood cell sedimentation rate (0-20 mm/h): elevated esr (High) 41 mm/h and 34 (High) mm/h. In 2021, Respiratory rate: 40 breaths/min (High) tachypneic. In 2021, SARS-CoV-2 test: negative (Negative) negative. In 2021, Serum ferritin (30-400 ng/dl): 550 (High) ng/dL and 454 (High) ng/dL. In 2021, Sputum culture: negative (Negative) negative. In 2021, Troponin (Unknown-19ng/l): 180.8 ng/l (High) elevated high sensitivity troponin, 117 (High) ng/dL and 85.2 (High) ng/dL. In 2021, Urine analysis: normal (normal) normal. In 2021, Venous pressure jugular: elevated (High) elevated. In 2021, Vital signs measurement: high (High) BP, mmHg= 169/96 HR, beats/min=141 Temperature (degree F)=101.2 RR, breaths/min= 26 oxygen saturation, %; oxygen requirement=92% 15L oxygen by NRB mask, high (High) BP, mmHg= 134/61 HR, beats/min=92 Temperature (degree F)=98.6 RR, breaths/min= 21 oxygen saturation, %; oxygen requirement=99%; BiPAP (12/8); 40% FiO2 and borderline (Borderline) BP, mmHg= 129/73 HR, beats/min=87 Temperature (degree F)=98.3 RR, breaths/min= 22 oxygen saturation, %; oxygen requirement=96%; 2L/min by NC. In 2021, White blood cell count: 17.86 x 1000/µl (High) leukocytosis. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (Acute myocardial injury/ Myocarditis), SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (MIS-A), HYPERTENSION (Hypertensive), DYSPNOEA (Worsening shortness of breath), ORTHOPNOEA (Orthopnea), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Increasing fatigue), CONDITION AGGRAVATED (acute exacerbation of CHF), HYPOXIA (hypoxia), TACHYCARDIA (tachycardia) and TACHYPNOEA (tachypnea) to be possibly related. Patient denied history of previous COVID infection or contact with a patient with known COVID-19 infection. Acute exacerbation of CHF was treated with diuretics and supplemental oxygen therapy. Tachycardia and Tachypnea improved with bronchodilators. A literature case with some reported events approximately 6 hours after the second dose of vaccine. 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. Probable confounding factors are the patient's medical history of Hypertension, Type 2 diabetes mellitus, Hyperlipidemia, Coronary artery disease, and Congestive heart failure, with procedural history of Stent placement and Coronary artery bypass graft.; Sender's Comments: A literature case with some reported events approximately 6 hours after the second dose of vaccine. 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. Probable confounding factors are the patient's medical history of Hypertension, Type 2 diabetes mellitus, Hyperlipidemia, Coronary artery disease, and Congestive heart failure, with procedural history of Stent placement and Coronary artery bypass graft.

Pt. states that after receiving the 2nd dose of vaccine 05/11/2021, started experiencing symptoms 05/12/2021 of shortness of breath, asthma attacks, and weakness of the body. Still continuing currently.

First part of April the patient leg started hurting more then usual. He was weaker. On April 18th patient walked to the end of the drive way when he walked back up he could not breathe. On April 19 patient went to hospital did a doppler on the left leg even thou the patient complained about pain the right leg. July 1st the patient passed out four time in less then thirty-minutes. Patient was transported to hospital. scan showed that patient had blood clots in both lungs. Patient was transferred to another hospital and they found that patient had a blood clot in the right leg. Patient is now on blood thinners.

palpitations, arrhythmia w/ dizziness and shortness of breath, prompted patient to go the the hospital

Moderna Vaccine 1/6/21 at 9:15 am. At 4:00 that afternoon, patient started complaining of slight cough and diarrhea. Later that evening, patient stated he started with body aches, shortness of breath, chilling, and inability to sleep. Patient did not take temperature that night. The morning of 1/7/21, patient had 100 degree F temp, feeling exhausted, with nausea. Patient went to work but was unable to stay due to exhaustion and nausea. Patient went home and slept most of day. Patient went to work on 1/8/21, only complaining of headache. Pt feeling much better on 1/8/21.

Shortness of breath on 12-31-20 about 9 hours Numbness in legs and feet on 12-31-20 about 9 hours Weakness on 12-31-20 about 9 hours Tiredness from 12-31-20 for 6 days

Covid symptoms began 2-3 days after shot. Presented to ER day 11 day after positive with extreme dyspnea O2 Sat at 88% Chest xray opacities throughout the bilateral hemithoracies would suggest multifocal infiltrate Admitted on high flow oxygen reduced to 6 liters currently D-dimer is >35.20

Started to feel tightness in my throat, dryness in my mouth, numbing lips and warmth throughout my body. Stopped at Hospital and was treated intravenously with Steroids and Pepcid. After 2 hours left hospital feeling much better with slight numbness in lips

PER PATIENT REPORT IN ABOUT THE 12TH HOUR MARK AFTER RECEIVING THE VACCINE PT WAS CONFUSED, LOOKED PALE, WAS NON VERBAL, UNRESPONSIVE, FAINTED AND PASSED OUT FOR ABOUT 10 MINUTES. HIS WIFE USED TO BE A REGISTERED NURSE AND SHE MENTIONED SHE HEARD HIS LUNGS AND THEY HAD FLUID WHICH RESOLVED LATER ON.

angina attack, difficulty breathing and uncontrolled muscle spasms treated and controlled with nitroclycerin, left side of body went numb, difficulty walking, disorientation/dizziness, blurred vision, severe headache, severe muscle and joint pain, weakness.

Severe weakness, shortness of breath dizziness, very elevated blood pressure and heart rate for about 4 hours Had to be transported from clinic via ambulance to Medical Center; Doctor attending in ED Symptoms continued for 6 days

Pericarditis with pericardial effusion. Treatment: Pericardiocentesis, Colchicine, Aspirin, Ibuprofen, Omeprazole Symptoms began (syncopal episode, retrosternal chest heaviness and aching worse with inspiration, fever, chills, lymphadenopathy for a for 9 days following vaccination) Outcome: Patient discharged home after 3 day hospitalization. Currently feeling better at 1 week follow up.

Mild shortness of breath during first sleep period following vaccination. Next moring no shortness of breath including during intense excercise

patient developed headache, myalgia and nausea around 8-9 hours post injection. He felt he was having a sickle cell crisis. He worsened overnight and developed acute respiratory failure with respiratory distress and diaphoresis. EMS called around 7am on 2/9 and placed on BIPAP and admitted to ICU

I started feeling fatigued on Sunday Feb 14. I started feeling this way in the afternoon. Next I felt like I had indigestion so I took some tums. At about 1:00am on Monday morning I woke up and felt really bad and thought I had indigestion so I tried to take some more tums and vomited. I was really weak and short of breath. I laid back down and tried to go to sleep but my heart felt like it was racing. Within an hour I was back up vomiting again with shortness of breath, weakness, heart racing. I tried to lay back down but within another hour I vomited again. This went on until 8:30am Monday morning. My pulse was everywhere. 97 to 112bpm. I was having chills all day and weak. I slept a lot Monday and also had diarrhea on Monday morning. I couldn't eat all of Monday and finally ate some soup on Tuesday. I am feeling much better today but still a little fatigued.

2/12/21 - Recieved the Covid 19 vaccine 2/13/21 - 5 pm. Fever, chills, no appetite, no taste, no smell, fatigue - was gone by 8 am the next day. Took Tyenol and rest. Taste and smell returned. 2/14/21 - 5 pm. Was eating and had a sip of wine. Felt like I was choking and had a strange sensation in the head. Felt like I blacked out for 2 seconds and was drolling. This is the only time that I have experienced this.

PATIENT'S WIFE REPORTS THAT, "IT FELT LIKE HIS THROAT WAS CLOSING X 7 HOURS, THEN CLEARED UP". PATIENT DID NOT TAKE ANY MEDICATIONS FOR HIS SYMPTOMS. DID NOT GO TO AN ED OR DOCTORS OFFICE. PATIENT'S WIFE CALLED THEIR PCP, AND REPORTED TO A NURSE THERE. SHE WAS THEN TOLD TO CALL HEALTH DEPARTMENT AND REPORT IT TO US. PATIENT'S WIFE REPORTS THAT HE DOES HAVE AN ALLERGIC REACTION TO ANTS SOMETIMES, BUT NOTHING ELSE.

Felt dizzy, blurry vision, passed out, pale. Short of breath and vomited. RPh gave epinephrine which worked right away. Squad came and took to ED where he was observed for 4 hours. They did a chest xray, troponin, EKG, Lab work. Everything normal. Name of physician or treating hospital: ED- MD. Pharmacist advised not to get the 2nd dose. ED MD advised to get a 2nd dose. His MD told him to get the 2nd dose in a medical setting where he can be monitored.

Patient experienced confusion and shortness of air when he woke up the morning after vaccination. His daughter went over to his house to help him and stated that his condition improved after he took a breathing treatment.

Pt. had facial swelling, and difficulty breathing the night he received the vaccine. Difficulty breathing resolved by morning and facial swelling resolved the next day. Patient also had redness, pain, and swelling at injection site. Patient never sought treatment for reaction and feels it has completely resolved

ON 2/25 THE PATIENT CALLED AND REPORTED BEING SHORT OF BREATH OVERNIGHT. HE STATED THAT IT WAS SOMEWHAT BETTER ON THE MORNING OF 2/25. PT WAS REFERED TO HIS PCP FOR EVALUATION

Patient felt lightheaded immediately after vaccination. Escorted to the post-vaccination waiting area. Mild inspiratory and expiratory wheeze on auscultation of lung sounds. No acute distress. Offered Powerade drink, patient declined. Patient recovered by 10:40 and was released.

Patient reports feeling dizzy, exhibited flushing, sweating, and lightheadedness. Had wheezing for 1-2 minutes. Has history of anxiety for needles. Cleared by EMS and refused ER transport. BP - 92/52

2-24-21 patient with development of cough, fatigue, increasing on chronic disability worsening debility and falls. scheduled for office visit 2-25.21 0900 call from spouse 0210 am patient was not breathing and lvad alarming low flow alarm on arrival of ems confirm asystolic not breathing and dead

Patients states he woke up the day after vaccination at 3am with aches all over his body. His muscles, bones, feet and hands ached. He states he also feels like he has a fever but did not check with a thermometer. His eyes also felt like they were burning and has slight labored breathing. He took 25mg of Benadryl prior to the vaccine and at 3am the next morning. He will continue with scheduled Benadryl and APAP until symptoms improve.

67-year-old male presenting with complaints of diaphoresis and tingling in his extremities approximately 10 minutes after receiving his initial Covid vaccination. He denies any history of allergic reactions like this in the past. At the time he did feel lightheaded though he did not pass out. He had been feeling slightly short of breath with onset of symptoms though it has improved now. He has not taken anything for relief and overall feels slightly better than when symptoms began. His blood sugar was approximately 270 Was discharged home with resolution of symptoms

Shortness of breath, joint aches, vertigo, brain fog, general malaise, weakness, fever. Lasted 1-1/2 days.

I woke up with heavy fever symptoms, sweating, chills, weakness in legs. The unexpected event included elevated resting pulse of 120, O2 level of 92 and a heavy pounding in my chest. I could feel my pulse throughout my extremities, and was short of breath. Symptoms subsided about an hour later. The next day I experienced anticipated fever symptoms and slept all day.

Pt admitted to hospital <24 hours after receiving dose #1 COVID-19 Moderna vaccine with abdominal pain, nausea/ vomiting, dyspnea, generalized myalgias and arthralgias.

severe fever after 7 hours-103-104 lasted 11 hours-reduced fever 15 more hours, chills, accelerated pulse, rapid breathing, nausea-no food or water 15 hours, enlarged lymph gland under right jaw (did notice an enhanced sense of smell during both 1st and 2nd shot reaction period)

The next day I developed a fever and over several day after I became more short of breathe. I had Covid and pneumonia in September 2020. It got worse after getting the vaccine. I seen a Rheumatologist, and spoke to my PCP, they ordered some additional blood work and images studies . I'm still having issues.

Angioedema; Difficulty breathing; A spontaneous report was received from a pharmacist, concerning a 68 years-old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced angioedema and difficulty breathing (dyspnea). The patient's medical history was not reported. No relevant concomitant medications were reported. On 04 Feb 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012M20A) intramuscularly for the prophylaxis of COVID-19 infection. On 16 Feb 2021, approximately 12 days after receiving vaccine, the patient was hospitalized for angioedema with swollen oral cavities, swollen lips and difficulty breathing. He was treated with diphenhydramine, famotidine and methylprednisolone. The patient was discharged from the hospital on 19 Feb 2021. The patient did not have any changes in his diet or at home medications. Action taken with second dose of mRNA-1273 in response to the events was unknown. The outcome of events, angioedema and difficulty breathing was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of these products and the start date of the event, a causal relationship cannot be excluded.

A lot of difficulty breathing, catching breath and getting oxygen; stabbing burning pain all over and joints ache; dizziness with eyes wanting to always close and seeing black spots; severe facial pain around bridge of nose and eyebrows; tremendous fatigue and weakness.

Cough, pressure in the head, almost exploding when coughing, pain of muscles joints and head; congested throat trouble breathing, nasal congestion, phlegm and mucus. Duration of 16 days, HAS REMAINED AN ANNOYING DRY COUGH, WITHOUT SPUTUM ... MILD TIREDNESS.

16 days after dose 1, I experienced a sudden hyperventilation at 7:00pm on March 15, 2021, which I calmed within moments. Then at 9:00pm on March 15,2021, a sudden fever of 102.5 occurred, giving a significant feeling of unwellness, but with no cold or flu like symptoms. I took Tylenol and the 102.5 fever dropped to 100 within hours. The next morning the fever was gone, but an unwellness feeling remained with no cold or flu like symptoms. Fever returned later that day but only to 99.2 and then was back normal that day. The next day a uneasy unwellness feeling with no cold or flu like symptoms occurred, with no fever. The third day I was recovered. I had no social interactions between the day I received dose 1 on Feb 27. Symptoms on Feb. 27th were minor. No fever.

Chest congestion; Sore arm; Body aches; Fever of 101-102°F; Fatigue; Headache; A spontaneous report was received from consumer, concerning himself, a 68-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever of 101 to 102 F, chest congestion, body aches, fatigue, headache and sore arm. The patient's medical history was not reported. Products known to have been used by the patient, within two weeks prior to the events, included atorvastatin, enalapril and travoprost. Patient took paracetamol for the symptoms. On 13 Feb 2021, prior to onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 038K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 13 Mar 2021, prior to onset of events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 030A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 13 Feb 2021, the same day post vaccination, the patient started having a fever of 101 to 102F, chest congestion, body aches, fatigue, headache and sore arm. Action taken with mRNA-1273 in response to events were not applicable. All events were resolved over a week.; 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.

SOB, fatigue, then AFlutter Pt received dose #1 covid vaccine on 3/2/2021. Pt noticed increased shortness of breath and fatigue the next day. Pt presented to the ED on 3/14/2021 with complain of worsening shortness of breath which had worsened over the past 2 weeks. In the ED, his EKG showed a flutter with 2:1 heartblock. COVID-19 swab is negative, procal is negative, d-dimer is negative. He was tachycardic to 130's and short of breath when talking to the physician. Otherwise stable. Per MD note: "ASSESSMENT AND PLAN: #New onset Atrial Flutter with 2:1 block, poa-noticed on EKG, troponin was negative, tachycardic to 130's, no chest pain- Diltiazem to attempt to rate control, will use Dilt drip if necessary-F/u EKG and troponins, monitor carefully for ischemia- Will obtain TTE and TEE cardioversion tomorrow- Apixiban for AC" Pt was admitted on 3/14/2021 for procedures. Pt was discharged on 3/17/2021. On 4/2/2021 pt presented for his appointment for dose #2 covid vaccine and reported this ADR to dose #1 covid vaccine. Pt decided he wanted to proceed with his vaccination & received his dose #2 today (4/2/2021).

Symptoms: 2nd dose of COVID dose received on 4/2/21 at noon. He reports the following day early in the morning his symptoms started. They are very similar to the symptoms he had after his first vaccine. He reports body aches and upset stomach as his main symptoms. Also reports mild dizziness but that is improving. He states he at times is feeling anxious which makes his heart race and feels mildly short of breath. Denies new SOB with activity and is not feeling SOB right now. Does have medication to take for anxiety and this does help. He also states he is having bouts of confusion with what day it is, where he is, etc. RN notes pt does not sound confused on the phone and was able to verbalize name/DOB and answer questions appropriately. Advised to call 911 but patient declines. He states symptoms are worse at night and he would prefer to be seen in the office.

Patient noted to be diaphoretic, tachypneic at regular rhythm, increased work of breathing, rales LUL, vocalizing with end expiration, O2 Sat 67% - was placed on 15 L nonrebreather with O2 Sat recovering to 96% - sent out via EMS to hospital where admitted for acutehypoxic respiratory failure from aspiration event. treated for possible PNA with IV antibiotics and discharged on oral antibiotics - on admission had elevated troponin to 0.9 with no EKG signs of acute ischemic changes and quick trending downward of troponin - treated with IV heparin but low suspicion for acute coronary syndrome and diagnosis of demand ischemia (type 2 NSTEMI) - discharged on aspirin chewable 81 mg daily

3/14/2021 Tightness in chest, attributed to physical work outside, 3/15 still felt tightness, 3/16 getting winded and went to the ER around 5:30pm, they took blood and ran test EKG, X-ray and ECHO complete with TTCV, ultrasound of chest, and test showed multiple blood clots in both lungs; by this time he was having trouble breathing and was admitted because of the blood clots. He was given Heparin and Vicodin through IV, on 3/17 they ran more test to see where blood clots came from and where they came from but nothing was found in legs. he was in a lot of pain Wednesday and he was sent home on 3/19.

24 hours after vaccine swelling to throat and face, shortness of breath, dizziness, weakness, headaches-symptoms lasted 3 days

Started wheezing on or about 3/23/2021; PCP prescribed Albuterol inhaler 3/25; SOB and wheezing worsened daily; 4/4/2021 was unresponsive 911 called and taken to ER with pulse ox of 58 and multiple bilateral PE noted on CT scan.

Pt developed chest pain and dyspnea on exertion about 3 days after vaccine. It lasted for about 3 weeks with exertion

At approx. 3 pm on Sunday March 21, suffered shortness of breath and extreme oxygen desaturation (down to 66% even on 8 liters/minute of oxygen). Called 911 and was admitted to Hospital and diagnosed with pulmonary edema. Treated with high pressure oxygen for 3 days, then on normal oxygen (5 liters/min) until discharged Thursday 3/25.

Difficulty in breathing, Left upper quadrant pain.ED visit 3/16/2021. Pulmonary emboli diagnosis. Unprovoked.

He was faint; Shortness of breathe; Rapid heart beat; Hungry; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (He was faint) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04021a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. 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 SYNCOPE (He was faint) (seriousness criterion medically significant), DYSPNOEA (Shortness of breathe), HEART RATE INCREASED (Rapid heart beat) and HUNGER (Hungry). At the time of the report, SYNCOPE (He was faint), DYSPNOEA (Shortness of breathe), HEART RATE INCREASED (Rapid heart beat) and HUNGER (Hungry) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications reported were blood pressure medications. No further information regarding names of the medications was provided. No treatment information for the events was reported.; 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.

Chest pain Shortness of breath Elevated heart rate Elevated Blood pressure Elevated Troponin Elevated D-Dimer

More breathing problems than normal/gasping; Oxygen level down to 80 after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (More breathing problems than normal/gasping) and OXYGEN SATURATION DECREASED (Oxygen level down to 80 after 1st dose) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included COVID-19 in January 2021 and Liver transplant. Concurrent medical conditions included COPD and Emphysema. On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced DYSPNOEA (More breathing problems than normal/gasping) (seriousness criterion hospitalization) and OXYGEN SATURATION DECREASED (Oxygen level down to 80 after 1st dose) (seriousness criterion hospitalization). At the time of the report, DYSPNOEA (More breathing problems than normal/gasping) and OXYGEN SATURATION DECREASED (Oxygen level down to 80 after 1st dose) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment included oxygen. 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. The patient's medical history of COPD and COVID-19 infection are confounders; 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. The patient's medical history of COPD and COVID-19 infection are confounders

COVID-19 pneumonia; Lost 17 pounds in 6 six days; Shortness of breath; Pain localised; Fever; Cough; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 PNEUMONIA (COVID-19 pneumonia) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A and 028A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis. The patient's past medical history included Alcohol use from 1964 to 26-Dec-1989, Cigarette smoker from 1964 to 09-Sep-2010 and Ulcerative colitis. Concurrent medical conditions included Emphysema (Severe emphysema from smoking, started in 2003 or 2004.) since 2003 and Diabetes since 2013. Concomitant products included INSULIN ASPART (NOVOLOG), DULAGLUTIDE (TRULICITY) and INSULIN DEGLUDEC (TRESIBA) for Diabetes, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for Emphysema, FISH OIL, ASCORBIC ACID (VITAMIN C PLUS [ASCORBIC ACID]) and FOLIC ACID for Supplementation therapy. In 2014, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg twice a day. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced COVID-19 PNEUMONIA (COVID-19 pneumonia) (seriousness criteria hospitalization and medically significant), COUGH (Cough) and PYREXIA (Fever). On 10-Mar-2021, the patient experienced WEIGHT DECREASED (Lost 17 pounds in 6 six days), DYSPNOEA (Shortness of breath) and PAIN (Pain localised). The patient was hospitalized for 7 days due to COVID-19 PNEUMONIA. On 16-Mar-2021, WEIGHT DECREASED (Lost 17 pounds in 6 six days) and PAIN (Pain localised) had resolved. At the time of the report, COVID-19 PNEUMONIA (COVID-19 pneumonia) was resolving, DYSPNOEA (Shortness of breath) had resolved and COUGH (Cough) and PYREXIA (Fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive for CoVid 19 vaccine. On 10-Mar-2021, Chest X-ray: abnormal (abnormal) COVID pneumonia. In March 2021, Computerised tomogram: inconclusive (Inconclusive) No significant finding. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered COVID-19 PNEUMONIA (COVID-19 pneumonia), WEIGHT DECREASED (Lost 17 pounds in 6 six days) and PAIN (Pain localised) to be not related. No further causality assessments were provided for DYSPNOEA (Shortness of breath), COUGH (Cough) and PYREXIA (Fever). Concomitant medications also included and unspecified probiotic. Treatment for the events included remdesivir, prednisone, paracetamol, and rivaroxaban. This case concerns a 68-year-old male with a serious unexpected event of COVID-19 pneumonia, and nonserious unexpected cough, dyspnea, pain, weight decreased, and expected pyrexia. Latency 2 days after first mRNA-1273 dose. 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-2021-108848 (Patient Link).; Sender's Comments: This case concerns a 68-year-old male with a serious unexpected event of COVID-19 pneumonia, and nonserious unexpected cough, dyspnea, pain, weight decreased, and expected pyrexia. Latency 2 days after first mRNA-1273 dose. 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.

Neuromuscular weakness, tingling/numbness, and fall prior to admission. Progressed to acute hypoxic respiratory failure requiring intubation.

After 4-5 hours of the 2nd dose of Moderna I start to get pain in the arms and legs, feel weir at night time like light headache, dizziness and uncomfortable in breathing that wake me up at the middle of the night. Blood pressure elevated higher than normal. After a week the arm's pain getting better,but the legs' pain gets worse. Since then my legs pain and join pain getting worse and worse, its hurts with activities and no pain at rest while seat or lay down. I've been through many doctors visits including the Urgent Care, ER, Neurology and rheumatology doctors and had many kinds of testing and found nothing wrong with my heart, lung, blood clots in the legs, Both of my legs are just progressively getting worse,both legs are getting more pain and weaker, that make me hard to lift them up for walking. I almost can't work now. I also feel so tired, dizzy and headache for 2-3 days each time that come and go since the 2nd dose of the vaccine. I'll have the MRI tests on 06/05/2021 and 06/06/2021.

Choking; Loss of consciousness; Ageusia; Anosmia; Decreased appetite; Drooling; Feeling abnormal; Fatigue; Pyrexia; Chills; This case was received via FDA VAERS on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of CHOKING (Choking) and LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 68-year-old male 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 High cholesterol. Concurrent medical conditions included Prostate cancer (Hormone shot taken 02-APR-2021 for prostate cancer) and Blood pressure high. Concomitant products included LISINOPRIL and ATORVASTATIN for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced CHOKING (Choking) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), AGEUSIA (Ageusia), ANOSMIA (Anosmia), DECREASED APPETITE (Decreased appetite), DROOLING (Drooling), FEELING ABNORMAL (Feeling abnormal), FATIGUE (Fatigue), PYREXIA (Pyrexia) and CHILLS (Chills). At the time of the report, CHOKING (Choking), LOSS OF CONSCIOUSNESS (Loss of consciousness), AGEUSIA (Ageusia), ANOSMIA (Anosmia), DECREASED APPETITE (Decreased appetite), DROOLING (Drooling), FEELING ABNORMAL (Feeling abnormal), FATIGUE (Fatigue), PYREXIA (Pyrexia) and CHILLS (Chills) 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. No treatment medications were provided by the reporter 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.; 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.

Approximately 24 hours after 2nd shot, patient couldn't breath good. He was admitted to hospital where patient reported to go into kidney failure and having pneumonia. He had an extended stay for 2 weeks in the ICU there. Patient does not remember treating physician, This was all patient reported.

That night my shoulder hurt and i had a little fever. The next day i was bedridden with a fever, body aches, and my shoulder hurt. Better the next day and went back to work. In the last 2 months i have had a slight headache daily, still some soreness in my arm where the shot was give, swollen joints in my hands, and a significant loss of smell and taste. I also have less energy and my breathing is a little labored.

I went into arrhythmia. I felt out of breath, lethargic, anxious. I called the doctor and sent him an ECG that I did on my watch. He said I was in a fib. We watched it for a few days, and then went in to the doctor. They did an EKG and determined I was indeed in afib. They switched my medication which did not really help. I began having intermittent episodes of the arrhythmia. I went back to the doctor and I was still in afib. They scheduled me for a cardioversion. When I went in for the procedure, they ran tests that determined I was not in afib. I was releases and I have been okay since.

July 3, 2021 - Admitted to ER for Chest Pains on Right side of Chest/Pelvis/Upper Legs at 2AM, Performed blood test and scans, diagnosed blood clots in both lungs by 4AM, origin from where blood clot came from are still not determined.

Moderna COVID-19 Vaccine EUA Patient received two doses of Moderna Vaccine at a Facility on the reported dates of 3/16/21 and 4/14/21. On 7/5/21 patient presented to ED with complaints of breathing difficulties and was diagnosed with multifocal pneumonia and COVID Positive with symptom onset of 7/1/21. Patient subsequently developed acute renal failure.Patient expired on 7/19/21 from complications of acute hypoxic respiratory failure due to COVID-19.

On 7/16 c/o nausea and SOB , sent to the ER and admitted to hospital with: Acute hypoxic respiratory failure due to fluid overload and pneumonia. He was placed on BIPAP, received urgent HD and broad spectrum empiric antibiotics. He weaned off of BIPAP to NC, fever resolved and cultures were negative. On 7/20/21 Pt discharged from hospital and returned to Rehabilitation Center

I had vaccination prior to noon on Feb 9, that afternoon I exhibited signs such as labored breathing, exhaustion. The next day I was not alert, that night Feb 10, just before midnight I had a grand mal seizure . The ambulance and police were at my home a little after midnight. They took me to Essentia hospital emergency room. I was there for observation for several hours. I notified my VA doctor about what happened, he scheduled a brain scan. nothing showed that would indicate a medical brain issue. Subsequently; I lost my driving privileges completely for several months and currently am driving on a limited license, which is normal in the case of a seizure in our state. See continuation page:

Started having shortness of breath and dyspnea on exertion on 7/26/21, was tested positive with COVID-19 on 7/28. Pt also has bilateral pulmonary emboli with a saddle pulmonary embolism. Pt was admitted to ICU.

Wheezing, nausea, diarrhea, muscle aches, severe headache. Rx?s albuterol, azithromycin, Mesronian pack and ondansetron.

UNKNOWN/ASYTOLE Narrative: Please refer to section 6. 68y/o male with h/o severe peripheral vascular disease with previous left AKA 2/3/20, s/p bilateral bypasses in the past. Pt recently underwent right AKA on 1/12/21. Per Hospital remote data 1/10/21 pt c/o shortness of breath, CXR demonstrated right lower lobe opacity & left basilar infiltrate. Pt s/p >10 days emperic IV abx. Moderna vaccine 0.5ml IM was administered via left deltoid on 1/22/21 around 16:21. On 1/23/21@05:14 code blue was called as pt found to be unresponsive, breathless and pulseless, facial cyanosis noted, CPR started immediately.Pt found to be in asystole. ACLS guideline followed but no return of spontaneous circulation, At 05:32 pt remained pulseless and breathless and was pronounced. Autopsy currently pending.

itching all over, puffy eyes. started 1/23/21, still present 1/25/21. On 1/28/21, resident reports he has been short of breath since the vaccine, joint pain, body aches, swollen lymph nodes, and resident's right eye is visibly swollen. Injection was done on the right arm, which is the side all symptoms have been on. Resident going to see doctor.

Pt reported to Health Services at approximately 2200PM on 1/28/21 after receiving vaccination 1/28/21 at 0925AM. He reported complaints of dyspnea beginning at 2000PM but did not report until 2200. He presented with an SpO2 of 81% on RA, HR 121, RR 44, BP 180/96, and temp 100.4. Previously, the patient required O2 therapy and oral steroids to recover from COVID 19 infection diagnosed on 12/1/2020. He was asymptomatic at the time of vaccination. He was treated with O2 therapy and Tylenol and states feeling much better this morning (1/29/21) at 0630AM. He continues to have a low grade fever of 100.6, and Tylenol provided.

The decedent experienced severe chest pain and dyspnea approximately nine days following the first series of the vaccine. He reported to family members that he was having a "severe reaction" to the vaccine and believed it was acute pericarditis due to the same symptoms he experienced prior. He reported that on 2/1/21 around 0300 hours, the symptoms were the most severe and he was going to seek medical attention, but did not. He waited till the convenient store opened and purchased OTC Tylenol for relief of symptoms. He continued to have dyspnea and chest pain up until 2/9/21, when he called 911 complaining of chest pain and was found to have a STEMI; subsequently died at Hospital in the ER.

Elevated heart rate Hyperventilating, inability to catch breath, literally thought I was dying Beyond chills, my legs and lower back were shaking so bad I could not stand or walk Next day I felt as if I had been extensively beaten with a pool cue If I had a way to go to the emergency room I would have

Pt started with weakness approx. 14 hours after the vaccine. Pt said he was so weak he fell out of bed and was on the ground for approx. three hours until he was able to get up. He has had nausea, vomiting and diarrhea. He came into the ER complaining of shortness of breath and chest pressure. Pt has received Normal Saline fluid, chest x ray and is being admitted to the hospital for acute renal failure.

Friday evening, pt. was shaking so much that he could not even hold on to anything, had pain in his legs, hips, joints, knees to where he could not walk, and had a fever. He had a hard time breathing as well so he went to the hospital. They checked him out and ran tests but it was all in relation to the shot they thought. Saturday he was very tired that he slept all day. Sunday he was feeling better but had some issues with his vision and his peripheral vision went away for part of the day.

tongue and throat swelling started 6 minutes after injection. Gave EPI autoinjector X1 with relief. EMS on site and transported to Hospital

Patient presented to the ED with SOB and substernal chest pain. He was tachypneic with use of accessory muscles. He was seen by nephrology and had HD. Pt felt better after HD with no further pain and improved breathing. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine

Patient started to slump in chair - RN observers attended to patient and alerted Lead to situation - STAT team called overhead. Pt appeared distressed and SOB, leaning over - coarse LS were audible - VS taken 142/82 HR103 SpO2 98%, as EpiPen administered into L thigh upon rapid assessment followed by 25mg IM Benadryl per protocol. ED STAT team arrived approximately 2 minutes later - who immediately transported patient to the ED for evaluation and treatment. Chart review indicates patient further treated with Solu-Medrol, fluids and pepcid. And released after 1400 with no further s/sx.

Woke up at 2AM and was not able to breathe. Tongue and throat were swelling, heart was racing, crawled to front room to call 911. Was dizzy, weak, throat and tongue were swelling.

@. 5 PM light headed, headache, ears clogged, nose stuffed up. @5:10 PM throat stated to feel a little thicker and I took an Allegra 24 he tablet (had taken an Allegra 24 he 24 hrs previously) @9 PM CHILLS and body aches (Took ibuprofen and went to bed)

Approximately 10 days after the vaccination I began to develop muscle and joint pain on my left side. two days later I started to have problems breathing and the muscle pain, all on my left side, worsened. A day or two later I developed a fever of 102 and the muscle and joint pain became worse, again all on the left side of my body. To treat the fever I took Motrin, this also helped with the headache. I also had a lose of appetite as these symptoms progressed and lost about 7 pounds. I developed a cough that persisted for about 7 days. These symptoms were intense for about three days and persisted at varying intensity for about 10 days.

Noticed shortness of breath approx. 2/2/21 but thought nothing of it until I went for my second shot on 2/17/21. After my second shot I asked to see my Dr. to talk about this shortness of breath issue as it had gotten progressively worse. He was not available so I was brought in to see a nurse, who checked my vitals etc and told me she was calling an ambulance to bring me to a hospital of my choice. I was brought to the hospital and the found my blood count down to 5.1. My last blood count check was in January and it was at 11.0. I have never had a low blood count issue prior to this. While at the hospital I was given three pints of blood and as of this day 3/11/21, I have received nine more pints and no resolve as of yet. There is no internal bleeding evident.

Patient at the time of vaccination on 3-8-21 has having issues with shortness of breath and edema consistent with congestive heart failure, the following day on 3-9-21, he was having more issues with shortness of breath, tachycardia, low O2 saturation. He was given meds in the clinic and monitored until he was feeling better with increased O2 sats. He was found unresponsive on his housing unit one hour later and failed to respond to resuscitation efforts and was pronounced expired at 1047.

Called to patient's side after receiving COVID vaccine, he became diaphoretic and dizzy. He states he was feeling dizzy prior to receiving the vaccine, but felt much worse immediately after. He denies n/v/chest pain/SOB. He denies any palpitations. On intial exam HR 120, patient diaphoretic, appeared weak, fatigued. He was placed in wheelchair, declined stretcher, and brought to recovery area. He had not eaten or had anything to drink. He tolerated juice without difficulty. He reports feeling really nervous. On exam he was found to be diaphoretic. Heart was found to have irregular rhythm with pauses on auscultation. Lungs mild wheezing throughout. He is alert in oriented, but seems somewhat slow to respond. He is answering questions appropriately overall. He denies fever, chills, cough. EMS activated. Transferred to EMS stretcher upon EMS arrival with plan to go to

Morning after vaccination body aches, headache, low fever, tiredness. Second day after vaccination same as above with additional symptom of difficulty swallowing, right side of throat feels swollen internally. these symptoms are continuing for several days up to and including date of this report, Tuesday 3/16/21

Patient did not tell that he was not feeling well. Later that day, he had to go to ER for heart related fluid issues. He stated that he was give medicine to get the fluid off his chest and that he had difficulty breathing. His doctor stated that this was most likely not related to vaccine.

Patient developed shortness of breath and leg swelling as well as on and off episodes of palpitations after receiving 2nd dose of Moderna vaccine. Also developed fever and chills and a worsening cough (fever and chills had since resolved).

He received his vaccine, had a sore arm and that evening around 7 hours later it was as if a switch flipped he was not able to breath, and his wife noticed on his body she could see all his veins like a track on his trunk and everywhere. He could not talk. He said that he was burning up, was hot and clammy. He got in the shower to cool himself down, and was told that the oxygen was not getting to where it was supposed to go. His wife called 9-1-1 and the EMT's said that his oxygen had dropped down into the 60's. He went to the hospital and they said he had pulmonary edema that filled his lungs that quickly. He was not intubated, and is on a BiPAP. He was given Lasix, steroids, antibiotics trying to pull the fluid off of his lungs. He has had so many different scenarios from people at the hospital right now and at one time one of his nurses said that his blood work showed a possible blood clot. They looked at his lungs and they said that they did not see it in his lungs. Then they said that he had a heart attack and that he needed a valve replacement. Today, 3/25/21 they told him that he did not have a heart attack, did not need a valve replacement. Last night they said that his BP was dangerously high and today, his BP is fine. He also had an adverse reaction to the steroids and had a ROID rage from that as well giving the nurses and his wife a hard time, hanging up the phone on her, and said that he was leaving the hospital. He was fine prior to the vaccine, and does not have any other issues for him to have this reaction. He is in ICU and they keep saying that they are going to put him in a cardiac care unit. He has a lot of IV lines and his 2nd COVID test came back negative. He feels like they are just running test to get money out of him. They said that he may be able to go home tomorrow.

According to daughter pt was in his usual state of health (pt was critically ill, so daughter provided hx) until he received his 2nd dose of the moderna covid 19 vaccination at 11am on 3/24/2021. He had not had any side effects from the first dose. Around 15 hrs after getting the vaccine he started having fevers, myalgias, fatigue, and sob. He has poor po intake following the vaccine. He arrived to the ER on 3/26 in hypoxic respiratory failure, septic shock, acute renal failure, nstemi, hyperkalemic with severe b/l pneumonia on chest x ray. He expired with in hours of arrival to the ER despite full attempts at resuscitation.

His symptoms began at 9PM of the day of the second dose of Moderna vaccine (gat 10AM 3/11/2021. He was well prior to the vaccine. He had no antecedent infection like the previous events of asthma attacks. He took Zyrtec the night before and the day of the vaccine of both doses of the vaccine. He has not been any asthma medication for six years except 3-4 uses of albuterol during the fall Wildfire season. Vaccine lot numbers: 1st 041LZ0A, 2nd 003AQ1A. H ehad similar incident in 2012 after Reclast second dose. Had flushing first and then asthma flare. Lasted a couple weeks with just inhalers then had to do prednisone to calm it down. When tapered off he relapsed and had to do three iterations over a couple months. After the second vaccine on Thursday AM, he was well until about 9PM that night, he developed sore throat and coughing that progressed through the night. On Friday AM he started using his nebulizer with albuterol and budesonide. His symptoms were manageable over the weekend. On Monday he coughed up a large collection of clear mucus and felt much better. On Wednesday 3/17, symptoms returned with cough and shortness of breath. He was started on a single dose of prednisone 40 mg and on Thursday he was seen in clinic. His symptoms seemed to be a mix of laryngeal and chest irritation. He was given an 8-day tapering course of prednisone and albuterol-ipratropium nebs every 6 hours. On follow up 3/25, he was much better except for side effects of the steroids. He is still being followed so I will provide updates if there is some change. He had a very similar reaction to Reclast in 2012 but has tolerated all other vaccines previously.

2/12/21-48 hours after first Moderna vaccine adverse event occur. He has a history of MI and Agent Orange exposure. He awoke from his sleep with palpitations and chest pain. He said he maybe breathing was affected. He arose from his bed, sat in a chair, and sipped warm water with easing of discomfort. Although he had a NTG, he did not choose to take any, nor did he check his pulse. Not wishing to repeat the experience, he refused a second vaccination.

Jaw very painful and sore, swollen badly, can't eat, very painful, side of neck and throat swollen painful and hurts badly, fever, cold chills.

Severe stomach cramping, decrease in temperature. Difficulty breathing. Patient reports he had a severe allergic reaction that needed emergency room evaluation that he treated at home with benadryl. Reports that his reaction was the same as with his food reaction to milk.

SUBJECTIVE: He presents today for COPD (Patient states noticed blood with his phelgm for a couple of days. No fever. Short of breath with wheezing at times. Denies any chest pain or tightness in chest. NO exposure of Covid. He has had vaccine.)

Severe reactions yesterday and last night (4/9/2021): chills, fever, fatigue, headache, heavy chest, difficult breathing, palpitations, high pulse rate, joint aches and pains, dizziness

Patient has had L leg blood clot and multiple mental co-morbity-Anemia, hypertension, heart disease, hypokalemia, liver enzyme off per MD, poor nutrition, tremors, hypothyrodism, COPD, small vessel disease of the brain

Patient is a 69 year old male with a PMH significant for CKD, DM, CAD, HTN, HLD and GERD presents for shortness of breath, fevers, and malaise. States symptoms started on Friday and have gotten progressively worse. He reports contact with a granddaughter who was subsequently Covid positive. He does report Covid vaccination approximately 1 month ago. He denies loss of taste or smell. No nausea vomiting diarrhea. No chest pain. Noted to be 92-94 percent the emergency room

Undergoing COVID-19 vaccinations and developed acute hypoxemic respiratory failure with bilateral palm infiltrates. Work up inconclusive for infectious etiology. Treated preemptively for pneumonia with antibiotics and glucocorticoids. Remains on oxygen but improving.

Extremely greater arthritis pain in hands and arms weakness i legs and back light headed, dizzy Slight shortness of breath

Ninety minutes after the vaccination I came home and took first bite of food ( a small piece of meat). This seemed to stuck in my esophagus causing pain in the chest. I could not swallow even water and the pain (spasm) subsided in 15-20 min. I did not try to anyting else on that day and only rested. Next day (04/08/2021) a similar problem appeared when I tried to swallow the first bite of lunch. It felt as the piece got stuct in the middle of esophagus and I could not move it in any direction. The pain kept increasing for 20 min and a clear flegm came to my mouth probably from stomach and started to interfere with breathing. I managed to wash my mouth and physically remove most of the sticky flegm. I managed to rest

4/3/21 at 0052 during Q15 rounds the patient was found laying awake on the floor next to his bed. He denied falling. Vitals showed BP 95/57, Temp 96, O2 sat 77%. He was evaluated and transferred to an acute care hospital with cardiac specialty. He was found to have elevated triponin and chest x-ray showed lung infiltrates; COVID test was negative. Diagnosis was MI and pnuemonia. He received a right coronary artery stent. The patient was intubated on full ventilation support. On 4/4/21 the patient went into cardiac arrest 3 times and was resuscitated. On 4/5/21 his condition declined and he went into cardiac arrest again and was resuscitated around noon. The patient died in acute care on 4/7/21 at 0608.

See continuation page Additional information for Item 18: 4/01 14:15 received vaccine in left arm. Injection site sore. 4/02 08:00 physical activity felt fine 4/02 23:00 unable to clear acid reflux 4/03 00:00 feeling off a little 4/03 02:00-04:00 extreme cold, pile on blankets, sock on feet, heating pad on chest. Uncontrollable shaking starting in the neck then on to the arms and hands, shoulders muscle and joint pain nausea, vomiting - first time blood only, second through fourth dinner came up. intestinal track was emptied multiple times heavy breathing temperature was normal 97.7 (this is my normal) 04/03 04:00-10:00 slept off and on temperature 97.7 04/03 11:00-12:30 slept temperature 100.2 04/03 12:30-14:30 got up and went out of the bedroom and feel asleep on couch 04/03 14:30- 24:00 no loss of smell or taste but no desire to eat skipped normal physical activity too sick and concerned about throwing up blood upper lip cracked and breaks out into what appeared a cold sore, spread to half the upper lip 04/04 08:00 a little cereal for breakfast, no lunch or dinner could only ski for four runs, panting after each a queasy stomach will continue throughout the days 04/04 10:00 extremely tired, muscle and joint pain, lips cracked, upset stomach temperature 100.2 slept the rest of the day 04/05 temperature 98.7 skied a little panting at bottom of each run ate a little breakfast, lunch and dinner (only rice with gravy) upper lip skin peals tired, slept remainder of the day 04/06 temperature 96.7 more cracking of upper lip, skin peels roof of mouth is sore causing difficulty eating gums are very sore to floss ate breakfast, lunch and minimal dinner still panting after each run still extremely tired and sleeping much of the day 04/07 temperature 97.7 ate breakfast, lunch and small dinner continue to pant after each ski run still tired and sleeping most of the day 04/08 temperature 96.7 first time not panting after each ski run upper lip, roof of mouth and gums still sore when bending over got dizzy (this occurred occasionally throughout the days) sleeping much of the day 04/09 temperature 97.3 The upper lip, roof of mouth and gums sores it not a cold sore, I suspect it is an auto immune response. This magnification was occurred too quickly for a cold sore and cold sores don't peel day after day Still day time sleeping 04/10 temperature 97.7 Still tired took a few ski runs, still panting after each tried an easy kayak run, only got 2.3 miles before nodding off while paddling, stopped at an island and slept. 04/11-18 daily routine is ski for 1 or 1.5 hours, go home and sleep for several hours a queasy stomach persists off and on, especially with physical exertion any other physical activity is exhausting somewhere in this time frame, stopped panting at the bottom of each ski run 04/19-23 temperature is now in the range of 96.2 - 96.4 still tired with daytime sleeping You have lost me. I will not follow guidelines that are against my best judgment for right or wrong. I knew better then to get the second vaccine so quickly. There was no research that indicated this was the optimum time frame. The only justification was what was done during the trials, which was to rush it to market and garner the highest efficacy numbers. As seen here, the outcome was anything but mild side effects and they continue.

Patient said that he called 911 with SOB, and he was admitted to the hospital and he stayed in the hospital for about 2 weeks. He is unsure of the date that he went into the hospital. Pt said he had a blood clot in both lungs.

Fatigue, sluggishness and difficulty breathing for a week to 10 days after vaccination. Difficulty breathing continues to date (April 28. 2021), with slight exertion - going up stairs or up a gentle slope. Prior to vaccination jogged 5 miles three times a week. Now barely able to jog 1/8 mile without having to stop because I cannot breath. I simply cannot breathe.

02/11/2021 - Stomach upset, a change to my sense of taste in that many foods taste different than before, some common foods now taste bad to the point of being unable to eat it anymore including some favorites, this has not returned to normal yet. 02/22/2021 Woke up to the pain of broken ribs on right side, a pinched nerve running down right arm, shortness of breath to the point that a moderate breath hurt. These symptoms began to subside the next day lasting four and a half days except shortness of breath that lingered for two weeks and still is not fully restored. As you can see by the dates these reactions happened at two different dates.

About 6 ? 7 days w/ side effects ? Significant Malaise, tiredness. Unable to function or concentrate. Likely a "self inflicted" situation by unknowingly sitting in chair in a daze ultimately developing blood clots (pulmonary edema), blood clots in legs, leading to mild heart attack, hospitalization. I believe there may be a direct connection to a medical procedure (vedolizumab (Entyvio) 300 mg intravenously infusion) that preceded the vaccination on the previous Friday (2/19/21).

NSTEMI; Septic shock; Hypoxic respiratory; Hyperkalemic; Bilateral pneumonia; Acute renal failure; Shortness of breath; Fever; Myalgia; Fatigue; Poor PO intake following the vaccine; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ACUTE MYOCARDIAL INFARCTION (NSTEMI), SEPTIC SHOCK (Septic shock), RESPIRATORY FAILURE (Hypoxic respiratory), HYPERKALAEMIA (Hyperkalemic), PNEUMONIA (Bilateral pneumonia) and ACUTE KIDNEY INJURY (Acute renal failure) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. the concomitant product the patient had taken are Norvasc , vitamin D, Metoprolol , Dexamethasone , Levothyroxine, Lexapro ,Lisinopril. the patient had certain medical history : Renal Cell Carcinoma on Chemotherapy , Hypertension , Hypothyroidism and Type 2 Diabetes Mellitus. Concurrent medical conditions included Renal cell carcinoma (on chemotherapy), Hypertension, Hypothyroidism, Type 2 diabetes mellitus, Critical illness and Penicillin allergy. Concomitant products included AMLODIPINE BESILATE (NORVASC), METOPROLOL, DEXAMETHASONE, LEVOTHYROXINE, ESCITALOPRAM OXALATE (LEXAPRO), LISINOPRIL and VITAMIN D NOS for an unknown indication. On 24-Mar-2021 at 11:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced FEEDING DISORDER (Poor PO intake following the vaccine). On 25-Mar-2021 at 11:00 PM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (Shortness of breath), PYREXIA (Fever), MYALGIA (Myalgia) and FATIGUE (Fatigue). On 26-Mar-2021, the patient experienced ACUTE MYOCARDIAL INFARCTION (NSTEMI) (seriousness criteria medically significant and life threatening), SEPTIC SHOCK (Septic shock) (seriousness criteria medically significant and life threatening), RESPIRATORY FAILURE (Hypoxic respiratory) (seriousness criteria medically significant and life threatening), HYPERKALAEMIA (Hyperkalemic) (seriousness criterion medically significant), PNEUMONIA (Bilateral pneumonia) (seriousness criterion medically significant) and ACUTE KIDNEY INJURY (Acute renal failure) (seriousness criterion medically significant). On 26-Mar-2021, ACUTE MYOCARDIAL INFARCTION (NSTEMI), SEPTIC SHOCK (Septic shock), RESPIRATORY FAILURE (Hypoxic respiratory), HYPERKALAEMIA (Hyperkalemic), PNEUMONIA (Bilateral pneumonia) and ACUTE KIDNEY INJURY (Acute renal failure) outcome was unknown. At the time of the report, DYSPNOEA (Shortness of breath), FEEDING DISORDER (Poor PO intake following the vaccine), PYREXIA (Fever), MYALGIA (Myalgia) and FATIGUE (Fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Chest X-ray: abnormal (abnormal) Severe bilateral pneumonia. On 26-Mar-2021, Electrocardiogram: abnormal (abnormal) ST depression on V2-V4. On 26-Mar-2021, Troponin: 8.496 (High) High. On 26-Mar-2021, pH body fluid: 7.12 (abnormal) Abnormal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient expired with in hours of arrival to the ER despite full attempts at resuscitation. Treatment for the events included resuscitation. Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded, although it is likely the patient's underlying critical state caused or contributed to the events. The cause of death is not specifically reported and event of death retained separately, although likely caused by MI, septic shock, respiratory failure, or a combination of these events; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded, although it is likely the patient's underlying critical state caused or contributed to the events. The cause of death is not specifically reported and event of death retained separately, although likely caused by MI, septic shock, respiratory failure, or a combination of these events

Fast Heart Beat; Lightheadedness; Shortness of breath; arrythmia; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (arrythmia) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Stent placement (Patient had a stent inserted in him 9 months ago) in May 2020. Concomitant products included PRAVASTATIN from 12-Sep-2014 to an unknown date for Cholesterol, ALLOPURINOL from 12-Mar-1999 to an unknown date for Gout, METFORMIN from 12-Jan-2008 to an unknown date for Prediabetes, TICAGRELOR (BRILINTA) from 12-May-2020 to 28-Dec-2020 for blood thinner, ACETYLSALICYLIC ACID (ASPRIN) from 12-May-2020 to an unknown date. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2021, the patient experienced ARRHYTHMIA (arrythmia) (seriousness criterion medically significant). On 03-Feb-2021, the patient experienced DIZZINESS (Lightheadedness) and DYSPNOEA (Shortness of breath). On 03-Feb-2021 at 5:00 PM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEART RATE INCREASED (Fast Heart Beat). On 05-Jan-2021, ARRHYTHMIA (arrythmia) outcome was unknown. On 04-Feb-2021, HEART RATE INCREASED (Fast Heart Beat) had resolved. At the time of the report, DIZZINESS (Lightheadedness) and DYSPNOEA (Shortness of breath) had resolved. Treatment information not provided. 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-2021-043170 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: New events added includes arrythmia, light headedness, dizziness and shortness of breath.; 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

Patient came to report to the pharmacy to report some adverse effects he had starting on Friday through Sunday after he got the shot on Wednesday. He exercises and reported feeling SOB with any type of physical exercise that he had not had before. He also reported disorientation. But it has gotten a lot better. He did contact his Dr and the Dr is monitoring him.

Pt developed chest pain/shortness of breath by 4/20, proceeded to local Hospital ER by 4/21 w/ N-STEMI on EKG w/ elevated troponin >8000, ECHO with global hypokinesis and mod-severe AR,, Chest CTA neg for PA/PNA. Emergent cardiac catheterization negative for CAD, Transferred to another Hospital 4/22 where cardiac MRI confirmed acute edema. he was monitored by Dr's team for 10 days with improvement in LV function and reduction to near normal troponin level. Workup neg for eosinophilic carditis. Discharged home by 5/1 w/ rest precautions and adjustments made to his BP medications. Now followed by local cardiologist Dr.

Started 5/05/21 with shortness of breath - increasing over the next 2 weeks with dyspnea on exertion Congestive Heart Failure and Cardiomegaly

COVID -19 Vaccine, Primary care MD. Wife, 5/23/2021 patient admitted through ED for chief complaint of 5 days shortness of air, tested positive for COVID-19; patient vaccinated 3/30/2021 at 'local church'. 5/24/2021 admitted to ICU - Attending, 5/26/2021 rapid response due to vitals, 5/27/2021 patient intubated due to respiratory failure/distress/hypoxia; identified in septic shock. 5/31/2021 went to surgery for left forearm and hand compartment syndrome. 6/3/2021 Code blue called, 6/3/2021 date of death. Allergies: Losartan (other) and Verapamil (intolerance) Date of Vaccination: 3/30/2021, Dose: 2, Vaccine Manufacturer: Moderna Lot #: Clinic Administering Vaccine: "local church" - no specific name was provided, Injection site: Description of event/reaction: Patient does not have vaccination card and reports not knowing date of first vaccine or exact clinic location. Date of Hospitalization: 5/24/2021 Reason for clinic visit or hospitalization: Shortness of air COVID-19 positive test result: Yes or No; if Yes, date 05/23/2021

The patient received the first dose of vaccine on March the 1st and the 2nd dose of the vaccine on March 28th. Patient had difficulty breathing with swelling feet and ankles that did not begin until April 12th. Patient had no history of breathing problems. Cardiovascular history is unknown at the pharmacy as we had only ever performed vaccinations on the patient. Patient was discovered in his house deceased. Exact date is unknown. The pharmacy was contacted by the patient's prescriber which requested we file this report. I apologize for the lack of precise information.

Pt began having SOB and lethargy around 03/2021. Increasing SOB in April until May. 6/11/2021 patient had emergent SOB and decreased LOC. Wife called EMS. Pt transported to ED for eval. Bilateral PE shown on CTA.

COVID-19 like symptoms; can't walk; still gets tired; short of breath; fell three times at work; didn't feel good at all/ feeling bad/felt "deflated"; no strength; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (COVID-19 like symptoms) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (mild case of COVID-19 infection) on 15-Aug-2020 and Difficulty breathing (many years ago he breathed in chemicals from a crop duster and was hospitalized due to breathing problems). Concomitant products included ATORVASTATIN for High cholesterol, TEMAZEPAM for Sleep disorder, Aspirin 325 mg and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced FALL (fell three times at work), FEELING ABNORMAL (didn't feel good at all/ feeling bad/felt "deflated") and ASTHENIA (no strength). On 06-Mar-2021, the patient experienced SUSPECTED COVID-19 (COVID-19 like symptoms) (seriousness criterion hospitalization). On 22-Jun-2021, the patient experienced DYSPNOEA (short of breath) and FATIGUE (still gets tired). On an unknown date, the patient experienced GAIT INABILITY (can't walk). The patient was hospitalized from 11-Mar-2021 to 22-Mar-2021 due to SUSPECTED COVID-19. The patient was treated with Rehabilitation therapy for Suspected COVID-19. At the time of the report, SUSPECTED COVID-19 (COVID-19 like symptoms), FALL (fell three times at work), FEELING ABNORMAL (didn't feel good at all/ feeling bad/felt "deflated"), DYSPNOEA (short of breath), GAIT INABILITY (can't walk) and FATIGUE (still gets tired) outcome was unknown and ASTHENIA (no strength) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative. Patient was in the rehab facility, every morning he was given a shot in the abdominal wall for use as a blood thinner. While in the hospital, he had to use a wheelchair initially, then a walker and then a cane. He stated that the second Moderna vaccine had put him in the hospital. On 22Jun2021, he was back to 70% energy. He reported he still gets tired, and short of breath, and could not walk as well as he used to, so he was using a cane. 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. Company comment: Based on the mechanism of action of mRNA-1273, a causal association between the event of suspected COVID-19 infection and mRNA-1273 is assessed as not applicable. Based on the current available information and temporal association between the use of the product and the start date of the other events, a causal relationship cannot be excluded.; Sender's Comments: Based on the mechanism of action of mRNA-1273, a causal association between the event of suspected COVID-19 infection and mRNA-1273 is assessed as not applicable. Based on the current available information and temporal association between the use of the product and the start date of the other events, a causal relationship cannot be excluded.

Patient completed her moderna vaccination series on 3/16 and 4/13. On 7/5 he presented to the hospital with 3 days of fever, dyspnea on exertion and generalized weakness after returning from another country, two weeks prior and tested positive for COVID on presentation. He was initially admitted because of an oxygen saturation of 90% on room air. He remained on room air and was treated with supportive care and discharged on 7/8.

About 2 weeks after the vaccine, I started having difficulty breathing and shortness of breath. I called my PCP who prescribed me Albuterol nebulizer 4 times a day. I was still having difficulty breathing so my PCP was going to order a chest x-ray. My symptoms were so bad I just decided to go to the ER. At the ER, they did blood work and chest x-ray and found fluid in my lungs. I was admitted to the hospital and stayed 6 days. I was hooked up to an EKG and given an IV. A cardiologist consulted with me and diagnosed me with A-fib. I was discharged with new medications, a portable defibrillator and to follow up with a cardiologist. I followed up with cardiologist who had to shock me 2 times to get me back into normal rhythm. I have reoccuring A-fib and will follow up with cardiologist for my plan of care.

Pneumothorax; Difficulty breathing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMOTHORAX (Pneumothorax) and DYSPNOEA (Difficulty breathing) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Squamous cell carcinoma in June 2018, GERD, BPH since an unknown date, COPD since an unknown date, Hyperlipidemia, Nicotine addiction and Lobectomy (thyroid) in 2019. Concurrent medical conditions included Lung cancer stage IV since July 2019. Concomitant products included Pembrolizumab for Lung cancer stage IV, GABAPENTIN (NEURONTIN) from 01-Jan-2009 to an unknown date, ATORVASTATIN from 01-Dec-2015 to an unknown date, MEGESTROL from 01-Jan-2009 to an unknown date, TAMSULOSIN from 01-Jan-2009 to an unknown date, PANTOPRAZOLE from 01-Dec-2015 to an unknown date and TRAZODONE from 01-Jan-2020 to an unknown date for an unknown indication. On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 10-Jun-2021, the patient experienced PNEUMOTHORAX (Pneumothorax) (seriousness criteria hospitalization prolonged and medically significant) and DYSPNOEA (Difficulty breathing) (seriousness criterion hospitalization prolonged). The patient was hospitalized from 10-Jun-2021 to 17-Jun-2021 due to DYSPNOEA and PNEUMOTHORAX. The patient was treated with TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) ongoing from 17-Jun-2021 at an unspecified dose and frequency; SALBUTAMOL (ALBUTEROL HFA) ongoing from 17-Jun-2021 at an unspecified dose and frequency and Surgery (thoracoscopic surgery with wedge resection for right pneumothorax) for Pneumothorax. At the time of the report, PNEUMOTHORAX (Pneumothorax) and DYSPNOEA (Difficulty breathing) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jun-2021, Biopsy lung: unknown (abnormal) lung biopsy video assisted thoracoscopic surgery with wedge resection for right pneumothorax. The patient has been on treatment for stage 4 lung cancer. Post taking the vaccine, the patient experienced difficulty breathing and was hospitalized. Surgery was performed and later patient was discharged. Is recovering well and reporter believes this is related to the lung cancer. 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 medical history of Squamous cell carcinoma, COPD and Nicotine addiction could be a contributory factor.; 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, the medical history of Squamous cell carcinoma, COPD and Nicotine addiction could be a contributory factor.

Pts wife stated pt experienced feverish 99. 9, diarrhea, shortness of breathe, cough, and running nose/congestion on 07/05/21. Pts isolation expires on 07/15/21 symptoms resolved. On 07/05/21,Pt was admitted to hospital for shortness of breathe, choking and abnormal color of urine (Red) . At that time, Physicians performed exams and administrated a Covid test and found a positive result for Covid-19 at the hospital. Pts wife continues to share the call to 911 was for abnormal urine , shortness of breathe and choking. Pts wife stated they were not aware of the pt having covid and that there were no close contacts. Wife has been vaccinated. . Pt was transported to another Hospital on 07/06/21 and released on 07/16/21. Pt has not traveled outside/country/state within 14 days of illness.

About 2 weeks after first COVID-19 vaccine, patient states he had trouble breathing and called 911. He states he was diagnosed with multiple blood clots at the hospital. He doesn't recall exact dates, states the difficulty breathing started at 2am. Was taken to on .

difficulty breathing/shortness of breath/tightness in lungs starting 6PM of 1/8 and lasting until 1/11 at 7AM. No other asthma triggers present. I did ski 1/8/21 with no breathing difficulties andgiven presistent tightness I thought waiting in lift lines could have resulted in covid exposure. Continued breathing difficulty not responding to albuterol finally caused me to get a covid test 1/10/21, which was negative. Breahting returned to normal by moringing of 1/11/21.

Narrative : Symptoms: BlurredVision, Dizziness, Myalgia, CoughWheeze & sore throat; tingling head, lips, extremities Treatment:

Sore arm that same day; day of injection - also diarrhea for a week ; minor breathing problems for two weeks - took Imodium for diarrhea

Following are my symptoms and severe side effects and events after receiving the COVID-19 Vaccine. 1- Receive COVID 19 vaccine at 4.00 PM on 01/15/21. 2- Stay about 20 minutes after Vaccination and observe no reactions and symptoms. Dive back home. take dinner and sleep well whole night. 3- Next day morning when I wake up feel till bit of Nausea/Vomiting. 4- Take breakfast at about 10.00 AM and after that feeling of Nausea got increased and i also start feeling weakness. These symptoms remains all day. 5- At about 5.15 PM I went to take Shower. After about 2 minutes during shower, i feel shortness of Breath,pressure on chest and Dizziness 6- These Symptoms was for about 4 to 5 second and goes off. 7- After about one minute I feel second time shortness of Breath, pressure on chest and Dizziness. It was bit intensive and for a longer period for about 10 second. 8- At this point I realized that this is something serious happening to me. 9- I came out from the Vertical Shower and called my wife that I am not feeling well. She was at this time at first floor. 10- I think it is about 1 minute after when I came from shower, I feel third time shortness of Breath, pressure on chest and Dizziness. I was very severe and within a second or so I passed out and fell down into the Jacuzzi which is beside the Vertical Shower. 11- Within a minute, my wife and my son came to the scene. At this time my wife finds me unconscious with my eyes open. 12- She shouted my name and then I came into my senses and told them to get me out of Jacuzzi. 12- My wife and my son get me out and carried over to the bedroom. I was feeling no shortness of Breath and Dizziness but mild pressure on chest, shivering and chill. 13- Thanks GOD I did not get any body injury except little bit of hit at my Neck and back of the Head. 14- My wife immediately called to my Primary Care Nurse and then I talk to her explain the whole situation and then asking for advise. 15- She advise me to go to any near Hospital Emergency for any urgent Medical care. 16-A about 6.00 PM I went to Emergency. At this time I was feeling Nausea and Shortness of breath. 17- The Nurse immediately check my blood pressure, temperature, oxygen and pulse. These all was normal. Nurse also provide me IV medicine for Nausea. 18- During my stay at Emergency, I again feeling mild tightness/pressure in chest beside shortness of breath and shivering, therefore Emergency Doctor advise me that will admit to the hospital and do the complete check of any stroke and heart attack. 19- I was in the Hospital for 2 nights. During this stay I was under care of: -Attending Physicism: -Cardiology Physician 20- They have carried out Multiple Blood and Radiology Test as stated below. As per Doctors, all of my Test results are Normal, and they did not find any sign of Stoke and Heart Attack. -Multiple Blood Lab test. -XR CHEST 1 V -CT C-SPINE WO CONT. -CT HEAD-BRAIN WO CONT. -CT ANGIO HEAD W&WO CONT. -CT ANGIO NECK W&WO CONT. -CTA CHEST FOR PE -MRI BRAIN WO CONTRAST . -STRESS TEST. 21- I was discharge from the Hospital on 01/18/21 at 17.34.

Fever of 99. 6 the morning after the shot, in the afternoon it went up to 100.1 and stayed that way until morning of 1/27/2021, chills, fatigue, night sweats, no appetite, achy, wheezing at night, coughing

Tachycardia >120, fever 101.3 , bp 169/104, difficulty breathing, atrial afib, headache patient had moderately severe covid disease 3/15/2020-4/10/2020

I began experiencing muscle aches, chills, night sweats, shortness of breath, blurred vision, dizziness and a nagging headache about 2 days after the first Moderna injection. These symptoms continued for well over a week but gradually got better each day for over a week. I monitored my body temperature and it was continuously normal and I never lost sense of taste or smell.

when i first got the shot i could feel a difference in my body immediately. i started hurt on my left side of my throat, then started getting puffy face and eyes. was given some Benadryl pulse 45 blood pressure 90/54 and did an EKG , then medic didn't like what he was seeing and called 911 . Medic gave him an epi pen because his throat started swelling. Went to the hospital where he was there for 5 hrs.

one day after vaccination; developed 4-5 days of headache, nausea, fatigue. Also had "hyperventilation" with difficulty completing deep breaths. No wheezes/ cough. No oral / throat swelling. Did have full body rash.

Pt received first dose of COVID-19 vaccine on 2/12/2021. Pt presented to ED 2/18/2021 with shortness of breath and confusion. He reported having an exposure to someone positive for COVID-19 prior to date of vaccination but was unaware of exposure until after. Pt had findings indicating pneumonia on chest X-ray and required supplemental O2 with admission to hospital (2/18/2021). Pt was discharged the evening of 2/21/2021.

Patient received Covid Vaccine Moderna at 1145, multiple syncopal episodes at pharmacy, sent to ER. Outcome Death

trouble breathing, blurred vision for about 40 seconds. arm still itching a week later. arm itch might be caused by band-aid

Severe respiratory distress on day 3 after vaccine administration. Pain in upper respiratory tract when breathing. Lasted 2 days with still some lingering pain with deep breaths.

Trouble breathing the next day, progressively getting worse each day. Muscle cramps and stomach/bowel problems. The 3rd day after i was ok (except the above) and then around 3pm i started a fever, chills, total body aches and being tired. Fever progressed each hour and hit a high of 102 degrees around 10pm. Started taking Tylenol around 8pm. About 2am fever hit it's hjigh and i began sweating a lot and was sick to my stomach. Lasted about 30 minutes. Fell asleep until 7am. Fever gone, felt much better and just tired.

PT C/O TIGHTNESS OF THROAT SHORTLY AFTER VACCINE ADMIN. PT SELF-ADMINISTERED OWN UNKNOWN ASTHMA MEDICATION, BUT WAS NOT FEELING SATISFACTORY RELIEF. PT WAS ADMINISTERED 25MG BENADRYL IM. 15 MINUTES AFTER ONSET OF S/S PT WAS BEGINNING TO FEEL BETTER AND WAS DRIVEN HOME BY RELATIVE.

Pt went to ER due to shortness of breath one day after vaccine on 2-19-21. Pt was diagnosed with pneumonia and was given antibiotics. stated the antibiotics gave the patient leg pain and then had to get pain medications.

Next day nausea, tiredness, weakness, loss of sleep/ following day shortness of breath, sneezing-- asthmatic chronic affect treated with use of albuterol inhalant

18 hrs after injection he experienced left chest pain, sore shoulder and bilateral chest pain and shortness of breath. We went to ER where they administered heparin IV, kept home, did an angiogram and then quadruple bypass. We are not doing the vaccination caused his blockages.. just want to make sure it doesn't cause blood clotting which led to his angina.

2nd dose of Moderna on 3/9/2021 at 8:30am. At 9:00pm started having upper respiratory distress leading to vomiting and diarrhea (every 10 to 15 min) on 3/10 at 10:00 pm. Went to ER on 3/11 at 1:00am. Admitted to ER with initial diagnosis (following lab work, x-rays, etc.) of Anaphylactic Shock. Symptoms were allergic reaction, chest pain, hypotension, acute kidney failure, diarrhea, DM2, hives/rash/itching. Multiple IVs of saline, antibiotics, steroids were administered. Remained In critical care/ER for ~12 hours until stable and transferred to hospital room. Discharged on 3/12/2021 at 11:00 am.

Breathing difficulty, fluid retention, upper respiratory congestion and flu like symptoms. No fever or chills.

Death Narrative: Patient with medical history significant for malnutrition and end stage COPD. Patient was on 5 to 6 liters/min of oxygen. On 3/10/21, patient received his first COVID-19 vaccination. On 3/12/21, patient was admitted to Hospice for home hospice care due to worsening of COPD. Per medical examiner, patient passed away on 3/13/21.

2/25/21 - sore arm, profound fatigue 2/26/21 - chills, fatigue, runny nose (cold-like sx) 2/27/21 - dry throat 3/02/21 - lost voice 3/03/21 - 3/04/21 - chest congestion, difficulty breathing, sounded like water in lungs 3/05/21 - became pale, eyes rolled back, shaking, immobile, caregiver called ambulance, taken to Hospital ER 3/06/21 - death, Hospital dx him with "pneumonia" but I believe that hospital medical staff were unaware of his sx following the COVID vaccine #2 shot.

After Modena vaccination first dose back of the hand started allergy, red large irregular spot allover, very itchy, both legs weak, couldn't lift leg when walking. After 2nd dose allergy became much more severe. Red large irregular spot also appeared allover body skin, allover back, legs, arms. On March 6, 2021 the legs were too weak hard to go on stairs. On March 7, 2021 went to the ER. After discharged on March 9, 2021, left leg became weak, right leg more severe, walking became unbalanced when had to walk. All over body weak, palpitation short of breath during activity, had to lie down. I'm an acupuncture doctor, already couldn't work, couldn't drive.

Sore Arm, Headache, temperature, irregular heart rate, chills, night sweats, loss of appetite, extreme fatigue, weakness, cloudy thought, swollen lymph node under left arm (size of tennis ball), labored breathing which has continued to date of this report.

Patient is a 70 y.o. male w/ h/o CHF,HTN, sleep apnea on CPAP and 2 L O2 at night, IDDM, CKD stage III-IV, prior tested positive for SARS-CoV2 (12/2020) presented to SAMC ED w/ the complaint of SOB. Pt states he received his 2nd dose of Moderna SARS-CoV2 immunization 4 days prior to arrival and developed SOB since then. He states that the SOB progressed and included coughing productive of bloody/blood-tinged sputum. The main reason he decided to come to the hospital was because of his shortness of breath and associated chest tightness which he says radiated into his abdomen. In the ED he was found to have new RBBB and troponin 7.2. He was seen by cardiology d/t concern for NSTEMI, started on heparin gtt, and taken to the cath lab. There he was found to have RCA lesions x2: the more proximal underwent stent placement, the more distal lesion was unable to be stented. Post-procedure pt's respiratory status was tenuous and therefore CCM was consulted. Patient discharged 9 days after admission after somewhat rocky course of recovery.

Severe pancreatitis with no specific cause identified followed by complications of peritonitis, fluid in lungs of 80%, deep leg vein thrombosis, and multiple episodes of coronary arrest and systemic inflammation.

got chills bad and later in the night felt like was have a sever seizure with the shaking, I was so cold had to put 2 extra blankets on me. also had a hard time getting a full breath. On Sunday when i got up and then had something to eat then went back to bed till 4 pm. Have been drink plenty of water. I still feel light headed on Monday at 2:30 pm.

Client vaccinated with second Moderna vaccine @ 11:30 am 3/11/2021. went to waiting room @ 11:33 am for 15 minute observation after injection. At 11:40 RN noticed pallor and hard breathing. Pulse 76, Respirations 36 and BP 142/82. Client stated it felt like his heart was beating fast. Rn applied oxygen by nasal cannula @ 2L./minute @ 11:45am. Pt asked RN not to call rescue squad because he had similar episodes in past. At 11:50 client reports feeling better. Facial color normal. At 11:53am removed oxygen.At 12:03pm after no oxygen times 10 minutes client denies shortness of breath. BP 150/84, pulse 64 and respirations 18. At 12:05pm client stood independently and ambulated to car without any assistance.

death Narrative: Pt received COVID vaccine dose #1 on 2/27 at facility. Pt admitted to Hospital d/t COPD exacerbation and severe hypoxia. Pt with longstanding hx respiratory complications including air hunger, use of continuous oxygen, panic attacks and pain requiring narcotics (also impacted respiratory drive). Pt evaluated by palliative care/hospice services at Hospital and was deemed appropriate for end-of-life care. Pt unable to discharge home for home hospice services, therefore remained at Hospital where he later passed away. Pt's wife called facility 3/29 to report the death of patient, exact date of death was 3/13. Anticipated cause of death includes respiratory failure d/t severe COPD, hypoxia and narcotic use. Was pt previously covid positive? No Are there any predisposing factors (i.e. PMH, HPI, allergy history etc) for patient experiencing adverse drug event? No Any occurrence of an ADR at time of administration or during time of observation? No Was there and ADR between observation period and date of death? No Was patient hospitalized prior to vaccination? No Was patient hospitalized between vaccination and date of death? Yes - d/t severe hypoxia and COPD exacerbation Was hospitalization attributable to ADE ? No Was patient hospitalized prior to death Yes What are the possible cause of death? severe COPD, hypoxia, reduced respiratory drive d/t narcotic use (chronic pain)

chest pain, shortness of breath, sense of throat closing. onset 10 min after vaccine, resolved after one hour.

Presented to ED on 3/20/21 with shortness of breath and was admitted for treatment for COVID-19 infection and COPD exacerbation.

Patient's wife called 3/22/21 and stated patient had a cough, fatigue, and low grade fever running around 99 starting 3/20/21. Patient went to airport testing center on 3/23/21 to have a rapid COVID test performed. Patient tested positive. Patient called PCP office on 3/29/21 to notify PCP that he had been admitted to Hospital. Patient was admitted for COVID pneumonia and acute respiratory failure with hypoxia. Patient was treated with Remdesivir and dexamethasone while in the hospital. Patient was discharged from Hospital 4/10/21. Patient was discharged home with home O2 of 1lpm.

Pt as admitted to the hospital with severe b/l pneumonia and hypoxia requiring high flow oxygen on 4/10/2021. He received his 2nd covid vaccination on 4/4/2021 and began to have shortness of breath 3 days later. He is still hospitalized with severe pneumonia as of 4/14/2021 and his condition has progressed to left upper lobe collapse which will require a pulmonary interventionalist as out pt.

severe bilateral pneumonia; hypoxia; shortness of breath; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (severe bilateral pneumonia) and HYPOXIA (hypoxia) in a 70-year-old male 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 Tobacco user since an unknown date, Hyperlipidemia since an unknown date, Chronic pancreatitis since an unknown date, Hypertension since an unknown date and Diabetes mellitus since an unknown date. Concomitant products included INSULIN GLARGINE (LANTUS), INSULIN LISPRO (HUMALOG), METFORMIN, OMEPRAZOLE, ESCITALOPRAM OXALATE (LEXAPRO), ASA, PROPRANOLOL and OXYCODONE for an unknown indication. On 04-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced DYSPNOEA (shortness of breath). On 10-Apr-2021, the patient experienced PNEUMONIA (severe bilateral pneumonia) (seriousness criteria hospitalization and medically significant) and HYPOXIA (hypoxia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 10-Apr-2021 due to HYPOXIA and PNEUMONIA. At the time of the report, PNEUMONIA (severe bilateral pneumonia), HYPOXIA (hypoxia) and DYSPNOEA (shortness of breath) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal wbc 17.3 with 79% neutrophils and 1.2 lymphocytes.. On an unknown date, Brain natriuretic peptide normal: normal normal. On an unknown date, Computerized tomogram: abnormal chest with collapse of the left upper lobe with dense consolidation with possible mass like density occupying much of the left upper lobe bronchus, diffuse ground glass opacities throughout the left lung are seen and ground glass opacities of the right upper lobe and right lower lobe are seen infectious/inflammatory. there is also mediastinal and hilar lymphadenopathy seen.. On an unknown date, Influenza: negative negative. On an unknown date, Procalcitonin: normal normal. On an unknown date, Productive cough: normal normal. On an unknown date, SARS-CoV-2 test: negative negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Reporter did not allow further contact

admitted to our ICU thru the ED for progressive and worsening shortness of breath with Large biltateral pulmonary embolus. remains hospitalized

Patient presented to the emergency room for evaluation of shortness of breath and chest pain that started two days prior (one day after receiving first Moderna vaccine). Symptoms worse with exertion. Chest pain is described as a heaviness, does not radiate. EKG in the emergency room that showed ST elevations in III and aVF and his troponin was found to be 40.5 and so code STEMI was activated. Patient had cardiac cath on an urgent basis and that showed triple-vessel disease, with a very short left main as LAD and left circumflex were almost coming from 2 separate ostia, subtotal occlusion of the LAD and left circumflex and 100% occlusion of the mid RCA. Evaluated for CABG, which was declined. Patient's echocardiogram showed global hypokinesia with EF of 20 to 25%. Patient underwent high risk PCI procedure using Impella support with 2 stents to the subtotally occluded LAD and 1 stent to the subtotally occluded left circumflex. Patient's symptoms subsided following procedure, however patient suffered mild CHF on initial CXR secondary to ischemic cardiomyopathy, successfully treated with Lasix as displayed by downtrending BNP. Patient's labs also displayed shock liver with AST and ALT liver enzymes both above 1000 on arrival; hepatitis and HIV titers came back negative. Patient suffered from AKI on arrival secondary to ischemia, with an elevated BUN and creatinine; CKD suspected due to lab values showing chronic anemia.

7 days following vaccination patient reported swelling to right lower extremity with pain and shortness of breath. 10 days post vaccine, patient admitted to hospital with pulmonary embolism as well as very large deep vein thrombosis.

ON 5/8, this 70 year old man was in his usual state of health when he went to bed. He was awakened with "the worst leg cramping of my life". He states that his right lower extremity tightened up and the cramping extended all the way into the foot. His leg began shaking uncontrollably. Called EMS and arrived in ED for evaluation. Noted to have labored breathing and confusion. Blood alcohol 170. Elevated D-dimer. The patient was given nebulizer treatments without significant improvement. BP 119/68, HR 76, RR 19. oxygen sat 96% on room air. Speaking in short sentences, audible wheezing. CT angiogram with contrast: findings suspiscious for pulmonary embolism, involving segmental branches of both lungs. No large central embolism identified. Patient started on apixaban. No signs of hemodynamic compromise. Plan 3 months anticoagulation.

3 days prior to receiving his covid 19 vaccine, the pt had a sedated bronchoscopy at hospital. At the time, no lung tissue samples were taken due to no symptoms of rejection. Within a few days to a week of receiving his covid 19 vaccine, he started experiencing shortness of breath, returned to the transplant doctor at hospital and was diagnosed with rejection. The timeline suggest to me that this could have been induced by the vaccine. I requested that the transplant coordinator make the report, but she said the rejection had nothing to do with the vaccine. Hospital is currently doing a study concerning rejection post covid vaccine in transplant patients. I want the accurate information reported

About 4 hours after my shot I started experiencing cold chills and shortness of breath, I went to bed and the symptoms continued for another two hours and after a short nap(10-15 mins) the symptoms went away.

Fever to 100.8, Nausea and vomiting, Pleuritic chest pain which was worse when supine and improved with sitting up. Symptoms started within 24 hours of the vaccination. Symptoms improved a few hours the initiation of treatment with anti-inflammatory agents.

71-year-old male with history of lymphoma on chemotherapy and heart transplant in 2011 on immune suppressants presenting with fever, fatigue, cough, shortness of breath x4 days. Patient is afebrile upon arrival with otherwise normal vital signs. He did desaturate to 88% while at rest and was placed on 2 L nasal cannula. He has clear breath sounds bilaterally without any focal findings. Work of breathing is not increased and very stable in my opinion. He appears clinically euvolemic and denies history of heart failure. No wheezing warranting treatment beta agonist. Patient will require admission given his acute respiratory insufficiency, will need to discuss appropriate Campus placement with the Heart Transplant Service and anticipate he will require transfer to Grand Rapids. Given his reported dyspnea, EKG ordered. Will obtain routine screening labs, COVID-19 swab. With his reported fever, although not objectively present during this visit, and current immunocompromised state, will treat via the emergency department sepsis protocol and collect blood cultures. Fri May 21, 2021 1059 EKG with a normal sinus rhythm, rate of 88 beats per minute, no acute ischemic changes are noted. Patient has a right bundle-branch block. EKG is unchanged from that of January 21, 2021. BNP is 404, no chest pain to warrant cardiac biomarkers. [SR] 1113 COVID-19 is detected. [SR] 1125 CMP was sodium of 128, chloride 95, glucose 303, creatinine 0.87. Magnesium is 1.9. Phosphorus 2.1. Urinalysis with trace blood, no urinary tract infection. Urinalysis without urinary tract infection. [SR] 1147 INR subtherapeutic at 1.2. [SR] 1149 Received a critical result from lab, white blood cell count is 0.04, patient is by definition therefore neutropenic. Platelets are 21 K without reported active bleeding. Hemoglobin is 9.3. Have a call out to Oncology to discuss need for IV cefepime given the reported fevers at home although etiologies presumably viral with COVID-19 test. Further, I do not know if IV Decadron is appropriate given his profound neutropenia, especially having recently finished a high-dose course of 100 mg prednisone orally x5 days. [SR] 1150 CXR: Airspace opacities are seen involving both the lungs, more prominent in the right lung, as described above. These are likely due to consolidation/pneumonia. Viral pneumonia can also have similar appearance. Correlate clinically. [SR] 1218 Discussed case with Dr. from transplant team who agreed with admission to his service . He did recommend that I broaden his antibiotic regimen to include both IV vancomycin and IV cefepime. He recommended that I do provided dose of IV Decadron despite the neutropenia to treat his acute respiratory failure secondary to COVID-19. Still awaiting call back from Oncology. [SR] 1454 After multiple pages, I have not been connected to Oncology. Patient was transported by EMS. He will need a formal oncology consult upon arrival to admitting facility. [SR]

Fainted in apartment parking lot, on morning of April 3; transported to ER,, via ambulance. Hospital stay for several days, moved to Rehab, sent back to ER with a cough, trouble breathing, and swallowing. Diagnosed with pneumonia. Went into coma on 4/18. Passed away on 4/22/2021.

COVID-19; feeling really tired; Having little trouble breathing; brain fog; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (brain fog), FATIGUE (feeling really tired), DYSPNOEA (Having little trouble breathing) and COVID-19 (COVID-19) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product MACITENTAN for Pulmonary hypertension. Concurrent medical conditions included Primary pulmonary hypertension. Concomitant products included SILDENAFIL for an unknown indication. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and MACITENTAN (Oral) 10 milligram. On 04-Nov-2020, the patient experienced FEELING ABNORMAL (brain fog) (seriousness criterion hospitalization prolonged) and COVID-19 (COVID-19) (seriousness criterion hospitalization). On an unknown date, the patient experienced FATIGUE (feeling really tired) (seriousness criterion hospitalization prolonged) and DYSPNOEA (Having little trouble breathing) (seriousness criterion hospitalization prolonged). The patient was hospitalized for 5 days until 05-Nov-2020 due to FEELING ABNORMAL, then until 05-Nov-2020 due to DYSPNOEA and FATIGUE. At the time of the report, FEELING ABNORMAL (brain fog), FATIGUE (feeling really tired), DYSPNOEA (Having little trouble breathing) and COVID-19 (COVID-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Nov-2020, SARS-CoV-2 test: positive (Positive) Positive. 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. No treatment information was provided. The patient got first dose of vaccine on March 2021 and second dose on April 2021. Company comment: Very limited information regarding the events have been provided at this time. Medication Macitentan can be a confounding factor. Based on the mechanism of action of mRNA 1273 and the timing of the event Covid 19 which happened prior to the vaccine schedule, the event is unlikely related to the vaccine. No further information is expected at this time. This case was linked to MOD-2021-163029 (Patient Link).; Sender's Comments: Very limited information regarding the events have been provided at this time. Medication Macitentan can be a confounding factor. Based on the mechanism of action of mRNA 1273 and the timing of the event Covid 19 which happened prior to the vaccine schedule, the event is unlikely related to the vaccine. No further information is expected at this time.

Hallucinations; STOPPED BREATHING; Drug interaction; Arm infection; Sleeplessness; Memory loss; Unable to walk; This spontaneous case was reported by a physician and describes the occurrence of RESPIRATORY ARREST (STOPPED BREATHING) and HALLUCINATION (Hallucinations) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products CARBIDOPA, LEVODOPA (DUOPA) suspension for Parkinson's disease and AMANTADINE HYDROCHLORIDE (GOCOVRI) capsule for an unknown indication. The patient's past medical history included Non-smoker since an unknown date and Abstains from alcohol since an unknown date. Concurrent medical conditions included Drug allergy (SULFA DRUGS MANIFESTED BY SWELLING). Concomitant products included ALPRAZOLAM (XANAX) for Anxiety, MORNIFLUMATE (FLOMAX [MORNIFLUMATE]) for Catheter removal, ZOLPIDEM TARTRATE for Sleepiness, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and VITAMIN D NOS for Supplementation therapy, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroidectomy, CARBIDOPA;LEVODOPA, LEVOTHYROXINE, PARACETAMOL (TYLENOL) and CARMELLOSE SODIUM (THERA TEARS) for an unknown indication. On 23-Sep-2017, the patient started CARBIDOPA, LEVODOPA (DUOPA) (Percutaneous) 1 dosage form. In 2018, CARBIDOPA, LEVODOPA (DUOPA) (Percutaneous) dosage was changed to dosage form. In 2020, the patient started AMANTADINE HYDROCHLORIDE (GOCOVRI) (Oral) 274 mg once a day. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced RESPIRATORY ARREST (STOPPED BREATHING) (seriousness criteria hospitalization and medically significant) and GAIT INABILITY (Unable to walk). On 23-Apr-2021, the patient experienced HALLUCINATION (Hallucinations) (seriousness criteria hospitalization and medically significant) and AMNESIA (Memory loss). On 28-Apr-2021, the patient experienced INSOMNIA (Sleeplessness). On 01-May-2021, the patient experienced LOCALISED INFECTION (Arm infection). On an unknown date, the patient experienced DRUG INTERACTION (Drug interaction). The patient was hospitalized on 28-Apr-2021 due to HALLUCINATION, and then for 12 days due to RESPIRATORY ARREST. In April 2021, RESPIRATORY ARREST (STOPPED BREATHING) had resolved. On 28-Apr-2021, GAIT INABILITY (Unable to walk) had resolved. On 03-May-2021, HALLUCINATION (Hallucinations) and INSOMNIA (Sleeplessness) had resolved. In May 2021, LOCALISED INFECTION (Arm infection) had resolved. At the time of the report, AMNESIA (Memory loss) had not resolved and DRUG INTERACTION (Drug interaction) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered RESPIRATORY ARREST (STOPPED BREATHING), HALLUCINATION (Hallucinations), GAIT INABILITY (Unable to walk), INSOMNIA (Sleeplessness) and AMNESIA (Memory loss) to be probably related and LOCALISED INFECTION (Arm infection) to be not related. No further causality assessment was provided for DRUG INTERACTION (Drug interaction). Whilst hospitalized, unknown labs and diagnostic tests were performed with normal results. The patient was treated with unknown antibiotic intravenously during the hospitalization to treat infection in the left arm caused by the intravenous line. 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. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Initial additional included patient demographics, medical history, new event information, reporter opinion of causality, suspect drug information, concomitant drug information and narrative description.; 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.

Diagnosed with pericarditis. I have slowly gotten more tired until I had significant aches, upper chest pain near sternum, intercostal muscles SCM and scalene very sore, couldn't breath deep and hard to walk up steps. Couldn't sleep and pain radiating down left arm. Went to ER 1 AM and they did EKG, flood work and chest X-ray. All vitals normal. Sent me home because I was feeling better having sat up. Two nights later significant pain, about 6 out of 10, couldn't sleep, couldn't breath fully, went back to ER. More tests and diagnosed with pericarditis.

Evaluated in Health Services for complaints of SOB on 4/13/21, states he felt 'winded and weak after the 2nd moderna vaccine."

Went for a routine checkup and found a blood clot in right leg....had catscan that showed both lungs full of blood clots

couldn't breathe; swelling of his whole body; whole body was red and rashy; seeing flashes and black dots in his vision; vision was blurry; he lost 11 lbs of water weight; headaches; dizziness/dizzy; His legs ... changed to red and ankles swollen when he dropped them to the floor; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (couldn't breathe), SWELLING (swelling of his whole body) and ERYTHEMA (whole body was red and rashy) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 017B211A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included SIMVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN) and FISH OIL for an unknown indication. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced DIZZINESS (dizziness/dizzy), JOINT SWELLING (His legs ... changed to red and ankles swollen when he dropped them to the floor), VISION BLURRED (vision was blurry), WEIGHT DECREASED (he lost 11 lbs of water weight) and HEADACHE (headaches). On 28-Apr-2021, the patient experienced DYSPNOEA (couldn't breathe) (seriousness criterion hospitalization), SWELLING (swelling of his whole body) (seriousness criterion hospitalization) and ERYTHEMA (whole body was red and rashy) (seriousness criterion hospitalization). On 07-Jun-2021, the patient experienced PHOTOPSIA (seeing flashes and black dots in his vision). The patient was treated with FUROSEMIDE SODIUM (LASIX [FUROSEMIDE SODIUM]) at an unspecified dose and frequency; PANTOPRAZOLE at a dose of 40 mg at bedtime; HYDROCHLOROTHIAZIDE at a dose of 45 mg in the morning; LOSARTAN POTASSIUM at a dose of 50 mg twice a day; CLOPIDOGREL at a dose of 75 mg once a day; VITAMIN B12 NOS at an unspecified dose and frequency; VITAMIN B3 at an unspecified dose and frequency; VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency; ZINC at an unspecified dose and frequency and MULTIVITAMINS [VITAMINS NOS] at an unspecified dose and frequency. At the time of the report, DYSPNOEA (couldn't breathe), SWELLING (swelling of his whole body), ERYTHEMA (whole body was red and rashy), DIZZINESS (dizziness/dizzy), JOINT SWELLING (His legs .. changed to red and ankles swollen when he dropped them to the floor), PHOTOPSIA (seeing flashes and black dots in his vision) and WEIGHT DECREASED (he lost 11 lbs of water weight) outcome was unknown and VISION BLURRED (vision was blurry) and HEADACHE (headaches) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Blood pressure increased: 179/110 (High) increased. On an unknown date, Computerised tomogram: negative (Negative) Negative. On an unknown date, Magnetic resonance imaging: negative (Negative) Negative. On an unknown date, Weight decreased: decreased (Low) Decreased. On 08 Jun 2021, a consumer reported that he took simvastatin for high cholesterol and baby aspirin and fish oil prophylactically. He got his first Moderna dose in his left arm on 01 Apr 2021, lot 017B211A. The next day his blood pressure skyrocketed from 100/50 normally to 179/110. He went to a heart doctor (cardiologist) on Thursday, 22 Apr 2021. His left arm had a higher blood pressure than the right arm. The doctor sent him to the emergency room as he thought he had blocked arteries. They did a computerized tomography (CT) scan and magnetic resonance imaging (MRI). The tests came back negative and he was sent home. He had headaches, dizziness and his vision was blurry. His blood pressure came down to 167/106 and stayed around that level. 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, based on the reported information there might have been previously undiagnosed medical conditions of medical relevance regarding the events. This case was linked to MOD-2021-213198 (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. However, based on the reported information there might have been previously undiagnosed medical conditions of medical relevance regarding the events.

General fatigue; sleepiness; malaise; head fog; tightness and sensitivity to heat. Extreme tightness in neck/throat (dryness). Nausea and diarrhea (5 days). Dizziness (off & on). Shoulders muscles painful. Hard to use arms. 1st dose in right arm. 2nd in left arm 37 days later.

I started on 05/02/2021 I started having these symptoms where my pulse rate drops down to 46-48 mins per beat and it lasts for a few mins an it last for about 3-4 mins and then it goes back to normal. An when it happens it feels like a little tightness and heaviness and it mess with my breathing and I have to stop what I am doing to be able to get it back to normal. Two weeks ago I got Bronchitis and I have never had that before and they tested me for COVID but it came back negative and I was put on Amoxicillin 875mg and put me on a steroid, Prednisone for 10 days and they put me on the Wellbutrin inhaler. I was weezing, coughing and congested.

Small cell carcinoma; cancer of pancreas / metastasized; Metastases to lungs; Metastates to bone; Metastases to brain; Wheezing; This spontaneous case was reported by a consumer and describes the occurrence of SMALL CELL CARCINOMA (Small cell carcinoma), METASTASES TO PANCREAS (cancer of pancreas / metastasized), METASTASES TO LUNG (Metastases to lungs), METASTASES TO BONE (Metastates to bone), METASTASES TO CENTRAL NERVOUS SYSTEM (Metastases to brain) and WHEEZING (Wheezing) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced WHEEZING (Wheezing) (seriousness criterion hospitalization). On an unknown date, the patient experienced SMALL CELL CARCINOMA (Small cell carcinoma) (seriousness criteria death, hospitalization and medically significant), METASTASES TO PANCREAS (cancer of pancreas / metastasized) (seriousness criteria death, hospitalization and medically significant), METASTASES TO LUNG (Metastases to lungs) (seriousness criteria death, hospitalization and medically significant), METASTASES TO BONE (Metastates to bone) (seriousness criteria death, hospitalization and medically significant) and METASTASES TO CENTRAL NERVOUS SYSTEM (Metastases to brain) (seriousness criteria death, hospitalization and medically significant). The patient was hospitalized from 25-Apr-2021 to 10-May-2021 due to METASTASES TO BONE, METASTASES TO CENTRAL NERVOUS SYSTEM, METASTASES TO LUNG, METASTASES TO PANCREAS, SMALL CELL CARCINOMA and WHEEZING. The patient died on 10-May-2021. The reported cause of death was Cancer of lung, Bone cancer, Metastases to brain, Pancreas cancer and Small cell carcinoma. It is unknown if an autopsy was performed. At the time of death, WHEEZING (Wheezing) 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. LABORATORY / DIAGNOSTIC TEST: Ultrasound, computerized tomography (CAT) scan and numerous other tests; result was not provided. Treatment information was not provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event 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.; Reported Cause(s) of Death: cancer of lung; bone cancer; metastases to brain; pancreas cancer; small cell carcinoma

I had the second dose on 3/18/2021 and on 06/14/2021 I noticed I was extremely short of breath and my left lower leg swelled up. I went to the doctor?s office and they had me do some tests and the D dimer came back very high, they sent me to the ER right away and they put me on heparin, I stayed there for 2 nights and then they sent me home with a prescription for Eliquis. They found a clot in each lung it was called pulmonary embolism and in my lower left leg they found a DBT.

sore arm; afib; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (afib) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included HYDROCHLOROTHIAZIDE and BUPROPION for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced ATRIAL FIBRILLATION (afib) (seriousness criterion medically significant) and DYSPNOEA (shortness of breath). On 31-Mar-2021, the patient experienced MYALGIA (sore arm). The patient was treated with FUROSEMIDE (LASIX [FUROSEMIDE]) at a dose of 1 dosage form; AMIODARONE at a dose of 1 dosage form and APIXABAN (ELIQUIS) at a dose of 1 dosage form. At the time of the report, ATRIAL FIBRILLATION (afib), DYSPNOEA (shortness of breath) and MYALGIA (sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. patient is wearing a life vest with a wearable defibrillator. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Patient explained that he developed heart palpitations, shortness of breath and difficulty breathing, gas pain and insomnia.

On 04/14/2021 patient lost his memory for about 3 - 4 hours starting at 1600. I called paramedics who suggested that he needed to go to ER due to an abnormal EKG. At the ER he was tested and Dr. concentrated on his memory loss, no mention about his heart report and he was sent home. 04/15/2021 I spoke with RN regarding the ECG report which I did not understand; she was concerned and suggested that patient return to the ER. The doctor called early on 04/16/2021 and demanded that patient go to the ER, he was having a heart attack and needed to get there immediately; the doctor called the ER and let them know we were on the way. We arrived at the ER at approximately 0900 and another ECG was performed and it was noted that he was having trouble with his heart and a Cardiologist was assigned to him. By 1600 the patient was having a pacemaker implanted into his left chest wall. The patient is now living with a pacemaker, but still suffering from dizziness, weakness, short of breath, and is now experiencing muscle or nerve pain on his feet, legs, and arms. The 3 - 4 hours that the patient suffered memory loss on 04/14/2021 is memory he has not been able to recall up to this date; he continues suffering from short terms of memory loss where he can't recall where he placed certain objects.

After the second dose of the vaccine I just had some tiredness. I had a cold on 06/01/2021 and I went to my doctor. I went to work the next two days. I got worse over the next couple of days. I was having trouble breathing, my chest hurt and I was coughing. I was hospitalized on 06/04/2021 for five days. I was given steroids afterward and I followed up with my doctor on 06/16/2021. I was diagnosed with acute pneumonia. I still have some coughing fits now after five weeks. It is improving.

On May 1 at 11:00 pm started exp heavy chest pains, sob, numbing of left arm. I called 911 looks like I was having heart attack. Upon the ambulance arrival started IV and gave me 5 tablets Aspirin then I was taken to medical facility where I was stabilized. I had tests done for two days on May 4 transferred to Hospital I had surgery had a catheter inserted, had 3 stents and 1 balloon to expand artery. I was discharged on May 5th discharged since then still feel tired, abnormal, sob, bruise easily and different way of living.

Patient developed dyspnea 1 week after vaccination and thought he was developing asthma at the age of 70. This progressed to frank orthopnea where patient could not sleep more than 30 minutes even upright due to dyspnea. He was admitted and found to have EF 10-15% and was treated for florid heart failure. Cardiology notes they do not expect an ischemic etiology.

Developed hypercapnic respiratory failure, CHF exacerbation - readmitted to Hospital. In ICU with BIPAP

Throughout the day, January 8, 2021, I found myself short of breath and my joints were painful more that usual. My resting heartrate went from 62 to 71-73. I felt lightly dizzy and certainly weaker than usual. I had a headache much of the day and when I got home, I immediately went to bed I was so tired. I slept for over 10 hours but did not feel refreshed.

Strong reaction(not moderate). High fever, labored breathing, vomiting, headache. Could not stand. Lasted about 12 hours and then started to feel better.

1-03-2021dose at 9:30 arm pain 6:00 pm went to bed 11:00 woke up around 5:00 with significant breathing problems. Did not improve with albuterol. called 911 and was taken to the hospital ER. Loss of memory for 4-5 hours. don't know what happened

Dizziness about 10 minutes after injection, lasted off and on about 4 hours. Throat tightness about 30 minutes after injection, lasted about 20 seconds

Fatigue, lethargy, change in consciousness, Fever Chills, weakness, loss of appetite, tachypnea Sent to local ER

On 2/3/21 a 71y/o Male arrived to the library to recieve a CoVID Vaccine from County Fire. Pt recieved Vaccine and during 30minute observation period pt began to have symptoms of SOB and Eye irritation. Pt was evaluated by FIre/EMS Staff.Pt c/c was SOB. Pt was evaluated by on site paramedic with no treatment. Pt was offered transport to local hospital but pt refused. Pt Signed AMA after hospital contact. For Further record of pt viitals, information, and care reference EMS PCR HCFA2021-00007716 Incident #HCFA2021-00007716

Received Moderna covid vaccination 1/14/2021. 1/16/2021 received report of cough and difficulty breathing. Proceeded to hospital and was diagnosed Covid+ on testing. Continued to decline, died 1/31/2021.

02/03/2021 The next day after the Covid 19 (Moderna) injection my dad felt chills thru out his body around 7:00 pm he took a Tylenol we assumed it was just a side effect from vaccine. At on or around 8:45 PM my dad called my sister that he was having trouble breathing and felt very short of breath. My sister was there in about 7min by the time she got to him my dad was gasping for air he would lift his head up trying to breath. They got him to the hospital shorty after about a 7 min drive. My dad was taken into hospital we were not able to go in due to restrictions.

Asthma became unpleasant about 30 hour following inoculation. Noticeable improvement with an oral Montelukast pill, about 40% better.

Shortly after first Moderna injection, while driving home, developed shortness of breath and chest pain, was diagnosed with an MI per the hospital, abnormal EKG and enzymes, currently on ventilator and awaiting surgery for coronary bypass surgery. Hospitalized at the point of this input.

First night (Monday) had a slight numbing in my tongue, second night my tongue was starting to fill my throat and I called 911, Thursday night my left side of my lip and cheek/face swelled up took a shot of children's Benadryl and a adult pill.

PATIENT HAS HAD LARYNGITIS AND MILD SHORTNESS OF BREATH WITH LIMITATIONS ON EXCERCISE THAT HE IS ACCUSTOMED TO. WALKING 2 MILES SEVERAL TIMES WEEKLY. HE IS FOLLOWING UP WITH HIS DOCTORS.

Fever for two weeks, nausea without vomit, shortness of breath and difficulty breathing since receiving vaccine, nothing "tasted good" but not complete lose of taste. Stomach is still "weak."

Tongue and lip swelling on one side (left) and throat closure, admitted to ER then ICU 2/17/2021. Discharged from ICU on 2/19/2021.

EYES SENSITIVE TO LIGHT, HEADACHE, WEAKNESS IN EXTREMITIES, ACHY JOINTS, RASH OR ITCHY ON ARMS, SHORTNESS OF BREATH. LOW GRADE TEMPERATURE. FATIGUE. TOOK TYLENOL .

severe COPD; could not breathe; chest pressure; pressure in the neck; rapid heartrate; premature ventricular contractions, extra heart beat; face swollen a little; A spontaneous report was received from a consumer concerning a 71-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) experienced severe COPD, could not breathe, had chest pressure, pressure in the neck, rapid heartrate (have extra heartbeat), premature ventricular contractions and swelling in face. No prior medical history and concomitant medications were reported. On 11 Feb 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. The patient experienced the events like severe COPD, could not breathe, had chest pressure, pressure in the neck, rapid heartrate (have extra heartbeat), premature ventricular contractions and swelling in face on 12 Feb 2021. The reported case is serious as the events, severe COPD, could not breathe, had chest pressure, pressure in the neck, rapid heartrate (have extra heartbeat), premature ventricular contractions and swelling in face lead to hospitalization and resulted in prolonged hospitalization. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events were considered not resolved and the patient is still in.; 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.

Acute congestive heart failure, unspecified heart failure type; Acute on chronic diastolic heart failure; Atrial fibrillation with RVR; CHF (congestive heart failure); Chest pain; Shortness of breath

About a week after receiving my second Moderna Covid shot I felt shortness of breath. 9 days after the shot I had a mild fever (100.5f), severe shortness of breath and chest pain (level 5+) and went to the emergency room. They found D/Dima was elevated and sent me for a CT scan. This showed a significant blood clot in the right lung and a lesser clot in the left. I am usually extremly health, walking 2 miles at least 5 days a week and bicycing about 50 miles per week

Vaccine on 1-30, developed dizziness and SOB 2-3, persisted intermittently until 2-5 when had syncopal episode with no LOC, symptoms gradually resolved over next few days with no further syncope

My arm was very sore, I had very bad chills-I was actually shaking, I had difficulty breathing (I have supplemental oxygen @3% 24/7 but couldn't seem to get enough), and I had a total loss of energy/strength. All this took place from the following morning about 10 a.m. and lasted about 24 hours.

Moderna COVID- 19 Vaccine EUA: Patient presented to emergency department two days after receiving vaccination and three days after symptoms of feeling ill and body aches started. Patient also reports fatigue and back pain. On exam patient had myalgias, dyspnea, cough, chills, fatigue, tachypnea (23 breaths per minute), and fever (39 degrees Celsius). Other vital signs within normal ranges. Administered intravenous fluids and antibiotics and admitted to another facility for further treatment. Patient discharged to home two days later with symptoms either resolved or returned to baseline.

following day: calf pain so severe he couldnt walk for 3 days, increasing coughing and wheezing, scalp felt like it was on fire, ongoing brain fog.

Patient received vaccine, went home, had shortness of breath, was brought to ER, coded, intubated and brought to ICU for liver and kidney failure.

Nearly immediate onset of throat tightness, facial swelling, difficulty breathing. Became unable to talk. Epinephrine, benedryl and zofran were immediately administered by on-site paramedics. Was able to talk after administration of Epi. Was transported to hospital via ambulance. We later heard that he had another episode within the hour and was admitted for observation.

102 degree fever starting about 10 hours after vaccination. The fever lasted the night of the injection, and the next two days. I was unable to sit up in bed without getting dizzy, had a headache, after walking 25 steps in my house I had to sit down due to shortness of breath and rapid heartbeat. Now, two weeks after vaccination I am experiencing a cough, syncope and occasional irregular heartbeat.

FROM MD NOTES 3/22/2021: - Acute hypoxemic Respiratory failure due to COVID-19 pneumonia. Decadron iv, empiric abx, maraviroc, remdisivir,proning and IS. Bumex and HD for volume mgmt. HFNC, NRB,. ID consulted. - ESRD on HD. Nephrologist consulted, cont HD with fluid removal - HTN. stable on meds. - Normocytic Anemia. Due to ESRD. stable. Monitor - Dark stools. R/o GIB, hold asa/plavix/hep, monitor CBC. PPI bid.appreciate GI follow up, pt clinically not stable for gi procedure, will cont to monitor, further GI work up when stable - Renal hyperparathyroidism. Due to ESRD. monitor phos and calcium per renal. - DM with PAD and aortic atherosclerosis and renal manifestation. Stable sugars, monitor on insulin. s/p R tibial arterectomy with angioplasty, L femoral arteriotomy in 2019, monitor on ASA/plavix if GIB ruled out. - Sec hypercoag state. Due to Covid-19, holding hep and ASA due to possible GIB. - Malnutrition, mild. Due to acute illness and low po intake, monitor diet. - Immunodeficiency due to other medical conditions. Due to malnutrition, educated on immunosuppression during flu season.

Came into ED 3.17.21 with chills, cough that caused chest discomfort, fever 103, chronic SOB with exersion, sats in the low 90s at rest. Was diagnosed COVID+ on 3.17.21 and admitted to the hospital. He had his second Moderna vaccine March 13 th.

Patient developed shortness of breath the day after receiving his first Moderna vaccine. Symptoms increased over the next five days. Patient presented to the ED on 3/12/21 after being found hypoxic at their Primary Care doctor's office with O2 sats in the 60s. Patient was admitted to Hospital for pneumonia. Patient continued to require increasing amounts of high flow nasal canula O2 to maintain O2 sats and was diagnosed with multiple segmental pulmonary emboli on 3/16/21. On 3/17/21, patient was also diagnosed with a DVT on the right lower extremity.

Approximately 5 minutes after vaccine administration, the observer noticed patient wasn't responding. Seated in wheelchair with head hunched over, RN went to PT and found him to be non-responsive to voice and sternal rub. Patient was dead, wife assisted in trying to wake the patient. Sx: Non-responsive, head forward on chest, shallow breathing, color normal, unable to obtain a radial pulse, weak carotid pulse was found, skin warm and dry Checked vital signs, mask removed, EMS responded and cared for PT on-site

Moderna COVID-19 Vaccine EUA Congestion, wheezing, slight difficulty breathing starting about 1pm on 3/26/2021. Symptoms lartgely controlled with my albuterol rescue inhaler. Symptoms stopped around 2am on 3/27/2021.

Patient received his Moderna #2 around 9:40 AM. About 4 minutes later his wife signaled that he was in distress by honking her horn. Upon arrival to the patient, he was clutching at his throat, wheezing, and whispering he couldn't breathe. Dyspneic with respiratory rate 20-30, heart rate 60's. No hives/flushing or signs of syncope. Given significant respiratory distress, decision was made to give epinephrine IM right thigh. About 4-5 minutes after injection, patient's respiratory rate came down and he said he felt his throat open up. He was then sent to the ER, where he received Benadryl, Famotidine, Methylprednisone, and Albuterol/Atrovent nebulizer. Pt sent home at 1PM, after 3 hours of observation. Pt is still doing well via phone follow up 24 hours after event.

PATIENT RECEIVED THE 2ND DOSE OF THE MODERNA VACCINE ON 3/17/21.THE NEXT MORNING HE BOARDED A PLANE. THREE DAYS AFTER HIS STAY, HE BEGAN TO EXPERIENCE SHORTNESS OF BREATH AND CHEST PAIN THAT LASTED ABOUT 30 MINUTES AND WERE NEVER REPEATED. HE DID NOT GO TO THE HOSPITAL OR SEEK MEDICAL ATTENTION. UPON HIS RETURN HOME, HE CONTACTED THE PHARMACY TO REPORT THESE SYMPTOMS . WE ADVISED THE PATIENT TO CONTACT HIS MEDICAL DOCTOR FOR OBSERVATION/CARE AND TO SELF REPORT .

Breathing problems starting on March 10th. Walk in health care did lung X-ray and other tests on the heart. Had to see regular doctor on the 18th. Doctor did a CT scan and it showed I had blood clots in the lungs. Doctor put me on Xarelto 30mg tablets

Severe headache, 100.2 fever, some shortness of breath, chest congestion, Tingling in right hand that has not gone away yet. Severe weakness.

Patient is a 71 year old male with a PMH significant for COPD, Hep C, HTN, and PE presents for worsening sob since last wed. He reports that he received his Covid vaccination last week but does not think that the two are causally related. He denies fevers but reports chills. No loss of taste or smell but decreased appetite. No diarrhea. He does have a history of COPD but no reported home oxygen use. Slightly hypoxic in ED.

Pulmonary embolism; Spitting out blood clots; Labored breathing; Diarrhea; Body aches; Joint aches; Fever; Exhausted; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse reaction (No medical history reported.). Concomitant products included METOPROLOL and LOVASTATIN. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced OXYGEN SATURATION DECREASED (Oxygen levels have gone as low as 76 and several in the 80's), HEART RATE INCREASED (Heart rate is normally around 60, and has been in the 90's several times), PAIN (Body aches), ARTHRALGIA (Joint aches), PYREXIA (Fever) and FATIGUE (Exhausted). On 07-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criterion medically significant), HAEMOPTYSIS (Spitting out blood clots), DYSPNOEA (Labored breathing) and VITAL CAPACITY ABNORMAL (Vitals are waked out). At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism), HAEMOPTYSIS (Spitting out blood clots), DYSPNOEA (Labored breathing), OXYGEN SATURATION DECREASED (Oxygen levels have gone as low as 76 and several in the 80's), HEART RATE INCREASED (Heart rate is normally around 60, and has been in the 90's several times), VITAL CAPACITY ABNORMAL (Vitals are waked out), DIARRHOEA (Diarrhea), PAIN (Body aches), ARTHRALGIA (Joint aches), PYREXIA (Fever) and FATIGUE (Exhausted) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 103.7 (High) 103.7. In February 2021, Heart rate: 90s (abnormal) In the 90s several times. In February 2021, Oxygen saturation decreased: 76s (Low) has gone as low as 76 and in 80s. In February 2021, SARS-CoV-2 test negative: Negative and Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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.

Pt. came to the ER via ambulance with the c/o SOB 12-14 hours after the COVID Vaccine. Went in to cardio pulmonary arrest CPR unsuccessful and patient expired. Emergency contact stated that he had been ill and not been eating much for at least 1 1/2 weeks. Other family members have/had COVID. He was exposed to them.

PATIENT RECEIVED 1ST DOSE OF MODERNA COVID VACCINE ON 4/8/2021. HE PRESENTED TO DIALYSIS ON FRIDAY 4/9/2021 MORNING. HE HAD A FEVER OF 101.4, LABORED BREATHING, AND HYPOTENSION. HIS DIALYSIS SESSION WAS CUT SHORT AND HE WAS SENT TO PCP OFFICE FOR EVALUATION. HE IS CURRENTLY IN CLINIC, RECEIVING A CBC AND CHEST XRAY FOR FURTHER EVALUATION.

2nd maderna vaccine was given to my dad on 02/26/2021 and on 03/15/2021 my dad was visiting me all day and he acted fine and normal. At the end of our visit between 8 & 9 pm we went to the store where he started to gasp for breath. He had to keep stopping and said he couldn't breath. I had him sit several times because I didn't know how bad it was. By the time we reached the doors to leave after a short trip he almost fell over and he became confused and said he couldn't breath. I had another customer get my dad a wheel chair close by while I called 911. The ambulance came quickly but at the hospital my dad went into cardiac arrest and his heart stopped 2 or 3 times and it had to be restarted. When I was able to get to the hospital my dad was on a ventilator and sedated. They had put him on medicine to blast the blood clots they had found. They said he had 2 very large blood clots with one on each lung. Later his kidneys started failing him and they said he would need to go on dialysis as soon as the next day. Later that night they told me my dads heart was shutting down and he had developed pneumonia. My dad died that night and I had to watch him take his last breath. If you want further information please contact Medical center would be the ones to contact for all information and my dad was in the critical care unit.

Patient has a history of Reiter's Syndrome. Roughly 24 hours after vaccination patient started experiencing headaches, extreme fatigue, lightheadedness, PVC's, and shortness of breath. Pt has also been experiencing numbness and tingling in his hands due to increased inflammation around his spine and radial nerve.

Dizziness; weakness; dyspnoea; throat swelling; Swelling face; Eye swelling; fever; vomiting; muscle pain; joint pain; Tiredness; Not moving so much due to the healing broken ribs; Broke 3 ribs; Hurt his left arm and forearm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (weakness), DYSPNOEA (dyspnoea), PHARYNGEAL SWELLING (throat swelling), SWELLING FACE (Swelling face), EYE SWELLING (Eye swelling), PYREXIA (fever), VOMITING (vomiting), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and FATIGUE (Tiredness) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included End stage COPD (stage four), Emphysema (stage four), Kidney disorder, Heart disorder, Rheumatoid arthritis (severe) and Dependence on oxygen therapy. Concomitant products included METHADONE, OXYCODONE and PREDNISONE for an unknown indication. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion hospitalization), ASTHENIA (weakness) (seriousness criterion hospitalization), DYSPNOEA (dyspnoea) (seriousness criterion hospitalization), PHARYNGEAL SWELLING (throat swelling) (seriousness criterion hospitalization), SWELLING FACE (Swelling face) (seriousness criterion hospitalization), EYE SWELLING (Eye swelling) (seriousness criterion hospitalization), PYREXIA (fever) (seriousness criterion hospitalization), VOMITING (vomiting) (seriousness criterion hospitalization), MYALGIA (muscle pain) (seriousness criterion hospitalization), ARTHRALGIA (joint pain) (seriousness criterion hospitalization), FATIGUE (Tiredness) (seriousness criterion hospitalization), RIB FRACTURE (Broke 3 ribs) and LIMB INJURY (Hurt his left arm and forearm). On 19-Apr-2021, the patient experienced MOBILITY DECREASED (Not moving so much due to the healing broken ribs). The patient was hospitalized from 14-Apr-2021 to 17-Apr-2021 due to ARTHRALGIA, ASTHENIA, DIZZINESS, DYSPNOEA, EYE SWELLING, FATIGUE, MYALGIA, PHARYNGEAL SWELLING, PYREXIA, SWELLING FACE and VOMITING. At the time of the report, DIZZINESS (Dizziness), ASTHENIA (weakness), DYSPNOEA (dyspnoea), PHARYNGEAL SWELLING (throat swelling), SWELLING FACE (Swelling face), EYE SWELLING (Eye swelling), PYREXIA (fever), VOMITING (vomiting), MYALGIA (muscle pain), ARTHRALGIA (joint pain), FATIGUE (Tiredness), MOBILITY DECREASED (Not moving so much due to the healing broken ribs), RIB FRACTURE (Broke 3 ribs) and LIMB INJURY (Hurt his left arm and forearm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Heart rate: high high. This case was linked to MOD-2021-080362, MOD-2021-080525 (E2B Linked Report).; Sender's Comments: MOD-2021-080362: MOD-2021-080525:caller's case

Dizzy; Weak; All of the sudden he had difficulty breathing¨; Fast heart beat; Is still very tired; Swelling of his face and throat; Fall; Rib fracture; Pharyngeal swelling; His eyes were swelled like mush mellows; Vomiting; Muscle pain; Joint pain; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizzy), ASTHENIA (Weak), DYSPNOEA (All of the sudden he had difficulty breathing¨) and HEART RATE INCREASED (Fast heart beat) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included COPD, Emphysema, Kidney function abnormal, Heart disorder, Rheumatoid arthritis aggravated and Hypoxia. Concomitant products included OXYGEN for COPD and Emphysema, METHADONE and OXYCODONE for Rheumatoid arthritis, PREDNISONE for an unknown indication. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced DIZZINESS (Dizzy) (seriousness criterion hospitalization), ASTHENIA (Weak) (seriousness criterion hospitalization), DYSPNOEA (All of the sudden he had difficulty breathing¨) (seriousness criteria hospitalization and medically significant), HEART RATE INCREASED (Fast heart beat) (seriousness criterion hospitalization), SWELLING FACE (Swelling of his face and throat), FALL (Fall), RIB FRACTURE (Rib fracture), PHARYNGEAL SWELLING (Pharyngeal swelling), EYE SWELLING (His eyes were swelled like mush mellows), VOMITING (Vomiting), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever). On 19-Apr-2021, the patient experienced FATIGUE (Is still very tired). The patient was hospitalized from 14-Apr-2021 to 17-Apr-2021 due to ASTHENIA, DIZZINESS, DYSPNOEA and HEART RATE INCREASED. On 17-Apr-2021, DIZZINESS (Dizzy), ASTHENIA (Weak), DYSPNOEA (All of the sudden he had difficulty breathing¨), HEART RATE INCREASED (Fast heart beat), SWELLING FACE (Swelling of his face and throat), EYE SWELLING (His eyes were swelled like mush mellows), VOMITING (Vomiting), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever) outcome was unknown. At the time of the report, FALL (Fall), RIB FRACTURE (Rib fracture), PHARYNGEAL SWELLING (Pharyngeal swelling) and FATIGUE (Is still very tired) outcome was unknown. This case was linked to MOD-2021-080525 (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. MOD-2021-080525:caller's case

Unknown which vaccine patient received. Patient states soon after vaccine he began having dizziness off and on. He states 2 weeks ago that he began having associated dizziness and shortness of breath. Prior to coming to ER he had severe chest pain and shortness of breath that was worsening. He was found to have left lower extremity DVT with extensive bilateral pulmonary emboli. He is currently stable. He has no risk factors associated with developing DVT/PE. He is active, does not smoke, and has no history of cancer. **Unsure of which vaccine patient received***

This patient received his second vaccine on 2/24/2021 and subsequently developed fatigue, altered mental status, and fever of 101.6. He was taken to the ED on 2/25/2021 by his son and needed supplemental oxygen at that time and had an increased respiratory rate. He was fairly high functioning prior to his second vaccine and has been in and out of 2 hospitals and the rehab facility several times since 2/25 and has never fully recovered. Palliative care has been discussed. He has had extensive work ups. I spoke to our covering physician prior to submitting this report and she agreed that I should submit it due to his huge decline and the timing of his vaccine. Of note, this patient did have COVID in October of 2020.

Hospitalization: PT WITH SOB, FATIGUE, LIGHTHEADED OVER PAST MONTH. STATES NAUSEA, NO VOMITING/DIARRHEA/FEVER. SYMPTOMS STARTED AFTER 1ST COVID VACCINE, IMPROVED AND RETURNED AFTER 2ND COVID SHOT ON 4/9

My dad started having breathing problems and heart fluttering shortly after getting his first covid vaccination on April 9, 2021. He had contracted Covid back in October 2020. He never told us he was getting the vaccination until we got a call on his cell phone from Public Health the day after he died of a pulmonary embolism. When he started complaining of symptoms, his doctor referred him to a cardiologist at a Clinic. He had an appointment with them a few days before he died. Apparently, they didn't find any blood cllots, possibly because they were looking for heart issues. Either way, I believe that my dad died from side effects of the Moderna vaccine. My dad died on May 1, 2021 of a pulmonary embolism. The coroner and County Sheriff both said it was one of the biggest blood clots they had ever seen. Since he had no history of blood clots, I thought it important that I report it.

presented to ED with intractable pain and associated shortness of breath, patients third trip to ED since 5/15 with same problem. Was not admitted, although pain did not change. Diagnosed with fractures of the ribs and COPD exacerbation. Encounter does not appear to be related to the covid vaccine but is reported as per requirement all hospital admissions following covid vaccine.

Two weeks after receiving the final injection, my father was admitted to the hospital with pneumonia. He had poor oxygen saturation which prompted a visit to the ER. Upon x-ray he was found to have a large pneumonia in his left lung. After 10 days at the local hospital, and being placed on a ventilator, he became septic and was air lifted to one of our area's larger hospitals. There, he was diagnosed with necrotizing pneumonia caused by pseudomonas aeruginosa. He also had heart rate accelerations that would climb into the 150s and they could never figure out why. He was treated aggressively with antibiotics and was successfully weaned off the vent. However, his body was unable to fight off the infection and he ended up passing away from necrotizing pneumonia that caused his respiratory system to fail. My father had underlying COPD that was well-managed at home and he did not require oxygen. I was questioned several times as to whether he'd gotten into or been around anyone or anything different from his usual, but he had not. The only thing out of the ordinary he had was the Moderna injections.

stiffness of neck and shoulders, inability to turn my head, shortness of breath, palpitations, acheing joints (knees) extreme fatigue.

headache; tiredness; Convulsion; Severe chest pain; Breathing problem; Swelling of his whole body; Severe Allergic reaction; significant drop in blood pressure; Shaking and Tremor all over the body; Pain all over the body; exaggerated pulse at 92 bpm; Body ache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Convulsion) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B214 and 03114211A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Malaria (Had 2 types of Malaria.) and Sick child (Sickly as a child). Concurrent medical conditions included Rheumatic fever and Drug allergy (Allergic to sodium Pentathol). Concomitant products included MULTIVITAMINS [VITAMINS NOS], FISH OIL, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), ASPIRIN [ACETYLSALICYLIC ACID], TRIAMTERENE, HCTZ, ATORVASTATIN, TERAZOSIN and DICLOFENAC SODIUM (FENDER) for an unknown indication. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 16-Apr-2021, the patient experienced SEIZURE (Convulsion) (seriousness criterion medically significant), CHEST PAIN (Severe chest pain), DYSPNOEA (Breathing problem), SWELLING (Swelling of his whole body), ALLERGY TO VACCINE (Severe Allergic reaction), BLOOD PRESSURE DECREASED (significant drop in blood pressure), TREMOR (Shaking and Tremor all over the body), PAIN (Pain all over the body), PULSE ABNORMAL (exaggerated pulse at 92 bpm), MYALGIA (Body ache) and CHILLS (Chills). On an unknown date, the patient experienced HEADACHE (headache) and FATIGUE (tiredness). On 16-Apr-2021, SEIZURE (Convulsion) had resolved. On 17-Apr-2021, TREMOR (Shaking and Tremor all over the body) and CHILLS (Chills) had resolved. At the time of the report, CHEST PAIN (Severe chest pain), DYSPNOEA (Breathing problem), SWELLING (Swelling of his whole body), ALLERGY TO VACCINE (Severe Allergic reaction), BLOOD PRESSURE DECREASED (significant drop in blood pressure), PAIN (Pain all over the body), PULSE ABNORMAL (exaggerated pulse at 92 bpm), MYALGIA (Body ache), HEADACHE (headache) and FATIGUE (tiredness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Blood pressure measurement (120-90 mmHg): low mmHg (Low) 107/65 Significant drop in Blood pressure. On 16-Apr-2021, Heart rate: abnormal (abnormal) Exaggerated pulse at 92 bpm. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information was not provided. Action taken with mRNA-1273 in response to events was not applicable. 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.

Severe pain when taking deep breaths (left side). Worse when lying down pain is nearly continuous. Better when standing or sitting up but still severe with deep breaths.

Within 6 hours of getting his last COVID vaccine, he stated he knew he was in trouble. For 4 days he could not even function. He couldn't even use the phone to call for help. He stated his temperature was 104. Stated he continues to have shortness of breath all the time. He can't even walk the full length of his house without getting winded. He has no energy and feels tired all the time. He wakes up in the morning feeling tired. He feels like it is slowly getting a little better, but it has been over 2 months already. He denies having any further headaches. He still gets floaters in his left eye but feels like the flashes of light are getting less. This report 6/15/2021.

Pt advised received first Covid Vaccine on Friday (Moderna) and began having shortness of breath, dry non-productive cough, BLE edema 3 days ago. He does admit to increased salt intake over the past week as well. He presented to ER in April with CHF/COPD exacerbation with TTE showing EF 30 to 35%, moderate MR with posterior jet impingement on wall, mild TR, bicuspid aortic valve, mild pulmonary hypertension. He underwent IV diuresis and steroids. He initially thought the level of shortness of breath he was experiencing was caused by his first Moderna COVID-19 vaccine because it became acutely worse after receiving the vaccine. He saw his outpatient cardiologist who ordered stress test which showed severe lateral wall and inferior wall ischemia, infarction in circumflex territory, EF 38%. He was then referred for left heart catheterization with diagonal 1 90%, LAD 75%, circumflex 100%, RCA 60%, PDA 75 to 80%, PLB 100%, DFR of the LAD 0.80 then 0.66 which is significant, EF 30 to 35%, mild MR. Since his hospitalization, he admits to shortness of breath while working in his yard but states that his shortness of breath improved. He underwent PFTs which showed FEV1/FVC 77, FEV1 3.11, FVC is 4.03, DLCO 49.5. Other past medical history of diabetes (A1c 9.2), hypertension, spinal stenosis. He is a former cigarette smoker with 35-pack-year history. Family history of father with heart disease.

I am filing this on behalf of my sister, who feels it needs to be reported but she is too grief-stricken to do this herself. The morning after the second shot, my sister texted that her husband was up at least 10 times during the night, and five times the next night. He was agitated and hallucinating (swatting at bugs that weren't there.) For the next four weeks he had progressively more difficult breathing, and on 4/28 a liter of fluid was drained from his chest. He continued to have difficulty breathing and was taken by ambulance to Hospital on May 2 where they again drained his chest and diagnosed him with pneumonia. A nurse told him they were seeing a number of cases of fluid around the lungs (his fluid was around the lungs, not in them) after COVID vaccines. He was sent home May 4 and commented that it was strange his cardiologist hadn't visited. Almost immediately he was experiencing liver and gall bladder pain, even though tests for those showed the two organs were healthy. On May 8 my sister said patient woke up hyperventilating, which also became more frequent. On the 9th his daughter told me the labs were not trending well, and on May 10 he saw his cardiologist. He diagnosed him with congestive heart failure and got him an appointment at the Heart Hospital on May 17 - he explained congestive heart failure is scary but can be managed through programs at the heart hospital. He began sleeping outside because it made it easier to breathe. On May 15 he was advised to go to the ER/Hospital for tests the heart hospital would need and, once there, they discovered his kidneys weren't functioning and he was admitted immediately. He spent 17 days at Hospital- if the kidneys improved, the heart got worse. If the heart improved, the kidneys failed. He was released on June 2. On June 7 my brother took him to get blood work done - Patient was too weak to get in and out of the car by himself. The blood work came back bad, and on June 8 he was admitted to the Heart Hospital. On June 10 he was transferred to the Regional Community Hospital to be closer to his cardiologist. From there he continued to decline, and the doctors wanted to do surgery for a LVAD but couldn't. To help him get stronger, he had an impeller put in by catheter on June 19 and died that night. His own cardiologist said congestive heart failure is manageable. The symptoms started the night of the second vaccine and his illness wasn't gradual - he went off a cliff. With all the heart problems appearing in males, we don't think this was coincidence.

right side of his cheek swollen; right side of his lips swollen; right side of his cheek swollen; right side of his lips swollen; tongue swollen; tongue swollen enough that his speech was different; Right side of cheek swollen; Swollen lip to the cheek on left side; Tongue was swollen three times the normal size; Unable to breathe; Sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Tongue was swollen three times the normal size) and DYSPNOEA (Unable to breathe) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039420a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF) for an unknown indication. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced ARTHRALGIA (Sore shoulder). On 09-Feb-2021, the patient experienced SWOLLEN TONGUE (Tongue was swollen three times the normal size) (seriousness criterion medically significant) and DYSPNOEA (Unable to breathe) (seriousness criterion medically significant). On 11-Feb-2021, the patient experienced SWELLING FACE (Right side of cheek swollen) and LIP SWELLING (Swollen lip to the cheek on left side). On 22-Feb-2021, the patient experienced the first episode of SWELLING FACE (right side of his cheek swollen), the first episode of LIP SWELLING (right side of his lips swollen), SWOLLEN TONGUE (tongue swollen) and SPEECH DISORDER (tongue swollen enough that his speech was different). On 24-Feb-2021, the patient experienced the second episode of SWELLING FACE (right side of his cheek swollen) and the second episode of LIP SWELLING (right side of his lips swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SWOLLEN TONGUE (Tongue was swollen three times the normal size), DYSPNOEA (Unable to breathe), SWELLING FACE (Right side of cheek swollen), LIP SWELLING (Swollen lip to the cheek on left side), SWOLLEN TONGUE (tongue swollen), SPEECH DISORDER (tongue swollen enough that his speech was different), the last episode of SWELLING FACE (right side of his cheek swollen), the last episode of LIP SWELLING (right side of his lips swollen) and ARTHRALGIA (Sore shoulder) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Allergy test: unknown (Negative) Negative to food he ate (pistachios, tomatoes, shellfish, prawns). The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient had a tongue swelling and reaction on the night on 09FEB2021 and was taken to the ER after calling 911. They released him in 3 hours and patient visited an allergist, who drew blood to check for a rare disease. Also did allergy testing for the foods that had eaten just prior was negative for them. The patient has never had allergy problems prior to this. 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.

Swelling in left arm, chills, breathing difficulties, left arm hot to touch. These are still persisting.

On 12/6/2021 Resident reported via telephone to this nurse he was having NVD, fever(100.4), SOB, HA and hypoxia; this nurse to resident cottage, assessment confirms reported S/S, dispatched ambulance to transport to ED for treatment of COVID-19 S/S S/P positive COVID-19 test from nasal swap on 3 Jan 2021. Family, MD, other staff, DON notified; called in report to Hospital. The resident was treated in the ER and returned on 12/6/21 after about 6 hours at the hospital. Resident returned from ED for tx of Covid-19; resident in stable condition, treated with Prednisone and dexamethasone discharged back. New orders for Prednisone PO x 4 days. F/U with PCP or return if worsening symptoms. Resident reported on 1/7/2021 he is feeling good and has no s/s of COVID-19.

Patient received the first dose of the Moderna COVID19 Vaccine on 1/8/21. He reports he had a sore arm for about 2 days, but soon after developed shortness of breath, generalized body aches and extreme fatigue, most of which lasted for 6 to 7 days. The shortness of breath worsened during this time and he also developed a bump in the right neck area. Upon admission his oxygen saturation was 91% and he had a 10 L nasal cannula placed, increasing saturation to 93%. As of 1/27/21, oxygen saturation has improved and pt is now on 5 L nasal cannula, saturating at 99%.

prior covid patient in march developed transient sob for fifteen minutes with subsequent three days intermittent chills and swollen painful red arm for six days

Narrative: Patient experienced cardiac arrest with PEA and a witnessed collapse upon arrival to the emergency department on 1/24/21. Patient received his first dose of the COVID vaccine on 01/15/2021and felt poorly thereafter. He was describing shortness of breath to his wife and requiring 5L of O2 at home to maintain saturations in 80s, while he usually was on 3L to maintain saturations in the mid 90s. He had been oriented but more fatigued than normal and described bilateral shoulder pain (which was not new for him) as well as indigestion. Took Tylenol with some relief. He had decreased PO intake and less appetite. The patient's wife encouraged him to come to the hospital daily for a week prior to admission, but the patient did not want to because he felt his side effects were secondary to the vaccine. Symptoms:RespDepression, Palpitations, Syncope & cardiac arrest Treatment: EPINEPHRINE 1 MG ONCE 3 rounds given ,CALCIUM CHLORIDE 1000 MG ONCE

Patient presented with sharp right lower quadrant abdominal pain with associated nausea and emesis beginning the day he received the COVID vaccine, after vaccine injection. He had decreased appetite and pain was made worse by eating. He presented to the hospital 3 days (2/6/21) after receiving the vaccine/symptom onset. His vital signs were T 101.5, HR 78, BP 156/67, RR 20, SpO2 94 on RA. As discussed below, imaging showed acalculous cholecysitis. The day after presentation, pain was more localized to RUQ. He was treated with IV ceftriaxone and flagyl. He underwent percutaneous cholecystomy tube place on 2/7/21 with plan for delayed cholecystectomy following drain placement x 6 weeks. Bile fluid culture has been no growth. We are attempting to test bile fluid for COVID-19 via PCR. He tested positive for COVID-19 via nasal swab RT-PCR and developed a 3L oxygen requirement and mild dyspnea. He was treated with remdesivir and dexamathasone 2/6-2/10 with resolution of hypoxia and dyspnea.

Patient received the Moderna COVID vaccine 1/28/21. He was tested for COVID 19 on 1/29/31. Results were received 1/30/21, at which time he was evaluated and found to be hypoxic with tachycardia. He was sent to the local ER and returned this same day. On 2/2/21, he was evaluated by the provider, who sent him to the emergency room with acute respiratory distress and poor O2 sats

Fatigue, congestion, short of breath, rattling, wheezing, high heart rate (100), 180/130BP. he was admitted to the hospital for 24 hours and diagnosed with viral pneumonia and sent home with an oxygen generator that he only used at night. after the second dose of the vaccine his symptoms were the same but escalated. he now has headache and nausea and fever and uses the oxygen generator daily. he had a swollen cigarette box shaped hard spot on the injection site.

Swelling in throat. Transported self to hospital but sat in car outside. Took anxiety med. Fell asleep in car. When awoke felt better and returned home.

Pt received vaccine (outside clinic) and complained of sweating and slight SOB and feeling anxious at 2:45 pm. Pt alert and talkative, and requested use of his own albuterol inhaler. Pt was given one does of Benadryl 25 mg also. Pt calmed after spoken to. BP and pulse ox attached, monitored, attached. Pt improved and then watched for an hour.

Arm extremely sore and happened quickly taking a walk. Patient started to change his walking gait and was leaning forward , wheezing and breathing heavily , and sweating profusely. He tried to sit down and feel on his knees missing the park bench.

Severe face and throat swelling; difficulty swallowing; rash (shingles-like) across chest and back. Swelling subsided after 2 days; Rash is still present, though lessened in intensity

Light headed 30 minutes after shot and slight headache. Following day; extreme fatigue, fever, chills, shortness of breath. Had Covid-19 virus December 17, 2020.

Immediate soreness in left arm. That evening, I felt flue like symptoms of severe ache of upper shoulders and back . Of more concern, when I lay down for bed, I felt a heavy weight in my upper chest, making breathing painful. Use of my CPAP machine allowed me to get some sleep. these symptoms continues for 4 days, after which they subsided.

Listed above is the first round, the 2nd round was on 02/27/2021. I have some COVID like symptoms after both, mostly just tiredness. Now a week or two after the 2nd shot, I'm having significant shortness of breath after very little exertion. I did NOT have breathing issues when I had the COVID back in NOVEMBER. I called my Doctor on 03/15/2021 and he prescribed WIXELA and MONTELUKAST , so far though and it's only been a few days, I see no improvement. I just felt like since it might be COVID related, I should at least let someone know about it. I feel fine other than when I do minor physical stuff, even tying my shoes will leave me gasping for air.

Patient reports feeling well at time of vaccination and according to patient's wife he appeared normal this morning before she left the house. The patient arrived to ED via ambulance with fever 103.1 F and altered mental status with disorientation. On chest X-ray, the patient has a right-sided pneumonia. The patient's rapid COVID-19 test was negative. The patient received ceftriaxone and azithromycin, acetaminophen, and a bolus of 0.9% NaCl. The patient is being admitted to the hospital.

Pt felt tired and short of breath. HGB redrawn on 3/12/21 and was 6.0. Pt sent to ER for transfusion.

24 hours after injection started with fatigue, shortness of breath, insomnia.shortness of breath continues 1 week later. winded even with conversation. some congestion in head on and off.

72 y/o with hx of HTN, Aortic valve replacement, venous stasis and venous insufficiency of both lower extremities, CAD, AAA, and s/p squamous cell carcinoma excision in 2019 Upon reviewing the history, here is what we found. 1. 2/27 -- Received send-out covid swabbing/testing- Patient did not disclose this information when screened for his covid vaccination at the clinic. 2. 3/2, 10:00 AM ? Presented to Covid Vaccination Clinic and received 1st dose of Moderna. Results of pending covid test were not back at this time, nor did he disclose this information when screened by nurse prior to vaccination. 3. 3/2, 10:30 PM ? Covid result came back to lab as positive SARS Co-V 2019 4. 3/3 ? patient called and notified of result per ED nurse 5. 3/3 ? Pharmacy recommended patient for mAB infusion (patient did not receive it) 6. 3/6 ? patient presents to ED in severe respiratory distress, DX of Covid-19 pneumonia & transferred to ICU 7. 3/21 ? patient dies after 15 day hospitalization in ICU (pt. had received convalescent plasma x 2 and remdesivir there)

3/26/21 HPI: 72 y.o. male who presents with SLURRED SPEECH, WEAKNESS AND CONFUSION. PT SENT OVER FROM DOCTOR'S OFFICE WHERE WAS NOTED TO HAVE ACCUCHECK OF 59. PT STATES HAS NOT EATEN SINCE 7 AM AND HAD EGGS AND SAUSAGE. PT HAD SECOND COVID VACCINE TODAY AND HAS TAKEN ALL HIS MEDS INCLUDING INSULIN AT REGULAR TIMES. PT DENIES ANY RECENT ILLNESS. PT WAS RECENTLY HOSPITALIZED 3/5/2021 FOR CELLULITIS AND DECONDITIONING AND IS GETTING HOME HEALTH FOR PT. 3/26/21 Transferred to HOME MEDICAL dx: inferior MI, hypoglycemia, right middle lob pulmonary infiltrate 3/30/21 returning to HOSPITAL for swingbed admission

Dizziness; Trouble breathing; Rapid heart beat; Issues with stomach; A spontaneous report was received from a consumer concerning a 72-year old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed rapid heartbeat (palpitations), dizziness, trouble breathing (dyspnoea) and issues with stomach (abdominal discomfort). The patient's medical history was not provided. Concomitant medications were not provided. On 18 Feb 2021, the patient received their first of the two planned doses of mRNA-1273 (Batch number: unknown) in the left arm for the prophylaxis of COVID-19 infection. On 18 Mar 2021, the patient received their second of the two planned doses of mRNA-1273 (Batch number: unknown) for the prophylaxis of COVID-19 infection. On 21 Mar 2021, patient experienced a rapid heartbeat, dizziness, trouble breathing, issues with stomach. Patient was hospitalized at Memorial Hospital where he was kept overnight. No discharge date provided. The events rapid heartbeat, dizziness, trouble breathing and issues with stomach resulted in hospitalization. Treatment information was not provided. Lab tests 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, rapid heartbeat, dizziness, trouble breathing and issues with stomach was considered unknown. .; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Client has history of COPD and CHF. Three days after the 1st COVID Vaccine, client had some SOB and he called 911. When the ambulance arrived they had to do CPR on him and got him to the hospital and at the hospital they got him breathing on his own. From the ER they transferred him to Facility. He spent 23 days in the hospital and Rehab. He was told he could take the vaccine. He was out of the hospital for one week before his 2nd COVID Vaccine. His friend/neighbor is the historian and she states that since he was out of rehab that he was having a lot of extremity swelling. He then came to the Health Services on 03/29/2021for his 2nd COVID Vaccine. On 3/30/2021 at 5:45 pm, client went to Pharmacy to pick up his medications, and after 9 pm was found by friend deceased in his car at Pharmacy. This information was received from friend/neighbor, no local family available.

congestion; Coughing; A spontaneous report was received from a Consumer concerning a 72-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events coughing, congestion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 6 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: 011L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 10 Jan 2021, the patient experienced the coughing, congestion. The event congestion was considered to be medically significant. Treatment details included Amoxicillin, cough medicine, Z-pack. Action taken with mRNA-1273 in response to the events was not reported. On an unknown date the outcome of events include, coughing, congestion was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.

went outside to mow. Started having shortness of breath, loss of consciousness, disoriented, nausea, uncontrollable vomitting. Wife reports pt possibly aspirated on the vomit. Wife reports he is in the step down unit.

Patient presented to the Emergency room for concern of trouble breathing. Pt was bradycardic with heart rate in 40's. Patient eventually needed to be subcutaneously paced, intubated, and brought to cath lab for temporary pacemaker.

3/23/21 Medical Group note: dx pleuritis Chief Complaint Patient presents with ? URI c/o sob, tired, chills, headache, achey. symptoms started today. 72 y.o. male Pt has had both COVID vaccines. URI :This is a new problem. The current episode started in the past 7 days. The problem has been unchanged. There has been no fever. Associated symptoms include abdominal pain and chest pain. Pertinent negatives include no congestion, coughing, diarrhea, dysuria, ear pain, headaches, joint pain, joint swelling, nausea, neck pain, plugged ear sensation, rash, rhinorrhea, sinus pain, sneezing, sore throat, swollen glands, vomiting or wheezing. He has tried nothing for the symptoms. The treatment provided no relief. Review of Systems HENT: Negative for congestion, ear pain, rhinorrhea, sinus pain, sneezing and sore throat. Respiratory: Negative for cough and wheezing. Cardiovascular: Positive for chest pain. Gastrointestinal: Positive for abdominal pain. Negative for diarrhea, nausea and vomiting. Genitourinary: Negative for dysuria. Musculoskeletal: Negative for joint pain and neck pain. Skin: Negative for rash. Neurological: Negative for headaches. Objective Vitals: 03/23/21 1604 Weight: 120 kg (264 lb) Comment: pt. reported Height: 69" Body mass index is 38.99 kg/m². Diagnoses and all orders for this visit:Pleuritis Chest wall pain Pt was advised to go to ER if symptoms persist or worsen. Pt was advised to come to office tomorrow for CXR and recheck. 3/24 sih med group dx rib pain: Patient presents with ? Chest Pain c/o chest pain/initially had chills, sob. symptoms started yesterday. Patient is a 72 y.o. male. Pt states he has gained 20 lbs in last few months. Pt sleeps in a recliner. He states he has to reach over the arm of the chair to adjust the reclining lever. Pt has pain to right ribs and abd. Abdominal Pain The current episode started in the past 7 days. The onset quality is sudden. The problem occurs intermittently. The problem has been unchanged. The pain is located in the RUQ. The pain is moderate. The quality of the pain is aching and dull. The abdominal pain does not radiate. Pertinent negatives include no anorexia, arthralgias, belching, constipation, diarrhea, dysuria, fever, flatus, frequency, headaches, hematochezia, hematuria, melena, myalgias, nausea, vomiting or weight loss. The pain is aggravated by palpation. The pain is relieved by nothing. He has tried acetaminophen for the symptoms. The treatment provided no relief. There is no history of abdominal surgery, colon cancer, Crohn's disease, pancreatitis or ulcerative colitis. 3/26/21 Admitted to Hospital, dx: elevated troponin, sepsis, acute renal failure, streptococcus bacteremia HPI: 4/5/21 Admitted to Hospital, swing bed status dx sepsis, physical deconditioning

Patient completed COVID vaccine series on 2/14. On 4/3 patient came to the emergency department with shortness of breath and cough. Patient tested positive for COVID-19 at emergency department.

pt reports he walked a long way from his vehicle and felt dizzy. he reported shortness of breath and dizziness. Pt felt dizzy just after receiving 1st dose of modenera (within 2 mins) said he thought it was exertion. Pt felt dizzy with no relief after rest. ASA 324mg and 3LPM P2 v12 lead EKG showed Afib and paced rhythm. hospital transport to hospital. Pt care and report given.

Vaccine reactions First dose = first day = slightly sore at injection site. Second day =arm soreness worsened fatigue-set in in the afternoon. Third day =slightly fatigued and injection site only slightly sore but hot to the touch , swelling under the eyes. Second dose =First day= injection site slightly sore. Second day= injection site swollen and much more sore , tiredness and fatigue , shortness of breath and dizziness was experienced later in the day Third day = injection site still sore and hot to the touch tiredness a fatigue , shortness of breath was experienced all day , loss of appetite and nauseous . Had a slight Headache and it hurt to brush my hair. Forth day= slept 10 hours which I never do, had to force myself to get out of bed, experienced extreme fatigue , shortness of breath and dizziness all day . Took blood pressure and found it to be very low 109/68 . I am on meds for hypertension. Injection site sore and warm to the touch. Under eyes very swollen. Fifth day= pretty much back to normal other than slight shortness of breath.

None at time of moderna vaccine 1 or 2 but on the 3rd day after vaccine 2, 02/11/2021, I was given the degarelix injection in the stomach which resulted in an allergic reaction with hives and difficulty breathing. and swallowing. The second degarelix injection on 03/11/2021, was no reaction but on the third injection on 04/08/2021, 911 was called at the Urologists Office to take me to ER in Medical Centre with a severe life threatening allergic reaction, difficulty breathing, hives, swollen face, hands arms, body., sickness and wanting to clear my throat. I have been having degarelix injection on a monthly basis since 2017, with no adverse reaction.

Both my mother and father had their shots on the same day. Mother (77) had mild fatigue the day after the shot with some arm soreness. She was fine after about a day. My father reported arm soreness and fatigue that lasted about three days after the shot. He thought he was rebounding from the shot and continued his usual activities. Though, he started complaining of being "winded" and difficulty breathing. He slept a lot and continued with fatigue and shallow breathing. A week after his shot he felt he needed to go to the ER because of difficulty breathing and being exhausted after walking up a flight of stairs (we live in a raised ranch style house).

death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there and ADR that occurred between the observation period and the date of death. Patient has PMH significant for neoplasm of liver, stage 4 esophageal adenocarcinoma congestive cardiomyopathy, AF, htn. Seen 3/22, per not "states that for the past three days he has had constant chest heaviness and shortness of breath along with productive cough with dark sputum." Discharged 3/24. Deceased 4/2/2021 however no notation or death certificate noted.

Right leg burning, red, swollen. Doppler showed XL blood clot and numerous small clots in right leg. Put in Eliquis for2-3 wk. brought to hospital on 5.6.21 with worse swelling, red, and right foot very painful. CT showed clots in legs and in lungs. Still in hospital as of 5.8.21

At approximately 8 pm pt. sucked in a deep breath, head began to roll and he began twitching on the right side of his body. Pt. only has muscle function in the right side of his body due to his stroke damage. His wife immediately approached him in his chair and asked him what was wrong and all he was able to state was "I don't know" before loosing consciousness and stopping breathing. 911 was immediately called and due to his wife being frail herself she was not able to remove him from his wheelchair to perform any CPR. EMS arrived and begin performing CPR until the DNR papers for pt. were located. Medical examiner came to the home and stated she did not feel that an autopsy was needed even though family had told her NUMEROUS times that pt. had received his second Covid vaccine the day prior. He was pronounced dead by the medical examiner and taken directly to the funeral home due to the DNR papers being present.

Per client, "I received the second dose of Moderna in my right arm on 03/19/2021. The next morning on 03/20/2021 around 9:00 AM, I noticed my left arm swelling. I got to feeling real bad. On 03/25/2021, I was feeling so bad that I went to Family Medicine to see my doctor, MD. He sent me straight to the Emergency room. They gave me the clot buster for my left arm. I was in there for 3 or 4 days. I was discharged. I have blood clots in my lungs. I had a follow up appointment. I also started seeing a new doctor, a pulmonologist, for the blood clots in my lungs. I lost a lot of weight, 32 pounds.

Rash presented several days after 2nd dose of vaccine. Seen in urgent care on 4/28 for this. On 5/8/21, patient had left weakness and numbness, dizziness, and loss of balance. Alteplase given,. Transferred to Medical Center, medical intensive care unit. Transferred to medical/surgical unit 5/9/21. Intermittently Febrile - T-max 39.5. CT for mild lethargy 5/9/21. 5/11 - mild respiratory distress and minimally responsive. Continued decline. TOD 1644 5/13

Very low 02 levels, extreme fatigue, cannot walk up stairs or light work without giving out of breath.

Patient had cataract surgery in mid May, developed shortness of breath after, was seen in ER and admitted. Found to have stage 4 small cell lung cancer (not a smoker to my knowledge). Stayed in hospital until June 3rd when he was transferred home to medical center for end of life care. Died June 7th.

can't walk; feeling very bad/brain is not working correctly/ head is wrong/feeling like a zombie; He vomit everything he eats, he cannot eat, he vomit even water/he have been throwing up; very dizzy, cannot walk because dizzy and vomit/woke up dizzy; pressure was down; short of breath; stomach was tight near the heart; he don't have appetite; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GAIT DISTURBANCE (can't walk) and FEELING ABNORMAL (feeling very bad/brain is not working correctly/ head is wrong/feeling like a zombie) in a 72-year-old male 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. No Medical History information was reported. On 31-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced GAIT DISTURBANCE (can't walk) (seriousness criterion hospitalization), FEELING ABNORMAL (feeling very bad/brain is not working correctly/ head is wrong/feeling like a zombie) (seriousness criterion hospitalization) and DECREASED APPETITE (he don't have appetite). On 07-Jun-2021, the patient experienced DIZZINESS (very dizzy, cannot walk because dizzy and vomit/woke up dizzy), HYPOTENSION (pressure was down), DYSPNOEA (short of breath) and ABDOMINAL DISCOMFORT (stomach was tight near the heart). On an unknown date, the patient experienced VOMITING (He vomit everything he eats, he cannot eat, he vomit even water/he have been throwing up). At the time of the report, GAIT DISTURBANCE (can't walk), FEELING ABNORMAL (feeling very bad/brain is not working correctly/ head is wrong/feeling like a zombie), DIZZINESS (very dizzy, cannot walk because dizzy and vomit/woke up dizzy), HYPOTENSION (pressure was down), DYSPNOEA (short of breath), ABDOMINAL DISCOMFORT (stomach was tight near the heart), DECREASED APPETITE (he don't have appetite) and VOMITING (He vomit everything he eats, he cannot eat, he vomit even water/he have been throwing up) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: blood pressure (Inconclusive) 170-71. On an unknown date, Body temperature: 98.4 (Inconclusive) 98.4 F°. On an unknown date, Oxygen saturation: 99 % (Inconclusive) Oxygen saturation. On an unknown date, Pulse abnormal: 60 (Inconclusive) Pulse. On an unknown date, Respiratory rate: 18 (Low) decreased. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. No treatment medication was 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. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Lab data were updated. Product and event tab were updated. On 08-Jun-2021: Seriousness criteria hospitalization 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.

I developed a rash all over my body but not on the face, about three weeks ago, like pimple sized, they itch a lot even in the night. The hospital didn't even know what it was from. I was given an antibiotic shot for the rash and I put lotion on it each day. I also have a congestion in my lungs since the rash began.

Pt hospitalized for COVID19 on 6/30/2021. Has had 1 week of SOB. Tested negative on 6/28 at PCP office. His shortness of breath started getting worse since then associated with dry cough, loss of appetite and nausea. Denies fever, chills and abdominal pain. Denies recent sick contact. Tested positive for COVID19 on 6/30/21

mild problems with cough he had voice problems. NO IMPROVEMENT. In April he couldn't breathe also slurred speech. Ultrasound came back negative. Hard to swallow , cant lay down and breathe.

FULLY VACCINATED WITH MODERNA - NO DATES DOCUMENTED ADMITTED TO FACILITY 7/6/2021 FOR RESPIRATORY FAILURE; PNEUMONIA DUE TO COVID-19; AKI

Initial symptoms - double vision and drooping eye-lid. Diagnosed as Myasthenia Gravis by blood test. Over two months, symptoms have gotten severe. Severe double vision. More generalized muscle weakness. Choking, and some difficulty swallowing.