Moderna

Presented about 60 hours after 2nd moderna vaccine with crushing chest pain and was found to have acute pericarditis and a troponin of 10.

Adverse event reported by nurse . Per RN report, early this morning the patient's mother heard him call out. When she entered his bedroom she observed "the tail end of a Grand Mal seizure." RN notes that the mother reported symptoms such as stiffness and flailing which was thought to be consistent with a tonic-clonic seizure. Patient was not incontinent, but did experience a period of confusion following the episode, thought be a post-ictal period. EMS was summoned at 8:10am and transported the patient to the emergency department for assessment. RN reports that the patient has no previous history of seizure. Symptoms have resolved and RN reports that the patient has had no recurrent symptoms or seizures while in the emergency department.

Patient noted on form that he had a severe reaction to peanuts which causes him to have anaphylaxis. He stated that he does carry an EpiPen and any time anything with peanuts touches his mouth/lips he immediately notices his throat starting to close. He also is allergic to cats. Before administering the vaccine, the patient noted that he does not like needles and was not going to look. I administered the vaccine and the patient and I exited the vaccination room. I explained that he should sit in the waiting area for about 30 minutes due to his severe allergic reaction in the past. By the time that I walked back into the pharmacy, the patient's wife shouted "He's not breathing!". My technicians called 911 while I grabbed an EpiPen and rushed to the patient. I immediately administered a 0.3 mg dose of epinephrine and observed that the patient had passed out, was not breathing, but had a pulse. A few seconds later he regained consciousness and his breathing was erratic. I gave him water and he stated that he felt very lightheaded and dizzy. I instructed him to remain seated. He also noted that his vision was blurry and he saw a black dot. His wife was fanning him to cool him down while I tried to obtain the patient's blood pressure, but could not get a reading. The paramedics came and evaluated him thoroughly. His blood pressure, heart rate, EKG, and blood sugar were all within normal limits. They determined that the syncope was most likely due to the patient not eating during the day and not liking needles. The patient was feeling much better and declined further medical treatment, including going to the hospital. He was instructed to go home and relax.

Per provider notes, 26-year old male was brought to the emergency room after he had an out of the hospital cardiac arrest/seizure. Mother of patient provided initial history. Patient received his first COVID vaccine 2 days ago and the next day he started complaining of some chest pain. Patient woke up on the 15th, mother made breakfast and acting normal. Mother went up to room and found him unresponsive foaming at the mouth and may have been shaking. Paramedics arrived and started CPR and noted he was in V fib and shocked once into an organized rhythm. Patient experienced another seizure in the ED. Patient's family was positive for COVID in January. Patient was tested then and tested positive at hospital. Cycle threshold was 39.9. Patient was intubated initially yet extubated on 4/16/2021

Grand Mal Seizure on March 19. 2021 at 7:00 am - Ambulance arrived to take patient to the hospital. and Grand Mal Seizure on April 11, 2021 at 8:00 am - Guardian knew of event so kept patient home.

Found dead on May 3, 2021. Question day of death 05/01/2021. Medical examiners case. Cause pending, possible SUDEP.

Sudden cardiac death. After vaccine patient experienced headache, chills, fatigue, chest pain and did not seek medical care. He had a witnessed cardiac arrest less than 3 days after vaccine #2.

The patient presented 2 days after receiving the 2nd Moderna Vaccine with worsening acute onset right-sided lower chest pain and right upper quadrant abdominal pain associated with shortness of breath. CT pulmonary embolus protocol showed subsegmental pulmonary embolus with evidence of pulmonary infarcts for which the patient was started on an anticoagulant. An echocardiogram showed a mild to moderate decrease in LV systolic function with global hypokinesis. Cardiac MRI findings were consistent with acute myopericarditis with underlying non-ischemic cardiomyopathy disproportionate to the degree of myocarditis. The patient was discharged on a beta-blocker.

Experienced fever, body aches and chills 3 days after receiving the 2nd dose. Around 9 o'clock in the evening I started having palpitations. Heart rate reached 170 bpm, tracked by my apple watch. Went to the ER. I was diagnosed with sepsis. Fever was 102.7, HR wouldn't drop below 105bpm. Procalcitonin and lactic acid were all elevated. I was given 5 liters of fluids that night. Was then started on Vancomycin and cefepime the following morning. I was in the hospital for 2 nights.

Following administration of the vaccine, the patient and his wife were seated and I requested they remain seated for 15 min after because I had recently had someone with a fear of needles collapse after their shot, at which point I had already counseled on the things to expect afterward but the patient stopped responding and slumped over. I was unsure if he was breathing as his wife was cradling his head, so I shouted for a technician to call 911. I heard a sound that I perceived to be wheezing and administered an epipen at which point the patients limbs began to contract so I then suspected it was a seizure. We lowered the patient to the ground and shortly after he became responsive. He was able to state his name and date of birth and breathing was unlabored. Pulse ox was 98 and HR was 88 BPM before EMS arrived. They examined the patient and determined it was "anxiety induced response" but also noted that the bloodpressure was "very low" which is consistent with anaphylaxis, but I did not examine the patient at that time. He was sent home afterward.

Presented to emergency department on 6/5/2021 with chest pain. He was found to be COVID-19 positive at that time and was treated for pneumonia. During admission, he was found to be in atrial fibrillation and possible myopericarditis. Patient improved clinically and was discharged to home on 6/14/2021.

Had AFib a couple days after receiving first shot of the Moderna vaccine. Heart felt like it was beating out of my chest, took a EKG on my watch, and it said that I had AFib heart rhythm.

Subendocardial Myocardial Infarction three days after the second dose. Heart function appears preserved.

THE PATIENT CALLED AND SAID HE WAS IN THE EMERGENCY ROOM ON WEDNESDAY MORNING 4-14-21 BECAUSE OF SEVERE CHEST PAIN. THE PATIENT STATED HE HAD A HEART ATTACK AND HIS TROPONIN LEVELS WERE ELEVATED. THIS IS ALL THE INFORMATION WE HAVE RECEIVED

Heart attack; Fever; Chills; Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 27-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. On 11-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 11-Apr-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Severe headache). On 14-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown and PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Severe headache) was resolving. Concomitant product use was not provided by the reporter. The patient forced himself to his place of employment for work on Tuesday 13Apr2021 and left work around 2PM. By that afternoon he felt terrible. He went to bed and woke up around 4am Wednesday 14Apr2021 with severe chest pain where he was rushed to the emergency room. Then they confirmed the patient had a heart-attack with no other offending agent besides the vaccine. It was not confirmed if the patient is on any other medication regularly. Treatment medications included Tylenol and Motrin alternating for fever, chills and headache. Action taken with mRNA-1273 in response to the events was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

I do not know the individuals medical hx or illness/complications. Due to new information circulating related to mRNA vaccines and myocarditis/pericarditis and being made aware that this person had suffered cardiac arrest after being admit to the hospital following complications with their health it warrants being reported regardless of prior health conditions.

Approximately 3 days after receiving the 2nd dose of the Moderna COVID-19 vaccine, this patient developed chest pain. He presented to the hospital where subsequent testing revealed pericarditis and myocarditis. Workup included EKG, labs, CTA of coronaries. His symptoms improved by time of discharge. He followed up as an outpatient and underwent cardiac MRI which confirmed diagnosis of myocarditis.

Patient developed myocarditis and required admission to Hospital 4 days after second dose of Moderna vaccine. An EKG obtained in the ER showed diffuse ST elevations versus early repolarization 6/7/21. The troponin checked in the ER came back to be positive for an acute myocardial infarction. He was emergently taken to cardiac catheterization lab 6/7/21 where his coronary angiogram was negative for significant coronary artery disease. His pre-discharge LVEF was normal.

pt had a massive stroke at 6:15 pm on 3/23/2021 when he was using the bathroom trying to have a bowl movement. He used his phone to text his mom to tell her he had a seizure. He was slurring, vomiting, and falling down. Ambulance was called. He was transport him to Hospital. Pt was aspirating. He was never treated as a stroke patient. He was monitored overnight. On 3/24/2021 the ER physician had a phone consult w/ a neurologist. He was referred to be transferred to another hospital. He was was being bagged in transit to hospital. He went into the ER stroke unit. Dr. called mother to let her know that if he didn't have emergency brain surgery he would die. Mother told him to save her son. He survived brain surgery and was put in the Neuro ICU. On 4/3 He was transferred to the Stroke Team floor. On 4/8 he was transferred to Rehabilitation Hospital. He will be at this location for weeks or months.

C/O throat swelling Gave IM benadryl at 3:05 O2 Sat 99%, BP 142/82, HR 51, RR: 18 Drank water and continued c/o throat swelling Gave EpiPen at 3:13 O2 Sat 98%, BP 160/108, HR 51, RR: 22 went to Hospital at 4:13 O2 Sat 100%, BP 182/99, HR 84, RR: 16

Associate administering the vaccine accidently stuck her left pointer finger after administration of the vaccine when attempting to close the needle safety device. She drew blood.

Three days after patient received Moderna COVID-19 vaccine shot 1, He went to ER complaining of heart palpitation. Patient were diagnosed of A-Fib. Patient were discharged on the same day with prescription of Flecainide 150mg to be used as needed for heart emergency. Patient didn't use the medicine and is doing ok. Patient stated that they have received the second shot on 06/17/2021at pharmacy with no adverse reaction.

Felt like fainting; Nervous after the second shot; Dizzy after first and second shot; Rhabdomyolysis; heart rate increased; Malaise; Tired with normal activity after the second shot; This spontaneous case was reported by a consumer and describes the occurrence of RHABDOMYOLYSIS (Rhabdomyolysis) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Emotional distress (upset about his parents) on 27-Apr-2021. On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced DIZZINESS (Dizzy after first and second shot) and FATIGUE (Tired with normal activity after the second shot). April 2021, the patient experienced RHABDOMYOLYSIS (Rhabdomyolysis) (seriousness criterion medically significant), HEART RATE INCREASED (heart rate increased) and MALAISE (Malaise). On 27-Apr-2021, the patient experienced PRESYNCOPE (Felt like fainting) and NERVOUSNESS (Nervous after the second shot). The patient was treated with ALPRAZOLAM on 27-Apr-2021 for Anxiety, at an unspecified dose and frequency. At the time of the report, PRESYNCOPE (Felt like fainting), NERVOUSNESS (Nervous after the second shot), DIZZINESS (Dizzy after first and second shot), RHABDOMYOLYSIS (Rhabdomyolysis), HEART RATE INCREASED (heart rate increased), MALAISE (Malaise) and FATIGUE (Tired with normal activity after the second shot) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Blood pressure measurement: 148/90 (High) Blood pressure at rest was 148/90 for the entire day. On 27-Apr-2021, Heart rate: 140 (High) Felt his heart in chest beating fast 140. Concomitant product information was not provided. On 27-Apr-2021, the patient visited an emergency room (ER) where he was prescribed an anxiety medication. The patient reported he thought he might have myocarditis after hearing about it on the news. 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-2021-243062 (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.

Heart Attack; Somebody stab me in the back; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart Attack) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Family history included Diabetic (Some members of his family are Diabetic, but he is not.) since an unknown date. Concomitant products included PANTOPRAZOLE, METOPROLOL SUCCINATE (TOPROL), ATORVASTATIN CALCIUM (LIPITROL [ATORVASTATIN CALCIUM]) and TICAGRELOR (BRILINTA) for an unknown indication. 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 14-May-2021, the patient experienced MYOCARDIAL INFARCTION (Heart Attack) (seriousness criteria hospitalization and medically significant) and BACK PAIN (Somebody stab me in the back). The patient was hospitalized from 14-May-2021 to 16-May-2021 due to MYOCARDIAL INFARCTION. The patient was treated with Surgery (Operation on 14-May-2021) for Myocardial infarction. On 14-May-2021, MYOCARDIAL INFARCTION (Heart Attack) and BACK PAIN (Somebody stab me in the back) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: an enzyme was high (abnormal) An Enzyme was high normal value is around 0.01 and he had it on 2. Concomitant medications included one additional unspecified medication. 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.

ventricular fibrillation cardiac arrest. Witnessed collapse. Bystander CPR performed. Paramedics performed ACLS with defibrillation x 6 before ROSC

Patient come in to our office to get the first dose of COVID-19 vaccine on 01/15/21 . Allergies reviewed first , all documented properly . Patient reported that he wake up on the same vaccine date at 11:55 pm with pruritus in the trunk and back , he turn on the light and looking for a mirror to see what happen . He saw multiples hives in the trunk , back , inguinal area , internal area of the thigh , also he felt and saw swelling in the lips and trouble to swallow , denied difficulty to breath or chest pain .Patient immediately take 2 tablets of Cetirizine 10 mg orally and went to sleep, next day he felt better ....continued

Shortness of breath that resulted in ER visit, patient was treated for URI/Pneumonia with changes on xray (atelectasis but infection cannot be r/o) treated with azithromycin and albuterol, symptoms are improving

Increased bruising approximately 4 weeks after 1st Covid vaccine, on 3/16/2021. CBC with severe thrombocytopenia, platelet count 11k. Started on dexamethasone 40mg by mouth daily x 4 days with Prilosec 20mg.

Within a minute patient became pale, cool and dripping sweat (pea size) from entire body. He stated "I don't feel well". He remained alert and oriented during the time period. Blood pressure 54/40 within 3 minutes; administered contents of Epi-pen 0.3 mg IM in left lateral thigh at 2:22pm and Benadryl 50mg IM in Right lateral thigh. At 2:27 blood pressure 104/54 Heart rate 89; His color was a little pinker and stop forming the balls of sweat. EMS arrived at 2:32 pm and took over. Patient express to EMS attendant that he did this once before when the lab tech had to draw blood. EMS took him to the local Hospital

HISTORY OF PRESENT ILLNESS Patient is a 29 y.o. with a history that includes # Asthma # Diabetes, recently diagnosed # Obstructive sleep apnea # Remote pulmonary embolism, no longer on anticoagulation who presented to the ED with worsening shortness of breath in the setting of known COVID-19, since admitted to Hospital for acute hypoxemic respiratory failure secondary to COVID-19 viral pneumonia. History herein is derived from patient interview and review of the electronic medical record. patient developed fever, cough, and shortness of breath approximately one week ago. These symptoms developed very shortly after he received his first dose of the Moderna vaccine. He initially attributed these symptoms to side effects of the vaccine. When they persisted, however, he called his primary care physician who recommended that he seek evaluation. He was evaluated at an urgent care on 3/30 where he tested positive for COVID-19. His shortness of breath progressed, and he presented to the ED on 3/31 for evaluation. CTPE was negative for PE but did demonstrate viral pneumonia. Ambulatory pulse oximetry was negative for desaturation. He was discharged home. Since discharge, his symptoms have continued to progress. He was planned to receive monoclonal antibody earlier today, 4/2, however when he presented for his infusion he was found to be hypoxic to 89% and tachycardic to 130s. He was sent to the ED for evaluation. He continues to have diaphoresis and chills although believes his fever has improved. He has some chest tightness with deep inspiration. He otherwise denies unusual headache, sore throat, productive cough, chest pressure, abdominal pain, flank pain, dysuria, and diarrhea. He reports that his PE was provoked by obesity and a lengthy plane flight in 2017. He was on anticoagulation for 8 months and has since been off. On arrival to ED, VS AF, HR 122, RR 30s, BP 120/90, SpO2 97% on RA. He was in significant respiratory distress and was therefore placed on HHFNC with improvement. VBG 7.42/39 and lactate 3.9. CMP w/ AST 40, ALT 40, AG 15. Serum creatinine elevated at 1.13 from baseline 1.0. CBC w/ WBC 5.6, HGB 17.7, PLT 257. HS troponin 10 -> 8. Given his hypoxemia and history of pulmonary embolism, CTPE was performed and negative for PE however did demonstrate bilateral consolidations consistent with COVID-19 viral pneumonia. Procalcitonin was negative. He was given dexamethasone. He was also given 500 mL LR with clearance of lactate. He was admitted to Hospital in stable condition.

A patient who is deaf passed out almost immediately after receiving 1st dose of Moderna while sitting in the vaccination chair. The vaccinating nurse called for help and a nearby vaccinating nurse came to the patient's side. The patient was not breathing and the charge nurse was called over. The charge nurse asked other nurses to call 911. The vaccinating nurse was performing sternal rub on the patient and he was coming in and out of consciousness. The emergency cot was moved to the patient and the patient was laid on it with his legs up and he regained consciousness. Vitals were taken at 1:53 PM B/P 149/79 HR 57 Temp 98.2 Resp 0 O2 96% and again at 2:03 pm B/P 128/76 HR 69 Resp 16 O2 98%. EMS arrived at 2:05 PM and the patient refused transport to the hospital with his husband serving as interpreter for EMS. Patient left with husband. His gait was steady and no further interventions were needed.

PATIENT DEVELOP CARDIOGENIC SHOCK AFTER RECEIVED FIRST DOSE OF MODERNA VACCINE ON THURSDAY 29 2021 PATIENT DIED

Lethargy began the day of vaccine and shortness of breath along with abdominal and chest pain followed the next day. Decedent was found deceased the next evening.

Patient presented to the ED on 5/3/21 with sharp chest pain since 5/1/21. He had received his second dose of Moderna COVID-19 vaccine on 4/15/21. The patient was diagnosed with gout approximately 1 week prior and had been placed on prednisone. The patient was found to have ST elevation MI with myocarditis along with cardiogenic shock. He was managed in the CCU requiring IV dobutamine and IV furosemide. Patient was transferred to secondary Medical Center on 5/4/21 for advanced heart failure therapy

The patient presented to his PCP's office with a 2 day history of chest pain associated with deep inhalation NOT relieved by heat or Tylenol. He was vaccinated with the Moderna COVID vaccine on May 5th which caused fevers and sore throat that resolved. His pleuritic left sided chest pain began 11 days from vaccination. Given the symptoms, the PCP ordered a CXR and d-dimer. Because of the elevated d-dimer and tachycardia while in the office, she ordered a CT chest for PE protocol. This showed bilateral pulmonary emboli so the patient was directed to the ER. He was admitted and started on anticoagulation therapy. Given the CT chest findings of adenopathy, Hemotalogy-Oncology service was consulted and ordered labs.

After receiving second dose of vaccine, complained of stomach pain and feeling "bloated." Later had muscle pain, insomnia, and nausea. Found dead at home on 6/1.

I was diagnosed with a blood clot ( Deep Vein Thrombosis) in my left leg after the event of my vaccine. No family history and clean bill of health. Am now on Eliquis blood thinners to ease the pain and reduce my blood clot. Seeing a hematologist in a few days

Father of patient came to store pharmacy to inform us of his son's passing. He stated patient died 5 days after receiving his Moderna vaccine on 6/13/2021 due to blood in the lungs. He stated the autopsy has not been done yet to confirm his death, however he was curious of the possibility. I contacted Moderna on July 8th at 4:30pm and spoke to a pharmaceutical representative of Moderna regarding possible side effects of the vaccine.

passed away; blood in lungs; This spontaneous case was reported by a pharmacist and describes the occurrence of DEATH (passed away) and PULMONARY HAEMORRHAGE (blood in lungs) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, the patient experienced DEATH (passed away) (seriousness criteria death and medically significant) and PULMONARY HAEMORRHAGE (blood in lungs) (seriousness criteria death and medically significant). The patient died on 18-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. 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 relevant concomitant medications were reported. No treatment information was provided. Company Comment: Very limited information regarding the events has been provided at this time. Further information is expected.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information is expected.; Reported Cause(s) of Death: unknown cause of death

Patient had 4 hours of chest pain 3 days after vaccine. EKG showed STEMI. Troponin elevated at 4.8. Patient sent for cardiac catheterization and results pending. At this time suspect myocarditis, but STEMI not yet excluded

Heart palpitations. Fast heart beat. 99-120. 95 when at rest. Up to 130 when stabding or moving from laying position. Chest pain heart area.

Anaphylaxis, severe body rash with hives that?s spread all over upper and lower body, along with neck and face.

Patient lives with family in private residence with parents and 2 siblings. Spends most of time in own room. First family member diagnosed with COVID-19 on 12/21 2020, the other 3 family members diagnosed with symptomatic mild COVID on 12/26/2020. Parents are healthcare providers and used specific informed diligent protective strategies to prevent infection in patient with minimal close contact and gloves, masks. Patient never had symptoms and was not tested for COVID.. Had first vaccine dose on 1/16. On 1/17 had shaking chills with temp to 101.3F, gone on 1/18.. No other overt reactions. Subsequently in usual state of health. On 2/15 he developed vomiting and fever with progressive abdominal pain and transient wheezing. Outpatient testing for SARS-CoV2 was negative and full respiratory pathogen panel (including SARS-CoV2) also negative. With worsening fever to 40.2C and abdominal pain, was admitted on 2/18. Found to have high leukocyte count, low lymphocyte count and transaminitis. CT imaging with terminal ileitis, thought possibly infectious but extended GI pathogen panel negative. Experienced persisting daily high grade fevers to up to 39.1.C. Developed transaminitis and hypotension and was transferred to intensive care unit on 2/21. Was intubated for hypoxia, agitation, required levophed, large volume resuscitation and empiric antimicrobials. Had transient AKI. Antimicrobials stopped on 2/22 with negative cultures. Colonoscopy performed with leal biopsy of identified ulcerative disease with focal active enteritis without specific etiology identified by stains. Ferritin rose to 24,000 with hypertriglyceridemia and thought to have possible HLH and underwent bone marrow biopsy which showed leukocytosis and lymphopenia, and rare hemophagocytosis. Dobutamine was started for low LVEF and levophed weaned. High dose dexamethasone started on 2/23 and pressor further reduced, dobutamine weaned to off on 2/25. Extubated on 2/24. Febrile still to 39 on 2/24 and with leukocytosis but transaminases, ferritin and triglycerides improving. Discussion ongoing about HLH vs macrophage activation syndrome. Currently meets 4 criteria for HLH with soluble IL-2R and NK activity pending.

Systemic: Allergic: Anaphylaxis-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild

Systemic: Allergic: Anaphylaxis-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild

Experienced anaphylaxis. Similar to what I experience for peanuts. Symptoms: Difficulty swallowing, indigestion, high pulse

Patient presented to ED 3/25/21 for left sided chest pressure about 3 days post Moderna dose #2. Troponin elevated but patient had normal ECG. Patient admitted to the hospital for NSTEMI. Cardiac cath done 3/26 showed no obstruction. Patient had resolution of chest pain during stay and was discharged on 3/28. Discharge diagnosis myocarditis, discharged on ibuprofen tapering dose.

Patient presented to ER severely hypothermic, and disoriented and what appeared to be sepsis with a leukocytosis. Workup was negative for any cause of infection and was even seen by infectious disease. Patient had received his first Moderna vaccine that morning, and had no prior exposure to Covid 19 virus.

Achiness, fatigue, and mild nausea on 4/7/21 (day of second vaccination). Chest pain, fever, achiness, fatigue, mild nausea on 4/8/21. Symptoms mostly subsided on 4/9, so I returned to work at 3:00 pm. By about 5:00 pm, the crest pain returned and worsened until I went home, and then to the hospital around 7:00 pm. Tests were done before I was diagnosed with "acute myocarditis, elevated troponin level, coagulopathy, NSTEMI (non-ST elevated myocardial infarction)", told I likely had a heart attack, and was put on a Heparin drip and kept for additional testing and observation until 4/11/21 at approximately 5:00 pm. Official notes state

irregular periods: after having the COVID19 vaccine, she read about this happening to other women, vet reports having 2 weeks of vaginal bleeding, despite having the Nuvaring in, she reports having a normal period 3 weeks ago, but had started bleeding again and not normal spotting but having what she describes as a full period. Vet reports she had always had random spotting between periods, that was light and not every cycle. Vet reports that she would sometimes keep the nuvaring in for 4 weeks to skip periods, sometimes. She was advised she May replace immediately with new ring after 21 days, to skip period for up to 3-4 months at a time, but she will have increased spotting risk when attempting to skip periods. Vet wants to continue the Nuva ring. Vet agrees to vaginal ultrasound and will report any problems with ongoing bleeding, or if she had pain, so that gyn referral could be placed.

Shortness of breath, burning in chest, not feeling well since second vaccine dose. Now admitted with acute hypoxemic respiratory failure with PULMONARY EMBOLI and pulmonary infiltrates that are suspicious for COVID 19 with + Ab testing but many negative PCRs.

Got shot Thursday May 6th, ran 103 degree temp Friday, Saturday had temp of 100 and felt like was going to pass out once around lunch, then a dizzy spell. Sunday morning (6:00 am) presented with chest pain for about ten minutes that subsided. Sunday night/ Monday morning at approximately midnight (12:00 am) presented again with chest pain that continued as we sought medical attention from local fire department, to which an ambulance was called, meds were given and diagnosis was heart attack from labs drawn at hospital. Took him back for a heart cath and there was no blockage. From everything I was told they couldn't figure out what caused the chest pain. He spent 2 days in CCU. He discharged Wednesday the 12th of May. He is now on Plavix, Coreg, a low dose aspirin, and Atorvastatin.

On 05/27/2021 the decedent began complaining of shortness of breath, cough, fever, chills, and pain at the injection site. On 05/28/2021 the decedent complained of the same symptoms.

Thrombocytopenia and Purpura consistent with Immune Thrombocytopenic Purpura. Awaits specialist evaluation and treatment plan.

Bruising that spread and didn?t heal, eventually went to doctor and was found to have ITP with a blood platelet count of 4

My son had been complaining of racing heart and became a week after the first dose of Moderna then started vomiting once or twice a week thereafter I tried to get him to go the doctor but he kept saying he was ok. He said he feels like something was wrong but didn?t know what. He received his second dose of moderna 6/13/2021, 5 days later on 6/18/2021 he didn?t feel well laid down around 9 pm was checked on at 9:21 he was unresponsive no heart beat no breathing 911 was called. They resuscitated him after 45 minutes then he was transported to hospital then to medical center. he was in ICU on a ventilator unresponsive brain swollen , totally unresponsive and organs shutting down. He passed away 9:45 pm June 19

within 12 hours had a reaction to include significant shakes and chills. After a period of respite patient developed chest pains, was admitted to hospital on 14FEB, and diagnosed as having had a Type 2 heart attack.

Chief Complaint fever and chills, body aches x 3 days. also complains of intemrittent chest pain since yesterday 02/20/21 10:28 History of Present Illness This is 31 year old male with no significant past medical history. Patient is health care provider and working in surgical center. Patient ha COVID 19 second dose of vaccination on Wednesday and he was feeling sick after that including fever, chills and tiredness. He had chest pain started Thursday and which is in left side of the chest and mostly constant in nature and intensity was up and down and highest intensity was 7/10. No aggravating and relieving factor, denied any shortness of breath, leg swelling. He visited to urgent care and had 12 lead EKG and which showed ST changes in inferior lead and transfer to hospital ER. He is currently having pain about 1/10 intensity. He denied any nausea, vomiting, urinary and bowel symptoms. (sic) Assessment/Plan Chest pain with elevated troponin NSTEMI vs myocarditis post COVID 19 vaccination

blood clot; Fever; sick feeling; chills; nausea; night sweats; A spontaneous report was received from a healthcare professional concerning a 31-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sick feeling/illness, chills, nausea, night sweats, blood clot/thrombosis, and fever/pyrexia. The patient's medical history included Cystic Fibrosis and only has half of their liver. No relevant concomitant medications were reported. On 26-JAN-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 26JAN2021, the patient began experiencing symptoms including sick feeing, chills, nausea, and night sweats. The patient had blood clot and fever on 21-FEB-2021. Patient was admitted into the hospital on 22-FEB-2021 and discharged on 26-FEB-2021. He received the following tests while in the hospital: MRI, Bone Density, and LABS. Treatment of the events included Eliquis. Action taken with mRNA-1273 in response to the events was not reported. On 25 Feb 2021 the outcome of event, fever was resolved. The outcome of events, sick feeling, chills, nausea, night sweats, blood clot were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Site: Bruising at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: unconscious not responsive-Severe, Systemic: Shakiness-Mild, Additional Details: Pt. unconscious, not responsive fell off his seat on face

occlusive DVT involving left lower extremity extending from the left common femoral vein through the femoral vein and popliteal vein: Patient noticed L groin pain when getting up after resting after a bike ride. Pain significantly worsened overnight and leg more red than right leg on exam with tenderness of groin. Venous duplex showed extensive left lower extremity DVT. Patient sent to ER for further evaluation and treatment. Patient denied any shortness of breath or chest pain. pulse ox 98%, pulse 88 bpm.

Patient received his second dose of the MODERNA vaccine on Thursday, 4/29. He started experiencing flu-like symptoms with fever on 4/30. He stated that he felt fine on 5/1 and went out and had two mojitos. Awoke at ~3 am on 5/2 with subxiphoid/epigstric pain, associated with L elbow pain. His father had an MI in his 30's. Patient is also going through a divorce. Treated in ED with lovenox, Pepcid, morphine, and nitro. Transferred for further management of NSTEMI.

grand maul seizure; vision changes; Feelings of pressure at the back of his neck radiating to right side of his head; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (grand maul seizure) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease. Concurrent medical conditions included Crohn's disease (moderate to severe). On 14-Oct-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) dosage form. 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 GENERALISED TONIC-CLONIC SEIZURE (grand maul seizure) (seriousness criterion hospitalization), VISUAL IMPAIRMENT (vision changes) and NECK PAIN (Feelings of pressure at the back of his neck radiating to right side of his head). At the time of the report, GENERALISED TONIC-CLONIC SEIZURE (grand maul seizure) had resolved and VISUAL IMPAIRMENT (vision changes) and NECK PAIN (Feelings of pressure at the back of his neck radiating to right side of his head) 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. The patient had a seizure three days after his first Moderna Covid vaccine and was hospitalized. CT scan was negative. The reporter's causality for co-suspect drug, adalimumab, was not provided. Concomitant product use was not provided. No treatment information was provided. This case concerns an adult male, with PMH of Crohn's disease, hospitalized with a serious unexpected event of generalized tonic-clonic seizure (grand mal seizure), and nonserious unexpected visual impairment and neck pain. Event onset with unknown latency after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns an adult male, with PMH of Crohn's disease, hospitalized with a serious unexpected event of generalized tonic-clonic seizure (grand mal seizure), and nonserious unexpected visual impairment and neck pain. Event onset with unknown latency after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

COVID the next day, double pneumonia, fatigue, weakness, heart arrhythmia and palpitations, blood clots x2

I started feeling that my heart rate is not steady and it?s very irregular. I had trouble sleeping from my heart beata for 2 weeks and I thought it was stress or anxiety. I went to see a doctor, they drew blood and then called me after 2 days and said I had to go to the ER because Troponin level was so high. I went to the ER and they kelt me at the hospital for 30 hours to monitor my Troponin level and they did and ECG and Echocardiogram. They said it was Pericardial effusion and Pericarditis. They prescribed me Ibuprofen 400 tid and my doctor have me Propranolol 20mg qd.

Patient father reported he passed away in his sleep the night of 06-07-21 and was pronounced diseased on 6-8-21

First Dose: I took Moderna COVID19 vaccine and passed out immediately onsite. One of the nurse have to call in ambulance services , they checked ECG and transported me to nearby hospital's emergency department. Where I received 3-4 hours of emergency treatment ( a bed, re-do ECG, an emergency doctor's visit and Benadryl I.V. injection). All this life threatening events occured to me because of Moderna COVID19 vaccine. I was very excited and walk on my feet to clinic to take vaccine but I have to go in ambulance and face all this difficulties at the cost of my job day off and all other related inconvenience. Both ambulatory services and hospital sent a huge bills, which upon my request, they submitted to my health insurance plan. Insurance company paid some amount but not in full. Insurance company said there is no government mandate for insurance companies to pay COVID-19 vaccine related emergiencies. so, they are not liable. Second Dose: Despite all this challenges, I decided to go for second dose to protect myself and the people of the from COVID-19. Again the same above story repeated even during the second dose. and they send bills to me. Now there are close to $3000 bills on me due to above circumstances, which I don't think appropriate for me to pay. I was simply aiming for safety for myself and other general public by getting myself vaccinated without any prior knowledge of this could cost me financially and dangerous to my own health. I was simply following CDC guideline and suggestion. In this situation, could you help me financial assistant or request ambulatory services and health to waive my financial obligations? Also, I request you to ask Moderna to reimburse for the cost of adverse effects of their vaccines.

After receiving the Moderna Covid vaccine, patient passed out while waiting for his 15 minutes observation. He fell off his chair and hit his nose on the floor/object. He started bleeding for a few minutes but became stabilized. 15 minutes later, he felt well enough to slowly get up and carefully walk around the pharmacy. He reported feeling fine and went home. Later on the day, I contacted him and he reported doing fine.

Almost exactly 24 hours after receiving the second injection, I had a tonic-clonic seizure. This is my first seizure in >2 years and they have been well-controlled with Lamictal which is prescribed by my neurologist.

The patient experienced an anaphylactic reaction characterized by throat closing, shortness of breath, cough, and inability to speak due to airway narrowing. The symptoms started at 0800 and were severe enough that he was having difficulty speaking, so he had a friend talk to dispatch. He was given 2 doses of IM epinephrine, 50 mg Benadryl, and 125 mg Solumedrol by EMS and transferred to the ER department at the Community Hospital.

Pt. was very sick the day after the shot, then Friday morning his heart was going into atrial fibrillation and jumping between 110 heart rate and 160+. He was out golfing when he noticed this. He rested later that day but was extremely tired and felt sick. Saturday morning (2.5 days after vaccine) he needed to go to the emergency room because his heart rate was back over 160. The EKG showed sinus tachycardia and gave him a message for it but it made it worse and the rate was over 200. They had to stop and start his heart then put on beta blocker which brought it to 180, then another beta blocker brought to 150. Following EKGs showed atrial fibrillation, postural orthostatic tachycardia syndrome, and super ventricular tachycardia. Pt. had this about a year ago but was fine after a few days. This was the first time he was hospitalized for it and is now on daily medications. He fears the Moderna vaccine triggered it and is very worried about the second dose.

Patient fainted around the pharmacy area within 1-2 min after receiving his covid 19 vaccination. He hit his head on the floor and started bleeding. I approached the patient immediately, he was alert and talking and confused as to what happened. we called emergency right away and paramedics arrived within 5 minutes and patient was taken to hospital for further evaluation. Initial BP 129/74.

This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (unconscious), HAEMORRHAGE (bleeding from forehead), EPISTAXIS (bleeding from nose), FACIAL BONES FRACTURE (nose is fractured), FALL (fell down from chair on the face down towards floor) and MALAISE (not feeling well) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. 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 LOSS OF CONSCIOUSNESS (unconscious) (seriousness criteria hospitalization and medically significant), HAEMORRHAGE (bleeding from forehead) (seriousness criterion hospitalization), EPISTAXIS (bleeding from nose) (seriousness criterion hospitalization), FACIAL BONES FRACTURE (nose is fractured) (seriousness criteria hospitalization and medically significant), FALL (fell down from chair on the face down towards floor) (seriousness criterion hospitalization) and MALAISE (not feeling well) (seriousness criterion hospitalization). At the time of the report, LOSS OF CONSCIOUSNESS (unconscious), HAEMORRHAGE (bleeding from forehead), EPISTAXIS (bleeding from nose), FACIAL BONES FRACTURE (nose is fractured), FALL (fell down from chair on the face down towards floor) and MALAISE (not feeling well) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication not reported. Treatment includes IV; 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 found unresponsive at approximately 12:00 am 10/11. EMS called and patient was pronounced dead at scene.

while in waiting area post vaccination pt started exhibiting sx of anaphylaxis. he was treated by EMTs onsite with Epi and transported to a local healthcare facility.

DVT; armpit turned purple with no sensation; armpit turned purple with no sensation; excruciating pain; axillary swelling in the right arm pit; body aches; headache; chills; brain fog; lightheadedness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (DVT), SKIN DISCOLOURATION (armpit turned purple with no sensation) and SENSORY LOSS (armpit turned purple with no sensation) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. Concomitant products included APIXABAN (ELIQUIS), OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]), PARACETAMOL (TYLENOL), OXYCODONE, DOCUSATE SODIUM (COLACE) and HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for an unknown indication. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced FEELING ABNORMAL (brain fog), DIZZINESS (lightheadedness), MYALGIA (body aches), HEADACHE (headache) and CHILLS (chills). On 29-Mar-2021, the patient experienced SWELLING (axillary swelling in the right arm pit). On 31-Mar-2021, the patient experienced DEEP VEIN THROMBOSIS (DVT) (seriousness criteria hospitalization and medically significant), SKIN DISCOLOURATION (armpit turned purple with no sensation) (seriousness criterion hospitalization) and SENSORY LOSS (armpit turned purple with no sensation) (seriousness criterion hospitalization). On 02-Apr-2021, the patient experienced PAIN (excruciating pain). On 30-Mar-2021, SWELLING (axillary swelling in the right arm pit) had resolved. At the time of the report, DEEP VEIN THROMBOSIS (DVT), SKIN DISCOLOURATION (armpit turned purple with no sensation), SENSORY LOSS (armpit turned purple with no sensation), FEELING ABNORMAL (brain fog), DIZZINESS (lightheadedness), PAIN (excruciating pain), MYALGIA (body aches), HEADACHE (headache) and CHILLS (chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment medication - Eliquis

a blood clot right below his lung on the left side; his chest was hurting; he couldn't breath; Second shot three weeks later; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (a blood clot right below his lung on the left side) in a 32-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 medical history reported). In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (a blood clot right below his lung on the left side) (seriousness criterion medically significant), CHEST PAIN (his chest was hurting), DYSPNOEA (he couldn't breath) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second shot three weeks later). At the time of the report, THROMBOSIS (a blood clot right below his lung on the left side), CHEST PAIN (his chest was hurting) and DYSPNOEA (he couldn't breath) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second shot three weeks later) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered THROMBOSIS (a blood clot right below his lung on the left side), CHEST PAIN (his chest was hurting) and DYSPNOEA (he couldn't breath) to be related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second shot three weeks later). Patient was taken to the ER (Emergency Room). Treatment Xarelto was started. Patient has Cardiologist appointment on 28-APR-2021. Company comment:Limited information regarding the blood clot, chest pain and difficulty breathing has been provided at this time and a causal relationship cannot be excluded. Inappropriate schedule of vaccine administered is unrelated to the vaccine and is not reported as specifically resulting in adverse events. This case was linked to MOD21-076660 (E2B Linked Report).; Sender's Comments: Limited information regarding the blood clot, chest pain and difficulty breathing has been provided at this time and a causal relationship cannot be excluded. Inappropriate schedule of vaccine administered is unrelated to the vaccine and is not reported as specifically resulting in adverse events. MOD21-076660:

Dyspnea secondary to PE. Treatment is full anticoagulation. Outcome is undetermined, since patient is still in the hospital.

Received 2nd Moderna vaccine on 4/15/21. Woke up on Saturday 4/17/21 with significant "cramp" in left calf. Pain persisted, so patient went to doctor on 4/19/21. Blood work did not "rule out" clot. Doctor ordered venous doppler which confirmed clot. Prescribed 3 month course of Xarelto.

He noticed a hard lump in his bicep this morning and it appeared to be in a vein. He went in to see his doctor and the doctor diagnosed him with a blood clot. The doctor said it was in a superficial vein and didn't give him any treatment. Told him to keep a watch on it and if it got swollen or turned red or he developed shortness of breath to come back in and be seen.

05/05/21-around 9 hours after vaccination developed chest pressure and mild shortness of breath. Symptoms worsened over the next 2 days and on 5/7/21 pain intensified. Pain is described as chest pressure, shoulder and back pain, and also endorsed shortness of breath due to tightness and constriction. 05/07/21-presented to ED in the morning and was admitted to the Coronary Care Unit, treated with colchicine, NSAIDs resulting in gradual improvement of his symptoms. Given response to treatment and EKG changes the presumptive diagnosis of pericarditis was confirmed.

no notable previous history who presented 5/1/2021 ~0130 with chest pain and shortness of breath. History notable for Moderna COVID-19 vaccination 4 days prior (that would be 4/27/21) with subsequent development of fever, myalgias, sore throat. Then on 4/30/21 developed acute onset of shortness of breath and chest pain. Seen at ED. Exam and work-up revealed elevated troponin, unremarkable CTA of chest, EKG with diffuse slight ST changes. Patient was subsequently admitted to hospital for possible myocarditis. Per consult - Differential diagnosis includes pericarditis, myocarditis, acute coronary syndrome. Later in the day (~1530), had worsening chest pain and ST elevated noted on EKG. Pt did disclose at that time that he used cocaine about 8 days earlier. Pt transferred to Hospital for treatment of STEMI. Note: covid-19 vaccine info is pt reported, unable to access any Immunization records for this patient. Place where pt received vaccine is also unknown.

DEVELOPED DECREASE IN PLATELET COUNTS, CONSISTENT WITH IMMUNE THROMBOCYTOPENIA, TEN DAYS POST VACCINATION. PLATELET COUNT 7000 ON MAY 21, 2021. HE WAS ADMITTED TO HOSPITAL AND RECEIVED TWO DOSES OF IMMUNE GLOBULIN AND DECADRON WITH IMPROVEMETN IN PLATELET LEVELS. HE REMAINED ASSYMPTOMATIC.

Passed out multiple times; Blood clots; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out multiple times) and THROMBOSIS (Blood clots) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047a21a) for COVID-19 vaccination. No Medical History information was reported. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out multiple times) (seriousness criterion medically significant) and THROMBOSIS (Blood clots) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out multiple times) and THROMBOSIS (Blood clots) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient was taken to hospital where it was discovered that he had blood clots that needed to be removed. Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

from 5/25/21 note: 32 y.o. male with a history of DVT (left leg; on Xarelto), recurrent PE, EtOH abuse, anxiety, and depression presents to the emergency department complaining of right leg pain since the last two days. He reports to receiving his Moderna COVID-19 vaccination three days ago. Thereafter, he noticed his leg pain to occurs. He also notes to intermittent pleuritic chest pain, but not currently. He notes that his leg is not as swollen compared to his previous DVT. He has full sensation and motor control of his digits. He admits to dizziness. He denies changes in breathing, abdominal pain, recent surgeries, recent travels, recent hospitalizations, or family history of blood clots. History is from the patient Old records reviewed. Last ED visit on 3/2/21 for pleuritic chest pain. Recent hospitalization 2/8 to 2/9 for pulmonary embolism in the setting of Xarelto non-compliance. US LLE Dplx (9/26/2020) DVT in the left popliteal, posterior tibial, peroneal and anterior tibial veins. US LLE Dplx (2/8/21) Nonocclusive thrombus in the left popliteal and posterior tibial veins. US RLE Dplx (5/25/21; today) DVT in the right femoral and popliteal veins. from 5/27/21 note: Patient is a 32 y.o. male with history of EtOH abuse and recurrent DVT/PE known to be noncompliant with Xarelto presenting to the ED with altered mental status. Of note patient was discharged from the hospital this afternoon where he was treated for DVT with heparin, previously on Xarelto but due to noncompliance was discharged with plan for Lovenox. Patient is alert and oriented x3, however intermittently not responding appropriately to questions and does not appear to be the best historian. Per EMS patient was found down, unresponsive in a bush. Patient admits that when he left hospital he went to gas station and drank "18 ounces of wine." EMS states when they arrived to scene patient had unsteady gait, frequent falls, no signs of significant head trauma. Patient was tachycardic in route and noted to be hypoxic in route. Patient currently complaining of mild headache but denies chest pain, shortness of breath, nausea, vomiting, diarrhea, abdominal pain, back pain or any further symptoms once again believe patient to be a poor historian.

Patient presented 2 days after second COVID-19 Moderna vaccination (pharmacy noted administration on 6/4, admitted to hospital on 6/7, unclear if symptoms developed on 6/6). Patient developed cardiac arrest in the field with witnessed arrest and bystander CPR, received defibrillation for VF in the field via medics. After presenting to hospital, underwent angiogram with normal coronaries, severely reduced ejection fraction with biventricular failure. Transferred to a different hospital to limit risk of ventricular arrhythmia recurrence and currently on ECMO.

On 6/11/2021, patient presented to the Emergency Department complaining of chest pain that started initially in the evening of 6/10, which had initially self-resolved, but has since recurred, now also with shortness of breath. Troponin was significantly elevated on presentation at 16.3, and 12-lead EKG showed an abnormal rhythm concerning for STEMI vs perimyocarditis. After negative cardiac/embolic work-up in cath lab & CT imaging, myocarditis was felt to be the most likely cause of this patient's symptoms. On the following day, patient was noted to have brief bursts of Vtach, for which metoprolol was initiated. The patient was subsequently discharged home in stable condition on 6/13/2021.

32yo M, presents to clinic after episode of syncope, and on presentation to clinic c/o SOB/DOE SpO2: 88-90%, left calf swelling, EKG showing S1Q3T3 signs and symptoms concerning for PE. Pt denies any prior history of blood clots and no risk factors on initial presentation. Pt reports only thing new has been receiving Moderna COVID-19 vaccine on 16 Jun 2021. He was transferred immediately via ambulance to hospital for high level of care, where PE was confirmed w/ Chest CT, and also noted to have markedly elevated D-dimer and cardiac enzymes. Pt was then reportedly transferred to hospital for definitive tx.

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: SEVERE DROP IN BP TO 90/52 AND EXCESSIVE SWEATING - TSHIRT SOAKED WITHIN A FEW MINUTES INTENSE THIRST-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Shakiness-Mild, Additional Details: PATIENT HAD IMMEDIATE DROP IN BP , EXCESSIVE SWEATING, EXCESSIVE THIRST AND SLIGHT SHAKING.

Death Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient died of a drug overdose and had a UDS positive for fentanyl and alcohol on 3/8/21 patient tested positive for Chlamydia due to high risk sexual behavior and substance use disorder. Patient was admitted to facility on 2/26/21 to detox from alcohol.

Immune thrombocytopenic purpura; petechia/ blood spots in his legs went from his feet up to his mid thigh; nose bleeding, heavy bleeding, more than 20 minutes to make it stop; blood pressure fluctuation; Fear; pain; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenic purpura), PETECHIAE (petechia/ blood spots in his legs went from his feet up to his mid thigh) and EPISTAXIS (nose bleeding, heavy bleeding, more than 20 minutes to make it stop) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0181321H) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Bleeding nose (No reported medical history). On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced EPISTAXIS (nose bleeding, heavy bleeding, more than 20 minutes to make it stop) (seriousness criterion hospitalization). On 04-Apr-2021, the patient experienced IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenic purpura) (seriousness criterion hospitalization) and PETECHIAE (petechia/ blood spots in his legs went from his feet up to his mid thigh) (seriousness criterion hospitalization). On an unknown date, the patient experienced FEAR (Fear), PAIN (pain) and BLOOD PRESSURE FLUCTUATION (blood pressure fluctuation). The patient was hospitalized on 08-Apr-2021 due to IMMUNE THROMBOCYTOPENIA and PETECHIAE. On 09-Apr-2021, EPISTAXIS (nose bleeding, heavy bleeding, more than 20 minutes to make it stop) had resolved. At the time of the report, IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenic purpura), PETECHIAE (petechia/ blood spots in his legs went from his feet up to his mid thigh), FEAR (Fear), PAIN (pain) and BLOOD PRESSURE FLUCTUATION (blood pressure fluctuation) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Platelet count: 130 (Inconclusive) raised to 130. On an unknown date, Blood pressure measurement: 150/90 (High) high and 90/50 (Low) low. On an unknown date, Platelet count: 0-2 (Low) down to 0-2 and 50 (Inconclusive) raised to 50. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. His treatment were steroids and ivIG. In the hospital, they told him that given the treatment they had to apply he no longer has a functioning immune system and that he will have to seek for constant medical care, all that will interfere with his life and work plans.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

onset of fever, swelling of right knee and distal leg, malaise, inability to bear weight on right lower extremity

Patient woke up on March 11 with vomiting and diarrhea, continued feeling ill through to the morning of March 15, when he was found to be lethargic and unable to communicate. I took him to urgent care where he was immediately rushed to the hospital emergency room at local hospital. He went into cardiac arrest for 20 minutes while in the ER. Besides the cardiac arrest patient presented with the following: Acidosis, acute renal failure, acute respiratory failure, shock, severe sepsis, septic shock, sepsis, right ventricular enlargement, pleural effusion bilateral, pericardial effusion, etc... Patient was in ICU and on a ventilator for 1 week, then 5 days in telemetry. He was released when stable as a diagnosis could could not determined. Discharge instructions were to follow up with primary care Dr for additional tests. Patient was discharged on March 26, 2021. He went to hospital March 30 for blood work for a primary care appt on April 2. Patient's blood pressure was again very low and his sodium level was dangerously low, he was again admitted to the hospital. After exhaustive tests it was determine he has Addison's autoimmune and Hashimoto's autoimmune diseases. He was discharged from hospital on March 5, 2021. Patient was put on hydrocortisone, fludocortisone, and levoxothorine. He is now doing fine on the medication.

Body aches, fever from date of vaccination and then on 5/16, woke up with significant pain on the right side of chest.

He got a COVID vaccine (location unknown to me) and called a few weeks after vaccine to report symptoms of blood clot was diagnosed this past weekend at emergency room.

Diagnosed with sepsis; Diagnosed with acute arthritic response; Felt feverish/fever of 103.8; Unable to walk; Joints were swelling; Felt dizzy; Sore in the knees and joints; This spontaneous case was reported by a consumer and describes the occurrence of SEPSIS (Diagnosed with sepsis), ARTHRITIS (Diagnosed with acute arthritic response) and PYREXIA (Felt feverish/fever of 103.8) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced PYREXIA (Felt feverish/fever of 103.8) (seriousness criterion hospitalization), JOINT SWELLING (Joints were swelling), DIZZINESS (Felt dizzy) and ARTHRALGIA (Sore in the knees and joints). On 30-Apr-2021, the patient experienced GAIT INABILITY (Unable to walk). On 03-May-2021, the patient experienced SEPSIS (Diagnosed with sepsis) (seriousness criteria hospitalization and medically significant) and ARTHRITIS (Diagnosed with acute arthritic response) (seriousness criterion hospitalization). The patient was hospitalized on 03-May-2021 due to ARTHRITIS and SEPSIS, and then for 3 days due to PYREXIA. At the time of the report, SEPSIS (Diagnosed with sepsis), ARTHRITIS (Diagnosed with acute arthritic response), PYREXIA (Felt feverish/fever of 103.8), GAIT INABILITY (Unable to walk), JOINT SWELLING (Joints were swelling), DIZZINESS (Felt dizzy) and ARTHRALGIA (Sore in the knees and joints) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 103.8 (High) high. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided by the reporter. Patient received antibiotics (unspecified) in the hospital for treatment of events. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, Very limited information has been provide at this time. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, Very limited information has been provide at this time. Further information has been requested.

I woke up the morning after my second dose experiencing the common symptoms related to the vaccine -- persistent headache, body ache, fever, cold shivers, and fatigue. These symptoms lasted for approximately 24 hours, and I continued to have a headache for a total of approximately 48 hours. However, I then developed pain in my left calf approximately 10 days after the second dose and on three consecutive evenings at approximately 9pm I developed an all-body itchy rash (big red raised welts) that would disappear by the time I woke up the next morning. The rash only occurred on these three evenings, but the pain in my calf persisted. I went to see my primary care doctor the following Monday (05/17/21) who gave me a referral for an ultrasound to rule out a DVT, although he said that it was not urgent that I go as I didn't have the other regular symptoms of a DVT (swelling, redness, warm to the touch) and I was too young and healthy to be at risk for one. My doctor said that if the pain didn't subside by the end of the week I should go for the ultrasound. The pain got worse and so I went for an ultrasound on Saturday (05/22/2021). I WAS SUBSEQUENTLY DIAGNOSED WITH A BLOOD CLOT (DVT), and sent to the emergency department.

About 10 seconds after injection he felt dizzy. They gave him a timer. He started throwing up several times. They gave him a choice of hospital or going home. He chose home. About 20 minutes later he had the chills and developed a headache. He then developed diarrhea. He went to bed. When he woke up in the middle of the night he felt like he went into a GrandMal seizure. He had memory loss and confusion. He could not get up. His entire body was hurting. He went to the hospital. They gave him anti-nausea medicine. Put him on an IV (UNKNOWN NAME). They prescribed him on a medicine for cluster headaches (can not remember name). Gave him 2 or different meds for his migraines. Dr. said he would call him in a week. The hospital gave him Ondansetron 8mg as needed.

Patient died on March 27, 2021. Coroner ruled it Acute Asthma Exacerbation. Because it was only a short time after his shot, his family wants to rule that out as a possible cause of death.

It completely messed me up. After I got the vaccine I got the normal symptoms, fever, chills, cough, and then I started having trouble breathing and very major back pain and chills. I ended up getting pretty bad hypothermia my body tempt dropped down to 91.2, my whole right side of my body was completely numb to the point I could not move my right arm or leg. 2-3 days later I ended up passing out in my bedroom. I was out of work for about a month and a half. I remember being very weak and trying to call for help and I just blacked out completely confused. I woke up again and then I tried to get up but I was to weak so I fell down in my bed. I blacked out again. I woke up very confused not knowing where I was. it took me a minute or two to realize I was still in my bedroom. I could not breathe so I drove to the hospital. They said I had double pneumonia, they gave me antibiotics, They also gave me an emergency inhaler that I am still using sometimes. I still sometimes have attacks that I cannot breathe and sometimes I cough off phlegm out of my lungs. Also, palpitations rapid and slow palpitations. Also, light headedness, I walk around and I felt very dizzy so I would have to sit down and catch my breath. I lost taste and smell. My oxygen levels dropped too below 95.

Gastro symptoms started the Monday following the vaccine. Acid reflux was continually getting worse and causing difficulty eating, and sleeping. Thursday I went to the ER and was diagnosed with pneumonia and given a gastro cocktail and recommended follow up with gastrointestinal physician. On Friday I felt worse and had a fever of 101 I took Tylenol and Motrin and continually felt worse. Went to ER with 103.4 fever and racing heart rate. BP was normal. Was discharged and told to continue medication. The next day (Saturday) I woke with a swollen penis and went back to the ER where I was given a steroid shot and told to ice and watch for any additional swelling. Fever has stayed down but have had aches and pains throughout the day

Heart attack (blood clot in major artery) approximately 6 weeks post 2nd Moderna dose. Surgery done in cath lab to address blockage. Released from hospital several days later.

The patient received his 2nd dose of Moderna (LOT#, site, time unavailable) at an outside clinic the morning of 2/10/21 and presented to the ED with coughing and hypoxia (sp02 occasionally dropping into 70's) at 8 PM that day. He had quadriplegic spinal paralysis as a result of a remote MVA and has been hospitalized and critically ill in the past due to recurrent UTI's and pneumonia with associated sepsis. CT negative for pulmonary embolism and showed bilateral infiltrates. Clinical presentation consistent with bilateral pneumonia and started on Rocephin/azithromycin. He was initially stable in the hospital on 1-2 LPM 02. The following evening he became febrile and acutely developed asystole without any pre-existing arrhythmia. Resuscitation was attempted for 45 minutes but unsuccessful. Overall, I suspect his death was related to bacterial pneumonia and resulting acute respiratory failure, complicated by his quadriplegia and autonomic dysreflexia but reported this event as it did occur within 2 days of receiving his 2nd Moderna vaccination.

Blood clots ( DVT in right leg and three pulmonary embolisms in right lung), symptoms appeared around 4/5/2021 and diagnosed on 4/9 and 4/10. Also started experiencing diarrhea during the same time period. Being treated with Xarelto and Azithromycin.

Developed ITP, initial symptoms included Petechia, bruising, and mucosal bleeding (mouth blood blisters).

I began to have a fever with chills and very severe body aches that lasted 3 days after the shot and developed the day after the shot was administered. In addition, I developed a rash on my arm and was bedridden. I took a small walk that day and proceeded to swell up on the left side of my body but it subsided within a few hours. The next day, I suffered a stroke due to blot clotting and the clot flowing to my brain. I had to go to the hospital and was there for a few days.

Spontaneous coronary artery dissection mild type 2 heart attack; Mild type 2 heart attack; Chest pain; Fever; body ache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CORONARY ARTERY DISSECTION (Spontaneous coronary artery dissection mild type 2 heart attack) and MYOCARDIAL INFARCTION (Mild type 2 heart attack) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 023M2OA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced PAIN (body ache) and PYREXIA (Fever). On 28-Mar-2021, the patient experienced CHEST PAIN (Chest pain). On 30-Mar-2021, the patient experienced CORONARY ARTERY DISSECTION (Spontaneous coronary artery dissection mild type 2 heart attack) (seriousness criterion hospitalization) and MYOCARDIAL INFARCTION (Mild type 2 heart attack) (seriousness criterion hospitalization). The patient was hospitalized from 30-Mar-2021 to 31-Mar-2021 due to CORONARY ARTERY DISSECTION and MYOCARDIAL INFARCTION. At the time of the report, CORONARY ARTERY DISSECTION (Spontaneous coronary artery dissection mild type 2 heart attack), MYOCARDIAL INFARCTION (Mild type 2 heart attack), PAIN (body ache), CHEST PAIN (Chest pain) and PYREXIA (Fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Electrocardiogram: results were fine normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were nor reported. Treatment information included unspecified medication. This case was linked to MOD-2021-066271 (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.

At 4:00am I woke up with my heart beating very hard and fast. I put on my Apple Watch and checked my heart rate. It was 149. I was also in A Fin. I went to the ER for a correction. I?ve never had A Fib before but I have always been slightly high blood pressure.

The adverse reaction begin with dizziness, light headiness and increased body temp. Upon being released from vaccine location while driving an allergic reaction occurred causing swelling of the throat, skin change to red and rash like. I called 911 as I had trouble breathing and an ambulance took me to the hospital and administred epinephrine and benadryl. They called it analphlatic shock or extreme allergic reaction.

Body aches and febrile illness same day as vaccine administration. Fever of hands and feet the following day that subsequently spread throughout bilateral lower extremities and trunk. Upon evaluation in hospital emergency department, found to meet criteria for sepsis without apparent source of infection. Tachycardia, hypotension, mildly elevated white count and absolute lymphopenia with bandemia. Clinical case highly suspicious for MIS-A.

anaphylaxis reaction; severe allergic reaction; throat closing up/throat started swelling; dizzy; lack of appetite; vertigo; headaches; started to feel hot; breaking out in a rash/skin began to break out; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (anaphylaxis reaction) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (anaphylaxis reaction) (seriousness criterion medically significant), ALLERGY TO VACCINE (severe allergic reaction), PHARYNGEAL SWELLING (throat closing up/throat started swelling), DIZZINESS (dizzy), DECREASED APPETITE (lack of appetite), VERTIGO (vertigo), HEADACHE (headaches), FEELING HOT (started to feel hot) and RASH (breaking out in a rash/skin began to break out). At the time of the report, ANAPHYLACTIC REACTION (anaphylaxis reaction), ALLERGY TO VACCINE (severe allergic reaction), PHARYNGEAL SWELLING (throat closing up/throat started swelling), DIZZINESS (dizzy), DECREASED APPETITE (lack of appetite), HEADACHE (headaches), FEELING HOT (started to feel hot) and RASH (breaking out in a rash/skin began to break out) had resolved and VERTIGO (vertigo) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment included: Epinephrine given in hospital, Benadryl and Predisone Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

34 YO male patient with no past medical history presents with sudden stroke-like symptoms including right sided arm and leg weakness, numbness, slurred speech and facial droop. Symptoms lasted for roughly 45 minutes. Suspected CVA. MRI done in hospital was found to be consistent with microinfarcts in the left hemisphere of the brain, mostly along the cortical ribbon with a single lesion in the left parasagittal/lateral pons. Full neuro and cardio workup is currently being done. ECHO w/ bubble study was weakly positive and plans are for TEE today. Otherwise, no exact cause identified and few risk factors. Found out that the patent was taking no medications prior and had no past medical history and was otherwise a 34 YO healthy male, who received their first dose of Moderna COVID-19 vaccine on 4/22. 3 days later the patient had this event. The timing of everything makes me report this as the potential is there that this is a vaccine ADE and plausible reason for this thrombotic event.

Patient passed away 4/12/2021 suddenly, found by family on couch. Was having shortness of breath day before. Per mom, patient had been laughing and talking the morning before patient passed away.

This patient was admitted on 5/1/21 with chest pain. He was found to have an inferior STEMI with a thrombotic lesion in the proximal circumflex artery that was stented. He was also found to have a chronic right gastrocnemius deep vein thrombosis on a lower extremity ultrasound on 5/3/21. He is currently undergoing a hypercoagulable workup. There is potential concern that the thromboses may have been related to his COVID vaccine, as he received the second dose on 4/25/21.

Immediate Care with Doctor: Chest Pain, disoriented, confusion, 99.1 temperature. Abnormal EKG, right bundle branch block(RBBB) determined by eltrocardiography. Doctor recommended I go to ER. ER visit with with Doctor-Diagnoses: Vaccination reaction, non-traumatic rhabdomyolysis. Pulse 91, temperature 99.3. Medication given IV sodium chloride bolus - 2 bags.

Seen for persistent myalgia and fatigue. Labs showing mild rhabdomyolysis. No evidence or symptoms of decreased urine output. Electrolytes and renal function within normal limits. Started on IV fluids and with follow up the next day.

Heart Attack; Panic attack; Couldnt breathe; Felt like chest caved in; Chest pain; Blood clot; Arm Pain; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart Attack), PAIN IN EXTREMITY (Arm Pain), PANIC ATTACK (Panic attack), DYSPNOEA (Couldnt breathe), CHEST DISCOMFORT (Felt like chest caved in), CHEST PAIN (Chest pain) and THROMBOSIS (Blood clot) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The patient's past medical history included Flu vaccination (received about 5 weeks ago before he got the Covid Shot and had chest pain) and Sinusitis (the patient stated that he violently threw up and he was sick for 2 weeks; the doctors then said that it may have been a stroke or a heart attack but he definitely had sinusitis.). Concurrent medical conditions included Diabetes, Cholesterol high and Blood pressure high. On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced PAIN IN EXTREMITY (Arm Pain) (seriousness criterion hospitalization). On 15-May-2021, the patient experienced PANIC ATTACK (Panic attack) (seriousness criterion hospitalization), DYSPNOEA (Couldnt breathe) (seriousness criterion hospitalization), CHEST DISCOMFORT (Felt like chest caved in) (seriousness criterion hospitalization), CHEST PAIN (Chest pain) (seriousness criterion hospitalization) and THROMBOSIS (Blood clot) (seriousness criteria hospitalization and medically significant). On 15-May-2021 at 4:00 PM, the patient experienced MYOCARDIAL INFARCTION (Heart Attack) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 3 days due to CHEST DISCOMFORT, CHEST PAIN, DYSPNOEA, MYOCARDIAL INFARCTION, PAIN IN EXTREMITY, PANIC ATTACK and THROMBOSIS. The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) ongoing since an unknown date at an unspecified dose and frequency; LISINOPRIL ongoing since an unknown date at a dose of 5 mg; METOPROLOL SUCCINATE ongoing since an unknown date at a dose of 50 mg; NITROGLYCERIN ongoing since an unknown date at a dose of 10 mg as required; PRASUGREL ongoing since an unknown date at a dose of 10 milligram; SPIRONOLACTONE ongoing since an unknown date at a dose of 25 mg and ROSUVASTATIN ongoing since an unknown date at a dose of 80 milligram. At the time of the report, MYOCARDIAL INFARCTION (Heart Attack), PAIN IN EXTREMITY (Arm Pain), PANIC ATTACK (Panic attack), DYSPNOEA (Couldnt breathe), CHEST DISCOMFORT (Felt like chest caved in), CHEST PAIN (Chest pain) and THROMBOSIS (Blood clot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. The patient reported that he had a heart attack on 15 May 2021, after football practice Patient was in the hospital for 3 days. Treatment also included catheter placement and then a stint in heart. 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.

on 6/17 patient developed L shoulder pain with progressive cough, SOB, and inspiratory chest pain. ER admission discovered large pericardial effusion, low grade fever, elevated ERS, CRP, WBC.

irregular heartbeat ( ATRIAL FIBRILLATION) went to emergency room They admitted me (24 hrs) then heart went back to regular rythm.

I fell the pain in my leg immediatley the next day and was limping all day fromt hat point on. Deep Vein Rhrombosis (DVT) in right leg knee.

Bilateral unprovoked pulmonary embolisms; A spontaneous report was received from a consumer concerning a 35-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bilateral unprovoked pulmonary embolisms. The patient's medical history was not reported. Concomitant product use was not reported. On 14-Jan-2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. On 31-Jan-2021, approximately 17 days after receiving vaccine, the patient was diagnosed with bilateral unprovoked pulmonary embolisms after a chest computerized tomogram (CT) was performed. Treatment included hospitalization and starting of anticoagulation therapy. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event was considered not resolved. The reporter did not provide the causality assessment for the events.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.

Patient received first dose of Moderna COVID-19 vaccine on 4/1/2021. On the evening of 4/17/21 patient developed right hand numbness and word-finding problems . Patient presented to the emergency department about 40 minutes after symptom onset. After neurology consult, patient was given tPA (administered on 4/17/21@ 2200) for suspected acute ischemic stroke. Patient's symptoms initially did not improve, but a couple hours after, patient had resolution of pronator drift and word-finding difficulties.

Was at the golf course. His arms flew up and he had a seizure falling to the ground and striking head on ground. Blood from nose and mouth. He was transported to hospital. Diagnosed a brain bleed.

Received 2nd dose of vaccine, 5 days later his left leg started hurting and swelling. He had severe headache afterwards, dizzy and blurred vision. 04/24/2021 he complained of not feeling right, coughed and passed out. Had fever and chills when he came to. Wife called 911 and was talking and walking. Was awake and talking in ambulance, oxygen level was low. Once arrived at hospital, he became restless and passed away within 3 minutes. Autopsy was performed due to his age - 35 and no pre-existing illnesses - was determined he died of Pulmonary Thrumbo Embolism

Patient is a 35 y/o MALE with a pmh Desmoid tumor of T spine dx 2007 s/p resection and XRT, last chemo 2017, followed by HEME/ONC last seen 3/22/21. Presenting for bloody cough x1 day. States was in usual state of health. Around midnight of day of presentation, pt. was awoken from sleep by hard cough. He noticed that he was coughing bright red blood, small volume but could not quantify. He was concerned however did not immediately worry because he otherwise felt fine. Later that afternoon, he had another episode of cough, this time darker in color and "thicker". This being new and the second time, prompted pt. to present to ED. While on his way here, he said he cont. to have cough with blood, small volume but frequent, states "training blood all the way here". Denies any prior similar event, no trauma, no recent illness, no sick contact, lives alone, no recent travels, no prolonged immobility, no recent surgeries, no leg pain/swelling. Of note, pt. received Moderna COVID-19 vaccine #2 on Wed of last week (4/28/21). ED Course: Pt was afebrile, initially tachycardic to 106, otherwise hemodynamically stable. Labs: BMP wnl, no elevated wbc, h/h-15.4/46.1, coags normal on admission. CTA w/ acute pulmonary emboli and left main extending into the lingulae and left lower lobe segmental branches, in addition to Nonspecific sub-5 mm pulmonary nodules; largest 5 mm nodule in right upper lobe. Pt started on hep drip.

Pt was admitted for hemoptysis and a PE 6 days following the event. The PE was in the lung previously damaged by the tumor. The PE was small, the hemoptysis is due to likely a small arterial bleed. He's been bronched twice and as of 5/10 continues to bleed. The PE is small but we are unable ot anticoagulate due to ongoing hemoptysis. The CT shows ground glass opacities/bronchiectasis in the area where there is bleeding. It's mostly likely this is due to previous tumor resection and damage from his surgery and XRT and shrunken lung. However, the PE and hemoptysis DID occur within a week of the second covid vaccine so we felt it necessary to report. Pt has no history of DVT/PE. His LE u/s for DVT were negative.

Death. While driving patient passed out and was found by County Sheriffs Office. EMT was called and could not save patient. M.E. Declared patient dead at 7:20 PM on May 4, 2021

PT NO SHOW FOR APPT 5/11 FOR 2ND DOSE -CHECK OF agency system SHOWS PT REPORTED DECEASED 5/14- CHECK OF database SHOWS PT FOUND DECEASED AT HOMEN 5/14/21- AUTOPSY Completed

Vertigo and fever occurred 24 hours after 2nd vaccination. Presented to ED and hospitalized for small right cerebellar stroke.

Pt developed aches, pain and headache and felt feverish day after receiving 2nd dose of Moderna vaccine. Continued on Sunday and on Monday developed leg stiffness and swelling. Patient presented to the ER with extensive lower leg DVT.

blood clot in left lung, left lung filled with blood; coughing blood; slight headache for 2 days; tightness of chest; night sweats; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMOPTYSIS (coughing blood) and PULMONARY THROMBOSIS (blood clot in left lung, left lung filled with blood) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Bronchoscopy (left lung filled with blood). Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) 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 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced HAEMOPTYSIS (coughing blood) (seriousness criterion hospitalization), CHEST DISCOMFORT (tightness of chest) and NIGHT SWEATS (night sweats). On an unknown date, the patient experienced PULMONARY THROMBOSIS (blood clot in left lung, left lung filled with blood) (seriousness criteria hospitalization and medically significant). an unknown date, the patient experienced HEADACHE (slight headache for 2 days). The patient was hospitalized on 03-May-2021 due to PULMONARY THROMBOSIS. The patient was treated with HEPARIN (intravenous) on 04-May-2021 for Clot blood, at an unspecified dose and frequency. At the time of the report, HAEMOPTYSIS (coughing blood) and PULMONARY THROMBOSIS (blood clot in left lung, left lung filled with blood) had not resolved, CHEST DISCOMFORT (tightness of chest) and NIGHT SWEATS (night sweats) outcome was unknown and HEADACHE (slight headache for 2 days) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. They did some tests and found there was blood clot in his left lung and put him on blood thinner but he reported that the blood thinner made his bleeding more worse. The patient still in hospital and currently in ICU and the Doctors are unable to determine where the blood is coming from and unable to remove the clot. And he is still suffering with blood cough. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. This case was linked to MOD-2021-116374 (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. Further information has been requested.

Pulmonary embolism; Unprovoked dvt; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) and DEEP VEIN THROMBOSIS (Unprovoked dvt) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 2ec5g) for COVID-19 vaccination. The patient was non smoker. No medical history was reported. On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-May-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization and medically significant) and DEEP VEIN THROMBOSIS (Unprovoked dvt) (seriousness criteria hospitalization and medically significant). At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism) and DEEP VEIN THROMBOSIS (Unprovoked dvt) had not resolved. Concomitant medication was not reported. Treatment medication included anticoagulants Action taken with mRNA-1273 in response to the event was Not Applicable This is a report of a 35-years non-smoker male, whose medical history was unremarkable; who presented DVT and pulmonary embolism, 102 days after receiving the second dose of the product. The patient required hospitalization 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.

Anaphylactic reaction to vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction to vaccine) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 016C21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Antihistamine therapy, MULTIVITAMINS [VITAMINS NOS] for Vitamin supplementation. On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction to vaccine) (seriousness criterion medically significant). The patient was treated with ALBUTEROL [SALBUTAMOL] on 02-Jun-2021 for Anaphylaxis, at an unspecified dose and frequency. On 02-Jun-2021, ANAPHYLACTIC REACTION (Anaphylactic reaction to vaccine) had resolved. On 02 Jun 2021, after the vaccination patient began to experience shortness of breath at 12:30 pm and patient's airways started to constrict at around 9:00 pm. Therefore patient went to the hospital. Action taken with mRNA-1273 in response to the events was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.

No side effects from first shot. Second shot was different. Got my second shot about 2PM and around 1-2 AM I was getting ready for bed. At first I was just feeling tired but then I started shaking uncontrollably and muscles in my neck and back were spazzing out. I lost all control of my body and fell over, convulsing for an unknown amount of time. I apparently foamed and/or drooled all over myself. I woke out of this effect around 3:30 AM. This was Friday/Saturday. Its Monday now. I still cannot stand straight and cannot create complex thoughts in my mind. I had a hard time perceiving colors for the first day and a half to two days after the seizure or stroke I suffered. I still have a migraine that feels like an elephant is sitting inside my skull. I still cannot perform complicated thoughts nor can I do complicated things with my hands because of a lack of motor skills. I successfully pulled every muscle in my back and neck and cannot stand upright. I'm 35 and now need a cane. Its already been 3 days and things really have not changed. Won't catch me lining up for a booster shot. NO THANK YOU. I did not seek medical attention because lets face it the healthcare system is a joke I would have needed a ride to a hospital, increasing my odds of getting the virus, to have them hold me as long as they can to stab me and poke me and take samples, give me no results, and a humungo bill. I will die before I go to a hospital ever again because the amounts of testing I required at the time would have covered back and neck and brain scans of various types and those tests are stupid expensive and 99% of the time I've ever got one they said oh I'm sorry we don't know what's wrong go see my friend who is a specialist blah blah blah and its the "doctor-go-round" where you blow all your money on morons that only care about lining their pockets.

I woke up with chest pain. Went to clinic and was told my potassium levels were high and needed to go to the hospital. My EKG and enzyme levels were abnormal was told I was having a heart attack. A catheterization was done and I was told my arteries were clean and there was no heart damage. I suffered a cardiac spasm, which I was told was a stress induced heart attack

Pulmonary embolism; Unprovoked dvt; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) and DEEP VEIN THROMBOSIS (Unprovoked dvt) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 2ec5g) for COVID-19 vaccination. The patient was non smoker. No medical history was reported. On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-May-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization and medically significant) and DEEP VEIN THROMBOSIS (Unprovoked dvt) (seriousness criteria hospitalization and medically significant). At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism) and DEEP VEIN THROMBOSIS (Unprovoked dvt) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-May-2021, Computerised tomogram: inconclusive (abnormal) Right lower lobe posterior pulmonary embolus.. On 30-May-2021, Ultrasound Doppler: inconclusive (abnormal) Duplex doppler and color sonography was performed of the deep veins. Noncompressible filling defect/thrombus with lack of vascular flow. No evidence of mass, adenopathy, or fluid collection.. Concomitant medication was not reported. Treatment medication included anticoagulants Action taken with mRNA-1273 in response to the event was Not Applicable This is a report of a 35-years non-smoker male, whose medical history was unremarkable; who presented DVT and pulmonary embolism, 102 days after receiving the second dose of the product. The patient required hospitalization Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up information received on 29-JUN-2021 contain Lab test data 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.

Was in good health until I had my vaccine. I developed unknown chest pains and went to the ER. I was showing no signs of being sick and when I was admitted to the ER I was having an irregular heart beat and my white count shot up to 17,000. I was diagnosed with pneumonia and sent home. Since then to date I have developed a twitch in my left leg and I have not been able to produce sweat since my injection.

Severe fatigue. Dysarthria. TIA like symptoms. Panic attack like experience. Death like experience with the feeling of impending doom. Difficulty understanding other people or interpreting what I see. Fell in the airport and canceled my flight

2/12/2021 woke up with sore arm and back. 2/13/2021 woke up with headache around 1am. Headache and nausea all morning. Mid-late afternoon started having seizures. Admitted to Hospital 2/15/2021 expired. Reported per wife on 2/25/2021.

0946-Moderna Vaccine 1106- Anaphylactic reaction, N/V 1115-methylprednisolone 1122- Epinephrine 1125-promethazine, 1206-Transfered to local hospital

He got his vaccine, and mother had talked to his girlfriend said that he felt fine other than a sore arm. He called his mother and told her that he was sick to his stomach with cramps and that he was throwing up blood. The girlfriend found him on the floor on the 21st dead on the floor in his hotel room at 8:00 AM. The girlfriend said she had spoken with him around 10:00 PM and that he said he was going to sleep on the floor in the bathroom as he was throwing up and the floor was cool. She subsequently found out that he was throwing up blood, and autopsy report showed that his stomach was full of blood and further testing is being done to see what has caused the bleeding.

grand mal seizure; This spontaneous case was reported by a consumer and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (grand mal seizure) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 017B21A) for COVID-19 vaccination. The patient's past medical history included Grand mal seizure since an unknown date. Concurrent medical conditions included Mental disability (Mentally handicapped). Concomitant products included PRIMIDONE (MYSOLINE) and LEVETIRACETAM (KEPPRA) for an unknown indication. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (grand mal seizure) (seriousness criterion medically significant). At the time of the report, GENERALISED TONIC-CLONIC SEIZURE (grand mal seizure) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information included midazolam and diazepam for seizures.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Patient suffered an acute myocardial infarction. On 2/12/2021 at 0230 hrs he was awakened with severe left sided chest pain/tightness radiating into his jaw associated with shortness of breath. He presented to the emergency department around 0330 hrs. He underwent cardiac catheterization around 0600 hrs where is coronary anatomy was normal without obstruction. His echocardiogram estimated his left ventricular ejection fraction to be 42%. He was started on appropriate medications and released home in good condition on 02/13/2021.

After patient received his shot, while sitting during the 15 min waiting period. The patient began getting lightheaded and hot, his color went out of him and his eyes began rolling back in his head. His eyelids turned a purple color and he appeared to momentarily stop breathing. Myself and another pharmacist got him on the ground and supported his head with a coat. When he "came to" and was talking to us. He described feeling better on the cold floor and his color began coming back. I was speaking with him the entire time. While we were out with his 9-1-1 was called and paramedics arrived 15 min later. by the time paramedics had arrived the patient had gotten up and back into the chair himself, was lucid and had color back in his face. Paramedics arrived and took over. He was given the green light from them and remained in the pharmacy area for a total of about 30 minutes before heading home. The patient was admittedly nervous for the shot and had not eaten or had anything to drink the whole day to that point. I believe he passed out from a variety of factors not related to the actual ingredients in the vaccine but cannot confirm this.

Spoke with patient via telephone on 4/20/21. Patient reports brief syncopal episode 4/15/21 at 6pm; reports he went to urgent care then to hospital. Reports he had CT scan and that multiple blood clots and pulmonary embolism were diagnosed. Reports he was transferred via ambulance early am on 4/16/21 to more advanced hospital. States thrombectomy was performed and he was discharged home on 4/17/21. States he is recovering at home and was advised he still has a blood clot in the leg. Reports he is on blood thinning medication at this time.

Patient received the moderna covid vaccine on 4/6/21. Developed general malaise and fever 4/7/21 around 1pm. Then developed acute sharp, pinching retrosternal, non-radiating chest pain at 9pm on 4/7/21. Chest pain was intermittent and nocturnal. no relief with nitroglycerin. He was admitted to the hospital 4/9/21 and started on colchicine 0.6 mg PO BID and indomethacin 50 mg PO TID with improvement. Troponins trended down with significant symptomatic relief following anti-inflammatories. At follow up visit 3 days after discharge (4/15/21) , patient reported continued improvement, reporting sternal chest pain 1 out of 10 . Also reported dyspnea that has improved since discharge from hospital but still worse than baseline.

On 4/13/21 patient developed difficulty walking and fell on 4/15/21. Also on 4/13/21 swelling and edema on both legs noted. Pt was admitted to hospital on 4/15/21 and found to have extensive DBT from lower IVC, Bilateral ileofemoral and both lower extremities. D-dimer was markedly elevated. Pt currently on anticoagulant Apixaban.

He is an healthy male with no past medical history or meds who developed headache and vision changes worse in left eye 2 days after the 2nd dose of the vaccine and was referred by local optometrist to the emergency department for optic nerve edema. He was then sent to me, who confirmed he does have papilledema (swelling of bilateral optic nerves) worse in the left eye with inferior peripheral visual field defect. He has had extensive workup including labs and MRI of the brain to r/o other etiologies, which were all normal.

2nd Moderna vaccine administered on 4/29. (First dose 4/1). Arrived to hospital via ambulance on 4/30 unresponsive and hypoxic. Temp 102.2 . Patient responsive only to painful stimuli. Patient was intubated and admitted to ICU. Noted to have WBC 12.0 and 'patchy left lower lobe opacities suspicious for pneumonia" on chest x ray. Lumbar puncture positive for human herpesvirus 6. ( Reportedly receives Ocrevus q 5 months for MS). He was extubated on 5/1. Reports feeling fine the day before receiving his second COVID vaccine. After second dose he reports that he felt very tired and has no recollection of being transported to hospital. Patient is currently on room air with mild SOB awaiting transport to SNF.

On Sat, May 8th around 4:30 PM, while sitting and watching TV, I felt a numbing shock to the left side of my body (particularly left cheek, my entire left arm, and legs) and got up to check myself in the mirror. I got chills and my teeth began chattering, but my arm in particular felt like it was on fire. I thought I was having a stroke so I managed to drive myself to the ER where I was admitted. When the doctors performed the initial tests on me, my skin felt dull on my left side but my arm felt a burning-numbness to it. The doctors performed two MRIs, a CT scan, an Echo Cardiogram, Blood Tests, Blood Pressure readings, and a Covid-19 test and found no problems in my brain or heart, no Covid infection, and a healthy cardiovascular system. I was released May 10th with the diagnosis of a Transient Ischemic Attack (TIA) of unknown cause. When I woke up today on 5/11, the burning-numbing sensation returned to my arm again (even as I type this) but this time I know it is not a stroke. I have had no medical history, exercise regularly, have a healthy diet (vegetarian/vegan for more than seven years), the only thing I've done recently is had my first Moderna shot injected intramuscularly in my left arm, the same arm where this burning-numbness is taking place. I thought it is best proactive to report this event and if there is any correlation to the vaccine

He had first dose of Mederna COVID vaccine and then 2 days later developed sob and LE pain/swelling. Now dx with extensive femoral vein to pop DVT to calf and bilateral PE with right heart strain

I got the shot around 3:15PM on Monday 4/26/21. Woke up Tuesday 4/27/21 with a minor headache and just felt out of sorts. Around noon that day I had a seizure at work and was rushed to the ER. While at the hospital waiting for a room to open up, I had another seizure. This one was much worse than the first. They had to intubate me and I spent 5 nights in the ICU. Another 3 on the Neurology floor for observation. The seizures caused Rhabdomyolysis which caused damage to my kidneys and significant muscle loss/damage. I wasn't able to walk at all for 3 days. After that I started to be able to get up out of bed and move around a little more each day.

Started having lain in right home on 4/15/2021. On 4/16/2021 complained more about right hip, said feels like he got hit by a truck, and that he felt like he was starting to get a cold. Then he died the night of 4/16/2021.

Patient presented with chest pain and was found to have pulmonary embolism 2 weeks after receiving the vaccine. Patient without any other risk factors for DVT or pulmonary embolism

Symptoms began around 8:30PM on 05/27/21. started feeling sick, getting chills and fever, back and joint pain. That went throughout the night and was the same all day Friday. Saturday at 4:00 am woke up vomiting and experiences chest pain. By 9 AM the chest pain was so extreme that I had my wife take me to the ER. Where they said I was having a heart attack. I have been at Hospital in the ICU since then.

Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Headache-Severe, Systemic: Hypertension-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium, Systemic: Stroke-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Unable to Sleep-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe, Additional Details: 2 days after receiving 1st dose had a stroke, went to Hospital had 3 more light strokes, loss of vision in left eye, shuffles to walk, BP not under control, patient was discharged and following up with PCP.

Cardiology Consult: Patient ID: (Name) Date of birth: (Date) Primary Care Provider: (Name), MD Admitting Provider: (Name), MD Admitted: 5/22/2021 Reason for Admission: Chest pain SUMMARIZED H&P: Patient is a 36 year old male with no significant past medical history, healthy gentleman, that presents post covid vaccine with chest pain. He got his second dose of Moderna vaccine on Wednesday and then later that evening developed fevers, chills, body aches and flu likely symptoms. They continued through Thursday evening. He was taking ibuprofen but was having a hard time swallowing it. He started developing neck and chest discomfort and initially thought it was due to difficulty with pills. Symptoms continued through Friday despite the flu like symptoms improving. They talked to a family member that recommended they present for presentation. On presentation EKG showed diffuse ST elevation with PR depression. PR elevation in V4. Troponin peaked at 16.57 and is now 6.59. Echo with normal EF and no effusion. He was started on colchicine yesterday. Tele without any arrhythmias. He reports that symptoms were worse when laying down or taking deep breaths. Has not had any symptoms today. No history of heart disease, exertional symptoms or family history of early CAD Patient Active Problem List: Skin lesion of left leg Anisometropic amblyopia of right eye Myopia of both eyes with astigmatism NSTEMI (non-ST elevated myocardial infarction) PMH: has no past medical history on file. PSH: has a past surgical history that includes pr create eardrum opening,gen anesth (11/06). FH: family history is not on file. SH: reports that he has never smoked. He has never used smokeless tobacco. Social History Occupational History ? Not on file Tobacco Use ? Smoking status: Never Smoker ? Smokeless tobacco: Never Used Substance and Sexual Activity ? Alcohol use: Not on file ? Drug use: Not on file ? Sexual activity: Not on file Allergies: has No Known Allergies. Medications: Prior to Admission medications Medication Sig Start Date End Date Taking? Authorizing Provider fexofenadine (ALLEGRA) 180 MG tablet Take 180 mg by mouth once daily as needed Yes Provider, Historical, MD FIBER PO Take 1 tablet by mouth once daily Yes Provider, Historical, MD ibuprofen (MOTRIN) 200 MG tablet Take 200-600 mg by mouth every 6 hours as needed for Pain Yes Provider, Historical, MD Review of Systems: A 10 point ROS was obtained and was otherwise negative except for chest pressure Physical Exam: GENERAL: thin, well-appearing individual in no apparent distress. Vital Signs:*BP 98/70 Pulse 79 Temp 96.3 °F (35.7 °C) (Oral) Resp 18 Ht 5' 11" (1.803 m) Wt 156 lb 6.4 oz (70.9 kg) SpO2 98% BMI 21.81 kg/m2Body mass index is 21.81 kg/m². EYES: EOM intact bilaterally. EARS: hearing is grossly intact. NOSE: patent and moist. OROPHARYNX: moist and pink. NECK: supple, no masses, no adenopathy, no thyromegaly, no JVD, no carotid bruits. LUNGS: Clear to auscultation bilaterally. No rhonchi, rales or wheezes. HEART: Regular rate and rhythm, normal S1 and S2, no murmur(s). No rubs or gallops. ABDOMEN: Soft, nondistended. Nontender to deep palpation. No palpable masses, or organomegaly. Positive bowel sounds. EXTREMITIES: No clubbing,cyanosis. no pedal edema. CIRCULATION: 2+ pedal pulses bilaterally. SKIN: No rashes or open lesions. NEURO/PYSCH: No gross focal deficits. Alert and oriented x 3. Appropriate affect and mood. Most recent diagnostics and Labs: Recent Labs Component Name 05/23/21 0808 CHOLESTEROL 142 TRIGLYCERIDE 60 HDL 44 LDL 86 NONHDL 98 Recent Labs Component Name 05/23/21 0808 05/22/21 1415 WBC 6.0 9.1 Recent Labs Component Name 05/23/21 0808 05/22/21 1415 SODIUM 141 140 POTASSIUM 3.8 4.0 CHLORIDE 104 102 CO2 32* 27* BUN 11 8 CREATININE 0.90 0.9 CALCIUM 9.4 9.2 GFR >90 >90 No results for input(s): APT, INR in the last 87600 hours. Echo: ? Ejection fraction is 5560%. Question extremely mild area of inferoapical hypokinesis. ? There is no clinically significant regurgitation or stenosis. ? Pulmonary arterial systolic pressure is within the normal range. ? No significant pericardial effusion. IMPRESSION: Myopericarditis 2/2 covid vaccine - EKG changes and positive troponin - No evidence of effusion - troponin trending down and symptoms are improving PLAN: I reviewed findings with patient and his fiancé. We discussed pathophysiology and treatment. Since he had a difficult time with ibuprofen, we will treat with colchicine for 6 weeks at 0.6mg BID. Discussed side effect of diarrhea. I reviewed recommendations for avoiding strenuous activity and contact sports for 1 month due to cardiac inflammation. I reviewed risk of cardiac arrhythmias with myopericarditis and do recommend continuing with metoprolol on discharge. Recommend follow up with general cardiology in 4-6 weeks for follow up Thank you, (Name), DO Cardiac Electrophysiology

Patient received 2nd Moderna shot on 6/11/21 at 10:32am. Went home after the shot and didn't feel well, so he laid down to rest. His wife checked on him and he was unconscious, so she called 911. Patient was taken to local hospital and died of Cardiac Arrest sometime between his vaccine and 7pm on 6/11/21.

Patient came to get his first dose of Moderna vaccine, and anaphylaxis happens after 3-4 minutes. Patient seems to gasp for breath. He did not respond to call/touch. Pharmacist ran out to give EpiPen, then laid patient down onto the floor with his legs up onto the chair while the tech called 911. EMS came and took it over. Patient however denied to go to hospital.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient was in waiting area after the shot, fell from his chair onto the floor unconscious for a moment. scraped his forehead, some blood. offered him water, which he drank all of it, and had staff member watch over him very closely. once he was fully coherent, patient said he has anxiety of shots/needles. He denies any trouble breathing or itchiness/rash. Says he feels some numbness in his hands as well. He denied the offer to call 911 or go to urgent care

Other than brusing and a sore muscle, on 01/05/2021 at 3AM, I noticed my stomach felt bloated after drinking soda. It got worse through out the day. At 5:30PM, I took medicine for gas. By 6:30PM, the pain was worse so I went to UC and after a check up, I was sent to the ED for a CT scan and they found an inflamed appendix. I had surgery to have it removed. After surgery, I developed asthmatic pneumonia which led to a 7 day hospitalization.

Atrial fibrillation; Hard to breathe; A spontaneous report was received from a consumer (patient's wife), regarding a 37 years-old white male patient, unknown ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced, atrial fibrillation, uncomfortable (discomfort), and hard to breathe (dyspnoea). Current medical conditions reported as controlled atrial fibrillation and cardiomyopathy. Past medical history includes atrial fibrillation diagnosis (May 2018) and stroke (May2018/hospitalized). Weight reported as 180 lbs.The patient's medication allergy included albuterol inhaler. Concomitant medications reported included are rivaroxaban, levetiracetam, bisoprolol and flecainide. On 15 JAN 2021, one day prior to the onset of events, the patient received their first of planned doses of mRNA-1273 (batch number: 029L20A), at a dose of 0.5 ml, intramuscular in the left arm for the prophylaxis of COVID-19 infection. The consumer reported that the patient became uncomfortable and it was hard to breathe on 16 JAN 2021. On 17 JAN 2021, in the morning, the patient went into atrial fibrillation. The patient received treatment medication with a double dose of flecainide and went back into normal sinus rhythm about 2 hours later. On 18 JAN 2021, in the morning, the patient had a second occurrence of atrial fibrillation, for which he received treatment with a double dose of flecainide and went back into normal sinus rhythm. On 21 JAN 2021, the patient again developed atrial fibrillation third occurrence, for which he received treatment with a double dose of flecainide and went back into normal sinus rhythm. On 27 JAN 2021, the patient had a fourth occurrence of atrial fibrillation, for which he received treatment with a double dose of flecainide and went back into normal sinus rhythm. These adverse events were reported to his physician. The consumer stated that she can be further contacted if the safety department follows up for any additional information. Action taken with second dose of mRNA-1273 in response to the events was not reported. The outcome of the events, atrial fibrillation, uncomfortable, and hard to breathe, were reported as not recovered.; Reporter's Comments: Very limited information regarding this event has been provided at this time. The patient's medical history of atrial fibrillation and cardiomyopathy remains a confounding factor. Further information has been requested.

This morning I gave a patient a moderna vaccine. During administration the patient expressed his fear of needles. After the vaccine I asked the patient to have a seat and wait in the waiting area for 15 minutes. He went and sat down for just a couple minutes and stood up to look for his spouse and when he stood up he passed out and hit the floor face first. I ran out there to check on him and he was unresponsive and bleeding a lot. My team immediately called 911. I started tapping him and slightly shaking him and after a few minutes he woke up. He told me the only thing he remembers is feeling dizzy then woke up on the floor. EMS showed up a few minutes later and took the patient to the hospital.

- Received first dose of mRNA vaccine on Thursday 4/8/21 - Febrile and lethargic on 4/9/21 - Chest pain started 4/10/21, radiated to arms bilaterally, associated with diaphoresis, went to ED - Dx with lateral ST elevation MI, positive and rising high-sensitivity troponin, taken to cath lab, clean coronary arteries, echo showed EF 45% with apical lateral hypokinesis - stayed for 24 hours in hospital, discharged pain free - seen in cardiology clinic at Medical Center on Friday 4/9/21. EF had normalized, ECG had normalized, no residual symptoms

Within five minutes of the vaccination, the patient expressed distress. Patient was slumped over in his seat, extremely labored breathing and his eyes were rolling to the back of his head. The Pharmacist spoke to the patient to see how he was feeling but he wasn't very responsive so we administered an Epipen and immediaetly called 911. The paramedics came at around 6:20pm and checked the patients vitals. EMT said the patients vitals were normal and have the patient the option to go to the ER. Patient was alert and able to drink water. Patient refused hospitalization. We advised the patient to go directly to the emergency room if he was developing any symptoms once home and to follow up with his primary care provider.

Unexpected death; found unresponsive 04/20/21 morning and pronounced dead after unsuccessful resuscitative efforts

Atrial fibrillation; Thyroid hormone (TSH) goes down; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) 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 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant) and THYROID HORMONES DECREASED (Thyroid hormone (TSH) goes down). At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation) and THYROID HORMONES DECREASED (Thyroid hormone (TSH) goes down) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, Blood thyroid stimulating hormone: low (Low) Low. On 21-Mar-2021, Electrocardiogram: atrial fibrillation (abnormal) Atrial fibrillation. On 21-Mar-2021, Stress echocardiogram: atrial fibrillation (abnormal) Atrial fibrillation. 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. Concomitant medications were not provided. The patient was in emergency room for few hours and was given 3 doses of apixaban (Eliquis) for treatment for the events. The patient was on holter monitor for 3 days. The patient reported, his thyroid level comes near normal after one and half weeks. 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. He is pilot and kept off the duty for Atrial fibrillation.; 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.

2nd dose of Moderna vaccine given on 4/23/2021. He presented with acute STEMI on 5/2/2021. He has no family hx of premature CAD and no known cardiac RFs. Although doubt relationship between the vaccine and his acute MI our ID agreed that reporting this to VAERS is reasonable.

About a week after his first dose he developed a skin reaction at the injection site. Redness, swelling, itching. The affected area was about 10 inches by 6 inches. The day following the second dose of the vaccine he developed chills, sweats, aches, and a low grade fever. He also developed the same skin reaction. He had these symptoms for 2 days (Thurs and fri). By Saturday his condition was improving. Sunday was even better, Monday evening he died. He was 37 with no known medical issues. He just died out of nowhere.

when patient turned in his timer (15 minutes), as he was walking back toward the waiting area, his wife noticed him very pale and lightheaded so she grabbed a chair to have him sit back down, but he fainted and fell back and hit his head and bled. i was just finishing up another vaccine when i was called to the scene at which point he was on the floor. we raised his legs on a chair and a few seconds later he came to and sat up. we called paramedics and placed a cool pack on back of his neck but advised him not to move too much. took his bp (101/71 p 63) and we conversed until paramedics arrived. pt wanted to go on his own to the er but when they stood him up he got dizzy so they took him on a stretcher and advised him to go to an urgent care facility. called wife at eod and she said he received 4 staples and ct scan was normal and they were observing him he was walking around.

fall on May 19 and admitted to ER May 22 with subacute R MCA stroke resulting in obtundation and left sided hemiparalysis. Complicating his presentation is acute COVID 19 infection with pneumonia along with acute on chronic systolic congestive heart failure.

3 weeks after receiving the first of the series of two injections, the patient developed SOB and CP. He presented to the ER with a R/O MI.

Right calf pain with leg swelling and heaviness over a couple of days then right medial calf pain with what appeared to be a bruise the size of my fist and a small central painful lump. Urgent Care appt. US done and found a medial distal thigh venous clot. started Aspirin 325mg once daily. On day 4 of taking this medication, my right leg completely resolved of the swelling and heaviness and the "bruise" completely resolved without any discoloration. This makes me think the "bruise" was engorged capillary vessels that were not flowing due to the clot.

Atrial Fibrillation that developed 18 days after the first vaccine dose. Felt change in HR, some chest pain.

June 13, 2021. Went to hospital for shortness of breath and chest tightness. Temp 99.2. DX: )Acute non-ST segment elevation myocardial infarction, Acute coronary syndrome ; Pulmonary edema Transferred to Medical Center Negative Covid test on June 13, 2021. Positive Covid test June 16, 2021 at Medical Center

27 days after my first shot, I had a physical where routine blood work was ordered. I had my second dose of the Covid vaccine that same afternoon (4/19). Blood taken prior to my second shot showed my platelet count had dropped unexpectedly to 50,000. Further blood work was ordered, and on 7/2/2021 my platelet count dropped further to 24,000. An immediate high dose of dexamethasone was prescribed, and an urgent referral to hematology was made. After the dexamethasone treatment, blood taken on 7/6 showed platelet count of 100,000 and a diagnosis of Immune thrombocytopenic purpura (ITP) was made. Bi-weekly blood draws beginning on 7/19 will track platelet counts for 2 months with a follow up appointment at hematology on 8/12/2021

Intense upper body pain, mostly around neck/should/upper back; accompanied by blood in mucus. Similar pain occurred with the 1st shot, but without blood in mucus. Later determined to be pulmonary embolism.

Anaphylaxis (urticaria, tongue swelling, subjective difficulty breathing) starting approx. 24hrs first moderna dose. No prior episodes of anaphylaxis/allergic rxn. Treated with Benadryl 100mg PO (prior to arrival, pt administered), famotidine 20mg IV, Epinepherine 0.3mg IM. Monitored in ED, complete resolution of symptoms, discharged home.

Patient experienced a lingering headache that increased in the days leading up to an ischemic stroke that occurred 16 days after receiving the second dose. Emergency Department CT confirmed an occlusion of the midline cranial artery. TpA (clot buster) was administered on 3/3/21. Subsequent TEE confirmed a patent foramen ovale (PFO), which was closed with a surgical procedure on 3/30/21.

On March 1st started with a stiff neck, which followed by a massive headache. Approximately two hours later started to vomit and went to the ER. CT scan completed and shown an subarachnoid hemorrhage. Transferred to Neuroscience ICU and hospitalized until March 13th before release. No aneurysm detected in scans and angios.

Event: Blood clot in right leg (superficial thrombosis) Treatment: Rest, elevation, heat and ibuprofen Outcomes: TBD

After receiving the second dose of the vaccine, my husband experienced left arm pain which he thought was from the injection. About a week later, the pain got worse and moved toward his chest. It got so bad, he had to be taken by ambulance to the hospital to find out he had been having a heart attack. He spent nearly three weeks in the hospital before he died on 4/15/21

Patient received Moderna Vaccine on Friday 4/16/2021 12:00pm in dialysis clinic. Over the weekend family called and left a message stating that patient CTB on Friday 4/16/2021 around 8pm.

Rhabdomyolysis; not able to work; Tiredness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RHABDOMYOLYSIS (Rhabdomyolysis) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history was reported.). On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced RHABDOMYOLYSIS (Rhabdomyolysis) (seriousness criterion medically significant), IMPAIRED WORK ABILITY (not able to work) and FATIGUE (Tiredness). On 02-Apr-2021, RHABDOMYOLYSIS (Rhabdomyolysis) outcome was unknown, IMPAIRED WORK ABILITY (not able to work) had resolved. At the time of the report, FATIGUE (Tiredness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Blood test: abnormal (abnormal) The result came and showed that he is diagnosed with Rhabdomyolysis.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. Treatment information was not provided. The reporter mentioned that he as well as his doctor is not saying that it is because of the Moderna Vaccine. Since he never experienced this before and happened 2 days after the vaccination, his doctor suggested to report to Moderna. He mentioned that he's been dealing with this symptom for two weeks. Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.

Clots; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Clots) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced THROMBOSIS (Clots) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 25-Apr-2021 due to THROMBOSIS. At the time of the report, THROMBOSIS (Clots) 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. No concomitant medications reported. No treatment information provided.; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded

0947-Pt passed out after receiving Moderna vaccine. EMS called. Pt awoke spontaneously after 90 seconds. Pt states he has passed out before with blood draws but did not mention before receiving vaccine. P 80 R 16 B/P 84/50. EMS left, pt remains in clinic for observation. 1035-Pt remains alert, only c/o heart palpitations. HR 120's-130's. EMS called to reevaluate. EKG performed by EMS. EMS states pt in Atrial fib and tachycardic. EMS discussed with pt need for cardiac consult to evaluate. Pt declined transfer to hospital. EMS called Urgent Care clinic and spoke with staff. Urgent care agreed to see pt and initiate cardiology consult. 1310-Pt walked to car with staff and drove himself across street to Urgent Care. 1201-Pt called and states he was seen at Urgent care and EKG repeated and he was shown to be in normal sinus rhythm. Blood work drawn. Has appt Monday 5/3/21 with cardiologist. States he was released to go home.

Severe flu like symptoms occured approximately 12 hours after 2nd dose of Moderna vaccine. Blood Clot formed approximately 2 weeks later and created stroke on 4/23/2021.

Admitted to hospital with rhabdomyolysis and renal failure. Also reported severe headache and abd pain prompting CT scans.

Dx unprovoked bilateral pulmonary emboli on 2/9/2021, started having right flank pain on. 2/6/2021. Admitted to hospital on 2/9/2021. Lack of recent surgery, travel and DVT. Given 11 hours of IV heparin, and discharged from hospital, and I am now on the oral blood thinner (eliquis) apixaban for life.

back pain; Pneumonia in right lung; Shortness of breath and couldn't breath; Malaise; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia in right lung) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21H) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in 2020 and Pneumonia (Patient had Covid about an year ago and it gave them pneumonia.) in 2020. Concomitant products included THYROID for an unknown indication. On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced MALAISE (Malaise), CHILLS (Chills) and HEADACHE (Headache). On 07-May-2021, the patient experienced PNEUMONIA (Pneumonia in right lung) (seriousness criterion medically significant) and DYSPNOEA (Shortness of breath and couldn't breath). On an unknown date, the patient experienced BACK PAIN (back pain). On 06-May-2021, MALAISE (Malaise), CHILLS (Chills) and HEADACHE (Headache) had resolved. At the time of the report, PNEUMONIA (Pneumonia in right lung), DYSPNOEA (Shortness of breath and couldn't breath) and BACK PAIN (back pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Blood analysis were good. On an unknown date, Scan: abnormal (abnormal) Found pneumonia in right lung. The patient was treated with doxycycline for five days and received antibiotics in the hospital. The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

Left sided numbness and incoordination, resolved in a few hours, admitted in hospital Right anterior cerebral artery small stroke, embolic appearing,

approximately 1 hour post injection, patient felt diaphoretic, syncopated and experienced Ventricular fibrillation/ cardiac arrest requiring CPR and defibrillation. he has no known history of similar

Patient presented to the ED on 5/12/2021 with hyperglycemia, hypertension, hypothyroidism. Patient presented to the ED on 5/14/2021 with hypertensive emergency, NSTEMI, atypical pneumonia. Patient presented to the ED on 5/15/2021 with elevated troponin and was subsequently hospitalized. These visits are within 6 weeks of receiving COVID vaccination.

Within 2 days, he had shortness of breath, rapid heart rate, body aches, fatigue. Sought treatment at the ER on 6/24. Heart rate was 220 bpm upon arrival. Had to be defibrillated back into normal rhythm. Was admitted to ICU for 6 days and diagnosed with myocarditis caused by Moderna vaccine and parainfluenza virus 3. Was in heart failure with heart function below 40%. Was released home on 6/29 with a life vest and 3 prescription medications to treat myocarditis.

pt received 2nd dose covid vaccine 5/1. 5/20 he goes to ED for toe pain, 5/21 starts pre-op eval with ekg->found to have new inferior lead q waves, new from prior ekg from feb 2020. Denies CP initial documentations, has 5th toe amputation, but reports to cards on out patient visit 6/17 that he has been having intermittent chest pain, presumably started sometime after 5/25 based on charting. On 6/28 he presents to the ED with STEMI. Cath reveals following with following intervention: 100% occluded proximal LAD s/p PCI with stent X 2 - 99% stenosed proximal circumflex s/p PCI with stent X 1 - 99% diffuse stenosis of the mid RCA s/p PCI with stent X 2 Patient develops cardiogenic shock, initially managed with impella device but decompensated and was placed on VA ECMO July 7th which he remains on at this point.

Headache, fatigue led to blood clot in the head and a seizure. _ diagnosis - Accute cerebral venous thrombosis (superior sagittal sinus{.

After his office visit with me on Tuesday 7/13, the patient went to get the Moderna COVID vaccine. He received the vaccine on Tuesday evening. On Wednesday, he developed new fevers as high as 104F (measured at home). Fevers improved with Tylenol. He did not report his symptoms, as per his wife, he assumed this was related to the COVID vaccine. By the following morning, his fevers had resolved. He took a nap midday, and shortly after waking, he reported to his wife that he was feeling short of breath. According to his wife, he appeared in respiratory distress and she heard wheezing. He asked to be helped to the ground, and she immediately called EMS. Unfortunately, before they could get him to a hospital, he died. At the hospital, his wife was told that because his death was outside the hospital, it was presumed to be due to "natural causes". She was told an autopsy would cost $5000, which she could not afford.

39 year old male no known past medical history received his second dose of the moderna vaccine on 2/5. That evening he developed headache, malaise, fatigue, fevers. The symptoms persisted on 2/6 and 2/7 with some improvement in his headache on 2/7. On the evening of 2/7 he developed high fevers to 103, rigors, "vivid dreams" woke up with night sweats. On 2/8 developed pleuritic chest pain and shortness of breath and went to the hospital.

Nurse/doctor hit blood vessel during vaccine injection. I bled afterwards but did not feel it. Immediately that evening I began to feel symptoms of fatigue. This grew into an overall feeling of sickness and 3 days later, I had major brain fog. This then developed into high anxiety. However after about day 6 I felt normal again. Then 20 days later, I am feeling the same symptoms again. My armpit is swollen and having brain fog and anxiety.

Severe middle back pain beginning February 21. Initially thought it was a kidney stone, but a visit to a urologist on February 25, determined it wasn't a kidney stone. The urologist ordered some blood work and that indicated that I most likely had blood clots. Went to the ER on the 25th and had further tests that determined that I indeed did have blood clots in my lungs.

2 DAYS AFTER SM RECIEVED HIS MODERNA VACCINE IN HIS LEFT ARM HIS RIGHT ARM TURNED BLUE. HE WENT TO THE EMERGENCY ROOM TO FIND OUT HE RECIEVED A BLOOD CLOT WHICH THEY THINK WAS CAUSED BY THE VACCINE. HE WAS PUT ON BLOOD THINNERS THAT DAY AND SENT HOME 6 HOURS LATER. HE WILL BE ON BLOOD THINNERS FOR UP TO 6 MONTHS.

Extreme itchiness; Numbness of lips; Closing of throat; Extremely high blood pressure 180/111mmHg; Anaphylaxis; Numbness; Numbness of tongue; Shortness of Breath; The patient's O2 sat would drop as well, O2 levels were reported to be 88%; 135bmp resting heart rate; Tachycardia; Sleepiness; Swollen eyes; A Spontaneous report was received from a Healthcare professional , concerning a male patient of 39 age , who received Moderna's COVID-19 vaccine experienced Anaphylactic reaction/Anaphylaxis, Hypoaesthesia/Numbness, Eye swelling/Swollen eyes, Hypoaesthesia oral/ Numbness of tongue, Hypoaesthesia oral/ Numbness of lips, Oropharyngeal discomfort/ Closing of throat, Blood pressure increased/Extremely high blood pressure 180/111mmHg, Somnolence/Sleepiness, Pruritus/ Extreme itchiness, Heart rate increased / 35bmp resting heart rate, Dyspnoea/Shortness of Breath, the patient's O2 sat would drop as well, O2 levels were reported to be 88%/and Tachycardia /Tachycardia. The patient had a medical history of celiac disease and is a kidney patient (other kidney surgically removed). The reporter states that Patient's concomitant medications are gabapentin and duloxetine hydrochloride for chronic back pain. On 11 Mar 2021, prior to the onset of events, the patient received his first of two planned doses of mRNA-1273 (unknown lot number) via intamuscular route on left arm for COVID-19 infection prophylaxis. On 11 Mar 2021, anaphylaxis 3 minutes post receiving the first dose of vaccine the patient developed numbness and his eyes became swollen, then numbness of the tongue, lips and closing of the throat, which all happened at the vaccination site.The attending EMT provided 3 pills of oral 50mg Benadryl (diphenhydramine) and did not apply an EpiPen. Patient's blood pressure went extremely high (180/111mmHg) instead of dropping. At that moment, it was decided to contact 911. The paramedics placed the patient on a stretcher and loaded him onto the emergency vehicle to be rushed to the hospital. On the way, the patient was given an EpiPen. While in the hospital, the patient was given more diphenhydramine and injected with methylprednisolone. Patient was in observation for 4 hours and then released with a prescription of an EpiPen. It was reported that the patient was extremely sleepy due to the medications given. When the patient arrived home, he went straight to bed. The patient was hospitalized on 11 Mar 2021 for Anaphylactic reaction, Hypoaesthesia, Eye swelling, Hypoaesthesia oral, Hypoaesthesia oral, Oropharyngeal discomfort, Blood pressure increased, Pruritus and released on same day after 4 hours. The next day, Friday (12 Mar 2021) the patient got up around 10:00am. Then at 10:05am, the symptoms began to reoccur with numbness of the lips, tongue, closing of throat and extreme itchiness. As soon as patient's husband noticed, he did not apply EpiPen and drove the patient to the emergency room. The emergency room followed the same protocol with methyprednisolone steroid, EpiPen and diphenhydramine. On Saturday (13 Mar 2021) and Sunday (14 Mar 2021), the doctor was seen and the patient was advised to take diphenhydramine every 4 hours. Then this past Monday (15 Mar 2021), patient started developing shortness of breath and a resting heart rate of 135bmp. That day, the patient was taken to urgent care. There he was administered diphenhydramine and the patient's heart was checked. Urgent care agreed that his heart was acting up and his blood pressure was acting up for an unknown reason. Reporter states that the patient had been developing tachycardia for no reason for a week now. Since the tachycardia had occurred, reporter would check patient's oxygen (O2) levels. When the tachycardia had started, the patient's oxygen saturation (O2 sat ) would drop as well. O2 levels were reported to be 88% and resting heart rate of 103bmp. The reporter would let 5 minutes pass, recheck, and everything would return to normal. On Monday (22 Mar 2021), patient is scheduled to see a cardiologist who will place the patient on a machine to check his heart rate for 3 days to see what is going on. Follow-up with various health care providers was scheduled for the rest of the week. Nephrologist will be seen on Monday, Neurologist will be seen on Tuesday, and Kaiser will be visited on Wednesday. Reporter stated that even though asked to run bloodwork and images, the emergency room did not do it. Lab work was performed on Monday (15 Mar 021) which came back normal. A check for blockage of the heart, also had looked fine. Action taken with mRNA-1273 in response to the event Anaphylactic reaction, Hypoaesthesia, Eye swelling, Hypoaesthesia oral, Hypoaesthesia oral, Oropharyngeal discomfort, Blood pressure increased, Somnolence, Pruritus, Hypoaesthesia oral, Oropharyngeal discomfort, Blood pressure increased, Somnolence, Pruritus, Tachycardia, Heart rate increased, and Dyspnoea was unknown. The outcome of the event Anaphylactic reaction, Hypoaesthesia, Eye swelling, Hypoaesthesia oral, Hypoaesthesia oral, Oropharyngeal discomfort, Blood pressure increased, Somnolence, Pruritus, Hypoaesthesia oral, Oropharyngeal discomfort, Blood pressure increased, Somnolence, Pruritus, Tachycardia, Heart rate increased, Dyspnoea, and the patient's O2 sat would drop as well, O2 levels were reported to be 88% was considered to be unknown at the time of this report. The treatment medications diphenhydramine, EpiPen injection x 2, and Methylprednisolone steroid injection x 2 was reported to be taken by the patient. The events Anaphylactic reaction, Anaphylactic reaction/Anaphylaxis, Hypoaesthesia/Numbness, Eye swelling/Swollen eyes, Hypoaesthesia oral/ Numbness of tongue, Hypoaesthesia oral/ Numbness of lips, Oropharyngeal discomfort/ Closing of throat, Blood pressure increased/Extremely high blood pressure 180/111mmHg, Pruritus/ Extreme itchiness were considered meet seriousness criteria of hospitalization, life threatening, and medically important.. The events Somnolence/Sleepiness, Pruritus/ Extreme itchiness, Heart rate increased / 35bmp resting heart rate, Dyspnoea/Shortness of Breath, and Tachycardia /Tachycardia were considered medically important. The causality per reporter was not provided.; Reporter's Comments: This case concerns a 39 Y/O M hospitalized with a serious expected anaphylactic reaction and unexpected BP increased, oropharyngeal discomfort, eye swelling, hypoaesthesia, pruritus, and NS unexpected somnolence, tachycardia, heart rate increased, and dyspnea with O2 saturation decreased. Event onset 3 minutes after first dose mRNA-1273. Based on current available information and temporal association between use of the product and start date of the event, a causal relationship cannot be excluded

Pt didn't want the second dose. We found out that he said he had a heart attack 2-3 weeks after first shot. He's not sur if it was related to Covid vaccine

2 hrs after he received his vaccine he experienced a sore arm - shaking - chills - and a temp of 101. I gave him Tylenol. He received his vaccine on a Wednesday. Thursday - He experienced Chills - a temp of 103.4 - nose bleeds and spitting up blood. Clots of blood coming from his nose and exhausted. I continued with the Tylenol for the fever Friday - A temp of 100 - his arm still sore - exhausted - very little nose bleeds. By evening time - low grade temp - nose bleeds had stopped - exhausted. Continued with Tylenol. Saturday - just exhausted and sore arm

Visited Zoom urgent care with chest pains, heart complaints and fatigue. Bloodwork showed elevated heart enzymes, hospitalized to Hospital ER with heart attack suspicion, looks like heart inflammation? test results pending, currently hospitalized and monitored

pain in calf; Deep vein thrombosis; Blood Clot; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (Deep vein thrombosis) and THROMBOSIS (Blood Clot) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Deep vein thrombosis. On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced DEEP VEIN THROMBOSIS (Deep vein thrombosis) (seriousness criterion medically significant) and THROMBOSIS (Blood Clot) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in calf). The patient was treated with APIXABAN (ELIQUIS) for Clot blood, at a dose of 1 dosage form. At the time of the report, DEEP VEIN THROMBOSIS (Deep vein thrombosis), THROMBOSIS (Blood Clot) and PAIN IN EXTREMITY (pain in calf) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, Scan: blood clot (abnormal) blood clot. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications included unspecified anti-coagulant and antibiotic. 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.

1 week after the second dose, I was exercising in the early morning when suddenly my vision and hand-eye coordination were flashing, my hand appeared in a different position than where I thought it was. I tried to tell my sons to get help, but I couldn't say any words, just some repetitive mumbling. I was able to walk upstairs but couldn't speak for about 10 mins, and then everything was coming out slowly. It was about an hour before I could resume normal talking. I went to the hospital, where they gave me a CT scan, MRI, heart echo, and eventually a TEE. They said that I had a Transient Ischemic Attack, and they found a PFO in my heart that probably allowed a blood clot to travel to my brain. They also did an ultrasound of my legs when I mentioned the timing of the vaccine, to make sure there were no other clots. I am taking baby asprin and crestor, and have an heart event monitor now for 30 days. I am also scheduled for more bloodwork and a pelvic scan. They say it is likely that they will want to close my PFO, but want to see all the test results first to rule out any other possible causes.

Patient has no clotting history. He developed body aches, left arm pain, and fevers immediately after immunization, but improved. Two days later on 6/2, he developed left flank pain and fevers. On 6/4, he was evaluated in the ED, with CT scan showing partially occlusive thrombosis of left renal artery with areas of renal infarction. Cr remained stably at baseline. Initial workup was otherwise notable for WBC 17 and negative infectious workup. He was initiated on therapeutic Lovenox. On 6/5, CTA chest/abdomen/pelvis was performed to evaluate for other clots. Left renal artery was complete thromboses with evolving foci of renal infarction. No other clots were detected. He continued to have fevers. By 6/8, his leukocytosis, fever, and flank pain resolved. Renal ultrasound with doppler showed restoration of some flow in the left renal artery. He is to be discharged 6/9 on Lovenox 1mg/kg BID without patient Hematology follow-up. His coagulability workup was notable for positive LAC, FVII deficiency, and PET/CT without evidence of occult malignancy.

I had a BVT in my leg and a PE in my lungs and I was treated with a clot blocker. I was sent home and was told that I would be on blood thinners the rest of my life.

Patient presented to another hospital 6/16/21 will cough fever illness was discharged from ED to recover at home, no cultures drawn at that time. Subsequently remained ill and came to our facility 6/30/21 was diagnosed with MSSA bacteremia. After persistent bacteremia despite appropriate antibiotics TTE was performed revealing large pericardial effusion requiring intervention. Patient still admitted and treatment ongoing.