Moderna

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

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.

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.

Nausea, vomiting, diarrhea, chills and fever, fatigue, PO2 dropped into high 80's. Diarrhea lasted about 24 hours, N/V about 48 hours. Chills ("teeth clattering") lasted 36 hour and fever (subjective, temp not taken by patient) lasted about 48+ hours. At 5 days post vaccine, PO2 is back up to 97 and she has only fatigue.

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.

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

nausea next day on second day 3 pm shaking, shot of breath then - had chill then fever, 3 day another chill and fever - lose of appitite

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.

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

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.

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.

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.

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

Patient developed COVID 13 days after vaccine administration presenting with shortness of breath and generalized weakness.

Hx dementia, CVA, CAD. 2-3 year history of only consuming 25% of 1-2 meals daily. All meds d/c early 2020 because of refusing to eat or drink anything. Suddenly began drinking april/may, gained weight back. Vaccinated on 1/7/21 & 2/4/21. On 2/22/21 had significant changes in respiratory status. Passed away 2/23/21.

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.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Shakiness-Severe, Additional Details: Pt experienced lower back pain, difficulty breathing, dizziness, light headed, shaking more than normal, cold, felt like she was fainting

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.

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).

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.

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.

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)

Skilled nursing facility reported that patient was hospitalized on 7/27/2021. Patient received a chest x-ray on 7/25/2021 which indicated right lower lobe pneumonia. Began antibiotics but signs/symptoms worsened. Sent to hospital on 7/27/2021 and received a positive Covid-19 PCR test upon admission. Facility reported the patient had a fever of 100.4 degrees and shortness of breath.

12/30/2020 07:02 AM Resident noted to have some redness in face and respiration were fast. Resident vital signs were abnormal except blood pressure. Temp at the time was 102.0 F taken temporal. Resident respirations were 22 labored at times. Pulse is 105 and pulse ox 94% on room air. Resident is made comfortable in bed. Notified triage of change in condition also made triage aware of resident receiving Covid vaccination yesterday morning. Resident appetite and fluid consumption has been poor for few days. 12/30/2020 07:32 AM Received order from agency to administer Acetaminophen 650mg suppos rectally due to resident not wanting to swallow anything including fluids, medications and food. This writer administered medication as NP ordered. Will monitor for effectiveness and adverse effects if any. 12/30/2020 08:41 AM Received new orders to obtain Flu swab, obtain CBC and BMP, and Chest Xray all to be obtained today. Notified family of resident having temperature and vital signs excluding b/p that was abnormal. Family was thankful for call and inierated to nurse that family does not want resident sent to hospital. Did educate family on benefits of Hospice services, but family persistant on continued daily care provided by nursing staff. Requests visits if decline continues. Family assured if resident continues to decline, facility will accomandate resident family to be able to be at bedside when time comes to do so. NP ordered IVF and IV Levaquin on 12/31/20. Family chose at that time to sign for Hospice services and not have resident provided with IVF or IV Antibiotics

At approximately, 1855, I was alerted by caregiver, resident was not responding. Per caregiver, she was doing her rounds and found resident in bed, unresponsive, mouth open, observed gurgling noises and tongue hanging out of mouth. This primary caregiver observed resident at baseline and ambulating after dinner at approximately, 1800 less than an hour prior to incident. This PCG called 911 for EMS and gave report of incident. Resident was taken to Medical Center Emergency Department. At ER, CT scan and X-ray was performed. Per report from ER RN, CT scan and x-ray revealed an intracranial aneurysm and fluid in the lungs. Per RN, resident was still unresponsive and was admitted to Medical Center for observation and comfort measures. This primary caregiver reported to RN, resident recently received the first dose of COVID-19 vaccine on 1/2/21. Primary caregiver received a call from Castle RN at 0700, resident expired at 0615.

Approximately 15 minutes after receiving the vaccination the patient began to feel a tightness in the throat and difficulty speaking with a sense of anxiety and fright. The EMT and paramedic summoned me and after arriving at the observation area and ascertaining the patient's symptoms i asked the medic to administer the .3ml of epinephrine via EpiPen which he then did. Responding paramedics then arrived and took over assessment and treatment of the patient. An ambulance had previously been called and the patient remained stable with slight improvement in the sense that she became less anxious and frightened. She exhibited no urticaria or angioedema. Vital signs included initial B/P of 183/95 with improvement to 176/76 and 99% pulse ox . Patient was transported to hospital and per daughter was released about 2 hours later.

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

PATIENT WAS MONITORED FOR 15 MINUTES AFTER RECEIVING INJECTION. AFTER LEAVING, RETURNED TO VACCINE POD COMPLAINING OF SWELLING OF TONGUE AND THROAT AND SHORTNESS OF BREATH. EMS EVALUATED PATIENT AND SHE WAS TAKEN TO HOSPITAL WHERE SHE WAS TREATED FOR ANAPHYLAXIS AND RELEASED.

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

Pt received moderna vaccine #2 at 1:30pm. No s/s of adverse reactions. Ate dinner at 4pm. She was in her room at 430pm and she slid out of her chair and was laying on her Right side. She reported she slid out of her chair because she needed to go urinate per staff. She denied pain. At 630p complained of right hip pain. mobile xray was ordered. At 825pm resident was sleeping x 30 mins in her bed when she was found to have no pulse or respirations. She ceased to breathe. Mobile xray did not make it on time.

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 woke up the night of the shot and experienced let crams, she was gasping for air, and had shortness of breath. She also experienced leg cramps. This lasted for 3 days.

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 intestinal cramps...very sharp, caught my breath a few times! Went away by the next night. About 24 hrs.

Acute onset shortness of breath approximately 11-12 hours post second dose of Moderna covid vaccine. EMS responded and briefly performed CPR before DNR was produced and life saving measures were discontinued. Patient subsequently expired.

Went down hill after receiving the 2nd shot and stopped breathing; Went down hill after receiving the 2nd shot and stopped breathing; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY ARREST (Went down hill after receiving the 2nd shot and stopped breathing) in a 92-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. No Medical History information was reported. On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (Went down hill after receiving the 2nd shot and stopped breathing). On 24-Mar-2021, the patient experienced RESPIRATORY ARREST (Went down hill after receiving the 2nd shot and stopped breathing) (seriousness criteria death and medically significant). On 24-Mar-2021, GENERAL PHYSICAL HEALTH DETERIORATION (Went down hill after receiving the 2nd shot and stopped breathing) outcome was unknown. The patient died on 24-Mar-2021. The reported cause of death was stopped breathing. It is unknown if an autopsy was performed. Reporter wasn't sure if patient received Pfizer or Moderna vaccine. The patient was in hospice care and reporter thought the patient received the vaccination from a local pharmacy. Concomitant medications and treatment medications were not provided.; Reported Cause(s) of Death: Stopped breathing

Admitted with increased SOB, acute respiratory failure secondary pneumonia. Previous COVID-19 infection in December 2020. Positive COVID-19 test on admission 4/16/2021.

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 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."

7.11.21: Patient presents to the ED with fatigue, dyspnea, cough, and malaise. found to be COVID-19 positive. has a history of receiving both doses of Moderna COVID-19 vaccine. diagnosed with Pneumonia. Found unresponsive during CTA of chest. Then coded in the ED. transferred to the ICU. 7.12.21: rapid response called for respiratory distress. intubated. started remdesivir. received 1 dose of tocilizumab. 7.16.21: patient still admitted as of today - the day of report submission. still intubated. completed 5 day course of remdesivir.

On 1/14/2021 resident began having a loose nonproductive cough. Lungs clear. Increased shortness of breath, Afebrile. Complaints of Left sided rib pain. Resident currently on hospice. Started Duonebs every 6 hrs. Resident also began having loose stools as well.

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]

(Did not have a reaction from the vaccine, tested positive for COVID after receiving both vaccines and required hospitalization) Received Moderna COVID-19 vaccine on 2/4/21 (lot # 011M20A) and second dose on 3/4/21. Developed shortness of breath on 3/18/21, went to hospital and tested positive for COVID-19 on 3/22/21

4/3-was feeling unwell and didn't eat much 4/4-could not get out of bed without assistance in the am; vomited mucus and could not eat; refused Easter dinner. 4/5-woke up and had trouble breathing; ambulance called "she had no pulse, and had trouble breathing" Throughout had no fever or chills.

Moderna COVID-19 Vaccine EUA: two days after vaccination patient admitted for management of recurrent right-sided pleural effusion and acute on chronic repiratory failure. Underwent thoracentesis. Discharged medically stable.

4/16 515am Itchy at vaccine area, nausea, used Sarna itching lotion, tylenol 230pm more itching lotion 315pm redness the size of baseball, hot to the touch, went to urgent care, icing 4/17 physical aches throughout, continued icing and tylenol 4/21 4am nausea and aching all throughout the limbs, couldn't walk due to pain in thighs, short of breath, tried to rest. the pain continued for over an hour till fell asleep.

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.

Vaccinated at about 9:50am Five minutes after vaccination, complained of itchy or "dry" throat. Gave water. 10 minutes after vaccination complained of throat beginning to close up. 10:01am given 0.3mg Epinephrine into right thigh. 911 called. 10:03 given 25mg Diphenhydramine oral tablet. 10:06am pulse 90 BPM. 10:09 pulse 96 BPM. She started to feel better by the time EMS arrived. 10:16am EMS took her to Hospital. She was returned home in the afternoon. Unknown if any further complications.

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

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

Not even 20 hrs after she received the vaccine she couldn?t breathe, she?s been fine nothing wrong at all. 7am she was awake sitting up in bed doing crosswords told her great granddaughter to have a good day at work and would see her shortly . 739 I walked out the room to take my kid to work was gone till 751 not even 12 minutes and I came in and my gram couldn?t breathe was yelling for me saying she couldn?t breathe. It sounded like my gram had come over with upper respiratory problems in a matter of 10 minutes she was gasping for air called 911 spoke to operator my gram was talking saying she couldn?t breathe she was trying to breathe, my grams last words were if they don?t hury I?m going to die I?m 100% sure my gram was dead in my arms before EMS arrived. Yes she was 95 but she is a healthy lady have had no issues of health problems lately. We?ve done everything to keep her save from the virus and then she gets her 2nd moderna shot and she?s dead 20 hrs later there?s a huge problem old age or not

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.

Hospitalized and died due to COVID-19 after being fully vaccinated. From vital records: ACUTE RESPIRATORY FAILURE WITH HYPOXIA, PNEUMONIA DUE TO COVID-19

administered vaccine left arm at 12:08pm about 5 minutes later, 12:13pm patient reported feeling mild dizziness, denied any other symptoms including breathing difficulties. patient was observed for 20 minutes from time the vaccine was administered. blood pressure was normal at 140/70, pulse was normal at 65 and pulse rate was regular. patient's color remained normal during observation. symptoms never worsened and patient wanted to go home. she then left the clinic accompanied by her son.

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

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.

Pt receieved her first dose of the Moderna COVID-19 on 12/29/2020. Lot number, route, and site not specified in medical record. No record of 2nd dose was found on medical record review. Pt was admitted to reporting hospital 2/2/2021 with an admitting diagnosis of failure to thrive/poor oral intake. Pt was reported in ER to have a sore throat, cough, shortness of breath, and general recent decline. Reported that pt and others in family had GI like illness about a week ago. Admission test for COVID was positive per PCR NP swab on 2/2/2021. Pt still currently admitted.

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

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

esophagus is severely inflamed; unable to eat or hold down fluids; nausea; vomiting (thick mucusy stomach fluid); Fluid at bottom of lungs; Acites; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PLEURAL EFFUSION (Fluid at bottom of lungs), OESOPHAGITIS (esophagus is severely inflamed), FEEDING DISORDER (unable to eat or hold down fluids), NAUSEA (nausea) and VOMITING (vomiting (thick mucusy stomach fluid)) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 05-Mar-2021, the patient experienced PLEURAL EFFUSION (Fluid at bottom of lungs) (seriousness criterion hospitalization). On 16-Mar-2021, the patient experienced NAUSEA (nausea) (seriousness criterion hospitalization) and VOMITING (vomiting (thick mucusy stomach fluid)) (seriousness criterion hospitalization). On 21-Mar-2021, the patient experienced OESOPHAGITIS (esophagus is severely inflamed) (seriousness criterion hospitalization) and FEEDING DISORDER (unable to eat or hold down fluids) (seriousness criterion hospitalization). The patient was hospitalized on 21-Mar-2021 due to FEEDING DISORDER, NAUSEA, OESOPHAGITIS, PLEURAL EFFUSION and VOMITING. At the time of the report, PLEURAL EFFUSION (Fluid at bottom of lungs), OESOPHAGITIS (esophagus is severely inflamed) and FEEDING DISORDER (unable to eat or hold down fluids) had not resolved and NAUSEA (nausea) and VOMITING (vomiting (thick mucusy stomach fluid)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood test: normal (normal) blood work done shortly before getting COVID vaccine and everything came back normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Additional information: Patient was admitted to the hospital 10 days ago on 21Mar2021. Nausea and vomiting was continuing, patient's esophagus is severely inflamed, patient is unable to eat or hold down fluids, had to start TPN, has had Gastro-Intestinal biopsies performed, Computed Axial Tomography scans, endoscopy, esophagram, oncologist consulted-nothing showing up, fluid in bottom of lungs, ascites-pulling fluid off abdominal cavity with paracentesis (first on 5Mar2021, second paracentesis scheduled for today.) Doctors have been in touch with another facility.; 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.

Extreme fatigue, shortness of breath. Stopped eating within 2 days, stopped fluid intake 3 days later. Family notified on March 3. ery little fluid intake until Sun, when fluid intake stopped as well. Death occured on mon, Feb 8 2021.

03/15/2021: Presented to the emergency department with shortness of breath and not feeling well. The patient was admitted with pulmonary vascular congestion on imaging and UTI. The patient is currently still admitted.

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

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.

Increased shortness of breath on 6/12/21, tested positive for SARS-CoV2 on 6/12/21. on 6/15 patient is on a medical unit on 5L O2 Nasal cannula

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.

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

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.

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

This 98 year old female received the Covid shot on 2/13/21 and went to the ED and admitted on 4/30/21 with the diagnoses listed below and died on 5/9/21. J44.9 - COPD (chronic obstructive pulmonary disease) S72.002A - Left displaced femoral neck fracture W19.XXXA - Fall, initial encounter S09.90XA - Head injury, initial encounter

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!

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.

Notes of the checks/events with resident: 18:36 2/2/21 Resident had no complaint of pain, swelling, redness or warmth to vaccine site. No signs and symptoms of fever, chills, tiredness or headache. T 97.2 02:50 2/3/2021 Resident received 2nd COVID vaccine. No complaint of pain, swelling, redness or warmth to vaccine site. No signs and symptoms of fever, chills, tiredness or headache. T 98.1 07:15 2/3/2021 Resident was observed not breathing. 911 was contacted along with the doctor. Resident was confirmed having passed away.

Patient stated she was having some SOB after being vaccinated. She states she is Asthmatic and have not had her nebulizer treatment in over a week, because she had received a new one and had no idea how to set it up. Patient's VS was stable and Sat @ 95% - 97% on RA. Patient urged to take 2 puffs of her Xopenex treatment. Patient was then monitored for an additional 10 minutes after which she states felt well enough to go home. Patient accompanied by her husband to home in stable condition

Swelling of tongue and throat, red itchy area on Left collar bone. Dr prescribed Benadryl and Prednisone 60mg 1xday for 5 days. Symptoms started around 9pm in the evening of same day as vaccine was given.

Statement from health worker from Mobile Vax Team: "We arrived at the patient's home and daughter explained patient was on hospice, had difficulty breathing and was on fentanyl and morphine but they definitely wanted to go ahead with the vaccination. Nursing student, who gave the vaccine said she saw the patient breathing. She wasn't blinking from my observations. We left after 15 minutes. I left my purse there by mistake so about 40 minutes later we called and the daughter informed us that her mother had passed away. Death verified by hospice nurse."