Moderna

Breathing difficulty-treated with nebulized medication. Received some relief after breathing treatment. I am on day 2 of having to take breathing treatments. Had fever as high as 102 degrees. I have been sweating profusely for 3 days. I had one night of hallucinating dreams and hardly slept at all. I had all of the general side effects, fatigue, headache, muscle pain, joint pain, chills. I had a rapid heartbeat.

Dose 1 was given to me on 12/30/20. Arm was sore at injection site x2 days which was fine. On 1/12/21 I experienced SOB/labored breathing for approximately 24 hours. O2 sat did not go below 95%. HR was between 80 and 105 for approximately four hours (75 is a typical resting heart rate). No history of asthma, but I felt how people with asthma describe difficulty breathing. Given the length of time between the dose and the SOB, I don't know if it's related to the vaccine. But I am submitting this just in case you end up with other, similar reports. Thank you.

Beginning night of 1/13 around 9pm, felt cold chills, nausea, headache, body & muscle aches, loss of appetite and fever. Tight chest and hard to breathe. Feels like asthma attack was triggered. Has been persistent symptoms since 1/13. Have been alternating Tylenol and Motrin. Using albuterol pump and vicks vaporizer, as needed.

Normally sore following the vaccine starting around 9:00 PM last night. Had shivers, nothing terrible. By 6:00 AM the chills were intense, weakness, having less coordination and depth perception issue. Closer to 9:00-10:00 AM felt like he had the flu 10 times worse than he should have. Had COVID in April/May but these symptoms worse. Got home at 11:15 AM was so cold, hands were ice cold, and took 2 hours of sleeping and all layers of clothing to feel warm. Took a few layers off and still shaking, feverish and feeling of worse flu to man. Pain all over the body, temperature at 3:30 is 99.5-100.4, above 98 is fever is fever for him, normal is 96-97. Sharp shooting muscle pains in extremities, top part of the hands, muscles, tendons, and also his legs and feet, but not fingers or toes. Pain is quite intense. All he wants to do is lay down in sleep. Thought he was going to freeze to death. Hands were so cold his kids were concerned. Ice packs on chest, and gloves and 10 layers on hands and arms. Had tremendous trouble breathing while having the intense chills. He is a responder for law enforcement. Symptoms have improved some, but still feeling feverish with shooting pains, depth perception issues, as well as pain. Headache in back of head, pressure type. Called off for work for today and tomorrow.

Patient received the vaccine on 1/18/21. He awoke early on 1/20/21 with nasal congestion. By that afternoon, he was having difficulty breathing. He was evaluated at Hospital outpatient clinic and sent to the Hospital Emergency Department. On arrival he was placed on oxygen and given a rapid COVID-19 test and COVID-19 PCA test which were both negative. He was also provided pulmonology consult. He was admitted and remained unable to maintain adequate oxygen sats without 10L oxygen until 1/22/21 late in the evening when he abruptly no longer needed oxygen. He was provided steroids initially. Ceftriaxone IV was added. Respiratory therapy provided ipratropium inhalation and vest therapy. He improved rapidly 1/23/21 and was released from the hospital on 1/24/21.

3:15 - Pt was leaning against wall c/o being dizzy and going to pass out - Pt was moved to reclining position - BP 144/100, RR 44, HR 120 - No itching ect. - Respirations rapid - O2 62 - Cannula applied - Pt continued c/o thinking he would pass out - Color pink - 3:15 1 cc Benedryl administered in R arm - 3:27 Epi 1 dose (0.7 cc) administered in R thigh - 3:30 EMS arrived - 3:34 EMS transferred pt to Medical Center

Received the following symptoms starting 15 hours after the vaccine. Full body fatigue. Could not stand up for two hours from my bed. This was followed by body aches pains and chills. It also included heightened skin sensitivity. Physical touch and contact on anywhere but my palms in the pads of my feet was extremely painful. The best example I can give is, taking a shower was like getting shot at by multiple BB gun pellets. At 1450 PST, I experience shortness of breath and wheezing. Struggled to walk up 12 steps. Continued with migraine. Weakness in body. Pain and body. Skin sensitive until about 36 hours after the vaccine. Did not try walking up and down stairs again, but breathing was slightly challenged Until about 30 hour mark. Struggled with migraines from The 24 hour mark until the 48 hour mark.It was the weekend. I did not go in. I just graded it out. Fatigue lasted all the way until the 48 hour mark. Funny enough? I did not developed a sore arm symptom.

Pneumonia; difficult time breathing; A spontaneous report was received from a health care professional concerning a 40-year-old male patient who was administered Moderna's COVID-19 vaccine and experienced having a difficult time breathing (dyspnea) and pneumonia. The patient's medical history included autism and mental retardation. Concomitant product use was not provided by the reporter. On 18 Jan 2021, approximately 2 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection. On 20 Jan 2021 early in the morning, the patient had a difficult time breathing. Around 17:00 the patient was taken to the emergency room and was given 10 liters of oxygen. The patient was admitted to the hospital. On 22 Jan 2021 everything cleared suddenly, so the patient was able to leave the hospital. The patient was diagnosed with pneumonia. The reporter indicated the patient did not have a history of lung problems, so she was concerned and wanted more information on what happened. Treatment for the event included 10 liters of oxygen. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, having a difficult time breathing and pneumonia, were considered recovered/resolved on 22 Jan 2021.; Reporter's Comments: This case concerns a 40 year old male subject, who experienced a serious unexpected event of pneumonia after first dose of mRNA1273 (Lot# unknown). Very limited information has been provided at this time. Further information has been requested.

Diffuse allergic reaction with urticaria, mild difficulty breathing the next day, right upper arm swelling.

Uncontrollable shaking; rise in blood pressure; hives; (stomach, back, face, injection site) high heart rate; swelling in face and neck; shortness of breath.

Dry mouth, dizziness and throat tightness. Benadryl 25 mg oral administered by . Pt was observed for an additional 30 min, symptoms improved. Pt discharged home.

Patient states that approximately 2-3 days post-injection he began to have swelling in throat, neck, jaw, and ear on the left side of body. He states that it was severe swelling and that he had difficulty swallowing. States that he took OTC antihistamine in large doses. Rates the severity of his condition on a scale as 10/10. Approximately three days post onset, he states his condition is now 6-7/10.

Patient received vaccine at 3:15 pm on 3/12/21 and stayed in pharmacy area for 15 min (he left feeling fine). After about an hour 4:15 he showed back up at the pharmacy telling our pharmacy technician that he lost his voice and his throat was closing. She rushed him to the waiting room where I, pharmacist, came out and asked him what was going on. He stated he was with a client and suddenly lost his voice, and felt his throat starting to close. I asked if he was having trouble breathing and he said yes because his throat was closing and his whole arm was tingling. I had him take his mask down and try to take a few deep breaths first. I asked for permission to administer an Epi-pen which he gave verbal consent. 911 was called. Patient stated he did not want 911 called because he was going to refuse service. After a min or so patient stated his throat was back open and he was feeling good. I informed him paramedics are on their way and he needed to stay in the waiting room because effects of the EpiPen can wear off in 15 min. I stayed with him and watched until paramedics arrived. Paramedics sat with him and he did refuse service (they did take his blood pressure). When paramedics asked the patient about when he came in they asked if he was having trouble breathing and he responded "no I could breathe, my voice was just hoarse" (which is the opposite of what he told the technician and myself). He also sounded like it was very hard to breathe. I did information to the paramedics after saying that he told us his throat was closing of which they stated that they figured that was the case and they knew the patient and assumed he would refuse service. Patient was in contact with his primary care doctor who told him he could go home if his BP was ok but to make sure he had someone to drive him home. Patient had his wife come to get him and they left.

Medical staff was called for patient distress. Upon getting to the car that the pt was in, he reported trouble focusing, left sided chest pain, and sweating. Gen: Awake, Alert, Moderate Distress, diaphoretic Cardio: RRR w/o m/g/r Resp: LCAT in all fields, mildly increased work of breathing Skin: no rashes noted, no edema noted of the face or angioedema noted of the lips Psych: anxious Neuro: able to answer questions appropriately, able to follow instructions, CN 2-12 grossly intact Pt instructed that his symptoms were not necessarily consistent with anaphylaxis but with diaphoresis and left sided CP I recommended that he be evaluated in the Emergency Department. Pt agreed to this. Transport to ED via EMS was offered and pt declined as he had a driver. Informed pt that I could not make him go via EMS but I did recommend it. Pt expressed understanding but thought that he would be fine with it being as close as it is and him being the passenger, so he again declined transport via EMS. They were instructed to proceed directly to the ED for further Eval.

08MAR was given the vaccine around noon. Started to develop throat tightness and pain within the next 4 hours. Shortly thereafter developed temp 100F, chills, body aches and fatigue all which resolved within 2 days. Throat pain continued (tightness resolved) and patient then began to develop post-nasal drip and productive cough. Symptoms are continuing to today, 3/15 now 7 days post-vaccine

1 hour after shot, felt: Chest tightness Increased heart beat Felt warm in face Difficulty breathing Loss of taste Lasted about 1 hour. Chest tightness and difficulty breathing were mild and intermittent. Occasional chest pain. Nothing severe just felt uncomfortable. After symptoms subsided, contacted doctor who recommended I go to urgent care to be checked out.

Approx1255: Patient stated he was not feeling well, light-headed. Patient pale, sweating. He asked to lie down. Encouraged to take deep breaths. Patient asked to step outside of room, assisted to hallway chair for air. Wife at side, encouraging to take deep breaths. Patient stated he could not see us and slumped in chair with eyes open and glazed. Shallow breathing, unresponsive to sternal rub. Lips noted to turn purple-blue and then gray. Called for assistance and LVN at patient side obtaining VS, patient took deep breath and started to become responsive. VS at approx. 1303: BP104/47, HR 57, 02 Sat 95%. Patient talking, continued pale and diaphoretic. 911 called and EMS arrived at approx. 1305 Transferred to hospital.

Fatigue during the first two days(so far). Starting to experience asthma conditions (wheezing, and some shortness of breath). Muscles and arm where shot was administered tender still and hurts to the touch or motion.

Headache, emotional lability, body aches, difficulty breathing/shortness of breath. Headache began within hours of receiving vaccine. Emotional lability began the next day (4/2/21). Body aches and shortness of breath began 4/5/21.

3 days sustained fever over 102, cardiac arrest Thursday night, back & chest pain, vomiting, difficulty breathing. Went to ER, admitted to ICU, currently in ICU at hospital.

uncontrollable shivering/convulsions to the point that my muscles started cramping and were sore the next day difficulty breathing and hyperventilating night sweats, vomiting (1 time), confusion, body aches

Had usual reaction on day two: chills, tired, sore, etc On day 5 I experienced very painful chest pain quite suddenly- went strait to ER, turned out to be lung pleurisy. I?ve never had this, nor have I ever had chest pain or been to the ER before this.

What a nightmare. Moderna shot #1 caused rapid hair loss and arm soreness for a week and low grade nausea. But shot #2, holy moly... 12 hours post shot, I developed a fever, chills, violent shaking much of the night, weight loss, nausea, kept throwing up, massive migraine, heart rate racing, every cell in my body throbbing in pain, difficulty urinating, simply staying alive was exhausting. It faded a couple days after the shot, and in its place, fatigue, difficulty getting a full breath in. And now I have tinnitus--constant ear ringing. Absolute torture. And of course significantly more hair loss. So let's add anxiety and depression to the list because of this hell. What a regret it was to get injected with this poison. Rather just keep masking and avoiding people than be stuck with these permanent, life debilitating problems. I know it wont change anything, but I figure I'd report it anyway. What a nightmare. This crap should not be given to anyone with an autoimmune disorder.

Patient received COVID vaccine intramuscular in right arm. Patient was waiting in waiting area then notified the front desk 6 minutes after injection, that he was having dizziness and nausea. APA advised patient to have a seat and went to notify RN about the patients status. Registered nurse went to see about the patient. Patient was slumped in the seat with labored breathing, gagging and eyes rolled back. EMS was notified. RN removed mask, assisted patient to lean over, to allow patient to vomit in trash can. As patient continued to vomit and started regaining consciousness after about 30 seconds. Vomiting was complete. Symptoms had subsided. EMS arrived and examined patient.

Intense back aches and joint aches, acute fever, shortness of breath, and exhaustion. Treatment consisted of increased hydration, 3 rounds of 800 milligrams of ibuprofen, and many hours of sleep and rest. Symptoms persisted for 18 hours.

Symptoms: vomiting, shakes, fever, body aches, lethargy, weakness, loss of appetite, migraine, chest pains, difficulty breathing, wheezing, shortness of breath.

#2 Moderna Vaccine given on 4/20/21 On 5/7/21 patient became SOB before syncope to cardiac arrest, event was witnessed and CPR started immediately. Patient expired 45 min later at Medical Center.

Mild SOB with moderate intensity activity, similar sensation to asthma he had when he was younger. No wheezing. Improved after the first week.

-Dark coloring (purple&blue) around knees -Severe migraine beginning at 12:30 AM Today -Severe joint pain hands & body. Can barely walk. Cannot work. -Mild shortness of breath -Mild Chills The last time I felt this type of pain I ended up in the hospital for 3-4 days with extremely high white cell blood counts. While I realize the vaccine may have side-effects, I'm also aware I have a weak immune system. So I'm taking extra precautions in the case things get worse. I'm sure I'll get better but I'd rather say something and be safe. When I get sick I tend to go down quick and I don't have any family closeby to rely on in case of an emergency. I'm completely played out on the floor hoping it will pass. Not an emergency now but it could turn the other way as it has before. Sorry for any inconveniences.

Fever, chills, chest pain, shoulder pain, short breath. Recommended to see cardiologist and GI doctors. Admitted into emergency hospital and found out that my lungs and hearts inflammations. it was pericarditis and treatment given for this and still on medication and still PCR report shows the inflammation high count.

Pt reported five days after vaccinating started feeling shortness of breath. Symptom lasted until day #7 post vaccination. Symptoms resolved without intervention.

Acute Liver and Kidney Injuries, severe fatigue, difficulty breathing, heart damage, body aches, etc.

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Patient felt faint, had increased heart rate, and a pressure at back of neck. Stated he felt some minor tightness on and off at throat area. No difficulty breathing.-Mild, Systemic: Nausea-Mild

Chest pains (left side only), Shortness of breath, Increasing worse over 3-4 days. Went to the ER because I thought I was having a heart attack.

tightness, pain in chest, shortness of breath, weakness, pain and tightness in left lower neck and shoulder and upper inner bicep area. Symptoms were 5-15 min duration at a time coming and going at all times of the day both with physical exertion and without. Resting pulse was around 120 with each event, symptoms came and went over the course of a week and have since subsided on their own.

Presented to ER with fever, chills, cough, shortness of breath and diarrhea. Suddenly became hypotensive and diaphoretic in ER, which prompted hospital admission. Had 1/2 positive blood cultures during admission of coagulase negative staph, which was thought to be contaminant. Recieved 1 dose of IV vancomycin during stay. Required supplemental oxygen during admission and received 2 doses of dexamethasone while inpatient.

Chest pain and trouble breathing ending in ER visits on Jan 11 and 16, intermediate cardiologist visit Jan 14. Significant increase in blood pressure with any exertion (160/100 after 1 flight of stairs with "one sentence" dyspnea, my baseline ~120/80, baseline weekly exercise of 4 - 8 miles running and 1+ hours strength training). Chest pain @ 2/10, some radiation to left arm. Resolved in ER with IV Toradol. Spontaneously resolved after ~2 weeks. Subsequent persistent chostocondritis, no dyspnea.

First shot one month prior, no issues at all. Soreness at the injection site. Second shot: Next day, high fever, chills, severe muscle and joint pain. Two days after, violent vomiting. increased joint pain, fever, trouble thinking clearly. Three days after, numbness in my left hand, and loss of sensation in my entire right foot. As of 6-16, loss of feeling still continues. 1 week after, chest and lung pain, I think my heart is hurting, almost like random stabbing pains through it, random waves of muscle and joint pain. Issues sleeping. Issues with thinking clearly. I have felt run down since receiving my second shot. Loss of appetite and foggy brain.

Passing out; pain; Difficulty breathing; Dizziness; Mental issues; Physical issues; Hypomanic; "Weird"; Weakness; pain in ankle; Gout pain; Feeling ill; Feels like he almost wants to fall asleep; Vaccination site bruising; Fatigue; headache; arm sore(left arm), muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passing out) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 053621A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hypoxia (Low oxygen), Mental disorder and Ankle operation. Concurrent medical conditions included Gout. On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced VACCINATION SITE BRUISING (Vaccination site bruising), HEADACHE (headache), MYALGIA (arm sore(left arm), muscle pain) and FATIGUE (Fatigue). On 09-Jun-2021, the patient experienced ILLNESS (Feeling ill) and SOMNOLENCE (Feels like he almost wants to fall asleep). On 13-Jun-2021, the patient experienced GOUT (Gout pain). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passing out) (seriousness criterion medically significant), PAIN (pain), DYSPNOEA (Difficulty breathing), DIZZINESS (Dizziness), MENTAL DISORDER (Mental issues), PHYSICAL DISABILITY (Physical issues), HYPOMANIA (Hypomanic), FEELING ABNORMAL ("Weird"), ASTHENIA (Weakness) and ARTHRALGIA (pain in ankle). The patient was treated with INDOMETHACIN [INDOMETACIN] for Gout, at an unspecified dose and frequency and IBUPROFEN for Gout, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (Passing out), VACCINATION SITE BRUISING (Vaccination site bruising), PAIN (pain), GOUT (Gout pain), ILLNESS (Feeling ill), DYSPNOEA (Difficulty breathing), DIZZINESS (Dizziness), MENTAL DISORDER (Mental issues), PHYSICAL DISABILITY (Physical issues), HYPOMANIA (Hypomanic), SOMNOLENCE (Feels like he almost wants to fall asleep), FEELING ABNORMAL ("Weird"), ASTHENIA (Weakness), HEADACHE (headache), MYALGIA (arm sore(left arm), muscle pain), ARTHRALGIA (pain in ankle) and FATIGUE (Fatigue) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant medications include unspecified mental health medications. Treatment information was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-215030 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Updated new events- Mental issues, physical issues, Loss of Consciousness, Gout, Arthralgia, Hypomania and feeling abnormal. Updated patient history and treatment medications.; 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.

My adverse events were that I was having trouble breathing, I felt like someone was stepping on my chest consistently, I was coughing a lot, I felt depressed, I had no appetite and felt extremely fatigued. I was admitted to The Emergency room because of high blood sugar so I went back on Lantus and everything has normalized. I was admitted on 06/09/2021 and discharged 06/10/2021. I had blood work drawn and a COVID test. My COVID test came back normal and my blood work showed that my blood sugar was very high.

Patient called 7/14/2021 to report that on 7/9/2021 at 11PM he experienced heaviness in chest and trouble breathing that lasted 24-25 hours and went away. Stated he did not go to the hospital or talk to his PCP.

seen patient of at this time for syncopal episodes while driving and at work; worsened Bipolar; Decreased level of consciousness; worsened Depression; Difficulty breathing/issues with breathing; worsened Anxiety; Feeling ill; felt really tired; felt really tired like he couldn't keep his eyes open / his son later woke him and he stated he hadn't realized he went to sleep/Feels like he almost wants to fall asleep; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (seen patient of at this time for syncopal episodes while driving and at work), BIPOLAR DISORDER (worsened Bipolar) and DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053C21A and 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Surgery (2 surgeries on other leg). Concurrent medical conditions included Bipolar disorder, Gout (In one leg), Penicillin allergy (reaction- nausea), Drug allergy (Revatio (reaction- nausea)), Drug allergy (Vicodin (reaction- nausea)), Seasonal allergy (reaction- congestion), Anxiety (worse with COVID mask use) and Depression (worse with COVID mask use). Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) from 19-Apr-2021 to an unknown date for Depression, INDOMETACIN (INDOCIN [INDOMETACIN]) from 07-Oct-2020 to an unknown date for Gout, NAPROXEN SODIUM (ALEVE) from 24-Sep-2019 to an unknown date for Pain. On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient experienced SOMNOLENCE (felt really tired like he couldn't keep his eyes open / his son later woke him and he stated he hadn't realized he went to sleep/Feels like he almost wants to fall asleep), ILLNESS (Feeling ill) and FATIGUE (felt really tired). On 14-Jun-2021, the patient experienced ANXIETY (worsened Anxiety). On an unknown date, the patient experienced SYNCOPE (seen patient of at this time for syncopal episodes while driving and at work) (seriousness criterion medically significant), BIPOLAR DISORDER (worsened Bipolar) (seriousness criterion medically significant), DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness) (seriousness criterion medically significant), DEPRESSION (worsened Depression) and DYSPNOEA (Difficulty breathing/issues with breathing). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and OLANZAPINE (ZYPREXA) (oral) ongoing from 07-Jul-2021 for Bipolar affective disorder aggravated, at a dose of 10 mg. At the time of the report, SYNCOPE (seen patient of at this time for syncopal episodes while driving and at work), BIPOLAR DISORDER (worsened Bipolar), DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness), ANXIETY (worsened Anxiety), DEPRESSION (worsened Depression), SOMNOLENCE (felt really tired like he couldn't keep his eyes open / his son later woke him and he stated he hadn't realized he went to sleep/Feels like he almost wants to fall asleep), DYSPNOEA (Difficulty breathing/issues with breathing), ILLNESS (Feeling ill) and FATIGUE (felt really tired) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ANXIETY (worsened Anxiety) to be possibly related. No further causality assessments were provided for SYNCOPE (seen patient of at this time for syncopal episodes while driving and at work), BIPOLAR DISORDER (worsened Bipolar), DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness), DEPRESSION (worsened Depression), SOMNOLENCE (felt really tired like he couldn't keep his eyes open / his son later woke him and he stated he hadn't realized he went to sleep/Feels like he almost wants to fall asleep), DYSPNOEA (Difficulty breathing/issues with breathing), ILLNESS (Feeling ill) and FATIGUE (felt really tired). After getting the vaccine in the morning, the patient felt really tired. The patient went to the family doctor for a previously scheduled appointment regarding his condition. On the way there he couldn't keep the eyes open, and felt as if he didn't get enough sleep. The patient hadn't realized that he slept. The patient had assistance from his son because he felt like he could catch his train of thought. The patient told his O2 level was fine and was instructed to take Benadryl. The HCP reported that anxiety, depression and bipolar might be psychological and wondered why these had gotten worse. 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, history of bipolar depression and anxiety may remain as risk factors. This case was linked to MOD-2021-215030, MOD-2021-214836 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up contains New event , Medical history On 08-Jul-2021: Follow-up included: Medical history was updated, Patient weight, anatomical location of vaccine administered, Dose 1 details added On 14-Jul-2021: Case has been updated from non-serious to serious due to the addition of Serious events. New non-serious events also have been added. Patient's demographic details and reporter contact details were updated. Patient's medical history including allergies and current conditions, concomitant medications and treatment details were added.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, history of bipolar depression and anxiety may remain as risk factors.

I started to have numbing on my right side especially on the back of my head. After that I had dizziness and confused. I felt like I could not breath. I was finally able to catch my breath. I am still not able to catch my breath. I went to the ER. They checked my pulse and took notes. They were just trying to rule out everything. They monitored me for a while. The did do an MRI. After that I followed up with my PCP, she ran labs, and they came back normal. They did a COVID test which cam back negative. I still experience irregular heartbeat. I am going to follow-up with my cardiologist at the end of month.

40 year old patient received second dose of Moderna lot number 026A21A. Began to complain of rapid heart beat, tingling, difficulty breathing, difficulty speaking. No physical evidence of allergic reaction. Vitals were normal except mild tachycardia. No rash or wheeze. Normal oxygen sat. Watched longer, offered food, but patient continued to state he did not feel right. At over 1 hour, asked if he would like to drive to ER, but said he could not drive. Called EMS. Gave Bendadryl IM (no po in kit).

DX: Pericarditis; S/S Headache, fever/chills, Acute chest pain or pressure, Chest pain made worse by lying down, deep inspiration, or cough,Chest pain relieved by sitting up or leaning forward-- onset 04/14/2021 "Progressive severe diffuse anterior chest pain radiates towards his anterior neck...describes a pleuritic component to his chest pain."

Left sided pleuritic chest pain developed about 24 hours after vaccination and continued to get worse for 2 days after which it is now slowly resolving. Used ibuprofen and tylenol PRN to help with pain symptoms.

Started with flu like symptoms, chills, aches, etc. For about 12 hours. Then I rapidly spiked a 102.7 fever and became so physically weak I felt paralyzed. Oxygen saturation dropped into the low 90s and I began to have labored breathing. I made an attempt to stand up and urinate, then passed out and collapsed. Ems came to the house and checked me out. I declined their offer to go to the hospital because I broke the fever, was breathing better, and had no concussion signs from the fall.

at the end of pt's 30 minute observation, he was brought to me due to report of redness/rash at vaccine site as well as itchy sensation/tightness in his throat as he has had with prior anaphylactic reactions; no diaphoresis, no pallor. mild erythematous patches around vaccine site; HR 70 BP 126/76

Mild symptoms - cold chills, achy on the night of vaccine. At about 24 hrs after vaccine administration, developed high fever(102), rapid heart rate, low o2 sat, eventually passed out and EMS had to be called. Was not transported to hospital per pt request.

Within 5 minutes of vaccination, patient developed throat tightness. Patients vital signs and symptoms monitored, diphenhydramine 25mg po x 1, diphenydramine 37.5mg IM x1 and subsequently Epi-pen was administered (no progression of symptoms but incomplete resolution of throat discomfort led to decision to administer Epi. ) Monitored x 5 hours total in office;patient discharged home stable with epi-pen and plan of care.

After 15 minutes of the receiving the vaccine, the patient came and said that he felt that his throat felt tight. He did not experience any shortness of breath or trouble breathing. EMS was called just to be sure that the patient was not experiencing an allergic reaction. Patient was not in distress and blood pressure was normal and could communicate fine.

Day 1- pain and lack of range of motion at deltoid left arm , existed for about 5 days. Burning in chest, possibly lung. Shortness of breath, scanty urination/dark urine, problems with bowel movements. Days 2-4: dizziness, disorientation, gait changes, delay thinking, headaches, shortness of breath chest burning, whole body joint pain, neuropathy like sensations in arms, blood pressure spikes/ pulse rates dropped to 42.

Pt reported throat feeling tingly and tighter ~20 minutes after vaccine, thought it was normal. Later that day, pt experienced tongue swelling and trouble breathing. Went to urgent care, got steroid treatment. Still lasted after several days. Went to the hospital, got more steroid treatment. Pt reports it is "on and off" now, 4 weeks after first dose. No history of allergic reactions to other meds/vaccines.

shortness of breath, tightness in chest feeling for about 12 hours. Started 36 hours after second dose.

2 minutes after received 1st dose of Moderna COVID vaccine, patient stated unilateral headache, advised to drink water. 3 minutes after receiving vaccine, patient stated " I feel funny, I can't breathe" and lost consciousness x 5-10 seconds. Patient airway clear and breathing monitored. Patient regained consciousness, diaphoretic, oriented. Patient A&O x 4 after sternal rub. HR: 52, SPO2: 97% RA. Provided breath coaching, held patient in upright position, monitored breathing, had patient orally drink water. Manual B/P: 95/60, HR: 64. Patient became more coherent and stated prior to loss of consciousness he felt chest pain, denied any current chest pain, SOB, dizziness, headache, confusion, itching, rash, swelling. Consulted with MD on site who advised EMS called and to monitor patient vitals. Patient declined EMS. Patient placed in wheelchair and taken to private room to lay supine and orally drink fluids. 15 minutes later supine vitals: B/P: 117/77 HR: 68, SPO2: 99% RA. Patient rested for additional 15 minutes, sat upright for 5 minutes. Vitals sitting: B/P 117/79, HR: 69, SPO2: 99% RA. Per MD, patient approved to return home but advised not to drive. Patient stated had not eaten or been drinking water and driven 2 hours prior to vaccination. Patient stated all symptoms resolved except feeling fatigued. Advised patient's wife to drive, to eat/drink prior to leaving, if develops chest pain, SOB, facial swelling, hives, loss of consciousness, lethargy, confusion to go to ER or call 911. Patient and wife verbalized understanding. Patient monitored for 1 hour after loss of consciousness. Telephone call to patient 4 hours after vaccination. Patient stated "feeling much better," ate and drank water after leaving clinic, and resting. Patient denied SOB, chest pain, loss of consciousness, confusion, lethargy, HA, dizziness, lightheadedness. Patient advised to inform PCP of symptoms/reaction and discuss plan for when/if 2nd dose. Explained may have been vasovagal response. Patient stated several years ago having similar episode at ER when seeing blood, stated at vaccine clinic today, watched wife receive vaccine, then saw small drop of blood on his arm before loss of consciousness. Patient stated he will discuss with his PCP.

Choking sensation, difficulty breathing Given 0.3 epi at 1319 Transported to ER via Rescue Squad Evaluated in ERx4 hours

Patient became flushed, sweaty, and experienced shortness of breath, per his report. This occurred approximately 1 1/2-2 hours after vaccine.

blood pressure was 200/120; felt like it was hard to breathe; felt dread; felt a strange cold rush over his system; A spontaneous report was received from consumer concerning a 41 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and felt a strange cold rush over his system/ feeling cold, felt like it was hard to breathe/dyspnoea, felt dread/fear, blood pressure was 200/120/hypertension. The patient's medical history was not reported by the reporter. Concomitant medications taken by the patient were not provided. On 8 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) through intramuscular route at left arm for prophylaxis of COVID-19 infection. On 8 Feb 2021, less than a minute after receiving vaccine, patient felt a strange cold rush over hissystem felt like it was hard to breathe, he felt dread. Patient reported that the facility had checked and his blood pressure was 200/120. Patient was not sure if it was a panic attack, but he took antianxiety medicine. Treatment activities for event was done with antianxiety medicine. The seriousness criteria for the event hypertension was assessed as medically significant. The seriousness criteria for other event was not reported. Action taken with mRNA-1273 in response to the events was unknown. The outcome of events, and felt a strange cold rush over his system, felt like it was hard to breathe, felt dread, blood pressure was 200/120 were unknown.; Reporter's Comments: Based on the information provided which includes a STRONG temporal association between the reported events, administration of mRNA-1273 vaccine and excluded all other etiologies, a causal association cannot be excluded

Shortly after receiving his second dose of Covid 19 vaccine, he reported feeling throat and chest tightness, SOB and palpitations.

He had second dose of Moderna COVID vaccine on March 13th. He was admitted with progressive SOB and acute right leg limb ischemia 4/7/21. He was found to have massive Bilateral PE and right common femoral artery and right external iliac atery occlusion. He was unstable and required embolectomy, tPA and EKOS for PE and embolectomy for right leg arterial occlusions. He remains sedated in ICU now.

Sore throat and throat swollen, fever, severe chills, headache, diarrhea,. Symptoms started within 1 hour.

Fever, fatigue, 12 hours after injections Difficulty breathing 2 days after injection required 3 day hospitalization

Shortness of Breath, Weakness, Lightheadedness. BP was 76/49 , after 10 mins bp was 105/79. o2 sat 96%, gave 500ml water orally, the patient was stable after 15 mins. The patient was advised to seek medical help if needed

20 minutes after shot, I went from feeling fairly normal to very suddenly had very severe problems including dizziness, confusion , significant difficulty breathing, significant difficulty staying conscious, tingling all over, loss of control of some body movements, inability to sit or stand, pulse dropped to 51 according to medic,. I believed I was dying. Medic indicated I turned "white". The symptoms peaked within 1-2 minutes after onset and stayed bad for several minutes. After a few minutes My pulse started to increase and all symptoms started improving. Within 10 minutes I was feeling well enough to sit, and within 30 minutes I was able to drive home.

About 8 minutes after receiving vaccine, patient asked for water and reported that he did not feel well. He reported feeling faint and slight shortness of breath. The pharmacy staff gave him water and advised him that he could remove his mask to assist with breathing and began to observe him closely. The patient began to fee l better almost immediately, and was asked to remain in the observation area a little longer in case of worsening symptoms. During the next several minutes the patient experienced two more brief spells of faintness, which were relieved with more water and deep breathing. The patient reported that he had been working out in the sun earlier in the morning and that he was possibly a little dehydrated when he came in for his vaccine. He said that the symptoms he was experiencing were similar to episodes of dehydration he had experienced in the past. After about 40 minutes of total observation the patient said that he was feeling fine and that he felt fine to leave and drive home on his own. He walked around the store for a few minutes to make sure he would not feel faint while walking, and then left the building. I called and left a message for the patient tonight, and will attempt to call again tomorrow morning.

Patient described swelling in throat (2/10) 16min following receipt of vaccine. POD staff administered diphenhydramine liquid 36mL/90mg PO at 11:43am. Patient requested transport to nearby ER at 11:52am via ALS; at 12:00pm the patient declined transport/medical care and stated he was feeling better.

Overnight the night of the vaccine: severe chills, body aches, next day severe headache/migrane, mild nausea, weakness, winded, fatigue

Left and right lung wheezing 2 days after vaccination for 3 weeks on Moderna #1. Moderna Shot #2 same result with only right lung wheezing.

Approximately 20min following vaccination, patient apparently experienced throat swelling and itching, but did not inform clinic staff of symptoms and left to return to employment. Approximately 45min later, patient returned to clinic requesting assistance for throat swelling (7/10). Patient received liquid diphenhydramine 91mg PO, throat swelling improved to (3/10). Patient was released to home and advised to seek medical treatment if symptoms did not resolve or worsened.

On April 27th, I went to local ER with acute shortness of breath. X-ray and CT scan showed possible fluid build up in lungs. I was admitted to hospital on April 28. Echocardiogram diagnosed heart failure, ejection fraction was 25%. Pulse was also quite high (120-135), and blood oxygen was low (88-90%). Cardiac catheterization showed no blockages in coronary arteries. Echocardiogram, EKG, and bloodwork were negative for heart attack. Ultimate diagnosis from doctor was idiopathic cardiomyopathy. Currently taking several medications and under care from primary care physician and cardiologist. At follow up appointment with primary care following discharge, she suggested I report the incident out of an abundance of caution.

After headaches and fatigue following the shot (within 24 hours) I began to notice slight shortness of breath 3-5 days following. I didn't give it much thought, but, roughly two weeks after my dose I began to experience severe intercostal pain and sharp pain in the lower lobe of my right lung upon inhalation. I thought this was musculoskeletal at first but after it didn't abate within days, I went to the hospital and was diagnosed with several distal pulmonary emboli. Luckily I survived and am currently on blood thinners while trying to determine the cause of this, having no history of blood clots personally or in extended family.

Patient had no previous issues with vaccines in the past. Patient went to the post-vaccination chairs and about 2 minutes after giving the Moderna COVID-19 vaccine, patient's wife informed me he was not feeling well. Patient was sweating profusely, shaking, light headedness, and difficulty breathing. Site of injection looked normal. I brought him back to the immunizing booth, laid him down, gave him something soft to lay his head on and cover- up with. His sweating and shaking seemed to get worse. He wanted to sit in the chair since the floor was cold. We sat him up, gave him an ice pack, and gave him some orange juice. We called 911 and instructed EMS where to find us and the patient's symptoms. While waiting on EMS, his symptoms improved slightly. They arrived quickly and assessed the patient's blood pressure, heart rate, and blood sugar. He did not feel as if he needed to go to the hospital. I had the patient wait in the immunization booth a bit longer. He felt better, and color came back into his face. He went home with his wife. I gave them the V-Safe info, so he can report any issues while at home.

Patient reported difficulty breathing, dizziness/weakness, numbness/tingling and a fast heartbeat - and suicidal ideation - went to ED. CHIEF COMPLAINT: SUICIDAL IDEATION (pt. reports suicidal thoughts) and FEVER (pt. received 2nd Moderna vaccine approx 1100 yesterday approx 3-4 hours ago developed chills/fever/anxiety/visual hallucinations/generalized body aches) HISTORY OF PRESENT ILLNESS: HPI: Patient is a 41-year-old male who presents to the emergency department from home with his wife for chief complaint of suicidal ideation, anxiety. Nursing noted him to be hyperventilating in triage. Patient states these thoughts started about 4 hours ago after he started feeling unwell. Patient states that he got his 2nd moderna COVID vaccine at 11:00 a.m. yesterday. This evening after trying to go to bed he started getting fevers body aches and myalgias. He took Advil around 8:00 p.m.. After this, he started having increased thoughts of wanting to harm himself. He states he is having "hallucinations of himself cutting his arms and legs off". He called telemedicine who told him he needs to go to the emergency department. Patient originally did not want to wake his wife up and did not want to go in but he eventually woke his wife and she brought him here. Patient does have a history of PTSD and depression. He is on Cymbalta which apparently he has been taking. He has not been able to see a counselor since the beginning of the year because of his insurance. He does see physicians through the hospital. he has never had to be inpatient but has had to come to the ER a few years ago for suicidal ideation. He also tells me that he quit his job yesterday because he doesn't like seeing people be mean to other people. ED Course as of May 19 0613 Wed May 19, 2021 0339 Patient is a 41-year-old male who presents to the emergency department with suicidal thoughts. Patient has PTSD. Suicidal thoughts started about 4 hours ago. He did get his 2nd moderna COVID vaccine at 11:00 a.m. yesterday and now has a fever and generalized body aches and fatigue. I do believe this is a normal immune response to the COVID vaccine. We will give him Toradol. Patient is very tearful and anxious. I will give him some Ativan while we are waiting for lab work to return. Medical social worker will have to evaluate the patient. 0521 MSW is currently talking to the patient. 0611 Medical social worker and wife felt that patient could be discharged home with the safety plan. He will follow up with the hospital for mental health counseling services. Patient feels much better after fever subsided. He will continue to rotate between Motrin and Tylenol. ED Course User Index DO

On 5/2/2021 I woke up with severe shortness of breath. I went to a walk in clinic two times and then I ended up going to the ER two times, and I have seen my primary doctor and a pulmonologist. Through out all the visits they have done lab work, chest x-ray, CT scan, Echocardiogram. At the walk in they thought I had bronchitis so they prescribed an inhaler and another medication, later they prescribed a steroid, my first visit to the ER I was not prescribed nothing, the second time they prescribed oxygen at night and as needed, and from my pulmonologist they prescribed a different inhaled steroid.

A few days after the second vaccination, patient started feeling poorly. Shortness of breath, tiredness and could not shake it. Ended up at hospital and after multiple tests he was flown to another hospital with a pulmonary embolism. He is currently in hospital being treated for PE and multiple clots in his legs.

Heart attack like symptoms. Severe chest pain, shortness of breath, Heart rate elevated around 10 bpm from normal, tired, thumping heart beat, occasional murmur. Symptoms start about a week after first vaccine shot.

Shortness of breath, with low grade chest pain, and then the onset of symptomatic atrial fibrillation requiring cardioversion.

Moderna COVID-10 Vaccine EUA. Patient developed congestion, slight tightness in throat and a funny taste in mouth. Vital signs stable. Feeling continued, administered famotidine and cetirizine HCl, monitored until symptoms resolved.

Congestive HF diagnosis 6/30/2021. Symptoms of SOB beginning 4/15, issues with sleep except when sitting upright and anxiety. No history of medical conditions.

Patient contacted the clinic on 6/21/21 with symptoms of an upper respiratory infection. Patient tested negative several times for COVID-19. He was treated with multiple courses of antibiotics with no improvement. Patient went in to the ER for shortness of breath and was diagnosed with Guillain-Barre Syndrome.

Chronic cough started sometime in March. At first I blamed allergies, but oral antihistamines and nasal steroids did nothing. I then blamed worsening GERD. I was constantly clearing my throat and coughing/choking all the time. It had been previously well controlled with OTC Nexium. My GI Dr scheduled an EGD. It showed gastritis and signs of GERD. My symptoms worsened and I found that albuterol would sometimes help my coughing fits. They continued to worsen to the point that I was using albuterol every 4 hours, gasping for air, wheezing, O2 dropping to the low 90s. Three weeks ago, my PCP gave me samples of Breztri to see if it helped any. It immediately started working on day 1 and improved over time. I hardly have any symptoms while taking it. I had some pulmonary function tests done 2 days ago and was told my lungs were horrible, and they referred me to a pulmonologist. I do not smoke.

Heart palpitations and shortness of breath starting around 11 this morning. Received vaccine yesterday at 4:30.

Client reports covid19 symptoms: fever/ chills /headache/elevated Blood glucose/weakness/confusion/itching/shortness of breath

Two hours after vaccine, I had pain in the neck at my thyroid gland and what seems to be the lymph glands behind it on the right hand side. It was tender. I took tylenol to deal with it. That pain persisted all the next day on Friday and again took tylenol and ibuprofen to deal with it. Then Saturday AM I was awaked early with severe throbbing pain in same thyroid/lymph area, it hurt to swallow, turn my head, and the pain was radiating up to my right ear. I was also having cold sweats. I managed to get the pain down again with tylenol and ibuprofen. On Sunday I spiked a temp of 100.8 and was having flu like symptoms, like body aches and more chills. I got the temp down but my heart rate remained elevated and I found it difficult to catch my breath. This went on for hours. I eventually had to go to the ER, where my pulse eventually came down. Nothing like this has ever happened before. The ER staff could not explain what had happened to me. At the time of writing this on Tuesday, 5 days after vaccine, I again had a lot of cold sweats this morning and there is still some tenderness in the lymph gland area near above the right side of my thyroid gland, but I am feeling better overall.

ER for shortness of breath for 3-4 days; they took x-rays of lungs - clear; inhaler - Albuterol ; tested for COVID - negative

15 minutes post vaccination starting with shaking, feeling hot and flushed, and sensation of throat closing. Brought to ER. Treated with IV benadryl and PO Tylneol. EE refused epi-pen injection. Discharged from ER aprox 3 hours post vaccination

Per patient: "I experienced some side effects approx 12 hours after receiving the vaccine. Symptoms included fever, chills, body tremors and labored breathing. These symptoms lasted 3-4 hours followed by general fatigue the next day lasting approx 24 hours after side effects appeared. On a side note, I did test positive for Covid Dec.10th and have had lasting side effects of no taste or smell but have recently had 3 instances of returned smell since getting the vaccine".

States about an hour after the shot went back to work-was sitting there-felt warm & fuzzy-the next thing he woke up-was on the floor-staff called 911-was taken to ER-states had coughing & couldn't catch his breath & apparently passed out.

I have existing peptic ulcer and acid reflux I have been dealing with for years. I also have elevated cholesterol level for which I am being treated. Within 24 hours of receiving the first dose of the Moderna vaccine, the pain from my peptic ulcer went from 2 to 10 on a scale of 10. It became so severe that I could not sit at work. I had to leave work and went back home. Then on January 13, 2021, I started noticing a back pain that radiates throughout my left back side. On January 15, 2021, I went to the ER because the pain was so severe that I could not not lie down, sit, or breath. I was diagnosed with pleurisy (inflammation of the lung linings). The X-ray also showed enlarged heart but the ER doctor said my heart is fine. They also performed EKG on me. I did not mention receiving the vaccine to the ER doctor because I never thought the vaccine could result in such side effects. I did not mention it to my PCP also because I believe the vaccine is safe. But recently I went through the sequence of events myself and the only thing that happened regarding my health was the vaccine. Nothing else. After vaccination, I went to ER on Jan 15, 2021 at around 11:30PM due to severe back pain and was diagnosed with pleurisy through X-ray. My X-ray also showed an enlarged heart but I suspect that was due to the fact that I could not breath properly when the x-ray was taken. I will repeat the X-ray in a couple of weeks. Never experienced pleurisy or heart enlargement in my life prior to the vaccine. Not sure the vaccine was responsible but the coincidence is suspicious.

Approximately 15" after receiving vaccine, patient stated his 'throat started to feel tight, tongue felt swollen and face and head itchy". Medical staff administered Benadryl, took VS and stayed with patient. Voice is very hoarse. Medical provider in with patient and did a physical assessment. At 30" patient stated his tongue remained swollen, more Benadryl given. Medical staff remains with patient. After about 60 minutes from time of administration of vaccine he drove himself home. Rested all afternoon, did take Tylenol. Stated he had a restless night, not much sleep, very achy, tongue and throat better.

G.I. side effects using the bathroom up to seven times a day constantly bloated aches and pain in lower back felt as if I was 20 years older. A sense of mental confusion felt as if I could not breathe very well symptoms lasted a day and a half

~ 1 -2 second patient stated that he was feeling heat in his arm; face noted to flushed ~30 seconds continue to have burning ~ 1 min moved to Isolation; c/o metallic taste in mouth and feels nausea ~ patient appears the same - allergic symptoms reviewed multiple times 1514 162/102 112; c/o tongue thickness ~1516 stated he felt mild tightness to in throat ~ 1518 136/96 100; states he is feeling worse; EPI pen suggested patient declined ~1520 paten states his allergist had told him that he is not a candidate for the Moderna Vaccine ~ 1524 EMT was called given patients condition and the allergist suggested no vaccinations ~1524 patient continues to refuse EPI administration despite c/o throat tightness and enlarged tongue; able swallow and tongue visually appears normal 1528 131/81 100 99%; stated tightness is improving 1530 158/106 104 flushed able to swallow; lung sound are clear; no increased WOB 1533 EMT at bedside - care endorsed to EMT after rport given As he was leaving with EMT patient stated he may have had COVID 19 ~ December 12 to 20 2019

Difficulty breathing; Allergic reaction; Pain in the arm that radiated up to the neck; Hot and cold flashes; Hot and cold flashes; A spontaneous report was received from a consumer, who was also a 43-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an allergic reaction, hot and cold flashes, difficulty breathing and pain in the arm that radiated up to the neck. The patient's medical history, as provided by the reporter, included asthma and allergies. Concomitant medications were not reported. On 15 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number: 026L20A; expiration date: 28 Jul 2021) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 15 Jan 2021, four hours after vaccination, the patient experienced hot and cold flashes and pain in his arm that radiated up to his neck. He had some food and went to bed. The next day, on 16 Jan 2021, the patient had an "adverse reaction, allergic reaction". This event was considered to be medically significant. treatments at home but had no relief. The patient still had trouble breathing so he went to the emergency room as his physician told him to. He was given three more nebulizers of ipratropium bromide (+) albuterol sulfate, steroids, diphenhydramine hydrochloride, and famotidine but he still had trouble breathing. Therefore, the patient was admitted into the hospital for observation. The patient was discharged on 17 Jan 2021 with two to three bags of normal saline and four bags of "lactose ringers". In addition, his physician put him on a steroid and inhaler. Action taken with mRNA-1273 in response to the events were not reported. The outcomes of the events, allergic reaction, difficulty breathing, hot and cold flashes, and pain in the arm that radiated up to the neck, were unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. Of note, patient's significant medical history included asthma and allergies.

On the first day I had a huge lump underneath my armpit I did not become too concerned with that I read it was something that could happen regarding the lymph node. 10 days later I woke up at 3:30 in the morning and had to dial 911 my throat felt like it was closing and my lips were both swollen. I went in the ambulance they brought me to the emergency room where they gave me Benadryl a steroid and some IV fluids. as soon as I receive the Benadryl my throat started to open up and my lips both started to go down . My lip continue to swell for the next three days on and off often on. Every time it swelled up I took Benadryl and every time sure enough it went away . The day I came home from the hospital I thought I was doing much better until that following night I became severely nauseous. I don?t know if it was something that they had given me in the hospital or still a reaction that was going on in my body, but I had some sort of stomach bug I threw up that whole day, had chills sweats and a pounding headache that would not go away for over 48 hours .I was unable to eat or drink for 24 hours and had to go to an urgent care where they provided me with some medication for nausea. My concern right now is I am hearing that the second shot hits a lot harder than the first one and if this was a reaction to the shot I am very afraid of what will go on if I get the second one. I cannot take a chance with my life. I really want to shot I work in an environment where I am working with the department which is why I was able to get the vaccine so early I feel safe being vaccinated I am very disappointed that this happened I just cannot take a chance having a family etc. Also I have very bad medical in Sherance so I am dealing with all of the bills from this hospital stay I have a deductible which I can?t afford and then only 50% is covered afterwards. That is the reason I do not go to the hospital under no circumstance unless I am dying which that night I was that scared I felt the need I had to go.

Feels like my asthma got worse. My chest feels much tighter and I'm short of breath. When I woke up today, it felt worse.

I have had shortness of breath, with people thinking I have just run up the stairs when I was just sitting in the room.

Hard to breath deep. Continuously since 3 days after the vaccine. No interaction with anyone outside the house. Everyone in the house did not go outdoors or had already been vaccinated with the second dose a month before.

pt states that 6 hours after recieveing the moderna vaccine he developed blisters on his right arm and right torso that were itchy. Blisters bled. Fever of 103. Pt states he took benedryl and blisters resolved with in 15mins. Pt states he has some labored breathing, howver, states it could have been from anxiety. ot denied any swelling of the throat or difficulty swallowing. Pt also stated that the area of the injection site turned black and that it has sinced resolved. Pt went to see his PCP who advised him not to receive the 2nd dose of Moderna, however; to get the J&J vaccine insteasd.

Within 24 hours I spiked a 101.2 fever and begin having digestive issues. Gas, bloating, and diarrhea. I was weak and had no energy for 5-6 days. Since my second dose I experience almost daily bouts of generalized weakness, dizziness, and shortness of breath.

Several hours after vaccine was given, had arm pain/numbness, intermittent dizziness. Chest pain, shortness of breath, anxiety.

Fever up to 103.2. Fever over 24 hours. Severe nausea and vomiting. Shortness of breath. Diarrhea, fatigue, extreme muscle pain and some joint pain. Confusion at height of fever. Fever is 100.7 at 32 hours after injection. Treating with Tylenol.

Symptoms started around a week after COVID-19 vaccine, when patient started having shortness of breath cough and nasal congestion. He was having yellow sputum production and he had chills. Upon arrival to the hospital on 4/18 the patient was tachycardic and chest x-ray that showed cardiomegaly with fluid overload. Progressively became severely hypoxemic and had to be emergently intubated and placed on mechanical ventilation. Patient developed cardiogenic shock which may be acute myocarditis and was placed on an Impella device and norepinephrine drip. The patient continued to worsen and developed acute kidney injury and hyperkalemia and was placed on CRRT. LFTs were also elevated. Patient also went into atrial fibrillation and was started on amiodarone drip. All of the above mentioned occurred within a 12 hour period.

This is a 42-year-old male patient with past medical history of hypertension presented to the emergency department today with complaints of nausea, vomiting, diarrhea over the last 5 days. Patient also noted having a nonproductive cough. Denies any fever, chills, chest pain, shortness of breath. Patient notes he got his 2nd CoVID vaccination on the 9th. Imaging done in the emergency department showed Left midlung infiltrates and probably also in the middle lobe. Patient's labs sodium 136, potassium 4.2, BUN 21, creatinine 2.87, glucose 154. Patient was started on IV antibiotics in the emergency department.

As patient arrived to 2nd floor observation area, patient informed us that her throat was getting tight and did not have her Epi-pen with her. Patient stated it was getting worse. Patient denied chest pain, n/v, itching or hives. Patient was transferred to UC. Patient refused wheelchair and ambulated to UC. Epi-pen given in UC

Caller stated that he received his first dose of Moderna on 3/28/2021 and 24hrs later he developed SOB, he has followed up with an allergist and PCP and was given an inhaler, but the SOB has not improved. Whenever he goes upstairs he runs out breath and has to sit down. He plays sports but, cannot play because of SOB.

On 4/22/21, approximately 1 hr after the Moderna COVID-19 first vaccination injection, I started to encounter allergic reactions that I used to suffer about 20 years ago. My air intake decreased, and my skin began to become irritated. I formerly had environmental allergies that would reduce my air intake, and the first place I noticed the effects were on my skin and I would become irritable. Physicians told me that when my oxygen levels were low, the body would channel the air to where it was most needed, which is generally not the skin, so my skin would become irritated. When this used to occur, I would respond involuntarily with facial twitches and pulling at my face and hair. Physicians explained that these twitches and pulling actions would draw air to the surface of my skin where I was air depleted. When I took the Moderna injection, this happened again -- I found myself with low air, my face was twitching, and I was pulling on my face to draw air to the area. The result when I was 19 and dealing with allergies is that I would remove small patches of hair from my head or eyebrows or eyelashes, and this would happen almost unconsciously as I tried to stimulate the areas and draw air to the surface of my skin. I did the same thing on 4/22/21, and found later, when looking into a mirror, that I had removed a section of my eyebrow unconsciously. It all comes back to oxygen depletion. A different and more intense event occurred in the night of Friday, 4/23/21, and the early morning of Saturday, 4/24/21. I went to bed at about 11 p.m. or 11:30 p.m. Between that time and approximately 1:30 a.m., I had difficulty sleeping, and I dreamed of pain in my chest. I finally woke up about 1:30 a.m. and found the pain in my chest was real. I was having difficulty breathing deeply. It felt as if the lower part of my lungs (at least on one side) was solidifying or inaccessible. What I did was begin forcing myself to breathe as deeply as possible. Over a period of 30 minutes or longer, I was able to gradually reclaim the use of the deepest part of my longs. With every forced deep breath, I was able to chip away at the area that felt like it was freezing up. Finally, I felt that I could access the deepest part of my longs and breath normally. The pain and lack of use in my lower lungs were very concerning.

Per Patient report: Headache started within 1 hour of vaccination. the following day, Blood sugar and Blood Pressure rose to dangerous levels. Nausea and vomiting. Blood pressure 2??/185, Blood sugar so high unreadable >600?; Unresponsive, breathing labored O2 Stat was low and on oxygen, went by EMS to Medical Center. At ER Blood pressure and HR decreased to dangerous levels for approximately 6 hours. Patient stayed in the hospital for 7 days while he was monitored for continued changes in blood sugar and blood pressure as well as severe nausea and vomiting.

Headache, vomiting, lightheaded, dizzy, shortness of breath, chills, body aches, 101.7 fever, fatigue.

These symptoms happened during the time of the injection on 4/24/2021 and lasted from Saturday 4/24/2021 until Tuesday 4/27/2021: intermittent slight tongue spasms, slight tightness in the back of the throat, dry mouth - since 4/27/2021 these symptoms have stopped but now there is less sensation than normal in the tongue and the back of the throat which is still ongoing as of 5/1/2021. // These symptoms happened during the injection on 4/24/2021 and only lasted until the observation time at the vaccination location was over : lips felt very lightly swollen, very slight tinge in eye sockets.

Drowsy, AMS, difficulty breathing, clutching at throat, was not moving air Benadryl 12.5 mg IM, patient lost consciousness, given EPI Pen x 2 Oxygen 5L Foaming at the mouth, suction provided Patient sent to ER

Mild fever Extreme weakness and body ache Pounding head ache Mouth ulcer Breathlessness Increased heart rate (85bpm instead of normal 65bpm resting) Symptoms started about 12 hours after vaccination (this was the second dose) an persisted till 48 hours after vaccination gradually getting better Taking crocin alleviated symptoms

Patient received his first dose of COVID vaccine on 4/24/21. Around 4/30/21 (~ 1 week prior to admission), pt developed cough, runny nose, lack of appetite, loss of smell, and shortness of breath. Pt's symptoms became progressively worse, and he presented to the ED on 5/7/21, where he tested positive for COVID. Pt was found to be hypoxic (89% SpO2) and was started on supplemental O2. He was also admitted to the hospital for COVID treatment .

Patient received his second Moderna shot at approximately 11:45am. He waited for 15 minutes at the pharmacy, then went shopping. He later came back around 12:20 and said he felt a little short of breath. He did not appear to be in distress and was talking normally. I had him sit down and remove his mask. I got him some cold water and his sister asked him if he was just nervous. He replied no. She said he had heart issues and that she was going to take him to the urgent care to just make sure he was ok. He was able to walk and talk normally and did not appear to be in distress. I called him later to check on him and he said the urgent care said it was probably an allergic reaction and they gave him prednisone and benadryl and he felt fine now.

Within 12 hours I started running fever, having trouble breathing, and a cough that would not stop. These symptoms continued to worsen over the next 48 hours. It got to the point that the only way I could breath and grasp air was laying down on my side. I went to the ER and was admitted within hours. They had to put me in a medicated coma and deep lung intubate both lungs. I had internal bleeding which the doctors could not explain. They tested me for everything across the medical spectrum looking for some underlying health issue and found none. Several of the doctors said there is no explanation other than I had an extreme adverse reaction to the vaccine.

- sleeplessness, headache and night sweats - 5/17/21 8PM - 6AM - passed out - 5/18/21 6:30AM - light headed and headache - 5/18/21 7AM - 10PM - shortness of breath when talking - 5/19/21 10AM - 6PM - headache has dissipated - 5/19/21 12PM

None on the first shot. Severe headaches, high fever, tiredness, cough, chills, sweats for2-3 days. Developed cough and shortness of breath which has persisted. Now I get winded easily while walking or talking. This has become concerning as a long time runner. I went to urgent care and they said seems like bronchitis contracted prior possibly, though I socially distance, always wear a mask and only go out if it is needed. I avoid crowds and indoors. Cough persists and winded easily

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Weakness-Mild, Additional Details: pt experienced fatigue diziness minor tingling of the tounge and minor tightness of chest. paramedics were called to the store however after examantion paitent decided he was fine and decided to leave

Pericarditis or pleurisy. Was better after three days. Had myocarditits in 2019 and the infection timeline was identical. That one took 6 days to heal.

Patient experienced facial numness/tingling, chest tightness, possible throat swelling, and shortness of breath about 10 minutes after administering Moderna Covid vaccine dose 1. Instructed patient to stay in consultation room for observation. I stayed with the patient and called 911. EMS arrived on scene about 5-10 minutes later. Took vitals, oxygen saturation within normal limits, elevated bp, normal heart rate. EMS monitored patient for about 15 minutes after which patient was still conscious and alert. EMS advised patient to go to hospital for further evaluation and patient accepted. EMS took patient to hospital. Patient generally seemed fine when he left the pharmacy which was about 30 minutes after receiving the vaccine.

Person presented for first dose of Moderna at a mass vax site on 4/20/21. This was given-- had some mild sob, seemingly anxiety. Stated that he does this often with shots. Give a dose of diphenhydramine. EMS checked out and he did not need anything further and refused transport. Was advised to talk to PCP before receiving dose 2. Upon a quality check to follow up with people who had not followed through with dose 2's, it was discovered that he had received a full series of Pfizer site on 3/28/21 and 4/18/21. Multiple attempts to reach him over several days-- no contact. Today, he answered and immediately hung up.

After the vaccine 4 hours later I started to hyperventilate. Woke up next morning throwing up, diarrhea , extreme lethargy, muscle aches and absolutely no energy. I've missed 3 days of work and I can't get out of bed I'm so sick. I can't provide for my family in the shape I'm in. I truly need help. My medical doctor told me yesterday all my symptoms WERE VACCINE RELATED

Beginning On July 2, 2021, started to feel nasal congestion and had a hard time breathing especially at night. On July 5, 2021 (2M) I found him on our living room floor having a seizure. 911 was called and he was rushed to the hospital and was hospitalized for three days.

Severe chest and abdominal pain never felt before in life. Pain caused difficulty breathing lasting 4-6 hours, fading and remaining uncomfortable for 12-24 hours.

tonic-clonic seizures; Husband is now an epileptic; started convulsing; stop breathing; lots of blood coming out of his mouth; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (started convulsing), GENERALISED TONIC-CLONIC SEIZURE (tonic-clonic seizures) and EPILEPSY (Husband is now an epileptic) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 036B26A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Appendectomy. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced SEIZURE (started convulsing) (seriousness criterion medically significant), DYSPNOEA (stop breathing) and MOUTH HAEMORRHAGE (lots of blood coming out of his mouth). On 22-Jul-2021, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (tonic-clonic seizures) (seriousness criterion medically significant) and EPILEPSY (Husband is now an epileptic) (seriousness criterion medically significant). At the time of the report, SEIZURE (started convulsing), DYSPNOEA (stop breathing), MOUTH HAEMORRHAGE (lots of blood coming out of his mouth), GENERALISED TONIC-CLONIC SEIZURE (tonic-clonic seizures) and EPILEPSY (Husband is now an epileptic) outcome was unknown. Weeks after taking his second dose of the Moderna COVID-19 vaccine, on 24May2021, the patient started having convulsions, stopped breathing and his wife had to bring him to the hospital. Also started having lots of blood coming out of his mouth, at the hospital they said he could have bitten himself when having convulsions but they could not find signs of that. On 22Jul2021 the same thing happened, he started having convulsions, but there was no blood coming out of his mouth this time. The patient is now an epileptic and wife thinks he is screwed and she's scared that she may loose him. They said they're tonic-clonic seizures. Patient did not take any medications prior to this. Concomitant medications information not reported. Treatment information not reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further assessment.; 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, more information is required for further assessment.

On 12/24, at 8:30a I began to get nauseated which lasted about 2hrs. Around 1am I woke up with SOB which continued thru the night, with off and on sleep. I woke back up at 5:45am, went to work with the SOB which lasted until 12N and resolved on its own. Around 3-330pm I began to feel feverish and had chills and was told I was disoriented. My temp was 100.5, HR 122 R 34 BP 170/100 O2-93%. I notified the DON of my feelings who advised me those were possible side effects of the vaccine and made me continue to work until I just couldnt take the feelings anymore and went to the ER. I was there for about 2 hrs and my body began to calm down. I took taken 100mg of Tylenol on my own just to help with the fever which did break shortly and I have been fine every since. I was positive for COVID 12/14.

about 10-15 minutes after injection, felt tightness in throat and sore throat with a little difficulty breathing. Notified onsite RN who immediately gave him 50mg oral Benadryl. Vitals done by EMT onsite, BP `164/108, P=110, slightly swollen tongue. Did not have Pulse Oximeter until 30m after reaction. At that time, O2=94%. 15m after Benadryl patient stated he felt 80% better. 45m after Benadryl patient felt 95% better, BP = 134/96, P= 64, O2=98% and no tongue swelling. Patient wife will pick him up and drive him home. Instructed to take 50mg in 4 hours and call 911 if any symptoms return.

Tachypnea, Angina, Tachycardia, Sore Muscles Narrative: Started feeling ill on the 28th. Drove himself to get checked out at the hospital. Hospital sent him home. Called EMS at 12/30/2020 @ 0200 and was hospitalized for 1 day. He is more stable now but still has these symptoms at a moderate level.

CoughWheeze Congestion, Fatigue, Local injection site tenderness Narrative: Took OTC naproxen and zyrtec.

Patient reported tongue pain located on the edges of the tongue, dizziness, shortness of breath. Initial vital signs 108- HR 99% Pulse OX room air- 220/100

Pt states that he experienced throat tightness 40 minutes after receiving the vaccine and lasted 2 days. He also reports that he woke up the day after the vaccine with left neck tightness and a tense sensation in his right cheek from the ear level to his mouth. He has symmetrical eyebrow lifts and smile is symmetrical. He denies difficulty with extremities or swallowing. or breathing.

Modern a COVID-19 Vaccine EUA Should and neck stiffness and pain. Throat swelling. Took ibuprophin and zyrtek

Telehealth phone call on 2/2/21 with provider. Patient described having mild palpitations and exertional dyspnea that is new onset without airway involvement, did not require current treatment, advised to continue to monitor, if progressing airway involvement advised to see ER care. No history of personal prior MI or CAD, not a current tobacco user.

chills,flu like symptoms. PT presents with burning sensation in chest with tightness and SOB x Saturday denies cough. Reports receiving 2nd moderna vaccine Tuesday prior to onset with hx of covid 10/2020. 43 yo m c/o acute atraumatic onset of substernal cp 'burning' sensation and difficulty breathing w/dry cough x24hrs states sx's feel similar to when he had COVID19 back in Oct2020; Pt states that then he was successfully tx'd w/hydroxychloriquine+azithromycin+zinc by civilian provider; initially dx'd w/covid and went in for tx after he woke up 'feeling like I was drowning' 48hrs s/p dx; Pt states burning sensation 'somewhat' similar to that episode; Pt recently received covid19 vaccine w/2nd dos

Baseball sized diameter swelling around injection site, red (like a rash) in color, itchy, painful to touch and warm to touch. Rash looked yellow to black and blue around the edges as it progressed down the arm. Over the course of 5 days spread from injection site, around the elbow and into the forearm. Hip, knee, foot, shoulder and elbow pain on left side only, Body aches, nausea, visual impairment and loss of balance. Difficulty concentrating and relative "brain fog". Severe drowsiness in the sense of falling asleep while talking to someone and then no memory of it. Chest pressure and constant feeling of being out of breath. Cannot catch breath walking across the house from one room to the next. Severity of symptoms subsided within 24 hours, but some linger up to the time of this report. They are shortness of breath, rash with warmth and pain, lack of concentration and brain fog. Elbow still tender to touch.

Patient received a COVID-19 vaccine on 07MAR21 @ 1900. At 2111, he complained of a scratchy throat and shortness of breath. He has a history of asthma and uses Prednisone and nebulizers at home. He was given Benadryl 25 mg po at 2111 by our onsite nurse and was monitored an additional 30 minutes.

ITCHY THROAT, FEELING OF THROAT TIGHTENING, PRODUCING A LOT OF PHLEGM. GIVEN OXYGEN, ALBUTEROL NEBULIZER, EPINEPHRINE, BENADRYL. FELT DIZZY AND LIGHTHEADED. TRANSPORTED VIA AMBULANCE TO ER IN STABLE CONDITIONS WITH VITALS WITHIN NORMAL LIMITS EXCEPT FOR RESPIRATORY RATE OF 21, SLIGHTLY ELEVATED.

Prior to receiving vaccine, patient was nervous and diaphoretic temperature and o2 was within normal limits. Tolerated the administration of vaccine well. With in the 15 minutes of waiting after vaccine, became tachycardiac, SOB , and developed tremors. Sent to ED for further evaluation

At 16:05 this RN was called to evaluate a patient with a reaction after receiving his first dose of the covid shot. He stated that he had shortness of breath for 1-2 minutes and then Slight dizziness and tingling throughout his body that came and went every 4-5 minutes. Patient was brought to the nurse clinic for observation. I observed patient for 30 + minutes as his symptoms subsided and he returned to his baseline. See vital signs below. At 16:45, patient denied any further symptoms and stated he felt better. Dr. was called with a brief report of these findings and advised that patient was ok to leave and to follow up or to go to Urgent Care if symptoms return or become worse. Patient was provided with these instructions. He verbalized an understanding of information provided him. Patient left ambulatory with no distress noted.

43 y/o man with significant for asthma developed lightheadedness and the sensation of an object in the back of his throat with swallowing about five minutes after getting his vaccine. He denied difficulty breathing. His initial vitals were 160/100, HR 100, O2 saturations 96%. On examination, his tongue was not swollen and he had faint expiratory wheezing. He was given 12.5mg of liquid benadryl. He reported his symptoms slightly improved after five minutes of liquid benadryl. His vitals were measured again about 20 minutes after his first set of vitals and his vitals were 150/100, HR 105, O2 sats 95%. He was given a second dose of 12.5mg of liquid benadryl. After another 20 minutes, he reported that his symptoms were much improved. On examination, his tongue was not swollen and faint expiratory wheezing was heard. Last set of vitals were 140/95, HR 95, and O2 saturations 96%. He calm and relaxed and was released. He was told that he would not get his second dose with the current team due to the location being a non-clinical setting. He was told to follow up with his PCM and/or allergist regarding if he should get a second dose in a hospital setting.

Patient complained of dizziness about 15 minutes after vaccine was administered. After another 5 minutes symptoms progressed to include shortness of breath and chest pains. Was sent to the Emergency Room immediately.

On my first dose vaccine, 01-22-2021, I went to bed at 9:00pm. On 01-23-2021 in the next morning I woke up with heart racing with chest pressure, felt dizzy with SOB. I called an ambulance and they performed an EKG which was normal. I went to the hospital and they did triponine values, EKG and I was released after 24 hours of monitoring. About five days later I went to see my PCP for a physical I had scheduled. He performed another EKG and this time it looked abnormal, showed I had gone into cardiac arrest and other tests, such as stress test, reactive blockages test and heart test were also performed. I had no blockage nor heart attack. I then drove home and since then I have been going to doctor's appointments. I have also scheduled a second dose of Moderna vaccine in three to four weeks.

Whole body became red, swollen, itchy, throat closing up, felt like I had a severe sunburn, anaphylactic allergy

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Medium, Systemic: Hyperventilation-Medium, Systemic: Tachycardia-Medium, Additional Details: OSat: 92 Respiratory Rate: 22 Temperature: 97.5 F Blood Pressure: 135/93 Pulse 117

Initial reaction after the injection: Sore left shoulder, stiffness that continued for 2 days 04/12/2021 The patient went to the ER for left chest pain 04/15/2021 Chest CT obtained with pleuritic chest pain diagnosis CTA report: several pulmonary emboli in the left lower lung with lingular infiltrates; 04/15/2021 - 04/16/2021 admission to Hospital ER for pulmonary embolism and infarction 04/15/2021 admitted to hospital for observation for pulmonary emboli with hemoptysis He was started on Eliquis which he has tolerated. There was hemoptysis during this time and after admission. He experienced an increase in left-sided pleuritic pain followed by improvement after being on the Eliquis for several days. He continues to have discomfort with deep inspiration however asymptomatic with regular breathing and has been able to return to many of his routine activities. Started Eliquis 10mg twice daily x7 days, followed by 5 mg twice daily

throat started feeling tight; Throat was swollen; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (throat started feeling tight) and PHARYNGEAL SWELLING (Throat was swollen) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Seasonal allergy, Allergy to animal and Allergy to chemicals (possible polyethylene glycol allergy). On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced THROAT TIGHTNESS (throat started feeling tight) (seriousness criterion life threatening) and PHARYNGEAL SWELLING (Throat was swollen) (seriousness criterion life threatening). At the time of the report, THROAT TIGHTNESS (throat started feeling tight) and PHARYNGEAL SWELLING (Throat was swollen) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. Treatment medication was not provided. Based on the current available information which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, causal relationship cannot be excluded.; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, causal relationship cannot be excluded.

Extreme body aches, painful at site and painful swelling inside armpit. 24hr Fever 102 that won?t go away with Tylenol, Nausea, chills, headache and lethargy. Heaviness when breathing. Flank pain.

Patient reported fevers, chills and myalgia after 1st dose of Moderna COVID vaccine 4/22. Poor PO intake and had syncopal episode on 4/24 when standing from the recliner. Initially admitted at hospital, and developed fever, leukocytosis, AKI. Transferred to other hospital for further evaluation and eventually developed acute hypoxic respiratory failure requiring intubation and mechanical ventilation, found to have new onsert heart failure with reduced ejection fraction. He is currently being evaluated for auto-immune and underlying infectious causes, with concern for glumerunephritis, cardiomyopathy and coronary artery disease. Patient extubated to NC as of today but remains in the ICU.

Patient developed shortness of breath/chest tightness ~15 minutes after receiving second shot. Called paramedics who assessed the patient and referred to urgent care. Patient's blood pressure measured ~15 minutes post vaccination was 134/86 and HR 91.

covid-19 infection; SOB; Cough; Bilateral lung infiltrate; Fever; vaccination failure; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Apr-2021 and was forwarded to Moderna on 27-Apr-2021. This case describes the occurrence of COVID-19 (covid-19 infection), DYSPNOEA (SOB), COUGH (Cough), LUNG INFILTRATION (Bilateral lung infiltrate) and PYREXIA (Fever) in a 43-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 Kidney transplant (11.35 years from transplant), Pancreatic transplant (11.35 years from transplant) and Diabetes mellitus (Cause for organ transplants). Concomitant products included BELATACEPT, MYCOPHENOLATE MOFETIL and PREDNISONE for Immunosuppression. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid-19 infection) (seriousness criterion hospitalization prolonged), DYSPNOEA (SOB) (seriousness criterion hospitalization prolonged), COUGH (Cough) (seriousness criterion hospitalization prolonged), LUNG INFILTRATION (Bilateral lung infiltrate) (seriousness criterion hospitalization prolonged), PYREXIA (Fever) (seriousness criterion hospitalization prolonged) and VACCINATION FAILURE (vaccination failure). The patient was hospitalized for 11 days due to COUGH, COVID-19, DYSPNOEA, LUNG INFILTRATION and PYREXIA. At the time of the report, COVID-19 (covid-19 infection), DYSPNOEA (SOB), COUGH (Cough), LUNG INFILTRATION (Bilateral lung infiltrate), PYREXIA (Fever) and VACCINATION FAILURE (vaccination failure) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood creatinine: >0.3mg/ml (abnormal) >0.3mg/ml. 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. 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. 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 Bamlanivimab (MAB1), Remdesivir, Dexamethasone, Convalescent Plasma and Tocilizumab. Patient's concomitant medication Mycophenolate Mofetil (immunosuppression therapy) was withheld during hospitalization. Patient was discharge on 2 liters of 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. However the patient's concurrent medical conditions of Kidney transplant, Pancreatic transplant, Diabetes mellitus and use of immunosuppressants remains a risk 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 patient's concurrent medical conditions of Kidney transplant, Pancreatic transplant, Diabetes mellitus and use of immunosuppressants remains a risk factor.

Hospitalization kidney failure heart failure respiratory failure had to be ventilated. Six days in Medical Center and 10 days in Medical Center

Pt reports redness and tightening of his face, resolved by Benadryl. Next morning, pt had an episode of n/v, achiness, fatigued and SOB. Pt admitted to hospital for sepsis and cellulitis from a podiatry procedure. Pt in a state of hypercoagulability r/t to covid vaccine and sepsis. Pt advised not to receive 2nd dose of moderna or j&J.

Pt admitted to facility on 5/18 with shortness of breath, chest tightness and was found to have bilateral pulmonary embolism and mild patchy scattered groundglass opacities . Pt reportedly received 1st dose of Moderna COVID vaccine '2 weeks ago' (not vaccinated at this facility). Pt reportedly tested positive for COVID 1 week later (also not at this facility) and was also COVID positive on presentation here on 5/18. Admitted to ICU and currently being treated with Remdesivir, dexamethasone and enoxaparin for anticoagulation. Pt reportedly does have history of DVT/PE in past in 2012.

PATIENT WAS UNRESPONSIVE ABOUT 5 MINUTES AFTER VACCINATION... PATIENT RED FACED AND NOT RESPONDING TO QUESTIONS... PATIENT THRUST BOTH ARMS DOWN TO HIS SIDE AND TRIED TO GASP IN A BREATH OF AIR... 911 CALLED AND 1 EPIPEN INTRAMUSCULAR INJECTION GIVEN INTO LEFT THIGH. PATIENT WAS TALKING AND ABLE TO DRINK WATER WHEN PARAMEDICS ARRIVED. HE DIDN'T REALIZE THAT HE HAD "PASSED OUT"... AS PARAMEDICS WERE LIFTING PATIENT TO GURNEY, PATIENT LOST CONSCIOUSNESS AGAIN... WHEN HE CAME TO, HE DID NOT KNOW WHERE HE WAS.

A few weeks after the first shot, I started waking up in the mornings and couldn't go back to sleep. After the second shot, things got worse, and I started realize that it was sleep apnea. I went to the doctor and I am currently being evaluated for central sleep apnea. My breathing stops, and then I wake when I need to grasp for air. I am healthy guy that works out and in good shape. This came out of nowhere and I am worried it has to do with taking the Moderna vaccine.

ANAPHYLAXIS: Pt received his second Moderna COVID19 shot on 12Apr2021 at approximately 2:30pm. He waited the required 20 minutes to check for any adverse reaction and then left the facility to drive home. On his drive home, at approximately 3:30pm, he started feeling light headed and lost consciousness, striking a telephone pole. He was gasping and struggling to breathe, so the ambulance treated him with oxygen. When he arrived at the ER , the doctor assessed his condition and confirmed that he was experiencing an anaphylactic reaction related to the COVID vaccine and treated him with an epinephrine injection, steroids, benadryl, and nebulized albuterol.to open his airways. He remained at the ER for ~ 6 hours for observation until his blood oxygen levels increased and he was stable to be released. The car accident resulted in PT suffering a fractured sternum as confirmed via Chest CT Scan by his primary doctor. PT has no history of any allergic reaction to any medication or vaccine. Although he does have well-regulated asthma, this incident was not characteristic of any asthma-related reaction he has ever experienced.

Felt lethargic (aprox. 1 hour after shot) went home fell asleep for about 2 hours and woke up severe pain in chest and tightening of chest and airway and could only get about half at most of a full breath of air every breath. Could only get sufficient O2 it seemed when lying on back and laying down on my side. Was every bit of all my energy to just take a shower and nearly blacked out with heart racing as I tried to breath in the shower but steam in air was too much to breathe. Lasted for 4 days that way. I still feel like I am constantly winded and I as of today have only regained about half the lung capacity I had prior to incident, and that is just over 1 month mark. I also now have been getting these bad facial breakouts particularly on and around my nose and forehead /;eyes area. I never ever had any acne issues to speak of prior, even as a teen and during puberty. Never had any acne ever and now its bad breakouts some appear to may even leave ling term scarring in certain spots. My day to day diet and normal habits have not been added to or altered in any way either. My heart feels like it beats twice as fast and twice as hard now and I am always short of breath now too. I do not have a family doctor to go and see and I was afraid to call for an e.m.t. or go to the e.r. at the early onset of it all. I truly hought I was a gonner a couple of times though throughout the first 4 days.

Patient was seen once in my office complaining of persistent shortness of breath and chest tightness of sudden onset that happened few days after receiving second dose of covid vaccine. A CT angiogram ordered showing pulmonary embolism. Diagnosis made more than 10 weeks after vaccination. symptoms appeared in less than one week.

Chest pain/ shortness of breath caused patient to go to the ER and was admitted with elevated troponin levels, had cardiac cath that was normal, diagnosis was myocarditis. Started on metoprolol and full aspirin with cardiology follow up. Colchicine added and symptoms resolved but then he developed drug reaction rash and it has to be stopped

Patient developed a DVT in left calf that resulted in multiple pulmonary embolisms; patient complained of shortness of breath x 2 weeks and presented with a swollen and discolored lower leg. X-rays and scans confirmed DVT and PE's. Patient underwent thrombectomy and was on Heparin drip followed by Eliquis at home. Patient discharged from ICU after 3 days.

Severe Cold chills, headache, shortness of breath, joint an body aches an pain, fatigue. Used ibuprofen and albuterol, only lasted a day

MODERNA COVID-19 VACCINE EUA Rapid Heart, Dizziness, Unbalance, Wheezing, Lower Intestinal Bleeding, Constipation, Irritability

Swelling at injection site and extremely hot to touch and formed a hard mass for over one week and started within an hour of injection. 24 hours later, fatigue, fever, shakes, headache and aches set in. The second night all the previous mentioned symptoms continued but at an elevated state. This integrity lasted for three days. One week post injection, still suffering headaches, nausea, fatigue, shortness of breath, aches and sweats. Two weeks post injection, still suffering from previously mentioned symptoms.

Day after pain in the area of my lung scar and under arm , skin rashes as well in chest, they come back and then it was fine for a while but recently in June with Heatwave 1 and currently heatwave2- I felt horrible pressure and pain in my chest and could not breath and the nebulizer wasnt helping. I got an xray and the doctor at the City Md refused to believe me that this was related to vaccine and my lung wound from a previous surgery that increases inflammation as I am now experiencing. I am asking to please help me get a cooling airc conditioner in my kitchen/ bathroom area as it is also where I will be teaching virtually hybrid schedule and only feel relieved in cool air. My school that I teach at is in some rooms adding daily heat exhaustion and I would greatly like if possible any help or treatment and or rehabiliation phyical therapy and also reexamining the area where my origial surgery was and how this can be dangerous for people taking the vaccine.

Rapid Heart Beat Blurry Vision High Fever - Approaching 2 weeks Strong Dizziness/Vertigo Rashes Week long Headaches Hard to breath Ringing in ears Deep ache/pain in leg & arm with leg swelling

Nonsustained ventricular tachycardia; Chest discomfort; Rash; S.O.B; Palpitations; This spontaneous case was reported by a consumer and describes the occurrence of VENTRICULAR TACHYCARDIA (Nonsustained ventricular tachycardia), DYSPNOEA (S.O.B), PALPITATIONS (Palpitations), CHEST DISCOMFORT (Chest discomfort) and RASH (Rash) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030C20A and 011J20A) for COVID-19 vaccination. Concurrent medical conditions included COPD (Frequent exacerbation), Hypertension, Diabetes, Shellfish allergy and Allergy to antibiotic (Cipro allergy). Concomitant products included METOPROLOL for Arrhythmia, SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for COPD, ATORVASTATIN for Hyperchloremia, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) and AMLODIPINE for Hypertension. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced DYSPNOEA (S.O.B) (seriousness criterion hospitalization), PALPITATIONS (Palpitations) (seriousness criterion hospitalization) and RASH (Rash) (seriousness criterion hospitalization). On 27-Mar-2021 at 12:06 PM, the patient experienced CHEST DISCOMFORT (Chest discomfort) (seriousness criterion hospitalization). On 26-May-2021, the patient experienced VENTRICULAR TACHYCARDIA (Nonsustained ventricular tachycardia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 25-Feb-2021 due to DYSPNOEA and PALPITATIONS, then on 27-Mar-2021 due to CHEST DISCOMFORT, then on 25-May-2021 due to RASH, and then on 26-May-2021 due to VENTRICULAR TACHYCARDIA. At the time of the report, VENTRICULAR TACHYCARDIA (Nonsustained ventricular tachycardia), DYSPNOEA (S.O.B), PALPITATIONS (Palpitations), CHEST DISCOMFORT (Chest discomfort) and RASH (Rash) had not resolved. Patient reported that he visited cardiologist, primary care, emergency room multiple more times. He experienced unknown rash from beginning and continues. One of the emergency room visit on 27-May-2021 and went for palpitation, shortness breath and non sustained ventricular tachycardia was present. He admitted to hospital. He experienced rash on arm, then face, torso and now mid section and thighs have rah. Experiencing palpitation/ arrhythmias daily as well shortness of breath. Treatment information was not provided. Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. However, the cardiac related disorders are confounded by the patient's underlying cardiac conditions) hypertension, arrhythmia, hypercholesterolemia) and diabetes; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. However, the cardiac related disorders are confounded by the patient's underlying cardiac conditions) hypertension, arrhythmia, hypercholesterolemia) and diabetes

After the first dose heart palpitations worsened, muscle pain, fatigue, chest pain (sharp pains), shortness of breath, pain and numbness in legs.

I?ve been disabled for more than a year due to what I reported on the previous page. However, after getting the vaccine, I?ve had fatigue, occasional shortness of breath, increased pain & anxiety, no appetite and issues with sleep. Since I don?t know if the vaccine has caused this I?m going to check with my psychiatrist (since I haven?t seen a doctor I?ll Mark none of the above below) but since it?s not improving, thought I should report it as well in case other people have had similar issues.

4 hours after vaccine, sore arm, fatigue, headache, blurred vision 12 hours after vaccine, full body tremors, fever of 102, extreme muscle weakness, fatigue, deep chest cough, shortness of breath. fatigue, weakness and cough continued for three days after vaccine before subsiding

pt had brief palpations 20 minutes after vaccine, pain in left arm spreading across the chest to right side 5 hrs later. Felt like someone had punched him repeatedly in the chest the next day and that night he was profoundly fatigued and couldn't take a deep breath, was winded with simple physical tasks ie walking across the room. The next day 1/24/21 the pain resolved but was easily winded. Improving since then

At 15 minutes I felt flushed and a tightness in my throat. I was moved to private observation with nurse for an additional 30 minutes. After the additional 30 minutes, I started feeling better. I was released to go home.

Near vasovagal syncope 5 days after 2nd dose. 5 days after my second COVID vaccine, I was outside in snowy, cold weather about a mile from my car. I had stopped moving to rearrange some items. While stopped, I started to feel lightheaded, develop tunnel vision, and feel faint, almost to the point of blacking out. I put my head down and legs up and felt somewhat better. I then attempted to return to my car. I could go 100-200 yards at a stretch, before having to purposefully fall down and elevate my legs. I traveled the mile back to my car like this (slowly). I could not check my pulse because my hands were too cold; my respiration rate was elevated. At the car, I drank fluids and warmed up and began to recover enough to get home.

Reported palpitations which is a feeling of a single strong heart beat w/ associated catching of his breath and feeling of startle and mild anxiety which started w/ other post COVID vaccine symptoms of f/c, fatigue, and body aches. Other symptoms resolved but not startle symptoms and pt now also having cough and nasal congestion. Normal exam other than congestion. EKG NSR w/ no feeling of the startle while here and no CP or SOB. CXR normal. Full lab eval also normal including neg CRP, Trop, BNP, and D dimer. CBC and CMP also normal. TSH mildly elevated but normal T4 so likely c/w pt's prior minor thyroid abn but unlikely to be source of current symptoms. Given normal exam and w/u do not feel myocarditis, pericarditis, or clots or other significant process associated w/ current symptoms. Pt retested for COVID since not fully immune prior to symptom onset.

Tongue itching (given 25 mg benadryl) in 1 hr 45 min progressed to throat swelling (patient self admin epi pen while in car) drove to ER and given IV steroids. At time of report still mild tongue itching + headaches Some dizziness, MD followup 2-12-21.

Pt received his first dose of the Moderna COVID19 vaccine, while sitting in observation he reported his neck started to feel stiff and painful. BP was 169/131, HR 81, O2Sat 99%. Pt also started to c/o mild shortness of breath. ER care on site and evaluated the pt. Repeat BP 162/119. Pt reported he took his Lisinopril 20 mg the night before. Pt signed a refusal for transport to the hospital. Pt was advised to contact his PCP to discuss his symptoms. ED precautions given. Pt verbalized understanding.

Patient's wife texted school nurse as he is an employee of school district. She reported after patient left the school from receiving his vaccine, he began feeling lightheaded, low pulse in the 50's, dizzy, and shortness of breath. Patient has a history of bilateral PE and takes blood thinner. Patient was taken to the Emergency Department by his wife.

Ive always had a resting heart rate in the upper 70?s innthe past years until the vaccine. I have noticed that its been staying in upper 90?s to 103 most of the time especially when I stand up or simply walk across the room. I didn?t realize what was going on for sure for two or three days. This on top of being winded easily.

Patient experienced immediate vomiting; throat tightness. Medical Doctor - was on scene and administered IM Epinephrine 0.3ml Time line and Vital Signs 14:20 - BP 148/82 HR: 110 Epi administered 14:32 - BP 140/80 14:34 - O2 sat: 99% HR: 110 BP: 155/82 EMS Called 14:39 14:48 BP 146/78 Patient was alert and was able to ambulate.

Moderna vaccine dose 1 was administered at around 1:40 PM. Pt reports itchiness, N/V,and dizziness about 10 minutes after injection. Epinephrine 0.3 mg administered IM LVG 15 minutes post vaccine. S/S resolved for about 5-10 minutes. S/S returned including SOB, with throat/tongue/lip swelling and tingling. Started PT on 2 L O2 via NC. Administered another 0.3 mg of epinephrine IM LVG. S/S did not resolve so another 0.3 mg of epinephrine was administered IM LVG. Patient still reported SOB, generalized itchiness, and throat swelling. 125 mg of Solumedrol was then administered IM RVG. 50 mg of diphenhydramine was administered IVP in the left forearm. EMS was called and patient refused transport to hospital. S/S resolved.

3/12/2021: Fever 100.1F; lasting from 2:30pm through 3:30pm; elevated temp of 99.2-99.6 until 3/15/2021 3/12/2021: Chills ~8pm until ~2am on 3/13/2021 nasal congestion 3/13/2021 7:30am-11:00am elevated pulse ~115bpm sporadically from 3/13/2021-3/15/2021 swollen neck glands/throat tightness 3/14/2021 8pm-11pm numb lips & tongue 3/15/2021 2pm-3pm

Diagnosed with cellulitis; Diagnosed with sepsis; Temperature 102 degrees F/104 degrees F; Chills/Shivering; Discomfort; Difficulty breathing; Felt cold; Not feeling good; In a lot of pain; A spontaneous report was received from a pharmacist concerning a 44-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed cellulitis, sepsis, temperature was 102 and 104 degrees F/fever, dyspnoea/difficulty breathing, feeling cold, malaise/unwell, pain, discomfort and chills. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event were not reported. On 11 Mar 2021, the patient consulted wound care for his foot and was told to be fine. On 13 Mar 2021, prior to the onset of the symptoms, the patient received their dose of two planned doses of mRNA-1273 (batch number: unknown) for prophylaxis of COVID-19 infection. On 13 Mar 2021, within eight to ten minutes, after vaccination patient felt cold .The patient's temperature was noted to be 102 degree Fahrenheit. Also, patient reported a lot of pain and discomfort. Patient also complained about chills, cold and shivering and he was given an orange juice and blanket after five to ten minutes by the pharmacist. Pharmacist called patients wife and by that time patient developed breathing difficulty. Patient's temperature was raised to 104-degree Fahrenheit by that time and was taken by the emergency medical service to the hospital. The patient was hospitalised. On 16 Mar 2021, after 2 days, patients wife reported to pharmacist that the patient was diagnosed with sepsis and cellulitis and was given two antibiotics. The events sepsis and cellulitis were considered as serious (medically significant). The patient's wife reported that the patient was about to have an amputation in this past weekend. Treatment for the event included two unknown antibiotics. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the events cellulitis, sepsis, temperature was 102 and 104 degrees F/fever, dyspnea /difficulty breathing, feeling cold, malaise/unwell, pain, discomfort and chills were considered to be unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Systemic: Fainting / Unresponsive-Mild, Additional Details: After awakening patient said he felt like he couldn't breathe but was. EMS came to take him to the hospital. His parents who were with him said he does have anxiety around needles and may have a hystory of fainting with shots.

ITCHING ON THE LOWER STOMACH AND HIP, FOLLWED BY COLD SWEATS AND FEVER FOR SEVERAL HOURS. BAD HEADCAHE AND EVEN SHORTNESS OF BREATH AND A COUGH. ALL SYMPTOMS WERE GANE AFTER 24 HOURS

Patient in observation. Patient complaining of cottonmouth, tongue numbness, difficulty swallowing, numb lips, and throat swelling. Vital signs BP-153/97, HR-88, RR-18. Benadryl 50mg give orally by EMT. Patient AOx4, lung sounds clear bilaterally, no hives notes, no injuries noted. Patient monitored. Patient reports feeling better after receiving Benadryl. Vital signs BP-164/45, HR-82, RR-16. Patient reports no more symptoms. Patient educated about adverse reactions and when to seek medical attention. Patient verbalizes understanding.

PT EXP SHORTNESS OF BREATH AND CHEST PAIN; SELF REFERRED TO ER. D-DIMER ELEVATED. CHEST CTA SHOWS SOLITARY RIGHT UPPER LOBE PULMONARY ARTERY PULMONARY EMBOLISM. BILATERAL LOWER EXTREMITY ULTRA SOUND SHOWS THROMBOSIS FEMURAL ARTERY NO PERSONAL OR FAMILY HISTORY OF BLOOD CLOTS AND NO HISTORY OF BLEEDING EPISODES OR LONG TRAVEL OR SEDENTARYNESS.

FINAL DIAGNOSIS: o Acute pulmonary embolism and DVT SECONDARY DIAGNOSIS: Principal Problem: Pulmonary embolism and infarction (CMS/HCC) POA: Yes Active Problems: Tobacco abuse POA: Yes Opioid dependence (CMS/HCC) POA: Yes Pulmonary embolism (CMS/HCC) POA: Unknown DVT (deep venous thrombosis) (CMS/HCC) POA: Unknown Chest pain POA: Unknown Hemoptysis POA: Unknown Resolved Problems: * No resolved hospital problems. * PDMP Query Date: 03/24/21 PDMP Comments: 03/22/21 suboxone 8mg/2mg #14/14 days multiple fills ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- BRIEF HOSPITAL COURSE: a 44 year old male with h/o of anxiety, depression, substance use on Suboxone, history of alcohol abuse, admitted 3/24/2021 with pleuritic chest pain and shortness of breath. Evaluation was positive for bilateral DVT and pulmonary embolism Bilateral PE, infarction, bilateral DVTs -No obvious precipitating factors -patient underwent first COVID 19 vaccine injection, is actually due for second shot. Unclear if this is contributed, recommended to hold on getting second dose and discuss this with PCP. -Also follow-up with PCP for appropriate cancer screening -patient was treated with therapeutic subcutaneous Lovenox, remained hemodynamically stable and is feeling better today. Upon discharge we'll prescribe Elocon is 10 mg b.i.d. for another 5 days followed by 5 mg b.i.d. maintenance dose. He will be provided with coupon for 1 month supply, he was recommended to follow-up with PCP for further recommendations. He will probably need anticoagulation for at least 6 months or longer depending on further course. -Echocardiogram showed ejection fraction 50-55%, Mild mitral valve prolapse no evidence of RV strain. Hemoptysis -Most likely was related to PE and infarction -resolved. Pleuritic chest pain, h/o Afib -Most likely pain was secondary to PE, improved -Continue Cardizem as prior to admission -Stop aspirin since patient will be on anticoagulation therapy History of opioid dependence, alcohol abuse Continue suboxone Ongoing smoking smoking cessation was advised Disposition: Routine Discharge Home CONSULTS: Consults Ordered during this Encounter Procedures ? Ancillary Service Request - IV Team New IV Start (multiple sticks for labs) ? Ancillary Service Request - Social Services PROCEDURES: Procedures Ordered during this Encounter Procedures ? Patient is currently on therapeutic anticoagulation (warfarin, Pradaxa, IV heparin, Rivaroxaban) - no reassessment RADIOLOGY TESTS: CT CTA Chest Final Result 1. Segmental and subsegmental pulmonary emboli throughout the right lung, most prominent in the right lower lobe. Segmental and subsegmental pulmonary artery the left pleural effusion. 2. Wedge-shaped opacities at both lung bases concerning for small pulmonary infarcts. 3. No findings of right heart strain or pulmonary hypertension. Impression discussed with Dr of the ER at 20:44 on 03/24/2021 by phone. Electronically signed by: MD 3/24/2021 8:46 PM US Legs Bil Venous DVT Final Result Bilateral posterior tibial vein thrombosis. This critical result was called to the clinical team, including by telephone, at 6:00 PM by the sonographer, according to internal Department documentation. Electronically signed by: MD 3/24/2021 6:16 PM XR Chest PA and Lateral Final Result Small bilateral pleural effusions. Streaky left basilar opacity may reflect atelectasis or infiltrate. Small right basilar opacity of uncertain significance. All opacities are new since 2016. No pneumothorax. 4 week follow-up is recommended. If the abnormalities have not resolved by then, chest CT is recommended. Electronically signed by: MD 3/24/2021 5:36 PM ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- PROPOSED MANAGEMENT PLAN: Risk for readmission within 30 days: o Low Pending results: Unresulted Labs . . . Comprehensive Metabolic Panel [124639904] Collected: 03/24/21 1818 Updated: 03/24/21 1823 Specimen Source: Blood, Venous Morphology [124639439] Collected: 03/24/21 1700 Updated: 03/24/21 1715 Specimen Source: Blood, Venous Comprehensive Metabolic Panel [124637329] Collected: 03/24/21 1700 Updated: 03/24/21 1705 Specimen Source: Blood, Venous Troponin, HS [124637342] Collected: 03/24/21 1700 Updated: 03/24/21 1705 Specimen Source: Blood, Venous Recommended Testing: o Refer to Hospital Course DISCHARGE MEDICATIONS: Medication List STOP taking these medications aspirin 81 MG Chew TAKE these medications Dose Ordering Provider Morning Afternoon Evening Bedtime apixaban 5 MG Tabs Commonly known as: ELIQUIS Instructions: Take 2 Tabs (10 mg total) by mouth TWICE A DAY for 5 days, THEN 1 Tab (5 mg total) TWICE A DAY. Start taking on: March 26, 2021 Signed by: MD buprenorphine-naloxone 8-2 MG Film Commonly known as: SUBOXONE Instructions: Dissolve 1 Film under the tongue DAILY for 14 days. Instructions: NADEAN: xe2109242 Dose: 1 Film Signed by: MD diltiazem CR 240 MG Cp24 Commonly known as: DILACOR XR Instructions: Take 240 mg by mouth DAILY. Dose: 240 mg Where to Get Your Medication apixaban 5 MG Tabs High-risk Medication Changes: o Refer to Hospital Course PTA Medication Changes: o Refer to Hospital Course

After 2nd dose patient has developed SOB that has continually gotten worse. More recently has also developed a cough as well. Very sensative to "pressure Changes" which results increase SOB.

PT RECEIVED A FIRST DOSE OF THE MODERNA VACCINE IN THE LATE MORNING OF 04/17/2021. PT'S DAUGHTER CALLED ON THE MORNING OF 04/19/2021 AND SAID SHE WAS CONCERNED ABOUT HER DAD AS HE HAD BEEN COMPLAINING OF A "VERY BAD FEVER, HEADACHE AND CHEST PAIN." PT'S DAUGHTER WAS ASKED IF HER DAD HAD TROUBLE BREATHING AND SHE SAID YES. WHEN ASKED ABOUT HOW LONG IT HAD BEEN GOING ON, SHE SAID SINCE LAST NIGHT. SHE ALSO SAID THE FEVER HAD REACHED 102 DEGREES. PT'S DAUGHTER SAID HER DAD HAD NOT TRIED TAKING ANYTHING TO HELP TREAT THE FEVER OR HEADACHE. SHE ASKED ABOUT IF SHE SHOULD HAVE HIM TAKE TYLENOL, BUT DUE TO THE COMPLAINT OF "SEVERE CHEST PAIN" AND "DIFFICULTY BREATHING," IT WAS RECOMMENDED THE PT SEEK IMMEDIATE MEDICAL ATTENTION AND GO TO THE ER. PT'S DAUGHTER CONFIRMED THAT SHE WOULD.

Scratchy, itchy throat as well as feeling of throat swelling. Patient denied any chest pain, SOB, lip or tongue swelling. Airway clear, no notable obstruction. Patient was transferred to UC, clinician ordered: Benadryl 50mg IM, Solumetrol 125mg IM, and Epinephrine 0.3mg IM. Patient was transferred to ED where he recovered and was released.

Patient is 44-year-old Male, to the emergency department for evaluation of left sided chest/rib pain. Onset: Last night. Aggravated with movement and deep inspiration. No other associated symptoms. Saw primary doctor today in which she had a chest x-ray notable for trace left pleural effusion. In addition had blood work notable for nonelevated dimer

Patient received his first dose of COVID vaccine on 4/8 and developed GI symptoms ~ 4/16. Patient tested positive for COVID on 4/25 when he presented to the ED. However, he was sent home at that time since he was stable to go home and was not hypoxic. Pt presented to the ED again on 5/4 due to dyspnea on exertion and pain in the back of his knee. Patient was found to be positive for DVT and PE and was started on therapeutic Lovenox. Patient doesn't have a history of VTE, but he does have a family history of VTE. Since patient wasn't found to be hypoxic, COVID treatment wasn't started in the hospital.

sharp pain left chest. chest x-ray revealed pulmonary effusion in left lung. CT with radioactive dye ruled out Pulmonary Embolism. Swollen lymph nodes also noted in left armpit

Received vaccine at medical center. 5 minutes after initial vaccination felt dizzy. After a few minutes he was feeling better so left for car at 15 minutes post vaccination. Once getting to car developed lightheadedness, tachycardia, shortness of breath. Brought back into facility given IM epi 0.3 mg with improvement and send via ambulance to our emergency department. No urticarial lesions or angioedema. Observed for approximately 2 hours. No recurrence. Discharged home. No additional meds after epi given in the field.

Around 10am I was feeling a bit hungry and my stomach seemed 'sore'. I air fried some chicken for myself, but still felt hungry. I was feeling rather irritable, and an hour or two later I was violently vomiting. I tried to drink some water shortly after, and that did not help. My stomach was still rather upset and I vomited again an hour later. I laid down on the couch the rest of the day with my stomach feeling rather upset in way I've not really experienced before. I was able to sleep for a few hours and I was able to drink small amounts of water by midnight. I felt a bit cold but I don't remember anyone saying I had a fever. I was irritable, deep breaths kinda hurt, and I was a tad dizzy most of the day. I was able to eat and drink the next morning, but my abdomen was sore. It still is a bit sore, but I feel almost 100%.

1) WHEN HE CAME FOR HIS 2ND DOES HE RECEIVED MODERNA INSTEAD OF PFIZER. HE DIDN'T REALIZE IT UNTIL AFTER THE SIDE EFFECTS STARTED. HE DOES UNDERSTAND THAT THE SERIES IS COMPLETE. 2) HIS WIFE WOKE HIM UP BECAUSE HE WAS BREATHING DIFFERENTLY. TEMP AND O2 ARE BELOW. HE STAYED HOME FROM WORK UNTIL THE SYMPTOMS SUBSIDED, SO ABOUT 2 DAYS HOME. NOTE: HIS 1ST DOSE WAS ON 3/3/21

5/1/21: Patient woke with chest pain, elevated respiratory rate, nausea, and sweating. Recognizing symptoms of a heart attack, the patient presented to the emergency room at 5:30am. ECG normal, Troponin at 2.1 at presentation, continued to increase to 4.6 prior to being taken to Cath Lab. Coronary angiography showed no occlusion; patient admitted to telemetry unit for continued monitoring; discharged following day with order for cardiac MRI. Outpatient cardiac MRI conducted 5/5/21 revealed myocarditis. Treatment with beta blockers (Metopolol Succinate 25MG QID) and anti-inflamatory (indomethacin 25MG TID) with direction to avoid exercise. Light yardwork on 5/22 resulted in patient feeling "racing heart".

Shortness of breath and chest tightness. Hospitalized for fluid volume overload after a couple weeks of having symptoms. Responded well to iv Lasix and was discharged on PO lasix. Has not had any heart issues since transplant 2009

I felt like my throat was closing up, it was hard for me to swallow and it was hard for me to breathe as well. I have been having headaches over the past 4-6 months.

Pt presented to the hospital with abdominal pain and shortness of breath May 28, 2021 Noted to be thrombocytopenic - had normal platelet 20 days prior Had bruising, melena

Initially, the patient had dizziness, lightheadedness and a syncopal episode within 5 minutes of the vaccine. He returned to normal fairly quickly and went home by report. He presented to the ER shortly after with palpitations and shortness of breath and required a dose of IM epinephrine. Patient since had intermittent fatigue, dizziness, blurred and vision changes as well as tinnitus. On May 31, 2021, patient presented to the ER with headache, lethargy, weakness, diaphoresis and dizziness. Additionally, noted to have slurred speech by his wife. MRI of the brain done at 4 am on 5/31/21 showed the following "1. Acute bilateral cerebellar infarcts are seen with a right posterior 4.3 mm focus a left middle cerebellar peduncle 3.2 mm focus and a left superior cerebellar 7.9 mm linear focus. 2. Occlusion of the left vertebral artery extending into the basilar artery with reconstitution of the basilar artery via bilateral posterior communicating arteries. Findings are concerning for acute dissection occlusion. Consider further evaluation with MRA head and neck. 3. Question subtle area of restricted diffusion seen within the left dorsal medulla better appreciated on the maps measuring approximately 4.9 mm. Left lateral pontine 7.3 mm focus of restricted diffusion versus artifact. These infarcts are not definite and could be artifactual asymmetry.'. He required admission, heparin drip and neurology consult at that time, as well as permissive hypertension. shortly after 1 pm on May 31, he developed chest pain with ischemic changes on EKG requiring cardiology consult with possible intervention, though this was being coordinated with interventional neurology, as he also required basilar angiogram for his MRI findings. as cardiology and interventional neurology were coordinating taking patient for intervention, he became further unresponsive, though maintained his pulse, and required intubation and transfer to ICU, as well as repeat CT of the head to evaluate for continued thrombosis of his basilar system. Work up is still on going

Patient developed episode of diarrhea shortly after 1st shot in series, this was followed by lower extremity swelling and mild dyspnea on exertion, that quickly exacerbated after the 2nd shot on 5/15/2021, that resulted in severe dyspnea on exertion, severe lower extremity swelling with approximately 25 lb weight gain, orthopnea and hemoptysis. Patient reported temperatures of 99.2 F to 99.8 F. Outside CT chest abdomen pelvis angiogram showed moderate to large acute segmental/subsegmental pulmonary emboli with trace right heart strain and right lower lobe pulmonary infarction, moderate right pleural effusion, acute splenic vein thrombosis with extension to the proximal portal vein and associated splenic infarcts, bilateral renal infarcts, and evidence of portal hypertension. He was transferred to the Hospital for further management. Upon presentation here he was tachycardic but with stable blood pressures and requiring up to 5 L by nasal cannula. Initial laboratory studies were notable for WBC 21.0, INR 1.8, D-dimer 11653, NT pro-BNP 17684, troponins 603 to 579 to 574, CRP 127. He was started on a heparin infusion. He was admitted to the MICU for further management. Bedside ultrasound demonstrated reduced biventricular contractility. He was given two doses of 40 mg intravenous furosemide with about 3.5 L of urine output since admission (net negative 3.1 L). His oxygen was weaned to 1 L by nasal cannula. Lower extremity venous and arterial Dopplers were negative. Subsequent imaging demonstrated a transperineal inferior infarct with akinesis of the inferior septum, inferior and inferior lateral walls with apical and mid ventricle akinesis secondary to a complete occluded RCA. moderate pericardial effusion without tamponade noted. Upper extremity ultrasound demonstrated acute DVT in the lower right IJ, innominate, subclavian and proximal axillary veins. MRI venogram was negative for clots, but multiple acute and subacute enhancing infarcts within all 3 vasculature distributions consistent with embolic etiology were noted. TTE showed of mural thrombus along the septal and inferior walls of the LV apex, severely enlarged left ventricle with EF of 20%, severe hypokinesis. Patient was aggressively IV diuresis, with improvement in respiratory status. Maintained on high-intensity heparin for pulmonary emboli, DVT, and diffuse arterial and venous thrombosis. He was bridged to warfarin. Patient was prescribed LifeVest for primary prevention. Started on beta-blocker and ACE-inhibitor given EF. Patient planning on discharge 6/5-6/07, outcome pending.

The day after getting the vaccine he began to feel like he had the flu. He progressed each day to become weak and dyspneic. He became hypoxic with a pulse ox of 80%.

anterior STEMI admitted on 5/11/21 with left chest and arm pain. Underwent stent to LAD pt stated he developed chest discomfort and SOB a few days after his 1st moderna vaccine in Mid April

worst asthma attack he had ever had; unable to breathe; passed out/unconscious; cannot walk; lost weight; has no muscle left; teeth chattering; shaking; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHMA (worst asthma attack he had ever had), DYSPNOEA (unable to breathe) and LOSS OF CONSCIOUSNESS (passed out/unconscious) in a 44-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 Intubation (The doctor told him that he would have died if they had not intubated him.) from 14-May-2021 to 21-May-2021. Concurrent medical conditions included Asthma (The patient had asthma since childhood.). Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and ALBUTEROL [SALBUTAMOL] for Asthma. On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 14-May-2021, the patient experienced ASTHMA (worst asthma attack he had ever had) (seriousness criteria hospitalization prolonged and life threatening), DYSPNOEA (unable to breathe) (seriousness criteria hospitalization prolonged and life threatening), LOSS OF CONSCIOUSNESS (passed out/unconscious) (seriousness criteria hospitalization prolonged, medically significant and life threatening), TREMOR (shaking) and CHILLS (teeth chattering). On an unknown date, the patient experienced GAIT DISTURBANCE (cannot walk), WEIGHT DECREASED (lost weight) and MUSCULAR WEAKNESS (has no muscle left). The patient was hospitalized from 14-May-2021 to 31-May-2021 due to ASTHMA, DYSPNOEA and LOSS OF CONSCIOUSNESS. The patient was treated with Physical therapy for Gait disturbance. On 21-May-2021, LOSS OF CONSCIOUSNESS (passed out/unconscious) had resolved. At the time of the report, ASTHMA (worst asthma attack he had ever had), DYSPNOEA (unable to breathe), GAIT DISTURBANCE (cannot walk), TREMOR (shaking), WEIGHT DECREASED (lost weight), MUSCULAR WEAKNESS (has no muscle left) and CHILLS (teeth chattering) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The treatment information included many medications and physical therapy. 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

Went to bed with the chills, never checked temperature. Woke up in the middle of the night with chest feeling heavy , was hard to breath, Sat up on edge of bed and then passed out and fell backwards in bed. Came to and passed out again. Came to again and took temperature and had 101.3 temp. Ran a fever and had chills for most of the day. Fever was gone by the following day and felt back to normal, just a little fatigued.

I developed a DVT in my lower left leg, which I noticed from the swelling, warmth and pain. Then, a few days later, on a Sunday so my Dr's office was closed, I started having extreme difficulty in my breathing. I went to the ER and, after having multiple testing, was diagnosed with the DVT and a PE in each lung (almost to the point of full blockage). I was kept in the hospital overnight so they could monitor my breathing to be sure I wasn't stopping breathing throughout the night. I'm now on blood thinners for life.

Patient reported throat feeling dry 5 minutes after vaccine administration. He drank some apple juice. He reported that his throat felt tight, and that he was becoming hoarse about 25 minutes after vaccine administration. He was able to walk to a treatment area, where he was assessed and 0.3 ml Epinephrine by Epi Pen was administered into antero lateral thigh, and EMS was called. Patient reported symptom improvement after 3-5 minutes. EMS transported patient to the Emergency Department for evaluation.

Headache, chills, shortness of breath, fever, body aches from shoulders to feet, fatigue, slight confusion. Honestly, I feel worse now when compared to when I actually had covid. Took Tylenol. When Tylenol wears off symptoms come back.

Developed acute inspiratory wheeze approximately 6 hours after the vaccination was received. Wheeze persisted for 30 hours

Shortness of breath, coughing, some deep chest soreness. Worse when laying down in any position. Began using Albuterol this morning (approx 3 hours ago) with no change in symptoms.

Reported feeling light headed unwell and weak post vaccine, difficulty breathing and chills , hands were cold and clamy. DId not pass out, was alert and oriented at all time, took vitals until EMS arrived. Once EMS arrived and he was feeling better he declined to be transported to hospital. Left with wife who took him home.

Within 1 minute of receiving vaccination, heart rate increase to over 145 bpm. Blood pressure increased significantly. Began sweating profusely. Developed a very dry mouth and high rate of breathing. Lasted for about 20-30 minutes and then returned to normal.

20 minutes after vaccination, complained of tingling of the side of the tongue and mild throat swelling Pt was seen in ED, given pepcid and loratadine, and discharged home

Moderna COVID-19 Vaccine EUA: Swelling/Closing of my throat, swelling of my left hand (the hand on the injection arm), body itching, chills, soreness at injection site

Soreness at injection site radiating to whole arm and shoulder. Body aches, fever, chills, mild SOB x2days thus far

Rigors and dyspnea for about 5 minutes. Oximeter was at 77% on RA for 1 - 2 min before coming to normal.

I had muscle aches to the point where it felt like the chest and back were caving in at the same time. I had fast heart palpitations. I got dizzy and felt weak at points. I went to the Doctor and it was also determined that I was wheezing when he checked my lungs. He prescribed me a 30 day usage of the Albuterol Sulfate pump to help with the wheezing 3x a day.I saw the doctor January 23rd.3 days after receiving the Moderna Covid-19 Vaccine EUA.

PATIENT STATES HE CAME HOME FROM WORK. STATES HE SAT DOWN IN THE RECLINER WITH A GATORADE TO DRINK. STATES HE GOT CHOKED ON THE GATORADE AND STARTED COUGHING. STATES THAT THE NEXT THING HE REMEMBERS IS HIS WIFE TRYING TO GET HIM AWAKENED. STATES THAT HE FEELS FINE NOW. HE SAYS THAT HE FEELS TIRED BUT HAS BEEN SINCE HE HAD COVID.

I was feeling cold throughout the day, at about 9:00 pm I took a shower to try to get warmed up, I just kept getting colder and colder until I was severely shaking uncontrollably. Every muscle was so tense and I was shaking so badly I could barely walk or breathe. I went to the bedroom and got under blankets with a heater and in a few minutes the shaking diminished to where I could start breathing normal again. It took about an hour before my shakiness went away completely but I still needed to stay under the blankets and near the heater as I felt I was still cold and on the verge of getting the severe chills again. I had no fever. Next morning (as I'm writing) I'm still worried about getting out of bed as I still don't feel right and am scared of getting the chills like that again.

After about 30 minutes he said his throat felt weird. That night. Later he said he didn?t feel good and he said these are just normal reactions. I with pneumonia, or he thought he was catching pneumonia from me. Not possible he had the vaccine. Then the next morning he was still having difficulty breathing. Then Saturday 03/20/2021. afternoon he couldn?t catch his breath. I ran to get my phone and came back and he was dead. Called 911 and did CPR. They arrived and got a heart beat and put him on a breathing machine. He is in a medical induced coma. With a 50/50. Chance of survival.

Site: Itching at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: He appeared to have an allergic reaction. He had itchiness on multiple parts of his body with a rash on multiple extremities. He had shortness of breath, but throat did not start to close. He was observed for around an hour and 2 diphenhydramine 25 mg tablets were given to him. His vitals were monitored and they were okay. A nurse from the minute clinic came to observe him as well as a pharmacist. He was sent home later and told to go to the ER if his symptoms did not lessen.

Lungs lost a lot of capacity which I was able to gauge by my swimming as well as being easily out of breath which is not normal

Pt received his first Moderna vaccine on 2/25/2021. 3 days later he developed significant oral pain located on the roof of his mouth, back of mouth and throat. He presented to clinic about 1 week later for evaluation. There were no obvious signs of trauma or infection at the time. He followed up with this Dentist and it was suggested he likely had a chemical burn secondary to citrus foods. He followed up with another provider and was treated with a 3 day course of an antiviral medication for herpes without any change in symptoms. He hasn't had oral herpes before, but has had shingles. He received his second Moderna vaccine on 3/25/2021 and 3 days later developed significant throat pain and swelling in his neck glands that was visible to him. His symptoms improved slightly, but have never completely resolved. He has had what feels like a dry sore throat for 7-8 weeks and intermittent white patches in the back of his mouth. He has no history of or active allergy symptoms. Was treated for oral candidiasis on 4/19/2021, but it's unclear if his vaccine triggered these symptoms.

10:10am - pt stated he felt like he was going to pass out, appears diaphoretic and pale. Pt laid on floor and raised his legs, then stated he needed to use the restroom. Pt got up and attempted to ambulate towards restroom, but began to fall forward. Pt placed in chair, increased diaphoresis and gasping respirations with "seizure like" activity and moaning. 10:12am - On site EMS assessed and attended pt. HR 45, O2 100%RA, unable to assess BP as pt removed cuff. 10:15am - 911 called, pt informed staff of his history of syncopal episodes and bradycardia 10:25am - EMS arrived 10:32am - Pt transported via Ambulance.

10:10am - pt stated he felt like he was going to pass out, appears diaphoretic and pale. Pt laid on floor and raised his legs, then stated he needed to use the restroom. Pt got up and attempted to ambulate towards restroom, but began to fall forward. Pt placed in chair, increased diaphoresis and gasping respirations with "seizure like" activity and moaning. 10:12am - On site EMS assessed and attended pt. HR 45, O2 100%RA, unable to assess BP as pt removed cuff. 10:15am - 911 called, pt informed staff of his history of syncopal episodes and bradycardia 10:25am - EMS arrived 10:32am - Pt transported to Hospital via Ambulance.

massive blood clot in the right lung; painful knot under the skin on his arm; threw up about 20 times in 6 hours, and kept vomiting all the next day; massive blood clot in the lung ended up in different parts of the lung causing extreme amount or pain\ Left lung is beginning to hurt again and his chest is killing him; next day when he got up and could barely walk; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (massive blood clot in the right lung), PULMONARY PAIN (massive blood clot in the lung ended up in different parts of the lung causing extreme amount or pain\ Left lung is beginning to hurt again and his chest is killing him) and THROMBOSIS (painful knot under the skin on his arm) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Autoimmune disorder NOS in September 2020 and Broken bones. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced GAIT DISTURBANCE (next day when he got up and could barely walk). On 26-Mar-2021, the patient experienced PULMONARY EMBOLISM (massive blood clot in the right lung) (seriousness criteria hospitalization, medically significant and life threatening). On 04-Apr-2021, the patient experienced PULMONARY PAIN (massive blood clot in the lung ended up in different parts of the lung causing extreme amount or pain\ Left lung is beginning to hurt again and his chest is killing him) (seriousness criterion medically significant). On an unknown date, the patient experienced THROMBOSIS (painful knot under the skin on his arm) (seriousness criterion medically significant) and VOMITING (threw up about 20 times in 6 hours, and kept vomiting all the next day). On 19-Mar-2021, GAIT DISTURBANCE (next day when he got up and could barely walk) outcome was unknown. On 28-Mar-2021, PULMONARY EMBOLISM (massive blood clot in the right lung) had not resolved. On 04-Apr-2021, PULMONARY PAIN (massive blood clot in the lung ended up in different parts of the lung causing extreme amount or pain\ Left lung is beginning to hurt again and his chest is killing him) had not resolved. At the time of the report, THROMBOSIS (painful knot under the skin on his arm) and VOMITING (threw up about 20 times in 6 hours, and kept vomiting all the next day) outcome was unknown. Not Provided Treatment information provided as blood thinners (IV heparin) and antibiotics were used to treat the events. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to US-MODERNATX, INC.-MOD-2021-081632 (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. US-MODERNATX, INC.-MOD-2021-081632:2nd dose

Patient stated he started having trouble breathing and became shaky about 5 minutes after the vaccine was given. An epipen, gatorade, and an icepack were given to the patient, and he immediately started feeling better.

severe pain at injection site, horrible headache, dizzy, blurry vision, sensitivity to light, congestion, difficulty breathing, cough, heavy chest, abdomen swollen and tender to touch, nausea, bloating, loose stool, moaning, fever, sweats, chills, severe joint pain full body, restless, unable to sleep, unable to eat or get out of bed or work

By mid-afternoon (3 pm) on the day of the injection, I was suffering from moderate pain in my left arm, and was unable to lift it more than about 60 degrees from its downward position. Although it may not be correlated, I also suffered from severe intestinal gas throughout the night. The day after the injection, I had severe tiredness, diarrhea, generalized aches, and both fever and chills. I was constantly adjusting my clothing to warm up or cool off, and was unable to ascend one flight of stairs without resting.

Moderna COVID-19 Vaccine EUA: 2nd dose Please see continuation page ... Inside arm and armpit itching after 5 minutes Diarrhea after 3 hrs which stopped in an hr Transient Shortness of breath after 15 hrs ( last about half an hr): oxygen level 95-100 Chills starting after 15 hr Slight fever ~99f Hearth beat: 95 (normal rate ~60) Extreme Nausea w/o vomiting for 3 to 4 hrs Extremely sensitive to smells (pleasant or unpleasant) triggering nausea Stomach and esophagus intense cramps for 4 hrs so intense that I had to call 911 (they didn't prescribe anything other than Tylenol or NyQuil which I couldn't take due to nausea) Passed out multiple times Hallucinations and talking gibberish Lack of concentration

Shortness of breath, fatigue, chilis and sweats, headache, weight loss, sore arm injection site, racing heart, nausea, achiness.

Pt developed throat tightness, coughing and itching several minutes after her vaccination. She reports that she had similar symptoms after her first dose of Moderna on April 16. She did not notify the vaccinator of this at our site. She states she discussed this with her doctor several days prior and was told it was ok to proceed with her second dose. She premedicated with Benadryl prior to arrival. No rash noted on inspection and no definite signs of anaphylaxis. BP 140/86, SP02 97%, HR 79. Transport to the ER was recommended for extended observation period but the patient declined. She stated that her symptoms were resolving when she drove home after appx. 35 minutes of observation.

Pt reports on April 15th he began feeling fatigue, fever, aches, lip swelling, and soft palate swelling that lasted two days. Pt said he could not sleep laying down because his soft palate blocked his breathing. Pt reports taking an antihistamine and feeling better after 4 days. Pt showed photos of lip swelling, and he reported it to his health care provider. His health care provider sent an email that recommended not receiving the second dose of Moderna. However, pt was automatically scheduled from his first visit to get second dose, and pt showed up to site to discuss it and showed this vaccinator the email and photos and described this course. This vaccinator did not administer second dose of vaccine and recommended discussing alternatives with MD.

Patient presented to the ED with difficulty breathing and was diagnosed with pulmonary embolism prior to this visit. He then presented to the ED on 4/19/21 with similar sx and was subsequently hospitalized. These visits are within 6 weeks of receiving COVID vaccination.

Patient received vaccine on 5/21/21. Experienced what sounded like common ADRs. On 5/25/21 patient called sister that he was not feeling well. On 5/27/21 he was admitted to hospital. presented to the emergency department for evaluation numbness and tingling in his bilateral upper extremities. Patient's sister reported pt's symptoms seemed to begin soon after receiving the vaccine on 5/21/2021. Reports generalized weakness, anorexia, fatigue, and numbness in bilateral upper extremities. Sister also reported worsening exertional dyspnea over the past few weeks. Confusion started on 5/27/21.

Patient presented on May 15, 2021 with sudden right lateral inferior chest pain that awoke him. He noted a feeling of heaviness and mild dyspnea for two days prior. Worse when flat. Hypoxic. Right upper quadrant guarding and tenderness. Treated with anticoagulation as an outpatient.

Pt reported lips tingling, tight throat, Benadryl 25mg tab administered, no difficulty swallowing, VS stable. No symptom improvement at 20 minutes and expressed a feeling of having a golf ball stuck in his throat, denied SOB, itchiness, no noted hives, denied chest pain/tightness, dizziness, vision changes or anxiety. Benadryl 25 mg tab administered, no noted or voiced difficulty with swallowing. VS stable. Pt observed another 30 minutes and symptoms began to resolve. Full resolutions of symptoms at 3 hours, pt discharged home @ 13:20. Emergency situations reviewed with instructions to call 911 if reoccurrence of symptoms.

On June 3 he developed a sore throat. His voice sounded like he had a frog in it. Early on June 4 he had to urinate about 10 - 15 times overnight in about a 6 hour timeframe. Later on Friday he left home and a short time later called 911 saying he couldn?t breath. When the paramedics arrived they couldn?t revive him and he died.

Pericarditis - Hospitalization from May 17-21, 2021, symptoms: shoulder and back pain, rapid heart rate, fever, shortness of breath, body aches, chest pain, chills. Treatment 2 weeks round of colchicine and lasix, antibiotics. Re-occurring pericarditis symptoms starting on June 9, 2021

The evening of the 2nd dose, I had a fever of 100.4, the next day both my sciatic nerves felt like they were on fire. I couldn't even type an email, my hands and fingers hurt so bad. Strong fatigue, nauseous, headaches. On the Feb of 17th, my lymph nodes got swollen and they are still swollen. My head was light headed. Lymph nodes were so swollen in my arm pits that I had to lift my arms above my head to breathe. Experienced high blood pressure

16 days after receiving my first Covid vaccine shot (The 1st of the 2 shots required) Around 7pm on May 5th I started having a hard time breathing & slight chest pains. I decided to lay down & that seemed to make it worse. I've never had any issues like this before so I figured it would eventually go away on its own & continued to try and lay down on my bed but as each hour passed it continued to get harder and harder to breath & each breath I took became increasingly strained & felt as though my lungs weren't letting me take in large breaths, only short gasps. By 2am May 6th, 2021, I knew something was obviously veryyy wrong! I drove myself to the closest ER (that being Hospital approx 5 minutes away) & was admitted. After running several tests, I was presented with the news that I had ACUTE RESPIRATORY FAILURE, PNEUMONIA, HYPOXIA, PLEURAL EFFUSION & ACUTE SYSTOLIC CONGESTIVE HEART FAILURE...

For my 2nd dose vaccine, the first night I experienced seizures and was trembling a lot; also developed headaches and fatigue. I also displayed symptoms of dizziness and blacked out. I have trouble breathing and I am now diabetic. I have congestive heart failure. I cannot go outside to the heat because I black out. I am on an albuterol treatment due to coughing spasms. My arms also get stiff, and I feel when I black out, I am out for a couple of minutes. They performed lab work, EKG, stress test and I am following up with a cardiologist. My blood pressure went up to 210/178. I have to follow up with my cardiologist in two months to monitor my heart. For my 1st dose vaccine, I had two seizures the same night. I could not breathe and gurgled. I went to see my PCP who placed me on high blood pressure medications. I lost 67 pounds of fluid in my chest. I swelled up so bad that I could not put on my shoes. I did not have these problems before receiving the MODERNA vaccine, dose 1 and dose 2. I also got lab work down and found out I had type II diabetes.

Increased SOB." feels like I am breathing through a straw". Itchy rash chest, neck and eyes. " feels like I got hit by a truck".

Patient started having intermittent worsening chest pain and shortness of breath starting 5 days after 1st shot.

Joint pains, breathing issues, loss of appetite, extreme aches in legs, pain and discomfort in injection shot, extremely tiredness

Patient started feeling ill the evening of the vaccination and called the pharmacy the next day to report symptoms of light-headedness, dizziness, weak legs, shaking, shortness of breath, chills, and chest pain. I called patient back a few hours later and patient said he felt better and the chest pain went away. He later noted that it could have been his anxiety causing the pain. Patient had been taking ibuprofen, acetaminophen, and drink a lot of water for treatment. Patient did not feel is was necessary to see the doctor or emergency department.

Jan 15 – Moderna Shot #1 – no side effects. Feb 12 –Moderna Shot #2 – Side effects: fever, malaise, fatigue, site injection pain. Feb 13 - Side effects: fevers 99.2-100.4, body aches, lethargy Feb 14 – Side Effects: morning fevers, midday and afternoon felt like all nerves were on fire specifically the sciatic. Pain radiating down arms and it hurt to type email to (professors at ) Feb 14-17 – Side effects: nausea, mental fog, headache, fatigue Feb 18 – Side effects: (added to already listed above) lymphedema and swelling in ankles and feet. Feb 28 – side effects were still persistent, and breathing had worsened, so I sought out medical help.

Lethargic, drowsy, nausea, feeling of not being able to breathe dizziness not a regular feeling for me. I was almost afraid to walk around alone for fear of falling from vertigo effect.

Pt had L Upper chest pleuriti pain and DOE did not seek med attention 6 weeks later sought attention for R pleuriti pain and DOE - had pul infarct and LLE DVT

rapid heart rate and headache upon falling asleep, woke 30 minutes later with drenching sweat and feelings of doom. Jumped out of bed due to anxiety and rapid breathing from feelings of doom. paced the halls of house, attempted to go back to bed but feelings of doom would not go away. finally after an hour my breathing settled down, heart rate returned to normal and sweating dissipated. symptoms did not return but did wake with severe headache and nausea.

Patient seen in ER at Hospital on January 3rd. Patient felt his throat was swelling shut and had a sore throat. Hospital diagnosed patient with uvulitis. Patient last ate around 7PM the night before. No URI, no fever, no headache, no cough. They did a CXR which was negative and rapid strep that was negative. Patient was given a shot of steroids, Benadryl and told to follow up at IHS.

I received the first dose of Moderna vaccination on 01/13/21. On 01/15/21 in the morning, I felt chest compression, chill, bad headaches, muscle pains, shortness of breath and cough. I went to test for Covid 19 and the result came back on 01/16/21 as positive of Covid 19. My initial symptoms were mild without fever, but it is hard to compare my symptoms since no prior reference. The symptoms are getting better, but I noticed my back (between T8 to T6) has pain. I have consulted medical doctors and health care professionals regarding of being tested as positive after vaccination. No one can answer if I should take the second dose of Moderna vaccine in 4 weeks as scheduled, or I should wait for 90 days and start

Patient reported symptoms of nausea and severe lightheadedness approximately 10 minutes after vaccine administration. Symptoms progressed and patient report feeling itchy with throat tightness. New onset of rash on bilateral forearms. He was elevated by Doctor with recommendation to be transported to the local Emergency Department. Patient refused to be transported and asked to stay on-site for continued observations. Patient's symptoms failed to resolve after 45 minutes, rescue team was called. They presented and evaluated patient with recommendations to be transported to the local Emergency Department. Patient declined transport to the hospital. Rescue team spoke with the Emergency Department, the decision was made and the patient agreed to an additional hour of observation with the understanding if symptoms didn't resolve they would be transported to the Emergency Department. Symptoms unchanged after 1 hour, patient made the decision to leave and follow up with their Primary Care Physician.

Came down with bad head cold nasal congestion, cough and weezing. Also a rash similar to poison ivy all over my neck, both arm and body.

I received my 2nd dose of the moderna vaccine on 1/24/21. On 1/25/21 at approx 2am I had tremmors, feeling of intense cold, headache, body pain, fatigue. That lasted until approx 0300am 1/26/21. I slept most of the day 1/25 except for taking kid to school and monitoring another at home. I had read the side effects and I felt as though things were subsiding on 1/26 but I was still weak with body pain. I was not 100%. I was home alone with 2 kids (wife out of town). 1/25 I had a cough and was short of breath but didn't think much of it. The cough persisted. On 1/27/21 I was still short of breath. I went to a nearby fire station and had them put me on a lifepack. I was in atrial fibrillation. I could not do anything because my wife wasn't due back until 3pm. At 3PM she walked in and I walked out and drove myself to Hospital. I was diagnosed with A-Fib w/ RVR. I was in A-fib until I was cardioverted on 2/1/21 and was given a cryo-ablation.

Note: I had a PCR confirmed SARS-CoV-2 infection in March, 2020. Approximately 12 hours after the second vaccine dose, I experienced intense soreness at the vaccination site (significantly greater than the first dose). In the middle of the night I awoke with flu-like symptoms. At 9am I took acetominophen for fever, rigors, muscle aches. This brought mild relief from approx. 9:45am to 11:15 am. My condition continued to worsen through the early afternoon with rigors and significant generalized muscle aches. I experienced tachycardia (90-105 bpm vs normal of ~70bpm), SOB, and starting measuring pulse oximetry which read from 89%-94% (my usual does not go below 97%). This persisted until approximately 8pm with no improvement. I took 40 mg prednisone, 600 mg ibuprofen and within 3 hours was starting to have symptom resolution. I am a physician and up to date on all my vaccinations. I have never had anything approaching this type of response. I don't know if prior SARS-CoV-2 infection creates a situation were the very potent mRNA vaccine triggers a large immunologic recall response. I wanted to get this noted as there may be some reason to alter the vaccine schedule for prior SARS-CoV-2 infections

Per patient, woke up on the morning after the day following his vaccination (2/9/21) with chest pain, shortness of breath, and feeling light-headed. He tried to sit up, saw red dots, and "passed out" momentarily. He had severe headache upon awakening, ringing in ears, and blurry vision. Went back to bed and slept all day. Symptoms worsened every time he tried to get up. Woke up this AM, with symptoms persisting. Came in for OV, BP noted to be elevated at 150/106. Patient was sent to hospital via ambulance for further work-up and management.

Localized acute left axillary lymphadenopathy. Also expiratory wheeze, intermittent non-productive cough.

Moderna COVID-19 Vaccine EUA Tightness in throat lasting at least 6 hours. No problem breathing or swallowing but it was concerning.

Approx 4-5 hrs after vaccination, developed dry cough, wheezing, nasal congestion, left arm soreness, overall fatigue

within 5 minutes of receiving the vaccine patient became light headed, cold clammy skin with cold sweats, blurry vision, dizzy, pale/gray skin, and short of breath. Pulse was 60 and BP 90/60- epinephrine 0.5 mg given, pt BP 80/60 returned to 129/88. EMS evaluated patient- patient declined to go with EMS to ER or to go to the ER- pt stated 1 hour after onset that he felt fine and declined to go to ER eventhough he was advised to but states that he will go if he feels he needs to but that he feels normal now.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Medium, Systemic: Shakiness-Medium, Additional Details: Patient had a vasovagal reaction. He was \"not a big fan of shots\". Hadn't eaten well the day before nor breakfast. Didn't sleep well. Called 911. They did EKG and it was fine. Spoke with patient the next morning and he was good.

On 4/10/21 around 2:30 pm I gave the patient his first Moderna COVID vaccine and had him sit in the observation area for the standard 15 minutes. Around 2:35 he and his family notified me that he was feeling lightheaded/faint and nauseous; he also appeared pale and diaphoretic. It seemed to be a vasovagal reaction until he said he was starting to have trouble breathing so I called 911 and got the Epipen/emergency kit ready, and monitored vitals. Then his breathing trouble resolved without needing to administer medication. EMS arrived at 2:39 pm and confirmed his HR/BP/O2 sat were normal. EMS cleared the patient to go home with his family. The patient had never had a vaccine reaction or vasovagal reaction before.

Patient c/o SOB, pale and diaphoretic. Administered 02 2L/NC, NS 0.9 200 ml given, Benadryl 50mg IVP and Solu Medrol 125mg IVP given. called 911. Pt verbalized he feels better after medication administered but still want to go ER. Patient send to hospital via ambulance. Doctor notified.

After 5 mins of getting the 1st shot I felt an allergic reaction little bit hard to breathe and hot flash. I told the pharmacist and was advised to stay an extra 10 minutes. I left the Pharmacy and proceeded to the store and then home. Over the next 1.5 days I felt a sort of brain fog, my arm puffed up red about the size of a half dollar. The brain fog went away and then for the next 2-3 days my body felt like I was coming down with a cold. I seemed to feel better after that initial period until 3/24 when while driving a hot flash came over me and the next day I was again in a type of brain fog. For the next two days I tried to just deal with the brain fog but started to notice on the right side of my neck a feeling of constriction, with abnormally high blood pressure. I went to the hospital ER and the completed a CAT scan of my brain and neck, blood work and urine work up with no evidence of why my neck was feeling constricted and high blood pressure. The symptoms continued and on 4/1 my blood pressure spike to 168/93 and I again went back to the hospital ER and spent the night. I was having heart palpitations, anxiety and very high blood pressure. The hospital this time completed more bloodwork, MRI of my brain and neck and an Eco-cardiogram. I am now on 3 blood pressure and heart medications and have no diagnoses of why my blood pressure and heart rate are so abnormal. I am very healthy and exercise daily and have never encountered this and my BP has always been extremely good.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild

The day after receiving the moderna Covid vaccine, i came with extreme tightening of the chest, wheezing, and a heavy cough. I received the shout in 4/23 and on 4/26, which is today, I still have tightness of my he shear and wheezing.

Noticed slight pressure on chest, causing laboured breathing. Noticed a decreased oxygen level for about 1 hours. After that time, I napped and all issues were over. Also slight headache but nothing disturbing just noticeable.

lot: 026A21A NDC 80777-273-99.he started with symptoms after vaccine which progressed. SOBOE, N/V, fever & fatigue x 1 week in setting of recent COVID vaccine. admitted to hospital via ED with pleural effusion, AKI, Labs notable for +ANA, +smith/RNP, SSA/SSB,+Scl-70, dsDNA, low complements, lymphopenia, leucopenia, thrombocytopenia, rhabdo,worseing renal failure (now on dialysis) with PU, kidney biopsy largely unrevealing. Bone marrow biopsy concerning or HLH. DDx HLH 2/2 to new onset SLE with overlap syndrome/MCTD.patient needed to be transferred to a tertiary center, now at another facility in critical condition with encephalopathy.

The patient complained about his eyes being blurry, being light headed, and having shortness of breath. His vitals were taken every few minutes with the following results until Fire department EMTs came on site and monitored his vitals and recommended him to be taken to the hospital. He agreed and they took him to one of the near hospitals. 10:00 am 159/108, Pulse 63 10:07 am 164/110, Pulse 61 10:12 am 148/104, Pulse 61 10:16 am 142/103, Pulse 61 10:22 am 150/108, Pulse 60 10:28 am 157/111, Pulse 61 Oxygen when taken by EMT personnel: 97/60 He said he couldn't understand our talks. He said he couldn't make the words to talk.

Heart palpitations, pounding heart that feels irregular, at times. Felt nausea a couple of morning along with heart symptoms and a sensation of difficulty breathing. However, I am able to take a deep breath when feeling this way and am able to work out with no difficulty. The symptoms continue intermittently, but do not happen constantly. A Kardia Mobile device purchased and I was unable to detect irregular heart rhythms with it. I considered going to the doctor and possibly the emergency room to get it checked out, but decided against as the symptoms would stop. They still continue off and on to this day.

The day after the shot I began having severe abdominal pain, muscle and nerve pain, and shortness of breath. The abdominal, muscle, and nerve pain began at around 10:00am. The shortness of breath began around 2:00-3:00 in the afternoon and lasted for 30-45 mins (longer than the 20mins listed in the attending ER physician's report), at which point my wife called for an ambulance and I was taken to the emergency room of Hospital. I was prescribed diphenhydrAMINE injection 25 mg, droperidoL injection 1.25 mg, ketorolac injection 15 mg, and another pain killer by the paramedics that I do not see listed in the record. Although not to the same degree, I have continued to have gastrointestinal cramping since the second vaccination. This is a worsening of a condition (IBS) that I had previously, but which had mostly been in remission since beginning Mirtazapine in Fall 2019 subsequent to a heart attack on 8/7/19. I am meeting with my primary physician, Droctor, on 5/10/21 and contacted, my gastroenterologist, on 5/5/21.

FOLLOWING THE INJECTION THE PATIENT FAINTED MOMENTARILY. UPON AWAKENING HE WAS DIAPHORETIC AND BREATHING RAPIDLY. HE THEN VOMITED. PHARMACIST CHECKED BP AND IT WAS WITHIN RANGE,. 911 WAS CALLED AND UPON ARRIVING THE PARAMEDICS CHECKED VITALS AND CONCLUDED PATIENT WAS OKAY. PATIENT WAS NOT TRANSPORTED.

Evaluation on Day of Discharge: Stable for discharge Hospital Course: Patient was evaluated for sharp reproducible chest pain and shortness of breath. He was evaluated by cardiology who suggested MSK in nature. He started lifting weights earlier this week. His cardiac work up included EKG with NSR, CXR no acute process, troponin neg x3, inflammatory markers negative. He did have significant dyslipidemia and was counseled on importantance of healthy lifestyle, diet modification and importance of taking statin. Patient was treated with OMT with moderate improvement of symptoms and was rx'd muscle relaxer for a few days to help with muscle spasm. He is to follow up with cardiology and get a repeat lipid panel in 3 months as well as follow up with PCP for stress echo and EGD if sx persist.

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was elevated troponin, bilateral pleural effusion, hypertensive urgency.

Difficulty breathing; Covid-19 symptoms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Difficulty breathing) in a 46-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 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced COVID-19 (Covid-19 symptoms). On 06-May-2021, the patient experienced DYSPNOEA (Difficulty breathing) (seriousness criterion hospitalization). At the time of the report, DYSPNOEA (Difficulty breathing) and COVID-19 (Covid-19 symptoms) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-May-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. On 06-May-2021, started with breathing issues, and although being negative for covid-19 since 02-May-2021, had to go to hospital to receive treatment. 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 mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of the COVID-19 event is assessed as not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of the COVID-19 event is assessed as not applicable.

initial soreness at injection site (Left Shoulder) A couple days after the shot that soreness subsided but started experiencing tightness in left chest/heart area. Will experience the tightness for a period of time then it will go away. More prevalent with activity, and is accompanied with shortness of breath as well.

Broke out in hive and a rash, throat swelled, eyes swelled, problems with heart and lungs and sinus issues really bad... lasted over 3 months and still having some effects.

Sickness bedridden for 3-4 days. Symptoms I never had during my actual bout with real covid. heart palpitations, chest wheeze making breathing more labored. I had the real covid in March 2020 where I never had respiratory symptoms, tested positive for antibodies May 2020

Pt received moderna vaccine 4/7/21 and 5/5/21, and developed nausea and vomitting about four hours after the second shot. These symptoms plus epigastric and RUQ pain and decreased po intake persisted until evaluation on 6/15/21 to medical center when pt was diagnosed with biventricular systolic congestive heart failure complicated by an RV thrombus and subsequent subsegmental LLL pulmonary embolus. FYI - lot number above for 2nd covid shot is either 025B21A or 025821A (the 4th digit is either a 'B'or '8'). shot #1 given at clinic and #2 given at clinic(both VA clinical areas)

I had injection site pain . I woke up the next day with chills, body aches and pain, chest pains, heart palpitations, shortness of breath, arm soreness and swelling, fatigue, nausea and I could not get out of bed. I called the hospital and left a message. The doctor called me back and advised me to go to the ER. By the time the doctor called me back, my chest pains and heart palpitations had resolved. The other symptoms still persisted- extreme fatigue and headache which lasted another 4 days. I started to feel better and it took about 6 days for all symptoms to resolve. I did not go to the ER since the cardiac symptoms have resolved. I am still having SOB.

3 days after receiving vaccine, developed a severe cold which was diagnosed as pneumonia which lasted 3 weeks. Then when back to the doctor for follow up and was then diagnosed with bronchitis, Consistent trouble breathing , chest pain, left arm pain for 3 months and has been prescribed multiple inhalers, steroids, antibiotics, chest xrays, ultrasounds, stress tests. Has developed allergic reaction to peanut butter and bee stings. Patient was previously a vigorous healthy man with no serious health conditions.

Chest pain/shortness of breath/fatigue Myocharditis Ejection Fraction of left ventricle 30% Hospitalization, Nitro patch/morphine, angiogram, ultrasound, MRI, Heart Failure Clinic Still in recovery

Shortness of breath started a few days after second shot of vaccine. However it took 2-3 minutes maximum. But on 18th June and later 24 june, I was completely out of breathe. I had been hospitalized on mentioned dates. Test result turned out normal including Heart health. But the problem persiste. High palpitation and breathe shortness start around 8 to 9 pm and continue trough night. I go to sleep with sleep pills each night after walking around for hours.

Hypertension stage 3 for one week (used a good pressure cuff to monitor). Dizzy, fuzzy/foggy thinking. Forgetful. Headache. I couldn't think at all. When walking it felt like I was floating above my body. Anxiousness. Tired. Out of breathe. Irregular heartbeat. Lasted about a week. Then one morning it was gone. Almost like a fever breaking but instead it was my blood pressure.

Chills and fever started 2 days after the injection. The chills and fever have continued for a week and have intensified. Chills are so intense patient is shivering and shaking when he tries to sleep. Also suffering from what seems to be a respiratory infection. Patient coughed up sputum on Saturday 7/17 what showed signs of infection. Treating this like the flu- patient has taken Tylenol, Advil, Advil Cold & Sinus, Elderberry. Drinking lots of fluids, resting as much as possible, but having difficulty sleeping due to fever, chills, and breathing difficulty.

Pt received the 1st dose of Moderna and developed severe onset of vertigo 3 days later along with chest pain and shortness of breath. Shortness of breath and chest pain resolved but vertigo persisted until improved 7/21/21. Follow up visit 7/21/21 with his PCP. Vertigo has gradually improved.

Symptoms after and until now are injection site pain, tiredness, headache, shortness of breath when I move around and I have a habit of running every morning. Since the vaccine I lack of more air. I have dizziness and before I didn't have any, also I have slight chest pains and tiredness which previously I didn't have.

Dizziness, heart racing, nausea, severe body aches, fever, chills, difficulty breathing, extreme gas, cramps. Was transported the Hospital and received zofran, atavan, morphine and tested negative for COVID 19 and flu and pneumonia. released after four and a half hours but continued to experience pain in muscles and fever even today (01/14/2021).

2-3 min after vaccination he started feeling tingling in the right side of his face. About one minute later he felt like he could not get a full breath and he felt the need to run away. We connected a heart monitor, did serial vital signs, listen to lung sounds. He symptoms seem to worsen. He did not have hives, his lungs were clear. His HR was normal but his B/P was elevated. We started and IV and gave him 25 mg mg of IV Benadryl. We contacted Dr. via phone. He talked to the patient and he agreed with our assessment and treatment. He began feeling better about 10 min after the Benadryl and he symptoms cleared by 30 min after Benadryl. We kept him on the heart monitor for 1 hour. He reported he felt fine and back to normal when he left to go home. He refused ambulance transport to the hospital. All reports will be filled out by me.

My blood pressure went up to 170/106 and my heart was beating over 100 about 45 minutes or one hour after I was vaccinated, and I also felt nausea. Nurse called 911, and I was transported to emergency. About 1.5 hour later, my heart was even beating more quickly, and I could hardly talked and difficult to breathe. This happened when I walked to the restroom by myself and came back. After they did some medical tests, gave me medication for allergy (the doctor gave me this since he was not sure if it was my allergy reaction to the vaccines), injected 2 IV bags and rest for few hours, my blood pressure went down to about 140/9x and heart beat back to normal. I was released from ER on the next day at 4:00am.

01/18/2021-Patient became short of breath with c/o throat tightness and difficulty speaking 30min post vaccine. Given epi 0.3mg subcutaneous, Benadryl 50mg by mouth, placed on cardiac monitor for 4 hours with mild tachycardia post epi. Solu medrol 125mg given IV. Sent home and then returned 38 hours later with c/o epigastric pain, nausea, vomiting and weakness. Sent to Medical Center

Temperature 106, Malaise, Nausea, Vomiting, Joint redness, swelling and pain (hands), back pain, headache, visual disturbance (photosensitivity), Vertigo, Muscle Weakness, Shortness of breath all occuring over four day period. Continue to run a low grade temperature (99) intermittently.

Arm swelling , Soreness, pain. the following day(s) nausea, labored breathing, funny feeling like a heavy chest. dizziness ( still happens occasionally seven days after vaccination) fatigue still happening to date.

Within 20 minutes post injection the following occurred: Dizziness, light headedness, hives, feeling excessively hot, throat tightness w/feeling of needing to clear my throat

Red raised rash at injection site next day. Sore right arm for several days. January 22 sneezing, congestion and cough started. Then joint pain and body aches. January 25 extreme fatigue and nausea and had to leave work. Coughing worsened and lead to shortness of breath for three days. Developed red raised rash on my face January 28. January 29 cough, congestion, muscle pain and fatigue gone, continue with joint pain and rash.

Difficulty swallowing (started within 5 minutes; lasted for 60 minutes then subsided). Constriction of the airway with a swollen throat with about 50% constriction (started within 5 minutes; lasted for 45 minutes then subsided). No change in heartrate. No change in blood oxygen level.

Since receiving Moderna shot #1 vaccine I have experienced three gout attacks. It is unusual for me to have this many gout attacks in such a short time period. Additionally, physical activity has been very challenging since receiving the shot. I fatigue and become short of breath very quickly. During the first workout that I did, on 02/01/2021, after receiving the shot I became extremely dizzy, my eyes became light sensitive and my hands trembled; symptoms lasted for approximately 45 minutes.

48 hours post vaccine, patient developed low grade fever and respiratory complaints including shortness of breath. chest x ray showed RUL consolidation. when patient wosened over the next 48 hours from respiratory standpoint including new oxygen requirement and hypotension, decision was made to perform chest ct which confirmed presence of RUL pneumonia. the following day, the patient was bronched and the resultant bronchial alveolar lavage that was performed has thus far been completely negative. repeat chest xray four days later showed resolution of RUL consolidation and patient was no longer symptomatic.

My epoglottis began swelling about 8-10 hours after the shot. It was minor, and I did not see a doctor., nor did I take any meds or treatment The swelling was gone by the next morning.

On 2/23/21, about 12 days after the vaccine was received, I felt chest pains in the late afternoon. At midnight, I woke up with uncontrollable chills and shakes, with a low-grade fever that hovered in the 99.5 -100 range. I attempted to get up and struggled to breathe,; it was as if my abdominal and lower back muscles were seizing. I had to crawl to a kneeling position to urinate. I took several Tylenol then went back to lie down; after a few hours, the fever subsided, and I was able to briefly fall back asleep. At 4:00 a.m. the fever and major chills subsided, with no fevers reported since then, and only occasional chills. However, the muscle fatigue, pain and stiffness have become frighteningly debilitating. On Wednesday - Friday, the three days after I first experienced symptoms, each day it took me between 1.5 - 2 hours to get out of bed and finally get to a standing position. During the day on each day following my first symptoms, I have been able to gradually walk around, go up and down stairs, use the bathroom, and perform basic tasks. However, when the evening comes, it is a different story. 12 midnight - 10 a.m. are the worst hours, as any extended period lying down results in my muscles seizing, freezing and stiffening up. After falling asleep for an hour, it takes 10-20 minutes to mobilize enough (using a crutch and assistance) to get to the bathroom. After falling asleep for 2-3 hours, it takes 30-40 minutes to do the same. And, if I fall asleep for 3+ hours (which is about as long as I've been able to sleep since the adverse reactions began), it will take 1.5 - 2 hours to get completely mobile. This is when I finally wake for the day, and it takes about 10 minutes to raise my head and turn my torso, then another 10-15 minutes to get my legs off the bed and assume a crouching position, then 30-60 minutes to stand on my own.

Approximately 45 minutes after injection mild onset of anaphylaxis response. Numb tongue, tingly lips, mild throat constriction but no issues swallowing or breathing. About 60 minutes post-injection, the patient self-administered two 25 mg tablets of Benadryl. Symptoms subsided 120 minutes later.

A few minutes after the shot i started getting dizzy. it increased with intensity so i flagged down an attendant for help. I started feeling weak and tired. I went unconscious during which time i was told my breathing was irregular. I think i was unconscious for 2 or 3 minutes. I woke confused, shortly after i woke the medic showed up to my care. He took my heart rate and check my blood sugar. He said my vitals looked ok. He asked if i was feeling better. I was still very dizzy and nauseous. i sat in the parking log for awhile before driving home. I got home and went to bed slept most of the day. I had a fairly bad headache the rest of the evening and a slight nauseous feeling. The next morning i still have a slight headache still feel slight nausea but not bad.

I experienced some mild symtoms the night after my first injection. I woke up in sweat and a fast beating heart, around 110-120 bpm. I felt like I inhaled a bunch of cotten balls in my lungs. These feelings lasted a few hours then went away.

He received his Moderna vaccine and was sitting in waiting area with his spouse for his 15 minute post vaccine wait. RN was alerted that he did not feel well. RN #1 assessed him and gave him 10ml of Benadryl liquid due to his complaints of itchy/scratchy throat and difficulty breathing. Heart rate was 80 and respirations were 20. He reported he last ate at 8pm the night before and was too nervous to eat breakfast. RN #2 provided him with fruit juice and sliced apples. He reported feeling better and then two minutes later complained of feeling hot and cold and foggy headed and not right with some anxiety. RN #1 called local EMS/Fire Rescue and they arrived to assess him. Vital signs were within normal limits. He was transported to Hospital for further evaluation. He was alert and oriented and able to ambulate to EMS/Fire Rescue vehicle.

Patient had trouble breathing and took his inhaler. He continued to have trouble breathing and said his throat and chest felt tight. EMT gave 20ml of benadryl and assessed patient. Gave another 20ml of Benadryl. EMT asked and reassessed in 5 - 10 minutes. Patient still felt tightness and said it was getting worse. EMT asked if he wanted epi and patient said yes and said his throat was closing more. EMT explained that he would need to go to the hospital then and patient did not want to go to the hospital. Continued assessment and patient stated he was feeling better after EMT had him drink water and do some deep breathing. Patient stated he felt much better and was released from waiting room. Nurse at employer (Clinic was done on site) stated that this is normal for patient to have SOB as he has COPD and commonly has shortness of breath.

Patient was coherent during initial injection, as I removed my gloves and asked he remain in the waiting area for 15 minutes his chin fell to his chest and he began to breath heavily. I spoke to him and there was no response. He then began making snoring type noises and lifted his head but again was unresponsive. Patient then slumped sideways in the chair. I made one last attempt to arouse him with firm strikes to the chest and calling his name. I retrieved the EpiPen from the e-kit and as I removed it from the box he became conscious. He opened his eyes and gasped and tremored slightly. He was not immediately responsive verbally. I observed him carefully to evaluate if he was going to have a seizure, but he then became coherent. He was alert and oriented to time and place but did ask how ling it had been since the vaccine. He admitted to having a problem with needles and stated that was the root of the reaction. He does not remember any reactions to previous vaccines but also could not recall his last vaccination. We brought the patient water and offered snacks while he recovered in the patient care area. Approximately 20-30 minutes after the initial event the patient began vomiting. After a few minutes of vomiting he said he felt a little better and wanted to go to his car to lay down. Multiple times we asked if we could call someone to come pick him up and offered to have him seen by paramedics that happened to be shopping in store. He declined both offers and stated he would lie down in his car and call someone if he did not feel well after awhile. Staff checked on him in his car and he was instructed to call in before leaving. Upon trying to check on him again it was noted his car was gone. I called the patient and he assured me he was ok and he was now at home.

Injection site soreness 8 hours later, development of flu like symptoms. Next day full flu like symptoms, muscle aches, headaches, chills, weakness. Lasted for 4 days. On day 5 lungs really became sore and O2 began dropping into the mid to upper 80s again. Patient is a previous Covid pnuemonia patient with ground glass nodules from Covid 5 months ago. The lung pains and 02 swings felt as bad as Covid pnuemonia back in October and lasted for about 2 weeks. During this time the patient started Symbicort and Abuterol inhalers again for treatment of the lung issues.

1 am, headache, congestion cough 2 am, fever, chills muscle soreness, 5 am nausea, 6 am itching 6:30, previous symptoms subside, breakout in hives, 7 am ems arrives, hives cover 35% of body 7:25 rapid onset heartburn, hives worsen 7:30 difficulty breathing 8:13 ER injects epinephrine, symptoms lessen immediately 8:28, ER gives IV Benadryl, Pepcid, and methyl prednisone 8:50, symptoms largely gone, hives still fading. ER monitors till 12pm

Patient called 4/21/21 at 2:08 pm and said at 6 AM he woke up in a "pool of sweat" and started vomiting + chills. No fever. He vomited once and has been nauseous since. He feels very dizzy. He was walking down hallway, and he "blacked out" and fell down the stairs. He said he did not hit his head, but the right side of body hurts, as well as chest, after the fall. He said this pain is causing some difficulty breathing. He said his dad witnessed the fall. When asked if the pain is severe, he said "yes". He was told that if he's experiencing "severe" pain after a fall, accompanied with difficulty breathing, he should seek medical attention. He was told he can contact his Dr. for a second opinion first, if desired. Otherwise, it was suggested he check his BP, if possible, sit with head between knees or lay down with feet propped up and NOT walk around if feeling dizzy. He was advised to stay hydrated and introduce bland foods first to see if he can tolerate solid food. He was told he can take whatever oral pain reliever he normally takes that he's allowed to take if needed. Patient will report back to me.

Difficulty in breathing; Swelling of face; Swelling of face and tongue; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Difficulty in breathing), SWELLING FACE (Swelling of face) and SWOLLEN TONGUE (Swelling of face and tongue) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy (Not sure about the allergy). On 15-Apr-2021 at 1:52 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021 at 2:22 PM, the patient experienced DYSPNOEA (Difficulty in breathing) (seriousness criteria medically significant and intervention required), SWELLING FACE (Swelling of face) (seriousness criteria medically significant and intervention required) and SWOLLEN TONGUE (Swelling of face and tongue) (seriousness criteria medically significant and intervention required). At the time of the report, DYSPNOEA (Difficulty in breathing), SWELLING FACE (Swelling of face) and SWOLLEN TONGUE (Swelling of face and tongue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. EpiPen and 50 mg of Benadryl were given intramuscularly as a treatment for the events. 9-1-1 was called for further evaluation. No information on concomitant medications. 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.

Pt has been febrile with body aches, cough and shortness of breath for nine days following his Moderna COVID vaccine.

Moderna COVID-19 Vaccine EUA fatigue, headache, muscle pain, joint pain, chills, fever, difficulty breathing, fast heartbeat, weakness

I received Vaccine on 03/05/2021 and the next day I noticed wheezing and could not take a deep breath.. The following day I felt like something sitting on my chest. On 03/07/2021 I could not walk across the parking lot without giving out of breath. From 03/08/2021 up until now I have been to several Hospitals and Doctors. Diagnosed on 3/16/2021 at A Medical Center with Acute Systolic and Diastolic CHF .

Systemic: Dizziness / Lightheadness-Severe, Systemic: Hyperventilation-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Tingling in hands which went away after a while. Called EMS per patients request, vitals were fine, symptoms improved after about forty minutes

Patient was given his 2nd COVID vaccine and was sitting in our waiting area. Around 5 minutes after he received his vaccine he mentioned that he felt his throat was starting to swell and his throat was hurting. I sat him down to evaluate the situation. He was given 50mg of Benadryl and a bottle of water. He said he was starting to feel better, but we continued to monitor him. He seemed very agitated (sweats/clawing at throat). He then mentioned wanting to go across the street to the hospital because of this throat pain. He requested EMT come to check him out, as I would not let him leave alone at this point. EMT came and took the patient by ambulance to Hospital.

" I received the dose in my left arm and immediately after I was escorted from the treatment room to the waiting area I noticed a metallic taste in my mouth. I sat down to wait for my 15 minutes to be up as requested by the pharmacist. Within a minute of waiting my tongue started feeling numb on my left side and the left side of my face started tingling (cheek and region just below my eye). I also felt like my throat was tight and felt like I needed to clear my throat. I started researching "face tingling moderna" as I was getting concerned. I waited in the chairs for 20 minutes or so and no one came out of the pharmacy. My symptoms had not worsened but were not all the way gone with the face tingling remaining the longest. I decided to do some shopping as planned and would report my symptoms to the pharmacy if they didn't go away. All in all my symptoms lasted 25-30 minutes with the most intensity in the first 15 minutes."

MYOCARDITIS: Patient developed chest pain and shortness of breath. He was seen by me in the emergency department on 5/16/21 and was found to have an elevated troponin. He was admitted to the hospital and underwent a coronary angiogram which was normal. He has evidence of some global hypokinesis on his echocardiogram and eventually had a cardiac MRI which confirmed that he has myocarditis. He became ill the day after his 2nd Moderna shot and then more ill the next few days and I saw him on Day #3 after his 2nd shot. He is otherwise healthy. He was hospitalized for two days. He was discharged on Losartan and Metoprolol and was not on any medications prior to his presentation.

32 year endurance athlete with never any issues. Within 2 weeks of second vaccine now have chest pain, shortness of breath, and high heart rate. Been to listed family doctor. Got EKG, Halter monitor test, and Echocardiogram. Now told I have mild to mid leaky heart valve.

Patient presented to provider office visit 2 days after 2nd dose of Moderna vaccine with testicular pain for last 2 days, bluish color on tips of left fingers. Was prescribed levofloxacin x 7 days to cover for possible epididymitis and was told to monitor the finger discoloration and return to PCP next week for recheck. The following day (7/17), he presented to the Emergency Department for evaluation of the fingertip discoloration. He reported that the testicular pain had improved. ED provider noted: Fingertips on 2 or 3 fingers of a few small thin lines that are purplish in color almost as if discoloration of the fingerprint itself. But it is no more than 1 or 2 lines to 2 or 3 fingertips. There is no erythema no swelling no tenderness. There is no muscle soreness. No axillary lymphadenopathy. No ascending lymphangitis. ED Course Differential Dx: Adverse reaction to Covid vaccine, DVT, electrolyte imbalance, coagulopathy, electrolyte imbalance, localized trauma Lab normal white count hemoglobin platelet count mildly elevated hematocrit of 51.3. CMP showed a low CO2 22 I suspect this is due to prior elevated respiratory rate he does admit that he slightly anxious. Glucose was elevated 142 BUN was 6. Liver function studies normal. Coags normal Did do ultrasound of his arm since he recently was vaccinated there is no evidence of DVT or any occlusion. Patient's fingers are warm he has intact sensation I am not sure if this is an adverse reaction to the recent vaccine, some sort of unknown localized trauma. I suggested patient follow-up closely with primary care for reeval this week if no improvement and return if any acute worsening symptoms or problems.

January 1, 2021 about 7:00 p.m. Patient experienced sudden onset of "sciatic pain." Pt normally has recurring similar pain, but describes this as more severe. Pain extended from R hip to neck. On the morning of January 2nd, painful muscle spasms extended from lower back, mid back, between shoulder blades and neck spasm on right side, radiating to spine. Patient used ibroprofen and Tylenol. Tylenol provided some relief. Pain so severe, patient reports difficulty breathing due to spasm pain. No further respiratory distress. January 3, 2021 in the afternoon, patient reported to Emergency Department for evaluation. Was given toradol. Prescriptions for Flexeril and hydrocodone were given. As of 1/6/2021, patient is still on meds and reports improvement. However, 1/5/21 significant swelling and slight pain began in Left knee, restricting range of motion.

Dizziness After 5 minutes after being vaccinated, pt began to feel lightheaded and dizzy and slightly short of breath, heart rate was 160 and BP was 128/90 with 100% O2 sats on 6L. After that her heart rate started to come down two minutes later to 129

Approximately 30 minutes after injection, client began to experience shortness of breath, nausea, vomiting, hives on face and chest, tightness in chest and severe anxiety attack.

1st Dose admininstered 1/10/2021 @0800 hrs. Approx. 5 min later, 1st whole body Goosebumps/Chills lasting 3-5min. with clear nasal dripping/congestion. On 1/19/2021 in AM, started having SOB at rest, Febrile (101.1F), extreme fatigue, whole body goosebumps/chills preceding every episode of SOB (upper airway compromised) and a total autoimmune response, I am having episodes of whole body immune responses with severe SOB (>30 bpm), fever (Tmax 105.1F), whole body goosebumps (chills) preceding every episode. Never became hypoxemia/hypoxic. SpO2 was always >95%, with Blood Pressure and Heartrate always were WNL (115\75 +-20mmHg, HR 75-100 bpm, . Episodes lasted 4-5 days, after that episodes in a 'tolerable' range with full body goosebumps preceding each episode. Tx with 50-100mg Benadryl, 400-600mg Ibuprofen.

Evening of the vaccine: mild left arm pain at injection site. Day 1 post vaccine: mild left arm pain all day, By 3pm back pain, flank pain , skin over thighs and right arm tender to the touch. 10pm-5:30am uncontrolled rigors and chills with fever up to 100.5. Day 2 post vaccine: moderate left arm pain, moderate muscle aching, moderate fatigue, occasional nausea, some joint pain, had to leave work after 1/2 day. The evening begins with nausea, then diarrhea all night until Day 3 post vaccine: severe left arm pain, now arm is swollen over injection site for 1st time, sob with activities (1 flight of stairs) and pain when taking a deep breath. Diarrhea resolved by mid day. Muscle and joint pain is better today. severe fatigue, left work after 1/2 day. Day 4 post Vaccine: severe left arm pain, swollen over injection site, fatigue is moderate. muscle pain resolved, DOE and pain on deep breaths improving, muscle and joint pain resolved Day 5 post vaccine: moderate left arm pain, swelling improved. fatigue continues, DOE and pain on deep breaths improving Day 6 post vaccine:left arm pain resolved, fatigue continues to improve slowly, was able to work a full day, DOE and pain on deep breaths is mild. Day 7 post vaccine: DOE and pain on deep breaths has resolved, fatigue is mild and improving Day 14 post vaccine: fatigue has resolved and I was able to resume aerobic exercise.

On approximately the evening o 01/21/21 the patient began to experience headaches. The headaches have been intermittent continuing on till the date of this report (02/04/21). The patient has been taking acetaminophen with relieve. On approximately 02/01, it was noted by coworkers that the patient's right side of the face would not move when he would talk. Around the same time, the patients right eye became watery and the patient's wife stated she noted some gurgling. Due to the onset of these new symptoms, the patient went to see the doctor on 02/04/21. Per the patient's wife, the doctor diagnosed the patient with a very mild form of Bell's Palsy and prescribed steroids to the patient. The name of the steroid was not disclosed.

Patient developed sob. Admitted on 2/16/21 with cardiogenic shock, acute renal failure and liver inflammation. Diagnosed with multisystem inflammatory disorder from COVID-19. Thought to be related to diagnosis on 1/25/21 but given recent receipt of vaccine reporting in case there are trends.

I have had COVID-19 around Nov. 27, 2020. The symptoms I started having were like a more moderate version of the same symptoms I had had during COVID. Head arch, sore body, weakness, chills, a little shortness of breath with a slight cough. Right now at 2:37 PM on 3/26/2021 I feel about like I did on day 3 of when I had COVID. I still have some of the symptoms, but they are much more diminished.

shortness of breath, wheeze at approx 5 pm, pt took benadryl 50 on his own as well as albuterol inhaler

Patient felt shaky and short of breath , patient slightly aggravated and noncompliant, patient refused care from medical response team then changed his mind and was treated Patient refused medical transport and signed AMA form Patients symptoms resolved and drove self home

About 20 seconds after shot patient became dizzy, sweaty and labored breathing. He then told pharmacist that he had Covid in may of 2020. He then fainted and lost bladder control. The EMT's were called and about 45 minutes later his vital signs were normal and patient left under his own power.

48 y/o retired male comes to clinic with complaint of rash that has been present since 02APR2021. States he suspects this may be the effect of second COVID vaccination which was on 31MAR2021, confirms using hydrocortisone cream for symptoms. Denies any SOB, difficulty breathing, swelling of throat, vision changes, abdominal pain, diarrhea, but confirms itching. Confirms hx of similar rash after getting flu shot. PE show erythematous maculopapular rash over bilateral hand/arms/legs, neck and posterior trunk that is itchy.

Headaches, nausea, vomiting, diarrhea, cold sweats, tinnitus, nasal pressure, congested ear, fatigue, short of breath

Time of assessment 1144. Alert and oriented and Anxious. After sitting for 13 minutes of a 15 minute observation, patient reported feeling his throat tightening. He says it happened 2-3 minutes after receiving his vaccine and sitting down, but it went away. He says it came and went away another time, but this time it stayed. He was able to swallow water and his medication without difficulty. 1144: 129/87, P 89 1156: 139/81, P 87 (reports the feeling of his tightening throat is easing; denies itching to the throat, tongue not swollen, no rash observed) 1210: Reports feeling flushed, BP 139/81, P 83. (he says he's feeling his anxiety rising and says he will take 1/2 Xanax when he leaves) 1215-denies symptoms at this time. Actions taken: Vitals sign taken VAERS form obtained and completed by RN. Medications administered: Loratadine (Claritin) 10 mg by mouth. Time: 1147. Administered by RN. Famotidine (Pepcid) 10 mg by mouth. Time: 1147. Administered by RN. Diphenhydramine (Benadryl) 12.5 ml (25 mg) by mouth. Time: 1147. Administered by RN. Pepcid 20 mg given due to that is what is on hand and the pill is not scored, so unable to break in half. Disposition: Reports no further symptoms of adverse reaction after observation for additional 30 minutes minutes. Discharged home. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat. 1215 ambulatory out.

Patient reports around 5 days after receiving Moderna vaccine he experienced fever, diarrhea, n/v and SOB. Pt presented 4/07/21 to LGH ED with unremarkable blood work and negative chest x-ray, Covid negative- Pt discharged. 4/12/21 pt represented to LGH ED for some concerns and worsening sob with talking and walking and found to have PE and pneumonia

Reported tingling and pins prickles of both arms; SOB; decrease breathe snd at base of lungs; disoriented; hypertension BP190/100; 186/100; 170/100;Pulse-79; 74; O2 sats 99%.

Pt received second dose moderna vaccine. Did not bring first dose vaccine card, unable to obtain first dose lot number and date of vaccination from patient. Pt left facility and upon approaching stop light in front of building, pt began to experience SOB with fast heart rate and mouth dryness. Pt returned to facility to seek medical attention. Brought to med obs #1 via wheelchair by staff for evaluation. Reports mild improvement of symptoms upon arrival to med obs. No s/s of distress noted upon pt arrival. Pt reports taking prescribed lisinopril PTA this AM. Upon assessment of VS, BP elevated. Pt states he occasionally has SBP 200+/DBP 100+. Denies s/s of anxiety at present and denies headache/vision changes. VS are as follows: 1314: BP 187/107 (RUE), rechecked on LUE 233/134, HR 75, RR 17, O2 sat 98% on RA. 1319: BP 233/118 (LUE), rechecked on RUE 242/122, HR 104, RR 16, O2 sat 99% on RA. Per VS parameters, pt qualifies for EMS transport for ER evaluation of elevated BP. Notified in-house PA of need for assessment and confirmation of EMS need for transport as well as notification to lead supervisor. Constable at employee entrance notified to assist in arriving EMS. Upon assessment of pt by PA, pt disclosed he is non-compliant with prescribed lisinopril at home and will occasionally use medication PRN or double/triple his dosage based on symptoms. PA provided education on proper use of lisinopril and confirmed need for higher level of care. Pt agreeable to EMS transport for further evaluation. 9-1-1 called. While awaiting EMS arrival, pt reported sweating of hands and shallow breathing, stating, "I feel like I have to concentrate on my breathing now." Pt not in distress. EMS arrived to transport pt to Hospital. Pt alert and oriented x4 and ambulatory from stretcher to EMS gurney upon transfer. VS while awaiting EMS arrival are as follows: 1324: BP 249/126, HR 83, RR 17, O2 sat 100% on RA 1329: BP 247/109, HR 85, RR 18, O2 sat 100% on RA 1336: BP 243/112, HR 84, RR 20, O2 sat 100% on RA 1347: BP 245/144, HR 87, RR 18, O2 sat 100% on RA

Patient received the 2nd Moderna vaccine on 4/19/2021. On 4/20/21, patient had typical side effects such as fever, fatigue, headache, and arm soreness. Patient took Tylenol to treat symptoms. On 4/21/21, patient said he started to develop swelling around base of neck on both sides and had difficulty breathing. He stated that he also had right arm numbness where the injection was given as well as blurry vision. According to patient, his blood pressure was 220/145 and his blood glucose was over 300. Patient went to primary care physician on 4/26/21 about his neck still being swollen after his vaccination. He said his physician gave him diphenhydramine and a steroid shot for the reaction. Patient came to the pharmacy to report his side effects on 4/26/2021.

#1 = 011J20A on 1-6-21 #2 = 028L20A on 2-3-21 patient presented after sudden onset of chest pain early in morning and found to be covid +. ECG demonstrated diffuse ST elevation, troponins negative. CT without contrast didn't have much in it. He was found to be COVID rapid test+ and IGG negative. He was admitted into isolation, no oxygen needs. DDIMER was over 2000 and friction rub noted on physical exam. Cardiology ruled out STEMI, thought maybe viral pericarditis - but wanted echo done after out of isolation. CTA was planned for AM on 4-28-21, but patient died 4-27-21 PM after being found down in room. ROSC was not able to be achieved despite aggressive resuscitation efforts

Starting about 48 hours of the injection, I begin to develop a fever and chills, my bllod pressure increased, I begin to get chest and sinus cogestion, and about hour 54 my fever had spiked up to 101.5, by Pulse Ox had dropped to between 80% and 85% my blood pressure was at 145 over 110 with raipd and shallow breating for about two hours, I was close to going to the ER because of such sustained low oxygen levels. I took 1000 MG of tylenol around hour 55 and the fever begi to break, the blood oxygen levels went back up over 95% and the my blood pressure normalized

5/07 general ill feeling; runny nose, watery eyes. continued until 5/10. Wife denied fever or cough. continued until 5/10. 5/11 at work, patient collapsed. Was awake but non-responsive, breathing on his own, vomited shortly before EMS arrived. EMS arrived, patient stopped breathing, was bagged until arrival at hospital where he was intubated. 5/12 Patient was extubated and died in early AM 5/13. Medical records state cerebral brain hemorrhage.

PATIENT WAS NOT NERVOUS ABOUT RECEIVING HIS FIRST DOSE. OUR IMMUNIZATION CERTIFIED PHARMACY TECH ADMINISTERED THE DOSE. ABOUT 2 MINUTES LATER HE STATED HE WAS FEELING TINGLY AND HIS EAR TURNED A WHITE COLOR. THE TECHNICIAN CALLED ME INTO THE ROOM WHERE I EXAMINED THE PATIENT. HE WAS NOT RESPONDING AND HIS EYES WERE DILATED. HE WAS TRYING TO BREATH BUT HE WAS HAVING DIFFICULTY. WE MOVED HIM TO THE GROUND AND PLACED HIM ON HIS SIDE TO MAKE SURE HE DID NOT ASPERATE. AFTER ABOUT 20 SECONDS OF BEING ON THE GROUD HE STARTED BREATHING NORMALLY AND WAS CONSCIOUS. THE ENTIRE EPISODE LASTED ABOUT 1 MINUTE (MAYBE SLIGHLY LONGER). EMS ARRIVED A FEW MINUTES LATER. HIS PULSE WAS LOW (ABOUT 50 BPM PER EMS) BUT HIS BLOOD PRESSURE WAS NORMAL (UNSURE OF THE VALUE). HE SAID HE REMEMBERED TALKING TO US AND THE NEXT THING HE KNEW HE WAS LAYING ON THE GROUND. HE WAS VERY NAUSEOUS AFTERWARDS FOR ABOUT 45 MINUTES (HE THREW UP TWICE). WE CONTACTED THE PATIENT THE DAY AFTER AND HE SAID HE WAS FINE AND THAT HE ONLY HAD A SORE ARM. WE BELIEVE THAT HIS BLOOD PRESSURE DROPPED TOO LOW AND CAUSED A VASOVAGAL TYPE RESPONSE.

Patient came to the pharmacist for help about 5 minutes after his immunization, he was shaky. When the pharmacist came out to check on him, he collapsed. He was shaky, sweating, complaining of being on fire. He was given a bottle of water after asking for water. The patient then alternately complained of having trouble breathing and feeling better for several cycles. The EMS arrived about 20 minutes after being called and the pharmacist left the patient in the care of the EMT's. EMS left about 1/2 an hour later, then the patient's wife showed up to take him home. After 6pm, the patient was checked on by the pharmacist and he was doing well at that time.

Client presented to Healthcare Hospital at approximately 2300, overtly anxious and hyperventilating, c/o shortness of breath and chest ; daughter translating. C/o numerous complaints after having 1st Moderna dose today. She had onset of muscle cramping, weakness in legs, then diffuse myalgias, feeling prickling and poking sensations body-wide, chest discomfort sharp and pressure, feels anxious and short of breath. Also c/o increased itching without rash present on examination by MD., Hx non-ischemic cardiomyopathy, normal coronaries by agency at in Jan., managed with metoprolol and lisinopril, EF 30-35%. Cardiomyopathy attributed to thyroid disease.

Pt. received 2nd Covid vaccine on 05/14/2021. On 05/15/2021 pt. reports not feeling well with s/s of body aches and chills. Pt. reports that on 5/16/21 that he noticed fever, cough and increased SOB. Pt. presents with c/o increase SOB on 05/18/2021. Pt. was admitted with diagnosis of right upper and middle lobe pneumonia on 05/18/2021. Pt. required 2-3 L of O2 per nasal cannula. Pt. was also on antibiotics on Rocephin 1 gm IV every 24 hours. Pt. received a one time dose of Azithromycin 500 mg in ED.

Patient came to the store to receive his second dose on 5/27/21 at 1:40pm. He referred after getting 1st dose on 4/28/21 he had SOB and pain in the injection site, the event appeared 4 hours after the injection, he went to the ER and was advised it might be due to the vaccine, no information received about the facility he went to or other therapies received, patient was not hospitalized and recovered. Limited information provided by patient. ***This Event may have been reported by the ER department patient was seen at at that time, doing this report considering we do not have confirmation of whether that entity have reported the event already***

Started feeling light headed at 4am and had syncope x 2, his wife stated he was talking nonsense during this time, at 8am he had a fib, HR went from 40-155s, B/P 116/60, went to ER with chest pain and SOB, temp. 100.2, spent 3-4 hours in ED. He was sedated and converted.

For four days I had frighteningly strong heart palpitations, racing/pounding heart, shortness of breath while doing normal activities, and a sensation of missed heartbeats/difficulty breathing while falling asleep. This was not a psychological response; I had only a minimal reaction to the first shot, and no fear nor concerns with taking the second shot.

The patient did not want to wait the 15 minutes and went out to his truck. A customer brought the patient back in as he was complaining of chest pain and SOB. After resting 15 minutes pt stated that he was having a panic attack.

Headache, fever, chills, shortness of breath, generalized weakness, decreased appetite. Was seen in ER and labs were done. Troponin was elevated 0.525, CRP 10.2, D-dimer 1.01, WBC 10.02. CT of head was negative and CT angio of chest showed no PE or pneumonia. Has a headache and was given pain medication. Was transferred to Healthcare for admission.

Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Medium

patient reported rapid palpitations following the first vaccination. sometime between 05/07/21 and 05/10/21 he started having muscle pains in various places that kept moving around. winded easily. Came into the ED on 05/21/21 with complaint of left calf pain x2 weeks. no cause found. patient followed up in another facility on 5/26/21 where bloodwork was unremarkable, but was prescribed 6 day course of tapering steroids. symptoms improved, but returned as steroids tapered. patient developed right calf pain on 6/6/21. bloodwork showed elevated d-dimer and was sent to the ED for evaluation. no lower extremity or pulmonary emboli found. suspected that patient has COVID myocarditis and sent for follow up with cardiology. patient was prescribed steroids again on followup. patient presented to ED again on 06/25/21 with headache, chills, SOB and weakness. there was concern for vasculitis and sent to higher level of care.

After receiving the 2nd Moderna Covid Vacine I noticed shortness of breath, chronic dry coughing and fatigue/tirdness. Each week was progressively getting worse and rapid declining in my ability to fuction. I was gaining weigh and felt very tired, but thought it was respitory infection and tried to rest hoping it would clear up and improve. After several weeks, I noticed that both feet and legs started to swell and wouldnt return to normal. The decline was rapidly getting worse and I was not able to simply tasks. I tried to get an appointment at my primary physisan and was unable to get an appt, they recommeded I visit urgent care, so I went and was told to go to ER, where I was admitted to the hospital for congestive heart failure.

Acute Lymphoblastic Leukemia, Ph- Began feeling tired and noticed becoming slightly out of breath within 2-3 weeks of 2nd dose. First hospitalized on May 21 after blood work drawn on 5/20 showed hemoglobin below 5. Nurse at BMT clinic on Sunday told him that he was the 2nd patient that day who mentioned getting leukemia after 2nd dose of Covid vaccine, which prompted this report.

patient developed pleuritic pain , dyspnea, flulike symptoms shortly after receiving 2nd Moderna dose on 05/11/2021. He went to ED 05/13/2021 and was found to have pleural effusion, loculation and pneumonia and transferred to another hospital were he underwent 2 pigtail catheter placement. He had negative Covid testing and negative cultures. No surgical intervention required. All cultures, AFB and SARS COV 2 testing were apparently negative(per intial hospitalization DS) though results are not available. unknown if cytology was completed. Patient seen by this provider to review labs and screening CT chest on 04/28. He was asymptomatic at that time. CT chest dated 03/31/2021 showed minimal stable bibasilar subsegmental atelectasis and/or linear fibrosis unchanged from previous year. He reported receiving his 1st Covid 19 vaccination on 04/18 without side effects . On may 11th he received his second covid 19 vaccination and later that day reports he developed cough and right sided rib pain worse with coughing and deep breathing. The following day he felt like he "was run over by a truck" with increased cough, pleuritic pain, malaise and dyspnea.

Pt. symptoms included: swelling in the eyes, chest tightness, lump in throat, tachycardia, hypertension, and wheezes. Pt. was treated on scene with .5mg of epinephrine (IM) and albuterol inhaler in route to hospital.

Throat felt tight Narrative: Throat felt tight. No wheezes/rhonci. Tongue without edema. Able to swallow. O2SAT 100% Vitals wnl

5 days with fever. Headache, muscle pain, cough, trouble breathing, diarrhea, nausea, no appetite etc.

Fever, Tachypnea, HYPERtension, Tachycardia & HYPERglycemia Narrative: Was inpatient overnight in a telemetry until. DC with diagnosis of DM and CHF

Fever, Tachypnea, HYPERtension, Tachycardia & HYPERglycemia Narrative: Was inpatient overnight in a telemetry until. DC with diagnosis of DM and CHF

Mold/moderate wheeze and chest tightness. Onset ~20 min after administration. Lasted 30-45 minutes.

Onset of shortness of breath and cough on 1/3 that progressively got worse. Clinical diagnosis of pneumonia without fever was made, patient started azithromycin on 1/5 and albuterol treatments every 4-6 hrs. Initially he improved, but then worsened. chest xray on 1/6 was negative for pneumonia, PCR covid test was negative, albuterol treatment did not bring much relief. He started respiratory distress on 1/10 and was taken by car to the local ER where another covid test was negative and chest CT revealed multiple bilateral pulmonary emboli. The leg US revealed blood clots in both of his legs. He had an emergency catheter-delivered thrombolysis and was discharged home from the ICU on 1/12 on oral anticoagulants. He is gradually improving, but very weak. He tires easily and gets a drop in oxygen to 90- 93%, as well as an increase in the heart rate to 120 when walking less than half a mile. He runs out of breath with exertion.

Severe fatigue, muscle pain, joint pain, headache, nausea, dizziness and loss of balance. Mild difficulty breathing. Slept for 22 hours straight. Fever, hot flashes, chills and shivering. Burning in nose.

Received Vaccine on Friday January 15th 2021 at approximately 0715am after my Isolation and having had no symptoms for over a week. Received injection, was observed by our Physician staff for approximately 35 minutes with no adverse reactions noted at that time. Approximately 30 hours later on Saturday my left arm began to hurt and a very very strong fatigue came over me and I took a 2 and a half hour nap on the couch. I was still extremely fatigued upon waking, but my arm continued to hurt more and more up to the point it wasn't usable for anything heavy and/or strenuous at all, hurting just to use it for getting up from the couch. I was assisted to get me things like water, food and stuff. The arm pain began to radiate towards my left shoulder and eventually throughout the day the pain was spreading from my shoulder to include my left upper thorax and left rib cage. By Sunday, what had begun as left arm pain had now become stronger an approximate 5/10 pain. It started to present as atypical chest pain having the pain now fully encapsulated within my left upper chest. Felt what appeared to feel like intercostal pain and a general ache all throughout. By Monday the pain was still all throughout and assessed the situation from a cardiac standpoint and found that the pain was mostly positional and I wasn't exhibiting any cardiac symptoms such as shortness of breath, no sub-sternal pain, no jaw pain, no back pain. It hurt more as I would take a deep breath and began to move my left arm around and bringing it up from my side and did a stretch with my crooked elbow of my left arm I raised it to the ceiling and moved my thorax to my right side and found that this would make it hurt more, so I did some twisting of my thorax and abdomen and found that the pain would increase from movement, it was then that I began to think that it might be Pleuritic pain. Tuesday the 19th and Wednesday the 20th I had to call in Sick because I developed a severe muscle ache below my left calf between my calf and left ankle, as if it was in constant spasm and it affected my walking, like a Charley Horse feeling and wondered if it were the same kind of feeling that I had in my chest and I found it quite odd that all my symptoms were on the left side which is the same side I received the vaccine because my right side didn't have any muscle aches. The overall chest pain began to subside over the next couple of days, but the pleuritic pain that I described never decreased in intensity or pain level. I saw my Personal Dr yesterday January 21st 2021 at approximately 5:15pm as he was walking out of his office and we discussed my symptoms and believing that my symptoms seemed to indicate some kind of tentative diagnosis of a pleurisy issue as he had agreed that there didn't seem to be any cardiac involvement and am scheduled to see him again tomorrow Saturday January 23rd at 4pm As I write this the pain continues as before with no seeming end point and is not diminishing. I had phoned and talked yesterday afternoon and felt it best to check with my primary physician because he hadn't had any reports such as mine.

Symptoms: Severe chills, sweating, extreme fatigue, headache, bizarre dreams, restlessness, and wheezing. Treatment by doctor: Rest, albuterol, acetaminophen and ibuprofen. Outcome: Symptoms diminished 80% after 48 hours.

Severe chills, shortness of breath approx 13 hours after vaccination. Subsequent headache and body ache.

Day of vaccination (Day 1): Feeling of coldness on left side of chest, like there's ice in my chest; brought to ED for observation. EKG done, WNL. Given tylenol then sent home with benadryl. Once home, felt very, very cold, had to wear long sleeve shirt and fleece pants; persisted up to the present. Day 2: additional symptoms: dizziness, slight SOB, headache, head felt heavy, slight cough; SOB resolved by day 3. Other symptoms still present. Day 3: additional symptoms- salty taste in mouth & numbness of cheeks. Day 4: Dizziness, headache, salty taste, numbness of cheeks worsened. Went to ED, given IV fluids, sent home. Day 5 - diarrhea; Day 6 - diarrhea resolved; headache, dizziness/lightheadedness persisted. + nausea/retching but no vomiting v

Woke in the morning on 2-4-2021 with diaphoresis, SOB and pain and swelling at the injection site with 8- 10 cm area of induration. He used his inhaler without improvement. Diminished breath sounds and tachypnea O2sat 96%

Hospitalized with resp distress Jan1 , 2021 COVID-19 positive Severe illness, mechanical ventilation Remains hospitalized Feb 5, 2021

49 y.o male with a history of DMII, HTN, DVT, and obesity who was admitted for COVID-19 illness 3 months ago who developed fatigue, shortness of breath, malaise, and abdominal pain after receiving the Moderna COVID-19 vaccine. The symptoms persisted and two days after receiving the vaccine he developed chest tightness and left arm pain which prompted him to be evaluated in the emergency department.

Patient stated she felt like her throat was closing and started sounding hoarse. Doctor examined patient and took her vitals which was stable. Patient was given a Benadryl and then sat for a couple of minutes. Patient then stated she had difficulty breathing and was given a Epi Pen and 911 was called for a Ambulance. Took patients vitals before Ambulance arrive and it was still stable. Ambulance arrived and patient was taken to the hospital.

Administered Moderna vaccination at 1746 and patient stated that he has experienced vagal responses to injections in the past. Patient remained in the vaccination chair for 5 minutes after injection and he reported feeling well and moved to the observation chair without any problems [~10ft]. After being the observation chair patient stood up and took 4-5 steps toward the wall and sat down on the floor. The patient stated he felt dizzy and then became limp & slumped to the right side, eyes remained open with dilation of pupil fixed at 2mm with no blinking noted. Patient's breathing pattern became shallow & snoring sounds noted. Patient did not respond when spoken to nor did he respond to soft shaking of shoulders. Patient began to demonstrate large jerky body movements similar to seizure activity. The seizure like activity continued for 3-4 minutes before the patient was able to become aware of surroundings and answer orientation questions. BP 120/72, HR 64, O2 sats 99%, RR 20. Patient was diaphoretic, pale, shaking of hands and arms, restlessness of lower limbs with frequent repositioning/twitching of legs. EMS arrived to find the patient regaining stability. Patient reported to EMS that his is familiar with this type of response and declined to be taken to

Per Client received Moderna vaccine on 3/4/2021 at 2:15 pm in left arm, waited at clinic site for twenty minutes and no reaction to vaccine. At 4:00 pm on 3/4/2021, Client reported standing at kitchen sink and started having sudden onset of sharp, lower right sided back pain, which intensified with positional changes from standing to sitting. Client also reported that along with the back pain experiencing his breath being taking away at that times. Client did see a Chiropractor on 3/8/2021 for back pain, taking Tylenol, using warm packs and Icy Hot ointment. Per Client the pain level has been at 2-10/10 and no complete resolve at this time. Per Client will be following up with PCP on 3/10/2021.

Pt developed symptoms of anaphylaxis: nausea, anxiety, chest tightness, throat tightness about 13 minutes after injection. Was given 0.3 mg epinephrine and sent by ambulance to ER.

Tachycardia, Dyspnea, Dysarthria, wtihin seconds after receiving the vaccine injection. injection site showed no erythema, edema or tenderness. patient could not verbally describe what he was feeling. patient was given Epinephrine. After epinephrine patient stated improvement, but as patient was being moved the observation room symptoms returned mainly the dysarthria which was accompanied by cogwheel rigidity, petechias and global muscle contraction. EMS was called, benadryl injection was given as EMS arrived. Patient was then taken to ED.

Patient reports feeling pressure to chest, had difficulty breathing, sweating/clammy, and flushing. Patient reports feeling better after 20 minutes. Reported he only eats once a day for weight loss. Refused transport to ER

Severe shaking to the point I could barely walk, talk, or function in general. In fact, had to end work conference call due to effects. In desperation, I have my wife help me into a hot shower where I continued to shake violently for about 25 minutes. My wife continued to monitor me to make sure I didn't collapse or pass out and continually ask if we should go to the ER. However, after about 25 minutes the shaking subsided and I was left exhausted with some minor muscle pain due to shaking. It was very difficult to breath during the incident, noticed my hands turning blue so I focused on deep breaths and staying calm to eventually stop it.

Chills, body aches, joint pain, loss of energy, head aches, Kidney pain, shortness of breath and coughing. Teeth hurt, Point of injection sore ness

Shortness of breath, lips numb/tingling/swollen, redness around injection site spreading to right side of neck and across face with onset approximately 20-30 minutes after injection. Treatment: patient was taken to ED, given clonidine 0.1mg PO, Epi-pen 0.3mg, and solu-medrol 125mg IVP. Patient recovered and was discharged to home with Medrol dose pack and po Benadryl. Treating physician advised patient not to take second dose in series.

On Friday, 4/2/21, a client (49 yr old male) arrived to the 30 minute Vaccine Recovery lot after COVID 19 Moderna Lot# 020B21A administration at 11:40am. Patient had reported history of rash after taking both Cipro and Penicillin. At 11:55 am while pt was being assessed by vaccine recovery lot, pt reported sudden onset of involuntary movements and mild shortness of breath. The EMT called for the Vaccine Recovery Lot Medical Lead. Began assessing patient at 11:57 am, noting the pt was having involuntary movements of the upper and lower extremities every few seconds. 12:00 pm BP 152/98, pulse 65. Patient was alert and oriented with normal skin color. Pt reported feeling anxious and "maybe it is all in my head". Pt reported the blood pressure on scene was " higher than my normal at 120s/80s. Pt denied any history of recent illness or other vaccines. Pt stated, " I should have known something would happen, I had a premonition about this". Repeat vital signs at 12:32 pm BP 152/98 and pulse 65. Pt continued to have episodes of the involuntary upper and lower extremities lasting approx 3-5 minutes per episode. NP explained to pt that she could not allow him to drive with these movements and pt agreed to evaluation with EMS and transport to local ER for further evaluation. NP instructed to call for EMS. Call was made at 12:48pm and EMS/Fire arrived onsite shortly after. While awaiting Fire Department and EMS, pt reported to NP, "I have a history of Aspergers Syndrome". Also NP spoke with pt's spouse who also agreed pt should be evaluated at local ER. He was transported to the local hospital.

Flu like symptoms within 6 hours of being vaccinated, extreme fatigue lasting 4 days - 3 days bedridden, chest pain, cough, headache, neck ache, hard to breath, muscular aches, aches in armpits, sore back, stiff legs, face hurts, tingling in head, Still feeling sick on day 4 from vaccine. Would have not gotten the vaccine if I knew I would be this sick

no evaluation , treatment or outcome done by health Center. pt reported shortness of breath and asthma exacerbation 2 weeks post vaccine pt was evaluated by his own primary care provider office, please contact this provider for treatment and outcomes.

12-18 hours after vaccine had feeling of hot/cold/shivering/myalgia. Few days later started to have chest pain, shortness of breath that progressed and eventually was severe. seen at ER 2/22/21 and found to have large pericardial effusion on bedside u/s and acute ST changes on EKG. transferred to second hospital and admitted 2/22/21-2/25/21. He was treated with pericardial windows to remove fluid and discharged on ibuprofen and colchicine for presumed viral pericarditis.

Dizziness, blurred vision, fatigue, headaches, chills, low grade fever, muscle pain, joint pain, high blood pressure, and swelling of the throat.

Patient is a personal acquaintance of reporter. Patient contacted reporter on 4/15/21 at 10:18 pm complaining of onset of extreme dizziness, vomiting, "eyes not catching up with my head", extreme fatigue, and feeling like they are "about to pass out". Patient also noted onset of SOB and lower chest pain accompanied by "weird taste" but not metallic taste. Patient was unable to describe the unusual taste. Patient was encouraged to use OTC medications to treat headache and fever, encouraged to use OTC Benadryl/Dramamine. Monitor for worsening and report to ER if symptoms worsened, changed, or failed to improve. Per patient, symptoms lasted through the night and until approximately 3:00 AM on 4/16/21. Patient's wife reported blood sugar of 154 mg/dl, B/P 164/88, and Pulse 70 bpm using home monitors. On 4/16/21, the patient reported onset of fever greater than 101 at approximately 2:00-3:00 AM which lasted approximately 18 hours. Fever onset was accompanied by headache which has persisted from 4/16/21 through 4/22/21. Patient contacted writer on 4/21/21 to state that he still does not feel well, headaches continue and fatigue is persistent. Generally states that he does not feel well.

Friday PM 4/23 flu like all evening, Sat 4/24 woke up as if beaten up severely, weak, could not go down stairs. Then became to this day one week later at times stabbing pain in back, Confusion, Agitation, Eating Less, Choking, Higher Anxiety and Depression levels, metal fogginess and feeling out of it the entire time. I was out of work two days (Monday and Wednesday) this week sought Primary help on Wed video visit.

When I woke up this morning I could feel my throat was swollen and I had slight difficulty ingesting saliva. But I was able to drink water without too much problem. After a while when I was brushing my teeth I realized I could not gargle. I did not pay much attention. When I tried to eat breakfast I realized that I was not able to ingest any solid food at all. Then I realized my voice had become very hoarse. When I told my wife about it (she is a pediatrician) she looked into my mouth to check uvula but could not see it. She pointed out it could be an allergic reaction but was not sure of the reason. I took liquid Benadryl which we had at home and she also gave me a table of famotidine. I also had prednisone but did not take that as as I did not want anything to hurt vaccine's immunity effect. However, out of caution we drove to an ER and waited in its parking lot for an hour. Slowly I noticed that my swelling had reduced and I was able to see a little bit of uvula. So we decided to come back home. I am feeling much better now though not fully normal.

He was CONTAGIOUS, he had symptoms of" covid like "himself started friday, he was vaccinated thursday. Me & a child develop symptoms of covid , except it was about 30% lesser than the real virus we had in Feb 2020 & March 2020 , my symptoms begun Sat. pm , we rode on the same car went to the supermarket in am & the symptoms ended sunday am, weirdly the symptoms stopped for few days unlike the real one , the symptoms were continuous then gradually disappear, wednesday came symptoms started again ended friday, lingering symptoms of dyspnea due to congested nose for several weeks. On his 2nd shot, we wore masks & ate farther away from the vaccinated person, he had red face with bluish hue on day 2 of his 2nd shot. This time we did not get the synthetic virus infection, we were vigilant after what happened on his first dose..

Adverse Reaction Notes; 0920 Throat tightness. Hx of allergies. BP 151/87, HR 66, Resp 17 unlabored, Sats 98%. Refused epi injection reports he has epi pin at home. Stated "it's not that bad". 0930 left ambulating for home accompanied by his son. Stating "if it was going to be bad it would have gotten worse by now". Educated on S/S to seek immediate care for. He verbalized understanding.

Patient states he developed fatigue myalgias 8 hours after vaccine, then about two hours later, he became short of breath. He subsequently reported intermittent shortness of breath and leg swelling. May 5 noted to have atrial fibrillation/ flutter with rapid rate. Unclear if patient had atrial fibrillation at time of initial symptoms and unclear if related to the vaccine at all.

feel muscle aces all over body, bad headace,.wheezing ,trouble breathing. shortness of breath., feel like I have to throw -up, Flu like symtons, weakness, chills, but I do NOT have fever. was vaccinated May 6th 2021, seven days ago

Adverse Event : shaking and shivers with complaints of mild breathing problems. was cognizant and responsive to questions. 911 was called and the EMT arrived at 12:10 PM and took over treatment. Patients wife commented that these symptoms have happened in the past with Xanax and when I asked what the treatment was she replied, " they sat in the emergency room and they observed him for 2 or 3 hours and then the adverse event dissipated." Once the EMT arrived they took him to the hospital.

Red skin on the arm that took the vaccine. Feel Itchy on the same arm. My pollen alergy symptom gets worse - noses are completely blocked and hard to breathe.

Seizure like phenomena; Breath sounds abnormal; Dizziness; Dyskinesia; Eyelid function disorder; Fall; Hyperhidrosis; Hypopnoea; Hypotonia; Muscle twitching; Pallor; Presyncope; Restless legs syndrome; Tremor; This case was received via FDA VAERS on 18-May-2021 and was forwarded to Moderna on 18-May-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of SEIZURE LIKE PHENOMENA (Seizure like phenomena) in a 49-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. The patient's past medical history included Vagal reaction (patient stated he has experienced vagal responses to injections in the past). On 02-Mar-2021 at 5:46 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced SEIZURE LIKE PHENOMENA (Seizure like phenomena) (seriousness criterion medically significant). 02-Mar-2021, the patient experienced BREATH SOUNDS ABNORMAL (Breath sounds abnormal), DIZZINESS (Dizziness), DYSKINESIA (Dyskinesia), EYELID FUNCTION DISORDER (Eyelid function disorder), FALL (Fall), HYPERHIDROSIS (Hyperhidrosis), HYPOPNOEA (Hypopnoea), HYPOTONIA (Hypotonia), MUSCLE TWITCHING (Muscle twitching), PALLOR (Pallor), PRESYNCOPE (Presyncope), RESTLESS LEGS SYNDROME (Restless legs syndrome) and TREMOR (Tremor). At the time of the report, SEIZURE LIKE PHENOMENA (Seizure like phenomena), BREATH SOUNDS ABNORMAL (Breath sounds abnormal), DIZZINESS (Dizziness), DYSKINESIA (Dyskinesia), EYELID FUNCTION DISORDER (Eyelid function disorder), FALL (Fall), HYPERHIDROSIS (Hyperhidrosis), HYPOPNOEA (Hypopnoea), HYPOTONIA (Hypotonia), MUSCLE TWITCHING (Muscle twitching), PALLOR (Pallor), PRESYNCOPE (Presyncope), RESTLESS LEGS SYNDROME (Restless legs syndrome) and TREMOR (Tremor) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Blood pressure measurement: 120/72 (normal) 120/72 mmHg. On 02-Mar-2021, Heart rate: 64 (normal) 64 beats per minute. On 02-Mar-2021, Oxygen saturation: 99 (normal) 99%. On 02-Mar-2021, Respiratory rate: 20 (normal) 20 breaths per minute. 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 concomitant medications were provided. The patient remained in the vaccination chair for 5 minutes after injection and he reported feeling well and moved to the observation chair without any problems [~10ft]. After being in the observation chair the patient stood up and took 4-5 steps toward the wall and sat down on the floor. The patient stated he felt dizzy and then became limp and slumped to the right side, his eyes remained open with dilation of pupil fixed at 2mm with no blinking noted. The patient's breathing pattern became shallow and snoring sounds were noted. The patient did not respond when spoken to nor did he respond to soft shaking of the shoulders. The patient began to demonstrate large jerky body movements similar to seizure activity. The seizure like activity continued for 3-4 minutes before the patient was able to become aware of surroundings and answer orientation questions. The patient was diaphoretic, pale, shaking of hands and arms, restlessness of lower limbs with frequent repositioning/twitching of legs. EMS (emergency medical services) arrived to find the patient regaining stability. The patient reported to EMS that he is familiar with this type of response and declined to be taken anywhere. Treatment medications were not reported. Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded. The Company believes the event of Restless leg syndrome is not supported in the source documents and should be delete.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded. The Company believes the event of Restless leg syndrome is not supported in the source documents and should be delete.

heart disorder; Inappropriate schedule of vaccine administered; started feeling short of breath; pain in the back and chest; pain in the back and chest; pain bone; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CARDIAC DISORDER (heart disorder) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007S21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes and Blood pressure high (Patient was diagnosed at the hospital) on 19-Mar-2021. On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced BONE PAIN (pain bone) and CHILLS (chills). On 16-May-2021, the patient experienced DYSPNOEA (started feeling short of breath), CHEST PAIN (pain in the back and chest) and BACK PAIN (pain in the back and chest). On 19-May-2021, the patient experienced CARDIAC DISORDER (heart disorder) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Inappropriate schedule of vaccine administered). The patient was hospitalized on 19-Mar-2021 due to CARDIAC DISORDER. The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 06-Apr-2021, BONE PAIN (pain bone) and CHILLS (chills) had resolved. At the time of the report, CARDIAC DISORDER (heart disorder), DYSPNOEA (started feeling short of breath), CHEST PAIN (pain in the back and chest), BACK PAIN (pain in the back and chest) and PRODUCT DOSE OMISSION ISSUE (Inappropriate schedule of vaccine administered) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient received medications for diabetes and high blood pressure however, drug names were not provided. Company comment: This case concerns a 49-year-old male patient who missed the appointment to be given the second dose of the vaccine because of symptoms (Product dose omission). The other events show temporal association with the use of mRNA-1273 and, a causal relationship cannot be excluded. Nausea is consistent with the product known safety profile of the product. The event of product dose omission is not applicable. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No new information was received.; Sender's Comments: This case concerns a 49-year-old male patient who missed the appointment to be given the second dose of the vaccine because of symptoms (Product dose omission). The other events show temporal association with the use of mRNA-1273 and, a causal relationship cannot be excluded. Nausea is consistent with the product known safety profile of the product. The event of product dose omission is not applicable.

Experienced difficulty breathing after playing basketball with my son. Went to Hospital and initially was told that I may have Pneumonia. Then an EKG revealed that I had an issue with my heart. An Ultrasound revealed that mu heart was operating at 30%. Catheterization did not reveal any blockage.

15 minutes post injection pt complained of chest pain and tightness radiating to left arm and back. Pt rated pain 8/10. Pt also complained of shortness of breath making it difficult to catch breath. Vital signs checked, PCP notified. Per pcp orders; ASA 81mg administered, O2 administered via nasal cannula, and EKG performed. PCP met with pt. Per PCP orders, pt to be transported to hospital via ambulance. 911 contacted, pt transferred to nearby hospital.

So on May 1st I woke up, I had a sore throat on just one side of my throat. I was on a flight and I got fever and chills. I was having a really hard time breathing so I went to the ER, they checked me for strep and they sent me home with Prednisone and sent me home even though the strep test was negative. I got home and had a fever at 105. I called the ER DR and the DR was gone so I stayed home. I called my PCD the next day and he contacted the specialist and the specialist said I was in imminent danger. I took two nipagin injections, my white blood cell counts were extremely low. This was middle of May maybe, I lost 20 pounds in six days in the hospital. I have been out of work since then. I have seen hematologists, ENT specialist, and several others ands all of them are puzzled.

Severe swollwn face and lips, slurred speech and red hives all across the body. Mild breathing difficulty. Had to call 911 and was taken to the hospital

Chief Complaint Patient presents with ? Generalized Body Aches     Pt presents via EMS c/o DOE, dry non-productive cough, subjective fevers Tmax 101.9, decreased appetite, aches since testing + for COVID on 1/5.   Patient is a 50 year old male with PMH of Crohns/MS on fingolimod presenting to the Hospital for fevers, shortness of breath and weakness. Patient received COVID vaccine on 12/29. Patient had initial left arm discomfort though has had worsening weakness, cough, shortness of breath and fevers since that time. Patient tested positive for COVID19 on Patient has shortness of breath with exertion that is relieved by rest. Patient denies N/V/D. Patient has taken tylenol at home to attempt to alleviate symptoms.

5 hours after receiving vaccine, patient developed throat swelling. Treated with PO Tylenol and Benadryl. Swelling resolved by 1/11/2021.

The patient became short of breath and decreased oxygen saturation at home around 2000 on 01/18/2021. He reported to the ED on 01/19/2021 at approximately 0500. The patient was found to have bilateral pulmonary emboli.

pt stated that on 2/2/2021 he developed and SOB, choking sensation and fatigue. On 2/3/2021 he went to the ER for these symptoms. His O2 level was 98. He as given EKG, XRAY, tested for pneumonia, heart condition and Covid. All test came back negative. He was diagnosed w/ Acute Bronchitis and prescribed an Inhaler and Mucinex. . On 2/4/2021 pt went to his ENT Dr. where he was scoped for possible cancer reoccurrence. The triage of head and neck was negative for any illness. He was told to continue the Inhaler and Mucinex. On 2/5/2021 he went to his PCP and was told there was nothing they could do for him. Told him to wait about 10 days to see if his symptoms subsided, if not he was going to refer him to a Pulmonologist. From 2/5 to 2/19 the shortness of breath and choking sensation continued but the fatigue had subsided. On 2/19 pt woke up w/ severe SOB and choking sensation so pt went back to the ER. They performed another EKG, CT of neck and lungs, Covid Test, blood work, O2 level was 99 with wheezing symptoms. All test were negative but pt still had SOB. Pt was released and referred to ENT Doctor once again on 2/25 w/ Dr. which they will do another scope where they will go further down. Pt thinks his next option maybe a referral to a Pulmonologist.

7pm on date of injection I got very sleepy and fell asleep. I woke up at 12:45am sweating but chilled to the bone. I felt feverish but was too cold to get out of bed. When I actually got out of bed I had a very intense headache, and body aches. I took my temp and it registered 104. at 8am I took my dogs out but felt very old, chilled to the bone & lightheaded. It was chilly outside. I got back inside and got back into bed as fast as I could. The second I laid down, the sweat just poured out of my body, drenching my shirt, sheets, and blanket. The fever lasted all day but was slowly improving throughout the day. My arm was also incredibly sore at the injection site. It was very sore for shot one too but the pain lasted nearly 2 weeks the first time and is already just about gone now. Yesterday, or 2 days after dose 2 injection, the fever was gone. I still had a headache, and body aches but also developed nausea. I did not vomit but I did have diarrhea. I also noticed extreme shortness of breath over very minor exertion. I?m not sure if this was due to extreme dehydration , due to loss of fluids or if it?s associated with the vaccine. My lungs feel clear and I deny ever suffering from a bronchial spasms.. Day 3 I?m feeling more myself but am still suffering from gastric upset. Nausea has dissipated.

Same day March 17th, by 2230 or 1030pm slight injection sight pain and minor head ache in temple area mostly. Today the 18th Awoke with much greater injection site pain in the arm in delt area but no swelling or rash. Still minor headache but around the whole head. Approximately 1000-1030-AM and through 1300 hours (pm), extreme headache but tolerable, EXTREME FATIGUE and SHORTNESS OF BREATH and DIZZINESS (ALL CONTINUING) post physical activity.....ie: bending, lifting, moving etc etc.....Sitting now for 30 minutes still have the above listed items in CAPS ongoing. Temp is good and pulse is good. Aside from increased arm pain I have been feeling incredible burning sensation going from injection site left arm across upper back to right side .....thats it so far

After I got the shot, on the way home, I started feeling tingling on tongue and lips; had a metallic taste. I felt like I had allergies - I was a little congested - but the next morning, 04:00 am - I was still congested - and was still breathing short and shallow. I get to work and I'm open mouth breathing - not breathing correctly. It felt like my lungs were swollen on the inside and throat was swollen on inside. Couldn't palpate and feel it but just couldn't access the lower lungs breathing-wise. Started getting dizzy and couldn't think - from 05:00 am to 09:00 am - and I decided I couldn't work anymore. I went to headquarters and I couldn't talk from lack of breathing - would have to stop just to think or just to breathe. I drove by the clinic where I was got my vaccine and decided to go in - I was so dizzy and I realized I shouldn't be driving. They told me to get up and move and I told them I couldn't breathe and I'm not one to say that but they called an ambulance that took me ER. (I was a LPN at one time so I wasn't anxious.) And they told me it was anxiety - and they kept telling me to breathe. But it wasn't an anxiety attack at all. My heartrate was normal. I was shallow breathing. They gave me a paper bag to breathe into. That's it .I was there for a couple of hours. They had told me to rest. I shouldn't have gotten out of bed that morning - my body just didn't want to move. I felt a little better after a couple of hours and people helped me from there to get home. After that, I felt better - about 4 pm or 5 pm. Second vaccine - felt flu like symptoms for three days after. I still feel a little weird - my bones hurt and I'm achy. Just not feeling right. Note: When I was in the emergency room - my hands were purple. Circulation was weird.They told me my oxygen levels were fine and that I just needed to breathe. It caused carpal tunnel in my wrist - I had nerve damage on that about three weeks - I have about 80 percent nerve damage from previous and so when something irritates it - it takes a while to recover from it but I have. I consulted with a doctor about the reaction to first vaccine before getting the second vaccine.

Described throat tightness, itching of face/skin. BP 160/110 with medium BP cuff. HR 85 SPO2 97%. Describes feeling shaky. Reports history of anaphylactic reaction to allergy shot for bee stings. Reports history of feeling "panicky". After 30 minutes at rest, reports throat tightness improved. Reports never had difficulty breathing, just a tightness in the throat. Reports increase in skin itching, but has a history of similar reaction when exposed to mold in buildings.

50 year old male with history of allergic rhinitis, currently on AIT, presents for follow up. Since last seen he initiated AIT in December 2020 and reports he had tolerated his AIT injections without large local or systemic reactions until yesterday, 16 Mar, when he received his first maintenance dose. Within minutes of receiving his dose he developed shortness of breath, dizziness/altered level of consciousness resulting in collapse, and was noted to be hypoxic. He was treated with IM epinephrine with initial improvement but subsequently again developed shortness of breath, cough and altered level of consciousness. He received his second dose of IM epinephrine and a dose of IM Benadryl with transient improvement, but again developed shortness of breath, cough and altered level of consciousness followed by nausea and vomiting. He was noted to be hypotensive and hypoxic despite these interventions so a third dose of IM epinephrine and IV fluids were administered. He was transferred by ambulance to ER where he was given IV solumedrol, monitored, and admitted to the ICU overnight for observation. He reports fever (Tmax 101 F) last night in the ICU. He endorses he took his Allegra prior to his AIT dose and did not exercise. Of note, on 15 Mar he received his second mRNA COVID19 vaccine.

Severe abdominal pain began 4 days after receiving the vaccine. The upper stomach pain lasted 6 days and it caused difficulty breathing when lying down in certain positions.

11pm same day as shot. Started having chills, fever (101.6). Tired. Slightly winded. Symptoms lasted until 6PM the next day. fever went back to normal around 4pm next day after shot. * I NEVER had a fever when I had covid. I had an Antibody test completed back in January. It was positive for Antibodies. I had an antibody test back in 2020 BEFORE I had covid. It was negative. A week late after 1st does of vaccine. My heartrate started to increase and had symptoms of Afib again. same symptoms of the Afib and heartrate and breathing, back after I had covid. Exact same feelings and symptoms. The Afib/heart symptoms, stopped last week. I am supposed to get 2nd dose this Thursday, and I am most likely not going to. I don't want the heart rate to increase again. I am having problems making an appointment to ask my doctor. My PCM changed, so it is all confusing and a pain. Its best I just don't it. I had antibodies as of january. I just had the 1st dose last month. I think I am god to go. Not worth the risk for me. I am sick of having covid symptoms, so why force it upon myself again....

Pt was observed post Covid-19 immunization for 15 minutes . During the observation period, he experienced an adverse reaction with the following symptoms: difficulty breathing and rapid heart rate. Assessment : Time of assessment 1127. Alert and oriented, Anxious and Unlabored breathing. Patient reported 5-10 minutes after sitting for 15 minute observation, the feeling of his heart beating fast and hard, having SOB. He says he also has a feeling over his legs and arms of feeling "washed out." 1127: BP 139/82, P 77, Sat 100% RA (nurse felt pulse to wrist and it wasn't racing, just beating hard). Patient says his BP is usually not that high. 1129: BP 131/85, P 73 (reports feeling better) 1137: BP 120/85 P 75 (reports this is what his BP is usually running, reports feeling less better, says it's his anxiety kicking in) 1142: BP 121/78 P 72 Actions taken: Vitals sign taken VAERS form obtained and completed by RN. Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for additional 15 minutes minutes. Discharged home. 1145 ambulatory out.

Fever (100-102), chills, pain and stiffness in shoulder, elevated pulse (100-110), arrhythmia, weakness, shortness of breath Treated with ibuprofen, acetaminophen, aspirin, electrolytes, multivitamin supplement

10 days after 1st shot. Blood clot traveled to right lung. Placed on blood thinners, and pain meds, follow up treatment scheduled for mid May. Unknown reason for blood clot. No prior injuries or surgery.

He became dizzy and diaphoretic and appeared to be gasping for air. O2 sat was 98% with room air, B/P 153/83. Treated with ammonia whiffs, ice pack and taken to a treatment clinic for further evaluation.

Fever, chills, aches, difficulty breathing, confusion, shaking, Swollen joints hands, neck, throat, and tongue lasting from 4/15-4/18. Convulsions began 4/16-4/17. Treated with benadryl and ibuprofen and Tylenol and albuteral inhaler.

CC: patient was watching TV as reported by his mother. started seizing and having difficulty breathing. EMS was called for transport. On arrival to ED, patient was breathing 60-70 BPM, tachy at 135-140 sinus rythym. B/P stable at 140's/90's. his pupils were equal and reactive to light. no response to aggressive sternal rub. slight seizure like activity with arm and leg jerking. Ativan IVP given Patient is on non-rebreather sao2 at 90-100 fluctuating. IV established. he desats to 80-85 on room air. Has frothy sputum from mouth. RSI performed with succs and versed to secure airway and ventilate patient. 7.5 tube placed with one attempt at 27/teeth. verified via direct auscultation and capnography. Tube secured. maintanence medications given to ensure sedation. transfer initiated and airmed launched. Dr. accepted. patient left building at 1940 via airmed. Patients labs (electrolytes WNL) normal wbc. D-dimer at 1500. suspect for PE or flash pulmonary edema although his breathsound are clear bilateral. 18:10 03/27/21. BP: 124/89. MAP: 100. HR: 135. RR: 54. O2 saturation: 94%. Temp: 99.2 F. Pain level now unable to obtain due to patient condition. --20:05 3/27/21 Weight: 81.6 kg estimated

After both the first and second vaccine shots, I had the same reaction. 15 to 20 minutes after the shot, I felt a numbness in my mouth. I also had a slight throat constriction sensation that I know well given my history with severe allergic reactions to tree nuts. However, to be clear, the reaction to the vaccine shots was far more mild than my reaction to tree nuts. If I eat any tree nuts, I have a severe reaction that involves throat closure, hives, vomiting and related symptoms for 6-8 hours. While the Epipen shot helps with keeping my throat open, it does not reduce all of the other symptoms. Here, the throat constriction was only approx. 1/100th of the reaction I have when I eat tree nuts. Further, the slight throat constriction and mouth numbness only lasted 10-15 minutes, as compared to 6-8 hours if I eat tree nuts. I did not need to use an Epipen.

We have information concerning a member that received the Moderna Vaccine (first dose) on Sunday April 11, 2021; Patient denied any side effect immediately following vaccination. However on Sunday April 18, 2021 , patient had complains of shortness of breath, chest pain. At which time presented to the Hospital and was admitted on Sunday April 18, 2021 with a diagnosis of Pulmonary Embolism. Patient remains hospitalized as receiving treatment of blood thinner, and embolectomy procedure.

Was sweaty, unresponsive, and breathing shallow a few mins after administration. BP 97/68. Within a few mins, patient became responsive and BP 146/81. Patient chose not to go with EMS and walked out of store after they were feeling better. Today (3 days later) received report from medical examiner that patient passed away.

Swollen tongue and throat. Diagnosed as angioedema. Treated with epinephrine, benadryl, oxygen, and IV lines. Took a few days to recover.

HYPOTENSION (SARASOTA EMS RESPONDED TO PHARMACY); CLAMMY/SOB, EXTREMITY TINGLES; DEATH WITHIN 6-7 HRS

Significant chest pain. Much difficulty breathing. Most intense for about 4 hours. Soreness when breathing is still persisting, but not as intensely.

Visited ER on 5/3/21 with symptoms of shortness of breath, cough, fatigue, oxygen sats 90-91% on room air, tachycardia (HR 114), BP 182/127

All of the same covid symptoms from when I had the Covid virus in June 2020. I was in the hospital for a bit then. Cold child, all joints ache, headache, can?t breathe, tightness in chest.

Patient complained of tingling to his hands 15 minutes post-vaccination. Patient had no other s/sx of reaction. Patient observed for another 15 minutes and tingling did not worsen. Patient left observation area and returned to work. Patient returned to observation area around 4:40 p.m. and complained that tingling to hands was still present and he felt tightness in his forearms. Patient is a coach for the children and was outside in the 90+ degree heat during the afternoon. Patient came into observation area to cool down. Patient's blood pressure taken and was elevated, although patient stated that he had HTN. Paramedics called on site to evaluate patient. Patient began to complain of dizziness and was transported to local hospital. On the way to the hospital, the patient developed chest pain and shortness of breath. Patient was diagnosed with a non-STEMI at the hospital and transferred to higher level of care. The patient is currently undergoing observation and tests to determine the cause of the MI. The patient received epinephrine 0.5 ml at the hospital to cover any underlying vaccine reaction.

Reports that it has been 11 days since he received his 2nd COVID-19 vaccine and he is running a temp of 102. He has a continuous cough, headache, chills, diarrhea, fatigue and sore throat. There is SOB at times when he coughs. So much, he can't catch his breath. Patient said Tylenol will bring down the temp for about an hour then it shoots right back up.

Patient presented for second dose of Moderna Vaccination. At 1300pm, patient stated he started to feel sweaty and weak. Vitals were taken, BP 134/82 P 74 R 18 O2 98%. Lungs clear on auscultation. Patient verbalized that he has a history of anxiety and only drank one cup of coffee today with no other fluid intake. Patient denied H/A, C/P, SOB and nausea at this time. Patient verbalized that he was starting to feel better. Patient was monitored by nurse during this time. Within a few minutes the patient started to get upset and stated that he felt like he was going to pass out and that his left leg felt weak. Patient was red, flushed, diaphoretic, and appeared anxious with increased respiratory effort. Cardiac monitor in use, normal sinus rhythm analyzed. O2 applied at 2LNC. Patient stated that he wanted to lay on the floor. Patient transferred to stretcher by EMS. BP 146/76 P 76 R 20 O2 99% 2L NC Patient verbalized that he wanted to be transported to the hospital.

Fever, Chills, Diarrhea, mild sore throat, mild breathing impairment, severe fatigue and lack of appetite. All these side effects started 2 days after vaccination 5/13/2021 and have kept me soaking wet, cold, and in bed through right now 5/15/2021 at 10:25pm

Information below was sourced from the patient record in the hospital EHR system: Patient presented to ED with PMH of HTN and family history of premature CAD who presented with 2 hours duration of substernal chest discomfort. He had been in his usual state of health prior to this evening. He received the COVID Vaccine on 5/12/21. He went out with his wife for dinner and then upon return, started to have some substernal chest discomfort radiating down his arm. This is associated with some SOB and nausea. No vomiting, no diaphoresis. The pain continued for about 2 hours and then he decided to come to the ED. The EKG was consistent with inferolateral wall MI. States that he has been very active without exertional chest pain or dyspnea. He does have a history of HTN and is currently on lisinopril for this. No known history of hypercholesterolemia. Denies any diabetes. No smoking history. No history of PVD. His mother did have a bypass in her early 60s. At age 37, he did have a catherization following an episode of substernal chest discomfort. The patient states this catherization did not show any abnormalities. Following this, the patient proceeded for PCI stenting with a DES for an occluded OM2 . Patient received Aspirin, Brilinta, Atorvastatin, Metoprolol, and Heparin prior to PCI stenting. Cardiology note confirms acute inferolateral STEMI due to occluded OM@, successfully opened and stented acutely.

Shot area was swollen, pain in right arm- Burning sensation in wrist and up arm. tingling in hands and feet. Wasn't able to sleep that following night (Wed -Thur). Chest tightness- Slight shortness of breath but not enough to cause me to go to emergency room 5/19 -ongoing . Shot area swelling, burning sensation and tingling stopped the following day (Thurs). Chest tightness, slight shortness of breath is ongoing still today Sat 5/22. I had Chest tightness from first shot that went away after about a week. I just rested 5/19-5/21. somewhat active today 5/22

Patient said after first dose that his Right Arm became painful and was short of breath - not the typical muscle soreness but it was a noticeable pain that lingered. Lasted about a day in a half and it went away. patient checked with cardiologist and was cleared.

I had no noticeable issues with my first dose of the Moderna Covid-19 vaccine. I had the following issues after my second dose (April 29, 2021): Day 2 (April 30), 28 hours following injection, I experienced an internal feeling of ?jitteriness?, shortness of breath, and accelerated pulse. Pulse oximeter showed my oxygen saturation dropped to 92 percent (my normal is 98-99) and my resting pulse rate increased to 120 bpm (my normal varies from 66 to 75). Aforementioned symptoms subsided after 6 hours. Day 3 (May 1) following injection, local swelling and pain in muscle at site of injection (upper left arm). Arm swelling and pain subsided by Day 7.) Day 4 (May 4), noticed two swollen lymph nodes (size of pea and small marble) near collar bone area of neck (same side as injection). Day 31 (May 29), both lymph node swellings still exists (as of this reporting) though not as prominent.

4/8/2021 - felt very winded, dizzy and out of breath during physical exertion. Temporary chill developed. Went away over night. 4/12/2021 - same symptoms during physical exertion. Chills and fever developed shortly after and stayed for 2 weeks ranging from 99.5 to 102. Fever, fatigue, dizziness, headache, sore muscles and joints, rapid heart beat, tingling and burning sensation in hands and feet and increased tinnitus lasted for 3 weeks. Ongoing - sore muscles, joints and tendons, tingling/burning sensation in hands and feet, cold hands and feet, muscle fatigue and tiredness since 4/12/2021 and ongoing today.

Tightness in chest. Shortness of breath. Sore jaw. Pain in left arm. Called 911 and paramedic took EKG and informed me I was having a heart attack on the way to the hospital. Once at the hospital they measured my TnT-Gen5 and the baseline was 2658 ng/L with another test taken an hour later showing 2873 ng/L which led to additional tests listed in box 19. Final diagnosis was perimyocarditis and I received a prescription of Colchicine 0.6 MG to be taken twice a day for 6 weeks and then follow up with a cardiologist.

Beginning on the 4th day after my second vaccination I had shortness of breath, palpatations, irregular heart beat, hard time walking from chest pain

Around 6:30 p.m. my skin started to burn all over my face begin to swell shortly after that my tongue and throat begin to swell I feel pressure on my chest I can barely breathe when I was put into the ambulance I passed out when I woke back up the symptoms seems to have gotten worse the EMT called in a head to the hospital and ask what to do she was told to give me an EpiPen as we got closer to the hospital I begin to shake and tremble uncontrollably that lasted for at least another 30 40 minutes after being admitted to the emergency room my diagnosis was anaphylaxis.

0920 Throat tightness. Hx of allergies. BP 151/87, HR 66, Resp 17 unlabored, Sats 98%. Refused epi injection reports he has epi pin at home. Stated "it's not that bad". 0930 left ambulating for home accompanied by his son. Stating "if it was going to be bad it would have gotten worse by now". Educated on S/S to seek immediate care for. He verbalized understanding

05:02 through 06.30: ? Shortness of breath ? Fluctuating blood pressure. ? Severe chest pain. ? Pain in joints. ? Muscle pain. ? Petechiae ? Purpura ? Diziness ? Headaches ? Asthamtic-like phlegm ? Nerve pain in hands ? Numbness in hands

Within an hour of the test, I became extremely ill - chills, 102+ fever, headache, cough, asthma problems, and loss of appetite/stomach problems. This lasted 5 days and on the 4th, i was hospitalized with myocarditis.

March 18th 2021 he noticed that when he was sitting his lower left leg felt like it was falling asleep; kept happening over a couple of days. On March 24th, 2021 he reports a throbbing in his left thumb that came and went on throughout the day. On March 26th, 2021 he reports having chest pain. He states that when he laid down the chest pain would go away; did not go seek treatment that day. On March 27th 2021 he got his blood drawn and urine sample at the Hospital; results were normal. On March 30th he saw PCP and had EKG; results were normal. April 1st, 2021 had a stress test with normal results. On April 5th, 2021 he went and had ultrasound on left leg and chest x-ray; leg ultrasound showed complex cyst behind left knee and chest x-ray showed heart as normal size with no fluid around heart. Chest pain still continued. On April 21st, 2021 had "heart hiccup" he was working on the computer and felt like his heart stopped and started beating again and then had a headache for a few seconds. On April 22, 2021 reports that he was feeling "mostly better." He reports feeling "gassy" when he has the heart pain/pressure. Reports that when he is moving he feels better. On April 23, 2021 he is walking around Meijer and felt lightheaded and like he could throw up; went home and BP was 155/100 with chest pain and difficulty breathing. He then went to the ER; ran blood tests (normal), leg ultrasound repeat (complex cyst) , chest CT (normal). ER doctor recommended that he see a gastro dr. April 26, 2021 had virtual visit with PCP and he suggested that he take Motrin for the chest pain. Reports that he felt like he was having a "charley horse" in his neck. Leg sleepiness lasted a month and went away. Thumb throbbing lasted a couple weeks and went away. On April 30, 2021 reports bad chest pressure. Chest pain was not consistent, "the pain changes." Would hurt in different locations over his heart and collar bone. May 10, 2021 reports "strange breathing." States that the chest pain and gassy feeling is constant. June 8, 2021 saw gastroenterologist. and was scheduled for an endoscopy. Endoscopy was completed on July 1, 2021; results were normal.

Light headed, dizziness. Pain in back of head. Sore throat & difficulty swallowing Numbness in elbow and wrist. Severe pain in neck, back the upper arm or shoulder Prickling, pins and needles sensations in fingers, toes, ankles, wrists, knees, elbows , joints. Weakness in legs, arms Unsteady walking or standing, balance issues. Double vision, difficulty focusing, heavy eyelids closing randomly Severe pain, achy, shooting or cramps , spasms Difficulty with bladder control Rapid heart rate Difficulty breathing ,weakness, limpness in the muscles of the arm and shoulder Lack of muscle control in the hands, arms Lack of sensation or feeling in hands, feet, legs

Pt reports several hours after the vaccine he developed fever, chills, right arm pain then severe shortness of breath. It resolved within 24 hours. He did not seek care during this event. Reported event 4 days later with a routine follow up

headache, body aches, cough, chest pain when deep breathing, was tested for COVID-19 on 1/04/2021 and it was Positive

I experienced insidous onset of rapid heart rate with palpitations after approximately 2-3 minutes of inoculation. This episode lasted about 1-2 minutes. I was not expecting this having no prior history of adverse response to vaccines. I also felt a flushing sensation in my head. My breathing felt slightly more difficult. No sweating, throat closure or itching. I did not measure pulse and instead tried to breathe/meditate to bring it down. I estimate it was about 140 bpm . Breathing/meditation brought it down but it was still elevated when the nurse checked me after 20 minutes. I remained onsite an additional 15 minutes until I felt well enough to leave but my heart rate was still somewhat elevated, about 20 bpm higher than my usual. My heart rate seemed to fluctuate throughout the evening and my sleep was subsequently very poor. I feel much better this morning, just the usual arm soreness after a vaccination. I have reached out to my primary doctor concerning whether she feels this event would warrant my not getting the second dose or perhaps having a prescribed epipen on my person. Having no personal history but a family history of severe heart disease (father had first MI at age 42, second at 44 followed by triple bypass and CHF) this incident with my heart rate certainly raised some anxiety. I had a routine EKG done in June which was normal, I am a physical therapist and in good health. I am hoping to have the next vaccine in a proper medical facility. I have read CDC recommendations to not have the second shot if certain adverse responses are experienced and I am not certain whether this would qualify. I have no history of adverse reactions to vaccines. Considering the role of anxiety versus the insidious and nearly immediate onset of rapid heart rate with palpitations and persistent elevated heart rate for more than 12 hours, I feel this event was primarily driven by the vaccine.

Dizziness, Headache, Myalgia, CoughWheeze, self report temp: 100.9 on 12/29; ~99.0 on 12/30 Narrative:

Numbness in right side of head and right arm (where he received injection). Starting getting confused. Legs started to give out. Continued working. Symptoms got worse. On and off paralysis of legs. Eyes flickered and darted. When he sat down at 1am, he took two nitroglycerin for chest pain. He asked a nurse to take his blood pressure. It was low. He felt he was losing control. He was struggling for breath. Eyes were tearing up real bad and tremors started. He stated he fought to stay conscious. Was started on oxygen. Was assisted in a wheelchair and taken to ER. Waited there for 4 hours. Was delusional. I left without being seen by a doctor after blood work and EKG. Went to sleep and woke up in river of sweat. Went to urgent care at that time. Was given a COVID test and it was negative. Was prescribed zinc and vitamins. He had the same symptoms like he did when he originally got COVID. Today at 9:36am, have fever off and on. Continues to feel pretty bad. Still dizzy.

51 year old M with h/o O2 dependent COPD, Severe pulmonary fibrosis became increasingly hypoxic around 1800hours 1/7/2021. He was transported to hospital for acute on chronic hypoxia respiratory failure. On 1/12/2021 he decompensated further, and after discussing with family and palliative care, He was changed to comfort care. He expired on 1/12/2021@2325 at medical center.

Redness and pruritus of bilat upper extremities, followed by throat tightness with mildly enlarged tonsils Approximately 10 minutes after vax administration. . Benadryl 50mg IM administered . S/S resolved 30minutes post benadryl. Monitored for additional 30 minutes post benadryl administration. Monitored for 1 hour total.

On Friday, I had the second vaccine covid 19, at 9;00 am at the left shoulder and after 12hours at 10:00 I started to feel the symptoms was light fever ,chills, headaches, body aches. Symptoms that was high concern: shortness of breath, vision discomfort due to the light, high blood pressure, extremities(hand and feet) swelling accelerated pulse ,chest pressure. This lasted on an off proximally 3 to 4 hours. Saturday afternoon at 3pm once again heart rate went up and pulse lasted 1 hour .The entire Saturday was feel the primary symptoms with chest pain . Today Monday I woke up with pain at the left clavicle bone and found a lump that hurts and radiates to the chest and increasing in size .

Nausea, fever, weakness, body aches, headache, shortness of breath, upper abdominal pain, calf muscle pain, brain fog, joint pain, cough.

Became immediately hot, within 2 hours I was having issues breathing, blood pressure of 202/170. Put on oxygen as my O2 dropped to 90%, Irregular EKG, blood work taken.

chest tightness, shortness of breath and chest pain.All this symptoms occur during physical activity.

Lethargy/altered level of consciousness lead to hospital admission. Multiple interventions during hospitalization. Final hospital diagnoses: Acute respiratory failure with hypercapnia, acute pansinusitis.

Fever. Hypoxia. SOB. Hospital admission diagnoses: Aspiration, right lower lobe pneumonia, hyponatremia.

Shortness of breath: First noted about 18 hours after the dose, along with body aches, headaches and fatigue. The latter symptoms resolved after 48 hours, however, the shortness of breath has not resolved as of today (77 hours after the dose). No crackles or wheezes but inhalation and exhalation feels restricted. I had Covid-19 with symptoms beginning on 11/16/2020 and had shortness of breath along with crackles and chest tightness during the second week of illness. The oxygen level declined to 92-93%. I was treated with steroids and azithromycin at that time and the tightness of the chest resolved by about day 17 of illness. I am reporting this adverse effect (chest tightness and shortness of breath) because it may be an autoimmune reaction triggered by the response to the vaccine.

Drank fluids around 8pm followed by unusually early fatigue and somnolence 2 hours early, awoke before midnight cold, shivering, aching in larger muscles and joints from neck to ankle including shoulders, back, hips, and thighs, could not get warm wearing many layers and blankets, then headache after 3am with hot dry sore throat and awoke more short of breath than usual, eyes crusted, slightly dizzy on rising, am finding myself with poor attention this morning filling out this form incorrectly needing more corrections than usual. The first dose was much milder but lasted 6 days. This second dose seems much worse and am expecting it to last several days more.

1650 patient reports symptoms: lightheadedness, blurry vision, dry and thick throat, thickened tongue, left arm weakness and numbness in left hand. 1705 Center chest pain, chin and throat numbness. Twitching in corner of right mouth. Unable to puff out right cheek

Pneumonia, hypoxemia, Dyspnea, Tachycardia,SIRS, increased lactic acid level, dehydration,fever, HTN, hypomagnesemia

Nightime heart palpitations, Hollow feeling in the diaphragm(difficulty to get deep breaths), blood pressure spike. Effects lasted about 2 weeks.

Fever of 102.4, treated with ibuprofen and acetaminophen since vaccination. Started on 3/6 Bone, joint, and muscle pain. Started on 3/6 Sore throat, swollen lymph nodes in neck, ear ache (left). Started on 3/7 Cough and chest pressure, breathing difficulty. Started on 3/7

51 y.o. male from Facility. The patient was seen at his primary care physician's office for some left facial swelling. Apparently, he started getting more short of breath while he was there. He was sent in by EMS. His sats were initially in the upper 80s at his primary care physician's office. He denies any symptoms of URI, but does state he has a long history of COPD. The patient was given some DuoNebs and supplemental oxygen in the emergency room and shortness of breath basically resolved. However, he did have very significant left facial swelling. His CT did show facial cellulitis with possible abscess, but no fluid collection. His white blood cell count was almost 25. He had been having fevers at home. Because of all this the decision was made to admit for IV antibiotics. When I saw the patient, he was willing to stay for IV antibiotics for a few days. 3/11/21 remains hospitalized

Got the first Moderna dose, 5 minutes later, my heart started raising, I got lightheaded, my hands cold, my throat narrow. Personnel took me to observation, my blood pressure jumped up to 204, my heart bit to 190, felt like that for 15 minutes, then my BP started to come down. They called an ambulance took me to the hospital, in the ambulance my BP came down to 170. Go to the ER, blood test ok, after two hours there BP came down to 130 they released me. FYI, 51 year old man, very active, I can run a marathon (26.1 miles) in 3:45, Im not diabetic, I dont take any medication, I dont have high blood pressure. Dont know what that happened, no insurance, now waiting for a bill from the hospital, not to mention Im scared to death now taking the second dose.

First Covid Shot. Friday. Muscular ache by end of day. Went to bed early. Woke up with pain across shoulders and down left side stayed in bed. Six spasm in left side back began to spasm. 9 went to hospital as breathing became labored and spasm become intense

shortness of breath; weakness; diffuse chest tightness; confusion; dizziness; cardiac failure; pulmonary failure; A spontaneous report was received from a consumer concerning a 51-year-old, male patient who developed cardiac failure, pulmonary failure/respiratory failure and died. The patient's medical history included hypertension, obesity, bee allergy and bipolar disorder. Concomitant product use was not provided by the reporter. Patient received first dose of vaccine prior to two weeks to his death (died on 09 Mar 2021). A week prior to his vaccination as shortness of breath, weakness, diffuse chest tightness, confusion, and dizziness. These symptoms progressed following his vaccination and he was hospitalzed for two days prior to his death on 09 Mar 2021. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 09 Mar 2021 The cause of death was reported as cardio/pulmonary failure with secondary and tertiary causes of hypertension and obesity. Plans for an autopsy were not provided. The outcome of the events, cardiac failure and pulmonary failure were fatal.; Reporter's Comments: This is a case of death in a 51-year-old male subject with a medical history of HTN, obesity, bee allergy and bipolar disorder,who died 7 days after receiving first dose of vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: cardiac failure; pulmonary failure

Approximately 16 hours after receiving his first Moderna COVID 19 vaccine the patient developed chest tightness and wheezing, relieved by administration of albuterol by nebulizer given at home. He had no systemic anaphylaxis reaction.

Vaccination occurred just prior to 11:00 am, felt normal until shortly after arriving home at approximately 11:30. Dizziness, headache and fatigue have been experienced since, with occasional shortness of breath. Dizziness has at times been severe, as has headache. Fatigue has been severe throughout, with me sleeping much of an average day. I will be seeing my primary care physician Monday 4/5.

Tightness in the chest on and off, pain the the heart area on and off (I have experienced both of these symptoms on and off throughout my life but it has been worse since I received the shot), headaches almost every day since a week after the shot, lack of energy, tiredness, out of breathe when I climb two flights of stairs at work, and irritability.

Pt was sitting in observation chair after receiving vaccine and became pale, and then loss consciousness. Pulses were very weak, but thready. Respirations rates were also decreased. when patient awoken, ems was approaching patient. EMS found patient to be bradycardiac. Pulses remained weak, pt remained pale and diaphoretic, very shallow slow respirations but alert and orientated just weak at this time. Pt admitted this happens frequently with injections and blood draws. Pt was asked to see if he could sit up where patient became dizzy, nauseas and then vomited. Pt admitted to not eating today and then refused to go to the hospital. Pt was observed in waiting area for almost 45 minutes, where patient made a full recovery.

This nurse noticed that the patient was coughing and clearing his throat around 11:10 am. This nurse asked if he needed some water and the patient replied he thought he may be having an allergic reaction to the shot. This nurse went to get a bottle of water and gave two Benadryl capsules at 11:15 am. 911 was called. This nurse notice the patient's eyes were looking swollen and red and that his face and neck were turning red around 11:20 am/ 11:25 am. Patient also stated his throat felt like it was getting tighter. This nurse then gave 0.3 mL of Epinephrine in right thigh at 11:30am. Almost immediately patient stated he was starting to feel better. EMS arrived, checked him over, asked questions, and offered to transport to the hospital. Patient refused the hospital and signed their paperwork. This nurse asked patient to stay an additional 30 minutes and patient complied. No other complications occurred. Patient's eyes still looked slightly red, but was no longer swollen. Stated he felt a little jittery. Gave patient a snack. Patient left around 12 noon/ 12:15pm. Patient drove self and walked without assist.

Pt had severe nausea and vomiting 15 min after inj. noted to be SOB after emesis - VS stable, kept 10 min extra - no further emesis, VS stable. let go home

death Narrative: Patient with noted history of ALS was given Moderna covid vaccine #1 on 2/27/21. On 3/5/21, notes were entered in system for family requesting a specialty bed as he was having difficulty sleeping as it was hard to breath when he laid down. He was sleeping sitting up in his wheelchair. On 3/8/21, a note was placed that he was planned to have a trach placed on 3/12/21 and that he was now under hospice care. No further notes entered and a date of death was recorded as 3/17/21. No autopsy results available. 18 days from date of vaccine to date of death.

Syncopal type feeling. Nausea feeling and unsteady on his feet. Light headed when he was standing up.

Approximately 30 minutes after the vaccine, while driving home, my chest area started to feel very warm, then I started to have difficulty breathing. I was unable to swallow for the first minute or so, then my upper and lower lip got numb. After I was able to swallow my saliva tasted metallic and a mental fog settled in. I had difficulty concentrating for the next 2-3 minutes. All symptoms lasted for about 5 minutes. About a week later I developed a skin rash reminiscent to a "zoster." It was the size of my palm on my left thigh. Although is almost clear now, the affected skin area lost some sensitivity. Another subcutaneous inflammation persist to present day.

Presented with a swollen tongue and shortness of breath. Reports fever and chills the night prior per patient statement. Narrative: Patient escorted to the emergency department to be examined.

c/o fever, chills, dyspnea x 1 day. Had first COVID 19 vaccine(Moderna) on 4/21. EMS noted sats 87% on RA. Improved to 95% on 2L NC. Also had nausea, vomiting and diarrhea on 4/22 which is now resolved as per patient. States never had pills in his vomiting. Always vomited food as per him. Diarrhea was only a few episodes and was nonbloody and had no mucus. Feeling very weak and having diffuse myalgias also as per patient. In ER chest x-ray showed pulmonary edema and also had accelerated hypertension. He is admitted for further management.

Pain at injection site (continued), pallor (continued), excessive diaphoresis (20 hours), nausea (continued), vomiting (12 hours), diarrhea (12 bours), extreme malaise (lessened after 20 hours but still lingers), gastric pain (20 hours), headache (continued), impaired vision (12 hours), severely weakened gait (18 hours), inability to drive (18 hours), body aches (continued), memory loss and confusion (12 hours), dyspnea (12 hours), fever of 104° F (12 hours with no relief from antipyretics/acetaminophen), fever in excess of 100° F (another 10 hours), fever in excess of 99° F (12 hours), fear of death (36 hours)

After 1St vaccine. Chest pains, difficulty breathing, like breathing through a straw. Saw cardiologist doctor, and was seen at ER. Sent home with Aspirin and colchicine scripts. To this day still having severe chest Pain and difficulty breathing.

Patient stated he broke out in hives 3-4 hours after received the shot and began to have trouble breathing. He then administered an Epi-Pen, however he did not go to the hospital.

Severe mid-back pain (muscular) migrated around the rib cage and manifested itself into acute abdominal pain at the diaphragm. Back pain was significant enough to wake me up in the early morning. The abdominal pain required that I stand up as the pain intensified while laying prone. Abdominal pain resulted in difficulty breathing (unable to take full breaths without the pain intensifying). Abdominal pain subsided after 20 minutes, but the back pain continued into the next morning.

Patient received first dose of Moderna vaccine after which he immediately experienced weakness, myalgias, fatigue. Progressive weakness in limbs continued and by day 13 following his vaccine patient presented to hospital with difficulty speaking and inability to walk. Admitted to acute care hospital for progressive extremity weakness, bulbar weakness, and respiratory failure. EMG testing demonstrated findings of demyelinating neuropathy. Patient transferred 3/31/21 for intensive inpatient rehabilitation and remains currently hospitalized.

Acute hypoxic respiratory failure; adynamic ileus; Pneumonia; Progressive Extremity Weakness; demyelinating neuropathy; Bulbar weakness; Respiratory failure; Weakness; trouble walking; This spontaneous case was reported by a physician assistant (subsequently medically confirmed) and describes the occurrence of RESPIRATORY FAILURE (Respiratory failure), ACUTE RESPIRATORY FAILURE (Acute hypoxic respiratory failure), ILEUS PARALYTIC (adynamic ileus), PNEUMONIA (Pneumonia), DEMYELINATING POLYNEUROPATHY (demyelinating neuropathy), BULBAR PALSY (Bulbar weakness) and MUSCULAR WEAKNESS (Progressive Extremity Weakness) in a 51-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 Diabetes mellitus, Hypertension, Glaucoma and Hyperlipidemia. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced RESPIRATORY FAILURE (Respiratory failure) (seriousness criteria hospitalization prolonged and medically significant) and BULBAR PALSY (Bulbar weakness) (seriousness criteria hospitalization prolonged and medically significant). On 15-Mar-2021, the patient experienced DEMYELINATING POLYNEUROPATHY (demyelinating neuropathy) (seriousness criteria hospitalization prolonged and medically significant). On an unknown date, the patient experienced ACUTE RESPIRATORY FAILURE (Acute hypoxic respiratory failure) (seriousness criteria hospitalization prolonged and medically significant), ILEUS PARALYTIC (adynamic ileus) (seriousness criteria hospitalization prolonged and medically significant), PNEUMONIA (Pneumonia) (seriousness criteria hospitalization prolonged and medically significant), MUSCULAR WEAKNESS (Progressive Extremity Weakness) (seriousness criterion hospitalization prolonged), ASTHENIA (Weakness) and GAIT DISTURBANCE (trouble walking). The patient was hospitalized from 06-Mar-2021 to 31-Mar-2021 due to ACUTE RESPIRATORY FAILURE, BULBAR PALSY, DEMYELINATING POLYNEUROPATHY, ILEUS PARALYTIC, MUSCULAR WEAKNESS, PNEUMONIA and RESPIRATORY FAILURE. At the time of the report, RESPIRATORY FAILURE (Respiratory failure), ACUTE RESPIRATORY FAILURE (Acute hypoxic respiratory failure), PNEUMONIA (Pneumonia), DEMYELINATING POLYNEUROPATHY (demyelinating neuropathy), BULBAR PALSY (Bulbar weakness), MUSCULAR WEAKNESS (Progressive Extremity Weakness), ASTHENIA (Weakness) and GAIT DISTURBANCE (trouble walking) outcome was unknown and ILEUS PARALYTIC (a dynamic ileus) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Electromyogram: abnormal (abnormal) consistent with demyelinating neuropathy.. On 30-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported by investigator. Patient was presented to hospital on 3/6/21 with progressive extremity weakness, bulbar weakness, and respiratory failure attributed to AIDP s/p 5days IVIG. He had received his first Moderna COVID vaccination approximately two weeks prior to this and immediately following administration began experiencing weakness and trouble walking. EMG 3/15/21 consistent with demyelinating neuropathy. Hospitalization was complicated by the development of adynamic ileus which is improving and acute hypoxic respiratory failure (previously requiring O2 support). Patient was also treated for pneumonia with a 5 day course of azithromycin. Once medically stable he was deemed appropriate for inpatient rehabilitation and was transferred from Hospital to rehab on 3/31/21 under care. The patient tested negative COVID-19 on 3/30, and repeat testing since also has been negative. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Shortness of breath one week after second shot. Still have that. My resting heart rate is 80 and it is more typically around 60.

Patient presented to PCP office 5/17/2021 for intermittent SOB, pain with breathing, and acute pain to left lower calf. Calf pain began 5/16/2021. SOB had been intermittent and ongoing since after receiving 2nd COVID vaccine per patient. He was dx with acute DVT of LLE. Chest CT was not performed to evaluate for PE as patient reported improvement with SOB/breathing over the prior few days. He was started on Xarelto for blood clot. Blood clot was unprovoked, no prior history of clots/bleeding disorders. He is a generally healthy and active 51 year old male. Unclear if there is a correlation between recent COVID vaccination.

2 hours after injection I felt strong pain at the injection site as expected. 10 hours after injection I felt the expected side effects of tiredness, slight headache, sore body, and slight nausea. I went to bed. 12 hours after injection I woke up in intense pain feeling very sick. My entire body hurt on a scale of 10 out of 10. My neck muscles especially were so tight that it was unbearable and beyond a 10 on pain scale. I had a headache. I felt very nauseous like I might vomit at any moment. My breathing became shallow. I had chills to the point that my teeth were chattering and I was shivering uncontrollably even though it was 76 degrees inside my home. I considered calling an ambulance, but was hoping this would pass. There we moments I felt I might die and I left my door unlocked so EMTs could get in as I was still on the verge of calling for help. I was unable to sleep due to the intensity of pain. I could not eat and drank very little. Day 2 I was still in intense pain on a scale of 10 out of 10. I had a fever for a short time on and off. I did not eat for two days. I was able to take naps for one hour at a time, but then would wake up to a crushing headache and intense neck pain. The second night I was able to sleep, although I woke up in the middle of the night drenched in sweat. I would go from being extremely cold to sweating heavily feeling hot. I eventually became very hungry but was afraid to eat and was still nauseous. On day 3, the pain scale of my symptoms went down from 10 to 6. I felt much better. I was able to eat and drink well. Day 4 I was not in pain but was exhausted and depleted. Day 5 I felt I was recovered. Please note: I normally have a high pain threshold and I run up mountains and am used to pain. I also have always had flu shots with no bad symptoms. I am pro-vaccine. But something went horribly wrong with this 2nd Moderna vaccine shot.

Approximately 4 hrs after vaccine administration, dark, red, raised rash appeared on torso, arms, buttocks, and legs. So severe that dexamethasone started. Rash did not improve for weeks and steroids continued during that time. Patient noted to then go into congestive heart failure, had 2-3+ pitting edema, "ground glass"/pulmonary congestion in lungs, rapid A-fib with RVR 170-180s. treated at Hospital with admission from 5/15-5/17/2021. Patient complained of chest pain and trouble breathing starting 5/13/2021. Patient has mostly recovered, and is at home now. Now on high dose beta-blockers and eliquis for the new onset A-Fib.

24 hours after the second vaccine, I felt so out of breath and my heart rate had gone up to 115 that I had to go outside and have my daughter drive me home. I did not go to the hospital because I did not believe what was happening and I did not want to worried my daughter on her special day. This was on Saturday May 1 at about 5:00 pm. I went home and went straight to bed. My wife was in disbelief and thought I was faking it. I have been having shortness of breath ever since. I am a teacher and on Monday I spoke to the school nurse and she had told me she had the same reaction and that it would be over in a month or two. I have had the same issues, but over the weekend of the 22 and 23rd of May, I have not been able to sleep as much. On Monday, May 24, I went back to the nurse and she had took my blood pressure. It was 176/99 and that same day I went to the ER . I had all the blood work done and the only thing I had according to the doctor was high blood pressure. I had never had my blood pressure so high before.

Per Dr. "The patient had an adverse reaction to his first dose 4/30. Initially, patient at first c/o tingling on the left upper lip, headache and feeling "sleepy." No e/o angioedema. He seems to initially be anxious about developing something similar to the prior reaction. Patient given water and plan to monitor. Patient has had long covid syndrome from prior dg of COVID in 1/2021. Reassured patient and told him to stay calm. While laying in the medical area. The patient c/o throat tightening and difficulty speaking. Daughter confirms that his voice has changed. The patient has had normal vital signs. No hives. Activated anaphylaxis pathway. He is now saying he can barely swallow his saliva. Patient is objectively handling secretions well. Epi administered and benadryl 50 PO given."

Systemic: Dizziness / Lightheadness-Medium, Systemic: anxiety, said throat felt tight, tingly all over, very nervous-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium

head to toe body aches, chills, major fatigue, itchy watery eyes, trouble breathing, painful breathing, soreness in right arm, increased desire for drinking water (hard to quench thirst).

adverse events -Shortness of breath, elevated heart rate, hacking cough - Found to have be tachycardic, with pericardial effusion treatment - pericardiocentesis performed to drain fluid Outcome - heart rate slowly came down over days

Pt admitted for L lower extremity DVT and bilateral extensive PE's. No known medical history, family/personal history of clots, no known clotting risk factors. Pt noted swelling in his leg 2 days after getting second covid vaccine and later developed SOB leading to presentation.

Ear pain, throat, head and face, eye everywhere the left side, tiredness, the first weeks it increased week to week pain in part of the back, difficulty to breath, numbness in legs and arms around all of left side, blurry vision, chest pain, irregular heart beats.

Headache, body aches, joint pain, feeling hot and cold, sweaty, feeling tired, insomnia, congestion with cough, nausea and vomiting, on and off since March

This was very unfortunate 51 years old male with past medical history of hypertension, hyperlipidemia, obesity. Patient presented with chief complaint of shortness of breath and chest pain. EMS reported that the patient has been complaining of some shortness of breath and chest pain intermittent for couple of weeks. 12 leads EKG showed evidence of anterior ST elevation myocardial infarction. Code heart was called. Patient developed PEA arrest in the Cath Lab. CPR ACLS was initiated. ROSC was achieved initially after 30 minutes of CPR. Intra-aortic balloon pump was placed. Coronary arteries were essentially clean. Due to high suspicion for massive PE-TPA was given 100 mg without meaningful clinical improvement. CPR was continued for more than an hour. Despite all aggressive measures patient continued to deteriorate. At 3:26 PM patient has no spontaneous breathing, no peripheral pulses, no heartbeats by auscultation or by monitor. Pupils were fixed and dilated. No cough no gag reflexes . patient was pronounced dead.

1. After FIRST dose, I had reaction within 30-40 seconds where I found it difficult to catch my breath, felt like I might pass out, my palms were sweating profusely, & I experienced tingling in my extremities. These symptoms resolved themselves within a few minutes, with the tingling resolving in about an hour or so.(no more noticeable reactions after that) 2. After SECOND dose, ...no immediate reaction like the first time, but arm hurt, as expected for the next couple of days. I didn't notice any side effects until, 06/03, which was about 8-9 days later. So I was running at about mile 4(I am a trail runner), when something just didn't feel right around my heart...some tightness, even some pain across shoulder blades. I continued the run...turned into a run/walk. I continued my day, with something feeling a little off and experienced some night sweats, & poor sleep. I went a couple more days and then on Sunday I went to the local Immediate Care. They did an EKG & sent me to ER. At the ER, they did an EKG, and wanted me to stay to be monitored over nite. At that time, I did NOT feel bad enough to stay, so I left with the agreement that I would return on Monday to do a Stress Echo on my heart. HOWEVER, upon getting home and having a bowl of soup, I experienced what I would call my first episode. Upon getting off the couch, my heart started beating unusually fast, it became VERY difficult to breathe, and I thought I was having a heart attack. Long story short, I drove back to the ER, they checked me in, did another EKG, a chest X-Ray, a chest CT-Scan, admitted me overnite, where they drew blood every 4 hours, and attached me to a heart monitor for roughly 12-16 hours. The next day they also performed a heart stress-echo. Everything came back normal. Since that time, I have had roughly 4-5 of those major episodes, with some smaller ones as well. I went back to Hospital ER on 06/19/2021 with another episode that I felt was worse than the original one. Again, they did an EKG, a chest X-Ray, various blood tests, and everything came back normal. Amongst all of this, I have seen my Family Doctor twice, and a cardiologist once. Hospital performed a heart Calcium test, which came back with a score of six. I believe the range where medium risk of a heart attack comes in is around 100-200. I have also been put on a Holter heart monitor, of which I have a week left of a two week assignment. I haven't had a major episode in about a week and a half now, but I also stopped eating chocolate and given up all caffeine about a week and a half ago. All of that said, I still have tightness in my chest, as well as just an odd feeling there. Other symptoms I am having include being light-headed, dizziness at times, and, more concerning, tingling and numbness in my extremities. The tingling & numbness are primarily in my fingers, hands, and forearms. In addition, twice my index finger on my right hand has turned blue/purple, but ultimately returned to normal color after 24 hours or so. Finally, It is very difficult to get sleep. It seems my heart tries to wake me up every 2-3 hours to let me know something is not right. I can feel an unusual feeling almost immediately after lying down. I really can't even explain the feeling in my chest, but I have never had this feeling before, and have never had sleep issues. In summary, I WAS a 52 year old man with no history of any heart problems, a fairly avid runner with a resting heart rate between 40 and 50, and no history of dizziness, tingling, or numbness in my extremities. After the 2nd dos of Moderna, I now have stopped running, have a myriad of symptoms as mentioned above, and my life has been flipped on its head for a month now,....moreover, I am getting little relief. I need help.

high range d dime test / blood clot; brain fog; breathing issues; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (high range d dime test / blood clot) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011dz1a and 022cz1a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (high range d dime test / blood clot) (seriousness criterion medically significant), FEELING ABNORMAL (brain fog), DYSPNOEA (breathing issues) and FATIGUE (Exhaustion). At the time of the report, THROMBOSIS (high range d dime test / blood clot), FEELING ABNORMAL (brain fog), DYSPNOEA (breathing issues) and FATIGUE (Exhaustion) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Fibrin D dimer: normal (normal) normal and .55 (High) There is concern for patient that there is a blood clot. The patient treatment data was not provided. Patient allergies and medical history was not reported. Patient concomitant medication was not reported. Action taken with m-RNA1273 (moderna COVID-19 Vaccination) (Intramuscular) in response to events was not applicable. In between the doses of vaccine patient had done test (d-dime) and original came back in fine range but after second dose patient test came back in high range .55 so there is concern for patient that there is a blood clot. 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-2021-243110 (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.

The day after he received the vaccine (the 4th) he developed aching and "flu like symptoms". By Friday (the 7th) he had shortness of breath and back pain and was diagnosed with bilateral pleural effusions.

Shortness of breath, fatigue, body aches, cough, diarrhea, nausea. Supplemental nasal cannula O2, labs, VBG, D-Dimer, chest imaging, COVID-19 test. Low probability of pulmonary embolism; CXR- bilateral hazy opacities on wet read; dexamethasone

Patient is a 52 y.o. male. Chief Complaint Patient presents with ? Allergic reaction     Reaction to Covid Vaccine       Is patient concerned about a specific cause for the current symptoms? Yes Covid Vaccine Onset of symptoms: 0830. Symptoms include: difficulty breathing and/or wheezing, rapid heart rate or palpitations and generalized redness. Rash distribution: Face. How are symptoms changing over time? improving.   Patient describes symptoms as moderate. Has patient tried any treatment for these symptoms?No What makes the symptoms better? Rest and time What makes the symptoms worse? Nothing   Patient states that the shortness of breath and the increased heart rate started after about 4 minutes - then went away but came back much stronger at 10 minutes post vaccination   No itching, wheezing, cough - just flushed and chilled Increased HR and jittery   Did have surgery recently   Did have Moh's procedure in the fall and had a reaction to the lidocaine - increased heart rate, increased blood pressure   Associated symptoms:   o Fever No   o Sore throat No   o Recent illness No   o Exposure to person(s) with similar rash No   Patient has flu vaccine documented this season.  Patient Active Problem List Diagnosis ? Migraine ? Obstructive sleep apnea syndrome ? Calculus of gallbladder without cholecystitis without obstruction ? Hemiplegic migraine without status migrainosus, not intractable ? Low HDL (under 40) ? History of nonmelanoma skin cancer ? Encounter for screening colonoscopy ? Essential tremor   Medical History Past Medical History: Diagnosis Date ? Acquired hypothyroidism   ? Chronic kidney disease     Stage 2 ? Chronic migraine with aura 01/04/2013 ? Colon polyps   ? Color blind   ? Enlarged prostate   ? GERD (gastroesophageal reflux disease)   ? Hemiplegic migraine   ? Hx of febrile seizure   ? Kidney stones     x 1 - 2001 ? Nodular basal cell carcinoma (BCC) 09/08/2020   bcc nod, rt cheeck and rt medial cheek ? Obstructive sleep apnea syndrome 11/04/2013   Home sleep testing on 10/31/13 with apnea/hypopnea index = 9 and low oxygen saturation = 90%. Auto-PAP titration pending. Surgical History Past Surgical History: Procedure Laterality Date ? Colonoscopy   04/10/2020   ksc ? Hx lap cholecystectomy N/A 12/23/2020   LAPAROSCOPIC CHOLECYSTECTOMY ? Hx of mohs/skin cancer surgery and repair   09/08/2020   bcc nod, rt cheek ? Hx of mohs/skin cancer surgery and repair   09/08/2020   bcc nod, rt medial cheek ? Hx wisdom teeth extraction     ? Upper gi endoscopy   04/10/2020   ksc Objective: BP 116/74 | Pulse 84 | Temp 97.9 °F (36.6 °C) (Oral) | Resp 18 | SpO2 97% General:well-hydrated, well nourished, no acute distress HEENT: ENT exam normal, no neck nodes or sinus tenderness Lung: clear to auscultation bilaterally Heart: regular rhythm, tachycardia noted and no murmurs, clicks, or gallops. Extremities: extremities normal, atraumatic, no cyanosis or edema Skin: flushed (face and neck and chest primarily) , no hives Neuro: alert, orientation normal, speech normal   9:30 AM Improving symptoms Decreased HR, although patient states if feels like it is cycling, flushing is almost resolved No hives or shortness of breath Mild jittery feeling  

almost immediately started feeling warm and dizzy, stated I don't feel right. Had him lie down, administered O2 at 2l/m for feeling of SOB. B/P was elevated at 197/97, O2 sat 98%, heart rate was tachycardia at 140's. Had patient lie down while being monitored. HR slowly came down, B/P systolic dropped 30 points to 160's

1/12/22 @ 11 pm began to feel fatigue and headache. 1/13/21 in AM felt short of breath and winded, also felt as if he had congestion/phlegm in his lungs. Went to PCP & got Covid tested.

After 15 minute wait period, left vaccination site. Reports felt "like I couldn't breathe and nauseated but I went home". Started feeling "burning on left side of head and neck". He called the prescribing doctor and was referred to emergency room by prescribing doctor.

Patient developed sensation of rapid heart rate followed by urticaria. Vague sensation of dyspnea, "like running in cold weather" Patient has anaphylactic reaction to shellfish. About 6 hours prior to onset of urticaria and dyspnea, had eaten in a restaurant that does also sever shellfish. Cross contamination cannot be ruled out

Patient began experiencing flushing and tingling sensation in throat/lips about 30 minutes after receiving 2nd dose of COVID vaccine. Patient felt as though throat may have been closing so he administered an epi pen to himself. As no immediate relief patient administered a second epi pen which provided relief. Approximately one hour after vaccination patient felt back to normal and chose to leave the clinic with instructions to report to emergency room if symptoms began to return.

Patient within 5 minutes reported having tingling in his hands and swelling in his hands. Vitals at 9:19 am BP 132/80, O2 sat 96%, HR 102. Dr present in the hall and observed patient. We decided to watch and wait. A few minutes later, patient started clearing his throat. Patient stated "It feels like there is something in my throat and it is getting harder to breathe". Patient has allergy to bee venom, particularly ground wasps. Dr who was on-call called to the room. Ordered 0.3 mg Epi pen and 50 mg Benedryl IM at 9:37 AM. Given. Patient stated he felt better immediately. Hand swelling started going down. Sensation of throat discomfort and difficulty breathing subsided. Patient asked to wait another 30 minutes for observation. Patient continues to state he feels fine "just a little drousy from the benedryl".   Vitals at 10:33 am HR 100, BP 122/80, Pulse ox 98.   Dr is allowing to discharge to home right now where patient states he has more epipens.    

Low-grade fever, chills, fatigue, shortness of breath, restless leg syndrome-like symptoms (neurological), headache, nauseousness, body aches, insomnia, brain fog

22 hours after receiving the vaccine, I had fever and the chills. This was followed by a headache. This was not unexpected. I fell into a deep sleep that lasted 2 hours. I awoke suddenly with a very bad headache. I drank about 3 ounces of orange juice and then took 30 ml of pharmacy brand liquid Tylenol. This is the bad symptom that I want to report. As soon as the liquid Tylenol hit the back of my throat it felt as if my throat constricted tightly. I immediately stopped drinking it and was able to spit out some of what was in my mouth. I was unable to get air in or out. I stood up and eventually was able to get a big gulp of air into my lungs before everything closed up again. Eventually I was able to get another gulp of air in and I began to cough a little. Once I drank some water, I could feel the liquid Tylenol on the back of my throat get washed down and I was able to breath normally in about 2 minutes. The cup of liquid Tylenol still had about 20 ml of fluid in it and I spit out perhaps half of what entered my mouth; I'm estimating that 5 ml of liquid Tylenol went down my throat. Note that this is not a case of the liquid Tylenol going down my windpipe by mistake. I know what that feels like and it is different. It was all very traumatic.

signs of anaphylaxis after eating granola.. full body itching, lightheaded, wheezing, shortness of breath, sensation of throat swelling up

Reports developing progressive hives approx. 2 hours following vaccine, accompanied by feeling throat constricted.

I waited the 15 minutes required and felt ok. However, about 10 minutes after I left the facility my throat felt like it was constricting. According to the literature this was a known potential side effect so I paid attention. The constriction felt like it worsened for about 15-20 minutes and then finally started to fade approximately 45 minutes after onset. It scared me as I had no idea how bad it would get. At no time did I have difficultly breathing, but I was alarmed by it and am currently uncertain whether a 2nd dose is recommended.

Headache, Myalgia, Fever, CoughWheeze, SEVERE CHILLS, SWEATS, HA, BA, TEMPERATURE, MILD COUGH, LOST SENSE OF TASTE Narrative:

Bells Palsy; he lost strength in his left face, arm, and leg; Felt nauseous; couldn't breathe; burning sensation from the left side of face from temple to neck; Localized muscle weakness; A spontaneous report was received from a health care professional concerning a 52-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed bell's palsy, nausea, dyspnea, burning sensation in face and localized muscle weakness. The patient's medical history included covid-19 . Products known to have been used by the patient, within two weeks prior to the event, not provided. On 25 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 25 Jan 2021, the patient felt nauseous and couldn't breathe. The feeling went away so he did not think too much of it. 30 minutes after that, he lost strength in his left face, arm, and leg and diagnosed with Bells Palsy. There was a burning sensation from the left side of his face from the temple to the neck. Treatment for the event was not reported. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event's,reported, was considered not 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 events, a causal relationship cannot be excluded.

The morning after the vaccine after I ate my breakfast. My throat on the right side felt like it was closing and my neck hurt to do anything. Move or swallow. It lasted for three weeks until two days after the second dose of the vaccine. I was prescribed two courses of antibiotics , Cephalexin and Doxycycline , which only helped a little. I had gotten an insect bite the week before vaccination. I also had a CT scan after the second dose of vaccination but the pain had gone by then.

The patient received the COVID 19 vaccine. As he waited after receiving the vaccine, the patient stated that he did not feel well and was having shortness of breath. 911 was called and the patient was assessed. The patient stated that his throat was not swelling and refused to remove his mask. He did not appear to be wheezing and remained alert and oriented. His breathing appeared as someone who was hyperventilating. He continued to talk until the EMS arrived. I got a blood pressure cuff and proceeded to check his blood pressure. EMS arrived shortly and the patient stated he was feeling better. He was after to stand and get on the stretcher and was transported to the hospital. The patient was contacted the next day and stated his blood pressure on the ambulance was 140/90. He said when he got to the hospital the wait was long. He stated he was feeling better so he left and was not seen by the doctor. He stated he was feeling fine and had no more shortness of breath. He also stated he would not be getting the second dose of the vaccine.

Presented to urgent care on 3/20/21 with shortness of breath, fever, chills and body aches. Was referred to ED due to O2 sat of 86%. Was started on supplemental oxygen in ED and admitted to hospital.

ANAPHYLACTIC REACTION THE EVENING VACCINE WAS RECEIVED: DIFFICULTY BREATHING, FEVER, DROWSINESS, DISORIENTATION. 7 DAYS LATER: FEVER, PLAQUE PSORIASIS, RASH, BURNING/ITCHING SKIN, FEVER

I developed a shortness of breath and a dry cough. I previously had Covid and the feeling is the same. I also suffered the common effects listed (fever, chills, etc).

The first day I had no arm pain as others suggested but later that day I began to be enervated. After going to sleep early in the afternoon I woke up light headed. I spent the weekend having trouble breathing. On Monday I used a sick day because of shallow breathing. Tuesday my light headedness went away but I was having trouble with my bowels. That may have been due to snacking on cashews though. Tuesday night I ate some watermelon and drank two 32 ounce bottles of gatorade and I feel a lot better today. Breathing is still shallow but nowhere near what it was. It is back to being indicative of my morbid obesity

REPOERTED BY FAMILY MEMBER THAT THEY FOUND PATIENT DEAD IN SLEEP, NOT BREATHING SUSPECTING HEART ATTACK...AUTOPSY WILL BE PERFORMED

52-year-old male with no significant past medical history presenting with acute hypoxic respiratory failure and pancreatitis. Admitted to hospital on March 1, 2021 at Medical Center, for presentation of abdominal pain, elevated lipase and pancreatitis. Was airlifted to Medical ICU unit at a Larger Hospital on March 6, 2021. Was in the hospital until March 17, 2021 and was sent to Rehabilitation until discharge on March 26, 2021.

On Wednesday evening April 21st around 11:00 pm i could not catch my breath while trying to lye down or sit up, i went to the Hospital ER on Thursday morning at 8:00 am and they did a cat scan with contrast and found multiple blood clots (PE ) in my right lung.

(5/11) after eating beef jerky & salmon jerky :throat swelling, tightness in chest, indigestion, tongue burning, dizziness, lightheaded, high bloodpressure ?. (5/12) after eating pistachios, lettuce: throat swelling, tightness in chest, tongue burning, pain in mouth went to urgent care.. did ekg, heart ok , vitals ok initial high reading of blood pressure returned to normal and released (5/14) pain in chest, tightness same as above with throat swelling , went to ER ?. ekg, chest xray, high blood pressure ..nitro glycerine tablets given TWICE ...tightness in chest feeling gone, bp returned to normal .. follow up with primary care and cardiologist was recommended. (5/15) after eating baked potato, same allergic reactions returned in mouth, patient went to urgent care.. was seen and diagnosis food allergy given epi pen, Pepcid, bentyl (5/16) after taking medications : Bentyl and Pepcid was having allergic reaction, discontinue use of those 2 meds

54 days after the first vaccination with Moderna Covid-19 Vaccine, and 25 days after the second vaccination, at approximately 0730 on Day 1, a 52 year old male, height 175.2cm, weight 95.5kg, without significant medical history or prodrome, had an acute onset of dyspnea manifesting as a small sigh at intervals of 4-6 minutes, which increased in frequency to intervals of 2-3 minutes over the course of the day. At approximately 1400 he had a one minute episode of tachycardia >120 bpm. At 1515, his forehead became diaphoretic. He had neither chest pain nor a pericardial friction rub at any time. He went directly to the local emergency department. Additional information for Item 18: Blood pressure at admission was 155/87, pulse 97, respiratory rate 22/minute, SpO2 98%, and Temperature 37.2. ECG at 1539 interpreted as: "NSR at 85, Lateral ST depressions; ST elevations in aVR, ischemia / Posterior wall MI". ECG at 1541 showed: NSR at 82, unchanged from prior ECG. ECG at 1552 interpreted as: "Sinus tachycardia at 102, ST depressions remain in lateral leads but now also in V3 and V4; persistent ST elevations in aVR CW evolving posterior wall MI". PR depression in leads II and V4-6, and reciprocal PR segment elevation in aVR (pericarditis ECG Stage 1) Atypically for pericarditis, ST depression, rather than ST elevation, was present in leads V3-V6. Owing to a working diagnosis of an evolving posterior wall myocardial infarction, an emergent cardiac catheterization was performed, which demonstrated non-obstructive CAD and a small myocardial bridge. Initial laboratory values were notable for a white blood cell count of 11.89 K/mm3 (4.5 - 11.5), monocytes 1.1 K/mm3 (0.0 -1.0), 9.4% (2.0 - 9.0), neutrophils 7.9 K/mm3 (1.5 - 6.6), 66.9% (40.0 - 75.0). Troponin was negative at admission and 18 hours later. D-Dimer was negative. Viral panels including SARS-CoV-2, Influenza A, Influenza B, and RSV were negative. He was admitted for overnight observation. On Day 2 an echocardiogram was normal with no effusion, and ECG was notable for the absence of PR depression and persistent ST depression in leads (PR segment normalization part of pericarditis ECG Stage 2)…... His dyspnea persisted, with a moderate sigh every 1-2 minutes at rest. He was discharged with a presumptive diagnosis of coronary vasospasm or a pulmonary etiology, and told to follow up with his pmd. Over the next several days, his dyspnea was continuous and progressively worsened, and he had diaphoresis of the forehead every morning approximately 0900 until Day 20. Sleep remained normal. On Day 5 he was sighing deeply more than once per minute at rest, causing him distress, and ECG showed (?persistent ST depression in V4-6 with reciprocal changes in aVR). On Day 12, ECG showed T-wave inversion in V1-6 and ST depression in V3-6 (ECG Stage 3); a computed tomography of the chest was normal; and blood tests notable for normal monocyte count .57 K/microliter (0.0 - 0.8), normal CRP 2.15 (1.0-3.0), and an ANA titer of 1:80 (elevated) described as a speckled pattern, which is associated with several autoimmune diseases. Repeat echocardiography on Day 26 showed a small, generalized pericardial effusion and was otherwise normal. Cardiac MRI on Day 29 showed delayed gadolinium uptake. Pulmonary function tests on Day 38 were normal. Stress echocardiography on Day 44 was normal. Cardiac CT angiogram on Day 46was normal. The patient was diagnosed with pericarditis of unknown origin and started on aspirin 650 mg p.o. b.i.d. An ECG on Day 80 showed PR depression in II and V4-6, continued ST depression in II and V3-6, without T wave inversion (T wave normalization c/w ECG Stage 4). Symptoms progressively worsened from onset to nadir around Day 12, on which he had continuous moderate dyspnea upon awakening with severe dyspnea with mild exertion. Symptoms then generally improved until after Day 47, he began to have alternating periods of several days without symptoms followed by several days of mild dyspnea. Clinical symptoms resolved on Day 85.

Patient developed dizziness, chills, fever, body ache, sore throat, difficulty breathing, and stopped eating beginning April 26, The adverse effect is the belief that a breakthrough case of Covid-19 will be less severe if you had the shots. A false sense of security.

Chest discomfort. Difficulty breathing. Still have dyspnea. Went to Urgent Care clinic and had neg. chest X-Ray. Wake up frequently at night due to shortness of breath.

Tightness and pain n the chest, shortness of breath, aching feeling in the upper back, lethargy/loss of energy, heart palpitations. cold feet and hands.

On 05/30/21 I woke up about 5am with chest pain, shortness of breath, palpitations, heart racing. Drove myself to the ER. Had EKG, labs done, Metoprolol given in ER. Was told I was in Afib. I stayed in ER until shortly after 4pm. I saw Cardiology doctors and then given discharge instructions for a follow up appt for Echo and cardiology doctor appt. Before leaving the ER I returned to normal sinus rhythm.

Cellulitis in parotid gland; Jawline was swelling quite large; Swollen throat; Difficulty swallowing; Damage from surgery where my lip wont move in one part; Missing two teeth; Infection in my face; earache; Sore throat; Headache; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (Cellulitis in parotid gland), SWELLING FACE (Jawline was swelling quite large) and INFECTION (Infection in my face) in a 52-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. No Medical History information was reported. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced CELLULITIS (Cellulitis in parotid gland) (seriousness criteria hospitalization and medically significant). On 10-Mar-2021, the patient experienced EAR PAIN (earache), OROPHARYNGEAL PAIN (Sore throat), HEADACHE (Headache) and CHILLS (Chills). On 12-Mar-2021, the patient experienced INFECTION (Infection in my face) (seriousness criterion hospitalization). On an unknown date, the patient experienced SWELLING FACE (Jawline was swelling quite large) (seriousness criterion hospitalization), PHARYNGEAL SWELLING (Swollen throat), DYSPHAGIA (Difficulty swallowing), LIP DISORDER (Damage from surgery where my lip wont move in one part) and TOOTH LOSS (Missing two teeth). The patient was hospitalized from 13-Mar-2021 to 20-Mar-2021 due to CELLULITIS. On 20-Mar-2021, CELLULITIS (Cellulitis in parotid gland) had resolved with sequelae. At the time of the report, SWELLING FACE (Jawline was swelling quite large), INFECTION (Infection in my face), PHARYNGEAL SWELLING (Swollen throat), EAR PAIN (earache), OROPHARYNGEAL PAIN (Sore throat), DYSPHAGIA (Difficulty swallowing), LIP DISORDER (Damage from surgery where my lip wont move in one part), TOOTH LOSS (Missing two teeth), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. On 11-Mar-2021, the patient consulted the doctor because his sore throat and earache on the side of the injection site was painful. He was sent to the emergency room on 12-Mar-2021, for infection in the face. The doctor told the patient that the swelling and pain was from the vaccine and prescribed Motrin. The patient reported that he was getting worse and developed jawline swelling, He went to the hospital on an unspecified date. He was advised admission as he had severe infection and was prescribed antibiotics. On an unspecified date, surgery was done to drain the infection. Drainage was minimal. The patient had surgery a second time, to drain the swelling. He was admitted for a week in the hospital. The patient reported damage from the surgery which included loss of movement of lip in one part and loss of two teeth. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.MR review complete. Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up information received on 21-Jun-2021: Case was upgraded to serious, patient details were updated, additional events were added, hospitalization details and treatment details were updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.MR review complete.

Beginning on Friday, 6/25/21, began to feel like lungs were 'heavy,' and that normal oxygenation wasn't occurring even with a deep breath. I had attended a memorial visitation the evening of June 6/22/21 at the Funeral Home in town and it was the first time post-vaccination that I attended a gathering (small) without a mask; others were also unmasked. I suspect the issue emanates from this interaction. As of this writing, I feel that I am not getting a full, deep and fully-oxygenated breath when I breath. This morning, around 1AM EST, I had slight wheezing on my inhales, which seems to have subsided after I walked the dog down the block and back (slowly). No other discernable Covid-related symptoms to report.

Red spots on chest, trouble breathing, fever , stuttering, stammering, bowel movements once every hour

Patient is a 53 year old male who presented to Medical Center Emergency Department on 5/12/2021 with the chief complaint of fever. He is not under the care of a primary care provider and does not take any regular medications. On May 4th patient received his second Moderna COVID vaccine. Several hours later he developed a subjective fever with chills, body aches and a headache. These symptoms have been ongoing since onset. Since this time he has also developed a dry cough, generalized weakness and burning with urination. Denies any shortness of breath, chest pain, nausea, vomiting, or diarrhea. No bloody/dark stools. Wife is at the bedside who states that patient has recently developed "little red bumps" all over his body.

After receiving the shot I walked up to sit down in the bleacher seats, Talked to the doctoer to set up my reaction site and after he left I felt a wave of panic and felling that my breathing was suffering. Then felt tingleing in my tounge. Just feeling of breath issue. MY blood pressure was high a liitel bit 140-100 and my heart rate was 88.

Lower arm sore after 12 hours, fever severe convulsions, high fever, nausea, vomiting, shortness of breath, body aches after 15 hours that lasted about 2 hours in severity. Today is 4 days post incident and still have weakness, body aches and fever are subsiding.

Developed palpitations and dyspnea about 8 mins after vaccine. Was treated with Benadryl. Seen at my clinic 45mins later. No symptoms and feeling fine

Fever, fatigue, no energy or strength, could not get a full breath, progressed throughout the day, temp 100.4 heavy sweat until the third morning from onset. By fourth day all clear.

Patient had second COVID19 vaccine at 12:30pm on 2/8/21. Late that night, started with fever, chills, muscles aches, and pain at injection site (left arm). Had SOB on and off. Does not have thermometer, not sure of temp when feverish. He took ibuprofen for fever. Fever and SOB resolved yesterday (2/10/21). Chills and muscle aches are imroving, very mild today. Still has tenderness around injection site, but improving. He reports similar symptoms after first COVID vaccine but sx were more severe with first vaccine. Denies redness o swelling to injection site. Denies facial or throat swelling or chest pain.

53-year-old male who received the Covid 19 vaccination today and after 10 minutes developed dyspnea and pain in his left arm. He denies rash or swelling in his mouth, throat, lips. He has a history of asthma. No hypoxemia. Anxiety

Diagnosed with Covid-19 on 03/01/2021. Admitted to hospital ICU on 03/01/2021. Presented with dyspnea, fatigue, shortness of breath. Patient had skipped dialysis treatments for an unknown amount of days. DIscharged from hospital on 03/04/2021. Total number of days: 4. Treated with Vitamin C, Vitamin E, Vit D, zithromax 500mg daily x 7 days; Zinc 50mg; dexamethasone 4mg x 10 days; Tussin DM; acetaminophen 500mg as needed. Currently in isolation for 21 days (03/01/2021 to 03/22/2021). Pt reported Symptoms resolved on 03/04/2021. Continues with Dialysis although schedule days have temporarily changed to Tuesday, Thursday and Saturdays until cleared from Covid-19.

over the course of the week following the vaccination, tiredness, swelling of hands/fingers/wrist/palms that moved to mouth/throat/eyes, itchiness, soreness

Patient was having a hard time breathing and swallowing water. Felt that his throat was hurting. Pt was given epinephrine 0.3mg and EMS was called. Pt left site and went to the hospital via ambulance.

Pt stated that he became SOB, had chest tightness, and felt flushed. He then became pale and diaphoretic. SAO2 98% HR 103

The day after my shot I developed an itchy rash that felt like a bad case of poison ivy that progressively got worse over the next few days. It got to the point that my throat started swelling shut and I went to the hospital emergency room.

Woke up the Morning of 3/25/2021 with a bad rash on my arms chest back and legs and slight shortness of breath. Treated with Benadryl and Prednisone. Shortness of breath gone, rash diminishing.

Patient report to have been in A-fib for three days after receiving first dose of vaccine; Throat closure; Felt like anaphylaxis; A spontaneous report was received from a consumer who was a 53-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who developed atrial fibrillation and an anaphylactic reaction. The patient's medical history included heart failure and allergies to butter and NSAIDS. Products known to have been used by the patient, within two weeks prior to the event, included metoprolol, diltiazem, apixaban, lisinopril and loratadine. The patient received their first of two planned doses of mRNA-1273 (Batch number: 040A21A) on 11 Mar 2021 in the left arm for prophylaxis of COVID-19 infection. On 11 Mar 2021, the patient reported that he experienced a moderate reaction; throat closure (not complete). He stated that it felt like anaphylaxis. He also reported having a numb tongue. He reported that the reaction was not immediate and that it started about four hours after the vaccine. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event, atrial fibrillation, was considered recovered/resolved. The outcome of the event, anaphylactic reaction, was considered recovering/resolving.; Reporter's Comments: This case concerns a 53-year-old male who experienced a serious anaphylactic reaction with serious unexpected event of atrial fibrillation and throat closure. Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Atrial fibrillation resolved, and anaphylaxis resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

101.4 Temperature/fever, aching joints severe, malaise, no appetite, diarrhea, migraine, nausea, heart palpitations, breathing difficulty, dizziness, unable to move, unable to sleep regular times, severe exhaustion.

Shortness of breath**; cough; fatigue; slight loss of taste and loss of smell; sore throat; runny nose; vomiting tendency; slight nausea: symptoms started showing late afternoon (after 24 hours) around 4pm on Tuesday, March 30, 2021. Symptoms were very predominant the day after, Wednesday, March 31, 2021 since 7am.

I TOOK THE SHOT ON 03/20/2021, FELT BREATHLESS WHILST TAKING A WALK ON THE TRAIL ON 03/27/2021. DIZINESS ABOUT FOUR TIMES ON 03/27/2021 AND I PASSED OUT MOMENTARILY/CHECKED INTO ER. NOT EXACTLY SURE IF THE VACCINE IS THE CAUSE, BUT IT REQUIRES LOOKING INTO BECAUSE I HAVE NEVER HAD SUCH AN EXPERIENCE IN MY ENTIRE LIFE.

Started to black out; Trachea collapsed; Swallowed saliva; Could not breathe; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Started to black out), TRACHEOMALACIA (Trachea collapsed) and CHOKING (Swallowed saliva) in a 53-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 No adverse event (No reported medical history). On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Started to black out) (seriousness criterion medically significant), TRACHEOMALACIA (Trachea collapsed) (seriousness criterion medically significant), CHOKING (Swallowed saliva) (seriousness criterion medically significant) and DYSPNOEA (Could not breathe). At the time of the report, LOSS OF CONSCIOUSNESS (Started to black out), TRACHEOMALACIA (Trachea collapsed), CHOKING (Swallowed saliva) and DYSPNOEA (Could not breathe) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Based on the current available information a temporal association between the use of the product and the onset date of the events, a causal relationship with the events cannot be excluded.; Sender's Comments: Based on the current available information a temporal association between the use of the product and the onset date of the events, a causal relationship with the events cannot be excluded.

Patient in observation area, unresponsive to verbal commands, elevated heartrate (120-140), elevated bp 180's-210/100-105, tachypnea (20-26), normal O2 sat (99-100%). EMS activated. Shaking extremities, able to move all extremities on command. No diaphoresis. At 10 minutes more alert and c/o chest pain 8/10. Transported by EMS to ER.

fevers, chills, shortness of breath (acute respiratory failure requiring intubation) 1 day after vaccine administration

24 hours after the vaccine my arm started to get sore to a very painful point for over 72 hours where I experimented with sweat, dizziness, and insomnia, after 72 hours the pain when over my body, and I started feeling chest congestion, it remained bad for four more days. 10days after the vaccine I decided to come back to my routinary exercise (bicycle) but the pain in my legs is keeping me from trying. I still feel very tired and sore and I'm seriously concerned about the second dose. I need the advice to know if I should avoid it? Should I go for an anti-bodies test?

Pt states he woke up early and couldn't stand due to head spinning, but was okay laying flat. Lasted 20 seconds then able to stand slowly. Reports continues to have <5-10 second vertigo episodes 3-4 times a day ever since. Describes vertigo as if riding on a roller coaster and feels room spin in back of head by his neck area behind ears bilaterally. No issues with eyes or ears. Quick position changes or moving from flat to sitting/standing or turn head quickly side to side triggers sensation. No neck pain.

Moderate to severe pain in left shoulder around injection site (8? circumference) started at 4 hrs post injection. Day 2 (8 am) immediate chills, shaking, joint & muscle pain in hips and legs, weakness, out of breath easily (walking to leave work). Day 2 (10 am fever of 99) chills, weakness. Fever of 101 -Tylenol helped. Day 3 Continued with same, but less severe symptoms through Day 3. Some relief of fever and arm pain with Ibuprofen or Tylenol.

Joint pain, severe headache, shortness of breath, 104.9 fever, nausea, discomfort in upper right lung I had the same reaction after the first shot on March 14. They started about 22 hours after the first shot. However, after the second shot, I started having the adverse reactions within an hour of the shot.

Soreness in injection site after 12 hours. After 18 hours, weezing , coughing, difficulty breathing. Deep breathing painful. Nauseous. It is 5 am on the 18th, almost 3 days after injection. Symptoms are getting better. Still raspy when breathing. Will call My Doctor if continues

Presented to ED with shortness of breath on exertion and tachycardia. Patient reported getting covid-19 2nd vaccine 4/11 (moderna) Lot #037B21A. Patient found to have acute saddle pulmonary embolism and right leg femoral DVT. Placed on heparin drip then transferred to hospital on 4/16/2021. Converted from heparin IV to Apixaban PO.

Code Cowboy called around 1610. Went to the parking lot to assess the patient after having a request for help as physician on call for code cowboy was assisting another patient. Patient wheeled inside to collect vitals. He reported that he was having chest tightness and some shortness of breath. Has never had an allergic reaction to anything but latex, and it was not anaphylaxis. Denied swelling of his lips, tongue, throat and trouble swallowing. Denied rash or itching. Patient's BP was 151/75, HR 100. Physical exam: mildly tachycardic, no murmurs. Lungs, CTA bilaterally. No swelling of lips, tongue, face noted. No rashes. EMSA arrived shortly after vitals were taken and he was assessed. He refused to go to the ER via ambulance, but agreed to let his wife take him for evaluation. No medications were given before he left. No major progression of symptoms before he left with wife in car.

Acute bilateral pulmonary emboli without known risk factors for this condition. Onset of symptoms consistent with acute pulmonary embolism started 2 days after vaccination. Formal diagnosis made on CT chest on 4/13/2021 after worsening symptoms of shortness of breath with exertion prompted evaluation in ER

At 3 months post second COVID-19 vaccine (Moderna), developed onset of intermittent left sided chest pain, syncopal episodes, intermittent vertigo, intermittent SOB, and lethargy. All symptoms can be exertional or non-exertional. Have underwent inpatient hospitalization for the above and undergone multiple testing. Have had a CT of the chest, CXR, echocardiogram, cardiac stress testing (chemical), EKGs, multiple labs, and heart catheterization. All testing has been essentially normal including ruling out inflammatory process.

Pt was administered second Moderna vaccine at 12:55 pm. Pt stood up from seated position at 1:01 pm and fell to floor, unresponsive to touch, verbal commands, noxious stimuli, and sternal rub. O2 satting at 86%, normal HR, at time of fall. At 1:02 RRT was initiated at Health Center. At 1:03, 911 was called. At 1:07, pt had no pulse or respirations for 30 seconds, during which 20x compressions were administered and AED shock was not advised. ROSC at 1:08, unable to obtain VS. Paramedics responded within 10 minutes and took pt to Emergency Room

Patient reported to onsite health clinic to see nurse at 1930. Complaints of not feeling well. Vomited then dyspnea. Went into cardiac arrest, AED used x1. EMS called at 1945. CPR, intubation until 2055. Time of death 2055.

Approximately 48 hours after my second Moderna Vaccine I started experiencing breathing difficulty and shortness of breath. After 58 hours was admitted to emergency room but CT scan of lungs and heart normal. Breathing difficulty continued 24 hours a day until 8 days later in which the breathing difficulty became worse and increased light-headedness occurred On 4/13. A second trip to emergency room happened on 4/13 another CT scan of lungs and heart normal. Breathing difficuly continued until On April 24th I collapsed and blacked out while out for a walk. Was admitted to emergency room on the 24th and remained hospitalized with brain fog, light-headedness, breathing difficulty and sharp pain in right side of chest. Ecco cardio gram test negative. Breathing difficulty, lightleadedness and chest pain have all been steadily increasing since 48 hours after the 2nd Moderna vaccine shot. To date, still no answer as to why this is happening and getting worse.

Patient with no known prior history of coronary artery disease, woke up early morning between 4 and 5 with severe substernal chest discomfort, associated with some dyspnea. He had the 2nd COVID Moderna shot 2 days prior and has been experiencing mild fever, and chills. He did not get relief with ASA and antacid, and elected to come in . ECG at presentation showed left bundle branch block which was not present on previous ECG done in the hospital and stress test 2 years ago. His initial high sensitivity troponin was markedly elevated around 2500 ng/ml, and second set withint next 60 minutes rose to over 4000 ng/ml, consistent with acute coronary syndrome. Urgent coronary angiography was performed which did not reveal any culprit lesion. A stat echocardiogram showed normal EF and valve function. He was observed for 24 hours and discharged without incident on medical therapy.

patient reported facial swelling and L sided droop starting after the 2nd Moderna vaccine he received on Friday 4/23. Noted initially a headache, not localized to any area, and about 8-10 hours after noticed facial swelling bilaterally on eyes, lips, and down to his throat. His L side of the face was also noted to be drooping, the next day, including inability to raise his eyebrow on L, difficulty closing L eye, and a L sided mouth droop. Reports the swelling started to get better just prior to arrival in ED, however is still persistent and includes the lips and throat, says it feels like the inside is swollen. Was able to tolerate liquids but noted some difficulty. Denies any difficulty breathing. Also denies any extremity weakness, vision changes, balance issues, speech deficits other than what's related to lip swelling and mouth droop

Patient states that he ended up in the ER on 4/7/21 and was diagnosed with a stroke. He states no previous health conditions prior to vaccination/stroke. He also states he experienced chills, fatigue, headache, nausea and breathlessness after first dose.

4/5 Night sweats; 4/9 dizziness at work. Admitted to the hospital on 4/20/21 with fever, dry cough, difficulty sleeping, shortness of breath, headaches and muscle aches and pains

Since my 2nd shot, I have had very painful achy joints and muscles, it has been 2 and a half weeks now. Flu like symptoms, diarrhea,dizziness, very weak. Short of breath, low pulse o2.

As a patient with Asthma, Aspirin is a medicine that makes me short of breath. I do not think it is an allergy as such, but a hypersensitivity to Acetylsalysilic Acid. 1 hour after the application of the vaccine, I felt the same symptoms as when I used any component that contains acetylsalysilic acid. In those cases I must apply inhaler. So I did, in 1 hour, I was already better. I didn't need to go to a doctor or hospital.

PATIENT PASSED OUT 30 SECONDS TO 1 MINUTE AFTER RECEIVING VACCINATION. PATIENT'S BREATHING BECAME ABNORMAL AND STARTING TO SOUND LIKE SNORING. AN EPIPEN WAS ADMINISTERED AT THAT TIME. FACILITY EMERGENCY TEAM WAS CALLED. Upon provider/nursing arrival patient was alert and oriented but very pale. Patient denied complaints of shortness of breath, chest pain, racing heart. Patient complained of feeling hot and sweaty. Patient assisted to exam room and vitals obtained and examined by Dr.. Patient to be monitored for 30 minutes after administration by pharmacy department. Pt's significant other is the driver today. Pt will be monitored and released to go home.

Hospitalized after vaccination with acute submassive PE. ASSESSMENT / PLAN: Patient is a 53-year-old male in no significant past medical history who presented with complaints of progressively worsening shortness of breath, chest pressure and was found to have acute submassive pulmonary embolism for which he underwent successful mechanical thrombectomy per Interventional Radiology. Subsequent bilateral lower extremity DVT ultrasound demonstrated acute DVTs in the left popliteal, posterior tibial, peroneal veins. DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute pulmonary embolism, unspecified pulmonary embolism type, unspecified whether acute cor pulmonale present (HCC) [I26.99] HOSPITAL COURSE: The patient is a 53-year-old male in no significant past medical history who is admitted for Acute Saddle Pulmonary Embolism. In the ED, the patient was tachycardic, tachypenic requiring 2 L of O2. CT angiogram thorax showed saddle embolus with extensive bilateral pulmonary emboli and evidence for right heart failure. He was immediately started on IV Heparin. PERT Team was activated and the patient underwent a successful mechanical thrombectomy with IR. Dopplers of the lower extremity showed Left lower popliteal, posterior tibial and peroneal DVTs. After 24 hours of hemodynamically stable vitals, the patient was transition to Eliquis. The patient stay was complicated with elevated blood glucose along with Hba1c of 9.7. Endocrinology was consulted and started the patient with Lantus and LDC. The patient will be discharged with diabetic regimen and followed up with PCP/outpatient Endocrine. The patient was stable, AOx4, without complications and discharged safely to his home with his wife.

Vaccine Received on Wed 3/10/2021. On Saturday - shortness of breath, very elevated resting pulse (by 25 bpm) reduced oxygen saturation (87 on oximeter vs 95), moderate ongoing chest pain. Primary care doctor advised to go to ER. ER visit resulted in misdiagnosis of Heart Attack which was later changed to heart inflammation. Troponin levels elevated and stayed elevated and continue to be elevated 8 weeks later. AFter 8 weeks Troponin levels still elevated and pain occurs upon anything more than modest exercise. Patient has a history as an edurance athlete. All other tests on heart function - stress test/ Ekg, perfusion, echo - show a high peforming heart - no other defects other than heart inflamation.

Patient manifested with flu-like symptoms (myalgias, fatigue, cough, abdominal discomfort, shortness of breath) with high-grade fevers (TMax 103F) approximately 4-6 hours following administration of 2nd Moderna vaccine on 5/4/2021 per patient's wife. The symptoms progressively worsened to the point that he presented to an outside hospital on 5/12/2021 at which time he was found to be tachycardic and febrile (T 103.1F). Labs at that time were notable for significant thrombocytopenia, elevated creatinine, elevated lactate, elevated procalcitonin. Chest imaging showed bilateral airspace disease. CT of the abdomen noted hepatosplenomegaly with no evidence of lymphadenopathy. Echocardiogram showed normal cardiac function. He was empirically started on broad-spectrum antibiotics. Labs on 5/13/2021 were notable for a markedly elevated ferritin level, fasting hypertriglyceridemia, elevated CRP, elevated transaminase levels, hyperbilirubinemia, markedly elevated CXCL-9 level, markedly elevated IL-18 level, normal natural killer cell function. Of note, while his blood and urine cultures were negative, he was found to have elevated EBV viral load on peripheral blood draw. He had a bone marrow biopsy which reportedly showed rare evidence of cells with what appeared to be erythrocytes within their cytoplasm, concerning for HLH. Given strong clinical and serological suspicion for HLH, he was transferred to our hospital for a higher level of care. Upon transfer to our facility on 5/18/2021, his inflammatory markers were persistently elevated. He unfortunately developed worsened renal and respiratory failure, and required both hemodialysis and intubation respectively. He was continued on empiric broad-spectrum antibiotics, however we additionally initiated high-dose steroids as well as anakinra for treatment of HLH. Given EBV viremia, we also began rituximab therapy. He was successfully extubated, however as of 5/26/2021 remains dialysis-dependent with continued improvement in urinary output. His post-intubation course has been complicated by encephalopathy of unknown etiology. We have consulted infectious disease to proceed with a diagnostic lumbar puncture to ascertain potential CNS pathogens explaining the cause of his altered mental status. MRI of the brain showed no evidence of pathology. CNS involvement by HLH remains on our differential.

Patient reported signs and symptoms of SOB/right leg pain 1 week after receiving the Moderna vaccine. He stated that he was "breathing fire" and woke up with an extremely painful and swollen leg. Upon coming to the ED, it was found to be bilateral PE and right leg DVT.

Patient states one day after receiving second dose of the Moderna Vaccine he has been having moderate fatigue and c/o increase sob with running

They diagnosed him with delayed (about 18 Hours) anaphylactic reaction due to the vaccine; His lungs were filled with fluid; After 2nd dose, next day morning at 9AM, he didn't feel well while at work; He had upset stomach; He started feeling light headed while driving/very light headed; When he walked in the house, he was short of breath; Turned gray/about a minute and half later, he turned purple and blue; His oxygen was dropped to low 70s; His BP dropped to 80/50; His entire torso was covered in a rash; Very nauseous; On the way home, he started vomiting; He felt little achy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (They diagnosed him with delayed (about 18 Hours) anaphylactic reaction due to the vaccine) and PULMONARY OEDEMA (His lungs were filled with fluid) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced ANAPHYLACTIC REACTION (They diagnosed him with delayed (about 18 Hours) anaphylactic reaction due to the vaccine) (seriousness criteria hospitalization and medically significant), PULMONARY OEDEMA (His lungs were filled with fluid) (seriousness criteria hospitalization and medically significant), VACCINATION COMPLICATION (After 2nd dose, next day morning at 9AM, he didn't feel well while at work), ABDOMINAL DISCOMFORT (He had upset stomach), DIZZINESS (He started feeling light headed while driving/very light headed), DYSPNOEA (When he walked in the house, he was short of breath), SKIN DISCOLOURATION (Turned gray/about a minute and half later, he turned purple and blue), OXYGEN SATURATION DECREASED (His oxygen was dropped to low 70s), BLOOD PRESSURE DECREASED (His BP dropped to 80/50), RASH (His entire torso was covered in a rash), NAUSEA (Very nauseous), VOMITING (On the way home, he started vomiting) and MYALGIA (He felt little achy). The patient was hospitalized from 13-May-2021 to 14-May-2021 due to ANAPHYLACTIC REACTION and PULMONARY OEDEMA. At the time of the report, ANAPHYLACTIC REACTION (They diagnosed him with delayed (about 18 Hours) anaphylactic reaction due to the vaccine), PULMONARY OEDEMA (His lungs were filled with fluid), VACCINATION COMPLICATION (After 2nd dose, next day morning at 9AM, he didn't feel well while at work), ABDOMINAL DISCOMFORT (He had upset stomach), DIZZINESS (He started feeling light headed while driving/very light headed), DYSPNOEA (When he walked in the house, he was short of breath), SKIN DISCOLOURATION (Turned gray/about a minute and half later, he turned purple and blue), OXYGEN SATURATION DECREASED (His oxygen was dropped to low 70s), BLOOD PRESSURE DECREASED (His BP dropped to 80/50), RASH (His entire torso was covered in a rash), NAUSEA (Very nauseous), VOMITING (On the way home, he started vomiting) and MYALGIA (He felt little achy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2021, Blood pressure measurement: 80/50 (Low) 80/50. On 13-May-2021, Oxygen saturation: low 70s (Low) low 70s. Patient's concomitant medication included nasal spray. He was admitted to the hospital. They diagnosed him with delayed (about 18 Hours) anaphylactic reaction due to the vaccine. The patient was discharged from the hospital on 14-May-2021 evening. The patient was treated with Epi-pen and steroids. 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 had his 2nd Moderna vaccine at pharmacy at 2:00 and was struggling to breathe a few hours later. We were at the emergency room around 6:00pm and he was placed on a ventilator between midnight and 1:00am. He died 10 days later after experiencing clots that led to seizures and congestive heart failure. I have a death certificate if needed.

Terrible insomnia started the same night as 2nd dose of Moderna Vaccine was received. Insomnia would not allow ANY sleep for days and lasted for over a month. Breathing seemed to be labored and hard to get a full breath. Had to purchase a CPAP to allow enough air to be able to sleep. Still can not get a full nights sleep. Developed terrible anxiety which I have never had before. Lost appetite and couldn't eat. Lost 55 pounds in following 3 months. Developed stuffy swollen nose/turbinates which I have never had before. Constantly feel ill and no able to perform daily functions of job or living. Brain fog and fatigue. I continue to deal with this issues to this day, now over 4 months. These all started the same day I received the 2nd dose of the Moderna vaccine.

Seizures; Bood clots; Stuggling to breathe; Struggling to walk; ARDS; Acute hypoxic respiratory failure; Acute exacerbation of heart failure and sepsis; Acute exacerbation of heart failure and sepsis; Cardiac arrest; Blood infection; Fever; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS), ACUTE RESPIRATORY FAILURE (Acute hypoxic respiratory failure), SEPSIS (Acute exacerbation of heart failure and sepsis), CARDIAC FAILURE ACUTE (Acute exacerbation of heart failure and sepsis), CARDIAC ARREST (Cardiac arrest), SEIZURE (Seizures), THROMBOSIS (Bood clots), DYSPNOEA (Stuggling to breathe) and GAIT DISTURBANCE (Struggling to walk) in a 53-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 Obesity. On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) (seriousness criteria death and medically significant), ACUTE RESPIRATORY FAILURE (Acute hypoxic respiratory failure) (seriousness criteria death and medically significant), DYSPNOEA (Stuggling to breathe) (seriousness criterion hospitalization prolonged) and GAIT DISTURBANCE (Struggling to walk) (seriousness criterion hospitalization prolonged). In May 2021, the patient experienced SEPSIS (Acute exacerbation of heart failure and sepsis) (seriousness criteria death and medically significant), CARDIAC FAILURE ACUTE (Acute exacerbation of heart failure and sepsis) (seriousness criteria death and medically significant), CARDIAC ARREST (Cardiac arrest) (seriousness criteria death and medically significant), INFECTION (Blood infection) and PYREXIA (Fever). On 17-May-2021, the patient experienced SEIZURE (Seizures) (seriousness criteria hospitalization prolonged and medically significant) and THROMBOSIS (Bood clots) (seriousness criteria hospitalization prolonged and medically significant). The patient was hospitalized from 15-May-2021 to 25-May-2021 due to DYSPNOEA, GAIT DISTURBANCE, SEIZURE and THROMBOSIS. The patient died on 25-May-2021. The reported cause of death was Cardiac arrest, Acute hypoxic respiratory failure, ards and acute exacerbation of heart failure and sepsis. It is unknown if an autopsy was performed. At the time of death, SEIZURE (Seizures), THROMBOSIS (Bood clots), DYSPNOEA (Stuggling to breathe), GAIT DISTURBANCE (Struggling to walk), INFECTION (Blood infection) and PYREXIA (Fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-May-2021, Blood pressure measurement: elevated (High) Twice normal. On 15-May-2021, Glycosylated haemoglobin: elevated (High) High. On 15-May-2021, Oxygen saturation: low (Low) Required intubation and was placed on ventilator.. On 15-May-2021, SARS-CoV-2 antibody test: negative (Negative) 1 negative COVID antibody test. On 15-May-2021, SARS-CoV-2 test: negatie (Negative) 3 negative COVID antigen tests. No concomitant medications were provided. It was reported that within few hours after second dose of vaccine patient was struggling to walk and to breathe. The reporter and her husband went to see the patient and took him to an emergency room (ER). In the ER his blood pressure was markedly elevated (twice normal) and his oxygen level was low and by midnight he required intubation and was placed on a ventilator. His HbgA1c was noted to be elevated. Two days after admission (17-May-2021), he developed seizures which the medical team believed to be due to blood clots and he was anti-coagulated. It was determined that he did not have blood clots on his heart valves as the source of the clots. The source of the blood clots was never identified. He later developed fever and was diagnosed with a blood infection and treated with antibiotics. At one point his oxygen requirement on the ventilator went down to 65% but later returned and remained at 100%. He ultimately died on 25-May-2021 and as per copy of his death certificate he had 4 causes of death as cardiac arrest, acute hypoxic respiratory failure, acute respiratory distress syndrome (ARDS) and acute exacerbation of heart failure and sepsis. Treatment included, anticoagulants, antibiotics, intubation and ventilator. Very limited information regarding these events has been provided at this time. Further information has been requested. This case was linked to MOD-2021-219410 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Cardiac arrest; Acute hypoxic respiratory failure; ARDS; Acute exacerbation of heart failure and sepsis

She had rashes, worsening concentration and "brain fog" after the vaccine. On 4/14/21, she went to the ED for heart palpitations, shortness of breath, and fatigue for 3 weeks. At that time, she was found to be hyperthyroid.

Heqdache severe throwing up fatigue and outvof breathe alot having vision Horroble headache Chest pain Shortness of breathe Pain all over body

I suffer from lingering SOB with exertion after COVID infection. On the night of 12/31/2020 I began to feel more SOB than usual and was unable to correct my SOB with rescue inhaler. Became more SOB with exacerbated tachycardia and tachypnea, My family had to call 911 because I became aphasic and showing signs of possible stroke. I was taken to the ER and admitted for respiratory recovery and to role out stroke. The stroke was ruled out and I recovered with IV prednisone therapy, twice daily and supplemental oxygen. Released after HR, BP, & respiratory effort returned to normal: 01/03/2021

Headache, Myalgia, Fever, CoughWheeze & Diarrhea Narrative: Took acetominophen. Symptoms improving past 24 hours.

4pm 102.5 - 72-24 93% RA dizzy, nausea, headache, c/o SOB, Acetaminophen 650mg PO given, cooling measures started 6 pm Benadryl 50mg PO, 102.5-72-22 126/62 no c/o SOB, cooling measures, no acute distress noted 8pm 98.7-84-20 140/76 94% RA, no acute distress noted, fluids taken 1-15 1am 101-99-18 93% RA sleeping, Benadryl 50mg PO, Acetaminophen 650mg PO given 730am 97.8-76-18 118/72 94% RA reports feels good, ate 100% of breakfast, acting usual self

Throat tightness, tongue swelling, light headedness. Treated with 50 mg Benadryl po with relief of symptoms in 45 minuets.

Vaccinated 12/29/2020 @ ~0845. At ~7 pm same day, experienced extreme chest tightness and squeezing accompanied by SOB, mostly subsided by 10 pm. Next day, intermittent chest squeezing and SOB. Contacted RN by phone and advised to go to ER. Symptoms minimal to none at time of ER visit on 12/30/2020 @ ~1200. EKG, labs and CXR all negative. Sent home, all symptoms subsided by 12/31/2020.

Patient reports having shortness of breath when he woke the morning of Jan 15th. He contacted his physician and had an office visit. He was reportedly advised by the doctor to purchase a pulse ox and if O2 is lower than 90, he is to go to the ER. Patient experienced SOB for a few days, and has since recovered without further symptoms

Received vaccine at 1615. Within 1 min of receiving vaccine pt c/o "feeling funny", looked flushed. Developed a mild HA and about a min later complained of chest tightness and shortness of breath (subjective only). VS at 1620: 192/89-hr 84, SaO2 99%. Placed supine, placed on O2 @ 1L/Min via NC. EKG done, NSR w/o acute changes or ectopy. HA worsened (sill only mild-mod) and developed pain to back of neck. BP returning toward normal in 5-10 min. VS @ 1630: 154/89-73 w SaO2 100%. Gradually felt better, discharged about an hour later with mild HA and slightly flushed color. It's worth noting that pt has hx of getting "red" easily on any exertion or emotional changes.

Within 1 min of receiving vaccine pt c/o "feeling funny", looked flushed. Developed a mild HA and about a min later complained of chest tightness and shortness of breath (subjective only). VS at 1620: 192/89-hr 84, SaO2 99%. Placed supine, placed on O2 @ 1L/Min via NC. EKG done, NSR w/o acute changes or ectopy. HA worsened (sill only mild-mod) and developed pain to back of neck. BP returning toward normal in 5-10 min. VS @ 1630: 154/89-73 w SaO2 100%. Gradually felt better, discharged about an hour later with mild HA and slightly flushed color. It's worth noting that pt has hx of getting "red" easily on any exertion or emotional changes.

Right hand fingers that I had tendon transfer to started to pull together about 5 min after the shot, Also my breathing became rapid after walking out of the clinic about 30 min after the shot. Was out of breath doing normal work

21st - swollen big toe and upper part of foot - I had swelling but not as bad as first dose of vaccine; some of my joints sore, too. On 26th of January, I had shortness of breath and a little dizzy. It was tolerable but was there. Toe/foot symptoms resolved around January 31st but I did still have shortness of breath up until the 2nd of February. Dr put me on Colchesine and Alloepurinal

I had pain in arm from injection immediately, after injection, which was much different than first dose. But not unexpected. But the adverse symptoms started about 5 hours in or so, i developed a cough, and dyspnea, it was tight in my chest, hard to breathe. the cough was/is (it remains), sometimes hard and raspy, i was a bit wheezy, and I had air hunger, like i could not breathe or get air. if i exhale to strongly i cough, if i talk to much i cough, if i sing i cough, if i inhale too deeply i cough. I also have been very dizzy since the shot and vertigo. I am still coughing and it is 5 days post shot. I started developing headache and severe body pain, pain in my spine, low back and joints. which is expected, but i also had scalp pain and it hurt to be even touched the slightest bit on my scalp and everywhere on my body. I had very stiff neck and eye socket pain as well. I also feel "funny" in my head. LIke dizzy, and vertigo, but also like it is wrapped in a heavy towel and my eyes feel heavy and like i can't see well. my vision is as if it has diminshed. 5 hours after shot cough started, and the dyspnea, i started feeling chills and deep squeezing ache in my arm at jab site, and soon had fever of 100.6, over night it went to 100.8 and i felt terrible, headache, body ache, restless. but next day fever was 102. it remained all day, i had zero energy slept the whole day. no appetite, did not eat anything except a scramble egg which made me nausea. fever remained all day at 101.8. over night. next day temp was 99.8 (my normal is 97.6) and it was 99.8 all day. Cough was persistent and really bad with the dyspnea this whole time and i still have cough 5 days out, just giving a timeline here. by friday, my temp was 98 but i felt extreemly fatigued. I went and got a covid test which was negative. i saw the chiropractor and they helped my back and headache a little bit. went home and rested. cough has lingered, dizzy lingers, chest tight and sob lingers. fatigue lingers. Cough and dyspnea are NOT signs, the sheet i got for V-safe says right on it these are NOT expected.

"s/p 2nd Moderna shot 02/24/2021. arm swelling, feverish, ache, w/o erythema. - f/c/ns, - myalgia, -cough/Wz/SOB, -n/v/d, Smell & taste intact, No rash. Eat/sleep well, BM/Urine OK."

Deep vein thrombosis left calf; Difficulty breathing; Pulmonary Embolism; Felt doggy, sluggish, punky; Arm hurt; A spontaneous report was received from a nurse concerning a 54-year-old, male patient who experienced pulmonary embolism, deep vein thrombosis, vaccination site pain, sluggishness and dyspnoea. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 12-Feb-2021, approximately 2 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient received his vaccine on 12-Feb-2021 and reported that his arm hurt a little for a few days. On 14-Feb2021, he reported that he started feeling sluggish and on 20-Feb-2021 he began to have difficulty breathing and pain in the right lower base of rib cage. He went to urgent care where he was diagnosed with a pulmonary embolism for which he received treatment. On the evening of the same day, he again started having difficulty breathing with pain upon inhalation. He returned to urgent care and was subsequently admitted at 12:30 AM on 21-Feb-2021. That Monday, 22-Feb-2021, a doppler ultrasound revealed a deep vein thrombosis in the left calf. Patient was treated with heparin intravenously (IV). He was discharged 22-Feb-2021. Treatment for the event included Xarelto 20mg twice per day for two weeks and Heparin IV. Action taken with mRNA-1273 in response to the events was not provided/unknown. The outcome of the events, pulmonary embolism, deep vein thrombosis and dyspnea, was considered recovering/resolving as of discharge on 22-Feb-2021. The outcome of the events, vaccination site pain and sluggishness, were considered recovered/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 events, a causal relationship cannot be excluded.

After 1st injection (1/11/21) experienced severe shortness of breath with minimal activity with accelerated heart rate and drop in O2 stat. within 2 days of injection then developed wheezing cough. Primary MD prescribed Augmentin nd prednisone with eventual success. With normal blood work, chest x-ray and negative Covid test all done by 1/15. On 3/9/21 (28) days after second dose (2/11/21) experienced burning and swelling on right leg. Went to Hospital, ER and found extensive blood clots in right leg and saddle pulmonary embolism . Also had 50% Platelet blood count decrese since the 1/15 bloodwork Admitted for 3 nights on heparin dip. Discharge on home Lovenox injections for 30days.

Pt. began having tightness in the throat. 25mg Benadryl PO was administered and pt was monitored for 1 hour. BP:202/112 HR: 78, 93%R/A after treatment BP: 150/79, HR: 83, 98% R/A

Pt presented to the er on 3/12/2021 with c/o 5 days of worsening chest pain and sob. found to have a inferior STEMI and transported to different hospital for urgent angiogram. acute lateral MI found on angio resulting in placement of drug eluding stent

PATIENT WIFE CALLED AND INFORMED PHARMACY PT DEVELOPPED SEIZURE AND DIFFICULTY BREATHING THE EVENING OF HIS FIRST COVID VACCINATION. PT IS NOW BETTER STAYED AT HOME

Vaccine given to patient at 10:30am 4/14/21 and he called main office and left message that evening on nurse voicemail that he had symptoms starting at 4pm- Severe headache, chest pain, SOB, vomiting and diarrhea. Nurse practitioner called him back the next day when returned to office and retrieved messages and called patient back. He reported he has hx of Cardiac and lung problems and that he had a bad reaction to his flu shot when had in past. He replied no to all these questions on the questionaire, and when asked by staff giving the shot. He was advised by Nurse practitioner to go to ER

VTE legs, large intestine, & lungs Narrative: Patient reports received his first COVID vaccine dose of Moderna on 2/17/21 and reports in the early morning of 2/23/21 he began feeling pain in his right side. Patient states he thought his appendix had burst and he went to get checked out. Patient states they ran test and could not determine what was wrong, so he was sent to hospital. Patient states they found clots in his legs, large intestine, and lungs. States he underwent surgery to remove the clot from his large intestine and he now on Eliquis. Patient states he was "perfectly healthy" before receiving the COVID vaccine. Active meds: Ibuprofen 800mg TID for pain, Lidocaine 5% patch; 1 patch daily for 12 hours, and Sodium fluoride 1.1% oral cream; apply to mouth 1-2 times daily when brushing teeth

IMMUNIZATION GIVEN AROUND 10:15AM, APRIL 22, 2021. AROUND 10:30AM SAME DAY, PT COMPLAINED OF NUMBNESS OF LIPS AND SURROUNDING AREAS, TIGHTENING OF THROAT AND ABDOMINAL PAIN. i BROUGHT PATIENT INTO IMMUNIZATION ROOM. HE WAS AMBULATORY WITHOUT ANY ISSUES OR DIFFICULTY. ADMINISTERED 1 DOSE EPI-PEN. CALLED 911. FIRE DEPT AND EMS ARRIVED BEFORE 10 MINUTE WINDOW FOR SECOND EPI-PEN SHOT.

Moderna COVID-19 Vaccine EUA: A few minutes after receiving the vaccine, vaccine recipient developed slight shortness of breath and tingling sensation in mouth/tongue. Vaccine recipient was discharged from the vaccine clinic.

8 days after 2nd moderna covid vaccine kept waking up due to pain upon inhalation. by 2:48 am I could only take shallow, open mouth breathes because it hurt too much to take a deep breath. All mucles were sore, but especially the thigh muscles, headache, chills, temp = 100,

Client had concerns of dizziness, throat tightness, lightheadedness, dry mouth. Onsite EMTs called to the patient. Vitals and blood sugar obtained. Client was given water and allowed to lie on back to rest. Client reported a decrease in throat tightness, still felt dizzy. Client denies any history of anxiety and panic attacks. EMTs performed orthostatics. Client's wife was called to pick the client up. Client states he did not drink water today. Denies SOB or chest tightness. Client states feeling better. Client's wife took the client home and a handwritten note was given to the client excusing him from work. Client left the space.

MY THROAT IMMEDIATELY STARTED TO CLOSE AFTER RECEIVING SHOT #1. MY BLOOD PRESSURE (WHICH I HAVE NEVER HAD HIGH BLOOD PRESSURE) SHOT UP TO 215/120 AND MY HEART RATE SHOT UP TO OVER 115. AFTER PARAMEDICS GAVE ME A BENADRYL, AND AFTER WAITING THERE FOR AN HOUR, I WAS RELEASED TO GO HOME WITH INSTRUCTIONS TO TAKE ANOTHER BENADRYL. I ENDED UP TAKING TWO BENEDRYL WHEN I ARRIVED AT HOME AS MY THROAT WAS ABOUT TO CLOSE. SINCE THEN I HAVE HAD HEART ISSUES (PAIN, TIGHTNESS, HIGH BLOOD PRESSURE, ANGINA). I AM SEEING MY CARDIOLOGIST ON A REGULAR BASIS DUE TO NOW HAVING SMALL ARTERY DISEASE AFTER MODERNA'S COVID-19 SHOT #1.

Patient with past medical history of renal transplant on immunosuppressants received Moderna vaccine on 3/12/21 and 4/9/21. Presented to the hospital on 4/10/21 with worsening shortness of breath, cough, weakness, diarrhea for 5 to 6 days. Admitted for COVID pneumonia. Patient is currently intubated on ventilator.

Patient received 2nd COVID-19 vaccine at 2:11pm. He arrived in observation at 2:25pm. By 2:20 pm, patient was feeling like his throat was tightening and there was a "scratchy" feeling. Patient requested Benadryl because he knew that anaphylaxis was beginning. Benadryl 50 mg IM given in right deltoid muscle immediately. Charge nurse present as well for assistance. At 2:24pm - Pulse ox 97%, Pulse 74 and BP 140/80. Patient remained alert and orientated X3 and denied respiratory distress. Bottle of H20 given per request. 2:40pm - Patient feeling better, remained alert and orientated but feeling tired. Patient states no longer having tightness in throat. BP130/80, HR 70 and PO - 97%. 2:48pm - Patient sleepy but feeling good. 2:54pm - Patient feeling good and ready to go home. Patient lives close by and felt good to drive. Wife at home waiting for him. BP 128/76, HR-70 and PO 97%. Patient denies respiratory distress or any other sign or symptom of anaphylaxis.

Patient brought to attention of staff that he was feeling nauseaus and proceeded to bathroom. Patient reports that he vomited 2 times each a small amt. Patient came out of bathroom and reported that he was feeling short of breath and that the muscles in his neck were tight. He was also feeling itchy and warm throughout body. Brought patient to room for observation and immediately gave epipen to the L quad. This was approx 30 min after administration of Moderna Vaccine 2nd dose. Patient did not have any reactions to the first dose. Patient reported that he felt better almost instantly. Per NP on duty lung sounds were clear to auscultation and with good airflow. VS checked then after epipen admin they were as follows: BP 168/90, HR 80, )2 99% RA. Patient then began to c/o 10/10 headache. Ibuprofen 200mg 2 taps PO were administered with small glass of water. Patient tolerated well. Vitals rechecked 5 min later and were as follows: BP 146/88, HR 77, O2 97% RA. Per facility protocol patient was transferred to ER for further evaluation. EKG taken in ER and was found to be normal. Patient observed for 1.5 hours with no adverse events. Patient discharged home with cetirizine and epipen, education provided by ER staff. Follow up with patients PCP within 1-2 days.

Patient presented for first dose of Moderna vaccination at 12:13. Patient stated that when he rose from the chair, he felt lightheaded. Patient immediately sat down in a chair and subsequently lowered himself to the floor with assistance from a nurse. Patient remained alert and oriented, appeared pale and diaphoretic. Patient denied SOB, C/P, H/A and nausea. BP 160/108, P 69, R 18, O2 96% RA. Respirations are easy and labored, lungs clear on auscultation. Patient on cardiac monitor presenting with normal sinus rhythm. At approximately, 12:20 assisted to a sitting position and patient verbalized feeling better. Patient was then transferred to a wheelchair and continued to be monitored for an additional 15 mins. BP 160/80, P 58, R 18, O2 98%. Patient verbalized that he felt better and his mother was driving him home.

High fever 104 degrees Loss of Taste Loss of smell Body aches Sore throat Nausea Chills Fatigue Shortness of Breath - trouble breathing Headache runny nose

Subsequently developed respiratory distress and pneumonia after testing positive for COVID. Pt died due to illness.

Reports his throat was swelled, he had chest pain in which he took nitro for, tired, sweating both morning and night, and had an upset stomach.

2/20/2021- Non pruritic rash to trunk, arms, chest, hands and thighs. (Unilateral) Went to Emergency Dept and was treated with Benadryl, Solumedrol and Pepcid. 3/4/2021- Started on Prednisone 3/5/2021- Shortness of breath, stridor, edema to lips and periorbital. Treated in the ED with Benadryl, Solumedrol and Pepcid. 5/1/2021- Presented to the ED with cough, facial edema and shortness of breath. Treated with Benadryl, Solumedrol and Pepcid. 5/7/2021- Allergist increased Citirizine dosage to 40mg and started Pepcid daily as maintenance dosing. 5/18/2021- Presented to ED with dysphagia, shortness of breath and facial edema. Treated with Epinephrine, Benadryl, solumedrol and Pepcid. 5/20/2021- Presented to ED with facial/periorbital edema. Treated with solumedrol, pepcid and benadryl. 5/21/2021- Allergist prescribed Singulair (is working on insurance clearance for Xolair also)

Constitutional symptoms including severe fatigue, body aches, headaches, chills, and shortness of breath lasting 4 or more days.

After administration of the vaccine (yesterday), patient began to experience itching at the injection site and slight whelps at the injection site. He said he wasn't feeling great and reported having cold sweats and hot flashes. He also had dry mouth that caused him to have difficulty swallowing. I administered 50mg of diphenhydramine liquid and observed him for over 30 minutes. I checked his blood pressure three times; it was elevated but within what he said was a normal range for him. He had not had anything to eat nor taken his bp meds that am. After 30 minutes, he was feeling some improvement and he and his wife left. I spoke with her later and she said they had gotten something to eat and gone home and he was sleeping. I spoke to him again this morning and he said later in the day he felt like his throat was swelling, but he continued to take diphenhydramine and felt better today. He and I both reported this event to his primary care provider.

Per medical record, the patient complained of a productive coughing, difficult breathing, wheezing an chest pain. His discharge diagnosis was noted to be Saddle embolus of pulmonary artery.

SOB started 5/3/21, got worse today at walking. advise ER - Pt was admitted to hospital because bilat PE.

Second vaccination received 4/17/21. Leg and knee pain/discomfort and some difficulty walking noted six days after vaccination on 4/23/21. Discomfort continued intermittently for several days. Developed rib/side pain and difficulty taking a deep breath on 5/9/21. Went to ER on 5/10/21. Following extensive blood work, x-Ray and CT scan, was diagnosed with multiple bilateral pulmonary emboli. Started treatment on blood thinner (Eliquis) same day and symptoms have improved. Currently under care of a Hospital.

He got his vaccine, had pain on the side of the injection and from there it grew to feeling aches and pains and then the shivers the next day. He has had chills/sweating, fever that comes and goes, difficulty breathing as his nostrils block up, and has wheezing and when he gets up he's light headed and feels like he is going to pass out. At night the symptoms seem to get worse, and thought that he had the flu. He has bought everything for the flu and nothing has helped. He then thought that he may have allergies and bought stuff for that and nothing has helped. He has lost his sense of taste, he is extremely thirsty and could drink a gallon of water and his stomach hurts from drinking but his mouth is extremely dry and his throat is so dry as well. He also has a nasty bad headache that is persistent and at night it gets to the point that he cannot seen and had lost his vision and could no see anything out of his right eye. He called 9-1-1 and refused to go to the ER as he has no insurance and could not afford that kind of bill. Yesterday his headache was so bad that he could not see out of the left eye, he has a fever of 101.5 right now and his head is killing him. He has taken all of his medications that he has, medicated and nothing is helping the pain. His nose is also extremely dry and he has no appetite, and ate last at 5:00 PM yesterday. He also has vomiting, diarrhea, nausea, sweats/chills. He watches his diet carefully due to the diabetes, but has not measured it. He is very concerned about his vision and his fever and headache was so bad that he could not see, and he's worried about that. He also has brain fog as well, and cannot remember things, pounding, pulsating water.

Patient received vaccine, waited for 15 minutes. Just as patient was getting ready to leave, he reported being dizzy and short of breath. Patient reported nausea and became very pale. Vital signs obtained. Epi administered via EPI Pen. Patient reported that he began to feel better. EMS called to transport patient to ED for observation.

I had pericarditis 2 years ago and 4 days after my 2nd dose of Moderna I felt similar symptoms to when I?d had it. They subsided after a day but came back 3 weeks later. Because of my history of having had Pericarditis I had ultrasound and CT Scan and they showed some inflammation. Blood tests showed C-reactive Protein levels high (70). On my own I googled if pericarditis was a side effect from vaccine as it was odd to me that my symptoms started so soon after. I read that there have been rare cases reported recently but mostly in young people and they?ve subsided. Perhaps because I had it two years ago it triggered a recurrent effect. I was prescribed 600 mg ibuprofen as before by Cardiologist and colchicine as before. My PCP suggested I might want to notify you. I thought I should report this given what I read and that I'm 55, so it?s different than other reports you?ve received. I do not know if I have pericarditis again but the symptoms have been identical to when I did and the CRP level increase would suggest so. I had Echo and EKG and heart alright so it's not Myocarditis. Symptoms included: pain in abdomen chest area, pronounced in URQ this time but it migrated, increased when walking or lying down, difficulty sleeping in side, slightly elevated fever 98.9-95 when I?m usually in 96-98 range, breath hiccups, some nausea. Since taking colchicine and ibuprofen have been feeling better, just concerned that this seemed to have recurred, and started exactly 4 day after my 2nd shot.

In February a few weeks after the vaccine, I started to feel more out of breath. I also noticed a change of taste and smell. I went to my general physician and regular follow ups with cardiologist and pulmonologist. They did EKG, Cardio sonogram, usual set of breathing tests and lung CT scan. They increased my dose of Trelegy and cardiologist included Aspirin.

54 year old male with no known past medical history who received 2nd dose of his Moderna COVID vaccine at the end of May 2021 (unsure of actual date). The day after he received his second moderna vaccine he developed polydipsia, polyuria and substantial fatigue in addition to muscle aches, nausea, and malaise. His symptoms initially improved but then slowly worsened again, developing shortness of breath, palpitations, heat intolerance, and continued polyuria, polydipsia. Three days prior to presenting to our hospital (which was 3 weeks after his 2nd vaccine dose), pt developed worsening nausea with vomiting and substantial worsening of shortness of breath. On admission to our hospital, he was found to be in Diabetic ketoacidosis (no prior history of Diabetes, auto-immune Diabetes labs pending) as well has having new pulmonary embolism, Atrial fibrillation with RVR, and hyperthyroidism with anti-tpo abs (other's thyroid antibodies still pending). Given the time course of his presentation, it seems to us that he developed these conditions as a complication of his 2nd dose of the Moderna vaccine.

I started to feel more and more tired kind of lethargic. I went to see my doctor after the first shot because I thought it was stress related from work. I let my doctor know I felt run down. He had some labs done to rule out anything that may be going on. He ultimately ruled everything out as fatigue. After the 2nd shot it was getting harder to sit still my back was bothering me and I was experiencing back pain. I thought it may have been related to a previous back injury from a car accident I had years ago. The tightness got more intense I went to visit my chiropractor and the pain did not get better. I went to see my rheumatologist and I did not need a cortisone shot in my knee for the first time in 3 years. I let him know that I had difficulty standing from my chair. I explained I need to push off in order to stand up. He determined I had myositis. I had an MRI completed and other labs he let me know I had polymyositis. After my first visit Dr. called in a prescription for prednisone and hydroxychloroquine. I went to see Dr. the following business. When I go down the stairs I have to hold the handrail and it is more difficult to walk upstairs. My doctor asked me if I had recently fallen because polymyositis is normally associated with a fall. But I have not fallen as I have been working from home. I had also experienced shortness of breath which I had checked out on 6/22/2021 at Urgent Care in. They recommended I have a CTA completed to rule out PE in my lungs.

I had a lot of pain and aches after the second vaccination. I rested in bed for the whole afternoon and night, and I felt better the next day

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Severe, Systemic: Dizziness Lightheadedness-Severe, Systemic: Exhaustion/Lethargy-Severe, Systemic: Fainting/Unresponsive-Severe, Systemic: Flushed/Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Shakiness-Mild, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe. Additional Details: ER determined patient had a vasovagal syncope episode. At the time of the reaction, patient appeared to have trouble breathing (head back and making noises). I could not find a strong carotid pulse, so 1 dose of epinephrine was given.

5-15 mins after the second dose, I started to feel: shoulder and neck pain (stiff and tight neck) followed by right side headache that traveled in a straight line to the opposite side then pressure towards the eyes, Chest restriction with breathing difficulty quickly followed The ENT on site took my blood pressure which was high (my normal blood pressure is below normal) I was watched for an hour before i felt good enough to drive home. The headaches continued day and night for 4 weeks after the second dose.

I developed severe pain and rushed to ER and after CT Scan, I was found to have blood clot in my lungs on the right side. I was also told by the lung specialist that I have inflammation all around my lungs. I have been on blood thinner since. However, I continuing to feel pain in my both left and right chest. The pain has continued to increase and I feel it all the time. Sometimes more severe when I lie down on my back. I feel the pain all around my ribs and sometimes going down on my lower back. I have also been having headaches and some coughing, however no blood. I am having pains in my joints in my fingers and ankles.

Patient had mild symptoms immediately after injection- his skin felt dry, uncomfortable. Symptoms progressed. ny 5pm (4 hours post vaccination), his voice changed, throat was swelling, lips tingling, congestion in throat, nose. Sought treatment at ED: received Solumedrol, Benadryl and Pepcid. No Epinephrine. Told Anaphylactoid reaction. monitored 4 hours in ED, then discharged to home. FU with PO benadryl. Some congestion persisted 24 hours after event.

Patient fainted and experienced a hard time breathing for 10 mins. Vital signs: BP: uncooperative HR: 110 RR: 24 O2: 90% and Temp: 97.5. He received 3 Ls of oxygen and 911 was called. He was sent to the ER.

PT developed shortness of breath and slight tingling. Sat and drank juice and symptoms resolved after 30 minutes

8pm on 01-14-2021 started to get shortness of breathing, difficult to take in a deep breathe and cough. 2am on 01/15/2021 night sweats, chills, nausea , muscle aches, head ache. 8am on 01/15/2021 fatigue, cough, shortness of breathing and head ache. On 01/16/2021 at 8am cough and some trouble with deep breath. 8am on 01/17/21 trouble taking deep breath.

palpitations, tachycardia, mild dyspnea which lasted several minutes; recurred several hours later then resolved

Developed severe pleuritic chest pain x 5 days, went to ER on 2/5/2021, D Dimer over 4000, CT chest showed bilateral segmental and sub segmental Pulmonary Emboli. Initial Ultrasound of legs was negative for DVT, follow-up U/S on 2/9/2021 was positive for large Femoral vein DVT. All family history, medical history and other risk factors for coagulation disorder was negative. I was initiated on anticoagulation therapy. (Enoxaparin)

bilateral pulmonary embolism; multiple areas of infarct; back pain; ateltheisis; chest pain; left leg pain; deep vein thrombosis; pulmonary effusions; fever; Chills; myalgia; A spontaneous report was received from a physician who was also a 55-year-old, previously healthy male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever/pyrexia, chills, myalgia, chest and back pains, bilateral pulmonary embolism/pulmonary embolism, multiple areas of infarct/pulmonary infarct, ateltheisis/atelectasis, left leg pain, and deep vein thrombosis. The patient's medical history included daily exercise and no personal or family history of clotting issues and no trauma. Products known to have been used by the patient were not provided. On 02 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 039k20-2a) intramuscularly for prophylaxis of COVID-19 infection. On 30 Jan 2021, approximately 28 days after the first dose, and prior to the onset of symptoms, the patient received the second of two planned doses of mRNA-1273 (Lot number: 012m20a) intramuscularly for the prophylaxis of COVID-19 infection. On 30 Jan 2021, the patient reports that for the first 18 hours, he experienced fever, chills and myalgia. On 01 Feb 2021, the patient reports that he thought the myalgia was continuing, as he had pain in his chest and back. The chest pains gradually worsened. On 05 Feb 20221, the patient went to the emergency room and was admitted. He was diagnosed with a pulmonary embolism. He was started on enoxaparin sodium but switched to apixaban. A computerized tomography study of the lungs showed that he had bilateral pulmonary embolism, multiple areas of infarct and atelectasis. His dimer was 4800. COVID-19 test was negative. An echocardiograph was performed, no results were reported. An ultrasound of the legs was performed and ruled out deep vein thrombosis. Date of discharge was not specified. On an unknown date two days after discharge, the patient experienced left leg pain and returned to the emergency department. Patient was diagnosed with deep vein thrombosis that ran the entire length of the femoral artery. Patient was switched back to enoxaparin sodium and taken off the apixaban. A repeat computerized tomography study was done to see if the pulmonary embolism was progressing and it was not, however, it showed pulmonary effusions. All current lab work was reported as normal, except for an increased prothrombin time. COVID-19 test was negative. Patient continues to be followed by a pulmonologist and hematologist. Consent to contact patient, pulmonologist and hematologist was obtained. Action taken with mRNA-1273 was not applicable. The outcome of the events, fever/pyrexia, chills, myalgia, chest and back pains, bilateral pulmonary embolism/pulmonary embolism, multiple areas of infarct/pulmonary infarct, ateltheisis/atelectasis, left leg pain, and deep vein thrombosis, was considered not resolved.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.

red rash on face and red spotson both palm , difficulty in breathing . increase heart rate. muscle pain in lower extremities, loss of appetite, fever , chills.

Developed head and body aches, strong malaise, and brain fog, all more severe than what I had experienced with the actual disease. Unlike during the disease, my hips strongly ached 24 hours after recieving the injection. COVID cough returned though not as bad as when I had the disease, as well as fealing weak and out of breath. All of this lasted for about 36 hours. Feeling a bit better now, but still winded and weak. Still plan to get 2nd shot.

"I received the second Moderna vaccine at a Med Com Camp on morning of 6 Feb. As the day progressed I began to feel body aches, chills, fatigue, rapid heart rate, shortness of breath, and numbness in my neck, arms, and hands. These symptoms are still persisting. The numbness that has since spread throughout my body (from my head to my feet), body joint and muscle pain and burning sensation, muscle cramps and twitching, and continued fatigue. Additionally, I have had a few of episodes of pressure in my eyes and head resulting in vision issues and issues with my hearing"

Mild case of pneumonia; Tested positive for COVID; Shortness of breath; A spontaneous was received from a healthcare facility staff member concerning 55 years of old, male patient who developed shortness of breath, mild case of pneumonia and tested positive for COVID. The patient's medical history included back issue. The patient had an epidural for bulging disk in back in an unknown date in December. Concomitant product use was not provided by the reporter. On 29-JAN-2021, eight days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) on left arm for prophylaxis of COVID-19 infection. On 20-JAN-2021, the patient had COVID symptoms including congestion and cough but tested negative on rapid testing. Since tested negative, the patient received first dose of Moderna COVID-19 vaccine as scheduled on 29-JAN-2021 at Hospital. On 06-FEB-2021 after experiencing shortness of breath, the patient was retested by rapid test, which was also negative. However, the patient tested positive for COVID on Polymerase Chain reaction test at Urgent Care. The patient had a mild case of pneumonia The reporter believes that the patient probably was positive before, as patient had been home since 19-DEC-2020 due to a back issue. Thinks that the patient's son may have been asymptomatic and all eight members in the household tested positive except the reporter. Treatment for the events included antibiotic azithromycin 5 days z-pack. The events shortness of breath, mild case of pneumonia and tested positive for COVID were considered recovered/resolved on an unknown date.; Reporter's Comments: Based on reporter's causality and high probability of corona infection from the close contacts where all eight members in the household were tested positive except the patient immediately before the vaccination, the event is assessed as unlikely related to mRNA-1273.

Patient complained of head pressure behind his sinuses while in observation. Nurse arrived to provide further assessment. Patient was moved to a quiet space and laid down on bed. Pain rated 5/10. Patient alert and oriented x3. Breathing labored and variable. Complained of dry mouth. Pulse rate 72, BP 170/110. Emergency services were called and arrived within five minutes as head pressure severity continued and alertness decreased. Patient was transported to hospital.

Patient developed a rash and proceeded to ER where he was treated and sent home. Patient returned home and then had some difficulty breathing so returned to the hospital where is was admitted for treatment and observation.

3/22 Patient had clinic visit for cough, fever and post nasal drip that started 3/20 evening, tested COVID-19 positive. Patient reported to ER on 3/23 with worsened cough, shortness of breath, fever, myalgias and headache. Noted to be tacycardic with wheezing and rhonchi present, low 90s O2 on room air. Treated with IV fluids, Remdesivir, dexamethasone, oxygen, acetaminophen, duoneb, xopenex, albuterol inhaler

AS SOON AS THE VACCINE WAS ADMINISTERED I WAS WINDED AND FELT TINGLING AROUND MY MOUTH. ON FRIDAY NIGHT I HAD A RACING HEART, WAS HAVING TROUBLE CATCHING MY BREATH AND BLURRY VISION. THAT SETTLED DOWN AFTER 3 HOURS. I WENT TO BED. SATURDAY MORNING AFTER BEING UP FOR ABOUT 1 1/2 HOURS MY HEART STARTED RACING, SHORTNESS OF BREATH AND BLURRY VISION STARTED AGAIN. I WENT TO THE ER . I WAS GIVEN INTRAVENOUS DRUGS TO HELP WITH THE ANXIETY. WAS EXHAUSTED BUT OK FOR SATURDAY AFTERNOON AND EVENING. I DIDN'T TAKE ANY cold medicine OR STEROID MEDICATION ON SATURDAY. SUNDAY MORNING AFTER BEING UP FOR 1 1/2 HOURS IT ALL STARTED AGAIN AND I WENT BACK TO THE ER FOR MORE INTRAVENOUS DRUGS FOR ANXIETY. I WAS GIVEN AN EKG ON BOTH SATURDAY AND SUNDAY TO MAKE SURE I WASN'T HAVING A HEART ATTACK. ON SUNDAY I WAS ALSO GIVEN A CHEST XRAY. SUNDAY I WAS SENT HOME WITH A PRESCRIPTION FOR VALIUM.

Patient could not breathe, was very stiff, sweating, salivating from the mouth, his eyes were rolling in the back of his head, he was incoherent and he could not sit up on his own. I administered an Epi-pen injection and called an ambulance. He was taken to the hospital.

6:30 PM: Strong heart beat, shortness of breath, weakness and sinus pressure. 2 dats latter: Gout in right big toe. Next day and to this date: Shortness of breath climbing steps, joints hurting from waste down. Low energy. Fine body shakes. Require naps. Chest plate hurts when pressed. Waking up often at night while sleeping.

Feeling like heart racing (>100bpm), could feel with hand to chest; accompanied by some shortness of breath. Radial pulse remained normal (70-80bpm) throughout event. Occurred roughly five times over course of three days (4/12-4/14), usually in evenings. Events lasted less than a minute each. Seems to have abated on its own.

rcvd shot 3/25/2021, symptoms started 2 days after ... two days later swollen neck glands , higher bp than usual, numb face...Mar 30 th 6:am faceial numbness, thick tongue, anaphylaxis went to ER, could not breathe , trouble speaking...by the time got to er BP diastolic was about 200. discharged after 4 hrs. Multiple body symptoms since include all over numbness, balance, Balance issues, fatigue, loss of taste, Heat spikes, myoclonus and stare seizures, sense of Euphoria, infusion, many more symptoms, contact me

Patient received first dose of Moderna Covid-19 vaccine on 4/20/21. On 4/21/21, the patient's wife called the pharmacy because she was concerned about his pulse-ox reading. The wife stated that his pulse-ox was 91 and they were checking because he felt similar to how he felt when he had Covid-19 last year. The pharmacist reminded the patient that some flu like symptoms were not uncommon within the first day or two, but also asked for more details and specifically asked about his breathing. The wife stated that his breathing was constricted. The pharmacist advised the wife that if the patient's breathing was constricted that they should contact a doctor or seek medical attention. The wife said she would see how things go but she was not specific on if they were going to seek further help.

patient received second dose of Moderna vaccine on 4/10/2021, and he developed his first symptoms 7 days after. He ultimately came to hospital with sob, diagnosed wtih bilateral PTE. no clots noted in his legs bilaterally. He did well, was on Room Air throughout his stay, which was less than 24 hours and went home on Eliquis for Anti-coagulation.

This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of WHEEZING (Wheezing), BRONCHOSPASM (Had Broncospasms) and DYSPNOEA (Couldn't Control Breathing) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy (did not have previous diagnosis of covid-19.). On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced WHEEZING (Wheezing) (seriousness criterion hospitalization), BRONCHOSPASM (Had Broncospasms) (seriousness criterion hospitalization) and DYSPNOEA (Couldn't Control Breathing) (seriousness criterion hospitalization). The patient was hospitalized from 19-Apr-2021 to 19-Apr-2021 due to BRONCHOSPASM, DYSPNOEA and WHEEZING. At the time of the report, WHEEZING (Wheezing), BRONCHOSPASM (Had Broncospasms) and DYSPNOEA (Couldn't Control Breathing) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient did not experience any events with 1st dose of the vaccine. Patient was treated with albuterol. He was discharged 3 hours later and given prednisone and albuterol. He was advised to take prednisone if required. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Additional document received on 20 Apr 2021 included seriousness criteria updated to serious; 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

About a week after my second dose I had severe muscle pains (legs, hips, back, and jaw) and trouble breathing. I went to my doctor and was tested for the flu and covid19 and various other things and everything came back negative. I was given prednisone and about a week later the symptoms went away.

Breakouts of hives / rashes all over body from head to toe intermittently. Breathing is labored. Taking Benadryl every 4 hours and using steroid cream.

Throat closed could not swallow water, violently threw up 2 min after vaccine was given for over a hour straight, feet welled and dizzy. . Kept on-site for 3 hours after vaccination. has been in bed with a headache and flue symptoms for 3 weeks , intentional severe cramping and constant diarrhea. Severe body aches requiringg pain medication. Still currently having side effects a month later

Client states wheezing, SOB, congestion at x's. Since both shots. States Symptoms since late January (before vaccines). Reports 2 bauts of bronchitis since Covid series. Treated with Steroids, + antibiotics. CXR neg. No CTScan done. Labs neg. States MD felt SX could be related to vaccine. Also treated with albuterol Inhaler.

Received vaccine on 5/26. Difficulty breathing and talking, possible epiglottis swelling occurred on 5/29. Seen by PCP on 6/2, prescribed oral Prednisone 50 mg daily x 10 days for continued SOB.

Patient brought to ED 6/8 am with substernal chest pain onset 6/7 pm. Tests include EKG, chest xray, serial troponin, Chest CT, BNP, d dimer, labs. Patient admitted for further work up which ruled out PE, aortic dissection, pneumothorax. Initial EKG showed ST changes in inferior lead and repeat EKG consistent with pericarditis. CXR showed pulmonary vascular congestion and prominent interstitial markings. WBC showed leukocytosis. Elevated CRP. Patient started on aspirin and colchicine with improvement and discharged home.

Patient complains of shortness of breath, very sore arm, inflamed lymph node under left arm, chills, fever and heart arrhythmias, Patients states he was in perfect health before receiving the Moderna Vaccine. He refuses to go to a doctor for evaluation. The request that I complete VAERS

Has not received 2nd dose; Arm pain; Shoulder blade catch sore muscle\ arm pain; Fatigue; Pain at injection site; Myocarditis; Shortness of breath; weakness; Chest pain; Neck pain; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included DULOXETINE, GLIMEPIRIDE, LISINOPRIL and METFORMIN for an unknown indication. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath), ASTHENIA (weakness), CHEST PAIN (Chest pain), NECK PAIN (Neck pain), PAIN (Arm pain), MYALGIA (Shoulder blade catch sore muscle\ arm pain), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Pain at injection site). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose). On 02-Apr-2021, VACCINATION SITE PAIN (Pain at injection site) had resolved. At the time of the report, MYOCARDITIS (Myocarditis), ASTHENIA (weakness), PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose), MYALGIA (Shoulder blade catch sore muscle\ arm pain) and FATIGUE (Fatigue) outcome was unknown and DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain), NECK PAIN (Neck pain) and PAIN (Arm pain) was resolving. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. No treatment information was provided. Patient stated that he thinks he may have had COVID in Dec2019 or Jan2020. This case concerns a 55-year-old male patient did not receive the second dose 4-6 weeks post first dose of mRNA-1273 product dose omission, .The remaining events are temporarily associated with the product use and hence, a causal relationship cannot be excluded. Myalgia and pain 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: Added new event and updated vaccine dose information.; Sender's Comments: This case concerns a 55-year-old male patient did not receive the second dose 4-6 weeks post first dose of mRNA-1273 product dose omission, .The remaining events are temporarily associated with the product use and hence, a causal relationship cannot be excluded. Myalgia and pain are consistent with the product known safety profile. Product dose omission is not applicable.

difficulty breathing during a regular exercise time and eventually even walking at all due to severe water retention, after visiting my doctor and having an exam as well as an ekg he determined that i was in afib/congestive heart failure. i was sent to a heart doctor who performed a cardio version which did not convert my heart, later i was hospitalized for the afib and water retention and another cardio version was performed and again it was not successful for more than a day. i am currently scheduled for a cardio ablation on 7-9-21.

Over 30 days of Acute asthma crisis requiring every 4 hours albuterol inhaler around the clock as well as other symptom relieving medications. Inhaled steroids. Antihistamine. Oral steroids. Symptoms after 1st injection. 2nd injection not received.

Received 2nd Moderna COVID-19 dose on 5/8. Experienced sore calf and sore groin around 6/17. Woke up morning of 6/21 with lower left leg pain and ended up passing out twice in 20 minutes (15 minutes unaccounted for). Experienced extreme sweating and shortness of breath. Called 9-1-1 and was treated by paramedics, then taken to ER.

15 hours after shot experianced, dizziness, feeling of fainting, difficulty breathing mild pressure chest pain. Was taken to local Er. Ekg, cat scan chest xrays all negitive. Blood work negitive. No past history of symptoms

Pt diagnosed with COVID-19 on 12/9/2020 (symptom onset 12/6). Had fully recovered and completed isolation period. Had vaccine on 12/27, developed fatigue, dry cough and mild SOB after that. Developed chest pain (substernal stabbing discomfort) on 12/28 and presented to ED on 12/29. Work up was benign. Pt discharge home that same night.

01/16 RN called patient for status after vaccination. Pt reported fatigue, diarrhea, shortness of breath, temporary loss of taste, sweaty during the night, headache, vomiting for first 3 days after vaccination, however did not seek medical attention. 01/18 patient was called back today for status by this nurse and he states he is still having fatigue, loss of taste, headache. Pt encouraged to come in to see provider. He agreed and is on his way to be seen in clinic this morning.

Approximately 1:10pm began sweating profusely. Complaints of SOB and throat "scratchy". Increased respiratory rate noted in the 30's. Breath sounds diminished bilaterally. Gray pallor. Given epi 3mg at approximately 1:15pm with positive response. Transported via ambulance to hospital.

Moderna COVID vaccine dose 2 received 1/25/21. Started experiencing L arm pain, fatigue, HA, chills, body aches, chest pressure and SOB on 1/26/21. Could not say whether or not chest pressure and SOB were related to vaccine. Sent to ED same day. ED returned person to work on 1/29/21.

Patient received Covid19 vaccine at 3:20pm to the left upper arm, and seated in front of myself (CNP) for monitoring. At 3:40Ppm, he stated that his throat felt tight, and he placed his hands to his neck. He had his epinephrine pen in his pocket. I injected 3mg IM to left upper thigh, and 50mg diphenhydramine IM to right upper arm. 911 was already activated by another staff member. Vital signs were monitored during entire event, and were stable. EMS arrived at 3:45pm, and transported patient to ER. Patient reported that he felt much better when he was taken by EMS.

Patient was seen by provider today with symptoms of low oxygenation, malaise, shortness of breath, cough, congestion, left arm pain where vaccination was received and jaw pain. Patient received Covid vaccine (Moderna) on Tuesday, Jan. 26, 2021. Seen by provider on Friday, Jan. 29, 2021 with symptoms. He was evaluated and it was decided that he be taken to the emergency room for further evaluation and monitoring.

First dose (Moderna) received 12/30/2020 - reaction 12/31 - 1/1. " Flu like sx: severe fatigue, chills, SOB, felt like hear racing" : was tested for COVID on 1/6 , reportedly negative & for Flu B . F/u with PCP, who dx'd with 'atypical flu' - sx su,bsequChills,Fatigue

January 31-Feb1 Fever to 102.7, muscle rigidity, spasm and pain, bone pain over entire body lasting 7 hours overnight, tylenol 1000mg fever broke and pain subsided. Wanted to call 911. Feb 1st muscle pain increased during the morning and by noon fever of 102.5 with extreme fatigue, tylenol 1000 mg, unable to work. Injection site intense pain radiating down to wrist. Feb1st overnight sweats and bone pain, muscle pain tylenol 1000mg, injection site pain and redness appearing similar to a sunburn near injection site, swelling of lymph nodes under right arm with pain. Headache, moderate to intense. Feb 2nd fever to 100.5 with moderation of the above symptoms. Asthma chest tightness, asthma related productive cough. Tylenol 500mg every 3-4 hours, working from home. Headache continues moderate level. Feb 3rd, no fever all symptoms continue with injection site pain, new increased asthma related wheezing. Tylenol 500 mg every 4 hours. Headache continues with fatigue. Feb 4th, no fever, symptoms moderating, asthma and allergy symptoms increasing. Fatigue increasing. Itching of injection site. Feb 5-current. No fever pain in injection site and lymph node area is moderating, still with Fatigue, Headache, Asthma and allergy symptoms staying steady with period of increased levels. Tylenol 500 mg 6-8 times a day.

Found lying face down without respiration or pulse, believed to be within 5 minutes of event. ACLS procedures unsuccessful. Unable to get autopsy. Believed to be heart attack secondary to COVID infection, but unconfirmed. Relative contribution of recent vaccination unknown.

2 days post vaccination, client began experiences fever, chills, severe headaches, severe body aches, joint pain, nausea and shortness of breath. Still experiencing symptoms at this time. Has taken Advil with some relief.

My arm was sore. Then I had fatigue and then at about 14 hours after the injection, I started having chills - like I had temperature with hot and cold chills. I got very cold; my blood pressure dropped - I happened to have a doctor appt the day following the vaccine - the bottom level was very low of my blood pressure - it was 45. I couldn't warm up - my extremities were very cold. I had chest pain and it felt like my heart rate was going in an out of atrial fibulation. I had shortness of breath. I measured my blood oxygen concentration and had dropped down to 90%. I didn't sleep well because I was so chilled and not feeling well. I felt like I had a bad flu. I rested the next day (10th) the symptoms slowly went away between 10 am and 1:00. At 3:00 pm, I saw my pain doctor and I told him about it but I was feeling much better although blood pressure was low. Fatigue lasted for 3-5 days afterwards but it wasn't anything last the first 24 hours. I didn't go to ER because it seemed to resolve itself in the day.

ABOUT 1/2 HOUR AFTER THE VACCINATION THE PATIENT REPORTED THAT HE WAS FEELING LIKE AN ALERGIC REACTION WAS STARTING AND LIKE HE MAY BE EXPERIENCEING A LITTLE SWELLING AND DIDN'T WANT IT TO PROGRESS TO DIFFICULTY BREATHING. 50 MG OF BENADRYL WAS TAKEN AT 4:30 PM AND THE PATIENT WAS MONITORED BY A PHARMACIST FOR 30 MINUTES AT WHICH TIME HE FELT LIKE IT WAS SUBSIDING. AT 5PM HE WAS MOVED FROM THE IMMUNIZATION ROOM TO THE GENERAL POST COVID VACCINATION AREA AND MONITORED. THE PATIENT HAD BROUGHT AN EPI-PEN WITH HIM TO THE APPOINTMENT BUT IT HAD EXPIRED IN 2014. WE CALLED HIS PRIMARY CARE WHO PRESCRIBED A NEW EPIPEN RX FOR THE PATIENT WITH INSTRUCTIONS THAT IF ANY FURTHER SYMPTOMS STARTED THE PATIENT SHOULD GET EMERGENCY SERVICES. AT 6PM THE PATIENT SAID HE FELT WELL ENOUGH TO LEAVE.

Within 30-60 minutes after vaccination he experienced numbness of his lips and face following by rapid onset of swelling of the lips and face. He then developed a rapid heart beat with shortness of breath. He then developed a lump in his throat with a throat closing sensation with worsening of shortness of breath. He elected to stay home without seeking medical attention. The shortness of breath attenuated over the next few hours but rapid heart rate continued for two more days

At approximately 11:45 p.m. I began to experience shortness of breath difficulty breathing - my throat began to swell up - and my heart was racing. Symptoms subsided after 90 minutes-2 hours

After about 24hrs severe headache, hot and cold sweats and Asthma that I did not have since I was kid. Felt like being hit by a bus. Severe muscle ache all over my body. Asthma subsided after about 18 hours. Today (2 day after vaccination) still coughing with substance. But definitely better. If the second shot is going to be worse - not sure I want it!

Leg pain Shortness of breath , rapid heart rate , Dizziness , Nights sweat Symptoms started March 24 .Went to Urgent care April 2, they referred me to the ER . I went to the Hospital ER April 6 , They admitted me at noon after finding Blood Clot down my right Leg and Chest . 2 shots of Lovinox for 3 to for days

In about 1.5 hours after the shot my throat started swelling up and making it very difficult to swallow but my airway was fine so i didnt get any treatment . This swallowing issue lasted about 4-5 hours then went away . After the swallowing issue i was getting dizzy for 3-4 hours randomly and that started about 4 hours after the shot and went away the same night and no treatment was sought .

Hairy throat, swollen tongue, ichy eye on the inside, throat close off, Given 50 mg Benedryl with water before it got worse. Epi pen was opened and prepared for use. Not needed Occurred 10 minutes after injection. Held at pharmacy for 2.5 hours for reduced symptoms before being allowed to leave. Took 50 mg Benedryl 4 hours later and at 6:00 am next day. Primary care physician notified and he prescribed Epi pen for relapse or further need.

Presented to the ER on 3/19 at 23:57 with 2 days of worsening shortness of breath. HR 60, Pulse Ox: 85% on Room air. Placed on BiPAP. could not maintain oxygen, intubated. The patient rapidly decompensated and went into cardiac arrest with PEA. ACLS performed for 35 minutes without the ability to reverse. Patient expired at 0222 on 3/20/21.

2nd dose Moderna administered on Feb 3rd, fatigue/ shortness of breath week of Feb 23rd, admitted to Hospital on March 1st, spent 18 days in ICU, developed Blood CLOTS which one attached to lung, blood clots In left leg as well, no family history of blood clots and no injuries to cause blood clots.

Previously diagnosed with Covid PNA in 11/2020 that was treated with course of Remdesivir and steroids, has 2 negative covid tests in the interim. He received his first Moderna COVID vaccine on 1/4/2021, but did not get the second dose. He had recently been hospitalized at a healthcare provider for COPD/CHF exacerbation was discharged 4/13/2021, returned this morning with URI symptoms, found to by hypoxic with O2 sats in the 80s, encephalopathic, and Covid test was subsequently positive (4/15/2021). Pt transferred that evening to our hospital for ICU level care.

Patient care coordinator on PCP team learned of patient death, as documented: TC to pt family for a welfare ck d/t co-worker mentioned saw in social media pt had passed? PCC-spoke with pt daughter states father passed on 4/18/2021 in the PM unknown exact time of death at home. PCC gave family condolences for their loss. Patient reports father got covid-19 vaccine on 4/13/2021 and he started having severe HA's on this day. Sx increased for the next few days, he had dry cough,sore throat,chest pain,SOB. States father declined for family to called an ambulance while sx were increasing. States ambulance was called on Sunday 4/18/2021 to take body to the morgue. States they are awaiting for autopsy results,and death certificate. States father's body will be taken to his family. On what date did they pass away? 418/2021 unknown time, at home Do you know what the cause was? Family is not sure of cause of death

Patient received first dose of Moderna COVID-19 vaccine. Vaccine given 1511. Patient complained of SOB and sweating. Patient had syncope, urinary incontinence, and nonbloody vomiting. Patient was seen by Dr. and EMS. Patient refused to be transported to ED. Patient's wife drove their car but within 20 yards, car stopped and patient vomited again. Patient re-encouraged to go to ED and got into EMS vehicle but then demanded to be let out and go home. Patient's wife then drove patient home.

Patient started complaining of being short of breath, weak and dizzy a day or two after receiving the shot. He started taking the asthma inhaler constantly rather than just once in months. He lay down for a nap and never woke up exactly 3 weeks after getting the shot. (more exact details will need to come from his wife).

Family friend of the wife, called our pharmacy on 04/28/2021 and reported that wife's appointment would need to be canceled for 04/29/2021 because her spouse passed away the previous night. This prompted our staff to look further and it was noted that her spouse, received his first Moderna vaccine on 4/26/2021 at our pharmacy. Friend was not reporting his death due to the belief that the injection was the cause. Only to report, so upcoming appointment for his wife could be canceled. It was reported to our Medical staff that Patient n has Chronic COPD and had difficulty breathing on the evening of 4/27/2021 and was taken to the hospital where he later passed away. Patient was on portable oxygen and resembled shortness of breath while ambulating at the time of his vaccination appointment on 4/26/2021. Patient immediately recovered from Shortness of Breath once seated in exam room for injection for a few minutes.

Difficulty breathing. Not severe enough to warrant emergency treatment but needed to put effort into breathing. When I tried to fall asleep I was woken instantly because I stopped breathing. This lasted about 12 hours Severe headache - did not take any medication. Lasted 36 hours Nauseous - did not take any medication. Lasted 36 hours

Fluctuating temperature. Had a fever for 3 hours from 11 PM to 2 AM after the first shot that would range from 100 to 103. After the second shot, has had fatigue, body aches, shortness of breath, dizziness, memory loss, seizures, temperature fluctuations from as high as 104.9 to a normal temperature of 97.6 and then back up again within the span of hours. So far, have not had a fever free day for 45 days straight.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Mild

Pt presented with tongue and throat swelling associated with scattered hives. Pt was treated for anaphylaxis and responded to IM epinephrine x1. He was observed in the emergency department and then discharged safely.

sometime between 4:30 and 5:00 PM (1-1.5 hours after the vaccination) Patient felt bad and went to take his BP with a monitor. He passed out before he took it and woke up face down in carpet with a bloody nose and had urinated on himself. He called his daughter for help. Upon her arrival, he passed out several times, complained of severe headaches, had severe vomiting, has trouble breathing, pain shot up up his neck and face, his BP reading was around 83/60 with a heart beat of 45. The Ambulance service arrived an confirmed he was having an active stemi heart attack. He was taken to hospital where the heart attack was confirmed again and he was taken immediately to the Cath Lab to have a stent placed. He was placed in ICU

diagnosed with bilateral Pulmonary Emboli on 5/11 (8 days later). Patient had immediate fatigue, myalgias and shortness of breath on exertion the day following his vaccination until the diagnosis of PE.

Patient had reaction to COVID-19 vaccine. Patient was monitored after COVID-19 vaccine as recommended per guidelines. The following reaction signs/symptoms were observed: difficulty swallowing, wheezing, stridor and other tongue swelling Emergency response notified: EMS (911) EpiPen administered by Nurse Required reporting completed?: Yes Report given to EMS (911) Pt received second Moderna Covid vaccine today. At 1319 EMT and Nurses responded to call from parking lot that pt "feels like cheeks are swelling on the inside". Responders took pt's vitals: BP 130/90, HR 60, SpO2 98%. Responders kept monitoring pt. At 1350 pt stated that his tongue was swelling, responders noted thick speech, wheezes bilaterally upon auscultation of his lungs, striderous squeaks to throat, and pt stated he couldn't swallow. Nurse administered epi pen per order and protocol in pt's L thigh and called EMS immediately. Responders took pt's vitals as follows: HR 68, SpO2 98% and stayed with pt while waiting for EMS. EMS arrived and pt report was given to EMS at 1356, noted that pt's speech was improving at 1402, EMS stabilized pt and drove away with pt at 1410.

12 hours after first injection - arm pain, severe headache that lasted multiple days. 15 hours after second injection awoke from sleep severe difficulty breathing, uncontrol able chills, fever, that lasted 2-3 hours. Difficulty breathing continued but was helped by rescue inhaler and regular inhaler (had not used either in over a year . 24 hours later, still having difficulty breathing , headache and severe ringing in both ears, spoke with my primary doctor that informed me these type of reactions are expected and will go away. Suffered daily with these conditions and the following Friday night severe difficulty breathing and went to Emergency room the following morning as Dr and walk in could not see me as I had "Potential Covid 19 condition". Hospital ER conducted a covid test that was negative and gave me a nebulizer treatment and started me on prednisone.

Unclear if related to vaccine, but just reporting: Chest cold> Head cold> low fever, fatigue, difficulty breathing> vertigo. Symptoms have changed from one to another but going on 3 weeks now.

-First week: Cough (with some mucous); hazing chest; some shortness of breath (exhaling); headache; joint pains (fingers, angles, spinal, toes, knee); body aches; fatigue; sleepiness; some dizziness; swollen feet and legs, -Second week: Cough (with some mucous); hazing chest; some shortness of breath (exhaling); headache; joint pains (fingers, angles, spinal, toes, knee); body aches; fatigue; sleepiness; some dizziness; swollen feet and legs, -Third week: Cough (with some mucous); hazing chest; some shortness of breath (exhaling); headache; joint pains (fingers, angles, spinal, toes, knee); body aches; fatigue; sleepiness; some dizziness; swollen feet and legs, -Fourth weeks: Cough (with some mucous); hazing chest; some shortness of breath (exhaling); joint pains (fingers, angles, spinal, toes, knee); body aches; fatigue; sleepiness; some dizziness; swollen feet and legs,

Short term (6-10 hours) low grade fever after first dose. Vomiting, fever (100-102.5) for 2-3 days after second dose; difficulty breathing. Four weeks after second dose, chest pain, low-grade fever, and difficulty breating.

TOOK MY 1ST SHOT 3/25/21, 3/26 STARTED FEELING LAZY AND VERY TIRED AT THE END OF THE DAY, WENT HOME WENT TO BED. 3/27 WORK UP BREATHING HEAVY WENT TO WORK LEFT WORK AFTER 4 HOURS WENT HOME WENT TO BED. WOKE UP AROUND 2:00PM TRIED TO START MY WEED EATER AND COULDN'T CATCH MY BREATH. CHECKED MY OXYGEN LEVEL IT WAS 78 WENT TO THE HOSPITAL MY OXYGEN LEVEL WAS 84 ADMITTED TO HOSPITAL STAYED THERE TILL 4/2 WENT HOME WITH OXYGEN WENT TO UK HOSPITAL ON 4/4 ADMITTED THAT DAY AND RELEASED 4/15.

Admitted to Tri-Valley Medical/Stanford in Pleasanton, CA for shortness of breath and chest pain, on June 1st. Diagonosed with Pulmonary Embolism in Right Lung. Admitted to Tri-Valley Medical/Stanford in Pleasanton, CA on June 14th for shortness of breath and chest pain, later diagnosed with a Heart Block

Can't even walk; Couldn't catch his breath; fatigue; Acute hypoxy respiratory failure; Pleuritic chest pain; Red ithcy eyes; HS pneumonitis; Decreased level of conciousness; ILD; non necrotizing granuloma; Flushing; Pulse ox reading in the 70's; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RESPIRATORY FAILURE (Acute hypoxy respiratory failure), CHEST PAIN (Pleuritic chest pain), OCULAR HYPERAEMIA (Red ithcy eyes), HYPERSENSITIVITY PNEUMONITIS (HS pneumonitis), DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of conciousness), INTERSTITIAL LUNG DISEASE (ILD), PULMONARY GRANULOMA (non necrotizing granuloma), FLUSHING (Flushing), OXYGEN SATURATION DECREASED (Pulse ox reading in the 70's), GAIT INABILITY (Can't even walk), DYSPNOEA (Couldn't catch his breath) and FATIGUE (fatigue) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. No adverse event reported. The patient's past medical history included Type 2 diabetes mellitus. Previously administered products included for an unreported indication: Accupril in 1996 and Accupril. Past adverse reactions to the above products included Ankle swelling with Accupril; and Knee swelling with Accupril. Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYZAAR) for Blood pressure, METFORMIN, SERTRALINE, CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]), IBUPROFEN, TADALAFIL (CIALIS), INSULIN LISPRO, CALCIUM, COLECALCIFEROL (CALCIUM VITAMIN D) and INSULIN GLARGINE (BASAGLAR KWIKPEN) for an unknown indication. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced OXYGEN SATURATION DECREASED (Pulse ox reading in the 70's) (seriousness criterion medically significant), GAIT INABILITY (Can't even walk) (seriousness criterion hospitalization), DYSPNOEA (Couldn't catch his breath) (seriousness criterion hospitalization) and FATIGUE (fatigue) (seriousness criterion hospitalization). On an unknown date, the patient experienced RESPIRATORY FAILURE (Acute hypoxy respiratory failure) (seriousness criteria hospitalization and medically significant), CHEST PAIN (Pleuritic chest pain) (seriousness criterion hospitalization), OCULAR HYPERAEMIA (Red ithcy eyes) (seriousness criterion hospitalization), HYPERSENSITIVITY PNEUMONITIS (HS pneumonitis) (seriousness criteria hospitalization and medically significant), DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of conciousness) (seriousness criteria hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (ILD) (seriousness criteria hospitalization and medically significant), PULMONARY GRANULOMA (non necrotizing granuloma) (seriousness criterion hospitalization) and FLUSHING (Flushing) (seriousness criterion hospitalization). The patient was hospitalized from 27-Mar-2021 to 02-Apr-2021 due to CHEST PAIN, DEPRESSED LEVEL OF CONSCIOUSNESS, FLUSHING, HYPERSENSITIVITY PNEUMONITIS, INTERSTITIAL LUNG DISEASE, OCULAR HYPERAEMIA, PULMONARY GRANULOMA and RESPIRATORY FAILURE. At the time of the report, RESPIRATORY FAILURE (Acute hypoxy respiratory failure), CHEST PAIN (Pleuritic chest pain), OCULAR HYPERAEMIA (Red ithcy eyes), HYPERSENSITIVITY PNEUMONITIS (HS pneumonitis), DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of conciousness), INTERSTITIAL LUNG DISEASE (ILD), PULMONARY GRANULOMA (non necrotizing granuloma), FLUSHING (Flushing), OXYGEN SATURATION DECREASED (Pulse ox reading in the 70's), GAIT INABILITY (Can't even walk), DYSPNOEA (Couldn't catch his breath) and FATIGUE (fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Glycosylated haemoglobin: 7.6. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment While hospitalized, the consumer was started on 100mg Prednisone, now at 60mg of Prednisone, calcium, vitamin D, insulin lispro, protonix, bactrim, and is currently on oxygen. Concomitant medications Glucometer, Insullin pen and Lansets. Company Comment: Although a temporal association exists, provided information is not adequate to assess the causal association between the event and mRNA-1273. The detailed medical history and diagnostic report has not been provided. Causality is also confounded by the patient's comorbidities. Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow-up received on 09/6/21: New event added: Acute hypoxy respiratory failure, Pleuritic chest pain, Red ithcy eyes, HS pneumonitis, Decreased level of consciousness, ILD, non necrotizing granuloma and Flushing.; Sender's Comments: Although a temporal association exists, provided information is not adequate to assess the causal association between the event and mRNA-1273. The detailed medical history and diagnostic report has not been provided. Causality is also confounded by the patient's comorbidities.

Rash on right arm, gradually turning into bruising, resolved after 2 weeks Developed intermittent shortness of breath on 05/30/2021 intermittent joint pains

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient left the store after waiting designated time after injection. Came back about 20 min later saying that he felt dizzy and like his throat was tightening (similar to when he was given penicillin in the past). He refused epinephrine and an ambulance. He did take a Benadryl and said he was going straight to the ER. Will contact patient to follow up.

5/15/21 - 2nd Moderna shot given to me. No reaction 1st 15 minutes. 5/15/21 - small fever in the evening 5/16/21 In bed all day with Fever and Fatigue. 5/20/21 Becoming short of breathe going upstairs in my residence. Complained to my wife after a couple of days saying I was getting winded just climbing the stairs. I thought maybe it was common chest cold. 5/29/21 1:00 am - woke up to 102 degree fever. Fever went down to 99 and up to 100.8 over the next 4 days cycling throughout the day and night. Shortness of breath was getting a little worse and it would take 10 seconds to recover going up the stairs in my home, after several deep breathes. June 1st, I went to CVC pharmacy to take a COVID19 test. The scheduled me for the next morning, June 2, 2021 at 10:00 am. I completed that test and returned home. At about 2:00 - 2:30 pm, I stood up from the couch and walked out to my front porch. I bent over to pick up some light items from the porch so the gardener could trim the bushes near the porch. As I walked to the garage (main front 2 car entrance), I suddenly became very short of breathe, my heart began racing, and I could not get a full breathe. I walked slowly inside my house and used my blood pressure cuff and oximeter. Blood pressure was at 170/121 heart rate 112, and the oximeter showed oxygen level 75 %SPo2 with heart rate 110. I was taken directly to the Emergency Room where X-ray and CT scans showed I had numerous blood clots throughout my lung arteries. I am on oxygen and blood thinners for an indefinite amount of time.

I had a Lifeline screening ( they did an EKG and a Carotid and Blood tests on me) after the vaccine- I got a odd reading on a c-reactive protein - inflammation and infection in the body - Can get those records from them. Started taking my blood pressure and I noticed thing weren't right with my heart. I went to my doctor his office clinic they are moving their office, though next month) with a federally funded program for the testosterone replacement therapy- he had give me testosterone replacement therapy which I have since stopped with recommendation by the cardiologist - it makes my blood very thick ) and he told me I had A-Fib - gave me samples of Xarelto and he said to come back on Monday and confirmed the A-Fib. doctor cardiologist and he confirmed A-Fib and recommended a procedure - to reset the heart with the paddles - I haven't done that yet. Since then, I have had chronic fatigue, heart palpitations, difficulty breathing; I think it's related to my heart. I am taking naps every day. I wake up and I'm just wasted. I go run errands and then I'm exhausted. Chronic fatigue. I will be seeing my brand new primary care doctor on Thursday and I want to talk to Doctor provided me with a whole bunch of diagnoses for all of it. They are saying on the diagnoses paperwork that I could have "blood cancer." But it could come from TRT treatment. Dental at first and then went to Affordable Dental - Periodontal work done - there was an infection there and they gave me antibiotic mouthwash. I will be going back in three months. I have not recovered from A-Fib - have to get Cardio Version test and I have chronic fatigue - it comes and goes. The blood cancer - I haven't had a chance to talk to anyone about it yet and no one has been in touch with me about it. I went to Hospital ER the other day - mostly to get a more accurate diagnosis - I do have chemical disorder history in past. I had mental confusion - it was chemical - it was just like what I had in 2000. But hospital misdiagnosed it.

He presented to the emergency room at Hospital 4/16/21 with chest pain and shortness of breath. D-dimer was elevated. Bilateral pulmonary embolism diagnosed by CT 4/16/21

12 hours after began to have a scratch throat. at 13 hours post dose, had a headache start and an unusual erythematous spot on the posterior palate above Uvula with almost a white scratch appearance inside the erythema. 16 hours post dose began to have fevers and chills. At 17 hours had severe sweats that soaked the bed with rigorous chills including teeth chattering shaking chills. Took 800mg ibuprofen and went back to sleep. Poor sleep with many awakenings. Woke 22 hours post dose with no fevers or chills any longer but had headache that is different than my usual migraines or tension headaches. Took 2 Fioricet with minimal change in headache. Felt off for most of the day, and felt warm and achy. Next night of sleep was again restless with some sweating beyond usual and awakened with swelling feeling in throat during the night. Woke 46 hours post dose with headache again, as well as substantial uvula and soft palate edema with mild erythematous appearance. The swelling gave me a fullness felling that made it hard to swallow and felt like my voice was changed. I have had this same uvula edema in the past with rare allergic reactions to food, and flower that I once smelled. The Uvula looks like a water filled ballon. NO nodes in the neck. The injection site has had mild induration, and swelling and has been itchy. Headaches have persisted to a moderate extent. Uvula Swelling has persisted to the point that I took a dose of prednisone 52 hours post vaccine. It is now 54 hours post dose and I just feel a bit off, swollen uvula, headache and itchy vaccine site.

presents with sudden onset of subjective fever, chills, headache, n/d/ since yesterday. received a COVID vaccine at the end of Dec 2020. denies chest pain, sob, abd pain. supposes to have 2nd vaccine on 28 Jan 2021.

FATIGUE, HA, CHILLS, JOINT PAIN, TENDER LOCAL LYMPH NODE TO SIDE OF INJ, PAIN INJ SITE, COUGH, SOB, SORETHROAT, LOSS OF TASTE/SMELL,

(first 24 hours) extreme fatigue, severe headache, photosensitivity, nausea and loss of appetite, muscle aches, joint pain, neck and back aches, swollen/puffy eyes, loss of color, sudden and extreme feelings of being cold and unable to warm self, extreme shacking /muscle spasms, shooting pain like lightning in feet when moved, labored breathing, 102 temperature, (next 24) severe headache, major fatigue, loss of appetite, body, muscle aches, Joint pain. loss of color (next 12) feeling hot and sweating, headache, inability to be comfortable to sleep, color loss

Subjective 57 y.o. male who was seen at COVID Vaccine Clinic today for his second dose of the COVID 19 vaccination. He was given the Moderna vaccination in the right deltoid muscle. During his 15 minute waiting period after the injection, the patient began to experience Right sided chest discomfort, mild shortness of breath and intermittent dizziness. He denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and he was then assessed in the emergency area. Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting. patient denies any previous cardiac history but does have Asthma. Chest discomfort did not worsen with activity and actually improved some per his report. ALLERGY REVIEW OF SYSTEMS: Patient complains of chest tightness (Right side, no radiation) and dizziness (Intermittent) Previous Reactions: None Objective Vitals Vitals: 02/05/21 1009 02/05/21 1019 BP: 136/83 130/83 Pulse: 70 62 Resp: 14 SpO2: 98% 98% Physical Exam Vitals signs reviewed. Constitutional: General: He is not in acute distress. Appearance: He is not diaphoretic. Cardiovascular: Rate and Rhythm: Normal rate. Heart sounds: Normal heart sounds. No murmur. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Neurological: Mental Status: He is alert. Assessment/Plan Treatment included: albuterol, water and Acetaminophen Follow up response to treatment: Excellent Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) Symptoms developed just prior to patient leaving, started visit at 10:05 am, self administered albuterol at 10:10am. Self administered Acetaminophen 1,000 mg at 10:24 AM, Symptoms resolved and patient discharged around 10:30 AM. History of anxiety. Showed great relief of symptoms with use of his personal Albuterol inhaler and 1,000 mg of Acetaminophen (also his own). Symptoms completely subsided prior to discharge.

sore throat, congestion, fever. 01/02/2021: COVID positive. Given Balmlinivimab and Decadron. Admitted to hospital through ER on !/5/2021 with chest tightness and shortness of breath. Throughout stay given Cardizem, Amiodarone without conversion. 1/5/2021 1800 transported by ambulance to medical center. Cardioverted at medical center.

At 10:45 am on 02/11/2021 begin to have difficulty speaking. Reports the symptom as "losing his voice". He states that the symptom continued to get worse and at 11:15 am he could not speak and was experiencing shortness of breath and throat tightness. He was taken to the local emergency room by another staff member. Does report he has had a history of having a anaphylatic response but not to a vaccine. He does not have a epinephrine pen prescribed to him.

02/10/21 received the shot in right arm - pain at site of injection, developed headache; 02/11/21 woke up with nausea, tiredness, headache, pain in arm - symptoms continued 4 days; 02/14/21 developed itching all over body- itching lasted one day, severe joint pain in right shoulder continued 4 days; 02/18/21 mild joint pain in right shoulder, mild pain started again in right shoulder, itching and rash developed at injection site; 02/19/21 woke up in night due to pain in chest and back when breathing in, this continued through the day so contacted doctor's office was was told to go to ER to get checked, went to ER 3:30 pm - Diagnosis chest pain, unspecified, pleurisy; 02/21/21 pain in chest with breathes continues

Developed Shortness of Breath about four days after being vaccinated. Went to the ER 2/21. Had bloody fluid removed from around his heart or lung 2/22//2021.

Moderna Covid-19 Vaccine EUA - 3/6/2021 Went to hospital at 4pm because I was coughing up blood and having a hard time breathing. Air lifted to another Hospital. admitted 19:00 hrs. Chest X-rays 2 sets, CT Scan, Ultrasound, Bloodwork and 2 Covid-19 test. I was told i had pnuemonia followin first chest x-ray on 03/06/2021. on 03/07/2021 after CT Scan and 2nd chest x-ray I was told I did not have pnuemonia or Bronchitus. I was dischrged on 03/08/2021. I have shortness of breath with little to no energy. I am not retired. I own a business and have not been sick until 03/06/2021

Myalgias, nausea, vomiting, weakness, SOB. Most likely secondary to his ESRD and missing dialysis on Saturday (1 day after receiving his 2nd dose of vaccine) but given the relation to his vaccination can not rule out vaccine adverse event.

A stroke occurred approximately 3 hrs after receiving vaccine. He was flown by helicopter to Medical Center. He had dysphasia which did resolve by the time he was admitted into the ER. He has since had CHF and Afib and is now on anticoagulation and diuretics. He continues to have problems with CHF, SOB, weakness and is undergoing treatment as outpatient. He is now followed by Cardiology, Neurology.

Patient c/o tickle in throat, SOB, and noted to have flushing. LVN brought patient to RN observation room for further assessment. Patient reported numbness of face/tongue, sensation of throat swelling, and coughing began at 12:47. Patient initial vs reading at BP elevated 195/109, PR 103, Resp 20, O2 sat 98%. Allergist on-call consulted, and patient given epi x1, 2 puffs albuterol, and Diphenhydramine 25mg PO with slight improvement. 911 called for transport to ED and further evaluation and treatment. Requested ED and patient wife requested to go to Hospital. Paramedics informed closest hospital for transport would be ED and patient agreed to transfer to Hospital ED.

pt states his tongue has been sore and swollen since about 9 hours after getting the vax. Pt is also having issues with SOB, and being short tempered and has had these symptoms for about 36 hours. Pt can barely speak because of his tongue being swollen and it does not seem to be getting any better. Pt will contact his PCP.

Elevated heart rate of 145. Elevated respiration. Severe joint pain. Body ached. Fatigue. All symptoms continued for st least 24 hours. Taking Tylenol and plenty of water.

A previous event was submitted 03/22/21 VAERS. Employee was seen in the ER initially for chest pain and under the care of a doctor. He his not working at this time. He reports additional symptoms of bilateral ankle swelling, Shortness of breath and easily fatigue, which he states he did not have before the vaccine. Employee reports his doctor believe it is a negative reaction to the Covid-19 Moderna Vaccine.