Moderna

Days 1-3: flushed, temp of 99-100, extreme pain in joints and muscles, dizziness, weakness, elevated blood sugar (400s), elevated blood pressure, couldn't stay awake. Treated with OTC cold/flu meds, no appetite~ Days 4-13 same plus wheezing cough, difficulty catching breath, difficulty talking, difficulty comprehension, focus, etc. Low oxygen level. Went to the ER on Day 8 with all of the above. Given oxygen and IV (of what another person had--as was my understanding), prescriptions: Promethazine-DM;methylPREDNISolone; albuterol;azithromycin. Currently--still difficulty breathing, coughing, difficulty focus, very weak. Treatment: walking, lots of water, cough syrup and albuterol

CARDIAC ARREST THAT LEAD TO DEATH - IT WAS REPORTED BY EMS THAT THE PT HAD RECEIVED THE VACCINE ABOUT 30 MINS PRIOR. HE ARRIVED HOME, BECAME SHORT OF BREATH & COLLAPSED. 911 WAS CALLED AND HE WAS TRANSPORTED VIA EMS TO HOSPITAL (16:17) WHERE HE LATER EXPIRED (23:01).

The day after the vaccination, I am experiencing difficulty breathing and fast heartbeat. I'm still experiencing these effects after the 5th day.

76 YO M WHO HAD JUST RECIEVED HIS FIRST COVID VACCINATION WAS IN THE OBSERVATION AREA POST-SHOT WHEN HE BEAG TO C/O OF CHEST DISCOMFORT THAT WAS DESCRIBED AS A BURNING PAIN FROM THE TOP OF THE STERNAL NOTCH TO THE XIPHOID PROCESS IN A STRIP. PT ALSO HAS RADIATION TO NECK AND IS SOB, AND SLIGHTLY SWEATY. PX DESCRIBED AS 4-5/10 AND HAD THIS PAIN FOR APPROXIMATELY 20 MINUTES BEFORE REQUESTING ASSISTANCE. NOTHING MAKES PAIN BETTER OR WORSE. PT SITTING A/O X4 IN NO OBV DISTRESS. HEENT - PERRL, NO JVD, SPEAKS IN FULL SENTENCES. CX - LS =/CLEAR, EKG ST WITHOUT ECTOPY. M-6 PERFORMED 12 LEAD AFTER PT TRANSFERRED TO THEM FOR TRANSPORT. EXTREM - PWD, GOOD PMS X4 Pt transported to ED

Pt is a 76-year old with SIDEROBLASTIC ANEMIA that had been mild and without need for treatment, and IgM MGUS. Presented to ED with newly diagnosed AML, in MDS with WBC counts ~250, 000. He had a normal (EX ANEMIA) CBC on Jan-21. He had COVID vaccine #1 on Jan-25. About 4-days later he developed diffuse dermititis and severe fatigue. He had an ED visit on Feb-8 for these issues and was prescribed Prednisone and Cefalexin (completed Feb-15). CBC was NOT done at that ED visit. He called HEME clininc on Feb-16 (see also the Hematology Note) stating that he was just NOT feeling well in general with increased fatigue and DOE. He noted that the dermatitis was mostly resolved. We rechecked CBC on Feb-17 (results available about 4-PM) that indicated ACUTE LEUKEMIA. Presents to the MC with MDS on FEB18.

Patient reported shortness of breath, chills and cough with thick clear sputum that came on suddenly.

Patient started to not feel well on 2/21/2021. Symptoms progressed throughout the week. Patient was seen for a clinic appointment 2/26 and was then admitted to the hospital. Patient complains of generalized weakness, body aches, fever, chills, cough and increased shortness of breath at rest and with activity. He was diagnosed with Pneumonia due to COVID-19 infection and started on oxygen, dexamethasone and remdesivir.

Flu like without fever. Extreme ache overall; Extreme muscle weakness, joint ache/pain, headache, labored breathing, eyesight slightly blurred, arthritis pain increased.

REPORTING SYMPTOMATIC POSITIVE COVID-19 TEST 5 WEEKS AFTER BOOSTER DOSE..... Pt received Primary dose of Moderna Lot 025J20A on 12/30/2020 and Booster dose of Moderna Lot 042L20A on 01/27/2021. Pt tested rapid positive for COVID-19 on 03/02/2021. At time of rapid testing pt c/o shortness of breath, fatigue, cough and generally feeling unwell "feels like when I have pneumonia"

My husband received the first injection on Feb 3, 2021 he developed a cough afterwards, cough would come and go. He was scheduled to receive 2nd dose on March 11 and I was concerned about having a cough at the time of 2nd vaccine. He went to walk-in clinic and got a covid test was negative, he said his exam was normal, they gave him prescription of Benzonatate 100mg he took one and it did not help so he never took any more. On March 5 while working in the yard he collapsed, paramedics arrived and he was in cardiac arrest, they started CPR, they used AED was in vfib, he was taken to Hospital then transferred to second hospital. I was told he had blood clots in both lungs, one in his leg, and possible clots in the mesenteric area of abdomen. His heart stopped due to the blood clots in his lungs. He remains in the hospital in the Intermediate Coronary Care Unit. He has not yet gained full consciousness.

Patient developed shortness of breath upon exertion on 2/16/21 after receiving his second COVID vaccine on 2/12/21. He had an office visit on 3/3/21 with his PCP where he was found to have an elevated d-dimer. He was sent to the ED for a CT-scan that confirmed an acute bilateral pulmonary embolism with large burden of thrombus within the right lung. He was admitted from 3/3 to 3/11. He underwent a pulmonary arterial embolism on 3/5. He was also on a heparin drip while inpatient. He was discharged on Eliquis.

SHORTNESS OF BREATH ISOLATION-INFECTIOUS DISEASE SIRS (systemic inflammatory response syndrome) Hypokalemia Hypomagnesemia Lactic acid acidosis Hypoxia Transaminasemia Generalized weakness Abdominal pain, unspecified abdominal location Suspected COVID-19 virus infection

Approximately 8 hrs after the second Moderna vaccination I starting having chills. These continued and increased in intensity along with the onset of fever. I did not have an accurate means of taking my temperature at the time. Over the course of the night on the 17th/18th of February the chills and fever never subsided, even with two doses of Tylenol. The day of the 18th, fever and chills continued along with a feeling of intense malaise. My sternum was very sore and it hurt to breathe as a result of the prolonged shivering. I had no appetite and ate absolutely nothing the day of the 18th. In the early morning hours of the 19th my fever broke as did the chills. However, later in the day, a thermometer was obtained and my fever was 101.4 degrees. When taken at bedtime, it was down the 99 degrees and returned to normal later with no future spikes. On the morning of the 20th when I awoke, I noticed a stinging soreness in my mouth and lip area, followed later in the day with my nostrils and inner nose. This turned out to be an intense outbreak of Herpes. The roof of my mouth, gums, upper surface of my tongue, lips, nostrils, and inner nose ultimately became covered and extremely painful. These lesions were not typical blebs, but were tiny, albeit most painful. After five days they resolved and I have had no further issues. As a possible area to investigate - I had had the second Shingles booster 14 days prior to my first Moderna COVID vaccination. I understand Shingles is also a Herpes family virus.

respiratory distress Narrative: Moderna Covid 19 vaccine on 3/12/2021 Developed respiratory distress one hour after the vaccine On 3/15/2021 BP 100/67 sat 69 ct chest angiogram negative for PE 3/18/2021

Pt diagnosed with COVID-19 despite 2 COVID vaccines (first given 1/15/2021. Pt developed respiratory symptoms, including dyspnea, which progressed over 3.5 weeks and then systemic symptoms of myalgias, malaise. He was admitted 3/21/2021 and had positive NP swab for SARS-CoV-2 x 2. He required admission to ICU and died of respiratory failure on 3/28/2021.

Respiratory failure; Messed up with medication; A spontaneous report was received from a Consumer concerning himself, a 76-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced respiratory failure and messed up with medication/ Medication error. The patient's medical history was not reported. Concomitant medication was not reported. On 24 Feb 2021, the patient received their first of two planned doses of mRNA-1273 mRNA-1273 (Lot number: 001A21A) intramuscularly for prophylaxis of COVID-19 infection. On 24 Feb 2021, after receiving mRNA-1273, the patient experienced respiratory failure and messed up with medication. He was hospitalized in ICU from 27 Feb 2021 till 08 Mar 2021 due to his medication messed up and had a respiratory failure. Action taken with mRNA-1273 in response to the events was not reported. The events respiratory failure and messed up with medication were reported considered resolved on 08 Mar 2021.; Reporter's Comments: There is insufficient details to assess the event of medication error as the specific drug and error was not ddescribed as well as the condition leading to error. In addition, limited information has been provide about the event of respiratory failure but for the fact that it was due to medication error. Hence assessed as unlikely due to mRNA-1273

7-8 hours after injection slight soreness at shot location; 20 hours after injection sudden wave nausea & possible need to vomit, defecate, urinate, & dizziness; sat on toilet & collapsed forward onto floor into stack of towels remaining semi-conscious for a several minutes trying to determine location; worked way upright, got to bedroom, and tried to sleep but severe chills; chills subsided and slept 6 hours; felt feverish and in period of 2 hours had temperatures of: 99.6; 100; 100.4; 101.5; 101.8; 98.8 & went back to bed for night; awoke feeling relatively normal 03/13/2021; thereafter to the present time of 04/04/2021 days of feeling relatively normal, but often waves of feeling light-headed; blood pressure my blood pressure taken at home on Omron wrist device has been highly variable from 136/74/58 down to 101/64/72 with prior normal being about 115/65 to 130/70 at home and as taken at the eye doctor's office on 03/01/2021 the week prior to cataract surgery on 03/08/2021 it was 128/70, but is commonly higher at doctors office exams likely due to stress of driving to the doctor's office and on day of surgery was up to 158/80; on those days of being light-headed the blood pressure was commonly in the 101/64/72 to 114/65/61 range; my body temperatures remained in normal ranges of 97-98; beginning on 03/30/2021 there was some feeling of some throat or esophagus constriction and harder to swallow; this has continued & included acid reflux on 04/03/2021 and feeling very tired and went to bed about 05:00pm & slept to 08:00pm followed by going to bed at 11:00pm and unable to sleep the rest of night due to acid reflux in throat all night; but better on awakening this morning; it remains that there is the feeling of being light headed; a few times during this period after getting the Moderna vaccination the area of the injection has had a minor soreness, and/or itchiness. I have not yet seen a doctor about this reaction, but I did indicate to my eye doctor prior to the cataract surgery on 03/08/2021 that I would be getting my second Moderna vaccination 3 days after. He felt it should be okay. Similarly at the time of my first Moderna vaccination, I told the nurse practitioner that I would be having cataract surgery 3 days prior to the scheduled second vaccination. She also felt it should be okay, as well as having had a reaction to Amoxicillin for the first time about 11 months earlier. That reaction was hives all over the body that kept recurring for 3 weeks and thereafter at places on the body for another month. I am otherwise in excellent health for my age and the only medication taken is Timolol for glaucoma. I am active and frequently walk several or more miles several days per week. My reaction seems unusual. I have only now ceased taking the last of the cataract surgery eye medications, that being Prednisolone eye drops. If the symptoms persist after seeing my eye doctor tomorrow, and after elimination of the eye drop medication as of today, I will be scheduling an appointment with my regular doctor for a checkup.

cardiac arrest Narrative: Patient received dose 2 series of Moderna COVID-19 vaccine. First dose was received on 1/17/21 and second dose received 2/14/21. After both doses patient was observed for 15 minutes and did not have any adverse reaction per administering RN. No data in database or database as to any other adverse events occurring 15 minutes post-vaccination. On 3/20/21, EMS was called to patient's home who was discovered on the floor with an unknown breathing status and pulse. AED was attached to the patient. A very weak pulse was found and patient had agonal respirations. Cardiac monitor was attached to patient with a HR of 32. 1mg of atropine was administered and patient's rhythm changed to PEA with no respirations or pulse. Per patient's wife and son, he was a DNR, therefore all resuscitation attempts were stopped (patient was never admitted to the hospital). Patient was never known to be previously positive to COVID. PMH that may have predisposed patient to this adverse event leading to death include h/o DVT on chronic anticoagulation, COPD, and abdominal aortic aneurysm. There is insufficient information to determine the exact cause of death or what led to the cardiac arrest given that the time from last vaccination to the adverse event was almost a month apart.

Patient has shortness of breath. He called 9-1-1 twice. The first time they didn't take him to the hospital. The second time they took him to the hospital and they released him after several hours.

Congestion; Respiratory issues; Oxygen breathing is off; Sweats; Coughing; Fever 100 point something; Really tired; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (Congestion) in a 76-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 Double vessel bypass graft. On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PULMONARY CONGESTION (Congestion) (seriousness criterion medically significant), RESPIRATORY DISORDER (Respiratory issues), DYSPNOEA (Oxygen breathing is off), HYPERHIDROSIS (Sweats), COUGH (Coughing), PYREXIA (Fever 100 point something), FATIGUE (Really tired) and NAUSEA (Nausea). At the time of the report, PULMONARY CONGESTION (Congestion), RESPIRATORY DISORDER (Respiratory issues), DYSPNOEA (Oxygen breathing is off), HYPERHIDROSIS (Sweats), COUGH (Coughing), PYREXIA (Fever 100 point something), FATIGUE (Really tired) and NAUSEA (Nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: 100 point (Inconclusive) 100 point. In March 2021, Respiratory rate: 92-96-97 (Inconclusive) 92-96-97. Concomitant product use was not provided by the reporter. Treatment information was unknown. Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

PATIENT WAS TIRED AND SORE AT SIGHT OF SHOT A COUPLE OF DAYS AFTER SHOT HE WAS DEHYDRATED AND HAD LOW BLOOD PRESSURE SO WEAK HE COULDN'T STAND NOT LIKE HIM AT ALL HE USUALLY IS VERY OUTGOING. CALLED 911 RUSHED TO HOSPITAL. ALL TESTS WERE TAKEN EVERYTHING IS NEGATIVE. SENT TO A REHAB FACILITY AT ADMISSIONS HAD TROULE BREATHING CALLED 911 BACK TO HOSPITAL. ADMITTED INTO ICU SAID HE HAS SWELLING ON THE BRAIN RAN EVERY TEST POSSIBLE NEGATIVE FOR EVERYTHING. DOCTOR HAS TREATED HIM FOR ANYTHING HE THINKS COULD BE WRONG. DISCHARGED TO A LONG TERM ACUTE CARE TO SEE IF ANY IMPROVEMENT FOR 25 DAYS. NO DIAGNOSIS OF WHY THIS IS HAPPENING. ONLY THING THAT MAKES SENSE IS THAT EFFECTS OF VACCINE.

death Narrative: Patient received Moderna covid vaccine # 1 on 2/26/21. Per scanned records on 3/18/21, he presented to the ER with reports of shortness of breath and was subsequently admitted and treated for acute CHF, NSTEMI and sepsis (ceftriaxone and azithromycin). He later developed AKI and surgery was consulted for placement of a Trialysis catheter. After placement of this catheter, he developed increasing respiratory distress and confusion and was transferred to the ICU where he received vasopressors, intubation and unsuccessful resuscitation after a code blue. Autopsy reports not available. 22 days from date of vaccine to date of death.

death Narrative: Patient received Moderna covid vaccine #1 on 1/22/21 and #2 on 2/24/21. On 3/4/21, he was admitted to a facility for shortness of breath x 1 week. Upon admission, he was found to be in heart block and was admitted to the ICU and placed on pressors. He did have a negative COVID PCR test on 3/4/21. He has a noted history of COPD, CHF and OSA. On 3/6/21, he underwent a new pacemaker placement. His course was complicated by the development of AKI, paroxysmal V tach and new aflutter and was initiated on apixaban. He was discharged on 3/18/21. No further records available and a date of death was recorded as 4/3/21. No autopsy results available. 38 days from time of second vaccine to date of death.

respiratory and cardiac arrest Narrative: Patient with PMH of esophageal cancer, larynx cancer, liver cancer, PTSD, A. fib, and alcohol abuse. He received his COVID-19 vaccines on 2/14/21 and 3/14/21. Both vaccines were administered without complications and patient was observed for 15 minutes post-vaccination without adverse effects. No other adverse events noted between time of last COVID-19 vaccinations and death. On 4/11/21, patient's wife called 911 in which EMS found patient unresponsive with abnormal breathing. Wife reported that patient was breathing up until 5 minutes prior to EMA arrival, but had been unresponsive. Wife reports that patient suffered from multiple forms of cancer, PTSD, and alcohol abuse. Wife believed that patient quit smoking and drinking but the morning of death found vodka and cigarettes in his coat. Wife reports that patient asked for help getting up from the stairs and then laid down in the bed, and went unresponsive afterwards. EMS attempted to revive the patient with CPR but were unsuccessful. Per EMS note patient suffered from respiratory arrest, cardiac arrest, then cardiac death. Patient was not brought to the hospital prior to death. It is very unlikely that the COVID-19 vaccinations contributed to this patient's death due to his extensive PMH with substance use disorder and cancer.

Pt received his 2nd moderna covid vaccine on 4/16/2021. admitted on 4/22/2021 from his long term care facility due to concerns for a chf exacerbation and acute on chronic respiratory failure. Pt was given IV Lasix. chest x ray showed mild pulm vascular congestion. there was no hypoxia, tachycardia and pt was on eliquis so pe was felt to not be a possibility. abg showed acute respiratory acidosis with hypercapnia which improved with bipap administration. His troponins and ekg were negative. vitals on arrival were stable. He was admitted. Labs were otherwise unremarkable. Pt began to have pauses on telemetry and was last seen awake and alert but when nursing staff went back to check on him minutes later he was found deceased

48 hours after 2nd COVID injection, severe shortness of breath. Unable to perform any activity, including getting dressed , walking from room to room any physical activity without sitting or lying down to catch a breath. Also during this time experienced chills, body aches, muscle weakness.

Acute kidney injury; acute myocardial infarction; cardiac failure congestive; Confusional state; dyspnea; Respiratory distress; Sepsis; cardio-respiratory arrest; This case was received via VAERS (Reference number: 1213568) on 11-May-2021 and was forwarded to Moderna on 11-May-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of CARDIO-RESPIRATORY ARREST (cardio-respiratory arrest), ACUTE KIDNEY INJURY (Acute kidney injury), ACUTE MYOCARDIAL INFARCTION (acute myocardial infarction), CARDIAC FAILURE CONGESTIVE (cardiac failure congestive), CONFUSIONAL STATE (Confusional state), DYSPNOEA (dyspnea), RESPIRATORY DISTRESS (Respiratory distress) and SEPSIS (Sepsis) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced CARDIO-RESPIRATORY ARREST (cardio-respiratory arrest) (seriousness criteria death and medically significant), ACUTE KIDNEY INJURY (Acute kidney injury) (seriousness criteria hospitalization and medically significant), ACUTE MYOCARDIAL INFARCTION (acute myocardial infarction) (seriousness criteria hospitalization and medically significant), CARDIAC FAILURE CONGESTIVE (cardiac failure congestive) (seriousness criteria hospitalization and medically significant), CONFUSIONAL STATE (Confusional state) (seriousness criterion hospitalization), DYSPNOEA (dyspnea) (seriousness criterion hospitalization), RESPIRATORY DISTRESS (Respiratory distress) (seriousness criteria hospitalization and medically significant) and SEPSIS (Sepsis) (seriousness criteria hospitalization and medically significant). The patient died on 20-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient presented to the ER and was treated for acute CHF, NSTEMI and sepsis with ceftriaxone and azithromycin. After placement of Trialysis catheter, he developed increasing respiratory distress and confusion and was transferred to the ICU where he received vasopressors, intubation and unsuccessful resuscitation after a code blue on 20-Mar-2020. Company comment: This is a case of death in a 76-year-old male subject with unknown medical history, who died 22 days after receiving the second dose of vaccine. Very limited information has been provided at this time. No follow up is possible. Concomitant medication use was not provided by the reporter.; Sender's Comments: This is a case of death in a 76-year-old male subject with unknown medical history, who died 22 days after receiving the second dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: unknown cause of death.

starving for air; rash; my breath is shorter than it used to be; Itching, it has increased all over his body; They're red & little bumps, juice comes off of them when I scratch it, then it makes a scab; They're red & little bumps, juice comes off of them when I scratch it, then it makes a scab; They're red & little bumps, juice comes off of them when I scratch it, then it makes a scab; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (starving for air) and DYSPNOEA (my breath is shorter than it used to be) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included OXYGEN and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced RASH ERYTHEMATOUS (They're red & little bumps, juice comes off of them when I scratch it, then it makes a scab), RASH PUSTULAR (They're red & little bumps, juice comes off of them when I scratch it, then it makes a scab) and SCAB (They're red & little bumps, juice comes off of them when I scratch it, then it makes a scab). On 24-Apr-2021, the patient experienced PRURITUS (Itching, it has increased all over his body). On 28-Apr-2021, the patient experienced DYSPNOEA (my breath is shorter than it used to be) (seriousness criterion medically significant). On 19-May-2021, the patient experienced DYSPNOEA (starving for air) (seriousness criterion medically significant) and RASH (rash). At the time of the report, DYSPNOEA (starving for air), DYSPNOEA (my breath is shorter than it used to be), RASH ERYTHEMATOUS (They're red & little bumps, juice comes off of them when I scratch it, then it makes a scab), RASH PUSTULAR (They're red & little bumps, juice comes off of them when I scratch it, then it makes a scab), SCAB (They're red & little bumps, juice comes off of them when I scratch it, then it makes a scab), PRURITUS (Itching, it has increased all over his body) and RASH (rash) outcome was unknown. The patient reported he presented to Urgent Care on 28-APR-2021 but they did not have any treatment recommendations. On 19-MAY-2021 the patient continued to experience rash and still itching. Treatment included oxygen therapy, antiseptic (Listerine) splashes on the rash without any relief and diphenhydramine once in the morning and twice in the evenings. Action taken with the mRNA-1273 in response to the event is not applicable. This case was linked to US-MODERNATX, INC.-MOD-2021-116720 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Significant follow up received as event details were added and updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-116720:

rom: To: Cc: Subject: Patient Concerns Date: May 29, 2021 6:42 PM Dear Sir/Madam, I would have liked to include her in this message but am not in possession of her official email address. To recap the encounter on April 29, 2021 : I went with my friend to the clinic,where we spent 12 most frustrating hours I expressedly told the staff with my friend present, that I have been an extremely healthy individual, who has never seen a doctor,/ER/hospital in over 40+ years. I am happy to give you my previous employers contact info to verify that I never missed a day`s work. I told the staff I suddenly fell very ill 2 days ago 2-3 weeks after my 2nd CVID 19 vaccination. with sudden massive bilateral leg edema up to the groin and extensive lower leg blood staining and mottling of my skin. The attending dr just called it Pedal Edema. He was not interested in my history (present and past), no examination, had to remove no clothes. My friend and later neighbors in the community where flabbergasted that he did not see the state of my legs. Obvious other symptoms such as abdominopelvic ascites was also present. Further tests were done and inexplicably suddenly pulmonary atelectasis and cirrhosis of the liver become important. Could that really make me so sick in two days? Absolutely incomprehensible. there was an avalanche/cascade of blood destruction with destruction of RBCs, hemolysis, loss of platelets, obvious very high total bilirubin, hypoalbuminemia and ascites. My bed sheets still show numerous blood stains where I bled from many of the skin lesions and scabs Those were all results due to one common denominator:: reaction to COVID vaccination. Forget about pulm atelectasis or liver cirrhosis making me so sick in 2 days i AM INTERESTED TO SEE YOUR EXPLANATION A quick comment for her and her comment about compassion, She is probably unaware, that are quite a few nations in this world, where medical colleagues do not charge their colleagues/family and the pastor/family of their church, I lived/worked for a for a few years in another country. One night I was called to drive into one of the park's camps to attend to a colleagues wife who had an incomplete miscarriage and bleeding, This was quite a drive through the night back to the hospital, doing a D&C and the couple could happily continue their journey that afternoon. No charge by the hospital or me. That is compassion. Dr.

Rheumatoid factor elevated at 45, CRP 122 Patient was in good health, with distant history of Graves Disease until April 5 when he presented to Hospital with complaints of chest pain, worse with sitting up. CAD was ruled out with troponins and he was taken to the cath lab and found to have essentially normal coronary arteries. He was started on colchicine with improvement in chest pain. On April 30th he presented to Hospital with low grade temps, cough and right sided chest/abdominal pain. He was found to have moderate pleural effusion. Because he was on Eliquis, for episode of afib thought related to pericarditis, pleurocentesis was delayed until May 3 when 1.5 L of fluid was removed from his pleural space. He continued on colchicine and 3 days later reported feeling essentially normal. Blood and fluid cultures were negative. Pleural fluid cytology showed predominantly chronic, inflammatory lymphocytes and macrophages/monocytes, reactive mesothelial cells. There was no overt morphologic evidence of malignancy. Patient was feeling well. Dr stopped Eliquis, Cochicine and patient did well until May 17 when he again reported aches, chills and pleuritic chest pain. Pleural effusion recurred and patient restarted cochicine with improvement

Worsening abdominal pain and distention on 3/2/21 which progressed to include shortness of breath for which he did not seek medical care. He was found unresponsive on the couch on 3/11/21 and resuscitation was unsuccessful.

on 6/16/2021 at approx. 2:00 PM patient presented with hypertension (BP 184/115), Elevated Temp (104.1F), Increased confusion, lethargy, weakness. Was sent to ER via ambulance where he was admitted. Per admitting H and P primary Dx. "Fever, Probably acute viral illness versus post vaccination syndrome". Patient was treated inpatient at hospital with IV hydration, symptomatic care, lab monitoring. Patient is stable and planning to discharge from hospital back to this long term care facility over the weekend.

Patient found in respiratory arrest at 4:20am on 6/19/21. CPR initiated and continued by EMS, along with IV fluids and intubation, remained in asystole throughout course of CPR. CPR terminated by EMS.

Loss of appetite; I had fever and chills which lasted three days; headache a couple days; itching started and hasn't stopped - arms, back, body - it comes and goes away - there is one or to places there's a little red but that's from my scratching but otherwise don't see anything; Feeling more fatigued. Loss of appetite - these lasted for at least a month; shortness of breath issues - continued for three or four weeks before it got to be a real struggle. I was going two or three steps and was having real bad shortness of breath. My son said it was called exertion something. ER - CAT scan- multiple blood clots on lungs - 4 of my 5 lobes were not functioning at the time - Bilateral Massive Pulmonary Thrombolism - I got there just in time. They sent me to Catheter lab - two catheters with Antivase and multiple bags of Heparin and other blood thinner with three day stay. Eliquis - prescriptions - 5 mg - twice a day for 6 months minimum and maybe for the rest of my life. They put me on oxygen on three days - 40's and 50's when I got to the hospital but within a day on oxygen it was back up to 90's. Kidney= Creatine levels were high when I got there but close to normal at release. Blood glucose levels were normal. Blood pressure was 120/80 when I left - laying down. When active it was 130 something over. They put me in Surgical ICQ and then they needed the bed and sent me home to rest. Six foot distance between me and the refrigerator - I do have my appetite back now 1200 calories a day in my diet. I am doing some light walking. Minimized stair climbing but I'm in a three story house so have to do it. Doing light construction work for my son so I'm banging nails. Not any running right now. Telephone follow with doctor - I don't have a primary because I hadn't seen a doctor for 35 years.

Seven weeks after the first dose I began to feel unwell. One week later I had fallen down the night before. I felt like my legs were very weak. My wife noticed that I was hallucinating. We went to Urgent Care and my D Dimer was high as well as my blood pressure. I had a slight fever. I was hospitalized on 05/26/2021. I was diagnosed with Pneumonia,, Community Acquired and ended up being hospitalized for 12 days. My blood pressure was hard to control and my hospitalization was extended. I had fluid in my Lungs. During the stay, I had bleeding in my stomach. It has been eight weeks and I have lost 24 lbs and my Stomach is still upset. I am still receiving Home Health Care.

7-8 hours after injection slight soreness at shot location; 20 hours after injection sudden wave nausea & possible need to vomit, defecate, urinate, & dizziness; sat on toilet & collapsed forward onto floor into stack of towels remaining semi-conscious for a several minutes trying to determine location; worked way upright, got to bedroom, and tried to sleep but severe chills; chills subsided and slept 6 hours; felt feverish and in period of 2 hours had temperatures of: 99.6; 100; 100.4; 101.5; 101.8; 98.8 & went back to bed for night; awoke feeling relatively normal 03/13/2021; thereafter to the present time of 04/04/2021 days of feeling relatively normal, but often waves of feeling light-headed; blood pressure Continuing description of events after second Moderna vaccination: my blood pressure taken at home on Omron wrist device has been highly variable from 136/74/58 down to 101/64/72 with prior normal being about 115/65 to 130/70 at home and as taken at the eye doctor's office on 03/01/2021 the week prior to cataract surgery on 03/08/2021 it was 128/70, but is commonly higher at doctors office exams likely due to stress of driving to the doctor's office and on day of surgery was up to 158/80; on those days of being light-headed the blood pressure was commonly in the 101/64/72 to 114/65/61 range; my body temperatures remained in normal ranges of 97-98; beginning on 03/30/2021 there was some feeling of some throat or esophagus constriction and harder to swallow; this has continued & included acid reflux on 04/03/2021 and feeling very tired and went to bed about 05:00pm & slept to 08:00pm followed by going to bed at 11:00pm and unable to sleep the rest of night due to acid reflux in throat all night; but better on awakening this morning; it remains that there is the feeling of being light headed; a few times during this period after getting the Moderna vaccination the area of the injection has had a minor soreness, and/or itchiness. I have not yet seen a doctor about this reaction, but I did indicate to my eye doctor prior to the cataract surgery on 03/08/2021 that I would be getting my second Moderna vaccination 3 days after. He felt it should be okay. Similarly at the time of my first Moderna vaccination, I told the nurse practitioner that I would be having cataract surgery 3 days prior to the scheduled second vaccination. She also felt it should be okay, as well as having had a reaction to Amoxicillin for the first time about 11 months earlier. That reaction was hives all over the body that kept recurring for 3 weeks and thereafter at places on the body for another month. I am otherwise in excellent health for my age and the only medication taken is Timolol for glaucoma. I am active and frequently walk several or more miles several days per week. My reaction seems unusual. I have only now ceased taking the last of the cataract surgery eye medications, that being Prednisolone eye drops. If the symptoms persist after seeing my eye doctor tomorrow, and after elimination of the eye drop medication as of today, I will be scheduling an appointment with my regular doctor for a checkup. Additional information as of May 24, 2021: I had an examination by Dr., Care Center on April 14, 2021. After discussing the reaction and symptoms that occurred thereafter an EKG indicated a slight heart beat abnormality. Combined with the continuing lightheaded symptoms that periodically recurred he considered the potential that the Timolol that I have used since my late 30s to reduce eye pressure from glaucoma could potentially have reacted with the Moderna shot. As such he later called my opthalmologist, Dr., at Eye Clinic in to discuss this possibility. Dr. also scheduled for me to have an echocardiagram to determine if there has been a resulting heart problem from the Moderna shot. Subsequently after discussing this with Dr. I discontinued taking Timolol for about 3 weeks with a subsequent eye exam to determine the pressure in my right eye to see if a new prescription may be necessary or other alternatives. This was on May 19, 2021. I had been taking my blood pressure daily, sometimes multiple times during the day since the collapse after the Moderna shot. Toward the end of the 3-week period of not using Timilol drops in my right eye the feeling of being lightheaded had become less frequent and blood pressure had become more consistently above 110/65. The feeling of being lightheaded had seemed to often correlate with blood pressure below that, but often my blood pressure was erratic going as low as 100/60 and upward to more normal areas of 120/68-130/75. However, it was not clear to me, or to Dr. if this was a result of having discontinued Timolol or if it was the needed period of time for the Moderna aftereffects to subside. He has me now using only 1-drop of Timolol per day, rather than 2-drops per day in my right eye as my eye pressure is just over borderline of concern for glaucoma in that eye. The cataract surgery on March 8, 2021, 3 days before the 2nd Moderna shot, had eliminated the need for taking Timolol in my left eye. As it stands, I continue to feel relatively normal. I had a second checkup with nurse practitioner at Unity Care Center on May 12, 2021 and she agreed that I should have the echocardiagram as scheduled on May 28, 2021 which is in 4 more days. Additional information as of June 25, 2021: I had an echocardiagram on May 28, 2021 and was provided the evaluation of the results on Jun 9, 2021 by nurse practitioner at Care Center. 1) overall results were good; 2) my ejection factor was 65% and normal; 3) the only abnormality is a mild resistance to ventricle heart relaxing when it is filling up with blood (she further indicated that in positions of some stress is when this was primarily occurring and could result in lower blood outflow and lower blood pressure potentially related to the feeling of being lightheaded and could possible pass out); 4) my heart valves look OK; 5) keep well hydrated to maintain a healthy blood pressure. At the time there was a period of several weeks of having felt relatively normal most of the time with few episodes of feeling lightheaded. However, during a period from June 11 to June 19 there reoccurred daily feeling of being lightheaded and at times the systolic blood pressure dropping to as little as 104 and often no more than 115. However, since that time the blood pressure has returned to the more normal range of 115-130 and feeling more normal. It remains unknown what part the second Moderna shot had to do with this, but there had not been these prior periods of feeling on the verge of passing out combined with lack of energy during these periods. However, the periods of feeling lightheaded seem to be shortening and the periods of feeling normal longer and whatever the causes are gradually subsiding.

Developed Guillian Barre Syndrome. Lost mobility in legs and unable to walk, shortness of breath, heartburn, severe burning in the chest.

Stomach Bleed; Flu symptoms; From that week on I've had no energy/ Ive felt weak; Dizzy; Short of breath / anything I do I feel out of breath.; Fever for a week.; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL HAEMORRHAGE (Stomach Bleed) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced INFLUENZA (Flu symptoms), ASTHENIA (From that week on I've had no energy/ Ive felt weak), DIZZINESS (Dizzy), DYSPNOEA (Short of breath / anything I do I feel out of breath.) and PYREXIA (Fever for a week.). On an unknown date, the patient experienced GASTROINTESTINAL HAEMORRHAGE (Stomach Bleed) (seriousness criterion medically significant). On 11-Mar-2021, INFLUENZA (Flu symptoms) and PYREXIA (Fever for a week.) had resolved. At the time of the report, GASTROINTESTINAL HAEMORRHAGE (Stomach Bleed), ASTHENIA (From that week on I've had no energy/ Ive felt weak), DIZZINESS (Dizzy) and DYSPNOEA (Short of breath / anything I do I feel out of breath.) had resolved. No concomitant medication was reported. The patient stated that per his doctor, his chest, heart and veins were all tested (type of tests were not specified) and all tests were negative. No treatment medication was reported. Patient reported that later found out it was a stomach bleed but said not related to vaccine. Is all fine now and does not want to be contacted for follow up. 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 to clarify causality for the event gastrointestinal bleeding is not expected due to patients denial to be contacted. Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant follow up added. Added event and upgraded case to serious. Outcome of case updated to recovered.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information to clarify causality for the event gastrointestinal bleeding is not expected due to patients denial to be contacted.

First COVID vaccine given 2/11/2021, second dose covid vaccine given 3/10/2021. Person was exposed to a COVID person. On 7/25/2021 experienced headache, fatigue, SOB and cough. Tested positive for COVID on 7/26/2021. Received Monoclonal antibody treatment on 7/26/2021. Pt was tested at our health system, but never cared her prior to that. No previous health records available.

At about 15 minutes post injection patient stated he thought he may feel a little "wheezy" Expiratory wheezes in full right lung. No shortness of breath. BP 148/90, Heart rate 63. O2% 98. Temp 98. Peak Flow 350. Dr. saw patient and ordered hydroxyzine 25mg po. Patient was observed another 30 minutes. He remained stable and then discharged at 5:25pm. Patient will contact Dr. if he continues to have symptoms.

On 1/20/21 the staff observed resident to be more restless constantly moving his legs. He had a decrease in his appetite and fluid intake and required assistance for consumption. His oxygen sats dropped to 89% on room air and was given oxygen at 2L. On 1/21/2021 the Resident observed moving restlessly, opened his eyes when this writer called his name, murmuring incoherent words, words were unclear, was observed taking off his Foley, attempting to grab something, dropped his hands and legs and at the same time restless. This writer was unable to auscultate lungs or heart, resident was moving uncontrollable. Resident positioned safely in bed. VS revealed high BP 147/101. MD ordered transfer to hospital. Resident was treated in the hospital for acute encephalopathy, sepsis with tachycardia and tachypenia and hypoxia.

Patient developed SOB but reported good O2Sats. Instructed on going to ER if worsening symptoms. Patient eventually expired on 1/22/21

Severe difficulty breathing; Blood pressure shot up to 200; Troponin level jumped up; A spontaneous report was received from a non-health professional concerning a 77-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe difficulty breathing and that his troponin level and blood pressure (BP) had shot up. The patient's medical history included chronic obstructive pulmonary disease (COPD). Concomitant product use was not provided by the reporter. On 09 Jan 2021, at approximately 14:42, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 09 Jan 2021 at 20:30, the patient experienced severe difficulty breathing and his BP shot up to 200. The patient went to the hospital and they found his troponin levels had jumped up. The patient reported no known heart issues. On 12 Jan 2021, he went to see his primary care physician (PCP). No treatment information for the event was provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the events, severe difficulty breathing and troponin level and blood pressure (BP) had shot up, were unknown.; Reporter's Comments: This case concerns a 77-year-old, male patient, with medical history of chronic obstructive pulmonary disease (COPD), who experienced a serious, unexpected event of dyspnoea, hypertension and raised troponin level. The event occurred 5 hours 48 min after the first dose of mRNA-1273 (Lot number: 039K20A). Based on the current available information and temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded.

Feeling normal before the vaccine, with exception of slight cough that Dr said was due to allergies. But then a fever, chills and aches the day after vaccine. Two days after, still febrile and feeling worse and experiencing shortness of breath and lightheadedness. Fatigue, fever and lightheadedness continue for three more days. On the 6th day post-vaccine, taken to ER and admitted to hospital with a pneumonia and blood counts dangerously low. Received 3 blood transfusions and is receiving 2 different IV antibiotics to treat pneumonia. Still in hospital and waiting to see how blood counts go. I can?t say the vaccine CAUSED this, but it all happened rapidly, immediately following the vaccine.

Shortness of Breath, decreased oxygen saturation, irregular heart rhythm, hypertension, Positive for COVID, bilateral pneumonia

Symptoms started on 2/4 SOB, nausea, diaphoretic. Pt admitted on 2/5 with STEMI with stent placement and thrombectomy

Moderna vaccine. I was fine and active until bed time 2/7/21. After shower I felt clogged, I did neti pot sinus drain with warm water and hydrogen peroxide 10 to 1. Went to bed (CPAP) and woke up at 2:30AM with nose running and unable to breath through nostrils. Got up and used warm compress over eyes and nose for about three minutes and congestion partially cleared. Upon returning to bed (CPAP} I began to again build up mucous. Repeated same routine at 06:00AM except returning to bed. Immediately became congested again. Took temperature reading 97.3F. Took Temperature again at 8:AM 96.8 BP 97-168 resp 66

pt received vaccine on 2/3. early on 2/4 developed chest pain, dyspnea, and was seen in ED and diagnosed with acute exacerbation of CHF and NSTEMI type 2, and anemia. on 2/5 transfusion was started and pt developed worsening dyspnea and then PEA arrest. Pt achieved ROSC and was transferred to the cardiac intensive care unit where he required vasopressor support. he subsequently declined and died on 2/7

covid shot 2/2; feel bad 2/5; covid positive diagnosis - 2/8 s/s cough, fever, shortness of breath , hypertension, afib (in er) - admitted went into DIC per intensivist 2/11 patient died

Respiratory distress, seizing, cyanotic, A-Fib with RVR occurring less than 24 hours after receiving his second dose of Moderna.

Rash x 3-4 days began 3 days after receiving first dose Covid-19 vaccine. Presented to walk-in clinic after trying benadryl and coconut oil. Also with chills and headache. Patient prescribed Medrol Dosepak. Also advised to try OTC benadryl/claritin as needed, OTC hydrocortisone cream as needed. Patient instructed to follow up with his PCP in 1 week and to go to the ER for shortness of breath, swallowing troubles, worsening rash, or worse symptoms.

1/28/21 - 9 pm nasal stuffiness/congestion; 1/29/21 - 2 am low grade fever 100.2; continued symptoms of malaise, weakness and joint soreness; around 12 pm increased lethargy, weakness unable to get up from chair - needed to use wheelchair. Difficulty breathing - pulse ox 87-90%. Dipped to 85% twice. Most symptoms including SOB resolved within 6-7 hours.

Chills, headache, body aches, oral mucous membrane burning, runny and stuffy nose, feet "hot", cough, chest pain, difficulty breathing, crampy abdominal pain, rash - Henoch-Schonlien purpura purpura and petechiae, edema, proteinuria, hematuria, decreased appetite, dizziness

The patient experienced a cardiac arrest 2 days after receiving the second dose of the Covid-19 vaccine. He later died on 2-17-2021 with complications including respiratory arrest and acute kidney failure.

More than 20 minutes after vaccination, but within 24 hours, patient experienced throat restriction. He was hospitalized.

2/24/2021 admitted to hospital with hypoxia, lethargy, rash, altered mental status with HA. Altered mental status with HA, could be due to metabolic encephalopathy and reaction to COVID-19 vaccine. Will check ABG, CT head. Hold gabapentin. Check depakote level. Rash, likely due to allergic reaction to COVID-19 vaccine, hx of reaction to first COVID-19 vaccine with fever needing hospitalization. Start patient on Solu-Medrol and Pepcid. Benadryl p.r.n. Suspected right lower extremity cellulitis, start patient on Ancef. Check MRSA, will rule out right DVT Abn CXR, Bilateral LE edema, CXR seems stable to me, clinically no pneumonia. He does not have "hypoxia" when I was in room, however assisted living reporte 2/24/2021 admitted to hospital with hypoxia, lethargy, rash, altered mental status with HA. Altered mental status with HA, could be due to metabolic encephalopathy and reaction to COVID-19 vaccine. Will check ABG, CT head. Hold gabapentin. Check depakote level. Rash, likely due to allergic reaction to COVID-19 vaccine, hx of reaction to first COVID-19 vaccine with fever needing hospitalization. Start patient on Solu-Medrol and Pepcid. Benadryl p.r.n. Suspected right lower extremity cellulitis, start patient on Ancef. Check MRSA, will rule out right DVT Abn CXR, Bilateral LE edema, CXR seems stable to me, clinically no pneumonia. He does not have "hypoxia" when I was in room, however assisted living reported he was hypoxic this AM, wife said he was wheezy on Sunday could be due to acute on chronic diastolic congestive heart failure, IV Lasix x1. reeval in AM. Echo TTE is pending Abdominal pain and distension, CT abdomen without contrast to rule out other etiology that can cause altered mental status Hx of COVID-19 pneumonia, history of CVA with dense right hemiplegia and expressive aphasia, chronic atrial fibrillation, depression, Will reorder home meds after pharmacist reconciles medication list Generalized weakness, PT/OT DVT prophylaxis warfarin and SCD

I developed serious hives all over my body, my throat closed up and my tongue swelled up. We called in 911 and the paramedics gave me benadryl and prednisone.

patient reported that he started to experiance: vomiting, diarrhea, difficulty breathing, muscle sorness, difficulty swallowing, and headache on 03/03/2021 @2230.. patient reported that today 03/07/2021 he is doing fine and all his symptoms are getting better.

He had the injection, had the sore arm and approximately 3 hours after the vaccination he began to experience severe chest pain across his entire chest and into his jaw, which was exacerbated upon taking a deep breath. He called his cardiologist who advised him to go to the ER. He was worked up, subsequently admitted from 2/8/21 to 2/11/21, a lot was ruled out but no specific diagnosis made at that time. They did note some pleural effusion and pericardial effusion at that time. Upon discharge on 2/11/21, starting Thursday evening he continued to have pain in the chest, but not as severe as when he entered into the hospital. Every evening including last night has began with severe night sweats, low grade fever and the chest pains have continued. Went to see his PCP, Cardiologist and his Electrophysiologist several days later the following after discharge, he does have a pacemaker, and was told by all three of them that he has pericarditis and that the reaction could have been related to the vaccination. It seemed more than coincidental that the symptoms did not appear until 3 hours after the vaccine. Was put on Colchicine to treat the pericarditis and then received a 2nd opinion and has reinstituted the colchicine. His low grade fever has finally dissipated. During the day he feels okay, but still continues with the chest pains and the night sweats. His hemoglobin dropped in the hospital possibly related to the heparin and then put on Eliquis postop, and now discontinued, and received an iron infusion to boost his hemoglobin. He is scheduled for another iron infusion this Wednesday. He went to see GI physician and feels that he may have a bleed due to the infusion. He has had an anastomosis due to Crohn's disease and feels that's where the bleed may have been coming from as he did have an ulceration at last colonoscopy. He did have atrial flutter due this and was advised to have an ablation, and trying to reduce the pericarditis and FU later with other heart related problems.

His breathing problem worsened on 02/23/2021, short of breath and tired. He died of a pulmonary embolism and heart attack in the hospital on 3/9/21 after being there for 9 days.

Not sure if covid vaccine caused this, but this is what happened - Received covid vaccine. two days later had violent shakes in the night. Immediately went to get a covid test out of precaution. Tested negative for covid, but positive for "flu b". Went home to treat flu with fluids and rest. Got no better. Went to heart doctor out of precaution, full work up...everything checked out great. Went home, got no better. Went to primary care physician, full work up...found a "spot" on left lung. Was given antibiotics and steroids, go home and in a few days will be getting better. 3 days later became incapacitated and had to be rushed to ER. Was admitted into hospital for 6 days to treat "pneumonia". Also possible UTI and sepsis. Also while in hospital found out that a mini stroke had happened. Treatment went well, oxygen levels were good. Was released with glowing reports. 24 hours later at home had to be rushed to ER again after becoming incapacitated.. Was admitted again 7 more days. During this time everything took a nose dive in succession. Lungs were failing, multiple unexplained strokes were happening (while on blood thinners, had been on blood thinner 15 years...after first stroke they changed to another blood thinner...only more strokes). After so many strokes and compounding of strokes, his neuro function started failing. He was put on life support. While on life support his organs started failing. He had to be put on comfort mode and was dead within 8 hours. A perfectly healthy 77 year old man who had never been sick a day in his life (literally) got his 2nd covid shot, two days later he fell ill. From that point on his health spiraled out of control until his death on March 19th. Every doctor (pulmonologist, cardiologist, neurologist, and all attending doctors said that it was "atypical and abnormal" what was happening. It should not have happened. 180 degrees from normal.

On 3/23/2021, Patient became ill, vomiting uncontrollably, throughout the day. On 3/24/2021, he continued his vomiting episodes, and developed a fever with chills. At about 2100 hrs, patient was extremely weak, he went to the bathroom, urinated, and attempted to crawl back to his bedroom, less than 10 steps away. His wife, called 911, and went down stairs to allow entry for the fire department, The fire department, found patient unresponsive, not breathing, and no pulse. He was pronounced dead in his home.

The patient described shortness of breath and a feeling of not getting enough oxygen starting 9 hours after the vaccination. He states this occurred when he tried to lie down on his side. He states he woke up the next morning feeling exhausted. He also stated that his heart was "pounding" all night long, however he stated when he checked his pulse it was normal. He states that his symptoms resolved after 4 days, and has no issues now.

Low oxygen levels; Breathing was shallow; Breath deeper and faster; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Mar-2021 and was forwarded to Moderna on 02-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of HYPOXIA (Low oxygen levels) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) 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 25-Feb-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 26-Feb-2021, the patient experienced HYPOXIA (Low oxygen levels) (seriousness criterion medically significant), HYPOPNOEA (Breathing was shallow) and HYPERVENTILATION (Breath deeper and faster). At the time of the report, HYPOXIA (Low oxygen levels), HYPOPNOEA (Breathing was shallow) and HYPERVENTILATION (Breath deeper and faster) outcome was unknown. Additional information:He does an average of 33 miles on a bicycle every other day. In 2017, he thinks he had scattered pulmonary embolism after a long flight and his oxygen level was lower this time than it did them. Based on the current available information and temporal association between the use of the product and the onset date of the reported event of hyperpyrexia, 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 onset date of the reported event of hyperpyrexia, a causal relationship cannot be excluded.

3/16/2021 Received 2nd Moderna Covid-19 vaccine 3/25/2021 Trouble breathing when exercising so stopped after 5 min and usually do 20 mim; temp elevated for me normal 97.6 and was between 98.6 and 99.3, hacking up yellowish phelgm. Phelgm had been coming up for longer period of time. 3/26/2021 went to clinic and put on treatment for possible bronchitus. Z-Pak and Prednisone 5 days and asked to schedule x-ray to see if something more showed. 3/30/2021 Completed meds and x ray scheduled. No improvement in breathing 4/1/2021 was finally able to get chest x-ray 4/2/2021 x-ray showed nodule on lung & calcified grandular - told to schedule ct to check out nodule - told clinic still no change in condition 4/5/2021 called clinic again due to pain overnight in left lung. Trouble getting ct scheduled so clinic sent to me emergency room rather than schedule ct 4/5/2021 - At ER blood work, x-ray and ct scan completed. CT chest was significant for large bilateral pulomanry emboli w r ventricular strain. Also r middle lobe lung nodule and r adrenal nodule. Started on heparin drip and admitted. Hospitalized 4/5 and sent home 4/8. Sent home on Xarelto to continue at least 3 months and consult w family doctor to determine cause of submassive clots and further treatment.

1. Feb 27 Pain throughout body, extreme shortness of breath, gasping of breath from simply standing up, 2. This shortness of

He got the vaccine, and didn't have any real reaction, anything unpleasant, he had a numb lip and 2 fingers were numb. He called his doctor and she told him to go to the ER, which he did at Hospital. They did a CAT scan of his brain. They tried to do an MRI and they pushed his head against the machine as his back is curved and he stopped breathing. They had given him 2 narcotics for anxiety before the scan. He was then transferred to Hospital in . He saw Cardiophysiologist/IM and he found that he had a blood clot (? where), and they inserted a pacemaker through his groin as his pulse dropped to 40 BPM. He was hospitalized for 7 days, and discharged him with instructions on what he is able to do. They started him on new blood pressure medicines for his kidney's. On 3/26/21, lot# 028A21A. He subsequently had the 2nd vaccine, and all liquids emptied from his body (vomiting and diarrhea), at the same time, and then he was fine once everything settled down which lasted for about 3-4 minutes and then he was fine.

On admission, the patient was also noted to be COVID positive. At the time of admission he was on room air, however his O2 requirements quickly worsened, with increased work of breathing. Requiring transfer to ICU.

Patient received second dose of COVID-19 vaccine on 3/22/2021. Patient presented to ED on 03/29/2021 at 7:45AM complaining of dyspnea on exertion for 1 week since COVID-19 vaccine. Patient also complains of R lower ribcage pain on inspiration for 3 days. Patient became unresponsive and was revived twice. Patient became unresponsive a third time and could not be revived.

Pt to ED on 3/1621 with : "pt c/o left sided chest and rib pain. pt states that other symptoms along with the pain started today. Pt is c/o SOB, numbness and tingling in bilateral upper extremities, bodyaches and "feeling cold." PT dx with PE of unknown origin

Patient developed fever after second COVID-19 vaccine and over the next two weeks became increasing encephalopathic before presenting on 4/18 and being admitted for encephalopathy and persistent fever. He was found to have mediastinal lymphadenopathy There has been no cause for fever through infectious, rheumatologic, and hematologic evaluations.

77 y.o., male come to ED on 12/24/20, with complaint of SOB and neck swelling. Per ED notes, PE: Large left side neck mass (Erythematous, warm and tender). Possible abscess vs gland infx vs lymphadenitis , which started 4 hours PTA. Pt stated he woke up with the symptoms after having his COVID vaccination yesterday (12/23/20). Patient was given clindamycin in ED, had an anaphylactic reaction (neck, tongue and epiglottis swelling), developed progressive respiratory distress requiring intubation. Noted to develop complete heart block, had 2 cardiac arrests with preceding bradycardia, had transvenous pacer and and tolerated procedure well. He was discharged back to SNF on 1/02/21. Patient noted to have a subclavian DVT on DC, and will start Eliquis.

Approx. 6 weeks after 2nd shot, experienced shortness of breath, fatigue, chest tightness, sinus/head pressure. Cannot exercise for more than 10 minutes without resting. Heart monitor and stress test results show no abnormalities.

Patient stated they felt extreme muscle aches in lower back which radiated to chest. Feel shortness of breath and a dry cough

Couldn't Breath, Died due to Blood Clots on Lungs, Bilateral Pulmonary Embolism, Bleeding on the Brain.

Treated for spontaneous pneumothorax on 04/26. Prior had recurrent right sided pneumothoraces (s/p talc pleurodesis 3/1/21 and blood patch pleurodesis 3/16/21). When discharged from hospital stay on 05/11, he left with pigtail chest tube still in place. Was still in place on 05/22 with difficulty breathing and pain.

Patient came into the clinic today to report the following: He states he received his first Moderna injection on 1-26-2021 and the second on 2-23-2021. One week after the second shot he began to have severe joint pain in his hands, knees and shoulder. 2 nd week after the last shot he had the shingles. The 3 rd week after the shot he was diagnosed with blood clots in both lungs and was hospitalized for 3 days. They gave him blood thinner in the hospital and sent him home with more to take. States as of today (6-4-2021) he is still having problems with fatigue and swelling/ pain in his hands, knees and shoulders.

77-year-old male, with a history of multiple medical problems including renal transplant, states he was exposed to a patient with COVID-19 5 days ago. The day after he was exposed he began to feel somewhat ill with generalized malaise, runny nose, mild cough. He has some mild associated shortness of breath. He attributes some of this to exposure to smoke. States he has no change in taste or smell. He has had a few episodes of diarrhea over the weekend. Denies nausea or vomiting. No chest pain. Temperature has been around 99 intermittently. Has been taking Mucinex and Tylenol. Denies abdominal pain or back pain. Review of Systems Constitutional: Positive for fatigue and fever. Negative for chills. HENT: Positive for rhinorrhea. Respiratory: Positive for cough and shortness of breath. Cardiovascular: Negative for chest pain. Gastrointestinal: Positive for diarrhea. Negative for abdominal pain, nausea and vomiting. Genitourinary: Negative for difficulty urinating. Musculoskeletal: Negative for back pain and neck pain. Neurological: Negative for dizziness. Psychiatric/Behavioral: Negative for confusion. All other systems reviewed and are negative. MDM Number of Diagnoses or Management Options Close exposure to COVID-19 virus: new and requires workup Lower respiratory tract infection: new and requires workup Diagnosis management comments: 77 yo male, with symptoms of acute upper respiratory tract infection. Overall description is viral in nature. Was also exposed to Covid but is vaccinated and he has no change in taste or smell making this less likely. Overall his exam is reassuring. Will perform a chest x-ray to further evaluate, treat with Tylenol. CXR shows questionable RLL infiltrate, by my interpretation, will treat with azithromycin. Rapid COVID was invalid. Will wait for PCR instead of re-swabbing. Encouraged to follow-up with his primary care physician if symptoms or not gradually resolving. Certainly return here if new or worsening symptoms develop. 1. Lower respiratory tract infection 2. Close exposure to COVID-19 virus Disposition: Discharge to home

short of breath Narrative: patient complained of shortness of breath prior to getting covid vaccine, patient and wife stating it was his norm. After vaccine he complained of increasing shortness of breath, and hypoxic with bluish nail beds, lips, and greyish in color. Applied O2 via mask, and nail beds, lips, and facial color returned, sent patient to local ER for treatment and evaluation.

SOB, Fatigue, weakness Narrative: F: Telephone call: Pt's wife called and said that patient is in the hospital- He went into hospital on 1/24/21. He had the Covid injection here at facility on 1/22/21@0945. He was feeling fine till approximately 1800 that night. His symptoms included the following: chills- fever of 102- he took Motrin 11PM on 1/22. On 1/23- @0200 fever was 99 on 1/23- he was fatigued feverish was back @ 101 degrees. He had no appetite all day. He was tired- weak- trouble breathing with SOB- Call was made to to this facility at 0230 but there was no answer. On 1/24/21- 0230AM patient could not breath and 911 was called. The EMT came- Sao2 was 65 %- couldn't walk- very short of breath. He was taken to hospital where he has been since. He was Dx with Pneu and placed on IV/ABT. Covid test was done and was negative at hospital. He has been on Oxygen since. His wife was very tearful. Family says that he may need O2 at home and a HHA.

Pain at shot site, chills, low blood pressure, rapid pulse. felling better now. went to doctor was diagnosed with atrial flutter. still gets out of breath and blood pressure jumps around.

We don't know what happened. 25 hours after the shot, he started gagging and stopped breathing. He was pronounced at OSF at 8:07pm after we took him off life support.

Resident was desated, into the 80's, short of breath. We went him to the hospital same day as vaccine given

Patient was vaccinated on 1/14/2021. On 1/22/2021, patient tested positive for COVID-19 and admitted to the hospital for acute hypoxemic respiratory failure, COVID-19 pneumonia, and severe ARDS. Patient was intubated on 1/23/2021 and later died on 2/10/2021 after being extubated and placed on comfort measures.

911 called to patients house for trouble breathing and abdominal pain. Patient coded, wife presented DNR paperwork. Patient presented to Hospital DOA at 0958.

pt stated that a couple of days after the vax he was headed to get lab work done at the hospital for a upcoming procedure when he started having shortness of breath. He was only able to walk about 20-30 yards and was gasping for air. He had the procedure and went home but was not able to sleep without sitting up. He has a C-PAP machine but has not been able to use due to having excessive mucus. He also had some body aches and pains that have since subsided. Pt went to the Hospital on 2/16/2021. He was given a chest XRAY, took blood work and was given O2. Pt was discharged and told to FU w/ PCP and Cardiologist ASAP. Pt took Covid Test on 2/19/2021 and is waiting for results. Pt has an appt w/ his Cardiologist on 3/17/2021 where they will and echo cardio- gram and he has also has an order to take a chest XRAY due to his SOB symptoms. Pt starts radiation on 3/1/2021 for prostrate cancer.

Patient started feeling weak, stomach pain, neck pain, respiratory problems, confusion, low blood pressure which led to death on February 21, 2021, 7 days after the vaccine was given.

The day after receiving his COVID vaccination, the patient was found unresponsive in his driveway in respiratory distress by his neighbors. EMSA was called and pt transported to ED, where he was intubated and placed on mechanical ventilation. Patient extubated 3/4, but remains critically ill at this time. Neurologic causes are being investigated.

THURSDAY STARTED WITH CHILLS AND SEVERE BACK PAIN ALONG THE BELT LINE. HE CALLED (PCP). COMPLAINED OF SOB (SHORTNESS OF BREATH). NO FEVER. AUDIBLE SOB SO HEALTHCARE PROVIDER INSTRUCTED THE PATIENT TO GO TO THE URGENT CARE OR CALL DR. ASAP.

Rheumotoid arthritis autoimmune compromised person who was told by multiple doctors that he should get the shot anyway. He had not had a RA flare for months but 1-2 days after shot he started having joint pain in hips, low back, between shoulders and neck. Pain shooting up head, random numbness in left pinky, wrist, and up to elbow which has not occurred before. Shortness of breath and heart racing. Went to PCP and they directed him to go to ER. 2 EKGs, Chest Xray, Bloodwork, Stress Test. Seeing Neurologist, Rhuemotologist and Cardiologist as symptoms are ongoing.

3/7/21 ER to inpatient Admission (covid positive 3/7/21) 3/11/21 Transferred to higher level of care Date of Service: 3/8/2021 Chief complaint: Chest congestion HPI: Patient is a 78 y.o. male with PMH significant for hypertension, obesity, coronary artery disease and CKD admitted to acute care from ED peR Dr with pneumonia due to COVID-19. Patient presented to ER brought in by EMS from local residence. Was complaining of chest congestion. Patient had been seen in ER earlier same morning complaining of cough. Was afebrile at that time. Oximetry 95%. Rapid COVID positive. Patient given Decadron 6 mg IV, albuterol inhaler, zinc and BAM(bamlarnivimab 700 mg) IV x1. Patient discharged home. Return later that evening per EMS with shortness of breath. Complaining that congestion was getting worse. Was now febrile & had fallen trying to get out of recliner. Vitals upon arrival-temp 102.8° pulse 87 respirations 24 blood pressure 169/71 oximetry 99% on 2 L. patient given Rocephin 1 g IV piggyback, azithromycin 500 mg IV piggyback, normal saline bolus 1 L & acetaminophen 1000 mg IV in ER. Labs revealed mild leukocytosis white blood cell count 12.5. Glucose elevated to a 9 but patient had received Decadron previously. BUN 32 creatinine 1.8. D-dimer 1240. No CT chest obtained due to patient's renal status. Patient subsequently admitted to acute care for further evaluation and treatment to include IV antibiotics supplemental oxygen pulmonary hygiene. Patient has received 1st COVID vaccine and due to have 2nd vaccine on March 20. Upon admission patient was continued on Rocephin and azithromycin IV piggyback & Decadron 6 mg IVPB. Continued hydration fluids normal saline at 100 cc/hour. Started on IV Remdesivir with loading dose. DuoNeb nebulizers q.6 hours. Patient continued on home regimen less Plavix. Was started on Lovenox 40 mg subcu daily for DVT prevention. Patient maintaining oxygenation on 2-3 L. Had initially been on 2. Was increased to 3 this morning due to decrease in oximetry down to 92%. Patient continues with exertional dyspnea. Does have loose nonproductive cough. Is complaining of pain to the left lower chest wall with cough. Describes as sharp. Denies any actual chest pain. No nausea vomiting. Last BM yesterday described as normal. Blood cultures pending no growth at present. Is currently resting in bed. Is in negative air pressure room. COVID precautions observed. CASE DISCUSSED WITH DR

Difficulty breathing. Inhaling and exhaling. Two visits to the ER. Swelling arm, ankles, swollen arm , very red. Breathing treatment, inhaler, antibiotics. I have a Dr appointment Monday to see my primary. Still struggling to breathe

Patient had dyspnea w/ exertion within 24 hours of getting 2nd moderna COVID19 vaccine. Continued for a couple weeks before coming into to office. CT chest demonstrated pulmonary embolism in primary branch of right upper lung. He was not symptomatic between his COVID diagnosis in Nov 2020 (after acute illness) and prior to receiving second vaccination.

8 minutes after the vaccine was administered, he started to act funny. At first, he looked like he was having a vasovagal/ syncopal episode: he became non-responsive, stared straight ahead. then shortly thereafter he started to take be gasps for air, his lips turned blue. It soon became clear that he was having an anaphylactic reaction. we called for an ambulance, we administered one dose of an Epipen, and administered oxygen. His pulse ox was in the low 80's. within a minute or two, he started to react and started to moan, breathe more normally, then began to speak to us. His BP was checked and was 118/83. His oxygen sat went up to 100%. after a few minutes, We took the oxygen off and his sats dropped into the 80's so we restarted the oxygen. We are rural, so it took the ambulance 30 minutes to arrive. He was very stable at the time that he was taken to an emergency room for further evaluation.

78 year old man without prior DVT/PE history, who had first Moderna vaccine dose on 12/29/20 (lot 011J20A) and second Moderna vaccine dose on 02/02/21 (030L20A) (information from patient provided vaccination card) who presented to the ER on 02/20/21 with one week of subjective dyspnea and palpitations. Chest CT with bilateral pulmonary emboli. There were also groundglass opacities in the right upper lobe. Rapid test for COVID 19 on 02/20/21 was negative. Subsequent antibody testing for COVID19 on 03/01/20 (IgG, IgA. IgM) also interpreted as negative. The pulmonary embolus was considered to be unprovoked and an association with prior COVID19 vaccination is interpreted as possible but unproven. The patient was initiated on anticoagulation. Further workup for underlying thrombophilia hematological disorders is pending at this time however the current assessment remains as an unprovoked pulmonary embolus occurring 18 days after second Moderna vaccine dose. Current CT imaging without evidence of recurrent malignancy and there are no identifiable risk factors for pulmonary embolus. The physician submitting this report is a Hematologist Oncologist.

About 5 days after vaccination, I started experiencing low grade fever. chest congestion, exhaustion, digestive issues. I went for a COVID test which was negative. Symptoms have gradually diminished except for exhaustion which continues.

He developed very labored breathing on Tuesday night. By Wednesday morning , upon waking it was severly worse. I would have taken him to the ER had I been home. When I returned home around 11am, he was having a very hard time breathing. I got him a rescue inhaler to use. He had a dailysis treatment that day, during the treatment they kept him on oxygen. I called Dr office to inform them, they ordered a new inhaler and told me if the symptoms did not decrease by 72 hours to inform them. His breathing did get somewhat better but he did not have his enegry levels that he had previously or his appeatite. 12 days after his 2nd dose of the Moderna vaccine he went into cardiac arrest in the home with myself and husband present.

extreme weakness, collapsed, ultimately patient was determined through repeated multiple blood tests excessively high inflammatory markers over a period of weeks, severe shortness of breath, confusion, fluid accumulation around the lungs. All is documented in Dr records as well as Hospital

Subacute fevers, cough, dyspnea for 2-3 weeks, found to be hypoxemic requiring up to max 5L nasal cannula, not responsive to coverage of community acquired pneumonia with 2 courses antibiotics. No bronch performed based on goals of care, empirically trialed on high dose steroids (soluemdrol 1000mg x3 days, then 500mg x1 day, transition to PO prednisone) as well as cefepime x7 days. Improvement to room air while continuing on steroids currently.

First day of shot had fever of 101, joint aches, breathing difficulty. Lasting for 3 days. Didn?t feel normal for a week.

3/14/21 complaints of low-grade fever, cough, chills and difficulty with taking in a deep breath after receiving his second COVID vaccine about 5 days prior. New diagnosis of pericarditis given based on symptoms and cardiac MRI

?Can?t get a full breath? Nauseated, Dizzy, balance was off. ?Thought I was having a heart attack. Couldn?t walk without a cane because of pain and weakness.?

Approximately 10 minutes after vaccine administration, patient became lethargic and unresponsive. Ambulance was called and arrived within 5 minutes. By that time he was alert and was transported to hospital.

Patient developed tachypnea 5-10 minutes after vaccinations. Evaluated by EMS. SpO2 100%, HR 90-100, BP 200/? RR 20s. Lungs were clear on exam. No wheezing, no edema around the mouth/lips/tongue/uvula. No rash. Pt transported via EMS to Hospital

went to ED c/o chest pain, Pain was non-radiating, intermittent substernal aching. It improved with sublingual nitroglycerin and PO ASA 324mg. Mild SOB was noted. No syncope reported. After arrival to the ED and administration of the above meds, symptoms improved. This AM he described mild worsening SOB during his stress test and an episode of chest tightness shortly thereafter which has now resolved. He also reports anxiety about his stress test result. A 1/2019 stress test was a normal, low risk study. Today's stress test was read as an intermediate risk study with a medium-sized fixed perfusion defect suggestive of infarction, with associated mild hypokinesis.

Within 24 hours of vaccination, he had chills, HA, malaise and increased dyspnea a feeling of dyspnea that began soon after the vaccination. All symptoms resolved within a few days except the dyspnea. It is improving now 6 weeks post vaccine, but not yet back to his baseline. The red rash was a fairly classical "Covid arm". It is resolving, but the left arm is still overall a littler redder than the right.

dribbles; heart rate when down to 38 beats per minute; loose bowels; breathing situation has gotten worse; feels terrible; increased amount of phlegm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRADYCARDIA (heart rate when down to 38 beats per minute) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031a21a and 032L20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Coronary artery disease, COPD, Enlarged prostate, Atrial fibrillation and Bronchitis. Concomitant products included WARFARIN for an unknown indication. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced DIARRHOEA (loose bowels), DYSPNOEA (breathing situation has gotten worse), FEELING ABNORMAL (feels terrible) and PRODUCTIVE COUGH (increased amount of phlegm). On 21-Mar-2021, the patient experienced BRADYCARDIA (heart rate when down to 38 beats per minute) (seriousness criterion medically significant). On an unknown date, the patient experienced URINARY INCONTINENCE (dribbles). At the time of the report, BRADYCARDIA (heart rate when down to 38 beats per minute), DIARRHOEA (loose bowels), URINARY INCONTINENCE (dribbles), DYSPNOEA (breathing situation has gotten worse), FEELING ABNORMAL (feels terrible) and PRODUCTIVE COUGH (increased amount of phlegm) outcome was unknown. Not Provided Treatment of these events included steroids. 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.

Oxygen saturation low; Difficulty breathing; Hallucinating; Incoherent; Wheezing; does not recall anything after that for the next 12 hours; Extreme Painful L arm; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OXYGEN SATURATION DECREASED (Oxygen saturation low), DYSPNOEA (Difficulty breathing) and HALLUCINATION (Hallucinating) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (Medical history was not reported.). Concurrent medical conditions included Type 2 diabetes mellitus and Asthma. Concomitant products included INSULIN ASPART and INSULIN DETEMIR (LEVEMIR) for an unknown indication. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced OXYGEN SATURATION DECREASED (Oxygen saturation low) (seriousness criterion hospitalization), DYSPNOEA (Difficulty breathing) (seriousness criterion hospitalization), HALLUCINATION (Hallucinating) (seriousness criterion hospitalization), INCOHERENT (Incoherent), WHEEZING (Wheezing), AMNESIA (does not recall anything after that for the next 12 hours), PAIN IN EXTREMITY (Extreme Painful L arm) and CHILLS (Chills). On 21-Mar-2021, OXYGEN SATURATION DECREASED (Oxygen saturation low), DYSPNOEA (Difficulty breathing), HALLUCINATION (Hallucinating), INCOHERENT (Incoherent), WHEEZING (Wheezing), PAIN IN EXTREMITY (Extreme Painful L arm) and CHILLS (Chills) had resolved. At the time of the report, AMNESIA (does not recall anything after that for the next 12 hours) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, COVID-19: negative (Negative) Negative. On 17-Mar-2021, Oxygen saturation decreased: abnormal (abnormal) oxygen 72. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Based on the current available information and 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.

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 the administration of the vaccine nor was there and ADR that occurred between the observation period and the date of death. Patient was hospitalized in early 02/2021 at Medical Center in the ICU for a bleeding ulcer. Was inpatient for over a month, but do not have records due to it being outside facility. Received a colonoscopy report which showed. diverticulosis and CT of abdomen showing pleural effusion, umbilical hernia and gallstones. Notable comorbidities include emphysema, CKD, CAD, ICM, and T2DM.

Patient had second covid 19 vaccine on 2/2/21 at pharmacy. Was admitted on 4/6/21 to hospital with Shortness and Breath, Vomiting, and COVID-19 (tested positive on 4/6/21). Patient expired on 4/8/21 @ 1954.

Patient was transferred from ancillary facility with complaints of fatigue, generalized weakness, and mild shortness of breath. Was found to be COVID-19 positive. Patient was admitted for further management of infection. He is still admitted at time of writing.

3/21/21 - Pt emails MD that he'd had SOB + fatigue since 3/10 when given first dose of infliximab, no energy, sitting all day. smell ok. taste reduced. poor appetite. +dyspnea on exertion. no chest pain or edema. HR nontachy at baseline, to 105 ambulating to bedroom. BP 164/97. COVID test scheduled for 3/23, which returned negative 3/24. 3/28 - Pt went to healthcare facility for generalized weakness, worsening SOB over days, R pleuritic chest pain, diagnosed with bilateral pulmonary emboli, left popliteal vein DVT. Required 5L O2. echo w/o LV strain. At the time he stated it may have been going on for 4 months. during hospitalization also had altered mental status, MRI/neuro diagnosed with hypoxic brain injury 3/30 - transferred to another healthcare facility given IV abx, lasix, 2-4L NC, 4/11 - discharged to another healthcare facility.

4/22/21. Patient was very lethargic, His normal patterns of behavior changed. He would sleep through his alarm daily . I would have to wake him up by shaking him. He was confused as to date and time. He had a non productive cough, he appeared flushed, wheezing SOB on exertion. He had hallucinations, told me i had a delivery of bees for my garden. He must have been dreaming? He remained lethargic sleeping on & off throughout the day with confusion. I pushed fluids I notified his PMD Dr. on 5/6/2021 He advised to take the patient to the Emergency Room for a Covid test and a chest x-ray. The patient refused to go. On 5/7/2021 I took him to Immediate Care (Urgent Care Center) they Did a. Chest X-Ray and a Covid Test, results pending in 2. Days. Chest X-ray was Negative. The doctor ordered a Azithromycin, and Methylprednisolone taper . Should he hold off getting the second vaccine?

This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NEPHROSTOMY (nephrostomy bleeding) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Urostomy, Nephrostomy and Colostomy. Concurrent medical conditions included Lymphoma (stage 4 lymphoma cancer), Renal failure (stage 4 renal failure) and Neuropathy NOS (chemo related neuropathy). On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm pain), DYSPNOEA (labored breathing), ASTHENIA (very weak), RASH (got rash on both of his forearms), HEADACHE (headaches), FATIGUE (fatigue) and CHILLS (he had chills). On 27-Apr-2021, the patient experienced NEPHROSTOMY (nephrostomy bleeding) (seriousness criterion hospitalization prolonged) and DEHYDRATION (he was dehydrated). On an unknown date, the patient experienced MYALGIA (hurting all over). The patient was hospitalized on 28-Apr-2021 due to NEPHROSTOMY. At the time of the report, NEPHROSTOMY (nephrostomy bleeding), DEHYDRATION (he was dehydrated), PAIN IN EXTREMITY (arm pain), DYSPNOEA (labored breathing), ASTHENIA (very weak), RASH (got rash on both of his forearms), HEADACHE (headaches), MYALGIA (hurting all over), FATIGUE (fatigue) and CHILLS (he had chills) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. After the patient got the vaccine, he was very fatigue for a few days. He had a lot of arm pain. The doctors noticed that he got rash on both of his forearms. He complained of headaches and it was hurting all over. He was very weak and had chills. He had labored breathing. His nephrostomy was bleeding a lot in the tubes so they had to hospitalize him. He went to hospital on 27-Apr-2021 and was currently in the hospital. He had blood transfusions and he was very dehydrated. He was put on IV saline. He took Eliquis but doctors wanted to stop it because his kidneys were not in good shape. Company comment: Based on the information provided which indicates patient's underlying history of nephrostomy, a causal association between the event of nephrostomy bleeding and dehydration and the administration of mRNA-1273 and the events is assessed as unlikely as the event is common local complication from nephrostomy tube placement, The other events are temporarily associated with the product use and a causal relationship cannot be excluded.; Sender's Comments: Based on the information provided which indicates patient's underlying history of nephrostomy, a causal association between the event of nephrostomy bleeding and dehydration and the administration of mRNA-1273 and the events is assessed as unlikely as the event is common local complication from nephrostomy tube placement, The other events are temporarily associated with the product use and a causal relationship cannot be excluded.

Nursing home pt w/hx of dementia and recent hospital stay (5/1-5/7) for treatment of healthcare associated PNA, recurrent UTI, recent antifen CDiff+ but toxin negative. Pt p/w worsening SOB, generalized body aches, abdominal pain, chills and test positive for COVID (5/8) despite having received Moderna vaccine (1/18 & 2/15). Was admitted for additional management of acute hypoxic respiratory failure due to COVID complicated w/chronic hypoxic resp failure d/t COPD. Pt treated with dexamethasone and bronchodilators as well as diuretics for volume overload in setting of diastolic heart failure. Pt was ultimately discharged to nursing home on 4L of O2.

Procedures - documented in this encounter Procedure Name Priority Date/Time Associated Diagnosis Comments SARS COV-2 RNA ROUTINE 04/23/2021 9:14 AM EDT Sick 4/26/2021COVID-19 virus infection +1 more Dx Progress Notes Encounter Date: 4/26/2021 ? ? Signed Expand AllCollapse All History of Present Illness: Patient ID: Patient is a 78 y.o. male who presents today, via phone, with the following complaints: Tested April 24 positive Covid 19. He got the first vaccine 3 weeks ago and was supposed to get the second one tomorrow. o When did symptoms start? 4/20/2021 o Fever: ?Yes ?No o Cough: ?Yes ?No "terrible" Productive--phlegm o Shortness of Breath: ?Yes ?No o Chest Tightness:?Yes ?No o Body Aches: ?Yes ?No o Headaches: ?Yes ?No o Sore Throat: ?Yes ?No o Nasal Drainage: ?Yes ?No A lot: Thin and wet o Sinus Pressure: ?Yes ?No o GI Symptoms: ?Yes ?No o Ear Pain/Fullness: ?Yes ?No o Loss of Taste or Smell: ?Yes ?No Both o Medications Taken: Mucinex, Tylenol, Zyrtec o Sick contacts:?Yes ?No Cough is the most bothersome symptom.

Patient hospitalized for shortness of breath on 2/11/2021. Patient had second dose of vaccine on 2/22/2021. Patient hospitalized on 3/30/2021 for coronary angiogram. These visits are within 6 weeks of receiving COVID vaccination.

ER visit with positive COVID antigen test. Back home but back to hospital by EMS for respiratory distress.

Resident had lunch on 01/14/21 and after lunch around 2:00pm, he vomited and stopped breathing. We coded the resident and 911 paramedics came. They pronounced him dead at 2:18pm.

Vaccine at 10:45 am. At 2 am patient awoke with severe chest, left arm, back of the head, neck, stomach and shoulder pain and was breathing heavily, in a panic attack. Said he feared he was having a heart attack. I gave him an extra strength tylenol, rubbed his neck, back of head, shoulders and suggested he was having a vaccine reaction. After about an hour, he fell asleep. He awoke around 8:30 am with a slight headache but otherwise feeling fine.

Patient received COVID-19 vaccine on 1/27/21 and had episode requiring ED visit on 1/28/21. He had nausea, chills, SOB, hypoxia on exertion and syncope with collapse. He went to ED and they found no reason for these issues. He has COPD at baseline but his lungs sound fine and he did not have Issues at the ED. ED did not provide any treatment, we provided 4mg Zofran. Vitals are at baseline 1/29/2021 and he reports he feels excellent, no further nausea, chills, lightheaded ness or SOB.

Patient rec'd vaccine on 1-25-2021. Patient woke up on 1-26-2021 feeling so bad with joint stiffness and trouble breathing, he called 911. He was taken to Hospital where he was admitted. He says by 1-27-2021 he was feeling much better with each passing hour. He was discharged on 1-27-2021. Then on 1-28-2021 he noticed a red and very itching rash at the injection site and all across his back.

Patient was hospitalized on 31 Jan for COVID pneumonia after 3 days of increasing baseline supplemental O2 requirements and dyspnea and ultimately died on comfort care on 3 Feb 2021.

Pt was in the covid clinic and after the shot started with tightness in the throat was given 50mg of po benadryl

Lightheadedness and rapid more shallow breathing 10 minutes after injection. Lasted about 10 minutes, began to subside and were gone in about 30 more minutes.

2-3-2021 pt reported to ER c/o dyspnea, A-fib HR 91, SARSCoV2 RNA test positive in ER, dyspnea on exertion occasional cough, pt admitted to medical surgical floor with acute systolic CHF and COVID-19 with bronchitis, pt was discharged to a nursing home for rehab

79 Yr old pt had Covid Vaccine 2nd injection on Tuesday. Pt became ill on Tuesday noc with generalized bodyaches and loose stools. No fever. No cough nor HA. No redness nor swelling of arm. Injection was the Moderna. Last voided this evening. Last normal meal was AM of vaccine injection. 2. Increased dependent lung base atelectasis 3. Mild gallbladder wall edema suggesting choleycystitis. No biliary ductal dilitation or calcified stone. 4. Mild pancreatitis without abscess or necrosis 5. Colonic diverticulosis without diverticulitis. Impression: 1. Mild-Moderate Dehydration 2. Reaction to second dose of Covid -19 Moderna vaccine 3. Elevated LFT's suggesting CD Obstruction 4. Elevated wbc most likely related to #3 or #5 5. Bibasilar atelectasis with low lung volumes and accounting for Hypoxia; suspect related to #6 6. Acute Pancreatitis with Amylase 348 and Lipase 1109 7. Elevated D Dimer ; DISCHARGE SUMMARY Date of Admission: 2/11/2021 Date of Discharge: 02/12/2021 Admitting Diagnosis: Acute pancreatitis, acute cholecystitis Discharge Diagnosis: Acute pancreatitis, acute cholecystitis, sepsis History of Present Illness: Pt presented with 2 days of generalized malaise, abd pain, and diarrhea, starting shortly after his second Moderna COVID-19 vaccination. In the ER, he was found to have acute pancreatitis and cholecystitis as determined by CT scan and U/S without biliary tree involvement. Given new O2 requirements, CT chest performed and was negative. Labs showed elevated amylase/lipase, elevated bilirubin, AST/ALT/alk phos. Disposition: Transfer to Medical Center for further management Condition: Fair

Admit date: 2/12/2021 Discharge date and time: 2/14/21 Admission Diagnosis: DOE (dyspnea on exertion) Hospital Problems: Active Problems: Pulmonary fibrosis (HCC) (8/24/2015) POA: Yes Elevated troponin (11/22/2020): Yes Cardiac pacemaker in situ (11/23/2020): Yes PAF (paroxysmal atrial fibrillation) (HCC) (11/23/2020) POA: Yes Recurrent major depressive disorder (HCC) (11/23/2020) POA: Yes DOE (dyspnea on exertion) (2/12/2021) POA: Yes Acute on chronic systolic (congestive) heart failure (HCC) (2/13/2021) POA: Yes

Patient admitted and treated for respiratory insufficiency, CHF, hypotension, AKI, metabolic acidosis, and hyperuricemia

Patient had sore arm the first day, the second day patient had slurred speech, couldn?t remember or say words, went to the hospital, CT scan and it showed a stroke, AFib came back that had been resolved, he had to be bagged for 2 minutes because he stopped breathing, MD told him the covid shot may have reacted negatively with his previous heart surgery

The next morning, I looked flushed and short of breath and had a temp pain was severe in my arm and all over. couldn't eat. Last night i was able to eat a little but it was hard to get down. i wasnt tasting things right. called Dr said to take a couple of Tylenol and to call vaers for advice. Was very weak.

Pt received COVID injection at doctors office. Approximately 1 hour later while sitting in recliner, wife noticed patient pale and unarousable. Paramedics were called and found patient with agonal respirations in asystole. Pt was intubated, received epinephrine, amiodarone and atropine per ALS care. Pt wife stated patient complained of dizziness and headache, but no chest pain or shortness of breath. Pt transported to ER. Following testing and treatment in ER, pt transferred to ICU.

patient received moderna covid-19 vaccines on 1/22/2021 and 2/24/2021. he presented to the ED on 2/26/21 with fall and shortness of breath. patient had been generally weak and having difficulty ambulating for some time and was worse the last 2-3 days. patient fell in the evening and could not get back up due to weakness. he was found the following morning and EMS was called. patient was brought to the ED. he was admitted for acute respiratory failure with hypoxia, COPD, pneumonia, NSTEMI, and rhabdomyolysis. also treated for type 2 DM, HTN, and paroxysmal atrial fibrillation. some concern that covid-19 vaccine may have contributed to the patient's rhabdomyolysis. per physician note on 3/3/2021: "Covid 19 infection November 2020, got vaccinated in mid January and then again in February and got a bad reaction which was somewhat to be expected to lead to more marked myalgias and muscle weakness left him lying on the floor unable to get up and he developed rhabdomyolysis." patient is still currently admitted, though CK levels have improved.

Dyspnea on exertion; Acute on chronic systolic (congestive) heart failure; A spontaneous report was received from a other healthcare professional concerning a 79-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dyspnea exertional and acute on chronic systolic (congestive) heart failure. The patient's medical history, as provided by the reporter, included pulmonary fibrosis, elevated troponin, paroxysmal trial fibrillation paroxysmal (PAF), major depressive disorder, and cardiac pacemaker insertion. Concomitant medications was not provided. On 21 Jan 2021 at 11:30 am, approximately twenty two days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 12 Feb 2021 the patient was hospitalized. Onset of the dyspnea was noted on the same date and acute cardiac failure started on 13 Feb 2021. He was discharged on 14 Feb 2021. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not reported. The events, dyspnea on exertion and acute on chronic systolic (congestive) heart failure considered was recovered/resolved.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information is requested.

Patient was admitted to Hospital on 3/1/21. Blood Sugar of 758. Patient diagnosis with Acute respiratory failure with hypoxia and acute heart failure and Metabolic encephalopathy. Patient put on ventilator and passed away on 3/2/21 at 17:04.

Patient developed worsening edema and shortness of breath. Became fatigued and went to Emergency Department. He was admitted for 3 days with CHF atrial fib.

5 min after vaccination had abdominal pain, emesis x1, bradycardia, bigeminal PVCs, rigors, chills, fever 101.2, low Mg+ 1.3, SOB , ground glass opaque appearance on CT chest in lungs bilat, needing 2L O2, and normallly only needs room air. Admitted to hospital medical unit.

Patient reports experiencing chest discomfort, shortness of breath, and congestion after vaccine dose 1 and dose 2. Patient seen for televisit after recieving 2nd covid vaccine 4 days ago. He has a little trouble breathing and has pain around his chest with some muscle pains. He reports that the pain is increased in his upper chest. He is more short of breath walking up stairs, coughs up a little bit, does use advair, has rescue inhaler. Patient was directed to seek further care at immediate care. Has hx of chest pain and tightness prior to vaccine most recently documented in 3/2020

Patient tested positive for SARS-COV-2. Patient positive for SARS-COV-2 in 09/2020. Patient tested negative x4 in 12/2020. Patient arrived to our facility with complaints of SOB, acute HTN, feeling warm and perhaps diaphoretic. Found with elevated BP, tachycardia, and tachypnea, afebrile, oxygen saturation 96% on 2L. Chest Xray consistent with COPD.

Chief Complaints: Progressive weakness with respiratory difficulty and severe shortness of breath Diagnosis: Guillain-Barre supported by progressive weakness, albumincytologic dissociation of cerebral spinal fluid, vocal cord paralysis, speech apraxia resulting in aspiration pneumonia Treatment: Guilain-Barre: Plasmapheresis requiring critical care management Pneumonia: Antibiotics

Symptoms: fatigue, SOB, chest pain middle of chest b/t breasts, tachycardia started 3/22pm and worsened overnight to morning of 3/23/21. "Felt like heart attack". Crick in neck developed overnight after fixing pillows to help with leaning forward b/c that position felt better. Ambulance called 3/23 around 10am. CXR, abdom ultrasound, CT angiogram, lab work completed. MI and PE ruled out. No gallstones, other organs ok on u/s. Small pericardial effusion noted on CT. Symptoms improved after Toradol 15mg x1. Chills developed around 3pm. Discharged to home. Tylenol given at home, chills subsided. Pt felt better later that evening 3/23. Minimal chest pain on 3/24 pm and 3/25 pm. Continues to improve.

Death; Trouble in breathing; chills; sweating; his body was really cold; A spontaneous report was received from a consumer concerning a 79 years old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events death, trouble in breathing/dyspnoea, chills, sweating/hyperhidrosis and his body was really cold/hypothermia. The patient's medical history included blood clotting, blood pressure and diabetes. The relevant concomitant medications reported were provided as medications for blood thinner, blood pressure medication and diabetes medication. On 03 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA (Lot number: unknown) through intramuscular route of administration for prophylaxis of COVID-19 infection. On 03 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA (Lot number: unknown) through unknown route of administration for prophylaxis of COVID-19 infection. On 04 Mar 2021, after second dose patient experienced sweating, his body was really cold. His wife called ambulance and paramedics had quoted that these were usual symptoms of second shot and if they want, they can take him to hospital for monitoring. The patient doesn't want to go hospital and wanted to take rest in bed. On 05 Mar 2021, at 2am, four hours after first ambulance call, his wife noticed that he was still sweating, had chills and also had trouble in breathing. She called the ambulance second time and while it arrived at home it was too late and he was already passed. All the events were provided as intervention/medically important. No laboratory data was provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The events trouble in breathing, chills, sweating and body was really cold were not recovered. The patient died on 05 Mar 2021, due to unknown cause of death but On 19 Mar 2021, his wife talked with primary care physician and he mentioned that vaccine is one of the contributing factors to his death and it is noted on his death certificate. Plans for autopsy was unknown.; Reporter's Comments: This is a case of sudden death in a 79-year-old fmale patient with a history of blood clotting, abnormal blood pressure and diabetes, who died 2 days after receiving second dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: unknown cause of death

2/03/2021: Patient stated shortness of breath and generalized weakness on admission. Patient started on Azithromycin 500 mg every 24 hours for 2 days, Ceftriaxone 2g every 24 hours for 2 days, and Acetaminophen 1000 mg once followed by acetaminophen 650 mg for 2 days. 2/04/2021: Patient diagnosed with pneumonia attributed to aerobic bacteria although no cultures were obtained. COVID and Influenza PCR negative. 2/05/2021: Patient discharged with no new prescriptions.

Spots in left eye Feb 23, normal headache cleared Feb 25. March 2 bad headache returned, March 3 about noon I notice tightness in lower throat. Progressed into lung area around 2:00. It became difficult to breathe. I went to the emergency clinic about 5:00. They did an EKG found no serious problems and suggested I head to the hospital. I arrived there about 6:15 the breathing was exceeding difficult. I could not lay on my back. My lungs on both sides felt like they were on fire when I tried to inhale

Approximately 3 hours after vaccine administration, patient experienced the following: Nausea, Vomiting, Abdominal pain, and the following day: Bloody Bowel Movements. Patient went to the emergency department the day after vaccine administration. Patient was made NPO, started on IVF and Zosyn. Patient was seen by GI who agreed with supportive management of ischemic colitis. Around 1730 on 2/6, patient unresponsive and rapid response was called. Patient responded to Narcan. On 2/8/2021, 0358, patient was seen as not breathing and code blue was called. Interventions were unsuccessful and patient was pronounced dead at 0439am.

patient was administered Moderna vaccine (initial shot) and within 48-72 hours became short of breath. He presented to my office for evaluation 4/14/2021 and found to have right leg DVT and massive bilateral pulmonary emboli with left lung infarction.

After the second shoe on 3/9/2021, and over the next few days I became increasing inactive and found that I was unable to breath deeply and had tightness in my chest area. On 3/20/2021 I went to the Emergency Room and Health Center.

Admitted to hospital with COVID-19 pneumonia. At time of admission, reports 2 weeks of dry cough with 4 days of progressive dyspnea on exertion. Required supplemental oxygen at presentation to ER.

Dyspnea and fatigue and low back pain starting 4/26. Seen at Urgent Care 5/1 and recommended to go to ED for ACS rule out. Declined. Followed up on 5/3 with persistent dyspnea, no hypoxia or tachypnea but visible increased work of breathing in office.

Almost immediated weakness within 3 or four hours, collapsed the next day, repeated falls, taken to Emergency Room on Thursday, March 25, 2021--admitted to Heart Hospital with heart failure, lung failure ( no history of lung problems), and severe sepsis, placed on ventilator until Saturday, March 27, 2021. Died on March 28, 2021.

Admit date: 2/12/2021 Discharge date and time: 2/14/2021 Admission Diagnosis: DOE (dyspnea on exertion) Hospital Problems: Active Problems: Pulmonary fibrosis (HCC) (8/24/2015) POA: Yes Elevated troponin (11/22/2020): Yes Cardiac pacemaker situ (11/23/2020) POA: Yes PAF (paroxysmal atrial fibrillation)(HCC)(11/23/2020) POA: Yes Recurrent major depressive disorder (HCC)(11/23/2020) POA: Yes DOE (dyspnea on exertion)(2/12/2021) POA: Yes Acute on chronic systolic (congestion) heart failure (HCC)(2/13/2021) POA: Yes

Heart problems; Breathing problems; Lymph nodes swollen; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (Heart problems), DYSPNOEA (Breathing problems) and LYMPHADENOPATHY (Lymph nodes swollen) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024m20a and 029I20a) for COVID-19 vaccination. Concurrent medical conditions included Diabetes, Lung cancer (in remission since November) and Liver disorder (liver problems). On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-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 CARDIAC DISORDER (Heart problems) (seriousness criterion death), DYSPNOEA (Breathing problems) (seriousness criterion death) and LYMPHADENOPATHY (Lymph nodes swollen) (seriousness criterion death). The patient died on 15-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. No relevant concomitant medications were provided. Daughter of the patient reported that the patient passed away after his lymph nodes swollen, had breathing problems, and hart problems. She stated that the patient was in remission of lung cancer since November, and that he was diabetic and had liver problems. They wanted to be part of the trials for the vaccine. She wanted his cases to be research because his lymph nodes were swollen, and that for her means there's a correlation between the vaccine taking and his demised. No treatment information was provided. Very limited information regarding these events has been provided at this time. Further information has been requested. The patient's medical history of diabetes, liver disorder and lung cancer are confounding factors that may play possible contributory roles.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested. The patient's medical history of diabetes, liver disorder and lung cancer are confounding factors that may play possible contributory roles.; Reported Cause(s) of Death: passed away

Patient presented to the ED on 4/11/2021 and was subsequently hospitalized for pneumonia and pulmonary edema. Patient presented to the ED on 6/4/2021 and was subsequently hospitalized for third degree heart block. These visits are within 6 weeks of receiving COVID vaccination.

Really bad headache first 3 days Horrible Chills still ongoing Disoriented and almost like hallucinations Most interesting randomly talking to himself. I mean like a full conversation with someone that isn?t there. He also sometimes feels like when holding something he doesn?t see it or feel it and drops it or vice versa ?.. thinks holding something and isn?t Balance is off Shortness of breath No fever thank goodness and taste and smell are normal

pneumonia Narrative: On 11/9/20, Patient had a presumptive positive COVID (COBAS) screen as part of routine CLC screening and then on 11/13/20, he had a repeat COVID (CEPHID) that was negative. Then on 12/22/20, he received his first COVID vaccine. On 12/26/20, he began to have c/o hurting all over. Noted history of aspiration and COPD. On 12/29/20, he began to have coughing, increased shortness of breath and runny nose with course breath sounds in his bilateral lower lobes. A chest xray was done and he was initiated on oral azithromycin and cefepime for a bilateral pneumonia. On 1/3/21, he continued to decline with increasing shortness of breath and was subsequently transferred to acute care medicine. All COVID tests have been negative since the presumptive positive on 11/9/20. He did have a CTA that ruled out PE but did show bilateral pneumonia. His antibiotics have been changed to meropenem, vancomycin and IV azithromycin. He remains on acute care at time and has not required ICU care.

The patient woke up at 0100 on 01/24/2021 reporting shortness of breath, expiratory wheezing, shaking with chills, subjective fever. The patient was seen in the Emergency Department and admitted with a dx of COPD exacerbation. The patient improved nicely after bronchodilators, antibiotic therapy and steroid therapy. The patient was discharged on 01/25/2020 prior to noon.

Client developed a mild covid infection 12/8/21 and recovered. He was admitted 12/25 with hypogycemia and mild weakness and sent home He was given his first dose of the Moderna vaccine 1/4/21 at approximately 9AM covid vaccine clinic He developed weakness the next day (1/5) prompting admission to a hospital and then transition to subacute rehabilitation briefly Work up at hospital revealed progressive respiratory failure and pneumonia requiring intubation and progressive ascending weakness and sensory loss without upper motor neuron changes. MRI : nerve root enhancement LP : protein 40, +/- 80 lymphocytes, cultures negative B 12 and B6 normal extensive CSF testing still pending campylobacter and Musk antibodies negative Neurology diagnosed likely AIDP (Guillain-Barre) and an EMG is planned for the near future. Neurology felt the cause of his GBS was likely his covid infection verses his Moderna vaccination He was treated with plasmapheresis. Client received dexamethasone, remdesivir, and zosyn and doxycycline when progressive leukocytosis and procalcitonin elevation was noted. Candida was cultured from tracheal aspirates but felt most likely d/t colonization with an option to treat further if he did not continue to improve. He is now extubated, unable to swallow and has profound weakness and distal sensory loss. He will transition to Acute rehab in the near future. Comorbidities:as described in the above section and... DM2, CKD3, HTN, DJD, BPH ( h/o prostate surgery), h/o Lumbar surgery and hernia repair, GERD, hypothyroidism, hyperlipidemia. Possible etiologies of his AIDP ( GBS) would include his recent covid infection, the Moderna Vaccine, or other undiagnosed infection. He got his flu shot 9/25 ( fluzone sanofi) so this is not likely to be the culprit

81 YOM with hx of RA, PUD and HLD presents to GVH ED with 3 days of LUQ abdominal pain. He states pain stared after he received his 2nd mederma covid vaccination. He stats 1-2 days after 2nd shot on 1/28 he had expected fever and chills but then developed LUQ pain worse with inspiration. Pain is minimal at rest and no other associated sx, denies CP, SOB (only hurts with deep breath) adn no N/V. CT abd/pel with contrast showed multiple peripheral wedge-shaped hypoenhancing dense regions consistent with splenic infarcts . Pt was placed in observation for starting AC and monitoring on tele.

80 year old male history significant for multiple cormorbities who presented to the ER with reports of shortness of breath and pleuritic pain. He reports sudden onset of back pain in his thoracolumbar spine which was associated with shortness of breath. He notes the pain was intermittent and sometimes positional but exacerbated with deep inspiration. Due to concern for aforementioned symptoms he presented to his PCP earlier who referred him to the ER. Subsequent workup with CT revealed right sided subsegmental PE. Etiology of PE remains elusive as patient denies recent trauma/immobilization, denies history of prior PE/VTE or coagulopathy

Went to Dr office and was found to have bradycardia, hypoxia, and resp distress. Sent to ED and was found to have complete heart block, uncontrolled hypertension, worsening resp distress. Adm to ICU for plans for permanent pacemaker placemen, now placed. Patient received COVID vaccine 2 days prior. Specific vaccine information unknown since administered outside of facility.

Had shortness of breath, chills, and fever up to 102 for the first day and half. On Sunday it came back to normal finally. Night sweats that are still continuing. Just during the day and get hot flashes. Flushing, upper body clamminess and then goes away and then has chills. His breathing has improved but is still not real steady on his feet. He is about 80-85% on his balance, 95% on his breathing. His biggest problem at this point is the hot flashes and the chills. He also has had loss of appetite and has had weight loss.

Cough started on 3/5. Hospitalization on 3/7, Expired 3/16. Doctor's Death Diagnosis: acute on chronic respiratory failure.

1. Inability to sleep after doses of Xyrem. 2. Loss of Consciousness ×3. 3. Falls x3--injuries to RIGHT arm, and lower back. 4. Confusion 5. Loss of Time Awareness 6. Reduced breathing, alamingly, during sleep 7. Clamminess; cold extremities 8. Shortness of Breath Lasted approximately 12 hours into March 21, 2021.

You probably after using my time will have some reason for not allowing me to report this field 18. Why have you been keeping me from reporting it? Four four weeks after the second Moderna Covid 19 vaccine I gained five pounds a week with no change in diet except I may have eaten less. Finally, I was wheezing one morning . I told a friend of mine who is also a retired Doctor. He checked me over and told me I was retaining water and was carrying at least 15 pounds of water in my legs alone. i was also carrying excess water in my abdomen. He took me to my doctor, but I was not allowed to be seen until they shove a stick up my nose until I gagged. After I received the negative results I was allowed to see my doctor. Should have never told them I wheezed. Anyway, after seeing me x-rays were ordered and the next day my doctor contacted me. I am retaining water, IMHO, as a result of the second Mocerna Covid 19 vaccination. I am now on a water pill. Weight has come down about 15 pounds in one week. Only 7 pounds more than what it was when I received the second Moderna COVID-19 vaccine. I feel I will be able to shed the rest of the water being retained as a result of the second Moderna COVID-19 vaccine. Cordially, patient Wonder if I will be allowed to report this or be stopped as before.

Presented to ED with dyspnea and lab showed elevated troponin and COVID PNA as well as CHF exacerbation. Steroids initiated, but no abx noted as needed ber ID physician. Bumex increased for CHF exacerbation. Discharged 4 days after admission oncce stable and recommended outpt follow up due to multiple comorbidities and poor overall prognosis. Patient had first dose of COVID vaccine followed by a positive COVID test at the hospital 21 days later.

Rapid onset in fever and myalgia. Dyspnea and hypoxia developed over days, and eventually patient was hospitalized with bilateral pneumonia consistent with COVID-19, however patient had multiple negative tests for SARS-CoV-2, both antigen and PCR. Patient eventually diagnosed with interstitial lung disease prior to expiring on 4/7/2021.

Patient brought to ED via EMS with cough and shortness of breath. Diagnosed with COVID pneumonia after received 1st COVID vaccine. Patient treated with oxygen, steroids, remdesivir, and antibiotics. Patient recovered and was discharged to home.

You got the vaccine, had no reaction initially. Arm never got sore, nothing at all. Approximately 8 days later he was watching TV, woke up, got up to use the restroom and walked about 40' to get to the bathroom and was breathing so hard that he had to sit down. He went to go back to the couch and was exhausted, got light headed and fell on the floor. He got his wife up, got her dressed and he went to the ER . They said he had a pulmonary embolism and kept him in ICU for 5 days. He has since been okay, been on Eliquis since he has been discharged. Admitted on 2/18/21 and discharged on 2/22/21.

3/26/21 Presents to ER with complaint of "cough x3 weeks after choking on some coffee with progressive shortness of breath" Wife reports O2 sat of 88% prior to coming to ER. HX of CAD, hyperlipidemia, COPD. Follows a pulmonologist. Scope was done after "choking" incident which was negative. Pulmonologist though maybe he had Pulmonary Fibrosis. Patient never heard anything back. Cough and Shortness of breath got progressively worse and came to ER. Patient is positive for pulmonary emboli, was admitted to the hospital, and is receiving Eliquis.

Narrative: 2/8/2021 UTI, sepsis, hyperglycemia, staphylococcus, MRSA infection-discharged to hospice care from Medical Center 2/9, passed 2/11.

80 yo male received first dose of Moderna COVID-19 vaccine on 1/22. Received second dose on 2/19. He also had COVID in December 2020. Around 3/18, patient presents to the hospital with chief complaint of 3-4 days of dyspnea on exertion. He denies fever and cough. Nasopharyngeal swab obtained 3/18 at 1847. Coronavirus PCR test resulted positive a few hours later. Rapid nasopharyngeal test was done on 3/19 and resulted back negative. Patient was diagnosed and treated for community acquired pneumonia with hypoxia.

Flu again after second vaccine dose; Pulse oxygen level dropped to 75 after second vaccine dose; Hard time breathing after second vaccine dose; Lungs had fluid after second vaccine dose; Horrible mouth sores after second vaccine dose; Very weak after second vaccine dose/No energy after second vaccine dose; Patient feels like he was hit by a big truck; Trouble sleeping at night; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of INFLUENZA (Flu again after second vaccine dose), HEART RATE DECREASED (Pulse oxygen level dropped to 75 after second vaccine dose), DYSPNOEA (Hard time breathing after second vaccine dose), PULMONARY OEDEMA (Lungs had fluid after second vaccine dose), STOMATITIS (Horrible mouth sores after second vaccine dose) and ASTHENIA (Very weak after second vaccine dose/No energy after second vaccine dose) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 007M20A) 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 provided.). In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced INFLUENZA (Flu again after second vaccine dose) (seriousness criterion hospitalization), HEART RATE DECREASED (Pulse oxygen level dropped to 75 after second vaccine dose) (seriousness criterion hospitalization), DYSPNOEA (Hard time breathing after second vaccine dose) (seriousness criterion hospitalization), PULMONARY OEDEMA (Lungs had fluid after second vaccine dose) (seriousness criteria hospitalization and medically significant), STOMATITIS (Horrible mouth sores after second vaccine dose) (seriousness criterion hospitalization), ASTHENIA (Very weak after second vaccine dose/No energy after second vaccine dose) (seriousness criterion hospitalization) and INSOMNIA (Trouble sleeping at night). On an unknown date, the patient experienced FEELING ABNORMAL (Patient feels like he was hit by a big truck). The patient was hospitalized from 13-Mar-2021 to 16-Mar-2021 due to ASTHENIA, DYSPNOEA, HEART RATE DECREASED, INFLUENZA, PULMONARY OEDEMA and STOMATITIS. At the time of the report, INFLUENZA (Flu again after second vaccine dose), HEART RATE DECREASED (Pulse oxygen level dropped to 75 after second vaccine dose), DYSPNOEA (Hard time breathing after second vaccine dose), PULMONARY OEDEMA (Lungs had fluid after second vaccine dose) and STOMATITIS (Horrible mouth sores after second vaccine dose) had resolved, ASTHENIA (Very weak after second vaccine dose/No energy after second vaccine dose) and FEELING ABNORMAL (Patient feels like he was hit by a big truck) outcome was unknown and INSOMNIA (Trouble sleeping at night) had not resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: normal (normal) normal. No concomitant medications were provided. Treatment medications included anti-herpes and mouth wash for mouth sores. Action taken with mRNA-1273 in response to the events was not Applicable. Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, excluding other etiologies causal relationship cannot be excluded. This case was linked to MODERNATX, INC.-MOD-2021-078124 (E2B Linked Report).; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, excluding other etiologies causal relationship cannot be excluded. MODERNATX, INC.-MOD-2021-078124:Case for patient 1

Left arm swelling, shortness of breath, leg pain, generalized discomfort 4/5/21 - was seen at Urgent Care - no orders 4/6/2021 - seen at Hospital ER - CT showed blood clots/pulmonary embolism of left arm and lungs and lymph nodes. Received IV fluids in ER. Kept overnight for observation and discharged from hospital next day. Sent home on Eliquis and Prednisone

Per Review of Charge Nurses Notes. Please see Below Called in to residents room by CNA, resident without respirations or pulse, resident placed on floor and CPR initiated at 0725, EMSA notified and called time of death at 0751. Specialists on call for Dr. notified. daughter notified. cremation services notified.

did not get second dose due to side effects from first dose; blood clot in lung; Really bad back pain; breathing was difficult; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (blood clot in lung) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PULMONARY EMBOLISM (blood clot in lung) (seriousness criterion medically significant), BACK PAIN (Really bad back pain) and DYSPNOEA (breathing was difficult). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not get second dose due to side effects from first dose). The patient was treated with APIXABAN at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (blood clot in lung), BACK PAIN (Really bad back pain), DYSPNOEA (breathing was difficult) and PRODUCT DOSE OMISSION ISSUE (did not get second dose due to side effects from first dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant products information was not provided. Patient experienced "really bad back pain" and "breathing was difficult". Went to see his doctor who then stated he had a blood clot in his lung. Caller stated he was then put on Eliquis and the doctor said he would have to take it for the rest of his life. Caller wanted to know if this was true or if he can eventually stop taking the Eliquis. He also wanted to know what caused him to get a blood clot. 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.

04/28/2021: Patient transferred from Hospital with shortness of breath, COVID-19 Positive 4/30-5/16: Patient condition deteriorated. Had repeated episodes of hypoxemia and hypotension - was intubated on mechanical ventilation, eventually switched to pressure control inspiratory pressure, extubated, had to be reintubated. Developed A-fib, leukocytosis worsened, Xray showed tension pneumothorax on right side - chest tube placed. 5/17: Family counseled - patient placed on comfort care, remained on ventilator. Time of Death: 05/17/2021, 16:00 Causes of Death: Bilateral Pulmonary infiltrate, Acute hypoxic type 1 respiratory failure, ARDS, Right Pneumothorax, Acute COVID-19 viral pneumonitis with probable bacterial superinfection, Atrial fibrillation with rapid ventricular response, Septic Shock, Bleeding rom lung/ETT - resolved, Possible Mucor in mouth, Candida tracheobronchitis, Previous history of prostate cancer status post radiation, dyslipidemia, hypertension present at admission.

Increasing fatigue and lethargy, short of breath after shot. Trip to urgent care week later resulted in ambulance taking him to emergency room Diagnosed with Atrial fibrillation and resulting clot in heart. Has had a second hospitalization since then. Zero heart problems prior. Now considered a heart failure patient.

trouble with breathing, breathing difficult, " my breathing went to hell"; Could not sleep; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (trouble with breathing, breathing difficult, " my breathing went to hell") in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included APIXABAN (ELIQUIS) and DOXAZOSIN for an unknown indication. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced DYSPNOEA (trouble with breathing, breathing difficult, " my breathing went to hell") (seriousness criterion hospitalization). On an unknown date, the patient experienced INSOMNIA (Could not sleep). The patient was treated with ALBUTEROL [SALBUTAMOL] at an unspecified dose and frequency. At the time of the report, DYSPNOEA (trouble with breathing, breathing difficult, " my breathing went to hell") had not resolved and INSOMNIA (Could not sleep) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. The patient stated that two weeks after the vaccination he went to Emergency room due to breathing difficulty and was admitted. He reportedly spent two days in the ICU. The patient continued to have trouble and did not get the second dose due to the breathing difficulty he experienced. The patient reported that he could not sleep since he could not breathe. Additional concomitant medications included heart medications and heart burn medications. Treatment medications included an Albuterol inhaler. This case concerns an 80-year-old male hospitalized with a serious unexpected event of dyspnea, and nonserious unexpected event of insomnia. Patient treated with antibiotics. Event latency 15 days after mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Case upgraded to serious, Patient demographics updated, additional event reported (could not sleep).; Sender's Comments: This case concerns an 80-year-old male hospitalized with a serious unexpected event of dyspnea, and nonserious unexpected event of insomnia. Patient treated with antibiotics. Event latency 15 days after 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.

I noticed on April 3rd at 5pm that I had a rash on my both legs I went to the hospital and they just treated with a topical lotion and I was also having SOB. and was given albuterol and that helped.

Chief Complaint ; Right ICA occlusion; History of Present Illness; Patient is an 80-year-old white male with a past medical history of HTN and gout brought to the ICU after undergoing R ICA angioplasty & stent placement with the NeuroIR team on 7/22/2021. The patient was admitted by the Stroke Service on 7/20/2021 after transfer from an OSH where he had presented earlier that day for aphasia and dysphagia. Of note, the patient was found to be COVID-positive at the OSH before his transfer to this facility for a higher level of care. The patient was diagnosed with R cerebral infarction (mechanism: atherothromboembolic) and found to have severe stenosis of the R ICA. He was started on dexamethasone and remdesivir on 7/20 by the stroke team.

Per records submitted by the hospital: Symptoms began 7/16, went to urgent care 7/19 with fever and cough, treated with albuterol and doxycycline. Hospital ED 7/22 after vertigo and a fall, hypoxic, placed on bipap. Diagnosed with CHF and pneumonia. Intubated 7/24/2021 and in ICU. Client had CABG 5/23/2021 and had post op complications with a-fib, AKI, hypervolemia and had 3 thoracentesis. Submitter does not have access to full medical record.

Received COVID-19 Moderna vaccine on 12/28. Developed nausea, vomiting, diarrhea, fever, and hypoxia at facility the day follow vaccine administration (12/29). He was sent to the hospital on 12/29 and admitted for post vaccine fever where he had a chest x-ray that showed infiltrates but WBC count was normal and fever resolved upon admission to hospital. Provider documented "expected reaction to vaccination in a patient with previous COVID exposure". He returned to the facility on 12/30.

36 hours after vaccination, the patient had increased respiratory distress. He was placed on high flow nasal cannula oxygen with mild improvement. He then continued to be hypotensive requiring IV fluids and subsequently IV vasopressors. Patient's BP was stabilized with vasopresor, however he continued to deteriorate clinically with altered mental status and lethargy, concerned for bowel peroration based on physical exam by MD. He was then emergency intubated and placed on mechanical ventilation. He was then transferred to acute care hospital near by.

Nurse was summoned to the dining room @ 0910 and found resident to be sitting in his wheelchair in an upright position with his head down with chin to chest. Lips were noted to be blue, resident was not responding to verbal or painful stimuli. Sternal rub resulted no change but a few small and deep breaths. Resident was assisted back to room , still remained unresponsive, assisted with 4 staff and hoyer back to bed. Noted VS at 98.3-54-12-87/46 O2 stats @ 85% on RA. O2 was started and increased up to 4 liters. Noted O2 stats at 86% @ 10:30 . Repeated B/P after 30 minutes was noted @ 75/35. Vitals @ 12:25 101/64 - 98 -57-14-O2 87% with O2 on, blood sugar 171, verbal response to questions @ this time.

Patient received his second dose of Moderna COVID vaccine on 2/6 at 12:40PM. Patient was observed for 15 minutes post-vaccination with no adverse events. On the evening of 2/6 (time unknown) the patient began to develop dry cough and fatigue. He was checked by a physician at that time (who was a family member). Patient continued to feel unwell into Sunday. His lungs were clear when checked Sunday afternoon (time unknown). At approximately 5:30pm on 2/7 the patient began experiencing sudden onset shortness of breath. A pulse ox was conducted at that time and it was 92%, and again shortly thereafter and it was 90% (as reported by family member). 9-1-1 was contacted at this time. CPR was initiated when he arrived at the emergency department, pulse ox was 60% (as reported by family member). The patient passed away shortly thereafter on 2/8/2021.

Received Moderna #1 on 1/12/2021. 1/15/2021 developed worsening shortness of breath. Went to hospital and diagnosed with anemia, 4 negative fecal tests, neg EGD and colonoscopy. Discharged and readmitted (circumstances unknown for this episode) then readmitted a third time 1/20/2021 for shortness of breath. Diagnosed covid + at third hospitalization and continued to get worse. He died 1/23/2021.

1030-pt reported to staff that he was feeling a tightness in his throat. Pt reports that he dose have an allergy to bee stings. Pt was taken to the triage area for monitoring. Initial vital signs are HR 58 B/P 172/70 spO2 100% without oxygen supplementation. Pt denies having chest pain or shortness of breath. 1038-updated vital signs: HR 56 blood pressure 153/76, SpO2 100% on room air. After observation period pt declined transportation to the ED. Pt was advised to call 911 for any concerning symptoms. At the time pt left the observation area with his wife. Pt states that his symptoms were improved. Total time in triage area was 15 minutes for a total observation time of 30 minutes.

Patient received vaccine on 2/8 at 2:50pm. On 2/9 at 10am, patient was found unresponsive. EMS noted R gaze preference and L sided contracture. Patient was intubated and symptoms resolved when given Versed. Concern for seizure activity.

Patient admitted for fatigue, dry throat, generalized weakness, dyspnea on exertion. Durion hospitalization was identified to have an acute ischemic CVA -- unclear time of symptom onset, possibly evening of 2/9 or morning of 2/10. Time course suspicious for possible COVID vaccine adverse event. He received his first Moderna COVID vaccine on 2/2/21 per WIR. Per PCP note on 2/9/21: Patient is here today accompanied by his wife with concerns for fatigue, headaches, head pressure and tremors. Received vaccine last Tuesday. Around 10 PM that evening he developed pressured in the head. On Wednesday morning, he states he got out of bed and was in a cold sweat - he states he pajamas were soaked in sweat and he felt chilled. He experienced brief numbness of the left arm down to his fingers. On Thursday, he felt fine - he went out to snow blow. Friday he developed headaches and head pressure. At night, he felt his breathing was labored as he was "gasping for air." On Saturday and Sunday, he sat and laid around all day. On Monday, he wakes up at 125 AM and his blood pressure was 165/104 and it remained elevated for 3 separate readings. Patient was then admitted on 2/10/21 with weakness and confusion, then on 2/11 MD noted ?word finding difficulty, slurred speech, possible subtle right upper lip droop, and possibly some mild right hemineglect? with MRI showing likely embolic source of infarcts and cerebral MRA with possible acute thrombus. His symptoms the day after the vaccine seem a bit suspicious for TIA. Per Drug Policy Manager call to Moderna, no current reports of TIA/stroke secondary to COVID vaccine, so time course may be incidental. Patient had echocardiogram without right to left shunt or clot identified, no known history of atrial fibrillation. Was monitored on telemetry for the duration of his hospitalization without any noted arrhythmias, discharged on e patch for 14-day outpatient monitoring.

Patient presented to ED with SOB. Of note, had recent kyphoplasty. Patient reports fever, productive cough, and sore throat as well as fatigue. Patient found to have post-operative pneumonia and was treated with antibiotics. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine

Per neurology consult: "Patient was at his baseline until when he received his 2nd dose of SARS-CoV-2 vaccination. He complained of dyspnea and fear of impending doom after waking up the following morning with some disorientation. He was found to be in AFib with RVR after it was brought to ER the following morning and the rhythm was converted to normal sinus rhythm. Patient continues to have confusion after admission yesterday that seem to get worse today to the point where he did not know his own name or birthdate, and seemed to have global amnesia. Patient has been more drowsy this afternoon after receiving lorazepam 1 mg IV for potential seizure activity so no reliable neurologic exam was obtained. Patient remains afebrile with pulse ox in the low 90s on 4 L of supplemental nasal oxygen in the hospital. He had moderate decrease in kidney function upon admission that has improved. He has baseline anemia with hemoglobin at around 10. Incidentally patient had shingles in the right thoracic dermatome week ago for which he received valacyclovir.

1100 Patient found unresponsive to verbal stimuli by RN, lips cyanotic, color pale, lowered carefully to ground. Pt then stated he could not breathe. 1105 epinephrine 0.5 mg IM administered to left vastus lateralis by EMT. Breath sounds clear in all fields per EMT. BP 124/70 per EMT. Pt began to report ease of breathing, alert and oriented to self. 1110 Benadryl 50 mg IM administered to right deltoid. Pt condition improving, color improving, alertness improving. 1115 Report given to responding ambulance crew and patient transported to higher level of care.

81 year old male with h/o M. Abscessus infection, glaucoma, HTN, HLD, BPH, TIA, who presents with 3-4 days of severe weakness and SOB found to have new bilateral upper lobe ground glass infiltrates;RPP negative, BAL gram stain negative . Per outpatient note: Started imipenem/cilastatin and tigecycline on 10/10/20 and on Arikayce and clofazimine 10/23/20. He was transitioned to omdacycline/clofazamine/arikayce 12/20/2020. Initially on the floor but now txf'ed to ICU for worsening respiratory distress. Relevant labs: His smears and cx have been negative since 11/23/2020 including 12/10/20, 12/11/20 2/8/2021. He was found to have new bilateral UL ground glass changes by CTA and underwent BAL 3/10 for possible atypical infection versus drug induced pneumonitis; covid 19 neg PCR What was used to treat this reaction? Held Arikayce. Gave Solumedrol. Unsure if his pneumonitis was caused by Arikayce or the Covid vaccine. ADR Prior to admission? Yes Severity: Severe Probability: Possible ADR Preventable: not preventable

A-fib; Acute hypoxemic respiratory failure; Acute on chronic congestive heart failure, unspecified heart failure type; Arrhythmia; Febrile; Multifocal pneumonia; SOB (shortness of breath) on exertion

Moderna Covid-19 Vaccine EUA After receiving the first vaccine, started making gasping noises at night, lethargy, fit bit would not register sleep at night, some breathing issues during waking hours. HR observed to decrease to under 40 over the last week of his life. 5 days after 2nd vaccine had extreme fatigue, nightmares, forgot to take regular meds in the morning, 6 days after he woke up very confused and had nightmares and 7 days after vaccination woke up late, exhausted, with shortness of breath all day and refused to go to ER. Went to bed early and died in the night with his CPAP machine on.

Difficulty breathing; Legs have also itched; Hives painful to touch; Hives; Little nausea; A spontaneous report was received from a consumer, who was a 81-year-old, male, patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed nausea, hives, difficulty breathing, legs have also itched, and hives painful to touch. The patient's medical history included afib (atrial fibrillation). Products known to have been used by the patient, within two weeks prior to the event, included finasteride, warfarin, sotalol, simvastatin, mesalamine, metoprolol, and oxygen. On 12 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient reported that he felt a little nausea for the first few days after vaccine administration. On 25 Jan 2021, the patient woke up at 1:00 AM with hives on his right arm from the elbow to the shoulder. He stated the hives were painful to touch. The patient took diphenhydramine and the hives disappeared that morning. Later that day, the patient developed difficulty breathing and the hives appeared on his left arm from the elbow to shoulder. The patient went to the emergency room and was hospitalized overnight due to breathing issues. He was given diphenhydramine and steroids and was released from the hospital on 26 Jan 2021. On 27 Jan 2021, the hives reappeared from the patient's hands, spreading to the arms, shoulders, head, neck, and face. He described some of the hives as being nearly a quarter-inch high and he stated they looked like water blisters. On 28 Jan 2021, the patient went to the emergency room again because he was having a lot of trouble breathing. On an unknown date, the patient's legs had also itched but there were no spots. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, nausea, hives, difficulty breathing, legs have also itched, and hives painful to touch, was unknown.; Reporter's Comments: This case concerns an 81 year old, male patient, with medical history of atrial fibrillation, who experienced serious unexpected event of dyspnoea, and non-serious unexpected events of urticaria, pruritus, pain, and non-serious expected event of nausea. The event of nausea occurred on day 1 after mRNA-1273 (Lot# Unknown). The event of dyspnoea, urticaria, and pain occurred 14 days after mRNA-1273 and the event of pruritus occurred on an unspecified date after mRNA-1273. Treatment included diphenhydramine and steroids. Concomitant medications included finasteride, warfarin, sotalol, simvastatin, mesalamine, metoprolol, and oxygen. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.

Shortness of breath, chest tightening, nausea, lightheadedness. Chest pain while in the ER. Intubated after cardiac arrest. Transferred to ICU. Life support removed 3/22/21. Pt expected to expire today.

Patient developed COVID-19 symptoms and tested positive on 3/21/2021 after getting vaccinated on 3/20/2021. Patient has a history of COVID - he tested positive on November 16 of 2020. Patient's records also list "Acute respiratory failure with hypoxia (*) likely secondary to COPD exacerbation secondary to COVID-19 vaccine reaction" - this was listed as a Problem in his chart on 3/21/2021. - This is his listed prinicpal problem at admission to the hospital on 3/21/2021.

SHORTNESS OF BREATH FEVER UTI (urinary tract infection) Systemic inflammatory response syndrome (SIRS) without organ dysfunction (CMS/HCC sepsis

81 y/o male patient was vaccinated 3/3/21 and died 3/6/21. Patient's wife reported he was having "some trouble breathing" but could not remember whether this problem started before or after being vaccinated.

patient complained of shortness of breath of 3/22/2021 to primary care physician approximately 1 week post covid vaccine. CT Scan was ordered. Confirmed on 3/26/2021 as Left Lower lobe occlusion and diagnosed with Pulmonary embolism. On 3/26/2021 at Emergency department, he also showed bilateral PE with large clot burden. Patient is hospitalized a this point since 3/26/2021 and has been treated for PE since. He was discharged on 3/28/2021 and continue treatment as appropriate with Rivaroxaban.

About 20 hours after the (2nd) shot I got up from my chair after watching the 6:30 PM News and walked about 4 steps and had a breathing "seizer." I could not get any oxygen and in a near panic tried to hyperventilate. After 45 sec I was able to walk another 4-10 steps but the seizer occurred again. Took me 5 minutes to get from the living room to the kitchen and then another 5 to get to the bedroom. In the morning I was reasonably "fine." but then had flu like systems for 1.5 days and then was totally over it all.

stomach and colon pain, headache, weakness, a-fib, short of breath, loss of taste. All symptoms occurred subsequent to suspected COVID 2/15/2020 (was not tested at the time because there wasn't much COVID in Utah where I lived at that early date). Symptoms continued for a year, was getting better the last couple of weeks before the 2nd COVID shot and then relapsed (including had regained sense of taste for 2 weeks. then lost it again after the shot).

Patient experienced shortness of breath a few days leading up to the adverse event. On the evening of March 11, 2021, he collapsed. An ambulance was called and he was taken to Emergency Room. He stayed there until the morning of March 12, 2021 when it was discovered that he had multiple blood clots in his lungs. At that time, he was air lifted to Hospital Intensive Care where he stayed until March 17, 2021. At that time, he was moved to Health Rehabilitation Hospital of where he stayed until March 27, 2021. First vaccination was on 01/22/2021; Second was on 02/17/2021.

Patient had a sudden change in status one week after receiving his first Moderna Covid 19 vaccine. He had sudden onset of tachypnea RR = 40/min, apparent severe pain, greatly elevated blood pressure, with normal heart rate (on beta blocker), diaphoresis. had been enrolled in hospice for 14 months prior to this episode, but had experienced only slow decline prior to this acute event. He died at home under hospice care on 2/27/2021.

NA Comfort Cares-acute hypoxic respiratory failure in the setting of bilateral pulmonary extensive infiltrates due to ARDS, pneumonia and possible component of CHF exacerbation. Non-ST elevation myocardial infarction.

myasthenic crisis, with worsening neck weakness, proximal muscle weakness and dyspnea, beginning 24hr prior to presentation. Treatment required IVIG, PLEX, brief intubation for respiratory support and eventual Rituximab dosing.

Patient presents with multiple complaints. He complains of all of his symptoms started after his Moderna vaccine in 1/2021. He complains of fatigue, and in particular muscle fatigue, muscle wasting, urinary frequency, urinary urgency (but denies dysuria), myalgias involving his legs, leg weakness, unsteady gait, frequent falls, nausea without vomiting, dyspnea walking across the room. He is wheezing a lot this morning, it started after the Moderna vaccine.He had a recent heart cath that did not show any significant blockage. He had a recent MRI of his head that was normal. He reports his wife had covid 19 in the latter part of 11/2020. He never developed symptoms. He was not tested after she became ill. He admits to significant reaction his first covid 19 vaccine in 1/2021. All symptoms resolved except for his complaints as listed above. He is a very active 81-year-old. He states he was winning weightlifting contests. He would do 3 sets 50 pushups, bench press 150 pounds and do pulled downs with 160 pounds daily. He now experiences dyspnea and muscle fatigue walking across the room.

81 year old male who presented to Medical ER 6/4/21 with possible seizure like activity at home after having his second dose of COVID vaccine on 6/3/21. His first dose of COVID vaccine was given on 5/4/21. After the patient arrived to the ED he was able so my questions. The patient had an EKG performed was not concerning for ACS. He was given a total of 1 mg of Ativan IV. CT head CTA head and neck were negative for any acute findings. He was started on IV lactated Ringer's. CBC was reassuring. CMP showed a sodium of 125 and potassium 3.3. The patient was started on a liter of NS. Magnesium was found to be 1.7 was given 2 g of magnesium IV. Ammonia level blood alcohol level were negative. Initial lactic acid level was 5.9. Repeat lactic acid level is down to 1.9. I had spoke with on-call neurology felt that seizure is most likely due to the patient's electrolyte abnormalities. Did not recommend antiepileptics at this time. I spoke with Dr. who is willing accept the patient for admission to the ICU. When Dr. came down and spoke with the patient he started having another seizure. After the seizure he continued to not breathe. The patient was bagged and started having some spontaneous respirations however continued to have a low O2 sat if he was not bagged. We were able to speak with the neurologist again who recommended giving Keppra 1500 mg IV. Dr. was able to speak with the patient's next of kin his son and the patient's brother who both recommend the patient not be intubated or any other life-saving measures. Would like the patient be kept comfortable. The patient passed away shortly thereafter time of death was 2044.

A few weeks after vaccination , blurry vision, , not feeling well,increased shortness of breath, ringing in ears, dizziness

Fully vaccinated patient admitted to hospital with positive COVID PCR test. Patient seen in ED for headache and increasing shortness of breath, and occasional (chronic) cough, abdominal pain. Denied chest pain, nausea, vomitting, change in bowel habits, vision changes, weakness, paresthesias. Denied known sick contacts. Patient was in A fib with RVR and PVC's. Rate 114 per EKG. US showed gallstones, labs showed elevated liver enzymes and bilirubin of 4.5. Patient seen by GI no intervention recommended at this time as patient reported all symptoms had resolved on day after admission. Patient to follow up with PCP and d/c'd from hospital.

Shortness of Breath, Difficulty Breathing, Difficulty Swallowing, Extreme wait loss, Low energy level. Progress over 2 month period

PATIENT ADMITTED TO REHAB FROM DR'S OFFICE COMPLETED MODERNA VACCINATIONS THE 1ST OF FEBRUARY PER PATIENT STATEMENT ADMITTED TO ACUTE CARE 7/19/21 WITH INTERMITTENT FEVER, SOB STILL INPATIENT

The day following vaccination, 12/31/2020 at 1230, the patient had an acute onset of shortness of breath, tachypnea (rate 34)wheezing, tachycardia (rate 130s and irregular), oxygen desaturation (89 to 91% on room air), and clear rhinorrhea, non-productive cough. Earlier in the day he complained of not feeling well, but non-specific. He was assessed and given an albuterol nebulizer treatment. In the coming hour, his wheezing resolved, work of breathing improved, heart rate and respirations decreased. He was ambulating around without signs of activity intolerance. It was felt that he was stable and back to baseline, so he was monitored by the nursing staff. A chest x-ray was ordered but not completed. On 1/1/2021 at approximately 0925, a nursing assistant described loss of consciousness for 20-25 seconds. It appeared that he was not breathing, slumped over in the chair at the breakfast table eating cream of wheat, eyes rolled back in his head. He regained consciousness, breathing normally after coughing. He did not appear to be choking. His heart rate was recorded as irregular, rate 32 by the nursing staff. He was transported to the Emergency Department at Hospital for evaluation. No concerning findings.

Within 15 minutes the patient was complaining of chest pain and shortness of breath. Epipen and Benadryl was administered and vitals checked every 15 minutes by facility's staff

Shortness of breath and tachypneic before and after vaccine. BP 178/71, repeat 154/63. HR 75, then 54. Respiratory rate 30. Given albuterol, resolved.

Extremely SOB around 1AM...tremors in arms & legs. Did not respond to any options available, oxycodone, Ventolin, Nebulizer, for approximately 2 hrs. Couldn?t get air in or out. Did not call 911 because he didn?t want to die in hospital. Gave Boost drink & sipped on drink for dehydration. Breathing finally calmed a bit. Oxygen now at 84-92. Extreme weakness, arm has big red blotch. Next day still extremely weak & SOB. Must use walker & assistance getting to bathroom. No appetite. Can?t dress, cook, or anything. 6 days later, still weak, low appetite, has to double up on Nebulizer.

Patient sent to the ED or sudden onset of shortness of breath on 02/02/2021. Per documentation by the MD, the patient had COVID19 "several weeks ago" and the nursing facility felt like he had recovered. A rapid test done in the ED was negative. When the patient worsened and seemed to be following the same path as other COVID patients, a send out PCR test was done, which was positive. The patient worsened and passed away that same day (02/05/2021) I was not made aware that the patient had the vaccine on 01/21/2021 until Monday 02/08/2021.

Pt awoke on 2/8 feeling tired and weak. On 2/9 patient developed fever to 102 and shortness of breath and vomiting. Was seen in ER and admitted for presumed UTI as well as small PE.

Pt had initial dose of vaccine 2/13/21 and noticed being short of breath/feeling bad the following day. He did not attend rehab on Monday, 2/15/21, as scheduled 2/2 SOB exhaustion. He did attend today, 2/17/21< but 3 minutes into exercise on treadmill he was unable to continue. He recovered quickly, refused clinic visit, and went home.

Patient and patient's daughter both describe increasing breathing difficult after receiving the first dose of the Covid-19 vaccine. Patient states that his breathing is twice as bad after receiving the vaccine and that he can no longer walk greater than five steps without having difficulty breathing.

2/6 (vaccine given): No side effects. 2/7: mild fever and chills (expected), weakness, low appetite 2/8: Severe weakness and fatigue, subjective fever/chills, low appetite, nausea, in evening diarrhea started. 2/9: Symptoms not improved in the morning. Went to ED. Hospital stay: Dehydration, give IV fluids. Continued symptoms, plus vomit and diarrhea with blood. Placed on clear liquid diet. GI consult. Diagnosed with duodenitis and gastritis. Started on oral PPI, no improvement in symptoms, switched to IV PPI. Vomiting resolved after a few days. Stool cultures all negative. Onset sore throat (possible reflux/esophagitis). Confirmed gastritis, gastric erosions. Fevers recurred. Consult with ID, possible TB, placed on isolation. Blood cultures and stool cultures all negative. AFB negative x2 (results of 3rd AFB pending as of today). Rheumatology consult for continued fevers, weakness, fatigue. Started on prednisone ~2/15, fevers resolved soon after. Severe weakness (bed bound), fatigue, low appetite, and diarrhea throughout hospital stay. Started on Megace and Immodium with slight improvement in appetite and diarrhea, respectively. 2/19: ALT and ALT increased, prednisone was dc'd (received 4 of 5 day treatment of prednisone). Crestor held. Anticipate dc for PT/rehab once LFTs are back to baseline.

Moderna COVID- 19 Vaccine EUA: one day after vaccination patient reported increasing fatigue after flying on an airplane to a high altitude destination. Two days after vaccination patient fell out of bed overnight and awoke confused with a temperature of 104 degrees Fahrenheit. Patient was transferred to another hospital by ambulance, admitted, received antibiotics, but developed acute hypoxemic respiratory failure. Eight days after vaccination patient transferred to intensive care unit at current hospital with acute respiratory distress syndome and bilateral pulmonary infiltrates requiring intubation and mechanical ventillation three days after arrival. Patient remains in the intensive care unit receiving antimicrobials and steroids.

Episode of confusion, fever to 104, and bilateral pulmonary infiltrates consistent with ARDS. Negative infectious diseases workup. Response to steroids. Patient was intubated due to need for supplemental FIO2 100%.

shortness of breath Narrative: Witin hours after 2nd COVID vaccine, patient began to have SOB,fever and lethargic. With hx of DVT and currently on Apixaban, patient was admitted for observation and was given Tylenol and fluids.

at midnight client got up to go to the bathroom. His legs became weak and he fell and hit his head on the wall. He called for his wife and said he didn't feel right. He denied any pain. She called EMSA and he stopped breathing while she was waiting on them. She gave him CPR with instructions from the dispatcher. He was pronounced dead at 1:30am. She has tried to call the clinic 3 times and left messages and no one has called her back, Her PCP told her this needed to be reported .

Client is elderly and has reduced mobility status. Client was ushered up into the bleacher seating at the vaccination site following the dose administration, and upon sitting down was experiencing shortness of breath (reported by the client to be from walking up the stairs). Client pulled out personal inhaler (albuterol) and self-administered a dose. Responder noted pallor and increased difficulty with speaking for the client, but client's breathing returned to a regular rate and rhythm in the minutes following albuterol administration. Client's pallor resolved. The client refused emergency medical services twice, and refused having his vitals taken. The client was monitored visually by responder until deemed appropriate for discharge from the observation area. When the client ambulated down the stairs, Responder noted unsteadiness in gait. Once the client was safely at the bottom of the stairs, a wheelchair was retrieved for the client so that the client could safely exit the facility. Client accepted the wheelchair at this time. Client refused a vitals check a second time at the checkout station, per responder.

LEG WEAKNESS, CHILLS, SHORTNESS OF BREATH Narrative: Patient reported after taking his second dose of Moderna vaccine on 2/25/2021 he developed extreme leg weakness, shortness of breath, fever, chills and elevated blood pressure. States the fever and chills lasted for 5 days and the chills were so bad he "shook all over". Patient states the leg weakness and SOB are not completely resolved yet. He completed a chest xray this week and the results are: streaky opacities at the lung bases, likely atelectasis and/or scarring. Patient to complete PFT soon. States his BP has been running 167/88 until 3/15. However patient reports he doesn't take his metoprolol all the time. Legs are still weak 3/15, but began using an exercise machine yesterday for his legs and "feels that may help". Patient also reports he had purchased a "so clean" device to keep his cpap machine clean. He received a letter from the Clinic stating those devices have been linked to asthma and lung problems so he stopped it.

Patient received dose 1 of COVID-19 vaccine on 2/2/21 and dose 2 on 3/2/21. Was admitted to the hospital for shortness of breath and tested positive for COVID-19 on 3/20/2021. Patient was transferred to another facility for higher level of care on 3/22/2021 and ultimately admitted to the ICU on 3/232021 for concern of intubation. Ultimately decided to pursue comfort measures on 3/25/2021.

COVID positive with mild infection; Difficulty breathing; Nose bleed; A spontaneous report was received from an 82-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nosebleed, difficulty breathing and COVID positive with mild infection. The patient's medical history included Pulmonary arterial hypertension and Concomitant medication include TREPROSTINIL SODIUM and TADALAFIL. Lab tests provided for COVID-19 tests positive. On 26 Jan 2021, patient received first of two planned dose and on 16 Feb 2021, received second of two planned dose. On 13 Mar 2021, the patient was hospitalized with nosebleed, difficulty breathing and COVID positive with mild infection and the treatment provided was unknown. Action taken with mRNA-1273 in response to the event was not applicable as the patient received both the planned doses prior to the event The outcome of events, nosebleed, difficulty breathing and COVID positive with mild infection was reported unknown; Reporter's Comments: Very limited information regarding these events has been provided at this time. Based on the known causative agent of COVID-19 infection, the event is assessed as unlikely related to mRNA-1273. It is likely that the patient was already infected with the virus but asymptomatic before being administered with the mRNA-1273 vaccine

82YM Admit 3/18/21 to hospital for small bowel obstruction within 1 week of second vaccine dose. PTA bowel obstruction led to a syncopal episode following use of laxative, and several episodes of vomiting in the days prior . Upon admission Patient was receiving conservative therapy for a partial obstruction when he developed increasing shortness of breath. The patient was transferred to the ICU for worsening respiratory status and eventually developed significant hypercapnic and hypoxemic respiratory failure requiring intubation. Neurology was consulted for altered mentation in the setting of respiratory failure. Patient with ascending paralysis. MRI of the head and neck as well as CTA were obtained x2. Patient was ultimately diagnosed with Guillain-Barre, variant and received 5 days of Intravenous Immune Globulin therapy. Patient's small bowel obstruction resolved and ultimately patient required percutaneous tracheostomy tube and gastrostomy tube placement for prolonged respiratory failure and neurologic compromise. The patient had uneventful ventilatory requirements and ultimately was performing intermittent spontaneous breathing trials; however, still had episodes of apnea, but improved. He was tolerating tube feeds at goal with resolution of his small bowel obstruction, which was thought secondary to his Guillain-Barre. The patient did develop abnormal LFTs which were thought secondary to cholecystitis not requiring operative intervention, with improving LFT findings on antibiotics. The patient had a nonobstructive cholecystitis. The patient's mentation was improving to the point where he was able to communicate and open his eyes upon discharge, as well as was working with Physical Therapy for strengthening. He was able to move his upper extremities and followed commands and lower extremities were improving in strength as well. Patient was discharged via private air flight to acute care ICU facility.

Finished 2 dose series in February. Tested + for COVID on 3/29 as outpatient. Admitted to- hospital on 4/14 w/ respiratory distress/dyspnea. Transferred to ICU level care for increasing hypoxemia on 4/15.

blood clot in his pulmonary artery and several others in his legs; blood clot pulmonary artery; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clot in his pulmonary artery and several others in his legs) and PULMONARY EMBOLISM (blood clot pulmonary artery) in an 82-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. Family history included Factor V deficiency, Factor II deficiency and MTHFR deficiency. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blood clot in his pulmonary artery and several others in his legs) (seriousness criteria hospitalization prolonged and medically significant), PULMONARY EMBOLISM (blood clot pulmonary artery) (seriousness criterion medically significant) and DYSPNOEA (shortness of breath). At the time of the report, THROMBOSIS (blood clot in his pulmonary artery and several others in his legs), PULMONARY EMBOLISM (blood clot pulmonary artery) and DYSPNOEA (shortness of breath) outcome was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Patient had increased respirations, SpO2 declined, 15 seconds of apnea, mottling to BLE, minimally responsive

U07.1, J12.82 - Pneumonia due to COVID-19 virus U07.1, J96.00 - Acute respiratory failure due to COVID-19

Patient presented to the ED for low oxygen saturation and confusion on 4/5/21. He presented to the ED on 4/5/21 and was subsequently hospitalized for acute respiratory failure with hypoxia. He presented to the ED on 4/28/21 and was subsequently hospitalized for pneumonia. These visits are within 6 weeks of receiving COVID vaccination.

Having an ICD for 8+ years (with no activations) and a checkup every 3 months with no problems (like afib) I had my first vaccine shot on 03-10/21. At a check up of the ICD on 04/08/21, the ICD reported that I went into afib on 03/31/21. An EKG on 05/07/21 proved the afib and I was cardioverted on 05/12. The cardivert went ok but I still was short of breath and felt (as before) that my heart was weak due to cardiomyopathy. I had had CM in 2007 and 2012 but no problems since. I am now feeling better since the CM seems to be gone but I do feel that ALL of the above problems are due to the vaccine.

developed a large amount of antibodies that is now causing his heart to be inflamed; Postural orthostatic tachycardia syndrome/ when he stands or walks,his blood report becomes very elevated.; Shortness of breath was more severe, started to breath hard; COVID-long hauler; Symptoms were worse today; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART INJURY (developed a large amount of antibodies that is now causing his heart to be inflamed) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 from 17-Jan-2020 to April 2020, Hemochromatosis, Ferritin (Ferritin was up to 1110, well out of normal range) in 2002 and Heart enlarged (Had a sonogram in the past which showed his heart was enlarged a little bit). Previously administered products included for an unreported indication: TETANUS VACCINE in April 2021. Concurrent medical conditions included Sleep apnea (Uses a sleep apnea machine), Holter monitoring (Wearing a heart monitor with expected removal on 26-APR-2021) since 12-Apr-2021 and Hypertension. On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced CONDITION AGGRAVATED (Symptoms were worse today). On an unknown date, the patient experienced HEART INJURY (developed a large amount of antibodies that is now causing his heart to be inflamed) (seriousness criterion medically significant), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (Postural orthostatic tachycardia syndrome/ when he stands or walks,his blood report becomes very elevated.), DYSPNOEA (Shortness of breath was more severe, started to breath hard) and POST-ACUTE COVID-19 SYNDROME (COVID-long hauler). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) for Shortness of breath, at an unspecified dose and frequency and IVABRADINE for Shortness of breath, at an unspecified dose and frequency. At the time of the report, HEART INJURY (developed a large amount of antibodies that is now causing his heart to be inflamed), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (Postural orthostatic tachycardia syndrome/ when he stands or walks,his blood report becomes very elevated.) and POST-ACUTE COVID-19 SYNDROME (COVID-long hauler) outcome was unknown and DYSPNOEA (Shortness of breath was more severe, started to breath hard) and CONDITION AGGRAVATED (Symptoms were worse today) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increases (High) With movement heart rate increases. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. This case was linked to MOD-2021-089705 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Additional event added. Other HCP information added and case updated accordingly.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities, additional information required.

Patient was hospitalized due to vomitus material in mouth, concerns for aspiration pneumonia, decreased alertness, unresponsive verbally, obtunded

04/03/21 Redness and swelling in upper left arm. On or about 04/09/21 very bad cough and great difficulty in breathing. On advice of Dr. went to Emergency Room. After chest X-ray, EKG, and blood panels was diagnosed with congestive heart failure and furosemide was prescribed. On 04/27/21, 05/05/21 and 05/12/21 had previously scheduled with Dr. Echocardiogram, Stress Test, and Carotid Svan, respectively. As a result, it was found that there was abnormal perfusion scan with severe evidence of infarct in the apex apical inferior, mid inferior apical anterior and mid anterior segment(s). Abnormal left ventricular size with abnormal systolic thickening and systolic function..

Resident became increasingly somnolent and short of breath with bilateral lower extremity edema. He was sent to the hospital for evaluation and treatment on 5/26/2021 where he was tested for COVID 19 and found to be positive. Resident had a previous negative COVID 19 test 5/23/2021.

Congestive heart failure, he had 32% of his heart; Patient asked caller to "help him with suicide"; escape from house, Confused; Super sick; medication having opposite effect on him; his kidney levels were also not where they needed to be; died after receiving the Moderna vaccine; Nails were blue; Very cold; Fidgety; Vomiting; Wasn't breathing right/abdomen breathing; Continued to deteriorate; Went outside and could barely make it up the steps; Neck veins distended; Had not slept the night before; Didn't feel good; right arm was swelling; Pale in the face; Right arm red; Chills; Nausea; This spontaneous case was reported by an other caregiver and describes the occurrence of DEATH (died after receiving the Moderna vaccine), CARDIAC FAILURE CONGESTIVE (Congestive heart failure, he had 32% of his heart) and SUICIDAL IDEATION (Patient asked caller to "help him with suicide") in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced PALLOR (Pale in the face), ERYTHEMA (Right arm red), PERIPHERAL SWELLING (right arm was swelling), CHILLS (Chills) and NAUSEA (Nausea). On 12-Apr-2021, the patient experienced INSOMNIA (Had not slept the night before) and FEELING ABNORMAL (Didn't feel good). On 13-Apr-2021, the patient experienced CARDIAC FAILURE CONGESTIVE (Congestive heart failure, he had 32% of his heart) (seriousness criteria hospitalization and medically significant), DYSPNOEA (Wasn't breathing right/abdomen breathing), GENERAL PHYSICAL HEALTH DETERIORATION (Continued to deteriorate), GAIT DISTURBANCE (Went outside and could barely make it up the steps) and VASODILATATION (Neck veins distended). On 25-May-2021, the patient experienced VOMITING (Vomiting). On 26-May-2021, the patient experienced DEATH (died after receiving the Moderna vaccine) (seriousness criteria death and medically significant), CYANOSIS (Nails were blue), PERIPHERAL COLDNESS (Very cold) and RESTLESSNESS (Fidgety). On an unknown date, the patient experienced SUICIDAL IDEATION (Patient asked caller to "help him with suicide") (seriousness criterion medically significant), CONFUSIONAL STATE (escape from house, Confused), ILLNESS (Super sick), PARADOXICAL DRUG REACTION (medication having opposite effect on him) and RENAL IMPAIRMENT (his kidney levels were also not where they needed to be). The patient was treated with HALOPERIDOL (HALDOL [HALOPERIDOL]) at a dose of 1 dosage form and DIAZEPAM at a dose of 1 dosage form. The patient died on 26-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, CARDIAC FAILURE CONGESTIVE (Congestive heart failure, he had 32% of his heart), SUICIDAL IDEATION (Patient asked caller to "help him with suicide"), PALLOR (Pale in the face), ERYTHEMA (Right arm red), INSOMNIA (Had not slept the night before), FEELING ABNORMAL (Didn't feel good), DYSPNOEA (Wasn't breathing right/abdomen breathing), GENERAL PHYSICAL HEALTH DETERIORATION (Continued to deteriorate), GAIT DISTURBANCE (Went outside and could barely make it up the steps), VASODILATATION (Neck veins distended), CONFUSIONAL STATE (escape from house, Confused), CYANOSIS (Nails were blue), PERIPHERAL COLDNESS (Very cold), RESTLESSNESS (Fidgety), ILLNESS (Super sick), PARADOXICAL DRUG REACTION (medication having opposite effect on him), PERIPHERAL SWELLING (right arm was swelling), RENAL IMPAIRMENT (his kidney levels were also not where they needed to be), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Renal function test: abnormal (abnormal) Kidney levels were also not where they needed to be. No concomitant product information was provided. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been request. This case was linked to MOD-2021-248336 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Additional information added in laboratory data, treatment drug and events.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been request.; Reported Cause(s) of Death: unknown cause of death

Patient contacted the office 3/31/21 with complaints of arm/shoulder/axillary pains since receiving the vaccines, treated in office 4/5/21 for lump at injection site and continued axillary pain, treated 5/25/21 for shingles outbreak on chest, contacted office again 5/28/21 with elevated bp, heart rate and confusion- possible med reaction, contacted office 6/9/2021 with low blood pressure, dizziness, confusion, increased edema, treated 6/15/21 for urinary tract infection. Treated with oncology - notes from 4/13/21 notes patient is doing well, but with 'knot' on arm and axillary tenderness following COVID vaccine, then notes from oncology 6/24/21 notes patient found to have new retroperitoneal and pelvic lyphadenopathy, along with new splenic lesions with sudden rapid change in mental status and new diagnosed pulmonary hypertension. Patient placed on hospice and deceased as of 7/7/2021

Pt received second dose of COVID vaccine on 01/20/2021 at 1430. At 1600 Pt developed a wet productive cough with coarse crackles. Pt ate dinner at 5 pm cough persisted. At 18:30 the nurse went to Pt's room to give him his medications. Pt still had a cough, denied shortness of breath. Pt was in a good mood and joking with staff. Pt asked to be shaved. At 19:45 Pt was sitting in the lounge and a CNA noticed that Pt was pale/white in color and clammy. 02 Sat was 85%. Respirations were labored. Pt was placed on 4 L of 02. Increased to 5 L via face mask and 02 sat was 89-90%. Ambulance was called at unknown time. Pt arrived at Medical Center at 2120 and was pronounced dead at 2127.

Stroke like symptoms; Water in lungs; A spontaneous report was received from a consumer concerning an 83-year-old, male, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stroke like symptoms and water in lungs. The patient's medical history was not provided. Concomitant products known to have been used by the patient included, insulin aspart, insulin glargine, ticagrelor, sacubitril valsartan sodium hydrate, furosemide, carvedilol, omeprazole, and sertraline. On 04 Jan 2021, one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 05 Jan 2021, the patient began experiencing stroke-like symptoms and had water in his lungs. On 06 Jan 2021, the patient was hospitalized and had a computed tomography (CT) scan and magnetic imaging resonance (MRI) scan of the brain. On 09 Jan 2021, the patient was discharged from the hospital. Treatment information for the events was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, stroke like symptoms and water in lungs , was not reported.; Reporter's Comments: This case concerns an 83 year old male patient who experienced serious unexpected events of Cerebrovascular accident and Pulmonary oedema. The events occurred the next day of their first dose of their first of two planned doses of mRNA-1273. Concomitant medications included, insulin aspart, insulin glargine, ticagrelor, sacubitril valsartan sodium hydrate, furosemide, carvedilol, omeprazole, and sertraline. 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.

Resident had an emesis, complaints of cough, congestion, and headache, increased respiratory rate, tachycardia, and fever.

Patient was admitted for pleuritic chest pain. It was determined during his hospitalization, that his pain was likely musculoskeletal in nature and was advised to follow up with PCP

Patient was admitted at Hospital from 2/11/2021 to 2/17/2021 after a fall with presyncope. Patient sustained head trauma with scalp laceration and staple were placed. Patient has longstanding history of atrial fibrillation and has been taking Eliquis. He was initially seen in the office complaining of fatigue blaming it on the Eliquis that was started. Patient had a Covid vaccination on 2/8/2011. Patient denies any respiratory symptoms. No cough no chills no fever. Complain of exertional shortness of breath. He was seen in the emergency room at and tested positive for COVID-19.

Patient states he was called a few minutes prior to 1000 today to remind him about his vaccine appointment; he relays he didn't know about his appointment and therefore he did not eat breakfast. Patient states he was observed for 15 minutes following the vaccine administration and was advised he could then go home. He states while driving home, he began to feel dyspneic, nauseous, and lightheaded. Patient also states he felt as if his voice changed. He states he then started to drive back to the hospital. When he arrived back to clinic, he was unable to park properly as he felt he was going to vomit.

Chief Complaint Patient presents with ? Rash C/o rash to extremities and buttock that started about 3 days ago. ? Edema C/o edema to lower extremities and abdomen. ? Shortness of Breath Having shortness of breath on exertion. Had to stop and take a break twice on the way to the office from the lobby. Subjective: HPI Patient is 83 y.o. year old male that presents for acute problem as noted above. Received call from patient late yesterday evening complaining of petechial rash to extremities. States they originally were pruritic. Now states they no longer itch. Patient states that the rash started about 3 days ago. His main lower extremities and buttocks. Also complained of increased edema to lower extremities. Also feels like his abdomen is swollen. Patient was treated for diverticular flare middle of February. Has completed antibiotic specifically Augmentin about 2 weeks ago. Patient having increased shortness of breath. States he does have a productive cough in the morning producing yellow sputum. Afebrile. Patient does have history of atrial fib. Has had no nausea vomiting but states any time he eats he can only eat a small amount then feels full. Patient is on Coumadin chronically. Recent INR has been within normal limits. Patient does have some tenderness to his abdomen more so to the upper quadrants. Denies any change in bowel habits. States he is mildly constipated. Denies any change in color stool. Denies any actual chest pain. Does get remarkably short of breath. Review of Systems A 10 point ROS was completed and negative except as noted in HPI 3/12 Presented to Emergency Room - admitted inpatient @ 1144

Patient received a covid vaccine on 03/05/2021. Daughter reports there were no side effects that night or the following days. The next Saturday, March 13, 2021, the daughter was at her parents house checking up on them. Her father was in the bathroom as she passed in the hall. He came out of the bathroom and proceeded to the living room, she stated dad are you ok? He said he couldn't breath. Giving his history of COPD and being short of breath sometimes, she didn't think anything of it. She proceeded to follow him to his chair and was checking his oxygen tank that he had been using with ambulation. It still had some in the tank. She raised her head to tell him he still had some in the tank and saw that he had started "agonal breathing". Daughter is a nurse and knew he needed help. She phone for an ambulance and with the help of her mother got patient to the floor and started CPR. Paramedics arrived on scene, continued CPR and administered meds and also intubated, but were unsuccessful in their efforts.

03/13/2021: Presented to the emergency department with cough and shortness of breath. The patient was admitted for pneumonia based on CT of the chest showing bilateral infiltrate on the upper part mainly on the right side along with bilateral pleural effusion mainly on the right. The patient is still admitted and has undergone a thoracentesis. Covid-19 negative.

tightening in his throat muscle; unable to move much; unstable blood pressure; unstable oxygen; bled due to blood thinner; weak in terms of walking; coughing; every joint and muscle from neck to toe in pain; every joint and muscle from neck to toe in pain; cold; entire body in excruciating pain; A bit off; Bruising in arm; A spontaneous report was received from a consumer concerning a 83-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following events: bruising in arm (contusion), a bit off (feeling abnormal), entire body in excruciating pain (pain), every joint and muscle from neck to toe in pain (arthralgia/myalgia), tightening in his throat muscle (throat tightness), unable to move much (hypokinesia), unstable blood pressure (blood pressure abnormal), unstable oxygen (oxygen saturation abnormal), bled due to blood thinner (haemorrhage), cold (feeling cold), weak in terms of walking (muscular weakness), and coughing (cough), The patient's medical history included small cancer treated last year with 38 radiation treatments. No concomitant medications were reported. On 11 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031620A) intramuscularly for prophylaxis of COVID-19 infection. On 11 Feb 2021, the patient experienced little bruising in the arm. On 12 Feb 2021, the patient was a bit off. On Sunday, 28 Feb 2021, in the evening, the patient got cold, and within minutes his entire whole body was in excruciating pain, every joint and muscle from neck to toe were in pain. It felt like it was invaded with COVID. He went to hospital and got tested for COVID, Strep throat and Flu, and all three test results were negative. On an unknown date, the patient experienced tightening in his throat muscle and he went to the hospital where he was admitted. While there, they did every possible test, chest MRI, Neck MRI, all possible viral tests, and rapid and full COVID test. The rapid and full COVID tests came back negative. Results for chest MRI, neck MRI and viral tests were not provided. The hospital also performed a blood culture for bacteria. Results were not provided. The patient was unable to move much, his blood pressure and oxygen were a little unstable. On 06 Mar 2021, the hospital did a major blood test which came back negative and the patient was released from a hospital. He stated that he was still weak in terms of walking and coughing. He stated that he recently bled due to taking blood thinner. Treatment included major antibiotic treatments and steroids for pain during the hospital stay. The patient was still taking prednisone at a tapering dose. Action taken with mRNA-1273 in response to the events was unknown. The events of weak in terms of walking, coughing were unresolved, while the outcome of the events of tightening in his throat muscle, unable to move much, unstable blood pressure, unstable oxygen, bled due to blood thinner, Bruising in arm, cold, entire body in excruciating pain, every joint and muscle from neck to toe in pain, every joint and muscle from neck to toe in pain was unknown.; Reporter's Comments: Based on a strong temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association cannot be excluded. Myalgia and arthralgia are consistent with the known safety profile of the vaccine

shortness of breath Hypokalemia Metabolic acidosis Pneumonia Chronic atrial fibrillation (CMS/HCC) Acute respiratory failure with hypoxia (CMS/HCC) Multiple myeloma not having achieved remission (CMS/HCC) Severe sepsis (CMS/HCC) ST segment depression

Lethargy and "achy" the first day after the second injection. increase in symptoms through that day and overnight. The following day unable to get up out of chair/walk. Confused and disoriented. Wheezing and SOB. Had to call an ambulance for transport to ER. Admitted. Became completely unresponsive. Testing revealed Ammonia level of 104. Liver function studies/scans negative for liver problems. MICU for 10 days, rehab for 3 weeks.

Admitted on 4/12/2021 with acute respiratory failure, bronchiectasis, possible UIP pulmonary fibrosis

Patient was admitted to the hospital with pneumonia the evening after her received the vaccine in the morning. He had been struggling with his COPD/ pneumonia since 3/1/21. He was hospitalized and died 8 days later

On 5/8/2021 patient started experiencing dyspnea with it worsening and leading to hospitalization on 5/11/2021 for respiratory failure/COPD exacerbation. Patient is currently inpatient on med surg unit currently on Vapotherm at 40% FiO2.

My uncle, died on February 17, 2021. He was admitted on February 2, 2021 6 days after taking the COVID-19 Moderna vaccine (1/28/2021). After the shot was administered, he developed all the COVID-19 symptoms (loss of taste, smell, high temperature, and had trouble breathing). He was deprived of oxygen and had labored breathing and was acting confused. The home health nurse contacted his primary care physician and was instructed to bring him into the ER.

The resident was administered his second COVID vaccine (Moderna) on 5/19/21 at 9:30am. Per nursing, the resident tolerated the vaccine well and no problems were documented throughout the day. At 10:00pm the nurse who administered the vaccine recorded the resident's vitals as follows: BP 118/68, HR 72, Respiration 18, Temperature 97.0 F. At 10:20am the resident's CNA discovered him lifeless with vomitus around his mouth and neck. The resident was not breathing, bluish in color, and cool to the touch. Vital signs were checked and no pulse was detected. CPR was attempted with not effect.

Within three days of shot started with blurred vision, swerving while driving, progressing rapidly to unable to hold fork, falling down. Hospitalized since. Lost all motor skills, unable to walk, stand, feed self, control urine, slurring speech. No stroke. MRI found "lesions" in brain, spine/neck area, lung and stomach. Four Neurologists examined. They still are perplexed. One said she has not seen anything like this in her 20 years. Spent week in hospital, now in rehab center Minor improvement in ability to feed self (still can not hold fork), Receiving physical therapy.

Gets cold very easy; Out of breath; Strep through body; Swelled all over body/left foot still swollen; Weak; Paralyzed for over two weeks; Possible A-fib; Arthritis aggravated; Face was swollen; Hands were swollen; Not feeling well; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARALYSIS (Paralyzed for over two weeks), FEELING COLD (Gets cold very easy), DYSPNOEA (Out of breath), STREPTOCOCCAL INFECTION (Strep through body), SWELLING (Swelled all over body/left foot still swollen), ASTHENIA (Weak) and ATRIAL FIBRILLATION (Possible A-fib) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Arthritis and Cane user. Concomitant products included HYDROCHLOROTHIAZIDE, FINASTERIDE, OLMESARTAN, SIMVASTATIN, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and PARACETAMOL (TYLENOL) for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced MALAISE (Not feeling well). On 04-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRITIS (Arthritis aggravated), SWELLING FACE (Face was swollen) and PERIPHERAL SWELLING (Hands were swollen). On an unknown date, the patient experienced PARALYSIS (Paralyzed for over two weeks) (seriousness criteria hospitalization and medically significant), FEELING COLD (Gets cold very easy) (seriousness criterion hospitalization), DYSPNOEA (Out of breath) (seriousness criterion hospitalization), STREPTOCOCCAL INFECTION (Strep through body) (seriousness criterion hospitalization), SWELLING (Swelled all over body/left foot still swollen) (seriousness criterion hospitalization), ASTHENIA (Weak) (seriousness criterion hospitalization) and ATRIAL FIBRILLATION (Possible A-fib) (seriousness criterion medically significant). The patient was hospitalized for 34 days due to PARALYSIS, then for 36 days due to ASTHENIA, DYSPNOEA, FEELING COLD, STREPTOCOCCAL INFECTION and SWELLING. The patient was treated with MORPHINE in April 2021 at an unspecified dose and frequency and Physical therapy for Paralysis. At the time of the report, PARALYSIS (Paralyzed for over two weeks) had resolved and FEELING COLD (Gets cold very easy), DYSPNOEA (Out of breath), STREPTOCOCCAL INFECTION (Strep through body), SWELLING (Swelled all over body/left foot still swollen), ASTHENIA (Weak), ATRIAL FIBRILLATION (Possible A-fib), ARTHRITIS (Arthritis aggravated), MALAISE (Not feeling well), SWELLING FACE (Face was swollen) and PERIPHERAL SWELLING (Hands were swollen) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Apr-2021, Hepatic enzyme: elevated (High) Patient experienced elevated liver enzymes.. In 2021, Heart rate: high (High) Heart rate- increased possible a Fib. Concomitant medication also includes an unspecified blood thinner. Patient was prescribed with Tramadol which was provided at discharge. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient's hx of arthritis and being a cane user are confounding factors that may play a possible contributory role providing an alternative explanation. FU1 received additional serious AEs after second dose does not change company comment. Further information has been requested. This case was linked to US-MODERNATX, INC.-MOD-2021-067304, US-MODERNATX, INC.-MOD-2021-067204 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up received on 07-JUN-2021, upgraded case to serious with the addition of event paralysis and hospitalization.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient's hx of arthritis and being a cane user are confounding factors that may play a possible contributory role providing an alternative explanation. FU1 received additional serious AEs after second dose does not change company comment. Further information has been requested. US-MODERNATX, INC.-MOD-2021-067304:First dose case US-MODERNATX, INC.-MOD-2021-067204:Crosslinked (family member)

Started slowly, but progressed overtime to present. DR. prescribed several medication for allergy and Afrin to relieve congestion temporally. The result was congestion relieved, not the breathing problem- negative. I then saw an ENT, Dr.. He treated cough, but said I should see an Allergist. This was because of my breathing problem. At night I cannot fall asleep. I gasp for air and have not had a good nights sleep in months-it's getting worse. I am seeing an Allergist this coming week. If he cannot help me, then reasonable suspect may be the final injection shot on 03/11/2021. I have a cough that won't quit and heavy breathing at night which keeps me from falling asleep. Before 03/11/2021 I was fine.

Increasing weakness, fatigue and shortness of breath. Went to MD. Lungs clear, no wheezing, pulse ox sats 95-100%. Nothing made sense, blood work done. Diagnosis autoimmune hemolytic anemia and ITP triggered by vaccine.

Patient experienced onset of COVID symptoms 05/26. Tested positive for SARS-COV-2 by PCR on 06/09. Presented to ER on 06/12/21 c/o cough, SOB, and hypoxia. O2 sat was 72%. Patient was hospitalized and passed away on 06/18/2021.

Moderna COVID-19. Vaccine EUA Exactly 12 hours after my injection, 1:30 am, I awoke with a severe coughing attack. In addition, my chest was wheezing and felt as if "bubbles" were in my chest. My arm felt very hot and tender at the injection site. This attack lasted for half an hour. I went back to sleep and awoke the following morning feeling very weak and confused. Feeling extremely fatigued, all I wanted to do was sleep. I also lost my appetite. The next day, I had occasional coughing which subsided with my over the counter cough medicine.

Pt. woke up the next morning after vaccination and "didn't feel well", described by wife as fatigue, no energy. At approximately 2 PM, he vomited. His wife checked on him at 4:20 PM and he wasn't breathing sitting in his chair. EMS squad was called but when they arrived he was asystole and mottling present. Did not start CPR since he was already gone too long. Pronounced by coroner on scene.

Patient states on the second day, he experienced arm pain. On day 3 (1/22/21), he had flu-like symptoms "I had fatigue and shortness of breath. I was useless." Stated he felt better by day 5

Resident came up to staff and approximately 1400 and said, "I have a fever" - temperature was assessed and was 98.4 resident came back several minutes later and stated again, "I have a fever" - temperature assessed again and was 98.2 - staff asked if resident had his window open, he stated no - staff suggested maybe he open up his window because it is quite warm in the building at this time. Resident said ok - went back into room - staff told writer he had c/o "I have a fever" while staff was in change of shift report and they assessed fever and it was 97.1. Around 1525, Resident noted to have sudden SOB. PRN albuterol neb given. RR before neb was 40 and did not improve. BP 136/66, pulse 158, temp 101.7 tympanic, and O2 sats 76% RA. Placed on supplemental O2 and sat came up to 86% on 3 L. Resident then started to complain of chest pain. Resident was weak and unsteady and insisted on standing but was guided to his chair to sit down. Resident said he wished to go to ER and daughter in agreement. 911 called. Writer assisting with transferring resident out to hospital. While waiting for ambulance, patient restless and visibly short of breath. Lips with blue discoloration, pale appearance, and breathing with accessory muscles. Changing positions frequently from lying to sitting and standing due to being uncomfortable. Temp 103.2 in left hear and 102.5 in right ear. Respirations 36. Blood pressure unable to be checked due to restlessness and moving around. Pulse 167. O2 92% with nasal cannula on 3L. Asked him to point to the pain and he pointed to his upper abdomen, but describes it as chest pain. Per EMTs he is being sent to clinic instead of the other clinic due to abnormal EKG readings. Received update from EMT around 1700 that patient arrived to ER and heart attack was confirmed so patient was being sent to cath lab for angioplasty procedure.

Death Narrative: 83 y.o. male with pmh of heart failure admitted on 3/9 for shortness of breath and weight gain. Had Vfib arrest on 3/12 and was intubated/xfer to ICU. Continued to require increasing levels of pressors. He suffered VF arrest in the setting of metabolic, septic and cardiogenic shock. He had end stage heart failure and required 4 pressors. Was made CMO and passed away. Noted to have not received 2nd does of Moderna likely due to hospitalization at the time that the second dose would have been due. Patients history of adverse drug reactions included: lisinopril, dabigatran, and penicillin.

Patient states that twenty-four hours after administration (3/4/21) he spiked a fever, went into a state of delirium, and had difficulty breathing. When he presented at the Emergency Room he had low SpO2. They supplemented him with oxygen and gave him acetaminophen and after the fever broke he was sent home (3 hours in ER) with normal mental status. Emergency Room ran some tests to determine if he had stroke or cardiac event which came back negative.

Patient passed away unrelated to covid vaccine Narrative: The patient had end stage COPD and placed in hospice care. Patient received first dose of Moderna vaccine on 1/20 and second dose of Moderna vaccine on 2/16. No adverse reaction was reported. Patient passed away at home on 2/24/2021. Cause of death not documented. No indication that death was related to COVID 19 vaccination.

He was sent to the hospital two weeks earlier for Pulmonary Edema, he was discharged and sent to hospice. When the caregiver takes her rounds, she finds the resident without vital signs, prior to that he had not manifested any symptoms. Certification of cardio-respiratory failure secondary to Alzheimer's disease

About 11:30 PM on 03/15/2021, started gasping for breath when laying down, sat up in lazy boy for a hour and half, beathing returned to normal. About 3:30 PM on 3/16/2021, started gasping for breath again. Called my daughter and she transported me to Hospital. They tested for covid - results negative. They did a C-Scan of my chest and saw a blood clot in each lung. While hooked to the monitors, they found I had Afib. They also did an ultra-sound of my legs and found a small clot in each leg below the knees in a small vein. I have never had any record of clots or Afib. They transferred me to Medical Center early on 3/17/2021. They started a heparin drip to soften the clots. In the afternoon of 3/17/2021, they performed a Suction Thrombectomy to remove the clots from my lungs. On 3/19/2021, they put me on Eliquis Tab. I was released from the hospital in the evening of 3/20/2021.

Became febrile, poorly responsive. Taken to the MGH ED. En route while in ambulance, he experienced a convulsion with rhythmic shaking in all limbs lasting several seconds. He had a second episode requiring midazolam and levetiracetam. On arrival to MGH ED, the patient was afebrile, heart rate 133, blood pressure 173/93, oxygen saturation 99% on a nonrebreather. He was found to be severely encephalopathic, mute, and not answering questions or following commands. He was admitted to the neuroICU and intubated for airway protection given his poor mental status. He was started on broad-spectrum antibiotics for empiric treatment of meningoencephalitis, but these were discontinued after his CSF was not concerning for a bacterial infection herpes simplex encephalitis. Antibiotics were discontinued. He was extubated on hospital day 2. After extubation he had persistent mixed receptive-expressive aphasia that was slowly improving over time. At discharge from the hospital, he was able to occasionally say a simple sentence, could repeat simple phrases, and could follow simple commands. He was discharged to Rehab

Patient has long standing COPD and asthma. He has been stable on his home medications for years. No hospitalizations for these issues in the past. During Covid times he has been very restricted to his home with no visitors. Approximately 5 days after receiving the 2nd Moderna Covid-19 vaccine, he started having increased difficulty with breathing. Over the next few weeks he continued to get worse and required home oxygen and an adjustment with his medications. He was started on steroids and antibiotics about 3 weeks after the vaccine and then hospitalized on 3/16/2021 with COPD exacerbation and pneumonia. He tested negative for Covid at that time. He was in the hospital for 9 days and discharged home on steroid taper and home oxygen. A few days after being at home, he had gradual onset of subacute dementia/delirium. All workup has been negative. MRI/MRA normal. He is currently continuing on oxygen and again on steroids and mental status may be starting to improve. The concern here is that patient was stable and had been stable on his medication regimen for years. He was doing well until approx 5 days after his second Covid vaccine when he started having worsening pulmonary complaints and eventually ended up in the hospital. He continues to be on oxygen at home and was recently started back on steroids. There has been no explanation for his subacute onset of Dementia/Delirium. MRI/MRA normal. This has been discussed with both Pulmonology and Neurology specialists.

Pulmonary Fibrosis; Shortness of breath that required oxygen; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PULMONARY FIBROSIS (Pulmonary Fibrosis) and DYSPNOEA (Shortness of breath that required oxygen) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Urothelial carcinoma. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced DYSPNOEA (Shortness of breath that required oxygen) (seriousness criterion hospitalization). On 16-Apr-2021, the patient experienced PULMONARY FIBROSIS (Pulmonary Fibrosis) (seriousness criterion hospitalization). The patient was hospitalized on 12-Apr-2021 due to DYSPNOEA and PULMONARY FIBROSIS. At the time of the report, PULMONARY FIBROSIS (Pulmonary Fibrosis) and DYSPNOEA (Shortness of breath that required oxygen) 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. Concomitant medications included were many medications for underlying urothelial cancer. Treatment included for the events was oxygen high flow nasal cannula. 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.

Worsening shortness of breath since the vaccination; collapsed in bathroom on day 10 post-vaccination

pt felt unwell shortly after vaccine with profound weakness after 2nd dose. later developed SOB and was diagnosed with pneumonia (in March approximately 1 month after the second dose) subsequently had ongoing respiratory symptoms and was later diagnosed with pulmonary embolism/DVT in May

acuate shortnee of breath; weak and feeble/turned into a skeleton; cannot perform daily activities smoothly; suffering badly; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (acuate shortnee of breath), ASTHENIA (weak and feeble/turned into a skeleton), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (cannot perform daily activities smoothly) and EMOTIONAL DISTRESS (suffering badly) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No reported medical history. Concomitant products included METFORMIN. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (acuate shortnee of breath) (seriousness criterion hospitalization), ASTHENIA (weak and feeble/turned into a skeleton) (seriousness criterion medically significant), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (cannot perform daily activities smoothly) (seriousness criterion medically significant) and EMOTIONAL DISTRESS (suffering badly) (seriousness criterion medically significant). The patient was hospitalized from 13-Apr-2021 to 17-Apr-2021 due to DYSPNOEA. At the time of the report, DYSPNOEA (acuate shortnee of breath), ASTHENIA (weak and feeble/turned into a skeleton), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (cannot perform daily activities smoothly) and EMOTIONAL DISTRESS (suffering badly) outcome was unknown. Treatment information also included Levothyroxine, Lisinopril and Metoprolol. Patient was discharged from hospital without any improvement and there is no benefit in patient's health. Very limited information regarding the event onset date has been provided at this time and is insufficient for causality assessment. A causal relationship cannot be excluded.; Sender's Comments: Very limited information regarding the event onset date has been provided at this time and is insufficient for causality assessment. A causal relationship cannot be excluded.

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was Acute hypoxemic respiratory failure

Moderna Dose 1 2/25/21 (041L20A) Moderna Dose 2 3/25/21 (011M20A) COVID Positive 5/10/2021 5/10/21: Presented to ED. 84-year-old male with history of liver transplant for primary sclerosing cholangitis currently on immunosuppressive therapy with CellCept and sirolimus, colon cancer status post partial colectomy with colostomy, prostate cancer s/p androgen deprivation therapy, CKD stage 4 and obstructive sleep apnea presented with cough. Patient reports symptoms started about 1 week ago with dry intermittent cough associated with shortness of breath, chest pain, generalized weakness body aches and worsening of chronic diarrhea. He was treated with Z-Pak but symptoms continued and he presented to the emergency room, found to be hypoxic requiring up to 6 L nasal cannula oxygen Patient also had fever no chills or rigors. Reports he has received both shots of COVID-19 vaccine. In the emergency room patient was hypotensive which was responsive to IV fluids and received levofloxacin. Chest x-ray showed bilateral pneumonia. WBC 15.5, lactic acid 2.8 and the creatinine 2 which is patient's baseline. 5/13/21: 84-year-old male with history of liver transplant for primary sclerosing cholangitis currently on immunosuppressive therapy with CellCept and sirolimus, colon cancer status post partial colectomy with colostomy, prostate cancer s/p androgen deprivation therapy, CKD stage 4 and obstructive sleep apnea presented with cough. Patient reports symptoms started about 1 week prior to hospitalization with dry intermittent cough associated with shortness of breath, chest pain, generalized weakness body aches and worsening of chronic diarrhea. Patient admitted for acute hypoxic respiratory failure secondary to COVID-19 pneumonia. Treated with dexamethasone and levofloxacin. With not a candidate for remdesivir based on poor renal function and ID consulted and did not believe patient qualifies for Actemra. Subsequently shortness of breath and hypoxia resolved and he was deemed stable for discharge and will complete 7 days steroid taper. Liver transplant team at pain clinic was consulted, recommended holding sirolimus while patient is on dexamethasone. I have clearly communicated to the patient and his wife to resume sirolimus after 1 week. On discharge patient was a febrile and hemodynamically stable. He was discharged home.

Pt showed up to the ER via EMS on 6/5/2021 with low back pain and weakness, bilateral leg swelling, shortness of breath. On 6/6/2021-developed bilateral upper and lower weakness that progressed to dysphagia and dysphonia. Transferred to ER on 6/8/2021 for Gillian Barre Syndrome On 6/11 had bilateral DVTS He was placed on palliative care and passed away on 6/19/2021

Suffered a stroke\ spent 2 to 3 days in the hospital\ spent 10 days in Rehab; Shortness of breath is now really bad/ shortness of breath sometimes extreme/ shortness of breath a lot worse now; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Suffered a stroke\ spent 2 to 3 days in the hospital\ spent 10 days in Rehab) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Shortness of breath. Previously administered products included for Atrial fibrillation: Diltiazem; for an unreported indication: PREDNISON ("burst" (one-week course)). Concurrent medical conditions included COPD. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), ALBUTEROL [SALBUTAMOL] and DULOXETINE HYDROCHLORIDE (DUAL [DULOXETINE HYDROCHLORIDE]) for an unknown indication. On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Suffered a stroke\ spent 2 to 3 days in the hospital\ spent 10 days in Rehab) (seriousness criteria hospitalization and medically significant) and DYSPNOEA (Shortness of breath is now really bad/ shortness of breath sometimes extreme/ shortness of breath a lot worse now). The patient was treated with APIXABAN (ELIQUIS) ongoing since an unknown date for Stroke, at a dose of 1 dosage form and LISINOPRIL ongoing since an unknown date for Stroke, at a dose of 1 dosage form. At the time of the report, CEREBROVASCULAR ACCIDENT (Suffered a stroke\ spent 2 to 3 days in the hospital\ spent 10 days in Rehab) and DYSPNOEA (Shortness of breath is now really bad/ shortness of breath sometimes extreme/ shortness of breath a lot worse now) outcome was unknown. Patient stated that he was on one litter of oxygen (unknown flow rate). Patient stated the stroke affected his right "writing" hand. He reported that he had no history of heart problems prior to receiving the Moderna COVID-19 vaccine series Action taken with mRNA-1273 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 which is greater than two (2) months a causal relationship is unlikely. This case was linked to MOD-2021-238669 (Patient Link).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events which is greater than two (2) months a causal relationship is unlikely.

swelling in my neck threatening ability to breathe as well as in ankle and face the threat to breathing most alarming to me and with all my allergies I have not gone back for second shot

The patient tested positive for COVID on 7/15/2021 after being exposed to family member(s) that were also positive. He came to the hospital on 7/19/2021 with symptoms of shortness of breath, hypoxia, and dyspnea.

PATIENT SPOUSE REPORTS THAT PATIENT RECEIVED VACCINE ON 1/4/2021 AND ON 1/5/2021 PATIENT'S ARM BEGAN TO TURN RED AND SWELL AT THE INJECTION SITE. THE SWELLING AND REDNESS BEGAN TO GO DOWN HIS ARM AND HE BROKE OUT INTO A RASH. PATIENT THEN BECAME SHORT OF BREATH. EMS WAS CALLED AND PATIENT WAS TRANSPORTED TO HOSPITAL, WHERE HE WAS TREATED FOR ANAPHYLACTIC SHOCK TO THE COVID MODERNA VACCINE.

Pt received Moderna COVID 19 vaccination at approximately 1145am 1/23/21. Patient complained of labored breathing and dizziness approximately 10 minutes after receiving vaccine. No medication/intervention given on site in vaccine clinic. Pt taken to 1st floor urgent care for evaluation.

1/24/21 0445- patient presents to the ED with complaints of neck pain, chest pain, and back pain for about a week. States also feels SOB, intermittent fever with temperature 100.3 on arrival. Patient was worked up for his cardiac type symptoms, found to have elevated WBC and CRP with no explanation. D-Dimer was elevated with CT showing no sign of PE. Patient was sent home from the ED with instructions to follow up with primary care and/or return if s/s worsen. 1/24/21 1705- patient is returned to the ED via ambulance after becoming unresponsive and some seizure like activity. Patient was intubated. Head CT showed large brain bleed that was irreparable and not compatible with life. Patient was also found with positive blood cultures x2 with gram positive cocci in clusters growing after 9 hours.

Shortness of breath--Transferred to Advanced Urgent Care, EKG and BW completed. Symptoms resolved and discharged with no treatment.

Patient presents today with his wife and son. He was recently hospitalized having developed a fever the day after his Covid vaccine 1 with associated confusion and some ataxia. He was admitted to the hospital overnight where an MRI scan suggested no acute change showing only moderate cerebral atrophy and some small vessel occlusive changes. He tested positive for Covid by PCR in the emergency department on 1/22. His oxygen saturation was stable. He did have a fever and describes falling off the toilet because of some generalized leg weakness and uncoordination. He has had some chronic left greater than right upper extremity sensory loss following prior cervical spine stenosis requiring urgent surgery in 3/2019. He has had some chronic left foot drop as well. He reports being somewhat deconditioned having spent some time in bed to the above episode but is now ambulating with a cane at home and has occupational and physical therapy in place. He has been mildly dyspneic on exertion above baseline but attributes this to some deconditioning. He did have an episode of lower dental pain with ambulation in the office that was more than usual though denies associated chest pain or pressure and has had no jaw or shoulder pain with exertion. Review of systems is negative for headache.

ER visit 1/25/21 patient walked into a prompt care and collapsed, witnessed and pulseless CPR with ROSC after 6-7mins, no shock no meds. Awake and speaking upon arrival to ER. 2 plus pitting edema ble ER diagnosis Anasarca, cardiac arrest, hypotension, elevated troponin I levels, Acute kidney injury and syncope. ER notes reveal a syncopal episode in the shower prior to collapse at prompt care. Central line placed and plan to ship to another facility, patient continued to decline despite dopamine and dobutamine expired in ER prior to transfer.

Symptoms started approximately 1 week after vaccination, symptoms include fatigue, shortness of breath, water retention, swelling in feet and lower legs, high blood pressure, cough.

Thick congestion in back of nose and throat; pounding rapid irregular pulse; heavy breathing; no sleep that night. Next morning all symptoms rapidly disappeared. No further problems.

Patient presented to the ED with worsening dyspnea and lower extremity edema. Patient was found to have an elevated BNP with chest x-ray showing pulmonary edema. Patient has been treated with IV diuretics. Nephrology was also consulted due to worsening BUN/creatinine. Patient remains hospitalized at this time. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine

My father passed away on February 10th, 2021. On Monday, January 25th 2021, he said he is feeling very uncomfortable in his chest area. He thought it was severe acid reflux. He took Gas X for Acid Reflux and told us that he does not want to go to the hospital. On Tuyesday, January 26th, he felt that his Acid Reflux symptoms got worse, he still did not want to go to the hospital. He took Tums. On that evening, he started having shortness of breath. We took his BP at home and it was very low. We begged him to go to the hospital, he still did not want to go. On Wednesday, January 27th, his shortness of breath got worse and we convinced him that he has to go to the hospital. We took him to ER. Doctor said that he had a heart attack on Monday morning and that is why he was not feeling well since Monday morning. While at the hospital, while the cardiologists were monitoring him, his heart condition got worse. By Friday, February 5th, cardiologists said that he is very fragile, his heart condition is very fragile and he won't survive any procedure. They said that something triggered the heart attack. We told them about the vaccination on 1/13/2021. They sent him home on hospice on Friday, Feburary 5th, 2021. He was on supplemental oxygen when he came home. He passed away due to a heart attack on February 10th, 2021 around 9pm.

Pt received his first covid 19 vaccine on 3/9/2021 and tested positive for Covid 19 on 2/11/2021- he progressed to covid 19 pneumonia with hypoxia and was hospitalized from 2/25-2/27 for covid pneumonia treated with remdesivir, oxygen, decadron and antibiotics and was discharged home. He was doing well and recovering and the received his 2nd covid 19 vaccine on 3/9/2021 and the following day developed fever of 102 and shaking chills, severe weakness, cough and sob and 911 was called and he was admitted to the hospital with possible vaccine reaction/pneumonia. He tested positive on pcr for covid 19-he was treated with zosyn, oxygen, ivf and PT and discharged on 3/12/21 home.

Heart failure; Renal failure; Acute renal failure; Cardiac dysfunction; Shortness of breath; Not producing urine; Lower extremity edema; A spontaneous report was received from a physician concerning an 85-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shortness of breath, not producing urine, lower extremity edema, acute renal failure, cardiac dysfunction, renal failure, and heart failure. The patient's medical history, as provided by the reporter, included COVID-19 three months ago. Patient had no prior history of heart failure. No Concomitant medications were reported. On 05 Mar 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. After four days, the patient presented at the hospital with a constellation of symptoms including shortness of breath, lower extremity edema, acute renal failure, cardiac dysfunction, not producing urine. Patient was determined to be in renal failure and heart failure. For treatment of the events the patient was admitted to the hospital. Action taken with mRNA-1273 in response to the events was not reported. The seriousness criteria for all the events was hospitalization. The outcome of the events, shortness of breath, not producing urine, lower extremity edema, acute renal failure, cardiac dysfunction, renal failure, and heart failure was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Unknown what if any adverse event may have occurred. This report is being submitted following a periodic review of death certificates . Death certificate for this individual indicates "COPD - Decline Acutely After COVID Vaccine 1st Dose" in "PART II. OTHER SIGNIFICANT CONDITIONS contributing to death but not resulting in the underlying cause"

Patient admitted to the hospital 3/16/21 2 weeks post #2 Moderna COVID-19 vaccination with sepsis, atypical pulmonary infiltrates, and hypoxia. Patient treated for pneumonia and discharged home 3/19. Patient readmitted to hospital 3/31/21 with dyspnea, CT with worsening miliary appearing pattern.

Frequent falling down, dizziness, inability to walk normally, confusion, inability to breathe , heavy chest

death Narrative: Patient received COVID vaccine #1 on 12/30/20 and #2 on 2/1/21. He was an inpatient in the facility and had been under hospice care since 12/9/20. No adverse events to vaccine found per notes. On 2/27/21, he began to have short and rapid respirations and was unresponsive. He was given morphine, atropine sublingual, lorazepam and nebulizers per hospice care orders and was determined to be imminent. On 2/28/21 at 2230, he passed. No autopsy results available. 27 days from date of vaccination to date of death.

Expired in between Dose 1 and 2. Non-vaccine related. Death Certificate indicates, COPD, Type 2 Diabetes & hypertension

Received Moderna Dose #2 on 3/10/2021. About 1-2 weeks after, he started experiencing swollen leg (unsure if left or right), had shortness of breath, and looked pale on 4/22 he was seen by a provider and was prescribed oxygen, later that night he passed.

was initially admitted to the hospital on April 23, 2021 because of COVID-19 infection for 3 days. She received 3 days of Decadron followed by another 3 days as outpatient. Initially the patient felt much better but since then her breathing has been deteriorating till she has been experiencing hypoxia with oxygen saturation 85 up to 88% on room air. This time her chest x-ray shows some worsening of infiltration comparing to the previous 1 done on April 23, 2021.

Patient was seen by an outpatient provider and was referred to the emergency department due to hypoxia and respiratory distress. He was found to have a COVID-19 infection. He was admitted to hospital for further management. On 4/28/21, his condition declined and resulted in intubation and transfer to ICU. He is intubated at time of writing.

Per discussion with wife, patient experienced worsening shortness of breath after each Moderna vaccine. The patient has history of inhalers used for COPD, but the patient's wife stated that he has had difficulty moving from room to room without becoming short of breath, which did not happen before the vaccines.

Patient was seen by an outpatient provided and was referred to emergency department due to hypoxis and respiratory distress on 4/27/21. He was found to by COVID-19 positive at that time. He was admitted to the hospital for further management. on 4/28/21, his condition declined. He was intubated and transferred to the ICU. Patient went into severe acute kidney injury and eventually into multi-system organ failure. He was placed on comfort measures on and was pronounced dead on 5/15/21.

Advanced coronary artery disease, Arteriovascular risk factors, Chronic obstructive lung disease.COVID-19 2/10/2021, Recurrent GI bleed with iron deficiency

6/22: 85 y/o male admitted to hospital from ED with complaints of fatigue, shortness of breath, and generalized weakness. Received 2nd dose of COVID-19 Moderna vaccine yesterday (6/21). admitted to med-tele unit. COVID-19 positive. Previous COVID infection in Dec 2020 s/p treatment with remdesivir and convalescent plasma therapy. 6/23-6/25: improvement in breathing and fever. 6/26: patient found to be bradycardic with heart rate as low as 30s and recurrent pauses. Likely due to recent increased dose of Coreg. Coreg held and Dopamine drip started and patient transferred to ICU. 6/27: remains on dopamine; HR stable. on 2L via nasal cannula. 6/28-7/4: afebrile. still on supplemental oxygen via NC. dopamine drip on hold and then discontinued on 6/29. 7/5: acceptable saturations on room air. will d/c to subacute rehab. denies chest pain/cough. 7/6: discharged.

Cardiogenic shock, Respiratory failure, Ventricular fibrillation, thrombocytopenia, Acute Stroke, seizure, acute deep venous thrombosis

Myasthenia Gravis; Death; Hallucinations; confusion; shortness of breath; dizziness; stroke like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death), MYASTHENIA GRAVIS (Myasthenia Gravis) and HALLUCINATION (Hallucinations) in an 85-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 Heart attack (20 years ago). On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYASTHENIA GRAVIS (Myasthenia Gravis) (seriousness criteria death, hospitalization prolonged and medically significant), HALLUCINATION (Hallucinations) (seriousness criterion medically significant), CONFUSIONAL STATE (confusion), DYSPNOEA (shortness of breath), DIZZINESS (dizziness) and CHEST DISCOMFORT (stroke like symptoms). The patient died on 12-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, HALLUCINATION (Hallucinations), CONFUSIONAL STATE (confusion), DYSPNOEA (shortness of breath), DIZZINESS (dizziness) and CHEST DISCOMFORT (stroke like symptoms) outcome was unknown. Patient started experiencing side effects 2 weeks after taking the vaccine. He was taken to the hospital for stroke like symptoms but it was ruled out by X-ray. He went to the hospital as symptoms persisted & got admitted on 13March2021. He died 24 hour later after being diagnosed with Myasthenia Gravis and thymus removal refusal. Concomitant medications were not provided by the reporter. Treatment medications were not provided by the reporter. 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.; Reported Cause(s) of Death: unknown cause of death

Rash on chest that went to his stomach; Went to hospital for fast heart rate; Trouble breathing; Felt like he had the flu; Sore muscles; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Went to hospital for fast heart rate), DYSPNOEA (Trouble breathing) and RASH (Rash on chest that went to his stomach) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy, METOPROLOL SUCCINATE and DOXYCYCLINE for an unknown indication. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 25-Feb-2021, the patient experienced MYALGIA (Sore muscles) and ARTHRALGIA (Joint pain). In May 2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like he had the flu). On 30-May-2021, the patient experienced TACHYCARDIA (Went to hospital for fast heart rate) (seriousness criterion medically significant) and DYSPNOEA (Trouble breathing) (seriousness criterion medically significant). On 01-Jul-2021, the patient experienced RASH (Rash on chest that went to his stomach) (seriousness criterion medically significant). At the time of the report, TACHYCARDIA (Went to hospital for fast heart rate), DYSPNOEA (Trouble breathing), RASH (Rash on chest that went to his stomach), INFLUENZA LIKE ILLNESS (Felt like he had the flu), MYALGIA (Sore muscles) and ARTHRALGIA (Joint pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-May-2021, Heart rate: fast (High) Fast. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-256548 (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.

Patient wasn't feeling well on Jan 2nd. felt like someone is pushing on his chest and is Short of breath. b/p 119-69 P 62 R 26 no temp. patient evaluated in ED symptoms subsided quickly and returned to normal environment. Same similar symptoms occurred again on Jan 6th. symptoms again subsided quickly. NO previous history of any cardiac disease.

hypoxia, secretions,cough, dyspnea Narrative: ALS patient on hospice with ongoing history of aspiration pna, receiving tube feeds. Developed incr in secretions, hypoxeia, temp and with recently noted clogged feeding tube.

1/16/2021 1:30 AM constant chills throughout the day, body aches, trouble breathing, coughing, congestion, severe fatigue for 3 1/2 days. Symptom s have resolved since

55 minutes (12:00pm) after receiving 1st dose of Moderna COVID-19 vaccine resident was shaky all over. States he's had panic attacks but it "doesn't feel like that". Denies chest pain. Denies shortness of breath. Visibly shaking. Facial Hx of diabetes and had just finished lunch. Blood sugar 189. 02= 98% on room air, BP 140/70 Pulse 106. At 12:07 complains that tongue feels numb and throat feels tight. 12:08 pm, Epi-pen administered to left outer thigh. 12:16pm states he's feeling better. Shaking has subsided. Tongue numbness almost gone. 12:31pm T= 98.3 02 = 98% P=80 BP= 114/72

Resident received 1st dose Moderna Covid-19 vaccine at 11:06am. At 12:00pm, resident complained of feeling shaky "all over" and was visibly jittery. Denied shortness of breath, chest pain or throat tightness. Face had a pallor appearance. States he's had panic attacks in the past but this "doesn't feel like that". Blood sugar 189 (had just finished lunch). BP = 140/70, P = 106, 02 = 98%. At 12:07 resident states that tongue and lips feel numb and throat feels tight. 12:08pm Epi-pen administered into left outer thigh. 12:16pm resident states he's feeling better. Shakiness resolving. Numbness letting up. At 12:30pm resident reports feeling back to normal. T = 98.3, P = 80, BP = 114/72, 02 = 98% on room air. Event reported to the resident's medical provider.

Resident passed away at 8:15 am on 1/28/21-found to be without pulse/respirations/DNR order in place.

[Casirivimab/indevimab] treatment under Emergency Use Authorization(EUA): Infusion started at 9:45 and was stopped at 11:00. At 11:30 Patient developed SOB and drop in Sat from >96% to 88%. Patient had a large cough and expectorated a quarter size of brown phlegm. Code blue was activated, patient placed on NRB 180/81, 72, 24, 91%. Patient was AAOx3 and talking during this time. Patient transferred to the ER gurney and transported to ER for further evaluation. From H&P: tested positive for COVID-19 outside facility on 1/22 w/onset of covid sxs on 1/18 after returning from hunting trip with son on 1/17. Patient s/p Moderna vaccine #1 on 1/14/2021. Initially symptoms were just fatigue, cough, and chills and then spiked low grade fever on 1/20. Patient began to experience weakness and difficulty walking on 1/24 and fell from standing on 1/25 and possibly hit his head but without LOC. Patient presented to ED complaining of SOB that began after receiving monolconal antibodies about an hour PTA. Patient states that prior to the infusion, he was not feeling overly short of breath. After the transfusion, a code blue was called in the parking lot due to the patient becoming light-headed and short of breath - he never lost pulses. Upon arrival to the ED, he was in obvious respiratory distress and O2 sats were 92% on 15L NRB and patient switched to BIPAP. Patient given dose of epinephrine injection,after which he states he began feeling better.

Had acute respiratory failure, dysuria NSTEMI after Dose #1 Lot # 025L20A (Moderna) hospitalized same day 12/31/20 administered @ 1040 back to baseline. 2nd Dose on 1/27/21 0950 Lot as above. Unknown exact onset same day, ED by EMS @ 1745, respiratory distress, febrile 39.4 degrees C BP 150/105 RR 29

Patient awoke at 1:00 AM on 2/10/2021, five days after his Moderna COVID-19 booster, with chest pain radiating to the back and worse with deep inspiration. Patient arrived in our office on 2/10/2021 at 9:30 AM for an evaluation. Patient was noted to have new EKG changes with new concave-up ST elevation across the precordium. Bedside echocardiogram showed no pericardial effusion and no pericardial friction rub was appreciated. Due to ongoing chest pain, patient was transported to Emergency Department by medics for further workup and evaluation for possible pericarditis. Formal echocardiogram in ED was normal. Acute myocardial infarction ruled out. ST changes improved. Patient now being discharged in stable condition 2/11/2021.

Right arm swelling and pain(not arm injected), difficulty walking, very weak, some dyspnea, elevated blood sugars, total body aches, subjective fever, patient report fever 102 deg F. S/S lasting >4 days. Sent by nurse to PCP for covid-19 rule out. Tested at clinic for covid 19, then sent into hospital for CXR and labs that were all "normal" No other treatment reported. Patient not admitted, sent home and remains a little better but still weak.

Patient was transferred from hospital for further evaluation and care by pulmonologist. He started having symptoms a week before with fatigue, emesis, decreased p.o. intake, shortness of breath, vomiting and diarrhea. The two previous takes before death required increasing oxygen and family wanted everything done including intubation. He was transferred to ICU.

The local hospice agency notified us that this patient was now under their care. The patient is experiencing severe intestinal inflammation to the point that he was admitted to the hospital for shortness of breath due to the inflammation of the intestines reducing space for the expansion of his lungs within the chest cavity. He discharged from the hospital under hospice care.

After receiving the injection and while walking the 75 yds to my parked car I experienced shortness of breath. This has continued, along with general tiredness, and I have seen my primary care doctor who referred me to a cardiologist. Both reported low heart rate. I am seeing a Electrophysiologist tomorrow and expect to have pacemaker surgery. I have heard anecdotally now of a relative who developed low heart rate after 2nd Moderna shot . I wonder if there is a relationship between low heart rate and the vaccine.?

VASOVAGAL SYNCOPE (PER NOTE) Narrative: Patient received vaccine, became dizzy, and cold without sweats. Albuterol was administered though patient does have breathing problems. O2 stats dropped and patient heart elevated. Patient was observed and once o2 was given via NC, O2 increased to 95-96% in minutes and HR returned to baseline of in the 70s. Patient was provided a warm blanket to offset feeling cold.

3-21-21 at 5:35am - Intermittent coughing during HS. Afebrile. Upper lung fields noted congestion; clearing when coughing/turned repositioned per staff, Afebrile. 3-21-21 at 9:30am - In residents room repositioning him, resident vomited tube feeding. Turned him on his side and swept out his mouth. Tube feeding pump turned off. Breathing became labored. Second nurse placed non-rebreather mask on him. Called 911 to take resident to hospital. 3-21-21 9:45am EMS now at bedside. Pulse palpable, Cheyne Stokes respirations. O2 on per non-rebreather mask. EMS assessed resident- now in VT/VF CPR initiated. Code cart placed outside of door. 3-21-21 10:00am Resident transferred out to Rig with an organized heart rhythm. Dr. ( on call for Dr.) notified of event and transport to hospital.

Congestive Heart Failure; fluid on lungs; He was found to have fluid on the heart; Shortness of breath; Stroke; A spontaneous report was received from a family member concerning reporter's husband who was also a 86-years-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced stroke/cerebrovascular accident, congestive heart failure/cardiac failure congestive, he was found to have fluid on lungs and hear /pulmonary oedema and pericardial effusion and shortness of breath/dyspnoea. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number: 027L20A) on 23 Jan 2021. On 20 Feb 2021, approximately one day prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 039K20A) intramuscularly for prophylaxis of COVID-19 infection. On 21 Feb 2021, the patient had a stroke. The patient consulted with general practitioner on 22 Feb 2021 who ordered a magnetic resonance imaging (MRI). Patient started to develop shortness of breath on 22 Feb 2021. The MRI on 24 Feb 2021 confirmed that the patient had suffered a stroke. On 05 Mar 2021 the patient went to the emergency room with shortness of breath. The patient was diagnosed to have fluid on the heart and lungs and with congestive heart failure. Treatment for the events included Clopidogrel and aspirin. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable. The outcomes of the events were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

One side of heart was not pumping right; Nauseous; Patient was not feeling well; Loss of appetite; Increased heart rate; Pale; hard time breathing; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DYSFUNCTION (One side of heart was not pumping right) in an 86-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. The patient's past medical history included No adverse event (No medical history reported). On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced CARDIAC DYSFUNCTION (One side of heart was not pumping right) (seriousness criterion hospitalization). On an unknown date, the patient experienced NAUSEA (Nauseous), MALAISE (Patient was not feeling well), DECREASED APPETITE (Loss of appetite), HEART RATE INCREASED (Increased heart rate), PALLOR (Pale) and DYSPNOEA (hard time breathing). The patient was hospitalized from 09-Mar-2021 to 19-Mar-2021 due to CARDIAC DYSFUNCTION. At the time of the report, CARDIAC DYSFUNCTION (One side of heart was not pumping right), NAUSEA (Nauseous), MALAISE (Patient was not feeling well), DECREASED APPETITE (Loss of appetite), HEART RATE INCREASED (Increased heart rate), PALLOR (Pale) and DYSPNOEA (hard time breathing) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment of the events included diuretic medications. 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.

Patient was in usual state of health when received first Covid Moderna vaccine on 2/2/21 and did fine until about 2/17. He started c/o discomfort and appetite decreased. 2/18/21 had low grade fever. 2/22 fever and generalized weakness and abnormal labs (elevated potassium). 2/22 hydration was started. 2/25 antibiotic started for UTI for 7 days. Patient seem to improve except appetite. Since vaccine, patient remained on frequent IV hydration and had poor appetite through February into March. On 3/2/21, patient received 2nd dose of Moderna Vaccine while on Augmentin for UTI, issue with dehydration and appetite. By 3/4/21, patient was noticed to have trouble chewing and swallowing. Speech was ordered. On 3/5/21, it was noted patient had continued poor appetite, weakness, dehydration risk, debility. On 3/8/21, it was noted patient had intermittent confusion. By 3/10/21, patient was more alert. Patient remained fairly consistent from that time with poor appetite, dehydration issue, weakness and dysphagia management. Then on 3/27/21 he became disoriented, wheezing, labored breathing, Vitals were 92% oxygen on room air, Temp 97.5, 158/62, pulse 94. Oxygen started and sent to ER. Family reported patient is admitted to hospital with mild stroke and UTI. The vaccine seemed to change patient's state of health about 2 weeks post first dose with multiple sequelae. This seems similar to timing of actual COVID infection pattern when it is the actual virus.

On or about April 17 he began having shortness of breath with exertion. On or about May 1 he began having severe right flank pain. May 3 he went to the ER a Bilateral pulmonary embolism diagnosed.

Fluid in lungs; Positive COVID test; Feeling poor; Dehydration; Loopy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY OEDEMA (Fluid in lungs), COVID-19 (Positive COVID test), DEHYDRATION (Dehydration), CONFUSIONAL STATE (Loopy) and FEELING ABNORMAL (Feeling poor) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PULMONARY OEDEMA (Fluid in lungs) (seriousness criterion hospitalization), COVID-19 (Positive COVID test) (seriousness criterion hospitalization), DEHYDRATION (Dehydration) (seriousness criterion hospitalization), CONFUSIONAL STATE (Loopy) (seriousness criterion hospitalization) and FEELING ABNORMAL (Feeling poor) (seriousness criterion hospitalization). The patient was hospitalized from 22-Mar-2021 to 23-Mar-2021 due to CONFUSIONAL STATE and DEHYDRATION. The patient was treated with Surgery for Pulmonary oedema. On 23-Mar-2021, PULMONARY OEDEMA (Fluid in lungs), DEHYDRATION (Dehydration), CONFUSIONAL STATE (Loopy) and FEELING ABNORMAL (Feeling poor) had resolved. At the time of the report, COVID-19 (Positive COVID test) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications include Blood Thinners (unspecified). The reporter did not mention any treatment medications for the events. Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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.

He developed an unprovoked DVT in his right leg that led to a pulmonary embolism that led to severe pulmonary hyperttension that led to dyspnea on exertion.

reed blodd cells/hemoglobin down; white blood cells down; possible lymphoma; platelets down; Spleen enlarged; liver enlarged; Not feeling well overall; Dizziness; Throwing up bile; shortness of breath; Consumer called 3Jun2021 regarding her father who within the last 4 weeks has declined significantly; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), GENERAL PHYSICAL HEALTH DETERIORATION (Consumer called 3Jun2021 regarding her father who within the last 4 weeks has declined significantly), HEPATOMEGALY (liver enlarged), ANAEMIA (reed blodd cells/hemoglobin down), LYMPHOPENIA (white blood cells down), LYMPHOMA (possible lymphoma), THROMBOCYTOPENIA (platelets down), SPLENOMEGALY (Spleen enlarged), MALAISE (Not feeling well overall), DIZZINESS (Dizziness) and VOMITING (Throwing up bile) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. The patient's past medical history included Blood transfusion (Patient has had 4 blood transfusions, has been hospitalized). Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), COLECALCIFEROL (VITAMIN D3), IRON, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), MACROGOL 3350 (MIRALAX), DOCUSATE SODIUM (COLACE), WARFARIN SODIUM (COUMADIN), ASPIRIN [ACETYLSALICYLIC ACID], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced MALAISE (Not feeling well overall) (seriousness criterion hospitalization), DIZZINESS (Dizziness) (seriousness criterion hospitalization) and VOMITING (Throwing up bile) (seriousness criterion hospitalization). On an unknown date, the patient experienced DYSPNOEA (shortness of breath) (seriousness criterion hospitalization), GENERAL PHYSICAL HEALTH DETERIORATION (Consumer called 3Jun2021 regarding her father who within the last 4 weeks has declined significantly) (seriousness criterion hospitalization), HEPATOMEGALY (liver enlarged) (seriousness criteria hospitalization and medically significant), ANAEMIA (reed blodd cells/hemoglobin down) (seriousness criterion hospitalization), LYMPHOPENIA (white blood cells down) (seriousness criterion hospitalization), LYMPHOMA (possible lymphoma) (seriousness criteria hospitalization and medically significant), THROMBOCYTOPENIA (platelets down) (seriousness criteria hospitalization and medically significant) and SPLENOMEGALY (Spleen enlarged) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 7 days due to DYSPNOEA and GENERAL PHYSICAL HEALTH DETERIORATION. The patient was treated with OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) at an unspecified dose and frequency; CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) at an unspecified dose and frequency and IRON at an unspecified dose and frequency. At the time of the report, DYSPNOEA (shortness of breath), GENERAL PHYSICAL HEALTH DETERIORATION (Consumer called 3Jun2021 regarding her father who within the last 4 weeks has declined significantly), HEPATOMEGALY (liver enlarged), ANAEMIA (reed blodd cells/hemoglobin down), LYMPHOPENIA (white blood cells down), LYMPHOMA (possible lymphoma), THROMBOCYTOPENIA (platelets down), SPLENOMEGALY (Spleen enlarged), MALAISE (Not feeling well overall), DIZZINESS (Dizziness) and VOMITING (Throwing up bile) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Biopsy bone marrow: unknown (Inconclusive) Inconclusive. In 2021, Biopsy liver: unknown (Inconclusive) Inconclusive. In 2021, Blood smear test: unknown (Inconclusive) Inconclusive. In 2021, Haemoglobin: low (Low) Low. In 2021, Platelet count: low (Low) Low. In 2021, Red blood cell count: low (Low) Low. In 2021, White blood cell count: low (Low) Low. Concomitant medications also include an inhaler (unspecified). Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Patient began experiencing Shortness of Breath, which increased until he had to be transported to the ER on 3/26/2021. He was diagnosed with severe Congestive Heart Failure, with an injection fraction of 15% and kidney function below 30%. He was released to hospice care 4/5/2021 with Pleur-Ex drains to both lung areas. He continued to get worse, including TIAs, until he died on 5/31/2021.

About one month after vaccination (second dose) patient experienced increased shortness of breath. Patient followed up with cardiologist and they conducted a stress test and a heart monitor. Heart monitor reported atrial fibrillation resulting in change of medication. Patient still experiencing shortness of breath.

Resident displayed with confusion/shaking at 1400, condition worsens at time went. Resident unable to state where he is, knows his name. can tell you he does not feel right. Temp 97.3, p 88, O2 91%, Bp 214/116 Transferred to ED with fever, temp of 103, and shortness of breath, admitted to ICU Positive COVID-19 test at hospital. Diagnoses include acute COVID-19 pneumonia and hypoxia. PO had confusion, fatigue, weakness, hypoxia, increased BP

Systemic: Nausea, Systemic: Vomiting, Systemic: shortness of breath, increased Heartrate, pulse ox fell to 88-93-Normal 95%, orthostatic hypotension

covid + on 1/21/21; admitted to hospital due to infection Narrative: Patient received the first dose of the COVID vaccine on 1/12/21. The patient tested positive for COVID 1/21/21. Admitted to Hospital on 1/23/21. Patient developed fever, cough, SOB, and diarrhea.

Got vaccine on 1/15/21. He was tired right away, bedridden the next 3 days. He couldn't breathe so he was taken by ambulance on 1/18/21. He was in hospital for several days. put on remdesivir cocktail for 10 days. Slowly getting worse and died in hospital on 1/30/21.

Patient awoke at 0600am with chest pain. He took two nitro and tried to go back to sleep. At 0800am he awoke again with the chest pain and took 2 nitro which again helped the pain. At that time he did experience shortness of breath and diaphoresis. He was found to have decreased O2 sats when the EMTs got to him and he was placed on a non-rebreather. On x-ray the patient was found to have a right pneumothorax, cardiac markers were negative. A chest tube was placed and the patient was transferred to a hospital.

presents to the ED with Chief Complaint: CHEST PAIN. It is described as pressure and it is described as located in the central chest area. This started 0500. No nausea, vomiting or diaphoresis. Patient states he awoke in morning with feeling that he had palpitations as well as central subtle chest pressure. He has had difficulty breathing and state CP seems to be worse with deep breath. IN ED Vitals were ( Temp: 98.8 F. BP: 150/98. MAP: 115. HR: 166. O2 saturation: 85% on RA) and Initial HR was concerning for A-Fib with RVR, HR 166, was given IV Dilt 20 mg IV with excellent response and F/U HR was in 80s and was transitioned to PO Dilt (30 mg Q8) and was started on new anticoagulation for a-fib.

Moderna COVID19 vaccine EUA given at Cheyenne Wy 2/6/2021 1:45 p.m. can't sleep, harder to breathe, anxiety, light headed - dizziness, loss of appetite, no energy

fatigue, high heart rate, sob, low blood pressure, feels cold all the time, no appetitive, palpitations

Patient was vaccinated at pharmacy on 2/9/2021, first dose of Moderna COVID-19 vaccine. Per medical records from hospital: patient developed fever, diarrhea, nausea and abdominal pain on 2/25/2021 and presented to the hospital E.R. on 3/1/2021. Patient was diagnosed with Sepsis and Pneumonia. Cardiac arrest on 3/6/21, renal failure, seizures. Patient tested negative for COVID-19 on 3/1/2021 and 3/8/2021. Patient has declined, was placed intubated and placed on a ventilator. Patient admitted to hospice services on 3/8/2021 and plan is for compassionate removal of life support at hospice. Prognosis is poor.

Narrative: Patient and wife contacted telephone triage nurse today requesting advice. States patient did fine with the first covid vaccine, but after he got his second covid vaccine on 2/20/2021 he became ill, has not recovered yet. Patient is c/o nausea/vomiting, "he looks jaundiced" per wife. Some mild SOB, + epigastric discomfort, chills, increasing weakness. No diarrhea, "some constipation." + Dark urine. This nurse asked wife to check V/S. [B/P: 116/65, pulse 75]. Pt still able to getup and walk around to use restroom, etc. - some lightheadedness with ambulation. No leg swelling. Patient has been vomiting several times daily since 2/20/2021. Emesis x 4 since last evening. Recommended local ER. Wife states she will take him to ER now. Please follow up, thank you.

Patient was admitted to hospice services on 2/11/21. Patient received vaccination on 3/2/21. On 3/16/21, patient developed severe ineffective breathing and is requiring palliative management of respiratory symptoms. Patient also suffered swelling to jaw and fever of 102 F. Patient is a DNR and appears to be approaching end of life. Patient was on the following medications prior to the current event: Citalopram, Quetiapine, Simvastatin, Furosemide, Miralax, Potassium Chloride PO, Vitamin D3, Zinc, Tylenol.

PATIENT'S SON CALLED ME. BP 141/85, TEMPERATURE 99.2, COUGHING, SLEEPY, VERY SHORT OF BREATH, RAPID HEART BEAT. DUE TO THE SHORTNESS OF BREATH & RAPID HEART RATE, PT'S MEDICAL HISTORY, I RECOMMENDED THAT THE PT GET CHECKED OUT. HE WENT TO THE HOSPITAL & WAS ADMITTED. ON A FOLLOW UP CALL,HIS SON INDICATED THAT PT HAD PNEUMONIA.

covid+ Narrative: Patient with diagnosis of chronic respiratory failure with hypoxia secondary to COPD, dependent on oxygen/steroid, GERD, Rosacea secondary to long term steroid use, CAD, HLD, HTN, Diet controlled DM, Granulomatous disease of the lungs, Hx Abnormality Imaging of the lungs early 1990's- further imaging resolved without treatment, Vitamin D/B12 deficiency, Chronic rhinitis, Adjustment disorder with anxiety, Osteoarthritis of multiple joints. Patient admitted 3/19/21 with +COVID symptoms/test. Transferred to facility 3/27/21 with new onset Afib/further respiratory decompensation requiring NRB/Amiodarone gtt. Was made comfort care for Patient request and placed on MSO4 gtt. Patient passed away 3/31/21 at 1640 of Acute on Chronic respiratory failure secondary to COPD/COVID with daughter at side.

Death Narrative: Patient received his first dose of the Moderna COVID-19 vaccination on 3/4/2021. He presented to facility 03/05/2021 for shortness of breath. He was originally treated for COPD exacerbation and COVID-19 was ruled out by negative testing. He was then found to have blood cultures positive for E. Faecalis. He was treated with broad spectrum antibiotics. His lack of improvement in respiratory status was the cause of discharge to hospice after which he died on 3/30/2021.

Death Narrative: The patient did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. Patient transported to ER on 1/14/21 after receiving first COVID-19 vaccine earlier that day. He was reported to have a reaction to the vaccine including diaphoresis, new onset afib, and hypotension(vasovagal reaction). He was discharged the next day with no signs of afib. Patient was later hospitalized around 1/28/21 for COVID pneumonia. He later passed away on 2/5/21 due to hypoxic respiratory failure secondary to COVID-19. Comorbidities include advanced age, obesity, HLD, atherosclerosis, DM2, HTN.

Patient developed swelling of his upper and lower lip on 4/11 and was given 25 mg benadryl at the care home. Swelling subsequently worsened and 911 was called, with EMS noting SpO2 at 88%. He was transported to the ER and found to have CHF/pulmonary edema and NSTEMI. Comfort care measures were implemented and he died 4/15.

BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider at Discharge: MD Admission Date: 4/22/2021; Discharge Date: 4/23/2021 Active Hospital Problems - Admitted for bilateral PE ? Acute pulmonary embolism without acute cor pulmonale, unspecified pulmonary embolism type (HCC) 04/22/2021 DETAILS OF HOSPITAL STAY: Patient is a 87 y.o. male with psoriatic arthritis, essential hypertension who presents today with right-sided chest pain. He reports onset starting yesterday. The pain radiated around to his back into the center of his chest. Thought he had pulled a muscle was having heartburn. Taking a deep breath made the pain worse. He tried Tums but no significant relief. It was not associated with shortness breath. Denied any, lower extremity swelling or calf pain. Today the pain was acutely worse so presented to the emergency department for evaluation. No prior DVT, PE, no FH of DVT/PE. No weight loss. No recent prolonged trip. On arrival to the emergency department his pulse was noted to be elevated to 120 but otherwise vitals unremarkable. CT angiogram thorax had significant findings of multiple bilateral pulmonary emboli involving segmental and subsegmental vessels. There was no evidence of right heart strain. He was started on heparin drip and transferred to another facility for ongoing care. He was switched to Eliquis 10 mg bid for 7 days, then 5 mg bid for 3 months. He has not sign of any malignancy, no weigh loss. He received Moderna COVID-19 vaccine on 3/4/21 and 4/1/21. It is conceivable that this PE could be complication of COVID-19 vaccine. He should follow up with PCP in 1 week. CTA also showed partial visualization of gas fluid collection within the right upper quadrant, likely reflecting a duodenal diverticulum which was present on 8/20/2012 CT abdomen, incompletely assessed. There is a small hiatal hernia. PCP to follow. Discussed with wife, and with daughter over the phone. Patient discharged home.

Patient presented to the ED and was subsequently hospitalized with sepsis, respiratory failure and pneumonia on 3/2/2021. Patient presented to the ED and was subsequently hospitalized with pneumonia on 3/22/2021. Patient presented to the ED and was subsequently hospitalized with sepsis on 3/31/2021. He died on 4/4/2021.

87-year-old male with history of chronic systolic heart failure and atrial flutter as well as significant renal dysfunction presented to facility seen hospital with increasing shortness of breath and cough. The patient had completed his COVID-19 vaccination but his wife had elected not to be vaccinated she evidently had contracted COVID-19 pneumonia and the patient likely obtain his infection due to close contact with her. He predominantly noted increased weakness and shortness of breath at the time of admission. He did require initially 2 L of supplemental oxygen which was relatively quickly weaned off over his 2nd hospital day. The patient was placed on remdesivir and dexamethasone for treatment of his COVID-19 pneumonia. He steadily improved over the course of his hospital stay

ED to Hosp-Admission Discharged 5/21/2021 - 5/28/2021 (7 days) DO Last attending ? Treatment team E coli bacteremia Principal problem Discharge Summary , DO (Physician) ? ? Internal Medicine Discharge Summary Hospitalist Medicine Patient: Date: 5/28/2021 DOB: Admission Date: 5/21/2021 PCP: , PA-C Length of Stay: 7 Days Discharging provider: , DO Discharge Date: 5/28/2021 Admission Diagnosis Medical Problems Hospital Problems POA * (Principal) E coli bacteremia Yes Atrial fibrillation with RVR (CMS/HCC) Yes Mitral and aortic valve disease Yes Overview Signed 11/4/2020 5:08 PM by , LPN Note: Moderate AR, MR & TR 1'15 Note: Moderate AR, MR & TR 1'15 Type 2 diabetes mellitus (CMS/HCC) Yes Dementia due to Parkinson's disease without behavioral disturbance (CMS/HCC) Yes Acute metabolic encephalopathy Yes Chronic systolic CHF (congestive heart failure) (CMS/HCC) Yes Sepsis (CMS/HCC) Yes Anemia Yes COVID-19 Clinically Undetermined Overview Signed 5/28/2021 12:11 PM by, DO Asymptomatic, had been positive back in January, tested negative on admission then tested positive when planning for discharge. May just be persistent viral shedding from previous Covid infection Hospital Course HPI:I refer you to the history and physical for completeness. Briefly, patient presented to the emergency department with his family stating that he is a little bit more confused, not as alert, and little bit more short of breath and shaky. Noted to have an elevated white blood cell count lactic acidosis. Hospital Course: Patient was cared for in hospital. Placed on broad-spectrum antibiotics. Blood cultures revealed gram-negative bacteremia most likely due to to possible mild diverticulitis. Throughout the course of his hospitalization he steadily improved. Was transition to oral antibiotics. His cardiac issues were continue to be managed during his hospitalization. He did have some mild encephalopathy associated with the bacteremia and as his infection cleared that improved. Adjustments were made in his home medications. He is started on therapies. Due to his severe deconditioning associated with acute medical illness will need some higher level care and increased rehabilitation. Arrangements were made for him to receive ongoing care at . When he presented to the hospital he tested negative for COVID-19. In preparation to going to the he tested positive. He was completely asymptomatic as far as COVID-19 symptoms are concerned. He was previously positive in January 2021 for Covid. This could just be a prolonged positive testing from his infection in January. Nondetected COVID-19 test on 5/21/2021 could potentially be a false negative. At this point would recommend isolation for 10 days from 5/26/2021. Otherwise his vital signs are stable. Improved the point where he no longer requires hospital level care and can be discharged to

Patient presented to the emergency department on 6/15/2021 with weight gain, peripheral edema, and worsening dyspnea. Patient has a history of CHF. Upon admission screening, he was found to be COVID-19 positive. He was treated for COVID-19 infection as well as CHF exacerbation. He is currently admitted at time of writing.

fatigue, stayed in bed most of day after vaccination and during therapy oxygen sats dropped to 82 % on Room air, needed to start oxygen, HR 101, R 36, mild non productive cough, mild SOB, T 99.5 Oxygen administered at 2 liters from 1/7 at 220 pm til 1/8 0930 off oxygen sats 95%, guaifenisin 5 ml given 1/7/21 at bedtime _history of taking this in evening already GNP updated and ordered labs and CXR and oxygen via email/phone communication Back to baseline 1/8 by mid morning, oxygen off and performing in therapy per prior (1/6 level and has since shown steady improvement in therapy as expected with rehab stay.

Admitted to hospital with sob upon exertion that started prior to vaccine. Hx COPD, HTN, CKD, hyperlipidemia, bladder cancer in remission. Stated he has been taking Eliquis and Xarelto between renal doctor and cardiologist Dr. Anticipating going home 2/5/21 but then turned blue and stopped breathing under a DNR. COVID test negative. Labs show acute on chronic renal failure with an elevated troponin likely from demand ischemia.

Shortness of breath beginning 4 days after vaccination. Pacemaker was checked per wife and it was fine.

Patient received dose 1 of Moderna Vaccine on 1/14/21 administered by pharmacy. Patient was hospitalized on 1/31/21 due to shortness of breath and diminished O2 sats down to 88%. Patient was in atrial fibrillation. Patient discharged from hospital on 2/25/21 to home. Patient received dose 2 of Moderna Vaccine on 2/25/21 prior to discharge from hospital. Last hospital note stated that patient was pleasant and cooperative with good motivation. Patient passed away after discharge from the hospital on 2/26/21. Patient's son called the hospital to report his passing.

-Rapid onset shortness of breath (10-20 minutes after vaccine administration). -Required ICU admission for acute respiratory failure and acute heart failure. -Acute reduction in ejection fraction (EF20-25%) in a patient that otherwise had a normally documented EF (>65%), see below. -Hospital course required BiPAP and dobutamine support and treatment for pulmonary edema with Lasix. -Cardiology consulted for acute heart failure management. Eventual wean of oxygen and dobutamine requirement and discharged on oral heart failure regimen. -Hospital course complicated by ICU delirium. -Total length of hospital stay 8 days

Patient states it started the day of shot with shoulder, arms, hip stiffness and so bad it was very difficult to get around. Presented to ER on 2/21/21 stating he hadn't felt good all week. C/o weakness, dizziness and shortness of breath and pain on right side ribs from coughing. Diagnosis: Pneumonitis, Hypoxia

Increased edema/fluid accumulation to lower extremities, increased dyspnea, requiring supplemental O2 use.

Patient received second dose of Moderna approx 0900. At 9:17 patient's caregiver informed Nurse mother was feeling SOB. Pt assissted to monitoring area and placed per request. AAOx3, difficulty articulating speech r/t CVA, PEG-tube in place. BP 146/71, 63, RR 20. S1S2 present, Lungs clear to auscultation and BS +4 all quads. Hx of Stroke, MI, Emphysema ( O2L @ home HS) and Dysphagia. Pt informed nurse SOA was subsiding, no medications administered. VS prior to D/c home 1134/62, 56, RR18.

Death. Narrative: Patient received Moderna COVID vaccine #1 on 3/3/21. He is noted to be a dialysis patient. On 3/24/21, his wife took him to a facility ER due to intermittent shortness of breath over the previous week. He was admitted for fluid overload. On 3/27/21, he was found unresponsive and CPR was initiated and a code blue was called. He received defibrillation, epinephrine, IV calcium, sodium bicarb and amiodarone and was intubated; however he did not survive and time of death is recorded as 3/27/21 at 0138. No autopsy results available. 24 days from time of vaccine to date of death.

Death Narrative: Patient tested positive for COVID-19 on 1/25/21 after receiving her first vaccine on 1/8/21. He was discharged from hospital on 1/26/21 with admitting diagnosis of COVID pneumonia. He 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 had made it through the COVID infection period but suffered complications including pneumonitis, lung, heart, and kidney failure requiring high flow oxygen. He required readmission to hospital for the complications in 3/2021 but ultimately passed away on 3/24/21 likely due to the multi organ failure complication of COVID

blood clots in his right leg and left leg; Emergency Room at 4am because he had trouble breathing and walking; found blood on both his lungs; chills especially at night that lasted 2 nights; He states he is still in misery; Patient was supposed to get second dose on 04-Mar-2021, but he is not going to get it; shoulder pain/hip pain; Pain in arms, leg; trouble walking due to his pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clots in his right leg and left leg), DYSPNOEA (Emergency Room at 4am because he had trouble breathing and walking), HAEMOPTYSIS (found blood on both his lungs) and CHILLS (chills especially at night that lasted 2 nights) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Asthma since an unknown date. Concomitant products included MONTELUKAST and FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) for Asthma, METOPROLOL and APIXABAN (ELIQUIS) for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced THROMBOSIS (blood clots in his right leg and left leg) (seriousness criteria hospitalization and life threatening), DYSPNOEA (Emergency Room at 4am because he had trouble breathing and walking) (seriousness criterion hospitalization), HAEMOPTYSIS (found blood on both his lungs) (seriousness criteria hospitalization and medically significant), PAIN IN EXTREMITY (Pain in arms, leg), GAIT DISTURBANCE (trouble walking due to his pain) and ARTHRALGIA (shoulder pain/hip pain). On 04-Mar-2021, the patient experienced INTENTIONAL DOSE OMISSION (Patient was supposed to get second dose on 04-Mar-2021, but he is not going to get it). On an unknown date, the patient experienced CHILLS (chills especially at night that lasted 2 nights) (seriousness criterion hospitalization) and FEELING ABNORMAL (He states he is still in misery). The patient was hospitalized on 20-Feb-2021 due to DYSPNOEA, HAEMOPTYSIS and THROMBOSIS, and then for 2 days due to CHILLS. At the time of the report, THROMBOSIS (blood clots in his right leg and left leg), DYSPNOEA (Emergency Room at 4am because he had trouble breathing and walking), HAEMOPTYSIS (found blood on both his lungs), PAIN IN EXTREMITY (Pain in arms, leg), GAIT DISTURBANCE (trouble walking due to his pain), FEELING ABNORMAL (He states he is still in misery) and ARTHRALGIA (shoulder pain/hip pain) had not resolved and CHILLS (chills especially at night that lasted 2 nights) and INTENTIONAL DOSE OMISSION (Patient was supposed to get second dose on 04-Mar-2021, but he is not going to get it) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: (abnormal) Found blood on both of his lungs. On an unknown date, SARS-CoV-2 test: (Negative) Negative. On an unknown date, Ultrasound scan: (abnormal) Found blood clots in his right leg and left leg. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient was taken to the ER (Emergency Room) on 20-Feb-2021 at 4 AM. Several tests including Chest X-Ray, MRI, Blood work, Ultrasound (groin and legs) were performed. Only few tests results were reported. Received treatment including Oxygen, Eliquis and Antibiotics. Patient has been on oxygen full time until 7Apr2021 Company comment: Based on the current available information and temporal association between the use of the product and the start date of these 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 these event, a causal relationship cannot be excluded. Further information has been requested.

Coughing up phlegm with blood present. Started on Antibiotic on March 31. Culture taken on March 31. Antibiotic changed on April 5 or 6 due to culture results. did not feel well and began having breathing problems the evening on April 7. Went to the emergency department on the morning of April 8 and admitted to hospital. Diagnosed with pneumonia. Leased from hospital on April 13

Difficulty to breath, pain in the lungs, patient was rushed to the hospital and after addition, patient goes to cardiac arrest.

He developed acute dyspnea with a drop in pulse ox to 90. Normally not dsyneic, on room air and sats in a good range. Symptoms progressed and he was seen at the ED and ruled out for a PE, MI and antibiotics stopped based on neg proclaimed, imaging, etc Chest CT read as interval progression of ILD and he was seen in consultation by Pulmonary. Additional cardiac workup with TTE with normal EF. Autoimmune/rheum workup was initiated with result to date unremarkable except for positive ANA and mildly positive dsDNA. He was discharge home on continuous O2, not weanable in hospital with follow up with pulmonary and no clear trigger as of discharge for acute change in pulmonary status from usual baseline.

Resident was seen by MD on 1/11/2021 due to increasing in edema and shortness of breath. Lasix 40 mg STAT given. New orders to get a STAT CBC, CMP, and BNP. Resident has been dependent on Oxygen since his diagnosis of COVID-19 on 11/23/2020. Labs were abnormal. Continued on the lasix 40 mgs. Resident remained short of breath with exertion and on oxygen. He was assisted to the toilet on 1/15/2021 in the morning where he subsequently passed away.

The adverse event was a slight tightening of the throat that lasted about 5-10 minutes then dissipated. No further effects evident.

Tested positive for COVID-19; Weakness; Sweating; Shortness of Breath; A spontaneous report was received from a healthcare professional concerning a 89-year-old, male, patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and tested positive for COVID-19, experienced weakness, sweating, and shortness of breath. The patient's medical history included diabetes mellitus, hypertension, hypercholesterolemia, and benign prostatic hyperplasia. Products known to have been used by the patient, within two weeks prior to the event, included metformin, glimepiride, atorvastatin, acetylsalicylic acid, norvastatin, irbesartan, triamterene, finasteride, mirabegron. On 13 Jan 2021, approximately three days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 16 Jan 2021, the patient experienced weakness, sweating, and shortness of breath. On an unknown date, the patient tested positive for COVID-19 and was admitted to the hospital for supervision. Chest x-ray results were negative. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event, tested positive for COVID-19, was considered not resolved. The outcome of the events, weakness, sweating, and shortness of breath, was unknown.; Reporter's Comments: This case concerns a 89 year-old, male patient with history of diabetes mellitus, hypertension, hypercholesterolemia, who experienced events of tested positive for COVID-19, weakness, sweating, and shortness of breath. The events occurred 3 days after the first and last dose of mRNA-1273 vaccine administration. Based on the current limited available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related. However, the patient was positive for COVID and may provide an explanation for the events. Further information have been requested.

2/4/21 Vaccinated at 1:15 pm. At 5:30 pm patient's throat began to swell and he could not hardly swallow water. At 10:00 pm, he noticed that his face was a little numb but proceeded to go to bed. 2/5/21 Patient feels better. He can swallow and eat. Face is not longer numb.

Developed chest pain, severe shortness of breath during the night following the vaccine. NO chest pains were reported for the previous 4 years prior to the vaccine. Was rushed to the hospital. Several tests were completed. Troponins were elevated but no EKG changes. Not able to complete a cardiac Cath d/t pt being too weak. Pt placed on hospice and sent back to facility.

Hospitalized w/Covid symptoms 5 days. Shortness of breath, fatigue , bad taste in back of throat still exist today 02/23/2021

chest pain & weakness Narrative: Pt received his covid vaccine dose #1 on 1/29/2021. On 1/30/2021 he experienced a fever, chest pains and weakness. Pt reported this at his appointment to receive his 2nd dose of covid vaccine on 2/26/2021. Nurse administering vaccine informed pharmacist pt reported he was still feeling weak from the first vaccine dose, so weak he could not perform ADLs without assistance. Pharmacist recommended pt be sent to the ER evaluation, possibly pt has an illness unrelated to the vaccine and another dose may cause worsening of symptoms. Upon further investigation pt was seen at outside hospital ER on day after his dose #1 covid vaccine for chest pain, pleural effusion and weakness and low grade fever. Pt was evaluated and transferred to ER dept. ER gave him morphine iv, magnesium iv, & furosemide 40mg iv. Pt was admitted on 01/31/2021. Pt evaluated by cardiology, internal medicine & given a course of antibiotics. Pt was diagnosed with Chronic Right side pleural effusion, POA. Pt was discharged on 2/3/2021 with the following medication discharge instructions: "SUMMARY OF MEDICATION CHANGES NEW meds: -Start cefdinir 300mg by mouth twice a day for infection - take first dose evening of 2/3/2021 and last dose evening of 2/4/2021 - Start ferrous sulfate (iron) 325mg by mouth every other day - Start pantoprazole 40mg by mouth daily 30 to 60 minutes before breakfast CHANGED meds: -Metoprolol succinate 50mg by mouth daily changed to metoprolol tartrate 12.5mg (=1/2 25mg tablet) by mouth twice a day STOPPED meds: -Stop taking lisinopril until follow-up with your primary care provider -Stop taking omeprazole Of note pt's medical history includes the following comorbidities: *Gastroesophageal reflux disease *Coronary arteriosclerosis *Carotid atherosclerosis *Carcinoma of colon * Colostomy present *Hyperbilirubinemia On 2/26/2021 vaccine dose #2 was held. Pt was encouraged by nurse to follow up with PCP or to report to ER for further evaluation. Pt was given phone # to reschedule dose#2 if appropriate.

Patient received covid vaccine at local health department clinic on 02/25/2021 and presented to this reporters facility ED on 03/01/2021. Patient with multiple comorbidities and newly diagnosed COPD presented after SOB not relieved by new rescue inhaler. Admitted to hospital with pneumonia/sepsis. Treated, improved and discharged to home

Pulmonary Embolism Narrative: Patient was hospitalized with acute pulmonary embolis on 2/12/2021. Was started on Eloquis and discharged on 2/15/2021, with primary diagnosis of acute PE and BLE DVT. Secondary diagnosis of acute systolic heart failure with bilateral pleural effusions. On 2/17 we got notification that patient was placed on hospital.

on 2/27 patient's wife called and stated that he had fatigue, body aches, low grade fever, and poor appetite. on 3/4, patient's wife called and stated he had some shortness of breath and extreme fatigue. on the evening of 3/4, he experienced sharp back pain and shortness of breath and was taken by ambulance to the hospital, where he was diagnosed with CHF exacerbation and NSTEMI and worsening CKD. he developed cardiogenic shock and renal failure. on 3/10 he was started on milrinone, then on 3/11 he went into pulseless VT and expired.

Death Narrative: Pt passed away ~3 weeks after dose 1 of COVID vaccine (Moderna). Daughter was home with pt and after he went to the bathroom she reports pt was out of breath, however that has been chronic/ongoing for him due to his diagnosis of COPD, pulmonary HTN and metastatic lung cancer. After sitting and resting in a chair, she states patient became unresponsive. She called 911 who told her he had no pulse and was not breathing. She states that they were not able to resuscitate him. Pt had been suspected to be positive for COVID as he had symptoms of increased cough, congestion and rhinitis. Daughter (that is primary caregiver and lives in home with patient) tested positive for COVID on 1/31/21. She started having symptoms on 1/25/21. Patient started having symptoms on 1/31/21. No COVID test confirmed prior to pt's death. Patient had a definitive diagnosis of metastatic adenocarcinoma in October 2020. History of multimorbidity. He did have a 60 pack year history of smoking. Most likely cause of death from available records is metastatic lung cancer, with other serious diagnoses contributing.

My father begain feeling chills, anxiety on the evening of March 30th, 2021 following administration of the Moderna vaccine earlier that day. The following day and throughout the week his symptoms continued to worsen including episodes of shortness of breath, anxiety, chills. My mother treated him with tylenol, cool wash cloth. His appetite was decreased but be was able to eat warm soup/broth. My mother contacted his physician approximately 2 days after the episodes began for an appointment but he could not be seen until the following week. On day 6 after the vaccine, April 5, 2021 he complained of significant shortness of breath and anxiety, The following day, April 6, 2021 my mother took him to a local free standing emergency facility where they diagnosed a possible MI. He was then transferred to the local hospital. There he was admitted and diagnosed with heart failure and given fluids/medications. He remains hospitalized as of this submission.

At 15 min after vaccine 1145 asked patient how feeling he said he felt normal but had hesitation when stated. After asking again who he was feeling stated he was "woozy". Wife states he gets dizzy after eating breakfast & had eaten prior to getting to the home. Pt denies other sx. Checked bp 200/80 left arm manual 98F 59 P. Pt alert oreinted, no distress noted. At 1147 pt reports feeling better bp 165/65 P 59 denies dizziness. 1158 pt states feeling slight sob, had mask on & had remove mask. Called EMS for evaluation at 1158. Pt alert oriented x 4, normal even respiration, color normal for race. prior to EMS arrival pt ambulatory with walker to bathroom deneis dizzy. EMS arrived at 1205 Paramedics along with EMT evaluated patient EMS vitals 189/69 100%RA pt states feeling better & refused transport to hospital.

Client reports having "every thing he can think of." Specifically reports SOB, rash from waist up and itching. He has not seen a doctor for this condition. This writer encouraged client to call and make an appointment with his doctor. He agrees. In the last few weeks, client had severe pain in his right hip. He saw a orthopedic physician that did an x-ray and determined it was arthritis.

pt had stated that he noticed his pulmonary fibrosis was exacerbated a couple of weeks after getting his 2nd dose of Moderna mid April. pt stated his breathing has become worse

Moderna COVID19 Vaccine EUA Hospitalization after 1 week history of hyspnea on exertion. Found to have acute saddle pulmonary embolus along with multiple bilateral pulmonary emboli throughout both lungs

Progressively worse muscle and body aches, shortness of breath upon exertion, aggressive behavior, insomnia, confusion,

Fluid in lungs; Lethargic after second vaccine; disoriented/confusion; Dehydration; Death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death), DEHYDRATION (Dehydration), PULMONARY OEDEMA (Fluid in lungs), LETHARGY (Lethargic after second vaccine) and DISORIENTATION (disoriented/confusion) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018821A and 024M20A) for COVID-19 vaccination. Concurrent medical conditions included COPD since 06-Jan-2021. Concomitant products included PREDNISONE from 10-May-2020 to an unknown date for Bullous pemphigoid, ROSUVASTATIN CALCIUM (CRESTOR) and ACETYLSALICYLIC ACID, DIPYRIDAMOLE (AGGRENOX) for an unknown indication. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced DEHYDRATION (Dehydration) (seriousness criterion hospitalization), LETHARGY (Lethargic after second vaccine) (seriousness criterion hospitalization) and DISORIENTATION (disoriented/confusion) (seriousness criterion hospitalization). On an unknown date, the patient experienced PULMONARY OEDEMA (Fluid in lungs) (seriousness criteria hospitalization and medically significant). The patient died on 26-Jun-2021. The cause of death was not reported. An autopsy was not performed. At the time of death, DEHYDRATION (Dehydration), LETHARGY (Lethargic after second vaccine) and DISORIENTATION (disoriented/confusion) had resolved and PULMONARY OEDEMA (Fluid in lungs) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. After 2nd vaccine 09-apr-2021, 36 hrs later (name) Lethargic, Disorientated ems to hospital. Some dehydration, fluids, than he has fluid in lungs. 8 days hospital. Never the some after discharged 4/19/21. (name) declined until his DEATH on 26-Jun-2021. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-042828 (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.; Reported Cause(s) of Death: Unknown cause of death