Moderna

10:10 am received Moderna vaccine; observation time 30 min due to previous allergies stated (shrimp-throat closure); 10:37 am RN was observing/talking to pt & mid-sentence pt. reported "I'm feeling funny." Resident's eyes appeared glazed over and she reported "feeing out of it. Like I'm in another world." Resident unable to provide any further specific descriptions of how she felt. Resident's radial pulse felt regular. No loss of consciousness. Resident remained in seated position. 10:39 am Resident reported no improvement & stated, "I feel week". Rn paged for assistance. 10:45 am another staff member arrived with bp cuff. L upper arm blood pressure was 136/72. Heart rate remains regular. Lungs sounded clear. Resident was able to drink a 1/2 glass of orange juice. 10:49 Resident reported feeling " a little better." 10:51 am We noted resident's face appeared flush. No baseline observation of what her cheeks looked like prior to vaccination due to mask, but questionable mild facial swelling present. 10:53 asked resident if she was able to swallow normally. Resident wasn't sure, so RN asked if she felt like she had a lump in her throat or like she needed to clear her throat, but couldn't and she confirmed that her throat felt different than normal. 10:55 am Epi pen administered to L outer thigh by RN. Call placed to EMS. Discussed expected side effects of Epi administration. 10:57 am Resident started to feel anxious and visible shaking present. 11:05 am Resident reported felling slightly better, perked up a bit. 11:08am EMS arrived. 11:10 Ambulance crew arrived. Resident was able to walk to stretcher with assist of 1. 11:17 am Ambulance left with resident. Resident was still reporting "feeling weak".

Staff reported low blood pressure reading. Patient admitted into ER with Dx Hypotension and given IV fluids. Pt later discharged back to home.

Pt started complaining of chest heaviness and shortness of breath on the afternoon of 1/21/21. EMS was called to the patients home and she was found to have an O2 sat in the 70's. She was admitted to hospital and found to have a proBNP of 5000. She tested negative for Covid-19. She was determined to be in acute-on-chronic heart failure and was referred for hospice care. She passed away on the evening of 1/24/21.

Thursday - day of shot after dinner she began to not feel good. Her stomach was upset & vomiting, increased mucus, and a slight headache we gave her Compazine suppository and she went to bed. Said she rested well that night. Friday all day her stomach was upset but was able keep down tea/toast and have some broth. Friday Night/Saturday Early AM she became mentally unstable, confused and knew she was confused, felt like she was going to die, had a hard time breathing, her chest was tight and had shortness of breath. Later that morning she was weak, shaking, vomiting. After a good bowel movement and a 4-hour nap she started to feel better. 1/28/21 PCP Televisit - reaction do not take 2nd sho

Positive Covid case investigation with the PA DOH. Spoke with case's daughter. States her mother recieved vaccine at clinic on 01/27/21. Had no complaints of illness or exposure to a positive case prior to vaccine. Daughter states she's independent and stays alone at night. Felt fine the day and the day after of the vaccine. Per daughter, case's last known well time was Friday 1/29/21 at 730pm. Daughter states they found her Saturday morning with stroke like symptoms and was admitted to Hospital step down unit. She was also informed by the doctor that her heart was irregular with atrial fibrillation.

Pt. received vaccine in AM. Reported feeling 'tired' and 'having trouble breathing'. Brought to ED by ambulance @ 1805hrs.. Per ED report, had mild tachypnea upon initial evaluation, HR 80, RR26, B/P 137/105, O2 sat 99% on room air.

left arm pain and Malaise immediately after, followed by sweling in both feet and purple discoloration in feet that resolved spontaenously over the next 4 days. Erythema and swelling to bilateral upper arms with associated skin tenderness, Malaise / intense fatigue both not yet resolved at time of this writing on 2/3/2021.

11 days post vaccination, warmth, erythema diffusely over R arm 10 x 4 cm, diffuse margins c/w cellulitis, no f/c . presented b/c palpitations

Shortly after receiving the Moderna COVID-19 vaccine, patient complained of chest and stomach pain, then became very sleepy and fainted. RN was unable to obtain a manual BP; Apical pulse 36. Pulse Ox in the 70s. She was placed in bed and eventually regained consciousness. Her pulse ox improved to the 90s. BP 92/55. Her only complaint was that her hands were cold. Medical Director believes it was vasovagal syncopy due to receiving the vaccine. Patient died on 1/28/2021, due to progressive dementia.

Patient family had been noticing onset confusion for a few weeks prior to vaccine and event. Patient was taken to ED when found unconscious and died of a subdural hemorrhage a few days after vaccine clinic at retirement home.

Patient awoke on 2/12/21 with altered mental status, confusion, respiratory distress, was taken to hospital by ambulance. Per ED notes from ED attending Pt presented with hypotension and respiratory distress. DNR status, patient given comfort measures and passed away in ED at 11:24 am on 2/12/21.

Client had pressed her call pendant this morning (2/18/2021) at 0750, LPN found client in her bed unable to stand. Client reported she had to use the restroom, upon standing client, LPN noticed blood on client's pillow. After assisting with ambulation to her bathroom, LPN noticed blood covering the floor near her shower. After further assessment, blood appeared to me coming from the back of client's head. Vital signs assessed while she sits on the toilet. BP: 128/92 O2: 89% on RA RR: 18 HR: 69 T: 99.1 Client reported significant dizziness, lightheadedness, and nausea. She reported unsteadiness when standing. Quarter sized lump with dried blood noted on the back of client's head. She does report left arm soreness, likely from where vaccine was administered. Ambulance was contacted while LPN assisted dressing client. Client was unable to recall the incident that occurred overnight, she did not utilize her call pendant during initial fall. Time of fall/incident unknown.

Patient presented with hematochezia and bright red blood per rectum. Platelets were severely down to 1k. This was about 2 weeks after receiving the moderna COVID-19 vaccine first dose. Patient also with extensive ecchymosis on upper extremities and petechial rash on legs. Concern for ITP related to the drug. Patient received IVIg, Platelet transfussion, and steroids. Platelets slowly increasing, patient received NPLATE. The patient remains hospitalized with platelets up trending from 1--- >4--- >6--- >5--- >9--- >11.

Patient says she felt well after getting the vaccine, but shortly before midnight the same day started feeling fatigue, body pain all over. Next day pain was improved; only remaining jaw pain and fatigue; then the day after pain resolved but persistent fatigue and SOB since then (for 13 days now). Severe dyspnea on exertion; baseline able to walk more than 5 minutes before getting tired; over last 13 days unable to walk from one room to another without severe SOB> Had a ride today so came to urgent care for evaluation. Patient found to be in atrial fibrillation with rapid ventricular rate at 140

arrhythmias; rapid heartbeat; slight nausea; slight headache; light bothered vision for some days; mild chills; A spontaneous report was received from a retired nurse concerning herself who is 90 year old received Moderna COVID-19 vaccine and have experienced arrhythmias, rapid heartbeat, slight nausea, slight headache, some visual problems (light bothered her for some days) and mild chills. The patient has prior history of irregular heart beat . Her relevant concomitant medications were cholesterol medication, Crestor and medication for irregular heartbeat. No information on allergies. On 28-JAN-2021, prior to the onset of events, the patient received her first of two planned doses of COVID-19 vaccine intramuscularly for the prophylaxis of COVID-19 infection. On 30-JAN-2021, 2 days after her vaccination, she developed arrhythmias, rapid heartbeat, slight nausea, slight headache, some visual problems (light bothered her for some days) and mild chills. After one week she felt like no more symptoms ongoing and felt good again. She visited her physician for arrhythmias, and he said, she should keep an eye on it, but no medication yet. She is concerned about her second shot. Action taken with 2nd dose of Moderna COVID-19 vaccine was not reported. The outcome of the events, arrhythmias, rapid heartbeat, slight nausea, slight headache, visual problems and chills were resolved at the time of report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. However, patient's advanced age and prior history of irregular heart beat are considered risk factors for arrhythmias.

Patient was admitted in observation after receiving her second dose vaccine at 11:20am, patient was standing up , and nurse went over to pt, pt complaint of chest tightness (mid sternum) at 11:34am. Patient denies pain, and sat back down, vital signs were taken, patient was alerted oriented x 4. Patient stated she did not take her 10 cardiac medications this morning in fear that her meds will interfere. Patient states pressure is lessening, states feels better, denies sternal pressure/ tightness. Patient was encouraged to take prescribed medications, asked to go to ER for EKG and cardiac enzymes. Patient states she would rather call the cardiologist and make an appointment. patient's friend was here, Vitals taken again, continued monitoring.Patient signed Against Medical Advice form. Patient felt better released with friend at 12:10pm, Patient did not want to give name of her friend. Patients states she has a cardiac workup needed for surgery.

2/12 Patient presented with palpitations, sensation of heat with no chest pain. Of note patient had covid diagnosed 11/20. Work up showed saddle PE and had SVT treated with adenonsine. Treated with IV heparin. Patient on 2L O2 weaned to room air before discharge. Patient transferred to CIRS 2/17. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine.

Patient is currently inpatient at Hospital with atrial fibrillation. She woke up with chest pain on 3.16.21 at 4am with chest pain. She was taken by ambulance to the hospital where she was admitted. She is on heparin and has recieved an EKG, ECHO, and blood work. The medical team is evaluating next steps. Chest pain has not resided.

On Saturday morning, Mar 6th had erratic racing heart beat and high to very low blood pressure, 168/ , low 88/51, afib, unsteady, lightheaded, hot and chilled, headache, very weak. On 8:10am Sunday, heart beat ranged from 50 to 125 bpm, blood pressure dropped to 90/64. Doctor took me off all meds except Xarelto, said stay in bed, drink lots of fluids. I did not connect the symtoms to the vaccine at the time because problems happened after the 1st few hours, and I was too sick to think clearly. It was only when I read the side effects after 1-3 days, that I realized it could be from the vaccine. I worry about being deathly sick after the second vaccine shot, so I'm reporting this.

TIA diagnosis at hospital; Conscious after fall; Dizzy/ lightheadedness; Head bump (temple area and ear caused by hit sink during fall); A spontaneous report was received from a consumer who was also a 90-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced transient ischemic attack, fall, dizzy lightheadedness, and a head bump. The patient's medical history, as provided by the reporter, included transient ischemic attack; the patient experienced 3 events in 2020. No relevant concomitant medications were reported. On 23 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number 030L20A) intramuscularly for prophylaxis of COVID-19 infection. On 25 Jan 2021, the patient experienced dizzy lightheadedness and a fall, resulting in a head bump in her temple and ear caused by hitting the sink as she fell. The patient was hospitalized following the fall and diagnosed with transient ischemic attack. On 26 Jan 2021, the patient received magnetic resonance imaging and a laboratory test. On 27 Jan 2021, the lightheadedness and head bump had resolved. Action taken with mRNA-1273 in response to the event(s) was not reported. The outcome of the events, transient ischemic attack and fall, was considered resolved on 25 Jan 2021. The outcome of the events, lightheadedness and head bump, was considered resolved on 27 Jan 2021.; Reporter's Comments: This case concerns a 90-years-old female patient with a relevant medical history of three TIA within last year, who experienced a serious unexpected event of Dizziness and Transient ischaemic attack and non-serious unexpected events of Fall and Head injury. The events of occurred approximately 2 days after first dose of mRNA-1273, lot # 030L20A. Treatment details were not provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded. However, patient's advanced age and prior history of TIA are considered significant confounders.

Dyspnea, chest pressure, fatigue. Sought care at the hospital/ED -- found to have acute pulmonary emboli (by CT) with hypoxic respiratory failure. Treated with hospitalization, Xarelto, nasal canula oxygen. She improved to be stable on room air with improvement of her symptoms and went home after 3 days.

Diagnosis of ITP (immune thrombocytopenic purpura); Spontaneous rectal bleeding; Little bit of soreness; A spontaneous report was received from a consumer concerning reporter's mother a 90-year-old, female patient, who was diagnosed ITP (immune thrombocytopenic purpura)/immune thrombocytopenia, body's immune system attacking its own immune system/autoimmune disorder, spontaneous rectal bleeding/rectal haemorrhage, platelets abnormal/platelet disorder and little bit of soreness/pain. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 05 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) via an unknown route in the left arm for prophylaxis of COVID-19 infection. On 13 Feb 2021, patient's blood platelets were zero which was considered as life threatening event. On 13 Feb 2021 Saturday, patient had spontaneous rectal bleeding for which patient was taken to emergency room and admitted to ICU. Then patient was transferred to another hospital where patient was diagnosis of ITP (immune thrombocytopenic purpura) where body's immune system attacking its own immune system. The patient was seen by hematologist for 8 days. After vaccination the patient felt little bit of soreness, but patient was completely fine. The patient had three platelet counts one on 13 Feb 2021, in which showed a result of zero platelet, on 22FEB2021 platelet count increased to 57 and unknown date patient platelet count was 357. The patient also had tested for leukemia, blood cancers, and other blood work came normal. Treatment for the event included two Blood transfusions, IV steroids, Oral steroids maximum dose, Rituxan, N-platelet injections nonspecific. Action taken with mRNA-1273 in response to the events was not provided. The events, ITP (immune thrombocytopenic purpura), body's immune system attacking its own immune system, spontaneous rectal bleeding, platelets abnormal and little bit of soreness, were considered recovering on the time of reporting.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: MOD-2021-047223:Crosslinked case

Started in her back and goes across her back, shoots down the middle of her back and both sides. Front in the ribs and around the breast - chest pains. Exhausted - energy is gone. Can't do normal activities that she was able to do prior to vaccine. Sharp pains. When I breath or cough/sneeze or laugh it hurts. Had some relief from heat and cold packs. Left knee has hurt a lot since this happened, too.

Patient started with chest pain on 02/28/2021 and subsequently went to the hospital on 03/01/2021 and was diagnosed with a STEMI.

She was taken to the hospital for respiratory distress, she was turning purple. She dies arriving at the hospital.

On 3/31/2021, it was noticed that she was jaundiced. Labs were drawn which confirmed jaundice (bilirubin of 4.4 - unconjugated) due to a new Hemolytic Anemia (HGB 9.3). The HGB was 11.7 on 2/28/2021.

On 1/21/2021 Caregivers proceed to go on rounds taking vitals and found she was with low blood pressure. They call Hospice and they certify that she had passed away.

This was the Johnson and Johnson one shot. My mother received it and today is in the hospital with acculsive blockage in left brain, paralyzed from stroke and is being operated on. I believe it is a blockage from the vaccine. She was old but extremely cognizant, independent, healthy, strong of sound mind. This is why I am reporting it. If she dies I will report again.

One week after second Moderna shot, patient began low-grade fever, loss of appetite, foggy thinking, fatigue, general malaise. She was treated with three different meds for a possible UTI. All symptoms except fever continued for 10 days, and on March 25, she suffered a TIA. She went to the ER and stayed in the hospital for 36 hours. MRI showed no lasting damage. She is improving but is still fatigued.

patient reported to office on 1/26/21 complaining of SOB with lying down. Pain at sternum/shoulders/neck. She felt like she was being squeezed.

one week after 1st vaccine shot, mom started to feel sick around lunch. Took mom to hospital she had a heart attack. They dissolved the blood clot and found out she also had pneumonia with no symptoms. She died 2 weeks later. She had dementia but health was fine until she received the covid 19 vaccine.

Daughter reports vaccination was received on 5/21. On the morning of 5/22, patient began to develop fever (>100.0), bilateral leg swelling, and palpitations. She reports an episode of tachycardia up to HR 140's, but states she was most likely febrile but was unsure. She reports that at baseline she is confused but reports she was more disoriented than usual. She states that the patient was experiencing more DOE. Of note, she has hx of COPD and is on 2L NC at baseline. Per daughter, leg swelling and palpitations began to resolve after fever resolved -- now improved but still has more DOE. Also reports some mild suprapubic discomfort. No N/V/D.

Weaknesses. Dizziness. Headaches. Blurry vision both eyes. Sleepiness. Strokes. Hospitalization. Death

Pt had her 2nd Moderna vaccine on 3/18/21. She was brought to the ER on 5/25/21 c/o nausea and vomiting and abdominal pain and not feeling well. work up at the time was negative. she was thought to possibly have a UTI and sent home on antibiotics. urine culture from that visit was ultimately negative for infection/growth. She retuned to the ER on 6/1/21 c/o weakness, confusion and new shortness of breath. Her temp was 99.5, chest x ray showed extensive bilateral patchy opacities. head CT was neg. Her wbc was 14.4 with left neutrophilic shift, lactic acidosis of 2.1 and dehydration. She was admitted with sepsis and possible pneumonia. She was started on ivf and antibiotics and admitted. She was also started on oxygen for new hypoxia of 81%. CT chest showed interstitial pulmonary edema, interstitial pneumonia. echo showed normal LVEF and grade 2 diastolic dysfunction with severely dilated left atrium. Her wbc returned to normal and her shortness of breath improved. She was started on lasix 10mg qod. Previous chest x rays showed no interstitial disease. Covid 19 testing negative.

Pt was admitted on 6/15/21 with c/o sudden palpitations and was admitted with rapid atrial fibrillation and an NSTEMI. Her rate was difficult to control despite increasing her metoprolol to 100mg/d so diltiazem was added. Her rate was better controlled and she was discharged home on 6/22/21 to follow up with cardiology.

ADR: decreased HR, decreased BP, and Altered mental status Treatment: Benadryl and EPI Pen Outcome: Resident was not transferred and remains in facility

Resident became lethargic and reports of blood coming from resident's nose and mouth on the morning of 1/13/21. Resident went out to ER for eval, and came back to facility with dx of pneumonia and recommendations for resident to be placed on hospice. Resident deceased on 1/14/21. Unknown if vaccine related, but with timeline of events I was advised to report this per medical director of facility, as well as Pharmacy who administered the vaccine.

FIRST THING WHEN GETTING UP IN THE MORNING, FELT DIZZY, NAUSEA AND VOMITED 3-4 TIMES, Increase in Blood Pressure; Treated with Phenergan for N & V; and rest, fluids. Lasted just this day, but wasn't back to normal for 2 days.

Patient had no symptoms or adverse events until the next evening after shot (1/29/21) where daughter reported her having heart palpitations. Family told her to rest and did not seek medical attention. Saturday afternoon (1/30/2021), patient started experiencing labored breathing. Daughter called 911 and before the ambulance arrived, the patient's breathing became more and more shallow. Patient was taken to the local hospital and passed away Saturday evening around 5:30 pm.

Patient experienced weakness; BP 159/91, HR 102. Gave water - patient did not take BP medications. After water, patient felt better, and was safe for home discharge. MD speculated about vasovagal reaction.

The patient came to the Emergency Room at approx 3:30 am on 02/03/2021 with pain in right arm (same arm the COVID vaccine had been administered in approx 12 hours earlier) and feeling generally unwell. Patient was concerned about possibility of gout flare or that something was wrong with her arm. Elevated blood pressure was noted; this was attributed to anxiety. She was evaluated, given 500 mg Tylenol, and discharged since the pain was decreasing and blood pressure was stabilized. Patient instructed to follow-up with physician. The next day, on 02/04/2021, the patient arrived at the Emergency Room by ambulance; cardiac arrest was the chief complaint. The patient's daughter stated the patient had been "feeling generally poor and then suddenly collapsed." Daughter described "gurgling respirations" and being unresponsive. 911 was called, police arrived within 5 minutes and initiated CPR. Epinephrine, atropine, lidocaine and bicarb administered after arrival to Emergency Room. Shockable rhythm never demonstrated. Patient never recovered spontaneous respiration or movement. The death was called at 23:04. Coronary artery disease with cardiac arrest is the cause from the ER records; the coroner is putting COVID-19 vaccination in Part 1 of the death certificate.

vaccine given at 1532, symptoms started about 1545, client started coughing, said she felt funny, felt faint, pale, skin to touch was very cold, she said she was cold, BP 182/94, Resp 28, O2 99% on room air, HR 64, she was short of breath, was not tracking, would stare off looking at the ceiling, at 1552 0.5mg Epinephrine was given IM, EMS was called at 1553, EMS arrived at 1558, no relief in with the Epi, left via ambulance at 1605

91 YEAR OLD FEMALE FELT TINGLING AND NUMBNESS IN BOTH HER LEGS AFTER RECEIVING THE VACCINE. ON SITE EMS RESPONDED. BP 180/90. SHE STATED THAT SHE DID NOT TAKE HER MEDICATIONS THIS MORNING. IT WAS RECOMMENDED FOR HER TO GO TO HOSPITAL FOR FURTHER EVAL AND SHE REFUSED. SHE WILL GO TO E.R IF SYMPTOMS PERSIST BUT FOR NOW, SHE WILL GO HOME HAVE BREAKFAST AND TAKE HER MEDICATIONS.

Blood Pressure did not decrease significantly post medication; Blood Pressure increased to 224; Pain (Grade 8 out of 10) under breast line, chest and across the back shoulder blades; Intestine blockage; Constipation Continued (Initiated 3 days prior to Vaccination); A spontaneous report was received from a consumer concerning a 91-year-old, female patient who developed Pain (Grade 8 out of 10) under breast line, chest and across the back shoulder blades, Constipation Continued (Initiated 3 days prior to Vaccination), Blood Pressure increased to 224, Blood Pressure Did not decrease significantly post medication, Intestine blockage, and Reduced Pain (Grade 4 out of 10 now) post Bowel Movement. The patient's medical history included constipation. Concomitant product use was not provided by the reporter. On 28JAN2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number:031L20A) intramuscularly in the upper arm for prophylaxis of COVID-19 infection. On 28JAN2021 patient received the first dose of Moderna COVID-19 vaccine. For three days prior to vaccination patient was constipated and did not have a Bowel Movement at all. After the vaccination patient had pain (Grade 8 out of 10) under breast line, chest and across the back-shoulder blades. The evening of 28JAN2021 she visited the Emergency Room because of the pain. ER nurse reported patient Blood Pressure went up to 224 and was very high. Patient was treated with BP medication, but BP did not change significantly. This led to patient being admitted to the hospital at for overnight for observations. All tests were negative. She was diagnosed as "Intestines were blocked". She was released on 29JAN2021. She had a BM 6 days later on 03FEB2021. The pain is better (Grade 4 out of 10 now). The outcome of the events was unknown; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.

After correct administration of the shot, patient described feeling "funny" almost immediately after shot. Felt she had pressure in chest, throat closing up, heart racing. Administered a dose of epinephrine to the IM thigh, roughly 5 minutes after administration of vaccine. Patient reported feeling better, advised her to seek medical attention at an emergency room to follow-up. She was driven there and PCP contacted by caretaker, who was present.

The caregivers in their rounds indicates that resident was well, ate his meals and her vitals were taken. In their next 7:30 pm rounds they find that the resident was not breathing. Home physician certifies death as Congestive Heart Failure.

As reported by son and by DON of Medical Center: 02.06.2021 Son reports that patient had spoken with her daughter the morning of 02.06 via phone and that patient sounded fine. Patient's son tried to call her around 3:30 or 4 and there was no answer. Son called the facility where patient resided and staff went to check on her, where they found patient on the floor, conscious. Patient was communicating fine when they found her. It is unclear if she bumped her head when she fell, but patient deteriorated and was taken to ER where a CT was done and it was determined patient had a brain bleed as well as a UTI. Patient was admitted to hospital. Patient subsequently had a stroke while in hospital. Patient was discharged to rehab facility on 02.23.2021 and while she has regained the ability to walk with a walker and some use of her right hand, she remains unable to speak.

She found passed out on the floor by a friend. The ambulance was called. She was hospitalized for 24 hours and treated for dehydration. She had fever and diarrhea.

About 20 minutes after the vaccine was administered my Mother's speech became garbled and she was unable to speak understandably. I thought she was having a stroke so rushed her to the emergency room. They examined her and her speech returned to normal in about an hour. They kept her overnight for tests and after an MRI they said she had a TIA. We wanted to report it in case there were others who had a similar adverse affect. No one can say for sure if the vaccine caused it or not but we wanted to let you know what happened to her.

-Right closed, same side as vaccine -Right side of neck distended and stiffness, same side as vaccine Symptoms relieved within 12hours Patients physician consulted, recommended if family felt uncomfortable receiving 2nd dose, avoid

Morning after receiving vaccine patient experienced transient near syncope. Was non-responsive for up to a minute. Needed to be held up in her seat. Paramedics were called and found her BP and pulse normal and normal neurologic exam. Was transported to ED and had clinical evaluation and was released to home having fully recovered even prior to arrival in ED.

Systemic: blood clots-Medium, Systemic: Nausea-Medium, Systemic: Neurological Disorder (diagnosed by MD)-Medium, Systemic: Stroke-Severe

Had a TIA on day #11 after her second Moderna vaccine. Never had a TIA before. She was hospitalized for further evaluation. Could be a coincidence but I feel this should be documented and considered for review as a possible risk of the vaccine

VIIS ID: 7827510; Moderna COVID-19 Vaccine Vaccine Lot Number: 025B21A second dose. Vax clinic. Pt received vaccine in vehicle-unable to walk inside-family member stated that about 10mins after vaccine she began nodding off and was difficult to wake. 16:10: 123/80 POX 80% CPR not indicated. EMS On-site. S/S hypoxia, altered mental consciousness, unresponsive then alert. Family stated that she has been exhibiting similar symptoms recently-today is a 'bad day'. Son stated that it has been a difficult day for her. She has had to stop to "catch her breath' numerous times. "nods off' frequently. Assessment completed by EMS; transported to Hospital (doctors).

Facility manager informed us that patient had a seizure on 3/17/21, which was 2 days after the vaccine was given (3/15/21) which then lead to a stroke. Patient passed died on 3/17/21.

Balance disorder; Fall; hurt her arm; Bleeding; Blurry vision; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bleeding) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below. The patient's past medical history was not reported On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 05-Apr-2021, the patient experienced blurry vision, lost her balance and fell very hard and was bleeding everywhere and hurt her arm. The patient experienced HAEMORRHAGE (Bleeding) (seriousness criterion medically significant), VISION BLURRED (Blurry vision), FALL (Fall) and PAIN IN EXTREMITY (hurt her arm). On an unknown date, the patient experienced BALANCE DISORDER (Balance disorder). At the time of the report, HAEMORRHAGE (Bleeding), VISION BLURRED (Blurry vision), BALANCE DISORDER (Balance disorder), FALL (Fall) and PAIN IN EXTREMITY (hurt her arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant were given No lab details was provided. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2021-068245 (E2B Linked Report).; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-068245:Husband case

48 days post first vaccine and has not received the second dose; Weak; Underweight; Nausea; Dry Heaving; Upper Respiratory Infection; Fainted; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant) and CHILLS (Chills). On 16-Mar-2021, the patient experienced UPPER RESPIRATORY TRACT INFECTION (Upper Respiratory Infection), DYSPNOEA (Dry Heaving) and NAUSEA (Nausea). On 12-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (48 days post first vaccine and has not received the second dose), ASTHENIA (Weak) and UNDERWEIGHT (Underweight). On 23-Feb-2021, SYNCOPE (Fainted) had resolved. On 28-Feb-2021, CHILLS (Chills) had resolved. On 06-Apr-2021, UPPER RESPIRATORY TRACT INFECTION (Upper Respiratory Infection) had resolved. On 12-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (48 days post first vaccine and has not received the second dose) had resolved. At the time of the report, DYSPNOEA (Dry Heaving), ASTHENIA (Weak), UNDERWEIGHT (Underweight) and NAUSEA (Nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. She reported that she Fainted, and had chills, after the first vaccine. About 2-3 weeks after Vaccination she had an Upper Respiratory Infection with Negative COVID Test. She had Nausea, and Dry heaving since then. She feels Weak and Underweight. Today 12APR2021 and 48 days post first vaccine, She has not recovered from her upper respiratory infection. MD and Cardiologist told her to get the second vaccine. She wants to receive the second vaccine but she would like to delay it more, until she feels 100% well. Patient had a pneumonia shot and Flu shot SEP2020.; Sender's Comments: This case concerns a 92-year-old female with a serious unexpected event of syncope, and nonserious unexpected upper respiratory tract infection, dyspnea, asthenia, underweight, inappropriate schedule of product administration and expected chills, nausea. Event onset the same day as first dose mRNA-1273. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

extreme pain in her chest and abdomen on the R side of her body (around the heart); had very high blood pressure; The vaccine worsened her constipation problems; legs, feet, and ankles are swollen and sore; legs, feet, and ankles are swollen and sore; legs, feet, and ankles are swollen and sore; legs, feet, and ankles are swollen and sore; Dehydration; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLOOD PRESSURE INCREASED (had very high blood pressure) and CHEST PAIN (extreme pain in her chest and abdomen on the R side of her body (around the heart)) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hypertension. Concurrent medical conditions included Constipation. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced BLOOD PRESSURE INCREASED (had very high blood pressure) (seriousness criterion hospitalization prolonged) and DEHYDRATION (Dehydration). On 29-Mar-2021, the patient experienced CHEST PAIN (extreme pain in her chest and abdomen on the R side of her body (around the heart)) (seriousness criterion hospitalization). On 20-Apr-2021, the patient experienced JOINT SWELLING (legs, feet, and ankles are swollen and sore), PERIPHERAL SWELLING (legs, feet, and ankles are swollen and sore), PAIN IN EXTREMITY (legs, feet, and ankles are swollen and sore) and ARTHRALGIA (legs, feet, and ankles are swollen and sore). On an unknown date, the patient experienced CONSTIPATION (The vaccine worsened her constipation problems). The patient was hospitalized on 29-Mar-2021 due to BLOOD PRESSURE INCREASED and CHEST PAIN. At the time of the report, BLOOD PRESSURE INCREASED (had very high blood pressure), CHEST PAIN (extreme pain in her chest and abdomen on the R side of her body (around the heart)) and DEHYDRATION (Dehydration) had resolved and JOINT SWELLING (legs, feet, and ankles are swollen and sore), PERIPHERAL SWELLING (legs, feet, and ankles are swollen and sore), PAIN IN EXTREMITY (legs, feet, and ankles are swollen and sore), CONSTIPATION (The vaccine worsened her constipation problems) and ARTHRALGIA (legs, feet, and ankles are swollen and sore) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Blood pressure measurement: 217/157 (High) 217/157. Concomitant medications include Vault to treat constipation. Treatment included amlodipine tablets. 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.

91 year old female was sitting across the table from her husband while eating lunch when she passed out. She had slurred speech. 911 was called. She was taken to the ER and was diagnose with acute stroke. Her symptoms subsided on presentation to the ER. She was started on Plavix. Had negagive carotid duplex. MRI brain showed suspected subtle nonhemorrhagic punctuate left frontal lobe, Cortical 2-3mm acute -subacute vascular insult vs image artifact.

Son states that on February 7th his mother developed shingles. On February 12th developed Bell's Palsy. On May 15th at 9:00 PM his mother had a heart attack. Is recovering at healthcare facility.

Low platelet count (109) and serious bleeding on both legs under the skin Was told to stop taking baby aspirin until another platelet test for 05/23/2021 to see if her platelets have risen. If not, will be admitted to hospital. Attaching a photo of her legs.

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was acute respiratory failure with hypoxia and acute diastolic heart failure.

Systemic: Fainting / Unresponsive-Severe, Additional Details: Pt fell out of chair, bleeding from bridge of nose according to paramedics. Took her to the Hospital, left message for pt at only working number provided (family member), no response.

5/10/2021 Patient died. 5/3/2021 Patient is a 91 y.o. female with a history of afib, PE/DVT, hypothyroidism, GERD, htn, colon resection 206 and HTN who presented to the ED with AMS and difficulty breathing. Patient unresponsive in the ED and was intubated for airway protection. CTA chest with extensive acute pulmonary embolism with findings of right heart strain. Patient intubated and sedated, information is obtained from her son, medical staff and medical records. Patient was hospitalized with Covid 2 weeks ago, following discharge she seemed to slowly be improving until Saturday prior to admission Per son was more tired but she had worked with physical therapy and HH on Friday. Sunday she was having difficulty breathing and was brought to the hospital. 4/17/2021 Altered mental status, unspecified altered mental status type; Pneumonia of left lower lobe due to infectious organism; Atrial fibrillation with rapid ventricular response (HCC); Acute pulmonary embolism without acute cor pulmonale, unspecified pulmonary embolism type (HCC); Acute hypoxemic respiratory failure (HCC); Chronic respiratory failure with hypoxia (HCC); Pressure injury of sacral region, stage 3 (HCC); SOB (shortness of breath); Palliative care encounter; Shock (HCC); Chronic atrial fibrillation (HCC); Acute respiratory failure with hypoxia and hypercapnia (HCC)

Afib; edema; Muscle Spasm; Burning Sensation from upper extremity to lower extremity; Swelling below her knee; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Afib) and OEDEMA (edema) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced ATRIAL FIBRILLATION (Afib) (seriousness criteria hospitalization and medically significant), OEDEMA (edema) (seriousness criterion hospitalization), MUSCLE SPASMS (Muscle Spasm), BURNING SENSATION (Burning Sensation from upper extremity to lower extremity) and PERIPHERAL SWELLING (Swelling below her knee). At the time of the report, ATRIAL FIBRILLATION (Afib), OEDEMA (edema), MUSCLE SPASMS (Muscle Spasm), BURNING SENSATION (Burning Sensation from upper extremity to lower extremity), PERIPHERAL SWELLING (Swelling below her knee) and PAIN IN EXTREMITY (Sore arm) outcome was unknown. Concomitant medication information was not provided. Treatment medication information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. Patient reported that she was in hospital due to edema and A-fib. Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Case upgraded to serious, new events added, corrected email 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.

The day after vaccination EMS was called to the patients home EMS States: Pt had right sided gaze noted possibly for the past 2 days. upon EMS arrival pt had tonic clonic seizure activity x3, family denies history of seizures. 12 lead EKG showed afib RVR. Pt was stoke activated and transported to the hospital.

Day 8 following 2nd Moderna vaccine shot, patient began experiencing heaviness, dull pain in chest. She layed down which seemed to help alleviate the chest issues. Day 10 after receiving the second Moderna shot, patient died suddenly while sitting in her recliner of cardiac arrest. There were no symptom s leading up to the event.

blood pressure became very low; experienced cellulitis in her legs; Diagnosed with COVID a week later; she couldn't even remember anybody; acute Alzheimers; had mild dementia but towards the end it seemed to have exacerbated; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA ALZHEIMER'S TYPE (acute Alzheimers), DEMENTIA (had mild dementia but towards the end it seemed to have exacerbated), HYPOTENSION (blood pressure became very low) and CELLULITIS (experienced cellulitis in her legs) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Dementia. In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DEMENTIA ALZHEIMER'S TYPE (acute Alzheimers) (seriousness criteria death and medically significant), DEMENTIA (had mild dementia but towards the end it seemed to have exacerbated) (seriousness criterion medically significant), HYPOTENSION (blood pressure became very low) (seriousness criterion hospitalization), CELLULITIS (experienced cellulitis in her legs) (seriousness criterion medically significant), COVID-19 (Diagnosed with COVID a week later) and MEMORY IMPAIRMENT (she couldn't even remember anybody). The patient died on an unknown date. The reported cause of death was death was acute alzheimers. It is unknown if an autopsy was performed. At the time of death, DEMENTIA (had mild dementia but towards the end it seemed to have exacerbated), CELLULITIS (experienced cellulitis in her legs), COVID-19 (Diagnosed with COVID a week later) and MEMORY IMPAIRMENT (she couldn't even remember anybody) outcome was unknown and HYPOTENSION (blood pressure became very low) had resolved. Treatment included unspecified pressors. No concomitant medications were reported. Patient received the 1st dose of the Moderna COVID-19 vaccine in FEB-2021. Caller did not know the exact dates of administration of the two doses. Patient was then diagnosed with COVID a week later. Patient did not have much of a reaction to the 1st dose or any symptoms from COVID. She then received her 2nd dose of the Moderna COVID-19 vaccine in middle of FEB-2021, per the caller. In the end of APR-2021 or beginning of MAY-2021, patient experienced cellulitis in her legs. Her blood pressure became very low and she was hospitalized for treatment. She was put on pressors. She recovered from it and was sent back to her assisted living facility. However, on 25-MAY-2021, she passed away at the assisted living due to acute Alzheimers. Patient had mild dementia but towards the end it seemed to have exacerbated, where she couldn't even remember anybody. Her diagnosis at the time of death was acute Alzheimers. This case was linked to MOD-2021-034532 (Patient Link).; Sender's Comments: This is a 91-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch unknown) who experienced exacerbation of her DEMENTIA, ALZHEIMER'S DEMENTIA, HYPOTENSION and CELLULITIS after her second dose of vaccine, leading to her death from ACUTE ALZHEIMERS. Advanced senior age also could be attributed to the development of the events. It is unlikely, that the events are related to the vaccine based on long standing illness of DEMENTIA. . Very limited information has been reported at this time. Further information is expected.; Reported Cause(s) of Death: death was acute Alzheimers

Resident became chilled, unable to get warm, shivering, unable to get up, oxygen saturation dropped to 50% with heart rate of 133. Tachypnea

Cardiac arrest; Pain on her upper right chest; Lot of pain in lower abdomen; Pain underneath arm; Thought it was muscle aches; A spontaneous report was received from a nurse concerning a 92-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed upper right chest pain and underneath the arm, severe abdominal pain, muscle aches and cardiac arrest. The patient's medical history was not provided Concomitant product use was not provided by the reporter. On 14 Jan 2021, approximately five days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection. On 19 Jan 2021, the patient developed upper right chest pain and pain underneath the arm. They thought it was muscle aches. Sometime later, the patient developed a lot of pain in the lower abdomen. The called emergency services and an ambulance arrived but the patient then suffered cardiac arrest. Treatment for the event included tramadol. Action taken with mRNA-1273 in response to the events was not applicable due to the patient was died. The patient died on 19 Jan 2021. The cause of death was reported as cardiac arrest. Autopsy were not provided.; Reporter's Comments: Company Comment: This case concerns a 92-year-old female patient who experienced unexpected serious events of cardiac arrest, upper right chest pain and underneath the arm, severe abdominal pain, muscle aches. The event occurred 5 days after the administration of the first dose of the vaccine mRNA-1273 vaccine (Lot #: unknown, expiration date-unknown). Although a temporal association exist between the events and the administration of the vaccine, in the absence of critical details such as the patient's medical history, any diagnostic test or autopsy result, adequate evaluation and assessment cannot be established. Main field defaults to ‘possibly related' for all events.; Reported Cause(s) of Death: Cardiac arrest

Client unexpectedly collapsed and passed away on 1/13/21 from suspected sudden cardiac death. Prior to her death, she was in skilled care for rehabilitation following hospitalization from 12/21-12/31/20 for an acute lower GI bleed. Her hospitalization and skilled care stay were complicated by delirium and she was being treated for delirium with olanzapine (Zyprexa) at time of death.

Present to ED for chest pain, nausea, chest heaviness, mild headache and slight SOB with lower extremity swelling, Hospitalized starting today 2/5. EKG shows Afib with RVR (new oneset). Still in hospital at this time

Felt nauseated afteR Receiving vaccination. Did not eat or drink afteRwards. Stated had small emesis. Found on flooR in Bathroom with walker on top of heR 1230 AM 2/14/2021. Stated had lost consciousness. Side effects are as described to attending nurse.

3/2/21 became SOB, treated with oxygen and head of bed up in bed, only at dessert and drank supplement, for evening meal, no pain noted. 3/3/21 staff helped get her up in morning, went to weight room to take her weight, she then appeared to be struggling to breath, she was brough back to her room and the aides summoned nurse for assessment, was put back into bed, nurse noted poor color and shallow breathing, resident passed away shortly after that.

Patient is reporting elevated blood glucose after vaccine that will not fall into normal range. Pt states she never had Glucose level issues before vaccine and that she now has a blood glucose level that is consistently around 260

Chills; headache; extreme fatigue; gas or chest pain that was thought to be gas and went away Died 4 days later

Pt experienced altered mental status and chest pain the day after second vaccine. Pt was transported to Medical Center.

Approximately 4 hours after receiving the Moderna COVID-19 vaccine (left-arm), my mother began to have moderate pain in her left arm, particularly in the left shoulder area. The pain continued to increase throughout the afternoon, until it became so severe (10 on a 10-point pain scale) by 8:30 pm on 3/10/21 , that she could no longer lift her arm. She took 500 mg of Tylenol to attempt to relive the pain and went to bed early. At 2:45 am on 3/11/21, she needed to go to the restroom, and I (daughter) had to assist her to get out of bed, as she had no use of her left arm due to severe pain in that arm. While seated on the toilet, she indicated that her arm was extremely painful and she felt that she was going to pass out and felt nauseated. Within a minute, she lost consciousness and I called emergency services. EMT arrived within 5 minutes and stated that her blood pressure was extremely low and she needed to be placed on the floor. They placed her on a gurney and took her to the ambulance, where they started an IV and took her to her local hospital. I followed shortly thereafter, where she was taken to the ER. She was admitted to the hospital for observation and given Ativan (she refused any opioids) She was ultimately diagnosed with vasovagal syncope due to the pain in her left arm. Two days later, the pain has subsided.

Sore arm; Passed out; loss sense of time for 36 hr; so weak to get up; Vomiting for several time; A spontaneous report was received from a consumer, who was a 92 year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm, lose the sense of time, vomiting for several time, so weak to get up and passed out. The patient's medical history included cancer, restless leg syndrome, allergies to shellfish and currently living in hospice. Concomitant products included rivaroxaban, digoxin, diltiazem, omeprazole, pramipexole, vitamin D3, budesonide and paracetamol prn. On 19 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: 004M20A) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date after receiving the vaccine, the patient experienced sore arm. One night, she lost the sense of time for 36 hours. She got up in the middle of night and went to bathroom and was vomiting for several time. She then got back to bed with waste basket and was so weak to get up. She called the nursing home next door and she believed that they may have called 911 but was not full sure if they did or did not. The next day morning, one of the neighbors came to check on her at 11 am. When the neighbor tried to wake her up, she was passed out therefore the nursing home called 911 again. Patient believed that nurse gave her a shot to stop vomiting but do not clearly remember. She was not planning on getting the second dose of the vaccine. No treatment information was reported. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, sore arm and so weak to get up, were unknown. The outcome of the events, lose the sense of time and passed out, were considered resolved on 22 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Patient c/o feeling flushed, color pale pink, warm, dry. Radial pulse strong, steady. Breathing unlabored.Patient given bottle of cold water to drink, no swelling to face or lips. Patient stated she did eat breakfast that morning. Patient states water helping, then has some coughing after a drink. Patient states she often coughs after drinking things, denies difficulty breathing or swallowing. Patient c/o head throbbing after drinking. C/o nausea and has dry heaves x 1 but no emesis. Patient states has some chronic breathing problems and heart problems. Family member at side. BP 146/90 left arm sitting automated cuff, pulse 84. Respirations even and unlabored, O2 sat 88% on RA, Patient remains alert and talking, nausea subsides. Patient assisted to stand and ambulate with walker to be dismissed at 1053, but is dizzy so sat back down and dizziness subsides. Patient remains sitting and alert, talking to volunteer medical staff member. BP decreases to 132/86 and pounding in head decreases. Patient reports feeling okay to leave and at 1107 ambulates out with her walker and stand by assist from volunteer member and patient's family member.

Severe Dizzy, Nausea, vomited x5, elevated HR and Elevated BP . No short of breath, no fever. Day 4 still dizzy, nausea but vitals stable

CVA (stroke) around 2:00 p.m., was immediately transported to hospital. Meds were given (I believe Alteplase, but would need to confirm.) 3 brain bleeds after medications. Patient passed away at 5:40 p.m.

Patient went to hospital with complaints of tachycardia and tachypnea, also complained of lethargy and chills. Patient does have baseline shortness of breath and atrial fibrillation.

Patient presented to the ED and was subsequently hospitalized on 3/18/21 with atrial fibrillation. On 4/1/21 patient had their second dose of Moderna. On 4/9/21 patient was hospitalized for paroxysmal atrial fibrillation. On 4/12/21 Patient presented to the ED and was subsequently hospitalized again for atrial fibrillation. On 4/18/21 Patient presented to the ED and was subsequently hospitalized for acute cystitis. These visits were all within 6 weeks of receiving COVID vaccinations.

5/18/21 9:20pm - c/o general aches & soreness right arm 5/19/21 6:10pm - c/o general aches, sleepiness, soreness to right arm temp 99.8 5/20/21 11:21pm - redness adminstration site, redness & puffiness to eyes & face, arm very sore 5/21/21 11:02am - c/o pain at injection site, red, warm, swollen, afebrile 5/21/21 10:03p - arm red, warm, swollen at injection site, afebrile, states feels better today 5/25/21 4:27am - lethargic, tremoring, nausea, diarrhea, temp 103.4 pulse 128, SPO2 82%, sent to hospital

Patient presented to the ED on 3/29/21 for epigastric and chest pain. Patient presented to the ED on 4/22/21 with common bile duct stone and was admitted to the hospital.

2/18---dizziness/weakness (CMP, CBC, troponin, TSH, urine, EKG, chest xray)?ED visit. 2/24 traumatic hematoma (possibly from blood draw on 2/18)---xray, Doppler done 6/12 Nausea/vomiting hemocult + blood, maroon/coffee ground consistency, RUQ pain, diarrhea, colorectal enteritis, heparin given as prophylaxis against DVT. Hemoglobin trending down (14.1 to 11.5), type and screen done in case blood transfusion is needed (when hgb <7), endoscopy; CT scan showed the following: 1. Multiple regions of small bowel wall thickening and to a lesser extent large bowel wall thickening concerning for a coloenteritis. Differential includes infectious, inflammatory, or ischemic coloenteritis. Recommend correlation with lactic acid levels. No pneumatosis or free air. 2. Small volume ascites. Mesenteric edema. 3. Advanced atherosclerotic change of the abdominal aorta and side branches.

"Patient received her second dose of Moderna vaccination on 6/11. She was sent to the ER on 6/12 with SOB, respiratory distress. Diagnosed with CHF. VS: POX 72% and placed on O2, BP 168/106, HR 120, Resident was diaphoretic. DNR, DNH but family wanted her sent out. Doctor notified, ordered Lasix 20 mg and Coreg 3.125mg given immediately and 911 called. Went to hospital, diagnosed with CHF. Returned and family requested hospice and that was initiated. Resident is back to her baseline?up, participating in Bingo and other activities, eating in the dining room. Did not have fever."

Patient had Osats down to 80 around 20mins after vaccination with pulse upwards of 130. Gave patient 3-4L of O2. Patient did not respond and so epinephrine administered. EMS called. Patient's Osat was around 90 with pulse ranging from 80-120 after EMS arrived and consent received from family.

Osats down to 80; Pulse upwards of 130; A spontaneous report was received from a health care professional, concerning a 93-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Osats down to 80 and pulse upwards of 130. The patient's medical history, as provided by the reporter, included hypertension and heart disease. Concomitant product use was not provided. On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 05 Jan 2021, around 20 minutes after vaccination, the patient's oxygen saturation was down to 80 and she had a pulse upwards of 130. The patient was given 3-4 L of oxygen, but did not respond, so, epinephrine was administered. Emergency medical services (EMS) was called. The patient's oxygen saturation was around 90 with pulse ranging from 80-120 after EMS arrived. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, Osats down to 80 and pulse upwards of 130, was unknown.; Reporter's Comments: This case concerns a 93 year-old, female patient with medical history of hypertension and heart disease, who experienced events of oxygen saturation decreased and heart rate increased. The events occurred approximately 20 minutes after the first and last dose of mRNA-1273 vaccine administration. 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 and the events are assessed as possibly related.

Does not have lot number. About an hour after getting the vaccine started with fast heart beat, felt like my heart was like "boom boom boom" and was really loud, sweating, weakness, runny nose. Symptoms since then have been on and off and steady for 5 hours today. Today it feels like my heart is in down in my lungs.

About an hour after receiving the vaccine my heart starting beating really hard and loud. You sweating, weakness and runny nose. The symptoms have been on and off since then. But the last 5 hours they have been steady. It feels like my heart is in my lungs. I do have a pacemaker and my Doctor just prescribed Lasix for swelling in my legs. I have not received it in the mail yet. Does not have the lot number.

pt stated within 10 minutes after receiving vax she became flushed, had chills, cold sweats and palpitations. Pt stated her vitals were taken and her BP was 215/104. After about and hour it came down to 160/?. Pt stated that 2 weeks after the vax she developed a 6" red, warm, swollen, itchy area around injection site. Pt stated her symptoms have subsided but she has contacted her PCP about getting second dose and was advised not to take it.

Pt received Moderna COVID vaccine at 0850. RN responded when pt c/o dizziness at 0905 while sitting in observation area. Pt pink, warm and dry. RR easy and regular. Radial pulse 100, BP 174/108. Pt stated she took her morning meds including antihypertensives this am at 0800 on an empty stomach and then did not eat breakfast. Pt given water to hydrate and crackers. At 0910 pt denied dizziness. At 0910 BP 200/76 and pt stated I feel better. Both nurses remained with pt at all times. At 0918 BP 208/88. Pt encouraged to go to ER or her PCP for further evaluation. Pt's niece was in attendance and made an appt with pt to go to her PCP at 1215 today. At 0930 pt stood and ambulated and stated she felt fine to go to her doctor. Pt escorted by wheelchair to her car per volunteer staff. Pt discharged with her niece in attendance.

1/31/2021 12:50 Nursing Note Note Text: Res had low BP, low O2 sats, 30 breaths per minute, eyes open wide, making confused utterances. Started supplemental oxygen via NC, 2L, then 3L. Sats went up to 93% for a while, Sprvsr called. Unable to auscultate Left lung sounds. Called to update Res daughter. Called to page NP, writer went back to assess Res and O2 sats were 88%, turned O2 to 4LPM, called 911 for transport to Hospital ED. Left around 1030. NP called back afterwards, was updated. Family updated that Res was sent to Hospital ED. Note Text: Received phone call from daughter as well as information from hospital. Resident has pneumonia with septic shock. She is on abx and had thoracentesis performed for large pleural effusion. [linked]

Patient complained of chest pain,Non-Cardiac . Onsite EMS was called vitals were taken BP 169/97 96% O2 room air HR 60.Patient treated, Left aginst medical advice. .

12:30 Post vaccination reports generalized chest pain w/no associated symptoms, NAD, denies any sob/dizziness; medical monitoring x 30 min, rest, po hydration offered; vitals assessed: BP 114/87 P64 RR20 O2 sat 98% RA. "Some" chest pain persists post monitoring w/ recommendation for ER evaluation/ treatment w/relative decline. Released from facility w/daughter.

The patient recieved her second dose of Moderna and was sitting in observation when staff told us that the pt was falling asleep and was near syncopal. The patient was assessed by and the patients Power of Attorney was called to ask if they wanted the pt transported. who makes decisions for the patient did not want the patient transported and we advised him that it was against our medical advise and he still refused transport. He stated that he wanted staff to observe the patient.

Unknown if she had any symptoms or adverse reactions. She apparently was stubborn and kept to herself.

Patient was found passed out on the floor of her room after family called the facility as she was not answering her phone. She was taken to the Emergency Room and admitted to the hospital.

Pt presented for routine primary care visit 3/30 and reported swelling of right lower leg starting 2 weeks prior. Ultrasound positive for DVT.

According to family and certificate of death, patient suffered from an acute mid-brain cerebrovascular accident and died on 6/24/2021.

Admitted 6/10/21 w/current covid illness. Partial vaccination noted. 6/17/21 urine culture w/no growth. Progressed to release from Covid unit to general population in recovery status on 6/22/21. Seen/Assessed by NP/MD /IDNP during stay. 6/26/21 urine culture w/no growth. 6/27/21 seen by MD d/t increased falls and confusion. Fall on 6/29/21 w/increased confusion and immediate transport to ER for increased confusion, decreased oxygen saturation and fall w/possible head injury r/t unwitnessed fall and increased confusion. She expired at the hospital 7/3/21 w/respiratory failure.

93 y.o. Nursing home resident with comorbidities. On 2/4/21 resident complained of dyspnea and not feeling well. Resident and family refused transfer to Emergency Room. Supplemental oxygen consistently worn x5 days for symptom management. On 2/8/21, PA noted resident had transient hypoxia with elevated troponin suggesting a possible MI. Resident/Family continue to refuse transfer to ER. On, 2/16/21, resident had Syncopal episode and resident/family continue to refuse transfer to ER.

Tachycardia, resident was sent out to the hospital for evaluation on 12/30/2020 and came back to the facility on 12/31/2020.

Nurse: the resident received her vaccine at 09:25 am and immediately began to feel cold. This nurse was notified at 0945 at which time the resident complained of nausea and dizziness. The resident was also emotional, confused and experiencing high blood pressure (170/78) .

Patient reported not feeling well. Staff at the facility checked her blood pressure and it was high. 911 was called and paramedics determined patient was fine. She was not taken to the hospital.

Rapid decline in health status, Elevated BP&P, posturing, loss of consciousness, Glasgow coma Scale 4 starting 2/1/2021, Deceased 2/3/21

*extreme* fatigue. could not awaken for more than few seconds. When briefly awake she was coherent and not confused. slept deeply from 4pm and could not wake to eat or drink. No fever, bp normal, blood oxygen ok. Blood sugar at 11pm was 230. Gave her 15u lantus at 11pm (normally 25u). Was sleeping at 2:30am but had died at next check at 3:30am.

Received influenza vaccine 1/29 at PCP clinic. Received Moderna vaccine on 2/6 by pharmacist at her place of residence. She was taken to the ER on 2/9, unresponsive. Staff reported she wasn't acting normally since 2/7. During her hospital course (2/9-2/13) she was only able to open her eyes. Unable to follow any commands. MRI showed large right MCA stroke. She was discharged from the hospital on hospice.

Per patient's daughter, the patient told her that she "passed out" while she was on the toilet the day following vaccination. States she felt weak. Per daughter the patient is doing fine now.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: pt was not responding well, urinated on self and felt nauseas. Pt is on hospice and felt dizzy even before the vaccine.-Mild, Systemic: Nausea-Mild, Additional Details: Pt was dizzy and fell 02/21/21 at the site; paramedics called; refused to be hospitalized. Pt vaccinated 02/22/21, was dizzy and urinated on self, paramedics called, refused to be hospitalized. Staff told vaccinators then that pt was hospice and own guardian, so nothing could be done.

Awakened 12 hours after injection with chills and shivering. Got out of bed 18.5 hours after injection with temperature of 101.7 degreees F. By 24 hours after injection, temperature dropped to 100.0 degrees F. No other symptoms at all.

States had felt her heart beating fast, had a swollen tongue and a weird feeling. PHN checked BP and was 142/84, pulse 94 apically, O2 sats 94% on RA. Patient stated that the feeling lasted for just a minute. PHN gave juice to patient after checking vitals and she stated she felt much better. Asked if would like some Benadryl and she said she took an allergy medication this morning as part of her normal routine. Patient also stated she has a history of an irregular heart rhythm. She stated she ate well for breakfast this morning to ensure she did not have a low blood sugar while waiting for her shot. Note time of incidence at 1139am and had not eaten since breakfast. Patient stated she was fine to go home after her 30 minute wait time. Her VS were good at this time. PHN requested that patient contact her PCP if there were any further concerns following her leaving the site for the vaccination.

Family states patient had been coughing and was weak after the vaccine. Patient walked to the bathroom and then fell striking her head found in PEA with agonal breathing. Despite aggressive CPR medications patient remained in asystole. Unknow if Moderna or Phifzer

Red pruritic rash at the injection site Two days following vaccination, she had an episode of syncope with fall, head trauma, rhabdomyolysis that resulted in hospitalization

Hypoxia on 3/12/21 in afternoon around 3pm. New Right lower lobe Infiltrate on Chest Xray 3/12/21. Cough 3/13/21. Worsening generalized weakness 3/12/21 7am, Nausea 3/12/21 7am, No appetite 3/12/21 7am. Malaise 3/12/21 7am. Encouraged fluids. Placed on oxygen via nasal canula. Started Levaquin antibiotic. Started on Guaifenisin cough syrup. Patient is still on Oxygen and antibiotic as of this report. Incentive spirometer ordered 3/15/21

Blood clot in blood vessel in the left hand at the base of the middle finger causing darkening in the lower part of the finger and numbness in the whole finger.

Withing 24 hours of vaccine admin developed nausea, chills, aches, dyspnea, elevated heart rate. Saw PCP on 2/15 and was sent to ER and then admitted to hospital for 5 days-continued extreme nausea and atrial fibrillation after diuresis for CHF. HR 120s had to be put on multiple meds to bring ratedown. Discharged on 2/19. Cont worsening nauaea/chills/aches. Passed away on 2/23

Patient was a resident on a LTC wing. Received Covid-19 vaccine on 1/13/21 & 2/10/21. Pt stated she felt phlegm in her throat 3/14/21. On 3/15/21 patient started having trouble swallowing, and started needing supplemental oxygen for low oxygen saturation and needing suctioned for c/o being unable to swallow.. ST eval showed no gag reflex and inability to swallow effectively or safely. Pt needed 5L/O2 and unable to hold saturations above 90%. Patient became ?comfort care?, and passed away 3/18/21.

Pt had covid vaccines through Walgreens coming to her ILF. She had the vaccines 1/18/21 and 2/15/21. Pt presented with new edema on 2/17/21 and venous doppler confirmed. left peroneal DVT. Pt required oral anticoagulation. Pt is very self ambulatory and now previous hx of DVT. She has no dx of obesity.

Clinic appointment for RUQ abdominal pain and emesis. Admitted to unspecified hospital, treated with IV protonix and IV fluids with K+.

Resident began coughing then complained of abdominal pain and was taken to the Hospital. He began to vomit and breathed in. Had a heart attack

94-year-old patient presented to emergency department on 4/25/2021 with acute shortness of breath. Diagnosed with COVID-19 on 4/20/2021. Her chest x-ray in the emergency room showed left-sided airspace opacity with some pleural effusion. She was also found to be hypoxic at the assisted living facility and started on oxygen along with nonbreather oxygen mask and admitted to the hospital ICU for further management of COVID-19 pneumonia. There is history of cough and wheezing off and on.

Patient presented to the ED and was subsequently hospitalized for atrial fibrillation within 6 weeks of receiving COVID vaccination. She died on 5/26/2021.

Patient presented to the ED and was subsequently hospitalized for DVT within 6 weeks of receiving COVID vaccination. Patient died on 6/23/2021.

Was informed by local Medical Examiner that on 04/10/2021, 4 days after receiving second Covid-19 vaccine, that the pt slipped on a rug and hit her chin very hard and that she died. The family informed Medical Examiner that she was not feeling very well after receiving her vaccine and felt more fatigued than usual. Family raised concerned that the cause of her fall was due to vaccination. Medical Examiner ruled cause of death as a closed-head injury or cardiac arrhythmia, with significant other conditions at time of death being "mild symptoms following covid-19 vaccination"

Systemic: Chills-Medium, Systemic: Generalized Body Aches -Severe, Systemic: Joint Pain-Severe, Systemic: Diarrhea-Severe, Systemic: Fainting-Severe

Patient daughter reported that patient was admitted to Neurology with a stroke. She has cognitive and speech impairment as well as motor impairment. She was admitted either 2-2-21 or 2-3-21. She is still in the hospital.

Patient presented to ED with chest pain/pressure two days after receiving second Moderna vaccination. Chest pain atypical for cardiac s/s, hypertension. Per Pt/family report vaccine was the trigger. Pt given GI cocktail. Cardiac workup negative, discharged home without escalation of care.

patient complained stomach pain, responsive but lethargy and slightly clammy. Vital Signs: BP 112/45; pulse 41; O2 Sat 99 - 100%. Bradycardia patient put on gurney, heart monitor, started IV lock. transferred to ED for further evaluation.

nonocclusive deep vein thrombosis (extending from upper femoral vein to Popliteal vein in left leg,, ) pulmonary embolism affected left pulmonary lobe) - no heart damage or pulmonary infarct; Was hospitalized at Hospital on Saturday 4/10 and discharge is scheduled for 4/13.

irritated her heart condition; Clot blood; weakness in legs, couldnt walk with legs; Coma; couldn't breathe; stroke/massive stroke in left side of her brain; Irritated her heart condition, rapid heart beat; Headache; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke/massive stroke in left side of her brain), CARDIAC DISORDER (irritated her heart condition), DYSPNOEA (couldn't breathe), THROMBOSIS (Clot blood), COMA (Coma) and MUSCULAR WEAKNESS (weakness in legs, couldnt walk with legs) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Covid-19 Vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Heart disease, unspecified, Hypertension and AFib. Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy, SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO) for Hypertension, METOPROLOL for an unknown indication. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced HEADACHE (Headache) and FATIGUE (Tiredness). On 12-Mar-2021, the patient experienced MUSCULAR WEAKNESS (weakness in legs, couldnt walk with legs) (seriousness criterion hospitalization). On 13-Mar-2021, the patient experienced CARDIAC DISORDER (irritated her heart condition) (seriousness criterion hospitalization), THROMBOSIS (Clot blood) (seriousness criterion hospitalization) and HEART RATE INCREASED (Irritated her heart condition, rapid heart beat). On 15-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke/massive stroke in left side of her brain) (seriousness criteria death and medically significant). On 16-Mar-2021, the patient experienced DYSPNOEA (couldn't breathe) (seriousness criterion hospitalization prolonged) and COMA (Coma) (seriousness criterion hospitalization prolonged). The patient was hospitalized on 13-Mar-2021 due to CARDIAC DISORDER, COMA, DYSPNOEA, MUSCULAR WEAKNESS and THROMBOSIS. The patient died on 17-Mar-2021. The reported cause of death was massive stroke in left side of her brain. It is unknown if an autopsy was performed. At the time of death, CARDIAC DISORDER (irritated her heart condition), DYSPNOEA (couldn't breathe), THROMBOSIS (Clot blood), COMA (Coma), MUSCULAR WEAKNESS (weakness in legs, couldnt walk with legs), HEART RATE INCREASED (Irritated her heart condition, rapid heart beat), HEADACHE (Headache) and FATIGUE (Tiredness) outcome was unknown. Action taken with mRNA-1273 in response to the events was not Applicable. This case concerns an 95 year old female patient, with medical history of A Fib, Heart disease, Hypertension who experienced a serious unexpected event of Death 8 days after receiving 1st dose of mRNA- 1273 . Very limited information regarding these events has been provided at this time. However, the patient's advance age, multiple co-morbidities, may remain as risk factors. Further information is requested. This case was linked to MOD-2021-074814 (Patient Link).; Sender's Comments: This case concerns an 95 year old female patient, with medical history of A Fib, Heart disease, Hypertension who experienced a serious unexpected event of Death 8 days after receiving 1st dose of mRNA- 1273 . Very limited information regarding these events has been provided at this time. However, the patient's advance age, multiple co-morbidities, may remain as risk factors. Further information is requested.; Reported Cause(s) of Death: massive stroke in left side of her brain

Almost blacks out/when the patient bends down to tie their shoe their dizziness get to the point where the patient almost blacks out; Dizziness/when the patient bends down to tie their shoe their dizziness get to the point where the patient almost blacks out; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Almost blacks out/when the patient bends down to tie their shoe their dizziness get to the point where the patient almost blacks out) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history was reported). On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced PRESYNCOPE (Almost blacks out/when the patient bends down to tie their shoe their dizziness get to the point where the patient almost blacks out) (seriousness criterion medically significant) and DIZZINESS (Dizziness/when the patient bends down to tie their shoe their dizziness get to the point where the patient almost blacks out). At the time of the report, PRESYNCOPE (Almost blacks out/when the patient bends down to tie their shoe their dizziness get to the point where the patient almost blacks out) and DIZZINESS (Dizziness/when the patient bends down to tie their shoe their dizziness get to the point where the patient almost blacks out) outcome was unknown. The action taken with mRNA-1273 in response to the events was not applicable. Company comment: Based on the current available information and temporal association between the use of the product and the start date of 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.

Resident became hypoxic and supplemental oxygen did not bring oxygen saturation up to normal levels. The physician ordered resident be sent to the emergency room for evaluation.

Pt call hospital call center 5/14/2021. Pt c/o difficulty breathing, swelling throat, palpitation, itching whole body, tiredness, body aches whole body since pt got 2nd covid vaccine 5/12/2021. Pt recommended pt to call 911 or go to nearest ED d/t emergency covid vaccine side effects shown. Pt refused to call 911. The writer offered to call 911 on behalf of pt. Pt agreed the writer to call 911 on behalf of pt. Called 911 and connected with pt in conference phone connection.

On the evening of 10JAN2021, patient experienced a low grade fever, decreased oxygen saturation of 38%, heart rate of 124, confusion. Patient received oxygen via face mask, morphine and ativan. By 11JAN2021, patient was no longer verbal, able to eat or communicate and was kept on comfort measure only. On the morning of 17JAN2021, the patient passed away.

Patient reported feeling dizzy after vaccination. Patient's blood pressure was taken and trended high - it was 140s-150/80. It was high 10 minutes after vaccination. Patient was instructed to stay seated and wait under supervision for 15 more minutes. Patient was given water and BP remained high, ~140/80s. Over the entire course of observation, the patient's pulse was normal (80 BPM).

Resident complained of feeling "hot" at supper time. Had emesis an hour or so later. Became hypoxic and was transferred to the hospital emergency room. Her evaluation in the ED revealed continued presence of UTI, leukocytosis (19.8), and renal insufficiency (BUN 22 Cr. 1.3) BP 99/63; P 74; Temp 98.1; RR 16; and O2 sat of 95% with 2 LPNC (she is typically on RA). CXR reported changes most consistent with CHF with cardiomegaly and bilateral pulmonary vascular prominence. Bibasilar pleural effusions greater on the right than left with pulmonary edema. Large hiatal hernia and likely old chronic wedge defromities involving the mid thoracic vertebral body. She was admitted for IV antibiotics. She expired 2/6/2021

Fever of 104.5 at 330am. Reduced to 101.5 by 500am with Tylenol. Collasped at 830am on the floor unable to verbalize or move, 02sat =72. EMTs were called, checked vitals and transported to the ER.

After the pt received her 2nd dose of the COVID19 vaccine while sitting in observation she reported feeling "queasy." Also reported feeling like her heart was beating fast. Pt was evaluated by RN and EMS paramedic. BP 195/83 and repeat 175/129. HR 76 and 83. Per RN and EMS pt seemed to be in a-fib. Pt states her MD recently took her off of medication for a-fib. Pt was advised to go with EMS to the ED. Pt refused despite counseling and encouraging her to go an be evaluated. Pt signed refusal for transport with EMS. Pt's daughter came into clinic to walk her out. RN discussed with pt's daughter and reiterated the recommendation for ED eval. RN also advised both the pt and her daughter to call her PCP and speak with the oncall MD for further recommendations since she is refusing transport to ED. Pt and her daughter verbalized understanding.

Patient presented to the emergency department after being found down in her home and presented with right upper and lower extremity weakness and a right-sided facial droop. Patient's presentation was consistent with an acute ischemic stroke which was confirmed on MRI.

Pt c/o of left arm pain after injection and for several days after. Pt was in bed for 2 days after injection c/o generalized malaise and weakness. Pt c/o of feeling of funny heart rhythms and feeling of constant anxious feeling. Pt started having episodes of SOB and was very labored doing simple tasks such as using the toilet. Pt started using o2 for the first time and had to recover for any activity for several minutes. Different medications were tried to help control symptoms such as Morphine for SOB and ativan for anxious feelings. Symptoms were never well managed after vaccine. Pt eventually died from worsening symptoms on 3/20

TIA cardiomyopathy, EF less tha 20% new diagnosis I DO NOT KNOW WHICH BRAND COVID VACCINE SHE RECEIVED ++++++++++ no other option above but to pick one,

My mother fainted on the night she was vaccinated, early in the morning. She had gone to the kitchen to get a heating pad and felt faint while standing She didn't make it to a chair, but fell and broke her hip. While this could have been due to another health problem, my mother had never had a fall or a near-fall. it is concerning that very old adults are not warned to have someone with them after receiving the vaccine (for instance, overnight), I realize that the vaccine has not been studied specifically in geriatric populations, but it is realistic to assume that there are substantial numbers of very old people living on their own, particularly in cities where there is no need to drive, and where food and other necessities can be delivered. There should be a warning to people that they should not be alone after receiving the vaccine.

The patient fell the day after receiving the Moderna COVID-19 vaccine. She broke her hip in this fall. During surgery to correct the broken hip, she went in to sudden and unexpected cardiac arrest. The anesthetist did not notice any ST changes or A fib; dysrhythmia was very unexpected. The patient had a DNR. She died at 13:00 on 02/07/2021. Causes of death are listed as 1. Cardiac Arrest 2. Recent hip fracture with hip placement 3. History of Breast Cancer 4. Hypothyroid and 5. Dementia

Approximately 10 minutes after receiving her vaccination patient fainted, then once she gained conciousness she vomitted a small amount of water. Family that was present, said that this is a somewhat common occcurence as she's had several episodes similar to this within the past year.

I am the patient's daughter as well as an RN-BSN. My mother was given the Moderna vaccine on Feb 11, 2021 and on Feb 15, 2021 she had a CVA and MI. She was found on her apt. floor unconscious. She was transferred to the Hospital by ambulance where a CT scan and other tests were done. It was determined she had a stroke and heart attack. My mother was in great health, took no medications, and lived alone in her apt. before this incident. The medical professionals determined she would not recover so she was admitted to hospice and died on Feb. 21, 2021. I believe there is a relationship between the vaccine and the CVA and MI.

Hallucinating; Occasional rapid heart beat; Hadache; A spontaneous report was received from a caregiver concerning reporter's mother a 97-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced hallucinating/ hallucination, occasional rapid heartbeat/ heart rate irregular and headache. The patient's current conditions included chronic urinary tract infection. Products known to have been used by the patient, within two weeks prior to the event, included antibiotics for chronic urinary tract infection. On 26-Feb-2021, prior to the onset of the symptoms, the patient received their unspecified dose of two planned doses of mRNA-1273 (Batch number not provided) via an unknown route and site for prophylaxis of COVID-19 infection. On 27-Feb-2021 the patient had headache for 2 days, was hallucinating and had occasional rapid heartbeat. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The Outcome of the events, hallucinating, occasional Rapid Heartbeat, and headache was unknown. Company Comment: The reported events, hallucinations, heart rate irregular, and headache, were considered possibly related to mRNA-1273.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported event and excluding any other etiology, a causal relationship with the event cannot be excluded. Headache is consistent with the vaccine profile

pt presented at the pharmacy on 03/17/21 to say after getting her second dose of the moderna covid vaccine on 02/24/21, she fainted at the entrance of Dr's office less that one hour afterwards (she waited at the pharmacy for 15mins after receiving the vaccine) per pt she was taken by ambulance to the hospital were she spent 3 days in the ICU after she was released under the care of her family member. Pt stated that she did not experience any other symptoms. She stated that the Dr didn't think it was related but she thinks it is. she is feeling a little better now

Patient reportedly received COVID vaccine doses on 1/23 and 2/15, but we are unsure of which manufacterer or lot number. Patient admitted to our hospital on 3/9/2021. Patient presented with elevated D-dimer with concern for septic shock. Ultrasound of patient revealed no VTEs. COVID test on 3/10 resulted POSITIVE. Patient was going to require vasopressors but patient requested to go on comfort measures only. Patient ordered comfort measures on 3/10 and pronounced deceased on 3/18.

Pt. had hx of SOB prior to vaccination and Dx with hear failure Woke up day after vaccination with being very tired. Admitted to hospital with UTI, Sepsis

Pt's daughter reports that after the patient received her second dose of the Moderna vaccine on Friday, April 23, 2021, on Saturday, April 24, 2021 around 3:00pm the patient started having trouble lifting her foot, she was also having trouble standing; the pt's daughter evaluated her on Sunday and thought she was having a neurodeficit. The patient was taken to the hospital on Monday evening (4/26/21) and a CT scan revealed the pt had a stroke. The pt is anticipated to recover.

Patient was well 5/13/21 vaccinated 05/14/2021 with second Moderna COVID Vaccine and according to son pt rapidly declined with recurrent falls 5/15-seen in er 5/16 and sent home and cont to have worsening profound weakness presenting to the ER again 5/18 and admitted with Sepsis secondary to right lower lobe pneumonia, right 8th, 9th and 10th rib fractures, syncope/ rhabdomylosis and NSTEMI, profound weakness and new anemia with GIB needing 2 units prbcs. Pt was living independently alone pta with help from his son and was at his baseline up until getting his second vaccine. he was ultimately discharged to nursing home on 5/21/21. he was still too weak to walk or get out of bed at the time of discharge.

This patient has been under hospice care for over 2 years at the nursing home. She has had a steady decline with gradual weight loss. She was totally dependent in her care needs. She received the vaccine on 1/2/2021 as part of the facility vaccination campaign. No adverse events noted initially. On 1/3/2021 at 6:06 pm, she was noted on vital sign checks (done every 4 hours for first 72 hours after vaccination) with BP 64/52 but otherwise asymptomatic. Subsequent BP improved. On 1/4/2021 at 4:45 am, pt found with respiratory rate of 30 with otherwise normal vital signs. Tachypnea persisted, so she received liquid morphine 2.5 mg without improvement. Supplemental oxygen was applied. Tachypnea persisted. She had poor oral intake after that point had persistent tachypnea and worsening hypoxemia despite clear lungs on exam. She remained under hospice care and comfort measures were continued. No blood testing or imaging tests were done. She required increasing amounts of oxygen, became hypotensive, and died peacefully on 1/8/2021 at 7:45 pm.

3 days ago patient was started on Cipro for a UTI. Patient received the ModernaCOVID vaccine 2 days ago. The past 48 hours patient has had increased confusion, decreased p.o. intake. Patient was sent to emergency room for evaluation. Patient was found to have a low sodium, 112, high potassium 6.9 with corresponding EKG changes. Patient was bradycardic with a rate between 30 and 40. Patient was also found to be in acute renal failure with a creatinine of 5.6. In ER pt was confused, unable to tolerate PO fluids. Due to severity of illness patient's family has elected to avoid aggressive medical care. Patient has poor prognosis. Patient was returned to nursing home for comfort care only.

On 1/15/21, resident fell during the night while getting up without assistance and hit her head. She did not have any neurological impairment after fall and remained at facility to be monitored. 1/26/21, resident had sudden loss of consciousness with hypotension and tachycardia. This resolved slowly after resident was put in trendelenberg position. She has not had similar events in the past. She was sent to ED without a distinct underlying cause of the event identified, differential included cardiac arrhythmia, ? orthostatic hypotension, vasovagal syncope, stroke She had a similar event occur on 1/27 after she had returned to the facility from the ED. The family elected not to pursue further evaluation for second event and she was placed on hospice as she had been experiencing some gradual decline before these events occurred.

Swollen arm, lymph nodes, neck, sinuses, and chest on left side; redness and pain in arm; difficulty breathing and heaviness in left side of chest; chills; loss of appetite; fever (her normal is 96.5 and she had 101 degrees); lethargy; aching all over

Moderna COVID-19 Vaccine EUA In addition to chills, patient was pale and extremely weak, experiencing difficulty standing from a seated position and great difficulty walking. She stayed hunched over after standing and was unable to walk unassisted. With assistance it took her several minutes to walk about 15 feet. The weakness persisted for 6-8 hours after which her previous strength and mobility were restored.

Could not stand or walk Shooting Ppin in right arm Achiness Confusion High Blood Pressure High Heart Rate - 116 Trouble speaking No appetite

in and out of consciousness; blood pressure was 170/112; severe chills; UTI; A spontaneous report was received from a consumer, concerning a 98-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe chills/ chills, blood pressure was 170/112/ hypertension, was in and out of consciousness/ consciousness fluctuating, chronic heart failure/ cardiac failure chronic and urinary tract infection (UTI). The patient's medical history included were chronic heart failure and urinary tract infection. Concomitant medication included was apixaban. On 18 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 18 Feb 2021, same day of receiving vaccine, the patient experienced severe chills, blood pressure was 170/112, and was in and out of consciousness. She was hospitalized and remained at the hospital. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The outcome of events, were considered as unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time. However, advanced age, history of chronic heart failure and concurrent underlying urinary tract infection may remain as risk factors. Further information has been requested.

Narrative: Patient received dose 1 of Moderna COVID-19 vaccine on 3/11/21 from clinic. Vaccine was administered to patient without complications and patient was observed for 15 minutes post-vaccination without any adverse effects. No documentation as to any adverse effects following the 15 minutes post-vaccination. 11 days later on 3/22/21, EMS was dispatched to patient's home and patient was found lying supine, unconscious, and unresponsive to stimuli. Patient was noted to have shallow breathing per EMS staff, and was subsequently brought to the hospital. Per family, patient lives alone and was feeling well - they had spoken to her two days prior to the event. Per family patient did not have recent fevers, vomiting, diarrhea, or cough. Also no recent medication changes or trauma. PMH includes stroke approx. 8 years ago, gout, HLD, HTN, and RLS. BP upon admission was 126/93, HR 123, temp 37.1 degrees Celcius, RR 28. Patient noted to smell of urine. CT showed large completed right sided infarct consistent with MCA stroke. Per neurology the lesion was not recoverable and patient would be unlikely to regain any function. Family was notified and poor prognosis was discussed. Patient has been very clear in the past that she would prefer "to go when her time came". She had a DNR And DNI as well. Daughter requested to pursue comfort measures for patient, therefore she was transferred to hospice care. Patient passed away the following day on 3/23/21. Death very unlikely due to COVID-19 vaccination since CT imaging clearly showed cerebral infarct and patient had a PMH of stroke.

Facility Manager reported that she put hospital on hospice on 3/15/21. HCP knew that she wasn't looking well. Patient was transferred to hospice facility where she is currently. HCP caled hospice on 3/5 and they came for the tranfser about 3 weeks ago. Patient has Bone cancer

patient woke up on 04/22/2021 with shortness of breath and weakness. On exam, she was hypotensive, tachycardic and edematous

Looked like she had a stroke; Muscle pain; Disabled; Brain does not work with her body; She cannot use her legs; Swelling of hands and feet; Nausea; Felt Sick (After First Vaccine); Slurring words; Throwing up; Fever 100.3 F (After First Vaccine); Loss of Taste (After First Vaccine); Pain in arm; Redness in arm; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DISABILITY (Disabled), CEREBROVASCULAR ACCIDENT (Looked like she had a stroke), CEREBRAL DISORDER (Brain does not work with her body), MALAISE (Felt Sick (After First Vaccine)), DYSARTHRIA (Slurring words), LOSS OF CONTROL OF LEGS (She cannot use her legs) and NAUSEA (Nausea) in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-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 received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain in arm), VACCINATION SITE ERYTHEMA (Redness in arm) and CHILLS (Chills). On 04-Feb-2021, the patient experienced AGEUSIA (Loss of Taste (After First Vaccine)) and PYREXIA (Fever 100.3 F (After First Vaccine)). On 03-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Looked like she had a stroke) (seriousness criteria hospitalization and life threatening), MALAISE (Felt Sick (After First Vaccine)) (seriousness criterion medically significant), DYSARTHRIA (Slurring words) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and VOMITING (Throwing up). On 04-Mar-2021, the patient experienced LOSS OF CONTROL OF LEGS (She cannot use her legs) (seriousness criterion medically significant) and PERIPHERAL SWELLING (Swelling of hands and feet). On 14-Apr-2021, the patient experienced CEREBRAL DISORDER (Brain does not work with her body) (seriousness criterion medically significant). On an unknown date, the patient experienced DISABILITY (Disabled) (seriousness criterion disability) and MYALGIA (Muscle pain). On 16-Feb-2021, VACCINATION SITE PAIN (Pain in arm), VACCINATION SITE ERYTHEMA (Redness in arm) and CHILLS (Chills) had resolved. On 25-Feb-2021, AGEUSIA (Loss of Taste (After First Vaccine)) and PYREXIA (Fever 100.3 F (After First Vaccine)) had resolved. On 14-Apr-2021, PERIPHERAL SWELLING (Swelling of hands and feet) had resolved. At the time of the report, DISABILITY (Disabled), CEREBROVASCULAR ACCIDENT (Looked like she had a stroke), CEREBRAL DISORDER (Brain does not work with her body), DYSARTHRIA (Slurring words), LOSS OF CONTROL OF LEGS (She cannot use her legs), NAUSEA (Nausea), MYALGIA (Muscle pain) and VOMITING (Throwing up) outcome was unknown and MALAISE (Felt Sick (After First Vaccine)) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Based on the current available information and temporal association between the use of the product and the start dates of the event, a causal relationship cannot be excluded. This case was linked to US-MODERNATX, INC.-MOD-2021-076475 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: stroke, on hospice. On 22-Apr-2021: Additional info; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-076475:CROSS LINKED WITH DOSE 2

in and out of consciousness; blood pressure was 170/112; severe chills; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (in and out of consciousness) and HYPERTENSION (blood pressure was 170/112) in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included UTI and Chronic heart failure. Concomitant products included APIXABAN (ELIQUIS) for an unknown indication. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (in and out of consciousness) (seriousness criteria hospitalization prolonged and medically significant), HYPERTENSION (blood pressure was 170/112) (seriousness criterion hospitalization prolonged) and CHILLS (severe chills). At the time of the report, LOSS OF CONSCIOUSNESS (in and out of consciousness), HYPERTENSION (blood pressure was 170/112) and CHILLS (severe chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 170/112 (High) Increased. No treatment 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. Patients underlying chronic heart failure and advanced age are confounders. Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow-up information was received on 27-Apr-2021 contains information regarding follow-up consent (follow-up and consent was denied for follow-up).; 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. Patients underlying chronic heart failure and advanced age are confounders.

Extremely high blood pressure (200 Systolic); repetitive severe nosebleeds, resulting in a need for surgery (coil X 2 and particle embolization of right internal maxillary artery.

Patient became lethargic, extremely tired, unable to care well for self. Patient had no appetite, refused most food and spent many hours simply sitting in her chair. She felt that she was having a heart attack and called 911 using her emergency response button on 2/21/2021. Doctors indicated that the patient's life was in serious danger, but because of age they were hesitant to try to remove the clot pressing on her heart. She was only allowed to go back home because we utilized Hospice. When asked about her life expectancy, we were told she could die any minute or might live a few more months, but that she was not expected to live much longer. SHE WAS IN GOOD HEALTH PRIOR TO THE IMMUNIZATION!

developed stroke (unresponsive, unable to express herself or her needs, lethargic, unable to swallow)

Mini stroke; Numbness from shoulder to hand opposite arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Mini stroke) in a 99-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced HYPOAESTHESIA (Numbness from shoulder to hand opposite arm of injection). On 17-Jun-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Mini stroke) (seriousness criteria hospitalization and medically significant). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (Mini stroke) and HYPOAESTHESIA (Numbness from shoulder to hand opposite arm of injection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product were not provided. Treatment medication was not provided. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Address, date of birth and serious event added upgrading the case; 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 requested.

99 y.o. nursing home resident received 1st Moderna Covid vaccine on 7/13/21. On 7/17/21, Resident complained of chest pain and was transferred to ER and admitted to Acute with A-FIB. Resident returned to LTC unit 7/20/21 on hospice.

Vomiting the night of the vaccine. Low oxygen and high fever next morning. Has been on palliative care Was hospitalized, but section 21 will not let me fill the info. Hospital Admitting Dx: Sepsis, likely biliary cause; Acute on chronic encephalopathy likely sepsis related Returned 1/12 on hospice

The PA-C who patient sees per daughter in law said the PA suspects the vaccine given 2/15/2021 may have caused the stroke that occurred on 3/12/2021. Although, the patient had TIA three months prior. The PA-C from the Clinic in the area.

developed stroke with generalized body weakness, unable to speak or respond to command. Continues at this time with weakness/inability speak/feed for herself.

Resident received Moderna vaccine on 12/23/2020 around 5 pm. At approximately 3:35 am on 12/25/2020, resident had a CVA and died on 1/1/2021 at 3:00 am.

Patient presented to the ED on 4/4/21 and 4/7/21. Patient presented to the ED on 4/10/21 with NSTEMI and was subsequently hospitalized. These visits are within 6 weeks of receiving COVID vaccination.

Pt. received her 1st Moderna Covid vaccine on 1/28/2021 with lot number of 010M20-A at 0906 am. Family reports since the first vaccine pt. has had weakness and has fallen. Pt. received her 2nd Moderna vaccine on 2/24/2021; see information above for lot, etc. Pt. was brought into ER with c/o falls, weakness and confusion. Pt. had fallen on 2/27 and 2/28. With one of the falls pt. fx. her right radius and ulna. PCP due to altered mental status, right sided weakness and aphasia at times is r/o stroke.

102 female who is a COVID survivor.. had a mild case of COVID in May 2020. Received first dose of Moderna at assisted living facility on approximately January 20th and suffered no ill effects. Had second Moderna vaccination late afternoon of February 8th. Later that evening or in the early morning of February 9th tried to go to the bathroom and either fainted or fell onto the bathroom floor on her face. Lay on the bathroom floor face down until assisted living facility staff found her in the morning when they were passing out medications. Taken to ER at hospital on 2/9/2021. Was not admitted to hospital- all CT scans and x-rays and blood work were normal. Taken back to assisted living facility where she exhibited dramatic change in behavior- uncooperative, refusing to eat or take meds, refusing to get OOB. Mentally a decline in cognition. Transferred to different facility with higher level of care on February 15th and is improving somewhat.