Moderna

0840 Patient received vaccine. No reported allergies to any medications or immunizations. COVID19 pre-vaccination checklist completed. Patient moved to observation. 0852 patient complained of tightness in throat and slight shortness of breath. 0853 RN took BP 180/100, R 18, P66. Patient was sitting upright and took off jacket. 0858 Patient reports symptoms are the same. BP 172/108. 0859 Patient reports difficulty breathing and continued tightness in throat. RN administered 50mg IM Diphenhydramine. 0908 Patient reports that symptoms have started to improve. Reports continued some tightness but no longer having difficulty breathing. Patient reports that she is feeling some better. Family arrives. Patient explains that she has had the need for Benadryl with insect stings and had extreme reactions to some other items that were not previously reported to RN. Patient was observed and was feeling better. Instructed patient to contact PCP to report reaction and follow-up with PCP. Instructed patient to call 911 immediately with any further adverse reactions after returning home. Family to drive patient home and continue to monitor patient. 1500 patient called back to explain that she was feeling better. Some swelling in tongue. Patient follow-up with PCP today. PCP to continue to follow. No further medication needed at this time.

She reported that she began experiencing chills, muscle aches and respiratory symptoms last night. She went to see her physician today and was given a Covid test. Her results will probably not be in until next week

Employee received vaccine on 12/29/2020, was diagnosed with COVID-19 on 1/12/2021, had ED visit, received the Bamlanivimab infusion, returned to the ED on 1/16/2021, was admitted with dehydration, currently remains inpatient receiving Remdesivir infusion.

Acid indigestion, just tired. One incident of being a little short of breath. Checked my oximeter and my blood oxygen level was good and heart rate was good. Oxygen 95 and heart rate 70.

Five minutes after the vaccine was injected, I became dizzy, my eyes teared and face swelled up and throat tightened. The EMT's came, checked my lungs, etc. and talked me through the episode which lasted about 15 minutes. Then the swelling subsided. I suspect it had, because I had dermal fillers approximately a year ago. I had no other adverse affects, except for tiredness that evening. People should be warned about this because it is a frightening event. I have never had an adverse reaction to a vaccine before.

On 1/13/21 throat suddenly seized, had to work hard to expell or inhale air Turned slightly got dizzy then almost passed out but held on to handle of cart and then it passed and was able to breathe freely whole episode took about 20 seconds on the following night (1//14/21) about the same time was overwhelmed with nausea and strong abdominal cramps . Thought I was coming down with the stomach flu. Reaction disappeared after about an hour.

At 1038 Client started with flushing of the face and started feeling as though her throat was swelling. She took an allergy pill that she had brought with her in case of a reaction. She carries an epi pen but stated that she has never had to use it. She stated that she had a similar reaction to receiving a flu vaccine 25 years ago (flushing, itching and swelling). She was assessed by EMS staff that was on site.

1/9/21 At 3:50 am started with nausea, weakness, and complaints of body aches. Required more assistance with ADL's than previous. @ 4:28 am: complaints of SOB, O2 sats 85% on room air. Required supplement O2, with tremors noted. PRN Zofran administered for nausea. 7:42 am noted with fever, decreased O2 sats, Tylenol administered for fever. Fever continue to climb despite Tylenol, supplemental O2 increased to 4L, rapid covid test negative, new orders to start Rocephin IM x 3 days and stat Xray which showed pneumonia. Temperature continues to remain elevated- O2 status continues to decline. Sent to ER 1/9/2021 @ 4:53 pm via ambulance. Admitted to Hospital with ABT tx for pneumonia and UTI. Respiratory status continued to decline- pulmonology consulted- Placed in ICU 1/13/21 and started on steroids. Required BiPap and was eventually weaned to supplemental O2. Multiple Covid tests- all negative. GI complaints addressed with GI consult- unremarkable. Started on PPI and Linzess. Eventually was placed on telemetry floor, closely monitored by pulmonology, and was cleared for discharge on 1/19/2021 back to nursing home.

Got vaccine on Wed, fatigue started on Sat at first then headaches off and on and by Sun had muscle aches that got progressively worse. Mon I worked for 4 hours at desk job and by the end my ribs and back hurt so bad I caught myself holding my breath when breathing. Went home and laid sown the rest of day. Tues slept till 4:30 in the afternoon and then laid down rest of day. Slept till 11am on Wed and rested rest of the day. Headache and muscle pain not as bad. Called doctors office Wed and doctor wasn't in. Nurse will talk to him tomorrow and call if he advises anything mofre then what she had said which was rest. drink plenty of fluids and take tylenol. She advised to sign up for v-safe to VAERS.

Chills, shortness of breath (mild) joint and muscle pain, fatigue Essentially similar symptoms to when I had covid, towards the end of my illness. So like immune system symptoms. I had covid 3/15/20-4/30/20. I?m a long COVID sufferer, I still have resp pbs, arrhythmia, fatigue. I would like to get the second shot but am concerned about my over reactive immune response

Began to have slight wheezing and coughing on Wed afternoon, the day after getting the shot. Thursday wheezing and coughing increased and woke me up during the night several times. Cough was productive with clear sputum. Friday felt very tired all day and coughing and wheezing increased substantially, producing shortness of breath upon any exertion, like going up and down the stairs. Very tired. Began to think I'd have to go to see the Dr. because wheezing was significant with every breath. Cough was racking, increasing through the day into the evening. At 10 p.m. I began to wonder if I'd make it through the night without calling the rescue squad. Couldn't take a deep breath or speak a whole sentence with out a coughing jag. Then, suddenly about 11:30, it just ceased. The tightness in my chest went away, the coughing with every inhalation stopped and I could take a deep breath. It was a bit stunning. Because I had pulmonary embollisms about ten years ago, my lungs have been a weak spot in my body with bronchitis occurring frequently. I hadn't seen reports of this side effect of the vaccine, so I thought I'd report it. This morning, Saturday four days after the shot, I am breathing much better, not coughing, and do not have any wheezing.

My arm was sore and swollen at the vaccine site 3 hours after inoculation and thru the following 48 hours. On 1-23-21 I started feeling very short of breath, began using my Albuterol inhaler every 4 hours; and continue using it. On 1-29-21 my upper arm at vaccine site started itching and had some red spots, this stopped the next day.

Patient had already been observed for 15 minutes and left the facility. Patient stated while on her way home her and her husband were discussing side effects when she started to feel SOB, dizziness, and slight chest pain so they returned to the clinic. Full set of vitals was taken. Doctor evaluated patient. Patient started feeling better after drinking some water. Second set of vitals taken and patient discharged to go home with husband 1215pm.

Patient with COPD here to receive her 1st dose of Moderna COVID vaccine. Patient was feeling well prior and her husband states she has not had any breathing issues for 2 months. Approximately 10 minutes after receiving her immunization, she developed a dry, tight cough but lung sounds were initially clear. Over the next 10 minutes she progressed to audible wheezing. She took 3 puffs of her home albuterol inhaler. Oxygen saturation was 99% but patient reported no improvement with her inhaler. Acute bronchospasm secondary to vaccine administration Patient was given albuterol 2.5 mg via nebulizer along with 25 mg Benadryl. Following the nebulizer treatment, lung sounds were once again clear, audible wheezing was gone, and patient was feeling back to baseline. She was given 125 mg Solumedrol to prevent relapse of symptoms. Advised use of nebulizer every 4 hours as needed today if cough or wheezing returns. As for her second dose, we discussed pretreating with Benadryl 25 mg and an albuterol nebulizer treatment prior to arriving. I would recommend she be monitored for 30 minutes when she receives it as well and be ready with Solumedrol and Epinephrine in the event she has issues. Husband and patient encouraged to call back if worsening issues today.

2/10: fatigue, fever, decreased appetite. Tylenol 2/11: mental status wax/wane, lethargic 2/13 @ 0900: unresponsive to sternal rub, increased WOB, tachycardic, febrile D5 1/2 NS IV bolus, Rocephin Transferred to Hospital 2/13

Approximately 10 minutes after receiving 2nd dose of Covid-19 Moderna vaccine, patient began to have difficulty breathing. Husband reported that she has a history of panic attacks. No swelling in throat was noted. Instructed patient to take slow deep breaths. 911 was called. Vitals obtained with blood pressure 118/80, respirations 30-35 per minute, SP02 at 97% on room air. Patient was transported via ambulance to Hospital. Spoke with the ER and she reports that patient is doing fine, they diagnosed as anxiety and gave her Ativan . Patient discharged back home.

Slight fever, loss of strength, headache, extreme difficulty breathing. Oxygen, steriods, antibiotics for UTI, Cyanotic according to EMS and saturating at 80s at home. No accute pathology but hyperinflated WBC was 19. Sent home with oxygen

shortness of breath, chest tightness, elevated blood pressure. Was sent to urgent care for further evaluation and treatment

headache, fatigue, 02/16 thru 03/25/21 tongue thickening, 02/18 thru 02/25/2021 swollen face, throat, 02/22 thru 02/25/2021 Doctor prescribed PredniSONE 20 MG TAB CADI beginning 02/25/2021 for 5 days, on going, no outcome

2/23/2021, 6:30 PM facial flushing, 10:30 PM diminished. 2/24/2021, 3 am awakened from restful sleep, sinus congestion progressed to bronchial congestion to chest tightness to difficulty breathing, throat tightening sensation, tongue tingling progressed to thickened sensation, slight difficulty swallowing water. Symptoms occurred over the course of 1.5 hrs. 4:45 am symptoms spontaneously ended. 5:00 am symptoms no longer present, body fatigue, restful sleep.

Almost exactly 24 hours after 2nd shot, my mom was getting her hair done and she started breathing hard. Hairstylist removed her mask and she then passed out. Called 911. They observed my mom sweating, her lips and hands were swollen, she was slack jawed, pale and clammy. After several minutes she came out of it. Was given a piece of candy thinking it was a sugar low, but her sugar was high 285 @9:00am. Her color was still pale and she was still incoherent. While still on with 911, she became more lucid and said she was feeling better, so ambulance was canceled. I drove her home and checked her sugar @11:00 - 295 and BP 125/55 pulse 75. She stayed with me for the rest of Saturday. Her sugar was still high Saturday evening and Sunday morning. Upon checking her blood sugar log, her sugar had gone up for a week following the first shot.

Patient has known lymphoma but was on break from chemotherapy. No known lung disease. She developed a very large left pleural effusion and became markedly hypoxia need chest tube drainage. Multiple fluid cultures were negative for infection and fluid sent twice for cytology and flow cytometry were negative for tumor cells. She was too ?sick? for thoracoscopy. Over the next 7 days the symptoms resolved and the effusion has not returned which speaks against this being from the lymphoma. She had symptoms the night of the vaccine but did not become critically ill for about 36 hours as the effusion was developing. Her oncologist and I both believe this was related to the vaccine and will not give the second dose.

Chills, no fever, headache, body aches, loss of appetite, some heart palpitations, fatigue, muscle aches, shortness of breath. Unable to do daily tasks for five days. Swelling, redness and severe pain at injection site.

Periodic pressure and tightness across chest and diaphragm especially on day of vaccination and following 2 days. Rapid heart beat followed by afib that was not terminated with normal medications. Dizziness and shortness of breath. Hospitalized with atrial fibrillation with rapid ventricular response. It resolved after getting two injections of a medication called diltiazem in the emergency department, after which I was monitored overnight in the hospital. Underwent stress test and echocardiogram - results normal. On the day I write this (March 1) continue to have shorter periods of rise in blood pressure and heart rate, diaphragm tightness, insomnia and lethargy.

Afternoon on the day of vaccination patient felt a little weak and c/o mild pain at the injection site. Next morning after around 11 am patient started to vomit almost a lot, her fever went up to around 38.5C auxiliary, she reported extreme weakness and shakiness, her blood pressure also increased to 160s/high 90s, she complained of extreme shortness of breath. Elevated BP could be related to the fact that she was vomiting so much, she had hard time taking her scheduled medications, included BP medications. This lasted for 3 days. Patient was taking Ondasentron and that was only reliving nausea for 2 to 3 hours. She was taking Tylenol to bring her fever down. 650 mg Tylenol was only lowering temp to about 37.8. For about 72 hours she was complaining of extreme generalized pain and weakness and had very hard time getting up to go the bathroom. She started to fill a little better on March 27, 2021. Shortness of breath disappeared in the morning. Temperature fell to 37.1C. She stopped vomiting and was able to eat. Generalized weakness and shakiness persisted till March 2, 2021. At the moment of submitting this report, patient is still reporting that she does not feel that she is "100% back to normal"

Tiredness that night and the next morning i felt like i had not slept and continued over 5 days. i was so sleepy. legs were very shaky and i was very nervous inside. I had shortness of breath and i still have it. I road a bike 4 to 6 miles every day and now i cant. i had chills and body pain, i feel like i had the flu. dizziness, just just random spouts of sleepiness and it would last for about an 1 hr and half. My muscle in my chest just tightens and is hard as a rock. and then it goes away.

Patient presented to ED with SOB and hypoxia. She stated that this is a chronic problem for her. She had a video conference with her physician who told her to go to the ER. Her O2 saturation was noted to be 87%. She was found to have pulmonary edema and received Lasix. She is also scheduled to have a cardiac cath to evaluate ventricular tachycardia. Patient remains hospitalized at this time. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine

Pt. got lightheaded, and felt tingly all over about 10 minutes after shot (12:10). About 10 minutes (12:20) letter started feeling "Chest tightening". She denied not shortness of breath, and no other symptoms. About 2 minutes after that all symptoms were resolved. She denied BP check, & EMS. Reports when she got home felt yucky & whoozy but was still able to do chores. Around 9:00 pm started feeling short of breath and real tight chest. She put vicks vapor rub on chest and in nose and about 20-30 minutes felt a little better. She was able to sleep her normal amount. She reports she is back to her baseline this morning.

Patient stated that she had throat tightness and dizziness with in 15 minutes of receiving the vaccine. She report this to me on 03/04/2021. She stated that the sensation lasted about 1hour and 30minutes. She did not seek medical attention.

Sunday, Feb 21, 2021. Patient told her husband she didn?t feel well and she lay down next to him. She was tossing and looked like she was trying to get up. He was talking to her and she wasn?t answering him. She was having trouble breathing. Took her to the hospital right away at 7:30 pm. They put her into a comma with a respirator. Finally went from emergency room to ICU on Monday. Then on Wednesday they took the respirator out and I spoke to her ? told her we all love her and she could only say hoarsely ?terrible, terrible.? They said she might get moved to regular floor. But then Wednesday night couldn?t breathe again and put the respirator back in. Thursday morning husband had it removed and she died that evening at 10:51 on February 25.

Same day vaccine second dose given March 4. Between 15 minutes reaction was dizziness, difficulty breathing. Went into adverse reaction. Did not wake up - moved to ER

PATIENT WAS ADMINISTERED HER FIRST DOSE OF MODERNA. AFTER ABOUT 5 MINUTES THE PATIENT STATED SHE DID NOT FEEL WELL. SHE STATED SHE WAS NAUSEATED AND WEAK INITIALLY. AFTER A FEW MORE MINUTES SHE STATED SHE WAS SHORT OF BREATH. AMBULANCE ARRIVED AND GAVE HER OXYGEN AND TOOK HER TO THE HOSPITAL.

within first 24 hours lots of wheezing and difficulty breathing, headache. In 3rd & 4th day morning nausea along with terrible headaches. Taken inhalers for wheezing and better by 3rd day. I've been taking Extra Strength Tylenol and Musinex to relieve headaches but still have them.

tiredness,headache,musle pain, join pain,injection site swelling,injection site redness,feeling unwell,swollen,throat swelling,lost appetite.

Symptoms started suddenly without warning: weakness/fatigue- hard could get out of vehicle , needed assistance. chills shortness of breath excessive thirst

Fatigue, lost appetite, congestion, bronchial congestion, chest tightness, throat tightness, difficulty breathing, tingling/thickness of tongue

30 Minutes after receiving the vaccine, patient began having a self reported allergic reaction. Complaining that her nose and face was beginning to swell. + nausea. When I arrived to assess the patient, she was tachypneic and trying to self administer benadryl

They proceed to take the round and at that moment they realize that she was not breathing, she was already compromised . He dies of heart failure.

02/20/2021Shortness of breath on climbing 15-20 stairs, 02/24/2021/D-dimer test very high, 02/24/2021Admitted to hospital. CT Angiogram showed blood clots in lungs. Administered IV Hyperin. scans of legs-no blood clots, Scan of heart and arteries. 02/26/2021Released with perscription of Eliquis. 03/04/21 Blood test by Hematologist Normal; 03/08/21 CT Scan of body-Normal-no tumors/cancer detected

Debilitating fatigue, mild-moderate nausea, increased coughing/shortness of breath, general malaise for about 5 1/2 weeks.

Presented at PCP's office for progressive shortness of breath for the past few days. During visit patient had a syncopal episode regained consciousness then lost pulse for which she received 4 minutes of resuscitative care with chest compressions. She did regain a pulse after about 4 minutes of chest compressions. During that time emergency room physician said he saw a slow narrow complex rhythm. No reports of ventricular arrhythmias. Troponin and d-dimer were elevated. Heparin was started in the ED. During stay she was started on warfarin and bridging with heparin.

With the first dose about 12 hours later I experienced some numbness of my face. The next day I had a measles-like rash which went away in a few hours. Pain in my arm went away in 2 days. With the second dose on the third day after the injection I developed severe itching and noticed a red spreading rash in the area of the injection, just a little below the injection site. This is very red, sore and feels somewhat warm to the touch. The area is about 5 inches in size and is still painful. I have also noticed some shortness of breath but minor. Some numbness and itching around my face.

Pt is a previously healthy 76 year old woman who received her covid vaccine 2 wks ago. She received Moderna vaccine on 3/8/21. On 3/16/21 She developed symptoms of fatigue, chills, body aches, decreased exercise tolerance. 3/19/21 exercised at YMCA as she does regularly. She was not able to do her usual level of activity and was only able to exercise low level for 10 minutes. Yesterday was very sob and after washing 2 windows had to lay down and rest. In my office the nurse rooming the pt noted the pt to be very winded and sob just ambulating from waiting room to the exam room. Pox was down to 89% and took a while to come up to 94%. Transferred to Hospital ED. DiagnosedDiagnosis: Acute hypoxic respiratory failure secondary to massive Pulmonary Emboli, DVT without known precipitating factors. pt without previous history of clotting disorder, no known neoplasm, no recent travel or sedentary period. unprovoked DVT with MASSIVE PE. patient did not have previous pulmonary disease. Additional information for Item 19: studies: PO Chest Final Result Stable chest. No new opacities are identified in this patient with known extensive bilateral pulmonary embolus. US Venous Duplex Lower Extremity Bilateral Final Result 1. Acute DVT involving the right popliteal and posterior tibial veins. 2. No acute DVT involving the left lower extremity. CT PE Protocol WITHOUT legs Final Result 1. Positive exam: Large-volume central pulmonary emboli seen in both main pulmonary arteries with extension bilaterally into all lobes. Dilated right heart chambers suggesting acute right heart strain. 2. Peripheral groundglass opacities in the right upper lobe may represent small area of pulmonary hemorrhage or developing infarct. Red Level 1 findings were entered into the system. | Actionable Findings system for documentation and communications on 3/22/2021 4:31 PM, Message ID 191499. 3. Pulmonary nodules in the right lower lobe measure up to 4 mm maximally. See below consensus guidelines. TTE - INTERPRETATION SUMMARY: Left ventricle is normal in size. There is normal left ventricular systolic function. The quantitative LVEF based on modified Simpson's method is 62%. There is asymmetric septal hypertrophy with maximal wall thickness of 1.3 cm. There is mild (grade I) diastolic dysfunction with normal left atrial pressure. Right ventricle is normal in size. There is normal right ventricular systolic function. No previous echocardiogram in Froedtert Health system for comparison.

PATIENT RECEIVED 2ND DOSE OF MODERNA VACCINE ON 3/29/2021. PATIENT EXPERIENCED SHORTNESS OF BREATH ON THE EVENING OF VACCINATION. ON 4/1/2021, PATIENT CALLED TO INFORM THE PHARMACY ABOUT SHORTNESS OF BREATH. PHARMACY INSTRUCTED THE PATIENT TO CONTACT HER PRIMARY CARE PHYSICIAN. PATIENT RECEIVED ANTIBIOTIC AND RESCUE INHALER FROM DOCTOR'S OFFICE ON 4/1/2021. PHARMACY COUNSELED ON THE CORRECT USE OF THE INHALER AND WILL CONTINUE TO FOLLOW-UP. AS OF 5:45 PM OF 4/1/2021, PATIENT STILL EXPERIENCES SHORTNESS OF BREATH.

8 days after receiving the vaccine I developed shortness of breath & rapid hard heartbeat. Symptoms have lessened but are not totally gone. Hoping it doesn't happen again after my 2nd shot.

Pt received vaccine, started to experience throat tightness and difficulty swallowing. Vitals taken, MD notified. Pt escorted to exam room. Benadryl 25mg IM ordered and administered. Patient feeling much better. Second set of vitals taken. No SOB, or throat tightness, vitals stable. Pt discharged home.

Patient's husband alerted pharmacy staff that patient was having difficulty breathing with bright red pallor roughly 5 minutes following her second dose. She was slightly hyperventilating, had pain radiating from her neck superior to her ears and anterior down her back. She described the pain as "shooting" and moving downward. She was able to take deep breaths and converse with no issues so epinephrine was not administered. Paramedics were called to the scene to assess her condition. She was able to stand, showed no signs of dizziness or change in mental status, and her pallor began returning to baseline. EMS took her BP and oxygenation, she declined transport to a hospital and remained at the pharmacy for an extra 30 minutes.

Swelling in bottom and top lips, tongue, throat, knots on head, welts on both sides of abdomen, tonsils starting around March 21. Had to go to urgent care on March 28. Strange headache on left side. Finger tips and toes went numb. Covid vaccine related illness(chills, body aches, shallow breathing) started 1 week after 2nd vaccine. Ongoing shortness of breathe.

Pain coming from around the liver area but it radiated under my right and left breasts; Pain coming from around the liver area but it radiated under my right and left breasts; Lost my appetite; Urine was gold; Lost 10 lbs; Could not get a deep breath; Temperature reached 101F; vomiting; Nauseous; A spontaneous report was received from a consumer who is 76 year female who experienced a reaction to the vaccine, experienced pain coming from around the liver area radiating under right and left breast, loss of appetite, difficulty breathing, vomiting and nausea. The patient's medical history included fibromyalgia, ulcerative colitis, and obesity. Concomitant product use included:levothyroxine 150 mg, verapamil 120 mg (blood pressure), losartan 100 mg (blood pressure), Asacol 800 mg three times a day, Eliquis 5 mg, alprazolam (Xanax) 0.5 mg up to three a day, Centrum silver once a day, iron pill once a day, B12 500 mcg once a day, GNC probiotic 50 billion CFU, vitamin D 1000 mg, Citracal max Plus D3 once a day, magnesium glycinate, diphenydrinate. On 15-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Batch number015M20A.). On 16Mar2021,approximately 1 day prior to the onset of the symptoms, the patient received their first/second of two planned doses of mRNA-1273 (Batch number: 001B21A.) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 17Mar2021 about 10 am, the patient woke up screaming with pain coming from around the liver area radiating under the right and left breasts. The patient states that taking deep breaths lead to excessive vomiting resulting in the ultimate loss of 10lbs. After the initial episode of vomiting, there was only nausea. An ambulance transported her to the hospital, as she continued to scream, resulting in being medicated to calm her down. The medication used is unknown. In the hospital, received morphine for three days In the hospital, she was told her temperature reached 101F. Upon returning home on 19Mar2021 afternoon, her temperature ranged from 99.4 to 99.8, one day peaking 101F. Today (29Mar2021) it is back to a more normal temperature: 98F. In the hospital, ultrasounds, CAT scan, and blood and urine tests was performed, results were not provided. Patient reports currently she is still in pain, that has reduced from a 10 to a 2. The outcome of the events, pain coming from around the liver area radiating under right and left breast, loss of appetite, difficulty breathing, vomiting and nausea is unknown.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.

On 3/11, patient complained of shortness of breath with ambulation. She was sent to the ED and diagnosed with pulmonary embolism. Negative for DVT.

Provided Moderna COVID-19 Vaccine EUA. Adverse Reactions are as follows: Elevated heart rate, Shortness of Breath, Severe Pain throughout entire body, Extremely Cold and Uncontrollable Shaking of her Body through the night and over the next two days. (The shaking would come in waves over the three days). Fever. Fatigue that lasted a few days. Diarrhea, Lost Appetit. Swelled/Sore Arm. Diarrhea, Fatigue and little apatite is still an issue as of today 4/14/2021. All symptoms are identical to when my mother had the virus in 2020. She is not getting the 2nd shot as a result; too risky for her health.

Starting feeling bad about 4 hours after vaccination. By the next day (4/11) had difficulty breathing, nausea, severe bladder pain, stabbing pain in stomach, epigastric pain, chest pain, and alternating between severe chills and feeling hot. By 4/12 most of this had subsided and she was experiencing weakness and fatigue, in addition to loss of appetite. This resolved over the next few days.

Face / tongue / throat swelling sensation without problems breathing or swallowing or speaking Prescription medication needed

patient had covid shot given to her at drive up. she states immediately she started having a headache, labored breathing, tongue swelling and burning in her chest along with being flushed. the physician on site gave her benadryl and epinephrine, and she was then driven to another ED where she was given IV steroids. she states the vaccine adverse event was not reported by any of the facilities that took care of her that day. she also has had flu like symptoms since she got her shot and she is still recovering.

after 3 minutes of getting shot, patient developed headache, labored breathing, tongue swelling, burning sensation in the chest, and was flushed. she was at a drive through administration facility run by Hospital Systems. she was given benadryl and epinephrine and then was driven to the ED, where she was given IV steroids. she also developed flu like symptoms which she is still having now.

Patient received her 2nd dose of the Moderna Covid-19 vaccine on 4/20/2021 at 0935. On 4/25/2021, patient presented to the ER with SOB and mild CP that began after she walked a 1/2 mile to her nephew's home. Pt was diagnosed with bilateral PEs and admitted to the hospital for treatment. At this time patient is stable, improving , and remains admitted to the hospital.

Patient rec'd Moderna COVID vaccines 1/30/21 and 2/27/21. On 4/3 she presented to the emergency department following a syncopal episode. Prior to syncopal episode she had a 2 week history of dry, nonproductive cough, left side rib pain (Pain rating 8/10). She was admitted and treated for PE and possible pneumonia. She was discharged 4/5 on warfarin anticoagulation. She had follow up appointments with PCP and hematology and will likely be on anticoagulation for unprovoked PE x 6 months.

January 14th, (11 days after moderna covid first shot) my right lung hurt. Saw doctor next day. He Said oxygen level was good and lungs were clear couldn't find anything. Slowly developed not being able to breathe while sleeping at night. Got worse and worse. Then on April 30th was able to breathe during sleep and to this date, May 5th I no longer have problems breathing during sleep. Dr's did find heart mitral valve mildly leaking and tricuspid valve mildly leaking.

shoulder blades with pain number 2 and head number 6; jaw pain; chest pain, chest was hurting; very bad feeling in the head, back of the throat and lips.; it has been over 42 days since she receive the first dose; very bad feeling in the head, back of the throat and lips.; shoulder blades with pain number 2 and head number 6; headache; very fatigue; felt drained; funny feeling that she doesn't know how to describe it in her lips; shortness of breath; lips were swollen; feeling like anxiety; barley walk; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (chest pain, chest was hurting) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced ORAL DISCOMFORT (funny feeling that she doesn't know how to describe it in her lips), DYSPNOEA (shortness of breath), LIP SWELLING (lips were swollen), ANXIETY (feeling like anxiety), GAIT DISTURBANCE (barley walk), FEELING ABNORMAL (felt drained), FATIGUE (very fatigue) and HEADACHE (headache). On an unknown date, the patient experienced CHEST PAIN (chest pain, chest was hurting) (seriousness criterion life threatening), OROPHARYNGEAL DISCOMFORT (very bad feeling in the head, back of the throat and lips.), ARTHRALGIA (shoulder blades with pain number 2 and head number 6), PAIN IN JAW (jaw pain), INTENTIONAL PRODUCT USE ISSUE (it has been over 42 days since she receive the first dose), HEAD DISCOMFORT (very bad feeling in the head, back of the throat and lips.) and HEADACHE (shoulder blades with pain number 2 and head number 6). On 22-Feb-2021, CHEST PAIN (chest pain, chest was hurting), ORAL DISCOMFORT (funny feeling that she doesn't know how to describe it in her lips), LIP SWELLING (lips were swollen), ANXIETY (feeling like anxiety), GAIT DISTURBANCE (barley walk), FEELING ABNORMAL (felt drained) and HEADACHE (headache) had resolved. At the time of the report, OROPHARYNGEAL DISCOMFORT (very bad feeling in the head, back of the throat and lips.), ARTHRALGIA (shoulder blades with pain number 2 and head number 6), PAIN IN JAW (jaw pain), DYSPNOEA (shortness of breath), INTENTIONAL PRODUCT USE ISSUE (it has been over 42 days since she receive the first dose), HEAD DISCOMFORT (very bad feeling in the head, back of the throat and lips.), FATIGUE (very fatigue) and HEADACHE (shoulder blades with pain number 2 and head number 6) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment include Benadryl and Tylenol.. Event Start date and stop date updated. 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-Apr-2021: Event start date and stop date updated for events On 28-Apr-2021: Significant 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.

on post vaccine day #9 pt developed light bruising r antecubital [vaccine was l deltoid] and knots. she has had ongoing mild nontraumatic bruising here and sq nodular lesions ? clot. pt also has had generalized malaise and some mild shortness of breath with this and has generally felt sick.

O2 levels where they'd be mid 90s and would walk a little and go down to 79%; weakness; shaking; shortness of breath; unable to get out bed; heart rate would go into the 100s with minimal exertion; myalgia in neck and shoulder; chills; 103F fever; This spontaneous case was reported by a physician and describes the occurrence of HYPOXIA (O2 levels where they'd be mid 90s and would walk a little and go down to 79%) in a 76-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 COVID-19 (had COVID19 at the end of October) in October 2020, Fever (beginning of November 2020 where she presented fever, myalgia, loss of appetite that lasted about 2 weeks then she was back to normal.) in November 2020, Myalgia (beginning of November 2020 where she presented fever, myalgia, loss of appetite that lasted about 2 weeks then she was back to normal.) in November 2020 and Appetite lost (beginning of November 2020 where she presented fever, myalgia, loss of appetite that lasted about 2 weeks then she was back to normal.) in November 2020.Concurrent medical conditions included Hypertension (for which she takes a small dose of an antihypertensive medication). On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced HYPOXIA (O2 levels where they'd be mid 90s and would walk a little and go down to 79%) (seriousness criterion medically significant), ASTHENIA (weakness), TREMOR (shaking), DYSPNOEA (shortness of breath), HYPOKINESIA (unable to get out bed), HEART RATE INCREASED (heart rate would go into the 100s with minimal exertion), MYALGIA (myalgia in neck and shoulder), CHILLS (chills) and PYREXIA (103F fever). At the time of the report, HYPOXIA (O2 levels where they'd be mid 90s and would walk a little and go down to 79%), ASTHENIA (weakness), TREMOR (shaking), DYSPNOEA (shortness of breath), HYPOKINESIA (unable to get out bed), HEART RATE INCREASED (heart rate would go into the 100s with minimal exertion), MYALGIA (myalgia in neck and shoulder), CHILLS (chills) and PYREXIA (103F fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Angiogram: negative (Negative) Negative. In 2021, COVID-19: negative (Negative) Negative. In 2021, Cardiac stress test: negative (Negative) Negative. In 2021, Electrocardiogram ambulatory: negative (Negative) Negative.NThe action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant products included ANTIHYPERTENSIVES for Hypertension.BHer neck and shoulder pain persisted so she used Lidoderm topical and muscle relaxers which seemed to help as well as resting. Her doctor also advised she go to physical therapy to help.NBased 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.NThis case was linked to MOD-2021-103020 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event,s a causal relationship cannot be excluded.

A few days before she had trouble breathing, wheezing and then she got the vaccine and it got worse. Also had pains in her legs and chest. She gets weak and would have to lay down a walk and when she goes up and down the steps had to huff and puff, which she had not have this type of trouble in the past. She went to her cardiologist who took blood work, and he also did a chest x-ray. She then went to her PCP last week, who said he would check with her cardiologist and see the results of his tests. She is also a little light headed, but the breathing and wheezing is what is most bothersome.

COVID-19 Chills Body aches Fatigue, unspecified type Lyme disease Nausea and vomiting, intractability of vomiting not specified, unspecified vomiting type Acute nonintractable headache, unspecified headache type Dyspnea on exertion Acute midline low back pain without sciatica Diarrhea, unspecified type BMI 28.0-28.9,adult Close exposure to COVID-19 virus Fever, unspecified fever cause Care Coordination Progress Note RN (Registered Nurse) COVID 19 MAB Infusion Navigator Post Infusion Outreach #1 Infusion Date: 05/19/21 ED Course as of May 23 1036 Sun May 23, 2021 1025 EKG shows normal sinus rhythm rate 84 axis of 61. There is no acute ST or T wave changes noted. No signs of ST elevation. [RS] 1032 Patient was given meclizine and Zofran and saline. I reevaluated her. She says she is feeling much better. She is able to stand and walk without any difficulty. I discussed keeping her for MRI as we cannot completely rule out stroke. She verbalizes understanding of this. She still wishes to go home. She will get outpatient follow-up with her family doctor and return for worsening symptoms. We will give her a prescription for meclizine. Medication ? bamlanivimab/etesevimab ? casirivimab ? bamlanivimab

PATIENT DEVELOPED HYPOXIA, PNEUMONIA, PLEURAL EFFUSION AND LEFT LUNG PULMONARY EMBOLI PATIENT WAS TREATED WITH ANTIBIOTICS, OXYGEN ANDF STARTED ON HEPARIN DRIP, WHICH WAS D/C AND PATIENT WAS STARTED ON LOVENOX PRIOR TO D/C. PATIENT ALSO NOTED TO HAVE PULMONARY NODULES ON IMAGING AND ARRANGMENTS MADE TO F/U OUTPATIENT FOR BIOPSY.

Fatigue, feeling dizzy, not having good vision, leg cramping/hurting, HA, and SOB. She was diagnosed with myocardial Infarction in the ER with SOB adverse effect of the vaccine. She has no prior cardiac history

Very strong a-fib attack, blood pressure spiked. From 3/19 on shortness of breath when walking and pressure in head and blood pressure rise. Heart ultrasound 3/26 ok. Stress test with ultrasound 4/30 ok. Bloodwork, chest x-ray 6/4 ok. Drs. don?t know what?s going on. ER said people coming in with problems from the vaccines.

Patient presented to PCP from group home residency on 05/21/21 with C/O cough, dyspnea, fever, chills, and body aches. Known exposure to COVID-19. Rapid test in PCP office was positive for COVID-19. Chest Xray showed pneumonia. Patient admitted to hospital on 05/21/21

On April 18 I developed a headache and fever (101), fatigue, tightness/pressure in my throat/esophagus. Continued through April 20, when I called my GI physician to describe symptoms. Doctor recommended going to Urgent Care to be tested for COVID 19. Within an hour or two I went for the test, which was negative. The attending doctor then ordered EKG, blood tests, and CT scan to see what was going on. Found high white blood cell count and Pericardial Effusion. Sent me to hospital, where I was admitted and spent 6 days. The diagnosis was that the Pericardial Effusion was caused by inflammation, not infection, and I was started on a combination of drugs to eliminate the fluid. I was released on April 26 with only trace fluid around my heart.

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. The first time occurred on 03/09/2021 for severe sepsis, tachypnea. The second time occurred on 3/22/2021 for Acute cystitis without hematuria.

on 6/10/21, case experienced low blood pressure and increased heart rate. Tested positive for Covid-19 on 6/11/21. Case first visited emergency room at local Hospital due to low blood pressure, increased heart rate. Hospitalized 6/11/21 to 6/13/21. Fatigue, Shortness of Breath, and Cough also developed. Cough still persists as of 6/15/21

Pt was admitted on 4/16/21 to hospital from the ED for shortness of breath, after receiving second dose of vaccine on 4/1/21

Tachycardia, Afib, Pounding, Flutter (Heart) Short of Breath, runnier nose, Weak & Shaky, no Apatite.

The resident has redness and warmth on her LUA from her covid vaccination. The resident states she has a headache and some wheezing. New order received for Benadryl 25 mg po now and in 6 hours then PRN q6h x 3 days.

Tachycardia (160 to 180 beats per minute), shortness of breath, lightheadedness. Onset 2.5 hours after vaccine. Treated with diltiazem CR 120 mg. Resolved 6 hours after onset.

Tightness in chest with wheeze and cough, especially in evening on 1/16/21. These symptoms are slowly going away.

Pt received dose #1 Moderna COVID vaccine 12/28/20 @ Clinic. About 3 hours after had 30 minutes of rapid heart rate, and fluttering. Laid down, went to sleep, and it resolved. She didn't seek emergency care. Did not have chest pain or shortness of breath. Continued to have palpitations occasionally, fatigue, tachycardia. Presented to PCP on 1/7/21 for symptoms and was transferred to ED for additional cardiac workup and treatment after capturing SVT on EKG. Also diaphoretic, dizzy, nauseous, SOB with palpitations. Given IV metoprolol in ED with conversion to NSR. Per ED "Suspect that the vaccine may have been her trigger." Able to discharge without escalation of care. Entered for tracking.

Very high fever 6 hours after vaccine. Up to 104.3, chills, difficulty breathing, lower back sore. Lasted approx 2-3 hours with shivering

On 8th day after receiving the Moderna COVID vaccine, I awoke and noted that site of inoculation on left upper arm was very itchy with a 2x3 inch raised, red hive. I felt woozy, unsteady, a bit short of breath, a small headache, a bit of nausea,& fatigued. These symptoms subsided gradually over the next 4 days.

On 8th day after after the Moderna COVIDvaccine, I awoke and noted that site of inoculation on left upper arm was very itchy with a 2x3 inch raised, red hive. I felt woozy, unsteady, a bit short of breath, a small headache, a bit of nausea,& fatigued. These symptoms subsided gradually over the next 4 days.

On day of shot, after I got home, I had tingling in my mouth, dizziness, and slight tightness in my chest. The next day (1/27) I woke with chills and fever ranging from 99 to 102.4 degrees. And a severe headache., also very tired....Stayed in bed most of the day. On 1/28 I broke out in hives on my chest and stomach. Also have very sore muscles, especially in my legs, and shortness of breath.

Patient arrived at shot table in TCPH w/c, short of breath. Taken straight back to private observation from shot table. EMT on site in attendance. Upon assessment; patient having suprasternal, substernal, intercostal retractions. Patient on home O2 at 2 L/M per NC. Per EMT auscultation patient has inspiratory and expiratory wheezing. Patient has a loose congested cough. Pt's nail beds dusky, no blanching. Hands are cold. Unable to initially obtain O2 sat reading. Patient does not have inhalers with her. Pt. can't recall names of meds. 9:30 BP 132/62; HR 68 strong and regular per palpation. RR 30. 9:40 O2 sat 82% after hands warmed. Patient increased her own O2 to 3 L/m . EMS activated 9:45 O2 sat 84% with 3 L/m per NC. Still having deep retractions. 9:50 EMS arrived along with FWFD. Patient alert/oriented x 4, still labored breathing. Patient denies feeling badly. Med star team evaluating. 0957 O2 97% on 3 l/m per nc. HR 72; BP 104/58; ETCO2 41 1007 O2 97% on 3 L/m per NC; ETCO2 43; HR 112; BP 96/56. EMS recommends transport. Patient refused. Pt. states she will go home and take her own nebulizer treatment. Patient called brother for ride Patient left AMA, patient remains A/O x 4, taken via w/c to brother's car for transport home.

rapid heart beat followed by loss of breath. Couldn't get breath. Slight nausea called the nurse and she called 911. Then started in my intestines with numerous BMs that progressed to diarrhea . Breathing subsided back to normal within a half hour but the intestines continued through the next day.

Because of reaction on the first shot, when I got home after getting second shot I took a Benadryl. In the early afternoon I began to feel shortness of breath, breathing not normal and it steadily increased towards early evening when I took 2 more Benadryl which then quieted down the breathing reaction. Also that day I experienced a sore arm. The next day, breathing problems were almost all gone but decided to take 1 more Benadryl. During the day I felt flu like symptoms. The third day I feel like myself again.

I woke up the next morning and I was very short of breath much more then usual, by the next day it was even worse and everyday after. By Feb. 10, 2021 I had low fever and difficulty breathing so I went to Urgent Care, after blood work, received chest X-ray, EKG, CT scan. It came back with pneumonia. My biggest quest is can safely take the second one or a different one, with emphysema you need protection. Thank you

Current: COVID arm- small patch around injection site became red on day 8, Feb.11. It is not Feb.15, and the red itchy patch has grown to 2 1/2 " by 2 1/2". For the first 2-3 days, I had headaches, chills, extreme fatigue and had difficulty breathing. I had chest pressure the first day.

The evening of the vaccine started with fast heart beat, was unable to get to sleep as her heart was beating fast and she was breathing fast. She has a sore arm with a slight redness. They lasted over night and then resolved. All these symptoms have resolved.

Pt. began to have tightness in the chest and throat. Pt. refused epipen. After further observation, I called 911. Outcome unknown

2/19/2021 - 8:50AM - severe PAIN IN Back OF NECK AND ACROSS SHOLDERS, SHORTNeSS of BREATH.CHCKED B/P - 85/67. DRANK COLD WATER + LAID on COUCH - subsided in about 10min. 9:00AM - SEVeRe PAIN + MUSCLE CRAMPS, BOTH Legs, fROM knees to toes, couldn't stand up, crying with pain, leaned on walls to get to where husband was, He massaged it with Theraworx ~ 15min, got to wALK then. Exhausted NOW, Drinking a lot of fluids. 8:00am earlier syMPTOMS = Headache, PAiN IN LefT ARM, SLuggish

I had Covid on 25 Nov. 2020. I had extreme fatigue, shortness of breath, aching, headaches and abdominal pain. I have IBS which flared up during this time. It took me December and January to finally get over the fatigue part. When I received my vaccination on Feb. 12, 2021 (Moderna) by that evening I began to run a temp. of 102-103. I had chills, headache, abdominal pain (worse than in Nov.), fatigue, some dizziness, and short of breath. I felt like I had Covid all over again! I was down for 5 days. On Sunday afternoon, Feb 14 I went to the Clinic to see the doctor on call. I was told they could not test me since I had Covid November 25 and it hadn't been 90 days and I would still have the antibodies.

Shortness of breath; Hemoglobin went from 8.8 to 8.2; oxygen level was at 82 whenever she is standing or walking; Sore arm; A spontaneous report was received from a consumer concerning a 77-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shortness of breath, sore arm, oxygen level at 82 when walking, and hemoglobin went from 8.8 to 8.2. The patient's medical history was not provided. No relevant concomitant medications were reported. On 20 Jan 2021, the patient received their first of two planned doses of mRNA-1273(Lot number:039K20A) for prophylaxis of COVID-19 infection. On 20 Jan 2021, the patient experienced soreness in arm immediately after receiving the shot. The soreness resolved few days later. On 29 Jan 2021, Lab work done due to her being anemic and on perpetual oxygen therapy. Her hemoglobin level went down from 8.8 to 8.2 and her oxygen level was 82 on exertion. On 31 Jan 2021, the patient started experiencing shortness of breath. Patient stated that her saturation level was at 82 percent whenever she is standing up or walking and she runs out of breath. When she sits down, the level of the oxygen will go up. She said she is not sure if her medical condition is getting worse or if this is vaccine related Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the events, shortness of breath, sore arm, oxygen level at 82 percent when walking, and hemoglobin went from 8.8 to 8.2 were unknown.; Reporter's Comments: Based on the information from the source document that the patient is an anemic patient on perpetual oxygen, the events of oxygen saturation decreased, hemoglobin decreased and dyspnea on exertion is assessed as unlikely related to mRNA-1273. The event of pain in extremity is possibly related. Further information has been requested.

At aproximately 15 minutes after patient had the 1st Vaccine she complained of upper and lower lips feeling tingly. A couple of minutes later she said she had some difficulty swallowing saliva and the sensation of her throat feeling tight. She then reported resolve of her lips tingling but reoccurrence of same. She was given water and juice to drink w/o difficulty. She continued complaining of throat swelling sensation becoming worse and denied SOB. Patient stated she does smoke tobacco. VS 142/88 P 90 P/Ox 86% on RA Appears anxious w/o distress Heart RRR Lungs Some very mild diffuse wheezing A/P At approximately 45-55 minutes patient monitored with improvement in P/Ox to 91% on RA but continued complaining of sensation of throat closing. 911 called, IV started, paramedics administered Benadryl and patient was transported to ED without need of O2.

Developed shortness of breath. To ER and then hospitalized. Oxygen therapy and lasix given. Possible excerbation of HF. Hospitalized 2 days at Hospital . Discharged home with PCP follow up.

Pt received dose #2 Moderna COVID vaccine 2/1/21 @ clinic. 2/4/21 @ 1645 presents to ED for workup of hypotension, headache. Also reporting back pain, fatigue, shortness of breath. Given IVF and able to discharge home without escalation of care

Shortness of breath and respiratory distress resulting in mechanical ventilation. Some concern for myasthenia crisis due to presentation, started on course of IVIG. Possible azithromycin (home medication) could have been contributing to this as well. Also in septic shock with extensive lung infiltrates started on broad spectrum antibiotics with vancomycin and Zosyn - Zosyn was transitioned to cefepime. Lactic acidosis secondary to shock (initially 7.2 which has trended down to 2.5 at time of submission).

The patient had her second Moderna shot on Feb 17, 2021. At 3 am the next morning she reported to the ED c/o being "fluish" and short of breath. She was found to be hypoxic to the upper 80's on RA, and a CXR was consistent with CHF. She stated she had some off and on chest pain for the last few weeks, especially with exertion. Ultimately it was found that she had an elevated troponin and was felt to have had an MI. She underwent cardiac cath and a stent was placed in a 95% ostial right coronary stenosis. Although she was reported as having had a "hyperimmune" response to the vaccine, I can only say for certain she had flash pulmonary edema due to cardiac ischemia that was due to a stenosis in her RCA that had been there for quite some time, but possibly just happened to become critical right after her second COVID vaccine. It would be hard to blame the vaccine, but it is also impossible I guess to absolve it from any role in her MI.

Patient developed sudden SOB 1 week after she received #1 COVID vaccine on 1/28/2021 w/o associated chest pain/palpitation/cough. Her SOB was significant enough for her to seek Urgent evaluation on 2/8 then ED evaluation on 2/11 then again on 2/20/2021. she continues to have SOB/DOE even now. She also has dizziness intermittently. she had chills initially but no fever until she had transient fever for less than 12 hours 2.5 weeks later likely associated w/ unrelated problem( UTI). so far no causes found regarding her SOB after numerous tests( see below for tests).

Headaches, shortness of breath, left droopy eye.....achy and tired....lasted 5 days.... droopy eye lasted a week

Next day severe heat, swelling and pain at site. 2nd day severe heat, swelling and pain of entire upper arm 3rd day difficulty breathing, wheezing 4th day spasmodic coughing 5 - 12 day continued pneumonia like symptoms PLEASE NOTE: I HAD PNEUMONIA IN BOTH LUNGS AND WAS HOSPITALIZED FOR FIVE DAYS IN JUNE 2017. I HAD EMBOLISMS IN BOTH LUNGS, FLUID ON THE LUNGS, AND WAS ON OXYGEN FOR ABOUT 6 MONTHS, DAILY INITIALLY AND OCCASIONALLY AFTER 4 MONTHS. Treatment: I could not reach my physician despite repeated attempts. My pulmonologist had previously prescribed a protocol of prednisone and a z-pack should those symptoms recur. Day 6 after vaccine I began the protocol. Day 10 saw improvement in breathing and coughing. Day 14 symptoms resolved. Day 14 (Feb. 16) to Present (March 3) no unusual symptoms. Some nasal congestion and mild occasional wheezing, consistent with pollen season and my usual COPD symptoms. Thank you.

PAIN IN ARM VACCINATION SITE - TO DATE. RUNNY NOSE - TO DATE HEADACHE - TWO DAYS SHORTNESS OF BREATH - TO DATE RASH AND HIVES ON HANDS, RIGHT ARM, AND FACE. TO DATE

Significant throat constriction and difficulty swallowing 10 hours after first dose. This lasted for two days. Same symptoms occurred on day 4 and and day 11. Doctor recommended taking Benadryl every 6 hours and this did help.

Patient during routine observation a flag for 30 minutes began to feel sweaty, hot flash sensation and began tohyperventilate. Patient was identified by observation staff as follows: Awake x3, no chest pain, slight SOB, increased work of breathing without rales, rhonchi or wheeze. Pulses strong, capillary refill at 2 seconds, warm and dry. Patient is hyperventilation state without carpal spasms. Patient placed on pulse ox at 98% room air, pulse 88 and BP 174/84. No rash or hives, - supportive treatment - Refused additional treatment

After 1st dose on 1/29/21, pain at shot site, some redness & swelling. Tired for 2 days. After 2nd dose on 2/25/21, pain at shot site, redness & swelling. On 2/26/21, heavy chills, short of breath, face flushed, temp 98. Pain in low back & right upper arm (torn ligaments). Pain more severe than previously. 2/27/21 Shot site sore, itchy, red, swollen, short of breath, headache. Heavy chills towards evening. 2/28/21, Light pain at shot site, site swollen, warm to touch, labored breathing. Shakey, anxious, doom & gloom, food seems tasteless. Evening feeling better, swelling down, flashes if left eye. 3/1/21 arm itchy, no swelling, arm aches slightly. Pain in low back severe, right arm pain. There was only 26 days between the two doses. The pain in back may be from scoliosis. Pain in right arm, torn ligaments. But after receiving vaccine, these pains increased tremendously, as well as the shortness of breath and extreme groin pain (maybe from fibroids?).

IMMUNIZATION CLINIC NOTES: 77 y.o. female presented to Elementary School for second dose of COVID-19 vaccine. No known allergies. Patient reports history of hypertension, being treated with amlodipine. No history of asthma, COPD, use of inhaler for any conditions, or recent respiratory illness. Patient is a non-smoker. First dose of vaccine, Lot # 039K20A, administered on 2/6/2021 and patient reported no immediate symptoms during observation period after first dose. Second dose of vaccine, Lot# 013A21A, was administered on 3/5/2021 at 10:52AM to the left deltoid. Approximately 5 minutes after receiving second dose, patient reported feeling anxious and feeling like her blood pressure was increasing. Patient taken to EMS observation area. Patient observed by EMS. Nurse assessed patient at 11:23AM. Patient was alert and oriented x 4. Manual blood pressure was 196/86. Pulse, manually palpated, was 86 and strong. SpO2 99% on room air. Patient with flushing. No generalized hives. No itching. No swelling of face, lips, or eyes. Left deltoid injection site without erythema or swelling. Skin warm and dry. Lungs auscultated and inspiratory wheeze noted in all lung fields. No shortness of breath. No cough. No nasal congestion. No change in voice. No sensation of throat closing. No stridor. No dizziness or syncope. No GI symptoms. Patient experiencing skin and respiratory symptoms. RN was asked to assess patient?s respiratory symptoms and also noted bilateral wheeze. Patient?s symptoms post-vaccination involved more than one body system, skin and respiratory. Reviewed symptoms and standing order procedures with patient. Standing order for Medical Management of Vaccine Reactions in Adults in a Community Setting was followed. Patient was assisted to stretcher by EMS. 0.3mg epinephrine auto injector, Lot # G191202X Exp. 4/2021, was administered to the right outer thigh on 3/5/2021 at 11:39AM by RN. Patient was then transported by EMS to Medical Center. EMERGENCY DEPARTMENT COURSE AND TREATMENT NOTE: Patient's condition remained stable during Emergency Department evaluation. Decision made to obtain prior medical records. (+)Prior records reviewed. There is low suspicion for an allergic reaction given symptoms. Patient is well appearing with a normal exam. Plan to monitor. 03/05/2021 13:13 Patient remains well appearing will discharge home.

Lightheaded Vitals: B/P: 165/85 HR: 87 O2Sat: 98 Skin Signs: Cool and Dry Circulation: 5 Cap refill <2sec Resp: Wheezing (Chronic) Treatment: Supine position, water, 1 Nutter Butter Repeat Assessment at 11:40 am Vitals: B/P: 150/90 HR: 91 Resp.: 30 O2Sat: 97 Skin Signs: Warm and dry Circulation: 5 Cap refill <2sec Resp.: Wheezing (chronic) Treatment: sitting up in wheelchair, continued water, 1 Nutter Butter Disposition: Home at 11:57 am

patient status started to decline within a few hours of receiving her covid vaccine she was weak, developed increased shortness of breath and went to the emergency room were she was diagnosed with STEMI and within 2 days expired.

Moderna COVID-19 Vaccine EUA. Chills, fever, swollen throat, sore-red-itchy arm, headache, swollen sore lymph nodes, mild nausea, generally felt TERRIBLE.

C/o dizzy, lightheaded, shaky. Assess: - LOC, - NIV. VS 132/86, HR 96 Reg, + SOB, Resp 22 reg nonlabored. Within 5 min PT state I feel much better. Only had a muffin earlier. Encourage hydration & nutrition. Resp came down to 16 reg non labored. Daughter with her provided encouragement. Anxious about getting vaccine. Refused to wait 30 min. OK'd to exit. RN

I had quite an adverse reaction to the second MODERNA vaccine. That afternoon and evening I developed symptoms. I was experiencing chills, fever, body aches, headache, sore throat, shaking and nausea. As the week went on, my reaction became worse. I was sweating profusely and had shortness of breath accompanied with burning pain on the top of my hands and feet and a rash. On Friday morning, 5 days after the vaccine, I collapsed and had a stroke. I was rushed to hospital and was admitted. It was confirmed that I had a stroke. through a Cat Scan and MRI. On Saturday, I had another stroke. This time I was transferred to hospital. I had a huge blood clot on the left side of my brain which has effected my speech and walking. My entire life has been effected and changed. I had a plethora of tests done, MRI, CAT SCAN, EKG, BLOOD WORK etc. I also have to have speech therapy, physical therapy and occupation therapy. I spent about weeks in the hospital. The doctors think it is a possibility that the 2 Moderna vaccine caused my two strokes. What can be done about this? I will have problems for the rest of my life.

still having problems breathing; anaphylactic reaction; A spontaneous report was received from a consumer concerning a77-year-old, female patient who developed anaphylactic reaction and still having problems breathing (dyspnea). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received the unknown of two planned doses of mRNA-1273 (Batch number: 030M20A) on 24 Feb 2021 intramuscularly at unknown injection site for prophylaxis of COVID-19 infection. On 24 Feb 2021 the patient experienced anaphylactic reaction (lips went numb, face went numb, blood pressure went up, heart rate went up, her throat closed, and she couldn't breathe or talk). An ambulance was called and the patient was transferred to the ER (emergency room) where they administered intravenous diphenhydramine. Five hours later, the patient was okay, but reported that as of 25 Feb 2021, they are still having problems breathing. Treatment of the events included prednisone and diphenhydramine. Action taken with mRNA-1273 in response to the event was not provided. The event anaphylactic reaction was considered resolved. The outcome of the event, still having problems breathing, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

A-fib; difficulty breathing; sleeping on and off; dry heaving, feeling nauseated, not hungry; weak; chills; mild headache; Tired/fatigue; muscle pain on the arm; joint pain; Feeling nauseated; A spontaneous report was received from a consumer concerning a 77-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced difficulty breathing, chills, mild headache, sleeping on and off, fatigue, tiredness, A-fib, dry heaving, feeling nauseated, muscle pain on the arm, not hungry, weak and joint pain. The patient's medical history, as provided by the reporter, included prior COVID-19 infection. It is not clear if the patient had prior A-Fib. No relevant concomitant medications were reported. On 25-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. On 25-Jan-2021, patient was feeling fine right after first dose of the Moderna vaccine. On 26-Jan-2021, the patient felt difficulty breathing, chills, mild headache, sleeping on and off, fatigue, tiredness, A-fib, dry heaving, feeling nauseated, muscle pain on the arm, not hungry, weak and joint pain. Lab details was not provided by the reporter. Treatment for the events included rubbing gel. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, difficulty breathing, chills, mild headache, sleeping on and off, fatigue, tired, A-fib, dry heaving, feeling nauseated, muscle pain on the arm, not hungry, weak and joint pain was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Respiratory. Labored breathing, felt strange, little tingling in hands, tongue felt thick a little layet

Loss of voice! No ability to make a resonant voice. Just breathiness. This was preceded by fever and chills which lasted one night, the following day, and was better after the second night of sleep. Fever was gone in the morning but SO WAS MY VOICE!

Red, itchy raised area below injection site; pain in joints and muscles all over body (arms, legs, back, knee joints, elbows, wrists, ankles, calves), short of breath, weakness. Severest late Saturday and through night of March 27th and March 28th. Still feeling restrictions in back, lung area on Monday, March 29th.

Patient admitted to the hospital with a CVA with right sided weakness and chest pain. Chest pain radiated to her right arm and had significant shortness of breath. Symptoms started one week prior to seeking emergency care.

Patient presented to the ER via ambulance on 3/22/21 with a 5-6 day history of increasing shortness of breath. Patient is on home oxygen 2 L prior to admit. Patient hypoxic at home by EMS was 88% on 2L

High blood pressure spike 186/81; Rapid heart rate; Difficulty breathing; I had a visual aura I saw a big red ball with my eyes closed; Arm soreness; trembly; dry mouth; weak; A spontaneous report was received from a consumer concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events high blood pressure spike 186 81, rapid heart rate, difficulty breathing, a visual aura i saw a big red ball with my eyes closed, arm soreness, weak, trembly, dry mouth. The patient's medical history was not provided. Concomitant medications reported were Lotrel 5/10mg for drug use for unknown indication. On 3 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the event(s) high blood pressure spike 186 81, rapid heart rate, difficulty breathing, a visual aura I saw a big red ball with my eyes closed, arm soreness, weak, trembly, dry mouth. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), high blood pressure spike 186 81, rapid heart rate, difficulty breathing, i had a visual aura i saw a big red ball with my eyes closed, arm soreness, weak, trembly, dry mouth was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

30 MINUTES AFTER THE SHOT MY FACE BECAME NUMB, MY TONGUE BECAME HARD AND THE TOP OF THE TONGUE FELT LIKE THERE WERE LITTLE SWORDS, MY BREATHNG BECAME A LITTLED LABORED. WHEN I GOT OUR OF MY CAR AND WAS ALKING INTO Y HOME I FELT VERY WEAK. I WAS VERY AFRAID! I CALLED 911, EMT'S DID MY VITALS, BLOOD PRESSURE HIGH, OXYGEN 95 WHICH IS NOT Y NORM(99). AFTER MUCH DISCUSSION THEY WERE WORRIED I WAS HAVING A STROKE, THE AMBULANCE TOOK ME TO THE HOSPITAL. DID CAT SCAN. BLOOD TESTS. WATCHED ME. I WAS THERE ALL DAY. SENT HOME AT ABOUT 5:30PM HOSPITAL.

Gave the Vaccine at 12:42 client waited 18-20 minutes stood up to walk back to apartment and stated that she was not feeling well and sat back down. Stated that she was feeling short of breath and was not seeing clearling. Writer instructed Office support to call 911. Client continued to have heavy breating and pulse was weak at about 30 beats per minute. Gave epinephrine injection in Right thigh and EMS arrived. Client increased respirations and heart rate increased.

03/30/2021 @ vaccine drive though safe room site-pt received 2nd dose Moderna vaccine in left deltoid. Approx. 5 minutes after vaccination @ 10:15am, pt reported tightness in throat, chest pressure heart and palpitations. EMT assessed pt obtained v/s -b/p 144/78, P 64 o2sat 96% Pt was observed for 15 minutes after given Benadryl25mg po nurse Pt stated that she felt " a little better" left side. Pt stated she had a history of hypothyroidism and A-Fib

Pt presented to observation post 2nd Moderna vaccine- had been advised to remain in observation for 30 minutes. @6:00 PM pt walked up to observation RN to express "something is not right, I dont feel right and my teeth are chattering and my hands are tremoring" Pt was able to walk back to sit in a chair Initial BP was 225/205 and pt began to c/o feeling "I feel faint, very tired all of a sudden" RN advised CNA to alert staff for help Pt then began to wheeze and cough. Per adverse drug reaction kit IM Epinephrine 0.3 mg administered @ 6:05 pm 911 called. Within 2 minutes pt expressed "I feel better now" teeth chattering, fatigue and cough resolved. EMS arrived, son arrived Pt w/s/s similar to arrival at time of transport but lessened, pt left via stretcher to Hospital@6 bp recheck at time of discharge 169/64 Staff RN

Presented to emergency department with increased fatigue, body aches, fever, chills, and difficulty breathing and was found to be COVID-19 positive. Was treated with supplemental oxygen and dexamethasone and was discharged. Patient presented to the ED again following low pulse ox readings at home in the high 60s. Patient was found to by hypoxic and was admitted for further management. Patient is still currently admitted.

She had trouble breathing within days of the second vaccine. She went to the hospital 9 days after the vaccine. Her breathing continued to decline where she had to be placed on a ventilator. She stayed on that for almost 3 weeks. The doctors had no hope of her recovery and we chose to end life support exactly one month after her second shot.

fever, chills, body aches. Since my second vaccine, I have had difficulty taking a deep breath. I have seen my IM doctor, a pulmonologist and a cardiologist. I was tested for antibodies -IGG and they think I had covid. My antibodies were high. I am not 100% sure when I had Covid - I still don?t have sense of taste back. still have pain when taking a deep breath.

FEVER, Wheezing, Shortness of Breath DX Fever, unspecified fever cause R50.9 Pulmonary infiltrate R91.8 New Prescriptions DOXYCYCLINE HYCLATE (VIBRAMYCIN) 100 MG CAPSULE Take 1 capsule by mouth 2 (two) times daily for 10 days.

on 4/15 pt. presents to local ED with c/o SOB. Husband poor hx. but reports that pt. was not taking medications as prescribed. Documentation from MD in ED uncertain if pt. taking her amiodarone, torsemide and elquis. Noted to have O2 sats on RA of 81%. Pt. was in respiratory distress upon arrival to ER. Pt. was transferred to higher level of care, another Hospital on 4/15/2021 placed on Bipap.

swelling of ankles and feet; Difficulty breathing , Lethargic. has continued 3 weeks after 2nd shot.

Patient developed severe leg pain and increased shortness of breath 2 days after the vaccine. She was seen by her PCP and diagnosed with A COPD exacerbation, thought to be caused by the vaccine.

Patient contracted COVID 19 and subsequently expired from respiratory distress, following completion of the serious of two vaccination shots. She received her Moderna vaccinations on 1/7/21 and 2/4/21. I do not have access to the lot # info- would have to contact vaccination site to obtain

Patient presented to ED on 04/25/2021 with complaints of abdominal pain, abdominal distension, and AMS. Patient was admitted to ICU with following diagnoses: 1) Septic Shock, 2) A/C hypoxic/hypercapnic respiratory failure, 3) Acute metabolic encephalopathy, 4) Palliative care patient, 5) AE COPD, 6) ARF w/ATN on CKD3, 7) CAD, 8) Chronic sys/dia CHF, 9) Malnutrition/Failure to thrive. Patient died on 04/26/2021 at 1826. Patient was also previously admitted to hospital on 03/23/2021-03/29/2021 for sepsis.

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Primary diagnosis was acute on chronic respiratory failure with hypoxia and hypercapnia.

March 8th thru March 29 swollen ankle and left calf. Treated by patient with compression socks. Seemed to relive swelling April 13th Emergency Room at hospital, after extreme shortness of breath + coughing up blood at home. Admitted to hospital

30 minutes of rapid heart rate and fluttering; shortness of breath; supraventricular tachycardia; Dizzy; diaphoretic; Palpitations; Fatigue; nauseous; This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of CARDIAC FLUTTER (30 minutes of rapid heart rate and fluttering) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Dec-2020, the patient experienced CARDIAC FLUTTER (30 minutes of rapid heart rate and fluttering) (seriousness criterion medically significant), DYSPNOEA (shortness of breath), SUPRAVENTRICULAR TACHYCARDIA (supraventricular tachycardia), DIZZINESS (Dizzy), HYPERHIDROSIS (diaphoretic), PALPITATIONS (Palpitations), FATIGUE (Fatigue) and NAUSEA (nauseous). On 21-Dec-2020, CARDIAC FLUTTER (30 minutes of rapid heart rate and fluttering) had resolved. At the time of the report, DYSPNOEA (shortness of breath), SUPRAVENTRICULAR TACHYCARDIA (supraventricular tachycardia), DIZZINESS (Dizzy), HYPERHIDROSIS (diaphoretic), PALPITATIONS (Palpitations), FATIGUE (Fatigue) and NAUSEA (nauseous) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Dec-2020, Electrocardiogram: abnormal (abnormal) supraventricular tachycardia. On 21-Dec-2020, Heart rate: increased (High) increased. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were provided. About 3 hours after receiving vaccine, patient had 30 minutes of rapid heart rate, and fluttering. She laid down, went to sleep, and it resolved. She didn't seek emergency care. Did not have chest pain or shortness of breath. Continued to have palpitations occasionally, fatigue, tachycardia. She presented to primary care professional on 07 Jan 2021 for symptoms and was transferred to for additional cardiac workup and treatment after capturing supraventricular tachycardia (SVT) on electrocardiogram (EKG). Also diaphoretic, dizzy, nauseous, shortness of breath with palpitations. She was given IV metoprolol in ED with conversion to normal sinus rhythm (NSR). They suspect that the vaccine may have been her trigger. She was able to discharge without escalation of care. 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.

Congestion, stuffy sinuses fill up drain and repeat. Feels like lump in throat and cannot get deep breath in for 8 weeks. Anti histamines no help. Anxiety after 4-5 weeks. Lack of sleep due to drainage and asthma.

(Information gained secondhand from patient's close friend as patient was intubated and sedated at the time that potential relationship between events and vaccine administration recognized). 77 yo F with no known significant PMH (was independent in ADLs, active, line-danced twice/week) who developed nausea, headache, fatigue on first day after first dose of Moderna vaccine. Friend reports that patient complained of "just not feeling right" following vaccine administration. Complained of poor sleep, poor appetite, dyspepsia and began complaining of lower extremity swelling in the weeks following vaccine administration. Was no longer able to line-dance, etc. Was fatigued. Her friends became concerned and encouraged her to seek medical attention, patient reported that she had was prescribed "water pill" and told to "lay off salt,". Friends later found out that she had lied about doctor's visit and was self-medicating with over the counter "water pills" for all of the water weight she was gaining. Eventually developed worsening shortness of breath. Admitted to hospital on 5/4 with shortness of breath and worsening abdominal pain. Found to have systolic heart failure (EF 20-30%) and was in SVT. Also diagnosed with UTI and SMV thrombus. Grossly anasarcic on exam. Treated for heart failure with diuretic and for her UTI with antibiotics, was started on Heparin drip for SMV thrombus. Underwent left heart catheterization at OSH that was negative for significant CAD. Developed worsening septic shock and was transferred to our hospital for higher level of care. Unfortunately had ongoing decline, found to be fungemic. Eventually succumbed to her septic shock, passed away on 5/14/21. Patient had second dose of vaccine on 3/18/21 according to vaccine card in her purse. Friend states that because of symptoms she developed after first dose of vaccine, she was fearful of getting second dose. Friends insist that she was well before the vaccine---knee pain was limiting factor for her activity level, never shortness of breath. Of note, several friends tested positive for COVID on 2/11/21, the week prior to patient receiving her vaccine. Patient tested negative and reportedly got tested at frequent intervals and was always negative.

right side chest pain and mild heart failure with bilateral pleural effusion and increased SOB- seen in hospital ER twice in 24 hours

5/12 Admitted to medical center with new dysphagia and slurred speech. 5/17 Acute Hypercarbic respiratory failure; Neuromuscular dysfunction - 5/19 -CONCERN FOR GBS. Patient on BiPAP (no history of pulmonary disease)

heart cath; Fluid on the lungs; short of breath; Did not get second shot due to illness; sore arm; not being able to stand up and being weak; Aching all over every joint; not being able to stand up and being weak; This spontaneous case was reported by a consumer and describes the occurrence of CATHETERISATION CARDIAC (heart cath) and PULMONARY OEDEMA (Fluid on the lungs) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO), LEVOTHYROXINE, METOPROLOL, FUROSEMIDE, POTASSIUM, WARFARIN, GABAPENTIN and METOLAZONE for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced CATHETERISATION CARDIAC (heart cath) (seriousness criterion hospitalization). On an unknown date, the patient experienced PULMONARY OEDEMA (Fluid on the lungs) (seriousness criterion medically significant), DYSPNOEA (short of breath), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not get second shot due to illness), PAIN IN EXTREMITY (sore arm), ASTHENIA (not being able to stand up and being weak), ARTHRALGIA (Aching all over every joint) and DYSSTASIA (not being able to stand up and being weak). On 17-Mar-2021, CATHETERISATION CARDIAC (heart cath) outcome was unknown. At the time of the report, PULMONARY OEDEMA (Fluid on the lungs), DYSPNOEA (short of breath), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not get second shot due to illness), PAIN IN EXTREMITY (sore arm), ASTHENIA (not being able to stand up and being weak), ARTHRALGIA (Aching all over every joint) and DYSSTASIA (not being able to stand up and being weak) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Cardiac catheterization on 17-Mar-2021. Based on the current available information and temporal association between the use of the product and the start date of the events( cardiac catheterization, dyspnea, pulmonary oedema, dysstasia, asthenia, pain in extremity and arthralgia) a causal relationship cannot be excluded. However for the event of inappropriate schedule of Product administration for mRNA-1273, causality is assessed as not applicable; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events( cardiac catheterization, dyspnea, pulmonary oedema, dysstasia, asthenia, pain in extremity and arthralgia) a causal relationship cannot be excluded. However for the event of inappropriate schedule of Product administration for mRNA-1273, causality is assessed as not applicable

Onset urticaria 3/12/21. ED visit 3/14/21. Syncopal episode in context of rash 3/17/21 leading to hospitalization 3/17-8/21. Benadryl, loratadine, famotidine, cephalexin for UTI. 2nd Moderna shot 3/27/21. 4/2 Office visit dizzy, weak, headaches, nausea, loss of appetite since 2nd vaccine Na 127. 4/16 Office visit for Headache, neck pain. 4/25 ED visit for dizziness. MRI head NL, labs mild hyponatremia. Given meclizine. 4/27-8 Hospitalization for dizziness, orthostasis, URI symptoms. OC43 Coronavirus, orthostasis. Alb 2.7 Globulin 5. New cervical and axillary Lymph adenopathy. 5/8/21 admitted to hospital w/ new diagnosis of lymphoma (pathologic diagnosis Nodal peripheral T cell lymphoma w/ follicular helper phenotype. Large axillary lymphadenopathy, thrombocytopenia, elevated total protein, acute kidney injury, anemia. 5/15/21 patient passed away from acute hypoxic respiratory failure in the setting of new lymphoma diagnosis.

Positive covid test; shortness of breathe; diarrhea; no eating; tired; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Positive covid test) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes and Hypertension. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced COVID-19 (Positive covid test) (seriousness criterion hospitalization). On an unknown date, the patient experienced DYSPNOEA (shortness of breathe), DIARRHOEA (diarrhea), DECREASED APPETITE (no eating) and FATIGUE (tired). The patient was hospitalized from 17-Feb-2021 to 21-Feb-2021 due to COVID-19. At the time of the report, COVID-19 (Positive covid test), DYSPNOEA (shortness of breathe), DIARRHOEA (diarrhea), DECREASED APPETITE (no eating) and FATIGUE (tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2021: No specific follow-up information recorded.

Received Moderna vaccine against COVID on 2/15/2021 and 1/28/21 (lot number 037k20a). Vaccinated at a site but immunization in state database. Presented with shortness of breath and weakness in lower extremities. No requirement for supplemental oxygen. Treated with PT/OT. Shortness of breath resolved.

Intense diarrhea, stomach cramps and bloating. nausea, fatigue, memory loss, incoherent, skin peeling over entire body including face, immobile and labored breathing (over and above her COPD).

On 06/15/2021 pt. presents to ED with c/o weakness, SOB, cough, increased sputum production, pleuritic pain, and leg edema. Pt. cont. to smoke. Pt. reports having difficulty getting out of her chair at home to go use the restroom. Pt. states that she collapsed in the hallway, a soft fall and was unable to get up. Pt. was able to activate her life-line button for assistance. Pt. was found to have an O2 saturation on RA of 84%. Pt. had IV placed, received an Albuterol HHN UD breathing treatment, a dose of Levofloxacin 500 mg, lab work, EKG and CXR. Pt. was transferred to higher level of care.

Death 4/30/2021 Causes of death listed on death certificate: 1) Covid Pneumonia 2) Chronic obstructive pulmonary disease, unspecified Other: none

She was coughing blood clots and I took her to the ER and she was diagnosed with blood clots in her lungs.

Possible myocarditis. Patient experiencing profound non-ischemic cardiomyopathy and acute CHF, without obvious other cause on preliminary investigation. Sx of fatigue, dyspnea, exercise intolerance, myalgia began 24 hours after vaccination. Myalgias resolved but CHF progressed until Dx 6/29/21. Previously an active runner.

Shortness of breath; loose bowels, cannot eat fiber; Bled a bit; Spasm in Neck; Temperature of 100.3; Chills very severe; Headache; Severe joint pain for her rotator cuffs and neck, tendons in arm, ribs, and all bones; Injection really hurt; Nausea; Knocked out from going up stairs and getting up chair now; Pain in tendons in her arm/ sore arm; Pain in ribs; Pain in all her bones; Rapid heartbeat/Palpitation Continues; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Knocked out from going up stairs and getting up chair now) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Arthritis (Patient had arthritis attack prior to vaccination.). On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Knocked out from going up stairs and getting up chair now) (seriousness criterion medically significant), TENDON PAIN (Pain in tendons in her arm/ sore arm), MUSCULOSKELETAL CHEST PAIN (Pain in ribs), BONE PAIN (Pain in all her bones), PALPITATIONS (Rapid heartbeat/Palpitation Continues), VACCINATION SITE HAEMORRHAGE (Bled a bit), PYREXIA (Temperature of 100.3), CHILLS (Chills very severe), HEADACHE (Headache), ARTHRALGIA (Severe joint pain for her rotator cuffs and neck, tendons in arm, ribs, and all bones) and VACCINATION SITE PAIN (Injection really hurt). 03-Apr-2021, the patient experienced MUSCLE SPASMS (Spasm in Neck) and NAUSEA (Nausea). On an unknown date, the patient experienced DYSPNOEA (Shortness of breath). an unknown date, the patient experienced DIARRHOEA (loose bowels, cannot eat fiber). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever and Headache, at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) ongoing since an unknown date for Allergic reaction, at an unspecified dose and frequency. On 05-Apr-2021, CHILLS (Chills very severe) had resolved. On 25-Apr-2021, TENDON PAIN (Pain in tendons in her arm/ sore arm), MUSCLE SPASMS (Spasm in Neck), PYREXIA (Temperature of 100.3) and NAUSEA (Nausea) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (Knocked out from going up stairs and getting up chair now), MUSCULOSKELETAL CHEST PAIN (Pain in ribs), BONE PAIN (Pain in all her bones), DYSPNOEA (Shortness of breath), VACCINATION SITE HAEMORRHAGE (Bled a bit), HEADACHE (Headache), ARTHRALGIA (Severe joint pain for her rotator cuffs and neck, tendons in arm, ribs, and all bones) and VACCINATION SITE PAIN (Injection really hurt) outcome was unknown and PALPITATIONS (Rapid heartbeat/Palpitation Continues) and DIARRHOEA (loose bowels, cannot eat fiber) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, Body temperature: 100.3 (High) Temperature 100.3 Degree. On 01-Jun-2021, Cardiac monitoring: inconculsive (Inconclusive) Patient Wears a heart monitor.. On 16-Jun-2021, Antibody test: negative (Negative) Patient was reported to have no antibodies at all. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient's Date of Birth was reported to be 1944. Chills were reported to be very severe and she could not get warm even with a heater on. Patient was reported to have had a cardiogram done after consultation with physician. No concomitant medications were reported. Patient also reported that she could not eat fiber. Patient still has heart palpitation and wears Heart monitor. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow up was received on 17-JUN-2021. Lab data- antibody test was added. Additional event- diarrhea was added.. Event- Loss of consciousness was updated. Case was upgraded to serious- medically significant. Outcome of events- arthralgia, palpitations were updated. On 21-Jun-2021: Secondary reporter information was added. Added medical history Arthritis.Lab data-Cardiac monitoring was added. Added newevents spasm in neck and Nausea. Added stop date for sore arm/pain in tendon in her arm event.; 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.

weakness, fatigue, had a bad taste in her mouth as soon as she got the vax, shortness of breath, chills, was losing her balance, headaches, temporal artery on right side of her head is bothering her, diagnosed with gastroparesis, right arm/near breast is sore, developed tremors

Moderna COVID-19 Vaccine EUA chills, shortness of breath, fatigue, body and muscles sore to the touch headache with funny feeling, sluggish, flushed, no taste. sore throat, nausea (not vomiting), severe leg cramps, droopy, eyes won't focus and want to close, lumpy throat that is sore to the touch

Approx 3 hrs after the injection, I felt tightness in my throat like a lump, then noticed a blotchy vibrant red rash over both arms, legs, neck and shoulders. I took Benadryl, Claritin and Pepcid ( these were meds previously recommended for my daughters allergies). It took about 30 mins after the meds to be able to swallow comfortably without coughing. The rash however lasted three weeks. I has a telemedicine consult with my allergist who was hesitant to advise the second shot.

Chills, fever of 101.3 and then cough with wheezing And bad headache. Don't know if this is all related to the vaccination.

Patient developed cold like s/s on the 11/12 of January 2021. By the 15th of January patient became weak with mild shortness of breath and was sent to the ER. ER sent patient home. Patient was sent back to ER on January 18th as she remained weak with shortness of breath and was unable to get out of bed. On the 19 of January the patient was sent to a SNF for rehab services in which she remains as of today. According to the patient's son the patient is doing better but still requires assist with mobility. Patient is not on oxygen.

The first day felt fine, the next day when she got up in the morning she didn't feel well, but felt well enough to put a roast in the crockpot. Felt then headache, aching in all joints and muscles with achiness. Felt it in her heart, short of breath. The following day felt worse, just wanted to sleep, freezing cold and her temp was low, she could not get warm, and went back to bed and stayed there. She could not eat much, drank water. The following day after that felt a little bit better. She feels about the same she did yesterday, heaviness of her legs especially her knees, weakness and fatigue. Had a pressure like headache in the top of her head and back of her head, right side of her face. The 2nd day the pain was up her neck on the right side, it hurt bad. All her joints are hurting, she does have arthritis. Also having back pain. The 2nd day took Tylenol a couple of days, and took 1/2 pill of Hydrocodone, which causes liver/stomach pain. Not in the pain in the muscles now just a heaviness in her legs and shaky. Called her doctor who did not have much information and informed to call us.

head ache 3-4 hours day of vaccination, lips tingly 3-4 hours day of vaccination, shortness of breath 2-3 hours (2 different times) next day after vaccination, increased vertigo symptoms since vaccination & still remains, but other symptoms are improved. Note: just wondering if interaction of the steroid injections every two weeks with the covid vaccination???? (in answer to be if recovered...all except the increase of vertigo)

Pt reported dizziness and was observed coughing and continuing to c/o of SOB. Pt reported chest tightness and throat tightness.

Day #1 Intense itching, swelling and redness within 3 hours after injection Day #4 Swollen tongue, itching, difficulty swallowing, coughing, wheezing. Called 911 and transported to Hospital. Received Prednisone 20mg for 5 days, Famotidine 20mg Day #9 Tele-visit with Dr. Received Azithromycin 250mg for coughing. continued Azithromycin Day #10 Symptoms returned. Swollen tongue, difficulty swallowing, breathing difficulty, left arm is swollen, red and itching at injection site. continued Azithromycin Day #11 Woke up with same symptoms in addition to nausea. continued Azithromycin

3 days after the injection I experienced a heavy chest and shortness of breathe on exertion. This happened after receiving each shot.

about 3:30 the next morning i woke up with dry mouth and went to the bath room and tried to drink water and my throat had closed up and i couldn't breathe I was not able to drink water and and kept gasping for air. finally after a few minutes i was able to catch my breath and i started to wheeze and then my chest hurt when i would breath. And then i woke up today and i was fine.

HISTORY OF PRESENT ILLNESS: Pleasant 78-year-old female with history of lung cancer with remote partial pneumonectomy, some element of COPD and chronic respiratory failure on home oxygen therapy. She presents with worsening shortness of breath, which started rather abruptly the day prior to presentation. On arrival to the ED she was mildly tachypneic and slightly tachycardic and appeared to be in mild respiratory distress. Her O2 had been titrated to 4 L/m nasal cannula in order to sustain SaO2 values in the 90% or above range. Patient also noted to have pallor. No hematemesis, melena, hematochezia, abdominal pain, fever, cough or known exposure to COVID. Patient reports having received her first COVID vaccination just over one 1 week ago. A hypochromic microcytic anemia, progressive, was noted with a hemoglobin of 7.4 g/dL. Patient reported that she was up-to-date on EGD and colonoscopy within the past year without findings of acute pathology or bleeding. A CTA of the chest was conducted with findings of bilateral pulmonary emboli. She denies lower extremity swelling, pain or tenderness. Patient placed in observation in order to provide palliative blood replacement therapy and commence with anticoagulation for venous thromboembolism. DISCHARGE SUMMARY/OBSERVATION COURSE: Uneventful observation course for this pleasant 78-year-old female who presented with somewhat sudden worsening of her chronic shortness of breath and was found to have CTA evidence of bilateral pulmonary emboli. This in the setting of a progressive iron deficiency anemia without evidence of active clinical gastrointestinal bleeding. The patient received 2 units of packed red blood cells in a palliative fashion for her presenting hemoglobin of 7.4 g/dL. Posttransfusion hemoglobin was 10.1 g/dL. Concurrently, she was placed on weight-based low molecular weight heparin for full anticoagulation. I examined the patient on the morning of February 12 and found her to be nondistressed. Her SaO2 value was 96% on 4 L/m nasal cannula O2. Recall that her baseline flow rate historically had been 2 L/m his cannula. Etiology of the patient's thromboembolism uncertain. She had no clinical findings of unilateral or bilateral lower extremity swelling or tenderness. Patient noted to be a survivor of both breast and lung cancers but without known evidence of active persistent malignancy. Of interest, she had received a COVID-19 vaccine just over one week prior to presentation. I contacted pharmacy in this regard and encouraged him to report possible adverse event via VAERS. I recommended a course of rivaroxaban and provided a prescription with a VTE dosing schedule. Patient was advised to followup with Dr in 10 days. M.D., Hospital Medicine MD Feb 12, 2021 08:40

(7:06pm) Within one minute of receiving vaccine, patient started having difficulty breathing and started to turn red. (7:07pm) I asked the tech to grab the epi pen and call 911. Within 30 seconds of first event, patient was almost not breathing. (7:08pm) I placed the patient on her back and delivered the contents of one epi pen into her left upper thigh. (7:09pm) Patient started to regain her breathing. (7:10pm) Patient was breathing better and able to talk. (about 7:13) 911 arrived, accessed the patient, eventually taking the patient to the hospital. Patient was fully aware and breathing at that time.

I couldn't sleep the night of my shot. I felt like l had the flu. No fever but just so sick and because of the myesthenia my breathing was compromised. On the oxymeter it showed 92 and 93 at times. Today, the 22nd February l feel better but weak and tired and my head feels funny Hard to describe. I still feel it's difficult to take a deep breath

15 minutes after vaccination, Patient complained of non-radiating chest pain and "stomach discomfort." States chest pain 3-4 out of 10. Vital signs stable. Denies nausea or pain in other areas. States "a little" short of breath. Unable to determine pulse ox related to client nail polish. 911 was called, paramedics recommended client go for hospital evaluation, client refused. Client walked out with her husband. She was encouraged multiple times to go for evaluation, and to call her doctor to report symptoms.

Patient reported that her lips tingled and that she was having difficulty breathing at 11:00 am. An EMT onsite made contact with the patient and there were no signs of anaphylactic shock. EMS was contacted and responded. EMS evaluated the patient. Patient was not transported.

2:37pm Patient reported feeling shortness of breath after walking to car after 30 minute recovery post vaccine administration. Patient was wearing two N95masks. Patient reported having a history of shortness of breath recently and went to pulmologist yesterday for an eval. RN advised patient to remove masks for better oxygenation. Patient declined removing both masks and removed just one N95 mask. RN asked patient to take deep breaths and self administer inhaler as prescribed by provider. Patient refused to use inhaler at vaccine clinic setting. Vitals-135/71, HR-97, Pox-93-95%, RR- 24 pox after 15 minutes after removing mask- 96%. Patient reported feeling better and reported she would use inhaler when she arrived to home.

Low fever, diareahea, vomiting chills, hyperventilation, sore arm, nausea, exhaustion, loss of appetite. This after both the first and second injections. It lasted one day with total exhaustion the second day.

Admitted to hospital for acute on chronic respiratory failure following covid vaccination. (patient significantly fatigued, slept most of the day after vaccine, not on BIPAP as needed) HISTORY OF PRESENT ILLNESS: patient is a 78 y.o. female with a history of oxygen-dependent chronic obstructive pulmonary disease, obstructive sleep apnea, and persistent atrial fibrillation who presents today with general malaise. She received her 2nd COVID-19 vaccination yesterday and complained of fatigue, body aches, and general malaise all day. Later in the evening she noticed that her blood oxygen level was low. She denies having any more shortness of breath abnormal. She has had no vomiting, headache, or chest pain. On arrival she was noted to be febrile and required 6 L supplemental oxygen via nasal cannula. She usually uses 2 L nasal cannula at baseline, occasionally increasing it to 3 or 4 with exertion. She also had elevated troponin levels and noted leukocytosis. There was radiographic evidence of congestive heart failure. On exam, she is tired and wants to go to sleep. She is still requiring 4 L of oxygen via nasal cannula. Her daughter is at bedside. Plans are discussed for admission and she is agreeable. ASSESSMENT / PLAN: * Acute on chronic hypoxemic respiratory failure (HCC) Assessment & Plan Admit to medicine- hypoxic requiring 6 L nasal cannula, utilizes 2 L nasal cannula baseline Hypoxia appears to be secondary to robust immune response to COVID-19 vaccination Increased hypoxia, fever, leukocytosis, elevated troponin, radiographic evidence of congestive heart failure Will repeat troponin level in the morning, daily chemistry and blood count, will treat congestive heart failure as below CHF (congestive heart failure) (HCC) Assessment & Plan Transesophageal echocardiogram from October 2020 noted preserved left ejection fraction, and had no evidence for diastolic dysfunction Radiographic evidence of congestive heart failure, normal BNP, elevated troponin with an increase of 18 at the 2 hour mark, will recheck in the morning As this is her 2nd hospitalization since that echo with hypoxia and concern for CHF, will obtain repeat echocardiogram Received 80 mg IV Lasix in the emergency department, will continue 40 mg IV Lasix 2 times a day Daily weights, 2 L fluid restriction Patient was admitted with acute on chronic hypoxic respiratory failure. I think this is due to acute on chronic diastolic congestive heart failure that was brought on after she was sleeping most of the day without her BiPAP. She says she got her COVID-19 booster shot and felt so tired she slept all day. She did not think she needed her BiPAP during the day even if she was sleeping. She has not had a recent sleep study. Patient is diuresing and will likely be able to discharge tomorrow.

About 45 minutes after injection, funny feeling in face (can?t explain, maybe tingly, puffy), muscles in throat tightening. Both of these were fleeting. Following two mornings had no voice (laryngitis) first thing in the morning. Voice came back as day went on. No further issues

0854: Rec'd Covid vaccine 0859: About 5 min after rec'ing vaccine, pt c/o itchy throat; had previous reaction to Moderna vaccine & PNA vaccine 0903: BP 120/70 HR 62 RR 20 SpO2 98% 0904: Benadryl 25 mg po given 0908: Pt c/o sl more itchy throat & tongue swelling 0914: Itching resolved 0916: BP 122/72 HR 62 RR 20 SpO2 99% 0926: BP 121/74 HR 56 RR 18 Sp)2 100% Right arm tingling/itchy, tongue tingling/itchy again; breathing feels "ok" 0927: Benadryl 25 mg po repeated 0929: Feeling "a little bit more labored breathing"; clear lungs 0934: Feeling better 0939: Itchy throat resolving; breathing better

2 days after receiving first dose of vaccine, patient called to report worsening shortness of breath, back pain, fatigue and a cough. She was sent to the emergency room for evaluation. At that time, she was given a 7 day course of antibiotics. Patient then presented to the ED on 02/25/2021, with worsening symptoms, and was found to be COVID positive.

When I got the vaccine it hurt so much that I jumped. It felt like it burned for like 3min. The next day I had shortness of breath & I fainted the next thing I seen when I woke up was the paramedics taking me in to the ambulance to do an EKG. Everything was good except my blood pressure dropped. I was not taken to the hospital.

After 2 days pt experienced difficulty of breathing, dizziness, coughing, racing heart, palpitation, has a pacemaker, headache, was treated with Prednisone tablets

Patient was identified at the clinical station to have increased risks for vaccination reactions based on history, Vaccination administered, 30 minute patient watch assigned. About 12 minutes into observation, patient began to complain of tightness in throat and difficulty swallowing. Patient was without any signs of rash, no itch, no swelling, No observed SOB. Just described a sensation of "Throat Closing". Lungs clear, no wheeze or rhonchi, no change in pulses or capillary refill. Placed on pulse oximetry - initial reading of 97% room air, HR 94. No initial blood pressure taken. During assemment, patient with slight anxiety due to feeling of throat tightness, no changes in SOB, no tripoding, no changes in color, no stridor or wheeze. Patient treated with 50mg Benadryl IM (With consult of Dr. - Present at Clinic. EMS on scene with additional treatment and care to Emergency Department. Time of transfer, patient's awake x3, no chest pain, no verbalized SOB, no difficulty swallowing, no hives, no rash. Remians with the throat sensation of tightness.

right after receiving covid vaccine-19 second dose , pt started having audible wheezes, can only speak 1-2 sentences, grasping for air, cold clammy perspiration, pale. Pt states she has asthma and wheezing before she came in but worse after the covid vaccine dose. pt vital signs taken . Pt restless and asking for an injection to help her breath, Sats 96% RA. Pt had 2 puffs of albuterol and with slight relief. Pt was taken to Urgent care in stable condition ( same building) for an evaluation.

PATIENT RECIEVED 2ND DOSE OF MODERNA AND AFTER ABOUT 10 MINUTES SHE SAID SHE COULD NOTICE SOME DISCOMFORT IN HER BREATHING- NOTHING SIGNIFICANT BUT ENOUGH IT BOTHERED HER. SHE WAS MONITORED AND FELT SHE NEEDED A BENADRYL 25 MG CAPSULE. SHE ALSO COMPLAINED OF A SLIGHT HEADACHE. INJECTION SITE WAS NORMAL. SHE CONTINUED TO BE MONITORED AND CONTINUED TO FEEL THE SAME OVER THE NEXT 10-15 MINUTES BUT AT THE 20 MINUTE MARK SHE SAID SHE DID FEEL BETTER. SHE WAS NOT DRIVING AND SHE DID FEEL WELL ENOUGH TO GO HOME. SHE WAS COUNSELED TO BE SEEN AND SHE AGREED SHE WOULD BE IF SHE HAD ANY MORE SYMPTOMS. PATIENT WAS FOLLOWED UP 6 HOURS LATER AND STATES SHE HAS HAD NO ADDITIONAL PROBLEMS AND FEELS PERFECTLY NORMAL.

Experienced Shortness of Breath about 3 minutes after the vaccine was admistered. BP 168/80 - O2 sats 99. STated feeling better and slight notice of breathing. Shortly thereafter HR 34-40 briefly and not feeling right. EMS called. HR quickly returned to baseline in the 80s. BP 173/80. Patient has a history of HTN and did not take BP meds that Am. Given a lighter surgical mask as patient's mask felt "thicker than normal". EMS arrived, vitals were stable. Patient was feeling better, no more SOB. Patient cleared and released.

Called nurse line 4 days after 2nd Moderna vaccine, SOB, fainting, can't eat, dry cough, nose bleeds since shot. Advised to go to ED, patient refused as she feels a bit better today. Called again the following day with same symptoms - again advised to go to ED and quarantine for flu/covid-like symptoms. Patient agreed to come to ED, found to have bilateral PEs and RLE DVTs. Covid/flu negative. LUE red/swollen at injection site - no cellulitis. Admitted overnight and d/c'd home the following day.

Patient stated that 3 hours (7:40 pm)after receiving her vaccine she experience symptoms of: low grade temp of 93.6 (3 digital thermometers and 2 mercury thermometers) light headedness felt unsteady but blood pressure was ok per patient throat started to feel tight -these symptoms lasted for approx. 1/2 hour (8:10 pm) after giving herself an epi-pen injection, which she carries for bee stings -patient stated the next day on 02/19/2021, she took 2 tablets each 25 mg. of benadryl and never experienced the symptoms again from the previous day.

Burning; Allergic reaction; Hives all over her body; Face swelled up; Lips welled up; Throat swelled up; A spontaneous report, was received from a consumer (patient's daughter), concerning a 78 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced allergic reaction (hypersensitivity), hives all over her body (urticaria), face swelled up (swelling face), lips swelled up (lip swelling), throat was swelled up (pharyngeal swelling), and burning (burning sensation). The patient's medical history was not provided. No relevant concomitant medications were reported. On 04-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown), intramuscularly for the prophylaxis of COVID-19 infection. On 06-Feb-2021, approximately 48 hours after vaccination, the patient developed allergic reaction and had hives all over her body. The patient received diphenhydramine for hives. The patient also stated that inside of her was burning, face swelled up, lips swelled up and throat swelled up. The patient rushed to emergency room (ER). They needed to take the patient to an allergist because they wanted to find out if this was related to the vaccine. The allergist told her that they couldn't do an allergy testing. The patient asked if there were any reports on people showing allergic reaction 48 hours later after the vaccine. The patient was scheduled to get the second dose. Action taken with second dose of mRNA-1273 in response to the events was not reported. The outcome of events, allergic reaction, hives all over her body, face swelled up, lips swelled up, throat was swelled up, and burning, was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Hospice nurse reported patient started experiencing fatigue, nausea, dizziness, decreased appetite and shortness of breath immediately following vaccination. Hospice medications were ordered and patient began receiving morphine and nebulizer treatments. She then started having dysphasia. She then died on 3/5/21 from presumed respiratory failure.

Pt. came for her second Moderna COVID vaccine shot. After 15 minutes, noted flushing and tongue swollen and shortness of breathe. Tingling in her hands and lower legs. Shaking. Pt. was transported to our ED department.

She had breathing problems, bowel movement problems, sharp pain -site unknown No appetite and nausea. Went to the Doctor on wednesday and they gave her a prescription for nausea (promethazine) 12.5mg She Passed away 03/12/2021 at 8:54pm waiting to be picked up by a friend that was going to take her to the emergency room/hospital.

Patient was awakened at 0400 on 3/18/2021, with shortness of breath and her entire right side hurting. Pain was in the lower right chest, right upper abdominal quadrant and right flank pain. Presented to the ED. CT of chest /abdomen showed pulmonary embolus in the right lower lung. Patient is being treated with Eliquis and was sent home from the ED on 3/18.

patient presented to emergency department with chief complaint of SOB, b/l rash on arms, neck, and chest, as well as chills. Patient admitted to observation status with diagnosis of precordial chest pain.

Moderna Covid Vaccine EUA: Sent to ED from adult care facility (resides at home; PACE program participant with care center attendance multiple days per week. Received vaccine on 2/3/21 at care center. On 2/5/21 care center staff sent patient for ED evaluation due to decreased oral intake and activity, general weakness and lethargy, and fever. Cannot determine exact onset of symptoms but ED presentation was 1 pm on 2/5/21. Fever on ED presentation recorded as 101.9 F. Patient noted to be very sleepy/lethargic; appropriately responding to questions but requiring nearly constant stimulation to stay awake to answer questions. Workup revealed procalcitonin 0.08, serum creatinine 1.3 (baseline 1.0 to 1.1). Blood cultures and urine culture negative. CBC not available due to refusal of additional blood work. Received IV acetaminophen with improvement in fever and mental status. Discharged home.

Breathing issues; Death; A spontaneous report was received from a consumer concerning a 78 years old, female patient who experienced breathing issues/dyspnoea. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 08 Mar 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in an unknown arm for prophylaxis of COVID-19 infection. The patient experienced breathing difficulty on 12 Mar 2021. The patient died on 12 Mar 2021. Treatment information was not provided. Action taken with the drug in response to the events is not applicable. The patient died on 12 Mar 2021. The cause of death was not reported. The reporter wanted to conduct a autopsy to find out if the death was caused by the vaccine.; Reporter's Comments: This is a case of death in a 78-year-old female subject with unknown medical history, who died 4 days after receiving first dose of vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death

Patient states she received first COVID vaccination approximately one week ago (not a great historian); she tells me about 4 days later she became shorth of breath that progressively worsened - especially with exertion. She went to ER and was sent home on steroids and antibiotics. Shortness of breath became worsened so she presented back to ER and CTA was performed. There is no evidence of PE but patient has what looks to be a chronic DVT of left subclavian vein extending up to IJ junction. I do not believe this is for sure vaccine related but felt it was important to report it anyway. She cannot tell me why she takes warfarin at home but I do assume it is for this known chronic DVT. Unsure of Vaccine brand name. Most vaccines in this area have been Moderna.

First Moderna dose fine during 15 minute wait on 3/3/2021. Upon arriving for second dose 28 days later, patient states that 30 minutes after the first shot, she felt that her throat had a little tightening. Patient states she went to a restaurant to have something to eat, at which time she felt better and experienced no further issues . Second shot was declined , advised to receive in a medical setting.

Patient is a 78 year old female with background medical history notable for for COVID 19 on 30th Jan 2021 presented with progressive dyspnea and generalized malaise . She was dependent on oxygen. IV antibiotics, breathing treatments, steroids were initiated. Her symptoms slowly improved with the above-mentioned treatments. Once she was off oxygen and clinically improved she was discharged home.

Friday, April 2nd, in the late afternoon, I began to feel very weak . I had difficulty breathing throughout the night. Saturday, April 3rd, from the moment I woke, I had difficulty focusing due to severe dizziness and extreme weakness, unable to function normally. Shortness of breath continued and I remained in bed throughout the day. Today, April 4th, I am stronger, but unable to physically do more than necessary because of tiring easily with the weakness.

Respiratory arrest and was out; Diaphragmatic breathing (could not breathe) was on vent mask that delivered oxygen; Cough that felt like coming from another human being; Felt crappy; Covid red arm; Intermittent Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RESPIRATORY ARREST (Respiratory arrest and was out), DYSPNOEA (Diaphragmatic breathing (could not breathe) was on vent mask that delivered oxygen), COUGH (Cough that felt like coming from another human being), FEELING ABNORMAL (Felt crappy), ERYTHEMA (Covid red arm) and CHILLS (Intermittent Chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 029120A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension (patient reported hypertension as one of the health issues that she has.). On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RESPIRATORY ARREST (Respiratory arrest and was out) (seriousness criteria hospitalization and medically significant), DYSPNOEA (Diaphragmatic breathing (could not breathe) was on vent mask that delivered oxygen) (seriousness criterion hospitalization), COUGH (Cough that felt like coming from another human being) (seriousness criterion hospitalization), FEELING ABNORMAL (Felt crappy) (seriousness criterion hospitalization), ERYTHEMA (Covid red arm) (seriousness criterion hospitalization) and CHILLS (Intermittent Chills) (seriousness criterion hospitalization). At the time of the report, RESPIRATORY ARREST (Respiratory arrest and was out), DYSPNOEA (Diaphragmatic breathing (could not breathe) was on vent mask that delivered oxygen), COUGH (Cough that felt like coming from another human being), FEELING ABNORMAL (Felt crappy) and ERYTHEMA (Covid red arm) outcome was unknown and CHILLS (Intermittent Chills) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Erythema: (abnormal) (big - diameter 3.5 X 6 inches). In February 2021, White blood cell count: 15.5 (High) Her white blood cells were 15.5. In February 2021, X-ray abnormal: (abnormal) lung X-rays were horrible and was "tanked" due to all the diaphragmatic breathing (could not breathe). The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient received treatment with 3 antibiotics, steroids and oxygen. Patient reported that they wanted to intubate her and ativan was pushed by RN. Patient was on "vent mask" that delivered oxygen and was in cardiac intensive unit for 4 days and then the doctor decided it was not covid or pneumonia and were looking at cardiac issues.They had to give Narcan to reverse the effects of Ativan. Patient stated in the call that Moderna pushed her off the end of the cliff and reports that prior to this she was healthy and walked daily on regular basis. Very limited information regarding this events has been provided at this time. Further information has been requested. The patient's concurrent medical condition of hypertension remains a risk factor and as per the reporter the doctor were looking at cardiac issues as a confounder. This case was linked to MOD-2021-065711 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. The patient's concurrent medical condition of hypertension remains a risk factor and as per the reporter the doctor were looking at cardiac issues as a confounder.

The day following the injection, the patient experienced fever, chills, fatigue, aches. She began wheezing significantly and had tremors. Oxygen levels dropped to 82-84% which persisted following two albuterol nebulizer treatments. She was taken to the emergency department and was admitted for 2 days for oxygen and steroid treatment.

Patient received her second dose of the Moderna COVID vaccine in 3/2021 (unknown which specific date) and presents on 4/10/21 with feeling ill, shortness of breath, myalgias, and loss of appetite. Patient has h/o asthma, DM, HTN, COPD, CHF with pEF, severe OA b/l knees/r hip, and neurogenic bladder

The patient received her Moderna Covid vaccine and a couple of days later she had shortness of breath and was brought to the hospital a couple of days later. They found multiple blood clots in her lungs. The hospital discharged her too early and she had to go back, They told her to get her second dose on her regular scheduled date.

10 minutes after receiving the vaccination she started having chest pain, Sweating, numbness and tingling throughout entire body, headache. She started getting wheezing. She developed a rash on arms and legs. She went to the ER on 4/5/2021. She was discharged home with albuterol. Her shortness of breath got progressively worse and she was advised to return to the ER. She went back on 04/08/2021. She was given toradol and discharged home. Followed up with primary care on 4/15/20, still having shortness of breath, but improved from the last ER visit. She has significant exertional dyspnea. Her exercise capacity has reduced from 3-4 blocks, to barely able to make it across her house without stopping.

Extensive DVT(blood clots) involving both legs-- initially with tachycardia dyspnea. Now on 10a meds. Likely to have disability or permanent damage. History of post-op DVT with PEs following sholder surgery, subsequent placement of IVC filter.

Tiredness in leg; in a wheelchair after second dose of vaccine; Swelling; Heart racing; Out of breath; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Tiredness in leg) and GAIT DISTURBANCE (in a wheelchair after second dose of vaccine) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse reaction (no reported medical history). On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced MUSCULAR WEAKNESS (Tiredness in leg) (seriousness criterion disability), GAIT DISTURBANCE (in a wheelchair after second dose of vaccine) (seriousness criterion disability), SWELLING (Swelling), PALPITATIONS (Heart racing) and DYSPNOEA (Out of breath). At the time of the report, MUSCULAR WEAKNESS (Tiredness in leg), GAIT DISTURBANCE (in a wheelchair after second dose of vaccine), SWELLING (Swelling), PALPITATIONS (Heart racing) and DYSPNOEA (Out of breath) outcome was unknown. Action taken with mRNA-1273 in response to the event was not applicable. No relevant concomitant medications were reported. The patient was treated with prednisone and Percocet (oxycodone/paracetamol).; Sender's Comments: Based on the current available information and the temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.

Fatigue for 2-3 weeks. Sore arm for 10 days. Shortness of breath for 2 weeks. All symptoms have resolved.

Next day 04/01/21 patient hallucinated that there were spiders on the wall, a-fib went crazy, shortness of breath, sweating, vomiting.

Short of breath; Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Short of breath) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Tested positive for COVID-19). On 10-Apr-2021, the patient experienced DYSPNOEA (Short of breath) (seriousness criterion hospitalization). The patient was hospitalized on 10-Apr-2021 due to DYSPNOEA. At the time of the report, DYSPNOEA (Short of breath) and COVID-19 (Tested positive for COVID-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: positive (Positive) positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Two weeks after her first dose she got tested at the hospital and tested positive for COVID. Patient was short of breath and went to the emergency room on 10APR2021.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.

lightheaded, slightly dizzy immediately. had hard time breathing and my inhaler did not help. this lasted until about 7:00 p.m. the following night. By 3rd day I felt much better.

Shortness of breath and whizzing; Not receiving the 2nd dose; Tiredness; Dizziness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Shortness of breath and whizzing) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced DYSPNOEA (Shortness of breath and whizzing) (seriousness criterion hospitalization). On 07-Apr-2021, the patient experienced DIZZINESS (Dizziness) and FATIGUE (Tiredness ). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not receiving the 2nd dose). The patient was hospitalized from 28-Mar-2021 to 06-Apr-2021 due to DYSPNOEA. At the time of the report, DYSPNOEA (Shortness of breath and whizzing), DIZZINESS (Dizziness) and FATIGUE (Tiredness ) had not resolved and PRODUCT DOSE OMISSION ISSUE (Not receiving the 2nd dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. Patient received a lot of medications at hospital Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

an hour and a half after shot, rapid heart beat 101 hard to breathe like just after doing yard work, Took several slow breaths drank lots of water and rested. By 8 pm was back to normal.

Family member indicates that after the administration of the second dose of Moderna, in the following days started to have difficulty breathing.

If she walks little bit then she felt she passed out; After 2 weeks, she had shortness of breath; Dizziness; Vomiting; Chills; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (If she walks little bit then she felt she passed out) in a 78-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 Allergy to antibiotic (all cillins), Drug allergy (ibuprofen (MOTRIN)), Sulfonamide allergy (trimethoprim/sulfamethoxazole (BACTRIM)), Allergic to cats and Asthma. Concomitant products included DILTIAZEM, LISINOPRIL and ISOSORBIDE MONONITRATE (IMDUR) for an unknown indication. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021 at 3:00 AM, the patient experienced DIZZINESS (Dizziness), VOMITING (Vomiting), CHILLS (Chills) and HEADACHE (Headache). On 03-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (If she walks little bit then she felt she passed out) (seriousness criterion medically significant) and DYSPNOEA (After 2 weeks, she had shortness of breath). At the time of the report, LOSS OF CONSCIOUSNESS (If she walks little bit then she felt she passed out) had resolved and DYSPNOEA (After 2 weeks, she had shortness of breath), DIZZINESS (Dizziness), VOMITING (Vomiting), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: normal (normal) Normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient received her first dose of Moderna COVID-19 vaccine on 20-APR-2021. After two weeks, she had shortness of breath and "if she walks little bit then she felt she passed out." The patient's health care provider did some test (unspecified) and everything came out normal, her lungs are clear and her oxygen level is normal. Treatment information was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Acute respiratory failure with hypoxia (HCC) (Primary Dx); Shortness of breath; Tachypnea; Pneumonia due to COVID-19 virus Office Visit 3/4/2021 Internal Medicine Internal Medicine Cough +2 more Dx Shortness of Breath ? Cough Reason for Visit Progress Notes (Physician) ? ? Internal Medicine ? ? Encounter Date: 3/4/2021 ? ? Signed Expand AllCollapse All Assessment/Plan Diagnoses and all orders for this visit: Cough - X-ray chest 2 views; Future - B-type natriuretic peptide; Future - CBC and differential; Future Iron deficiency anemia, unspecified iron deficiency anemia type - CBC and differential; Future - Iron + Transferrin + % Saturation; Future Shortness of breath - B-type natriuretic peptide; Future

She had labored breathing in her chest and rib cage hurt for 36 hours post vaccination. She also had a urinary tract infection at the time and felt her heart flutter. In the past, she reported a history of reaction to any vaccine, including polio.

Infection and hospitalization. 2/13/2021 admission with discharge on 2/22/2021. Worsening SOB and epistaxis upon admission requiring intubation and admission to ICU. Extubated on 2/17/2021. Dx during visit include hypoxia, sepsis, hypotension, anemia, aspiration into airway, creatinine elevation, epistaxis, atrial fibrillation, essential hypertension, diastolic heart failure

Patient reports approx 48 hours after 2nd dose of Moderna COVID 19 vaccine nausea/vomiting, fatigue, headache. Pt has had ongoing symptoms of extreme fatigue, headache, feels like her heart "flutters". Pt began experiencing intermittent shortness of breath which began approx 2-3 weeks ago. Pt reports seen by Primary 3-5 times since 2nd vaccine and concerns. Pt reports had routine bloodwork, and everything has come back normal. Pt reports has been seen by endocrinologist for evaluation and all testing and bloodwork has also been normal

Patient is a78y.o. year oldfemale with a h/o afib, Diabetes, CAD, HTN, Hyperlipidemia, lung cancer S/p RUL lobectomy in 2015, PE and non O2 dependent COPD presented to BH secondary to SOB at rest. Symptom onset 3 day PTA, denies cough. States chronic DOE, but worsening SOB at rest. No N/V/D, no F/C, no loss of taste or smell. No known sick contacts Tested positive for COVID 5/15 Completed COVID vaccination with Moderna on 4/26 Afebrile with normal WBC. Tachypnic on ED arrival and placed on 2L O2 for comfort, no recorded desats. States feeling much better and anxious for DC.

Moderna COVID-19 Vaccine EUA: three days after vaccination patient presents to clinic reporting cough, chills, and over one month worsening of dyspnea on exertion, lower extremity edema, and orthopnea. Patient immediately transferred to hospital, diagnosed with acute on chronic volume overload and acute diastolic heart failure exacerbation, diuresed, and discharged to home medically stable. On outpatient follow-up patient is improved clinically.

Resident reported feeling of throat "closing off" upon return to Nursing Home facility after receiving her second COVID-19 vaccine at Dr. office. Resident then vomited large amount of liquid. At that time resident denied any shortness of breath or difficulty breathing. Vital signs stable. Tylenol and Bendaryl ordered and given by Nursing Home Nurse Practitioner. Resident did not require higher level of care.

Patient had difficulty breathing and throat closing/swelling within 5 minutes of receiving vaccine. Patient initially didn't want emergency care sent nor Epipen but changed her mind quickly. Pharmacist administered Epipen 0.3mg followed by 25mg oral diphenhydramine. 911 was called and EMS arrived shortly to take patient to hospital.

Patient developed blood clots in her legs, heart, and lungs within 48 hours after receiving her second dose of the Moderna vaccine. She was subsequently treated with Eliquis (apixaban).

COPD She was a resident at the Senior Living facility. My mother received the vaccine on Tuesday, May 18, 2021 at approximately 11:00 a.m. She was left by herself and called around at 11:32 to say she got the vaccine and she was having a hard time breathing. Around 1:40, the nursing home called to let me know CPR was being performed. My sister rushed to the site and she was pronounced dead around 2:10. p.m.

developed anxiety; Chest tightness/chest congestion; shortness of breath; it felt like she had asthma; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), ASTHMA (it felt like she had asthma), ANXIETY (developed anxiety) and CHEST DISCOMFORT (Chest tightness/chest congestion) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 028L20A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (atropine- high fever and vomiting) since 1952. Concomitant products included GEMFIBROZIL and AMLODIPINE for an unknown indication. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced DYSPNOEA (shortness of breath) (seriousness criterion hospitalization), ASTHMA (it felt like she had asthma) (seriousness criterion hospitalization) and CHEST DISCOMFORT (Chest tightness/chest congestion) (seriousness criterion hospitalization). On an unknown date, the patient experienced ANXIETY (developed anxiety) (seriousness criterion hospitalization). The patient was hospitalized on 10-Mar-2021 due to ANXIETY, ASTHMA, CHEST DISCOMFORT and DYSPNOEA. The patient was treated with GUAIFENESIN (MUCINEX) for Asthma and Dyspnoea, at an unspecified dose and frequency; LORAZEPAM at a dose of 1 dosage form; SALBUTAMOL SULFATE (VENTOLIN RESPIRATOR) for Asthma, at an unspecified dose and frequency and FLUTICASONE PROPIONATE (FLOVENT HFA) on 04-May-2021 for Asthma, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (shortness of breath), ASTHMA (it felt like she had asthma), ANXIETY (developed anxiety) and CHEST DISCOMFORT (Chest tightness/chest congestion) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal. On an unknown date, Electrocardiogram: normal (normal) normal. On an unknown date, Fibrin D dimer: normal (normal) normal. On an unknown date, Troponin: negative (Negative) negative. Patient height was 5 inches. Action taken with mRNA-1273 in response to the events were not applicable Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD21-032955 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow Up information was received on 01-Jul-2021 Patient demographics updated. patient medical history updated. Concomitant medications provided. Treatment medication was provided Start date for the events updated. Case is upgraded to serious and seriousness criteria included hospitalization. Outcome of the events updated ( from unknown to not resolved).; 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.

Couldn't breathe; When she called her HCP, they said they were out of vaccine.; She still has not received her 2nd dose as of today (29Jun2021); This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (Couldn't breathe) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included COPD and Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL] for an unknown indication. On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient experienced DYSPNOEA (Couldn't breathe) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT AVAILABILITY ISSUE (When she called her HCP, they said they were out of vaccine.) and PRODUCT DOSE OMISSION ISSUE (She still has not received her 2nd dose as of today (29Jun2021)). On 09-Jun-2021, DYSPNOEA (Couldn't breathe) had resolved. At the time of the report, PRODUCT AVAILABILITY ISSUE (When she called her HCP, they said they were out of vaccine.) and PRODUCT DOSE OMISSION ISSUE (She still has not received her 2nd dose as of today (29Jun2021)) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The reporter stated that the patient stated that she is currently taking medication for blood pressure. The patient also stated that she is also using nebulizer breathing machine. No treatment information was provided by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the Dyspnea event, a causal relationship cannot be excluded. Based on the mechanism of action of mRNA-1273, a causal association between the Product Dose Omission Issue and Product Availability Issue mRNA-1273 is assessed as not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the Dyspnea event, a causal relationship cannot be excluded. Based on the mechanism of action of mRNA-1273, a causal association between the Product Dose Omission Issue and Product Availability Issue mRNA-1273 is assessed as not applicable.

Fatigue, short of breath, night sweats, fingers tremble constantly. Healthcare professional provided antibiotics. Still experiencing symptoms.

About an hour after getting the shot I started not feeling to good. I ended up with a headache, shortness of breath, and swollen glands. I tried to wait it out but it continued to get worse so I went to the emergency room and was admitted.

- stye on left eye - uncontrollable diarrhea - diagnosed with lymphocytic colitis - shortness of breath - blood in urine - hematuria

Eleven hours after receiving COVID vaccine, client started experiencing stroke-like symptoms legs/arm weakness, couldn't speak, shortness of breath, and throat swelling. Hospital ruled out acute stroke but could not entirely exclude a cerebellar stroke due to her dizziness with vertigo and nystagmus (per hospital report). Client was in hospital 2.5 days, per hospitalist. note-all work up including MRI and tte were negative for acute findings- symptoms have resolved. Hospitalist noted symptoms may be worse following second shot. Spoke with client 1/19/21 and she reported feeling weak and tired only.

6:13 pm - 9 pm Extreme shooting pain, right shoulder, clavicle and neck causing my arm to jerk and sometimes my body spasmed. Pain was intermittent, coming and going but taking my breath away. I called CVS about aspirin and took 5 Baby Bayer aspirins. Pain went away at around 9 pm. Never returned. NO other adverse effects Surprising result is diminished pain in knees! When it gets cold, rainy, my knees have been extremely painful so I'd have to lift myself up from sitting but since then the pain is at 1 to 2 on the scale rather than 10 ! It sounds strange but it has happened and that's why I felt I needed to report this. Rainy days this week with no debilitating pain and I waited to report this for a week since the pain usually began days before.

Patient obtained initial dose of Moderna vaccine on Thurday, Jan 14. No adverse effects reported during initial 15 minute post vaccine waiting period. Saturday morning (Jan 16), patient developed severe cough, labored breathing, and fever. Additionally patient mental status changed suddenly, became non-communicative (unable to speak, but would scream if she was touched). O2 status was irregular, dropping to 78. Sunday morning, EMT and then hospice was hospice called. Monday morning, after hospice emergency kit was initiated, patient passed away.

Fever Feeling tired short of breath all night and morning after the vaccine My grandma had to be intubated and then passed away to a heart distress we think it was the vaccine because she was fine even with dialysis. When she got the vaccine it took hours and her health conditions changed.

Acute onset of SOB presented to ED and diagnosed with a pulmonary embolism. Tested positive for SARS-Co-V-2 on 01/25/21 using NAT.

Asthma attack - I took 2 puffs of the Xopenex inhaler every 4 hours for 12 hours. I also took the 12 hour Dulera inhaler and I took muncinex 600 mg.

Severe chills nausea severe stomach pain and lower back pain , diarrhea. At times felt like throat closing but kept clearing throat and okay, then drinking water Lasted Over 48 hours

Jan 24 - shortness in breathe, back and lungs hurt with deep breathe and pressure in chest lasted 2 1/2 days. Jan 28- large red rash on arm itchy , sill red . Also having light headiness and pressure in chest and short of breath at time

On 1/28/2021, starting having severe pain in chest/lungs and especially a quarter size area above rib cage located on top of right breast next to breast bone. This area was especially painful when pressure applied. No shortness of breath. Symptoms lasted for about 10 hours and subsided somewhat on 1/29/2021. Severe pain symptoms returned early morning on 1/30/2021 and resulted in my going to the ER at the local hospital around 10:00 a.m. An EKG , CT scan, and blood tests determined no heart attack or other life threatening conditions and I was released from the hospital around 4:00 p.m., still experiencing pain without a cause being determined. Pain and painful area were no longer present on 1/31/2021.

Tightness in chest, easily short of breath with lower oxygen levels. Oxygen level when vaccine administered was 97. Following few days concerning so bought pulse/ox monitor Thursday 1/28. Oxygen readings ranging 92-94 from 1/28 onward. Second side effect noted evening of 1/24: bright red as if sunburned throat and center of upper chest and puffy. as of 2/3/21 red color and puffiness diminished.

Immediately had visual disturbance: couldn't focus clearly. And felt tingly-sensation all across chest, deep inside, very uncomfortable and scary, and couldn't get a deep breath. Visual problem lasted about 1 hr.; chest/lung feeling lasted about 5-8 mins., tightness in chest lasted about 10-15 mins. Later in afternoon had pain/edema at injection site, left shoulder joint pain. As of today, 2/3, it's minimal.

Stroke like symptoms; Couldn't speak; Shortness of breath; Legs and arm weakness; Dizziness with Nystagmus; Throat swelling; Dizziness with vertigo; Dizziness with vertigo; A spontaneous report was received from a nurse concerning a 79-year-old, white, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stroke like symptoms, dizziness with nystagmus, legs and arm weakness, couldn't speak, shortness of breath, throat swelling and dizziness with vertigo. The patient's medical history, as provided by the reporter included anemia, overactive bladder, fibroid cystic disease, allergy to fluoroquinolone, ciprofloxacin, povidone iodine, morphine and adhesive tape. The concomitant medications reported included atorvastatin, calcium, colecalciferol, metoprolol succinate, pramipexole hcl and prasugrel hcl for unspecified indications. On 07 Jan 2021, 11 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient experienced stroke like symptoms, couldn't speak, shortness of breath and throat swelling. It was reported that the patient was hospitalized for acute stroke. On an unknown date, while still being hospitalized, the patient developed, dizziness with nystagmus and dizziness with vertigo. The lab findings included, magnetic resonance imaging (MRI) and computed tomography (CT) scans as negative for acute findings, electrocardiography (EKG), complete blood count (CBC), X-ray and chemistries were reported as within normal limits. The patient remained hospitalized for 2.5 days while the symptoms improved. On 09 Jan 2021, the patient was discharged. On 20 Jan 2021, the reporter stated that the patient felt weak and tired without other symptoms. It was also noted that the patient's discharge summary stated the patient's symptoms may be worse following a second dose of mRNA-1273 vaccine. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, stroke like symptoms, dizziness with nystagmus, legs and arm weakness, couldn't speak, shortness of breath, throat swelling and dizziness with vertigo. were considered as resolved on an unknown date.; Reporter's Comments: This case concerns a 79-year-old, white, female patient with medical history of anemia, overactive bladder, fibroid cystic disease, who experienced the serious, unexpected event of stroke, Aphasia, dyspnea and non-serious, unexpected events of , dizziness, vertigo, pharyngeal swelling, nystagmus and muscular weakness. The events of stroke, Aphasia, Dyspnea and pharyngeal swelling occurred 11 hours after the first dose of mRNA-1273 (Lot number: 025J20-2A) administration and the events of dizziness, vertigo, pharyngeal swelling, nystagmus and muscular weakness occurred on an unknown date while the patient was still hospitalized. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

2/10: fatigue 2/12 @ 1900: SOB, wheeze, rhonchi, decreased SpO2. Tylenol, 2L NC applied, duoneb, IM Solumedrol, ST CXR, mucinex 2/12 @ 22:00 SpO2 70's, transfer to Hospital via EMS @ 22:30

9:05 AM on 2/10/21 - Fever of 101.3F with lethargy; emesis x1 followed by Respiratory distress (O2 sat 90% room air, RR 40); HR 115 regular rhythm; decreased breath sounds with rales upper lobes and no breath sounds at base; tranferred via EMS to local hospital ER where received 2L fluids and admitted to care of hospitalist service with primary diagnosis of "adverse effect of COVID-19 vaccination and possible pneumonia." Presenting hypotension improved with fluid bolus and Zosyn IV was started empirically.

Day 1: Some blurred vision and labored breathing immediately after injection*, numbness and tingling of the tongue, body aches and pains all day. Day 2: Vision and breathing now normal. Numbness and tingling of tongue has lessened. Body aches and pain more prominent. * Please note that this mobile clinic that came to my mom's home was not set up for a serious reaction, nor did they stay and wait at least 15 minutes. My mom was told that she would have flu like symptoms and then they left.

Day 1 Rapid heart rate, Fatigue, chills, slight temp, Slept off and on 24 hrs thru Day 2 Day 3 Red rash over both arm pitts, below breasts, upper thighs, Rapid heart pulse, irregular pulse, called and visited Cardiology Clinic for Ekg confirmed PVCs Day 4 Light headed, dizziness affecting gait, forced lying down , general brain fog, rash continued, shortness of breath, rapid heart rate, went to ER, saw nurse for Ekg, blood work, blood pressure, Tylenol 100mg 3x a day Day 5

Patient tested positive for COVID 7 days after receiving her first COVID 19 vaccine. She developed symptoms including shortness of breath, fatigue and headache. She tested positive outpatient for COVID on 2/9

Extreme chills and shaking - 5 hours, nausea, aches, headache, fatigue, cough, shortness of breath , no appetite after shaking stopped.

Couldn't get up; Couldn't breathe; Lost voice; Felt very tired; A spontaneous report was received from a consumer concerning a 79 years old, female patient who received Moderna (mRNA-1273) vaccine and experienced couldn't get up/mobility decreased, couldn't breathe/dyspnoea , lost voice/aphonia and felt very tired/fatigue. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 13 Feb 2021, approximately three days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 022M20A) in the left arm for prophylaxis of COVID-19 infection. 15 Feb 2021, the patient couldn't breathe, felt very tired, lost her voice, couldn't get up, and was hospitalized following a visit to urgent care. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, Dyspnoea, Fatigue, Aphonia, Movement disorder and Hospitalization was unknown.; Reporter's Comments: This case concerns a 79-year-old female who was hospitalized with serious unexpected events of dyspnea, mobility decreased, and aphonia and a serious expected event of fatigue. The events occurred 3 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. 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 begin to experience throat tightening, sensation of need to clear throat frequently, voice hoarseness, trouble swallowing, choking sensation and headache 45 minutes after receiving 2nd moderna vaccine. Patient took Benadryl 50 mg OTC and went to ED. Treated with racemic epinephrine, IV benadyl, IV decadron, IV pepcid. Given script for epipen by ED provider, but has not needed to use.

Day after receiving vaccine patient noted tightness in chest and difficulty breathing. Went to local urgent care and ambulance called to transport her to hospital as was feared a cardiovascular event. Admitted to Hospital, 02/12/21 and discharged 02/13/21. Patient states stress test, echo, and CT with contrast, and xrays all normal. She states hospital did not know what caused her symptoms and could not tell her if this was caused by vaccine. She followed up with her PCP on 02/15 and was told that by her xray it looked like she might have had the starting of something like bronchitis. Administered antibiotic shot and steroid shot and RX inhaler. Moderna COVID-19 vaccine EUA.

Patient said she developed local erythema/swelling/itching to injection site and that it spread to her chest and abdomen. She developed a "bronchial cough" about 48 hours after receiving vaccine. She wanted antibiotics for cough from her primary care because her husband is having surgery on 3/15/21 and wanted to make sure she could go into the hospital with him. Her primary care provider prescribed her Ceftin 500 mg. She has taken Ceftin before without any allergic reaction. She said as soon as she started taking the Ceftin her entire body became itchy "down to her fingers" and had hives from head to toe. Also reports mild shortness of breath. Her provider was unsure whether the reaction was from the Ceftin with the vaccine or the Ceftin itself. Patient said her primary care may do some testing to find out if she is allergic to Ceftin.

2/26/21 History & Physical- History of present illness: "Pleasant 79 years old female who started to develop recurrent episodes of nausea and vomiting of nonbilious none bloody material 1 week ago then started to have frequent watery bowel movements with the last bowel movement was associated with rectal bleeding, she started to develop generalized weakness and fatigue, she had 3 falls in the last week without hitting her head, she did not have loss of consciousness, over the last 2 days she has been complaining of numbness and tingling to the hands and feet, she was not able to walk due to generalized weakness. She denied fever or chills she had no chest pain or shortness of breath. 2 weeks ago she got her second dose of COVID-19 vaccine. There was no change to her medications according to her, she denies sick contacts." Intubated and ICU transfer 2/28/21 for "Possible Guillain-Barré syndrome and impending respiratory failure" extubated 3/10/21.

I notice mild weasing after about 10 minutes but used my Albuterol Sulfate HFA Inhaler. Weasing went away. I did feel fine until I got severe chills about 6 PM. Chills remained for several hours. Went to bed with heavy covers. Woke up about 2 AM with stomach not feeling well. Was dizzy walking into kitchen getting a Sprite. Set in recliner with heavy covers. Took my blood pressure at 5AM & it had dropped to 104 /44 which was apparently why I was so dizzy. I then took a Tylenol and felt fine after 9AM. I still feel fine but wanted to report my extremely low blood pressure which usually is 135/65 in mornings. I' m thankful for the vaccine.

Elevated BP, shortness of breath, tightness of the chest/chest pain, palpations, dizziness 11 days after the vaccine. Continued daily for four consecutive days onset.

At 1415, patient reported tingling and numbness to her lips. No c/o shortness of breath, tongue swelling or itching. At 1416- assessed by Dr., lungs clear, no stridor, slight rash to bridge of nose. At 1421- 0.3mg epinephrine IM administered. BP 130/84, HR 84, and O2 at 97% on room air. At 1431- 25mg IM of Benadryl given and at 1432, 124 mg of Solu-Medrol administered IM. Patient's vital signs continued to be monitored and remained stable over the next hour. At 1525, patient was reassessed by Dr. and was able to be discharged from clinic. 1540 - Patient's son picked her up and took her home with instructions for a competent adult to remain with her for the rest of the evening. Patient had an Epi-pen at home already and was instructed to use and call 911 if additional symptoms. The following day, patient was contacted by clinic Provider .and reported feeling fine and no new symptoms. On the morning of 3/11/21, patient called clinic with onset of facial swelling and shortness of breath. She was advised to go to the ER.

Developed fever and chills around 6pm on day of vaccination. Severe febrile reaction. Developed respiratory distress and became unresponsive. Transported to ED where O2 sat'n on room air was 45%. Intubated and transferred to ICU. Extubated on 2/24/21 and transferred to telemetry floor with nasal cannula. Ultimately stable on room air. Treated for pulmonary edema, cardiogenic shock and acute on chronic CHF. Resolved and back to baseline by 3/4 when she was discharged.

Pt developed throbbing, pulsing pain down her entire Right lateral Ribcage, by day 5 Post Covid vaccination. Vx admin to R side. + Mild pleurisy also.

shortness of breath, pain in chest increasingly more severe as time went on. Noticed shortness of breath about 12 days after the vaccine was given. I am a 2 mile a day walker and very healthy. It was below freezing and I attributed the shortness of breath to weather. I went to an ER on March 8, 2021 after realizing symptoms were worse. I was admitted with Pulmonary embolism in both lungs and pneumonia in both lungs. The hospitalist could not give me a reason why this happened. He encouraged me to report this incident. You would need to contact him for tests and such. I am a patient. I live where medical help is limited. The vaccine was administered at a clinic but the ER I went to was a different system.

Pt completed 2 covid vaccine morderna doses Feb 18, 2021. Pt with increasing weakness and short of breath for 3 days PTA on 3/6/2021.

The patient stated that she gets paralyzed after getting vaccines. I asked her if she had someone in the pharmacy to help her. She said she came alone. I told her I would have her wait 30mins after dose to make sure there were no issues. After I gave her the shot, she looked at me and said that didn't hurt at all. Then she looked and said my neck hurts. So I had her take deep breaths with me to get her to calm down as she appeared anxious. She was doing great then she went limp. I held her head up and asked her is she was ok. She said she was, but then her breathing become shallow. She was un responsive at this time with her tongue pushing her mask off her mouth. So I lowered her mask and her tongue appeared to be enlarged. I had my technician call 911 and I gave her a dose of epinephrine 0.3 mg. She was unresponsive, but breathing on her own. The paramedics came and got her vitals, placed her on stretcher, and put in a medicine line to give her medications if need be. She left somewhat unresponsive. They said she should be fine and took her to ER.

Patient became short of breath and felt flushed within 5 minutes after dose administration. Pulse ox recorded at 92 and pulse of 99. Blood pressure 160/110. EMS was called and vitals had stabilized to pulse ox of 98-99 and systolic BP of 140s. Patient remained short of breath, has a cardiac history but as baseline status was unknown and husband was a poor historian we sent her to the ER for workup. Did not endorse symptoms of anaphylaxis. Unknown h/o COPD or other chronic lung conditions.

Pt. presented to ER on 3/19/2021. Family reports that pt. received her Covid vaccination on 3/17/2021. Since then her stomach started hurting and pt. is lethargic. Pt. did not open eyes when asked questions and was quite pale. Son reports increased confusion last day or two. Pt. reports that she started feeling ill immediately after receiving the injection. Complains of generalized weakness and fatigue. Denies dizziness or lightheaded. C/o abd. pain. Denies nausea, vomiting, but admits to diarrhea. Denies fevers, cough congestion. She is alert to place and name, but unsure of date at time seen in ER. When seen in ER she was afebrile, but hypoxic and hypotensive. Initial saturations were in mid 80's, but dropped to low 60's. With a non-rebreather mask she maintained at 90%. BP 60's systolic but with fluids increased to 90's . No rectal bleed or hematemeis. Diagnosis of septic shock, anemia, elevated LFT's, pneumonia, and UTI.

79 year old Female received the 1st dose of the Moderna COVID-19 Vaccine Lot# 030A21A on 03/12/2021 @ 09:40. Pt was placed in observation for 30 minutes and then released. On the drive home pt felt tightness in the chest, chest pain, roof of mouth was swelling and burning, severe itching on the arm, (shortness of breath was experienced while walking to the car), and immediately drove to ED. Pt was admitted to the ED 03/12/2021 @ 11:00 and was discharged 03/12/2021 @ 12:30. Pt was given Prednisone, Benedryl, Pepcid, Potassium, and Clonidine in the ED. Upon discharge, pt was advised by the ED to come back if symptoms come back/worsen, make an appointment with primary doctor, and was given a prescription for Prednisone and Atarax (hydroxyzine) 25mg. Morning of 03/13/2021 pt reported throat was narrowing, dificulty swallowing, lips feeling tingly, and shortness of breath when normally walking down the hall. Pt went to ED , was admitted 03/13/2021 @ 12:00 and discharged same day 03/13/2021 @ 17:00. Pt takes Amlodipine 5mg qd, Levothyroxine 25mcg qd, Losartan 50mg bid, Furosemide 40mg qd, Diltiazem 120 mg qd, Tizanidine 2mg qhs, Anatrozole 1mg qd, Venlofaxine ER 37.5mg qd, Clonidine 0.1mg (PRN when SBP > 170), K 20 mEq, Folic Acid, B12, Homocysteine Factor, IBU (PRN for discomfort), and Cetirizine. Pt is diagnosed with osteoarthritis, obstructive sleep apnea, degenerative joint disease, degenerative dsic disease, scoliosis, hypertension, cardiac arrhythmia, hypothyroidism, breast cancer remission (5 years of remission on the left breast and 4 years of remission on the right breast). Pt is allergic to Sulfa drugs, Nitrofurantoin (Macrobid), and Prempro. Pt made an appointment with the primary doctor for 04/01/2021 and the cardiologist appointment is scheduled for 04/22/2021. Pt was advised to call cardiologist and move the appointment to the next availability, consult primary doctor and cardiologist to see if it is advised to received the second dose and abide by their recommendation, and immediately go to the ED for for any symptoms/side-effects. SPI was consulted and Dr was notified.

cardiovascular event; Tightness in chest; Difficulty Breathing; Bronchitis; A Spontaneous report was received from a health care professional concerning a 79 year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Cardiovascular symptom, Chest discomfort, Dyspnea, Bronchitis. The patient's medical history as provided by the reporter included Neuropathy of feet, elevated Cholesterol, Osteoarthritis, Aortic aneurysm. Concomitant medication included Levothyroxine sodium, Sumatriptan, Rosuvastatin, Piroxicam and Vitamin D On 11 Feb 2021, prior to the onset of events the patient received first dose of their two planned doses of mRNA-1273 (Batch N0: MOD012M20A ) intramuscularly in the right arm for prophylaxis of covid 19 infection. On 12 Feb 2021, the patient had tightness in chest and difficulty in breathing. Went to local urgent care and ambulance called to transport her to hospital as was feared a cardiovascular event. Admitted to hospital on 12 Feb 2021 and discharged on 13 Feb 2021. She had stress test, echo, CT and x-rays all were normal. She followed up with her PCP on 15 Feb 2021 and was told that she might have starting of something like bronchitis. The events caused hospitalization and was serious. Treatment included antibiotics and steroid shot and prescribed inhaler. Action taken with mRNA-1273 in response to the events was unknown. The outcome of events, Cardiovascular symptom, Chest discomfort, Dyspnea, considered recovered on 13 Feb 2021 and outcome of the event Bronchitis considered recovered on an unknown date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

the evening of the vaccine started having tongue swelling, difficulty breathing, itching, and tachycardia. lasted 3 days

Pt presented w/crushing chest pain, diaphoresis, and SOB. Unlikely from vaccination, but entering VAERS for "Serious adverse event requiring hospitalization" 39 days COVID vaccination

Patient developed Covid; Breathing dificulties; Hallucinating; Legs felt like rubber; Coughing; 104 fever; A spontaneous report was received from a consumer concerning a 79-year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed COVID, 104 fever (pyrexia), hallucinating, legs felt like rubber (skin atrophy), coughing and breathing difficulties (dyspnoea). The patient's medical history was not provided. Concomitant medications were not provided. On 05 Feb 2021, the patient received their first of the two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for the prophylaxis of COVID-19 infection. On 18 Feb 2021, patient was hospitalized for Covid infection. He had a fever of 104, hallucinating, legs felt like rubber, coughing, and breathing difficulties. Labs and treatment information was not reported. Action taken with response to mRNA-1273 was not reported. The outcome of the events was not reported.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

feels like she is still not okay; choking on the mucus; 7 minutes after first dose immediate allergic reaction; mucus in her nose,terrible back drip; Tickle in her chest,tickle in her throat; heaviness in her chest; hoarseness; cough; lost her voice; described her symptoms as bronchitis like; described her symptoms as laryngitis; felt like she had an entire respiratory infection; A spontaneous report was received from a consumer concerning a 79-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events 7 minutes after first dose immediate allergic reaction(hypersensitivity), mucus in her nose and terrible back drip(secretion discharge), tickle in her chest and tickle in her throat(general discomfort), heaviness in her chest(chest discomfort) choking on the mucus(choking), hoarseness(Dysphonia), cough, lost her voice(aphonia), described her symptoms as bronchitis like(bronchitis), described her symptoms as laryngitis(laryngitis), felt like she had an entire respiratory infection,(respiratory infection) feels like she is still not okay(feeling abnormal). The patient's medical history was not provided. Concomitant medications reported were Claritin, Vit D, Calcium Pills, Mirtazapine, antidepressants, multivitamins for drug use for unknown indication. On 16 Feb 2021, approximately 1 day prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 004MZ0A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 16 Feb 2021, the patient experienced the event(s) 7 minutes after first dose immediate allergic reaction , mucus in her nose , terrible back drip , tickle in her chest, tickle in her throat , heaviness in her chest ,choking on the mucus, hoarseness, cough , lost her voice ,described her symptoms as bronchitis like, described her symptoms as laryngitis, felt like she had an entire respiratory infection . Event choking on the mucus was considered medically significant. On 24 Feb 2021, the patient experienced the event(s) feels like she is still not okay. Treatment details included Robitussin and Honey, she has taken Tylenol for symptoms with only 20% relief. Her doctor states that if she does not, improve he will give her prednisone. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), 7 minutes after first dose immediate allergic reaction, mucus in her nose,terrible back drip, tickle in her chest, tickle in her throat, heaviness in her chest, choking on the mucus, hoarseness, cough, lost her voice, described her symptoms as bronchitis like, described her symptoms a laryngitis, felt like she had an entire respiratory infection, feels like she is still not okay was unknown.; Reporter's Comments: This case concerns a 79 Y/O F with a serious unexpected choking and NS unexpected hypersensitivity, rhinorrhea, discomfort, chest discomfort, dysphonia, cough, aphonia, bronchitis, laryngitis, respiratory tract infection, feeling abnormal. Event onset 7 minutes after the first dose of mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.

Patient developed diarrhea within hour of receiving injection. She developed shortness of breath requiring trip to ED approximately 12 hours later. She had cardiac arrest in ED.

3/21 admit HPI: 80-year-old white female with a past medical history for oxygen-dependent COPD who presents to the emergency room today due to falls and possible confusion. According to the family member, he does not think her oxygen was set at the right level. He thinks it was set up higher because she tends to get confused and fall when this happens. The patient really has fallen twice of late. She said she aches all over. She also cites dizziness when she stands up. Because of the symptomatology, she came to the emergency room for evaluation. Workup, including chest x-ray imaging, was fairly unremarkable. The patient did not, however, feel safe going directly home. At the present again, she just feels achy. There is no chest pain or shortness of breath. No abdominal pain or urinary symptoms. No rash. 3/26/21 admitted 80 y.o. female with a PMH notable for COPD, atrial fibrillation, hypertension, diabetes and obesity who presented on 3/26/2021 for evaluation of physical deconditioning. Patient presents to our facility yesterday after hospital stay from hospital from 03/21 through 3/26/2021. Hospital course - The patient is an 80-year-old white female with a past medical history for oxygen-dependent COPD who presents to the emergency room today due to falls and possible confusion. According to the family member, he does not think her oxygen was set at the right level. He thinks it was set up higher because she tends to get confused and fall when this happens. The patient really has fallen twice of late. She said she aches all over. She also states dizziness when she stands up. Because of the symptomatology, she came to the emergency room for evaluation. Workup, including chest x-ray imaging, was fairly unremarkable. The patient did not, however, feel safe going directly home. In ER, patient's ABG showed significant CO2 retention. Pt is supposed to be using CPAP at home but admits it has not been used lately because of some problem with the machine. Since admit, patient admitted to pain in her back. CT spine showed L1 compression fracture which appeared new. PT worked with patient and felt she should go to rehab for continued therapies.Neurosurgery has ordered bracing for patient. No surgical intervention required. They also consulted neurology for myoclonic jerking and essential tremor. Patient is then to follow-up with neuro surgery and 3-4 weeks. 4/17 ER: 80 y.o. female who presents with increased somnolence and lethargy. Patient was discharged from the hospital 2 days ago after having a stay on swing bed. She has multiple medical problems and was admitted following a hospitalization at Hospital. She has generalized debilitation and advanced COPD with CO2 retention. Patient has been instructed to utilize a BiPAP machine. According to her family, she has been none a compliant with this and did not utilize it last night. Patient noted this morning that she was somnolent and lethargic. Prior to that she had been doing well since discharge. Other than the lethargy and somnolence there are no other complaints. 4/18/21 ER to admit: dx sepsis 80 y/o F with PMHx COPD with chronic CO2 retention and respiratory failure on 2L NC, OSA, non-compliant with CPAP, myoclonic jerks, essential tremor, type 2 DM, HTN, paroxysmal a.fib on eliquis, essential tremor and recurrent falls with recent L1 compression fracture s/p brace placement, presented to ED on 4/18/2021 for shaking and AMS.

Patients daughter states that about a week and a half after receiving the vaccine, patient started having trouble catching her breath. On April 9th, she called the squad and they administered a breathing treatment. She showed improvement and was not transported. On April 19th, she went to hospital to be seen in the ER. She was kept in observation status and was discharged home on April 20th. She went home on prednisone of levofloxacin.

Patient developed increased shortness of breath 4/21/21. Admitted to ICU via emergency with COVID pneumonia despite receiving 2nd COVID vaccination on 3/5/21

3 HOURS LATER AFTER VACCINE PATIENT EXPERIENCED: DIZZINESS, BACK AND CHEST PAIN, SHORTNESS OF BREATH, LEG AND STOMACH HIVES, INSOMNIA, AND VOMITING. CONTINUED FOR 3 DAYS. TODAY (ALMOST 2 WEEKS LATER SHE IS FULLY RECOVERED)

STATES SHE HAS BEEN FEELING RUN DOWN AND SICK FOR SOME TIME. STATES SHE HAS COVID IN NOV 2020 AND HAS NOT FELT WELL SINCE THEN. MADE AN APPT WITH HER HEART DOCTOR FOR FOLLOW UP TO TRY AND SEE IF THEIR WAS ANYTHING SHE COULD FIND TO HELP IMPROVE HER FEELING. WENT ON 4/22 FOR APPT AND MD SENT HER STRAIGHT TO THE HOSPITAL. WAS ADMITTED THAT NIGHT WITH FINDING OF BLOOD CLOT IN HER LUNG. CLIENT REPORTS AFTER EACH VACCINE SHE HAS SEVERE WEAKNESS WITH CHILLS AND FEVER OF 99-100. FEVER CHILLS RESOLVED WITHIN 1-2 DAYS BUT WEAKNESS JUST PROGRESIVLY GOT WORSE.

Hospitalization 4/8/2021-4/16/2021 with discharge home on hospice and death 4/28/2021. Admitting diagnosis: Acute respiratory distress, COPD, acute hypercapnic hypoxic respiratory failure, Hypomagnesemia; HTN; probable UTI with concerns for Severe Sepsis; Altered mental status with concerns for metabolic encephalopathy along with dementia.

Patient presented to PCP worsening fatigue and spells of shortness of breath, chest discomfort, felt like something was stuck in her throat and not feeling right for the past one week had the chills; legs weak, EKG showed ST segment elevation. Patient was transferred to hospital ED and admitted

Patient started to develop shortness of breath, worse with exertion after 2nd dose of Moderna. Not relieved with inhalers or nebulizers at home. Shortness of breath was relieved by Oxygen provided to her by EMS. Low BNP, elevated Troponins without significant peak noted. Treated for COPD exacerbation, which may have been set off by 2nd dose of Moderna. Patient being treated with 7 day course of increased steroids and Doxycycline.

very tired, slept all day; slept all day; She had trouble breathing; pain in back of right shoulder; found two blood clots on lungs and two in legs; found two blood clots on lungs and two in legs; there was damaged to his wife's heart too; weighed165 pounds initially and then went down to 145; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (She had trouble breathing), ARTHRALGIA (pain in back of right shoulder), FATIGUE (very tired, slept all day), HYPERSOMNIA (slept all day), PULMONARY EMBOLISM (found two blood clots on lungs and two in legs), DEEP VEIN THROMBOSIS (found two blood clots on lungs and two in legs) and CARDIAC DISORDER (there was damaged to his wife's heart too) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A2 or 078A2 and 028A2 or 078A2) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 31-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 an unknown date, the patient experienced DYSPNOEA (She had trouble breathing) (seriousness criterion hospitalization), ARTHRALGIA (pain in back of right shoulder) (seriousness criteria medically significant and life threatening), FATIGUE (very tired, slept all day) (seriousness criteria hospitalization, medically significant and life threatening), HYPERSOMNIA (slept all day) (seriousness criteria hospitalization, medically significant and life threatening), PULMONARY EMBOLISM (found two blood clots on lungs and two in legs) (seriousness criteria hospitalization and medically significant), DEEP VEIN THROMBOSIS (found two blood clots on lungs and two in legs) (seriousness criteria hospitalization and medically significant), CARDIAC DISORDER (there was damaged to his wife's heart too) (seriousness criterion hospitalization) and WEIGHT DECREASED (weighed165 pounds initially and then went down to 145). At the time of the report, DYSPNOEA (She had trouble breathing), ARTHRALGIA (pain in back of right shoulder), FATIGUE (very tired, slept all day), HYPERSOMNIA (slept all day), PULMONARY EMBOLISM (found two blood clots on lungs and two in legs), DEEP VEIN THROMBOSIS (found two blood clots on lungs and two in legs), CARDIAC DISORDER (there was damaged to his wife's heart too) and WEIGHT DECREASED (weighed165 pounds initially and then went down to 145) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: two blood clots on lungs and two (abnormal) two blood clots on lungs and two in legs. On an unknown date, Weight: 145 (Low) weighed 165 pounds initially and then went down to 145. The patient was hospitalized for around four days. The patient size of clots as 10 cm and 9cm in the lungs. The reporter stated that Heparin was used in the hospital and after the discharge the patient was put on Eliquis for the next 6 months. The reporter reported that the patient weighed165 pounds initially and then went down to 145 afterwards. Action taken with the mRNA-1273 is considered as not applicable. Company comment: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine, the onset of the reported events, a causal relationship cannot be excluded.

ED Discharged 4/4/2021 (4 hours) Hospital Emergency Department Last attending ? Treatment team Generalized weakness +4 more Clinical impression Weakness - Generalized ? Chills Chief complaint ED Provider Notes Emergency Medicine Expand AllCollapse All HPI Chief Complaint Patient presents with ? Weakness - Generalized ? Chills HPI 79-year-old female, history of COPD for which she wears oxygen at night and as needed, also with a history of leukemia and obesity who presents to the ED complaining of generalized body aches, fevers up to 103, feeling generally unwell and weak, poor sleep, onset 3 to 4 days ago. Patient reports that she received her second COVID-19 vaccine approximately 1 week ago. Tolerated this without any particular symptoms. She has had 2 days of watery/nonbloody diarrhea. Does admit to nausea with several episodes of vomiting earlier today. She is denying any particular abdominal pain. Does believe she felt her urine burning earlier today but has had no gross hematuria. Denies any flank pain. No ill contacts although her husband has been at home with a slight cough. Patient does have a cough presently but it is nonproductive. She is denying any particular chest pain or subjective shortness of breath. No rash or unusual lower extremity pain, swelling, or redness. ED to Hosp-Admission Discharged 4/6/2021 - 4/17/2021 (11 days) Hospital Last attending ? Treatment team Severe sepsis (CMS/HCC) Principal problem Discharge Summary Internal Medicine Inpatient DeathSummary BRIEF OVERVIEW Admission Date: 4/6/2021 Discharge Date: 4/17/2021 DETAILS OF HOSPITAL STAY Presenting Problem/History of Present Illness/Reason for Admission Patient is an 79 y.o. female morbidly obese with past medical history of chronic lymphocytic leukemia follow-up that was initially scheduled oncology follow-up for April 7 now postponed to the next 2 weeks, COPD on 2 L oxygen support at home, GERD, depression and anxiety. She was recently seen in the ED on April 4, 2021 with complaint of shortness of breath, nonproductive cough, fever, chills, nonbloody diarrhea, vomiting and weakness and subsequently diagnosed with COVID-19. She had however received a second dose of COVID-19 a week before and was discharged home due to lack of significant findings on imaging chest x-ray and lack of requirement for higher oxygen support. She presented to the emergency via EMS for evaluation of progressive shortness of breath with associated with fever, chills, headache, persistent shortness of breath, cough productive of thick clear sputum, nausea, vomiting and diarrhea. She denies abdominal pain, chest pain, or dizziness. Denies recent antibiotic usage or recent travel. Apparently, she thought she was getting better upon discharge after being kept for about 12 hours in the last ED visit, however she was not feeling well after going to bed last night and asked the husband to call 911. Upon EMS arrival patient was saturating in the 80s and in respiratory distress. She received 1 DuoNeb and was eventually placed on 10 L oxygen support. She was noted to be in significant respiratory distress during speech. Hospital Course Patient was admitted to hospital due to shortness of breath, and was found to have severe sepsis on presentation due to COVID-19 pneumonia. She had evidence of acute on chronic hypoxic respiratory failure as well. She was started on IV antibiotics, as well as remdesivir and Decadron at high dose. Unfortunately she continued to have clinical deterioration, and ultimately required high flow oxygen therapy. She was then transferred to the ICU, and ultimately required intubation due to severe profound ongoing hypoxia despite optimal medical treatment. She did not respond to remdesivir or steroids or antibiotics. Post intubation, she also developed acute renal failure during the course of her admission. Multiple discussions were had throughout the hospitalization regarding goals of care, and initially patient and family wish to be continually aggressive. She received full medical treatment, including life support, with minimal improvement. Despite being on ventilator for roughly 5 days, she continued to have severe hypoxia. She was proned, and was unable to sustain oxygen saturations when supine even for short period. Her renal function continued to decline as well, and at that point discussion was had with family regarding goals of care again. They were explained that symptoms continue to be persistent, and her illness continues to progress despite aggressive medical therapy. Ultimately decision was made to not pursue dialysis, and to allow the patient to be kept comfortable and pass away naturally from this infection. She was terminally extubated on 4/17 and passed away at 11:16 AM due to COVID-19 and acute on chronic hypoxic respiratory failure. Operative Procedures Performed X-ray Abdomen 1 View Result Date: 4/13/2021 Narrative: Single view portable abdomen INDICATION: Nasogastric tube placement, encounter initial Supine portable view of the lower chest and abdomen demonstrates nasogastric tube with tip and side-port in the gas-distended stomach. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View Result Date: 4/16/2021 Narrative: XR CHEST 1 VW IMPRESSION: No significant change from the previous examination. END OF IMPRESSION: INDICATION: Worsening hypoxemia. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: X-ray 4/13/2021. FINDINGS: The endotracheal tube, nasogastric tube, and right IJ central venous catheter are unchanged. Right-sided chest tube is unchanged. There is a small left pleural effusion. There is diffuse bilateral hazy airspace opacification. No change from prior. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View Result Date: 4/15/2021 Narrative: XR CHEST 1 VW PORT IMPRESSION: Tubes and lines as described. Small left effusion. Unchanged patchy bilateral airspace consolidation. END OF IMPRESSION: INDICATION: worsening hypoxemia. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: X-ray 4/14/2021. FINDINGS: The endotracheal tube, nasogastric tube, and right IJ central venous catheter are unchanged. The right-sided chest tube is unchanged. There is no pneumothorax. There is a small effusion. There is diffuse bilateral patchy airspace consolidation. There is no significant change. Cardiac silhouette is normal size. There is calcification of the aorta. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View - Daily Result Date: 4/14/2021 Narrative: Chest radiograph HISTORY: Covid 19 infection. Mechanical ventilation. Comments: Frontal radiograph of the chest was obtained and compared to the prior study dated 4/13/2021. The heart is at the upper limits of normal. The mediastinum is within normal limits. Interstitial alveolar opacities are demonstrated bilaterally consistent with pneumonia. There is an endotracheal tube with the distal end approximately 4.3 cm from the carina. Nasogastric tube is noted directed towards the stomach. There is a right jugular central catheter. A right-sided pigtail catheter is seen. IMPRESSION: 1. Persistent bilateral interstitial alveolar opacities consistent with pneumonia. 2. Lines and tubes in place as described. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View, Portable Result Date: 4/14/2021 Narrative: PROCEDURE INFORMATION: Exam: XR Chest Exam date and time: 4/13/2021 11:46 PM Age: 79 years old Clinical indication: Hypoxia; Covid+ TECHNIQUE: Imaging protocol: XR of the chest. Views: 1 view. COMPARISON: DX XR CHEST 1 VW 4/13/2021 10:50 AM FINDINGS: Tubes, catheters and devices: Endotracheal tube tip located at the level of the carina. Pigtail drainage catheter tip remains superimposed over the lateral right mid lung zone. Nasogastric tube enters the stomach but tip not included on the image. Tip of right internal jugular central venous catheter in SVC. Cardiac leads superimposed over the chest bilaterally. Lungs: Compared to chest x-ray examination performed earlier on 04/13/2021 at 1051 hrs, new consolidation and/or atelectasis in the left lung base. No significant interval change in scattered patches of ground-glass opacity (GGO) within each lung. Patient has history of COVID-19. Pleural spaces: Small right apical pneumothorax (12 mm). New small left pleural fluid collection. No right pleural fluid collection. Heart/Mediastinum: Stable cardiac silhouette Bones/joints: Unremarkable for age. IMPRESSION: 1. Endotracheal tube tip located at the level of the carina. 2. Pigtail drainage catheter tip remains superimposed over the lateral right mid lung zone. 3. Small right apical pneumothorax (12 mm). 4. Compared to chest x-ray examination performed earlier on 04/13/2021 at 1051 hrs, new consolidation and/or atelectasis in the left lung base. 5. New small left pleural fluid collection. 6. No significant interval change in scattered patches of ground-glass opacity (GGO) within each lung. Patient has history of COVID-19. THIS DOCUMENT HAS BEEN ELECTRONICALLY SIGNED BY MD X-ray Chest 1 View, Portable Result Date: 4/13/2021 Narrative: XR CHEST 1 VW PORT INDICATION: verify placement of right chest tube. Encounter: Subsequent. TECHNIQUE: AP portable erect projection of the chest is acquired. COMPARISON: Earlier today. FINDINGS: The left thoracostomy tube terminates near the lateral right midlung. No other change. Extensive pulmonary infiltrates. Stable life support lines. The previous right pneumothorax has predominantly resolved, only a thin crescent of air caps the right apex. END OF IMPRESSION: This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View, Portable Result Date: 4/13/2021 Narrative: XR CHEST 1 VW PORT IMPRESSION: Lines as described. There is a small right-sided pneumothorax. Unchanged bilateral airspace consolidation. END OF IMPRESSION: INDICATION: verify placement of CVC and post intubation. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: X-ray 4/11/2021. FINDINGS: There is a right IJ central venous catheter. Tip is projected over the SVC. There is a small right apical pneumothorax. Endotracheal tube terminates 2 cm superior to the carina. The nasogastric tube passes beneath the diaphragm. Multifocal areas of patchy airspace consolidation bilaterally. Findings do not appear significantly changed from prior. The cardiac silhouette is normal size. There is calcification of the aorta. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View Result Date: 4/11/2021 Narrative: XR CHEST 1 VW PORT IMPRESSION: Mildly worsened bilateral airspace consolidation. END OF IMPRESSION: INDICATION: worsening respiratory failure, covid pneumonia worsening respiratory failure, covid pneumonia. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: X-ray 4/8/2021. FINDINGS: The left costophrenic angle is partially excluded. The lungs are adequately expanded. There are large areas of patchy airspace consolidation bilaterally. Findings have mildly increased in severity. There is no effusion or pneumothorax. The cardiac silhouette is mildly enlarged. There is calcification of the aorta. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View Result Date: 4/8/2021 Narrative: XR CHEST 1 VW PORT INDICATION: Worsening hypoxemia, Covid pneumonia. Encounter: Initial. TECHNIQUE: AP portable erect projection of the chest is acquired. COMPARISON: 4/4/2021. FINDINGS: Scattered pulmonary infiltrates is developed bilaterally, greatest in the right upper and right lower lobe. No change in the heart, mediastinum, or bony thorax. IMPRESSIONS: Developing pulmonary infiltrates. END OF IMPRESSION: This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View - Portable Result Date: 4/4/2021 Narrative: XR CHEST 1 VW PORT IMPRESSION: No evidence of acute pulmonary disease. END OF IMPRESSION: INDICATION: SOB, weak, cough SOB, weak, cough. TECHNIQUE: Portable AP projection of the chest is acquired. COMPARISON: 6/5/2020 FINDINGS: Heart size appears unremarkable. There is mild prominence of pulmonary arteries. This is stable. There is no focal consolidation or effusion. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. Transthoracic Echo (tte) Complete Result Date: 4/11/2021 Narrative: Gender: Female Age: 79 Procedure Date: 4/11/2021 10:19 AM Study Quality: Fair Ht / Wt / BSA: 66.00 in / 218.00 lb / 2.07 m2 Heart Rate: 77 bpm BP: 181 / 81 mmHg Indications: Arrhythmia Transthoracic 2D, Color Flow, and Doppler Echocardiogram Conclusions: The left ventricle is normal in size. Ejection Fraction 55% (normal range 50-70%). All wall segments showed normal motion. Mild concentric LVH. Trivial aortic regurgitation. No additional significant valvular abnormality. No prior study for comparison. Presentation and History: Indication: The patient presents for evaluation of arrhythmia. The patient has a history of obesity and chronic obstructive pulmonary disease. Findings: Procedure Information: Contrast agent, definity, is being given per protocol without apparent complications. Due to technical limitations in the assessment of the left ventricle, imaging was performed after the administration of intravenous Definity echocontrast, as per protocol. Left Ventricle: The left ventricle is normal in size. There is mildly increased left ventricular wall thickness. The left ventricular systolic function is normal. The visually estimated ejection fraction is 55% (normal range 50 70%). Wall Motion: All wall segments showed normal motion. Right Ventricle: RV not well visualized. RV grossly normal in size and function by subcostal view. Atria: The left atrium is borderline dilated. The right atrium is normal in size. Aortic Valve: Sclerotic appearing aortic valve with no significant aortic stenosis. Trivial aortic regurgitation. Mitral Valve: There is trace mitral valve regurgitation by color flow and doppler analysis. There is no mitral valve stenosis by color flow and doppler analysis. Pulmonic Valve: There is no evidence of significant pulmonic valvular stenosis or insufficiency by color flow and doppler analysis. Tricuspid Valve: There is trace tricuspid valve regurgitation by color flow and doppler analysis. Great Vessels: All visible segments of the aorta are normal in size. Venous: The inferior vena cava is normal in size and collapses greater than 50% with inspiration. Pericardium/Pleural: There is no evidence of pericardial effusion. Prior Study Comparison: No prior study for comparison. Measurements: Left Ventricle: IVSd: 0.85 cm (0.6-0.9/0.6-1.0) LVIDd: 5.10 cm (3.9-5.3/4.2-5.9) LVIDd Index: 2.46 cm/m2 (2.4-3.2/2.2-3.1) LVIDs: 3.56 cm (2.0-3.6) LVPWd: 0.95 cm (0.7-1.1) Ao Root: 3.30 cm (2.1-3.5) LV Mass: 203.25 g (67-162/88-224) LV Mass Index: 98.19 g/m2 (43-95/49-115) LVOT Diam: 1.90 cm (3.0+(-)1.3) LVOT Pk Vel: 0.91 LVOT Mn Vel: 0.63 LVOT VTI: 0.20 LVOT Pk Grad: 3.00 LVOT Mn Grad: 2.00 LVOT Diam: 1.90 LVOT Area: 2.84 MV Pk E: 0.66 MV Pk A: 0.66 E/A: 1.00 E'Medial: 5.33 E/E' Med: 12.30 E' Laterial: 10.60 E/E' Lat: 6.20 Mitral Valve: MV Pk E: 0.66 MV PK A: 0.66 MV Decel Time: 209.00 E/A: 1.00 E'Lateral: 10.60 E'Medial: 5.33 E/E' Med: 12.30 E/E' Lat: 6.20 PHT: 61.00 MVA PHT: 3.61 Decel Slope: 3.14 Aortic Valve: AoV Pk Vel: 1.65 AoV Mn Vel: 1.22 AoV VTI: 0.39 AoV Pk Grad: 11.00 Aov Mn Grad: 7.00 AVA Cont.VTI: 1.42 Tricuspid Valve: TR Pk Vel: 2.89 TR Pk Grad: 33.00 RA Press: 10.00 RVSP: 43.00 Great Vessels: Ao Root-2D: 3.30 cm (2.0-3.7) Ao Asc: 3.30 cm (2.1-3.4) Updated on 4/11/2021 5:10:04 PM with Status of Final electronically signed on 4/11/2021 5:10:04 PM with status of Final Ct Covid Chest Low Dose Without Contrast Result Date: 4/6/2021 Narrative: PROCEDURE INFORMATION: Exam: CT Chest Without Contrast; Diagnostic Exam date and time: 4/6/2021 4:21 AM Age: 79 years old Clinical indication: Cough and shortness of breath; Patient HX: +covid; Additional info: Cough. Shortness of breath, covid TECHNIQUE: Imaging protocol: Diagnostic computed tomography of the chest without contrast. 3D rendering (Not supervised by radiologist): MIP and/or 3D reconstructed images were created by the technologist. Radiation optimization: All CT scans at this facility use at least one of these dose optimization techniques: automated exposure control; mA and/or kV adjustment per patient size (includes targeted exams where dose is matched to clinical indication); or iterative reconstruction. COMPARISON: CT CHEST WO CONTRAST 3/8/2021 2:28 PM FINDINGS: Lungs: There are patchy peripheral ground-glass opacities which can be seen with atypical pneumonia. Pleural spaces: Unremarkable. No pneumothorax. No pleural effusion. Heart: No cardiomegaly. No pericardial effusion. Aorta: Atherosclerotic changes of the aorta. Lymph nodes: Unremarkable. No enlarged lymph nodes. Bones/joints: Unremarkable. No acute fracture. Soft tissues: Unremarkable. IMPRESSION: Patchy peripheral ground-glass opacities which can be seen with atypical pneumonia. THIS DOCUMENT HAS BEEN ELECTRONICALLY SIGNED BY MD

My mom, patient was a health 79 year old women, only two health issues were COPD and moderate dementia. She had even gotten her annual labs done recently which came back all with in normal range, she as far as we knew did not have any issues with her heart. After her first vaccination in March she started to lose interest in things and didn't have energy to be as active as she was. After the second shot with in two days she started to report pain in chest and head and trouble breathing, She went to her PCP on 5/12 and he wanted her to go to a cardiologist, this referral was made but by the 16th she was in the ER due to extreme chest pain and trouble breathing, a stent was placed in her heart on 4/17/21 my mom's 80th birthday. with in 4 days she died. Her heart just deteriorated. i feel that if she didn't get this shot she would be alive today, she was healthy, now she is dead.

Cough, shortness of breath, sinus congestion, headache, generalized body aches, fever, nausea and vomiting.

Atelectasis; Back pain; Cardiomegaly; Dizziness postural; Essential tremor; Fall; Lethargy; Mental status changes; Myoclonus; Pain; Sepsis; Somnolence; Spinal compression fracture; Tremor; This case was received via FDA VAERS on 25-May-2021 and was forwarded to Moderna on 25-May-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of ATELECTASIS (Atelectasis), BACK PAIN (Back pain), CARDIOMEGALY (Cardiomegaly), DIZZINESS POSTURAL (Dizziness postural), ESSENTIAL TREMOR (Essential tremor), FALL (Fall), LETHARGY (Lethargy), MENTAL STATUS CHANGES (Mental status changes), MYOCLONUS (Myoclonus), PAIN (Pain), SEPSIS (Sepsis), SOMNOLENCE (Somnolence), SPINAL COMPRESSION FRACTURE (Spinal compression fracture) and TREMOR (Tremor) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for an unknown indication. The patient's past medical history included COPD, Atrial fibrillation, Hypertension, Diabetes, Obesity and Respiratory failure. Concurrent medical conditions included Allergy to allopathic drugs (Jardiance Lyrica) and Allergy to allopathic drugs. Concomitant products included CHOLECALCIFEROL and APIXABAN (ELIQUIS) for an unknown indication. On 11-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 11-Mar-2021, the patient experienced ATELECTASIS (Atelectasis) (seriousness criterion hospitalization), BACK PAIN (Back pain) (seriousness criterion hospitalization), CARDIOMEGALY (Cardiomegaly) (seriousness criterion hospitalization), DIZZINESS POSTURAL (Dizziness postural) (seriousness criterion hospitalization), ESSENTIAL TREMOR (Essential tremor) (seriousness criterion hospitalization), FALL (Fall) (seriousness criterion hospitalization), LETHARGY (Lethargy) (seriousness criterion hospitalization), MENTAL STATUS CHANGES (Mental status changes) (seriousness criterion hospitalization), MYOCLONUS (Myoclonus) (seriousness criterion hospitalization), PAIN (Pain) (seriousness criterion hospitalization), SEPSIS (Sepsis) (seriousness criteria hospitalization and medically significant), SOMNOLENCE (Somnolence) (seriousness criterion hospitalization), SPINAL COMPRESSION FRACTURE (Spinal compression fracture) (seriousness criteria hospitalization and medically significant) and TREMOR (Tremor) (seriousness criterion hospitalization). At the time of the report, ATELECTASIS (Atelectasis), BACK PAIN (Back pain), CARDIOMEGALY (Cardiomegaly), DIZZINESS POSTURAL (Dizziness postural), ESSENTIAL TREMOR (Essential tremor), FALL (Fall), LETHARGY (Lethargy), MENTAL STATUS CHANGES (Mental status changes), MYOCLONUS (Myoclonus), PAIN (Pain), SEPSIS (Sepsis), SOMNOLENCE (Somnolence), SPINAL COMPRESSION FRACTURE (Spinal compression fracture) and TREMOR (Tremor) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, Blood gases abnormal: abnormal (abnormal) patient's ABG showed significant CO2 retention.. On 21-Mar-2021, Chest X-ray: abnormal (abnormal) shows new cardiomegaly. Mild bibasilar volume loss is again seen. Remaining lungs are clear. No pleural effusion is noted.. On 21-Mar-2021, Computerised tomogram: abnormal (abnormal) CT spine showed L1 compression fracture which appeared new. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Because of the symptoms, patient came to the emergency room for evaluation. Chest x-ray imaging, was fairly unremarkable. She just feels achy. There were no chest pain, shortness of breath, abdominal pain, urinary symptoms or rash. On 26-Mar-2021, patient presented for evaluation of physical deconditioning. Patient presents to our facility yesterday after hospital stay from hospital . Patient tends to get confused and fall and has fallen twice. Patient has aches all over, dizziness when she stands up. In ER, patient's ABG showed significant CO2 retention. Pt is supposed to be using CPAP at home but admits it has not been used lately because of some problem with the m. Neurosurgery has ordered bracing for patient. No surgical intervention required. They also consulted neurology for myoclonic jerking and essential tremor. Patient is then to follow-up with neuro surgery and 3-4 weeks. On 17-Apr-2021, patient presented to the emergency room with increased somnolence and lethargy. Patient was discharged from the hospital 2 days ago after having a stay on swing bed. She has multiple medical problems and was admitted following a hospitalization at Hospital. She has generalized debilitation and advanced COPD with CO2 retention. Patient has been instructed to utilize a BiPAP machine. According to her family, she has been none a compliant with this and did not utilize it last night. Patient noted this morning that she was somnolent and lethargic. Prior to that she had been doing well since discharge. Other than the lethargy and somnolence there are no other complaints. On 18-Apr-2021 she was diagnosed with sepsis. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event 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 event, a causal relationship cannot be excluded. However, multiple underlying co-morbidities may re; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, multiple underlying co-morbidities may remain as confounding factors.

5/23/21 ER to Admission, HPI: Patient is a 79 y.o. female admitted to acute care from ED per Dr. with septicemia, acute UTI, pneumonia of right upper lobe.. The patient presented to ED brought in by EMS from local residence complaining of altered mental status. Patient states she woke up yesterday morning chilling. States she just could not get warm. Went back to bed for I while. States she did get up and go to church. After eating dinner had went over to her grandson's. She became confused at that point. Has been states that speech was difficult to follow. Did become slightly slurred. EMS was called and patient was brought to ER for further evaluation. Upon arrival to ER patient's temp is 102.4°. CT scan head negative for acute changes. Chest x-ray did show right upper lobe changes questionable infiltrate. Lactic acid 1.1 procalcitonin negative. Urine was highly positive with GNR on gram stain. Patient given L of normal saline along with Zosyn in ER. Subsequently admitted to acute care for further evaluation and treatment including IV antibiotics and further monitoring. Foley catheter placed ER.

Patient became short of breath about 5 days post covid vaccine. She presented to the office on 6/14/2021 and was noted to be SOB with a SPO2 of 74% on room air. Patient SPO2 did increase with oxygen at 2l/nc to 92-94%. Patient was transferred to local ER for evaluation and there she was noted to have multiple blood clots in both lungs. Patient spent 3 days in the hospital and was discharged today.

pt felt strange followed 5 min later by feeling short of breath and severe pain in head, mild wheezing auscultated

Pt received Moderna covid 19 vaccines on Feb 6th 2021 and March 6th 2021. She was diagnosed with new aggressive possible lymphoma or lung cancer for which she ultimately died from on 7/2/21 . Daughters reported symptoms started suddenly 5 1/2 weeks ago around 5/20/21. PCP notes confirm this. She saw her PCP on 5/25 for the cough and a cxr done that day was normal. She was prescribed tesselon perles and azithromycin. She presented back on 6/8 with persistent cough with new hemoptysis, decreased appetite and weight loss and ct scan done 6/15 showed a large heterogenous mass of the mediastinum 6.6 x 7.6 x 13cm encasing the r main pulmonary artery the r brachicephalic, r subclavian and common carotids. There was mass effect on the trachea and r main stem bronchus. The 6mm nodule seen in the posterior left upper lobe was stable and unchanged from previous ct chest from 9/20. This rapidly progressed in a very short time resulting in her admission to the hospital for respiratory failure on 6/28 and she was so unstable we were unable to transfer her for a biopsy and start of treatment as recommended by oncology. She passed away on 7/2/21. The family decided they wanted to pursue a limited autopsy to have the mass biopsied to determine what the cancer was which was so rapidly progressive. They describe her as prior to the start of the cough and hemoptysis on 5/20 that she was living alone, used no assistive devices and other than her dementia was generally healthy and was very interactive and involved with her family

patient developed weakness and onset of increased shortness of breath with rapid heartrate. She was taken to emergency room and found to have Atrial Fib. She had multiple episodes over 3 weeks and now hasn't had anymore since

PT became dizzy, short of breath, and nervous . IV started at site. PT transported to facility and given IV diphenhydramine and solumedrol.

Patient reported to the emergency room from fever and shortness of breath the day after receiving the COVID-19 vaccine. Patient was found to have a UTI and possible sepsis. Unknown if truly related to COVID vaccine.

It has been 6 days - I am still nauseus; lite headed; throat feels tight; lack of energy. I'm this way off and on thru out the day. I have been using Mucinex to relieve the mucus in my throat and Benadrl to relieve other side effects. I have not been ill nor have I experienced any pain. I have an allergy to bee stings but have never been on medication for it.

hours after vaccination arm soreness, stiffness in hands, two days after vaccination fatigue, breathing difficulty-feeling of tightness around rib cage, heart felt tight, headache, body aches, sinus trouble

pt c/o chest tightness, hx of chest in last week, took 1 nitro glycerine , appeared to faint with heavy breaths. 1505 bp 130/80, p76,o2sat 97% became diaphoretic nauseated , threw up ,became more alert 911 called O2 applied 1520 bp118/74 p61 o2sat 96% Ambulance arrived transport to ED

Moderna Vaccine Lot 029K20A Patient received second dose of vaccine on 2/2/21. Within 30 minutes patient had a near syncopal episode. She felt lightheaded and shortly after had episode of nonbloody vomiting. Hypotensive 81/69 and started on levophed. Alert and orientated. Lungs clear, abdomen benign on admission. Patient had no reaction when received first dose of the vaccine. Patient developed worsening shortness of breath, tachypnea, Afib with RVR, hypotension and required intubation and multiple pressors.

Mild stroke about 9am. Fell on floor, needed help to stand up and walk, garbled speech, headache, temp. 98.0, 98.2, 98/3; not swallowing food, couldn't handle food. Could not hold cracker, bread or find mouth with hand. needed help to go to bathroom, couldn't answer telephone, was dizzy, couldn't balance herself, she fell 3 times on Feb. 3, I took the top off a water bottle and handed it to her she kept trying to unscrew the lid even after I showed her I had the lid in my hand. Feb. 4 she had the dry heaves all morning, she slept all afternoon. I called the doctors office @ 8:00am and again later @ 8:30am. He said he wanted her to have a CAT scan Medical Center. He said they would call

Client felt tired on Friday after vaccine, on Saturday (2/6) clients arm was red and swollen, and she had some shortness of breath. Daughter said these symptoms progressively got worse. On 2/8 client went to MD who told her it was an allergic reaction and that she should report it to her local Health department.

Shortness of breath within 5 minutes and pale. Oxygen at 2l/min given. On room air at 1426. Patient is feeling well .

lst and 2nd day: sore arm 3rd day: shortness of breath, fatigue, body aches, headache one week later: arm itching , red and blotchey and warm Time Course: symptoms lasted 4-5 days

Suddenly this morning, 13 days after receiving the first Covid Moderna vaccine - my arm is red and feverish at injection site. In the meantime starting Sunday, Feb. 14th, I had pain in right chest and right upper back, that I contributed to making a wrong move and straining muscles. The back pain is better, but I still have it when I reach high , move wrong, or take a deep breath.

very labored breathing i used albuterol nebulizer for breathing treatments to relieve symptoms. symptoms lasted for 2 days.

Dr. called (pt's PCP) to report reaction that was reported to her by pt's sitter and husband. States pt would not eat and was lethargic the night after receiving the vaccine. The next morning pt was extremely fatigued and "not acting like herself." By Tuesday night, pt was experiencing rapid breathing, sweating, and was very agitated. PCP states sitter reported that she heard "rattling" in pt's chest. Pt short of breath this morning with heart rate of 123. Pt will not eat or drink and is very weak. Pt has not been communicating with them like she normally does. Can only walk a few steps before having to rest. Pt was on her way to ED when PCP called to report this.

Patient admitted to hospital with Covid-19 Pneumonia on 02/19/2021. Diagnosed with bronchitis prior week. Having cough and shortness of breath with associated fever x1week

Pain all over the body back pain more severe and hard to breath in the beginning for 17 days now after the second doze Hard to straighten up to walk

24hours after immunization patient experienced dyspnea - called office 3-8-21 - referred for CTA chest given symptoms + for bilateral pulmonary emboli, NO history of such and NO obvious predisposing risk

Patient is a very pleasant 80 year old female with a history of hypertension and recent pelvic fracture approximately two months ago who presented to the emergency department reporting right sided chest pain. She states that her symptoms started on Sunday. She has pain with a deep breath and also with exhaling. She reports it is a sharp pain. She states that she has had no lower extremity edema or calf pain, however, she did have a shooting pain down her right leg recently. She denies any history of personal or family history of deep venous thrombosis or pulmonary embolus. She reports that she has not had any hemoptysis. She denies feeling short of breath. She denies abdominal pain, nausea, vomiting, or diarrhea. She states that she has not had any COVID exposures or known symptoms. She has received two COVID vaccine doses. She reports that she has not been sick and denies fever, chills, or cough. In the emergency department she was diagnosed with an acute pulmonary emboli in the right main pulmonary artery with extension into the segmental pulmonary arteries. There is concern for early pulmonary infarct. This has prompted admission to the hospital.

Client states her eyes swelled shut, her hands became swollen and she had noisy breathing(maybe wheezing) all started 2 days after vaccine and the symptoms didn't resolve until 8 days after they started. She did not obtain medical care. She doesn't speak English and didn't know she should've gone to the ER. Plans to now schedule to see her doctor to find out if she should get a different covid vaccine as she had a reaction to Moderna.

03/15/2021: Presented to the emergency department with worsening lower extremity edema and dyspnea on exertion. The patient was admitted for a congestive heart failure exacerbation for IV diuretics. Patient currently still admitted and now having lower GI bleeding on a heparin infusion.

PATIENT HAD ANAPHYLAXIS. IT PRESENTED AS A LIGHT COUGH THAT GOT WORSE AND BEGAN PROGRESSING TO SHORTNESS OF BREATH . THIS HAPPENED APPROXIMATELY 15 MINUTES AFTER SHE RECEIVED THE VACCINE. I ADMINISTERED AN EPIPEN THAT IMPROVED SYMPTOMS FOR ABOUT 5 MINUTES. THE EMT'S ARRIVED AT THAT TIME AND TOOK OVER CARE.

Patient started experiencing shallow breathing and had a hard time breathing two days after vaccination. She said her ankles were swollen and hurting and she could not sleep for three days after these symptoms started. She did not seek medical attention and the symptoms resolved on their own without treatment.

Dizzy, couldn?t do normal housework, breathless after little exertions, terrible headaches . After 10 Days went to Yavapai Regional Medical Center ER and was admitted with high blood pressure 225/97.

Morning on 3/11 awoke with fever and body aches, breathing became difficult over the next several days, along with light headedness. ED visit on 3/14 diagnosed with COPD flare advised to follow up with PCP. 3/22 follow up with PCP, discovered blood in stool sent to ED. Admitted on 3/22 with low hemoglobin and blood in stool. Endoscopy on 3/23 and coloscopy on 3/24. Source of bleed undetermined. Released on 3/23. 4/1 returned to ED as symptoms continued. D-dime blood test and CAT found blood clots in lower right lung. Prescribed Eloquis and released. Returned to ED on 4/5 admitted with low hemoglobin (7.1) bleeding, breathing difficulty. Endoscopy repeated on 4/6 not bleeding found. Released on 4/9.

could hardly breathe/hurts me to breath; Right side of chest hurt/pain on right side of the chest like muscle pulled; two weeks ago had dysentery; This spontaneous case was reported by a consumer and describes the occurrence of DYSENTERY (two weeks ago had dysentery) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes mellitus and Blood pressure high. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced DYSENTERY (two weeks ago had dysentery) (seriousness criterion medically significant). On 31-Mar-2021, the patient experienced DYSPNOEA (could hardly breathe/hurts me to breath) and CHEST PAIN (Right side of chest hurt/pain on right side of the chest like muscle pulled). At the time of the report, DYSENTERY (two weeks ago had dysentery), DYSPNOEA (could hardly breathe/hurts me to breath) and CHEST PAIN (Right side of chest hurt/pain on right side of the chest like muscle pulled) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. At first she didn't feel bad but last night 31Mar2021, she could hardly breathe, right side of chest hurt, hurts me to breathe, pain on right side of chest like I pulled a muscle, two weeks ago had dysentery. Treatment included ointment. Patient didn't want to call doctor as her doctor would just tell her to go to the hospital. Doctor told her to get tested for COVID. Based on the known etiology of dysentery as being if infective origin, causality with mRNA-1273 is assessed as unlikely. Although a temporal association exist, it is not enough to assess the other reported events as related to the administration of mRNA-1273. Additional information has been requested as causality is cofounded by the patient's concurrent history of diabetes.; Sender's Comments: Based on the known etiology of dysentery as being if infective origin, causality with mRNA-1273 is assessed as unlikely. Although a temporal association exist, it is not enough to assess the other reported events as related to the administration of mRNA-1273. Additional information has been requested as causality is cofounded by the patient's concurrent history of diabetes.

could hardly breathe; right side of chest hurt, like I pulled a muscle; dysentery; This spontaneous case was reported by a consumer and describes the occurrence of DYSENTERY (dysentery) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Blood pressure high and Blood sugar abnormal. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced DYSENTERY (dysentery) (seriousness criterion medically significant). On 31-Mar-2021, the patient experienced DYSPNOEA (could hardly breathe) and CHEST PAIN (right side of chest hurt, like I pulled a muscle). At the time of the report, DYSENTERY (dysentery), DYSPNOEA (could hardly breathe) and CHEST PAIN (right side of chest hurt, like I pulled a muscle) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant products known to have been used by the patient, within two weeks prior to the event, included high blood pressure medication and medication for sugars. Treatment of these events included unspecified ointment. Very limited information regarding the has been provided at this time for the event. Further information has been requested. The reported events were considered possibly related to mRNA-1273.; Sender's Comments: Very limited information regarding the has been provided at this time for the event. Further information has been requested.

difficulty breathing; soreness after 1st dose left arm; Clot in Lung; chest pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY THROMBOSIS (Clot in Lung) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Heart disorder. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced PULMONARY THROMBOSIS (Clot in Lung) (seriousness criterion medically significant) and CHEST PAIN (chest pain). On 29-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness after 1st dose left arm). On an unknown date, the patient experienced DYSPNOEA (difficulty breathing). On 30-Mar-2021, VACCINATION SITE PAIN (soreness after 1st dose left arm) had resolved. At the time of the report, PULMONARY THROMBOSIS (Clot in Lung), CHEST PAIN (chest pain) and DYSPNOEA (difficulty breathing) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Echocardiogram: normal (normal) Normal. On an unknown date, Computerised tomogram: abnormal (abnormal) Blood clot in Lung. On an unknown date, Pulmonary function test: normal (normal) came back perfect. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. On 08-Mar-2021 patient had an echocardiogram (results are not provided). Concomitant medications are not reported. No Treatment for events is provided. Based on the current available information which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, causal relationship cannot be excluded. Vaccination site pain is consistent with the known safety profile of the vaccine This case was linked to MOD-2021-084017 (Patient Link).; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, causal relationship cannot be excluded. Vaccination site pain is consistent with the known safety profile of the vaccine

80 yo woman with hx of HTN, anxiety dneies any other conditions, presented to ER due to epigastric pain, vomiting x1. In Er presented with elevated heart rate, EKG with sinus tachycardia, regular rythm. CXR with COPD changes. There are bibasilar infiltrates suspicious for pneumonitis in the appropriate clinical setting. PAtient admitted to unit for further treatment and workup. WBC 16.91 4/27/2021

March 2 - second Moderna March 3 - spontaneous bruising appears March 4 - visit with primary care doctor, blood work shows significant drop in platelets March 9 - first visit with oncologist/haematologist & hospitalized March 9-19 - hospitalized for tests, treatment to increase platelets, & many blood panels. No official diagnosis, treat as ITP. Follow up visits with oncologist/haematologist to keep an eye on platelets as they increase. March 30-Apr 4 - ER visit due to swelling of ankles, feet, and left arm. Tests show superficial blood clot, fluid on lungs, and pneumonia. Oncologist said that "we have no official diagnosis", that she's being treated for ITP. April 6-14 - follow up visit to oncologist/haematologist show elevated kidney enzymes, then later liver enzymes, low sodium. April 14 - decision to move to short term rehab for regular PT and OT. Continued swelling (fluid in third spaces.) April 21 - visit to cardiologist to perform cardioversion, successful (during first week of hospital stay, heart rhythm med had to stop). April 23 - facility nurse discovered significantly low Hemoglobin and a blood transfusion was ordered. April 24 - returned to short term rehab facility. April 25 - discovered my mother on O2 and state of health was different, extremely weak and not moving, arm hurting badly. I insisted that her oncologist is contacted. Transported to ER. Discovered her blood work abnormal. After stabilizing her, rushed to the hospital ICU. April 26 - Discussed with her ICU doctor the history of what you have read above. He explained that the covid-19 vaccination has a tendency to affect three proteins specifically that clot and thin blood. I begged him to "get it out of her system." Her bleeding was significant and platelets dropped, again. Still has her mental facilities. Responding well to aggressive treatment: albumin transfusion, plateletpheresis, and CRRT. Pleural catheter to remove fluid from the lungs. Mention of Sepsis. April 27 - Lifted her head up today, opened her eyes, making doctors very happy. Her cardiologist and the ICU doctor both said they were "confused" and everything happening to my mom was "a mystery." Though going in to the evening, her nurse expressed to me that she's worried. The ICU oncologist called me at home in the evening. He asked me if she had been having a fever on a regular basis. He said he thought it could be TTP or a rare disease called HTH, but both results wouldn't be back for one week. He planned to consult with a doctor. He explained to me that the blood was attacking itself and "confused," and that her organs were shutting down. He indicated that the blood work wasn't indicating significant infection. He referenced how the vaccination has made her auto immune system "go crazy." April 28 - I get a call very early from the nurse that she has been fighting with my mother's blood pressure all night, trying to keep it elevated. She told me to come to the hospital, because she had taken a turn for the worse. I arrive to find my mother's eyes wide open, breathing shallow, and blood pressure steady, but drops without assistance from medication. She continues to have her mental facilities. She passed away, organs shutting down, and blood pressure dropped.

Patient felt lightheaded after the vaccine. She was asked to stay seated for about 15 minutes and then sent home. Once home she progressively had more symptoms including lightheadedness, confusion, fatigue, unconsciousness, expressive aphasia, loss of bladder and bowel control, elevated temperature, increased pulse, increased respirations, increased blood pressure, dehydration, stroke like symptoms with no evidence of stroke, loss of motor coordination

Patient stated to PCP that she developed significant weakness 2-5 days post second COVID vaccine. Pt also developed significant SOB. Pt is now unable to walk short distances and is unable to lift her legs, gets lethargic easily, and uses a wheelchair.

The morning after the second vaccine, my pulse was over 150, I was short of breath, light headed and experienced nausea. This has persisted since with pulse more often in the 105 to 120 range, although it will go to the 150's at times. The feeling lasts anywhere to about five minutes to the entire day.

Headache, nose bleed, body aches, swollen feet, anxiety, palpitations, very very tired, feeling of desperation , crying episodes, sob

After first vaccination, patient experienced sever flu-like symptoms with body aches, fatigue and chills. After second vaccination, similar though less severe flu-like symptoms occurred likely because the patient pre-treated with Essential Defense, an herbal blend. Shortly after the second vaccination, she began to experience loss of asthma control with worsening cough, wheezing and shortness of breath. Asthma regimen was maximized with nebulized inhaled steroids and both short and long acting beta agonists but she failed to improve significantly. Ultimately the patient required oral steroids after lung function dropped to 35% of normal.

Immediately after receiving her second Moderna vaccine, patient states that she felt a tightness in her chest. No shortness of breath noted. She did not tell anyone at the clinic, but went home to rest. She states that immediately after vaccine, she began to have cough, chest congestion and tightness. Two days later, she went to PCP for evaluation. The Dr diagnosed her with pneumonia and prescribed treatment of antibiotics, steroids and albuterol. Per patient, she has gone back to see the Dr four times and been on treatments continuously. She was referred to Pulmonologist and was seen on 4/14/21. She states that the insignificant nodules that were previously in her lungs were more pronounced. She continues to have cough and chest congestion. No fever has been noted. She will follow up with pulmonologist in July 2021. Patient states that she feels like she still has pneumonia.

pulmonary embolism chest pain shortness of breath, blood thinner given patient sent home on o2 and blood thinner still non o2.

Client reports that 2 weeks after the second dose she had difficulty speaking and her voice sounded differenet. She was told by friends that she sounded different, also. She also has chronic fatigue, which worsened. She met with her NP who said she may have had a stroke, per the client. She was given a prescription for a speech therapy and a swallowing eval. She also said that she has difficulty swallowing sometimes, and feels as if her throat is closing up, but then it resolves. Client was instructed, by this nurse, to go to the hospital for this symptoms. She said she can manage it and always "comes out of it." Client was instructed to make sure she calls 911, if she has this symptom again.

Myocarditis in 2 days - diuretics, Respiratory Failure in 2 days Bipap and Airvo, Clotted off leg in a few weeks Angiogram and Fascitomy, Ischemic gut weeks - comfort care orders, DVT in arm in weeks could have been due to PICC also - Elquis

Two days after second injection we noticed swelling in ankles, which has not happened before. We cut back her fluid intake but the swelling persisted for two weeks. She was brought to see doctor (NP) on 17th of March which lead to no resolution. She was brought to ER on the 18th and admitted. After inpatient treatment she was released two days later and has had no subsequent issues.

chest tightness; loss of appetite; irregular heart rate/palpitations; irregular heart rate/palpitations; extreme PMS; Diarrhea; Fatigue; sleeping on and off all day; shakes; trouble moving and walking; terrible cramping like menstruation; bloated; had a painful stomach; pain moved to the chest area; body aches; chest pain; body pain; lung congestion; so much muscle pain - Muscle pain throughout the body was intense; sick; Muscle pain; fever; Nausea; Headache; chills; Fatigue/ extreme fatigue; shortness of breath; Weakness in her body, muscle and legs; Intense pain; Sore throat; Shaking; Diarrhea; Dizziness; severe stomach cramps - PMS type; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (lung congestion) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Asthma since an unknown date, Bronchitis, Hives since an unknown date, Hypersensitivity reaction since an unknown date, Irritable bowel syndrome in 2000 and Reflux esophagitis. Previously administered products included for an unreported indication: FLU VACCINE VII. Concurrent medical conditions included Irritable bowel syndrome, Penicillin allergy (penicillin allergy), Drug allergy (arestin), Allergy to antibiotic (allergy to macrolides) and Allergy to antibiotic (ketolides used for red rashes). Concomitant products included ERYTHROMYCIN, DENOSUMAB (PROLIA), ARTHROBENE PLUS, VITAMIN D3 and DOXYCYCLINE HYCLATE for an unknown indication. On 07-Mar-2021 at 12:25 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced DYSPNOEA (shortness of breath), ASTHENIA (Weakness in her body, muscle and legs), PAIN (Intense pain), OROPHARYNGEAL PAIN (Sore throat), TREMOR (Shaking), the first episode of DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), ABDOMINAL PAIN UPPER (severe stomach cramps - PMS type), CHILLS (chills), FATIGUE (Fatigue/ extreme fatigue), MYALGIA (Muscle pain), PYREXIA (fever), NAUSEA (Nausea) and HEADACHE (Headache). On 28-Mar-2021, the patient experienced ILLNESS (sick) and MYALGIA (so much muscle pain - Muscle pain throughout the body was intense). On 12-May-2021, the patient experienced PULMONARY CONGESTION (lung congestion) (seriousness criterion medically significant). On 24-May-2021, the patient experienced CHEST PAIN (chest pain) and PAIN (body pain). On 08-Jun-2021, the patient experienced MUSCLE SPASMS (terrible cramping like menstruation), ABDOMINAL DISTENSION (bloated), ABDOMINAL PAIN UPPER (had a painful stomach), CHEST PAIN (pain moved to the chest area), TREMOR (shakes), HYPOKINESIA (trouble moving and walking) and MYALGIA (body aches). On 09-Jun-2021, the patient experienced HYPERSOMNIA (sleeping on and off all day), the second episode of DIARRHOEA (Diarrhea) and FATIGUE (Fatigue). On an unknown date, the patient experienced CHEST DISCOMFORT (chest tightness), PREMENSTRUAL PAIN (extreme PMS), DECREASED APPETITE (loss of appetite), PALPITATIONS (irregular heart rate/palpitations) and HEART RATE IRREGULAR (irregular heart rate/palpitations). The patient was treated with PARACETAMOL (TYLENOL) on 28-Mar-2021 at an unspecified dose and frequency; PARACETAMOL (TYLENOL) on 08-Jun-2021 at a dose of 500 mg; ARNICA MONTANA (ARNICA 30C) at a dose of 2 Tablets; MAGNESIUM at a dose of 500 mg four times per day; LOPERAMIDE HYDROCHLORIDE (IMODIUM) ongoing from 09-Jun-2021 for Diarrhea, at a dose of 2 mg as required and CHLORPHENAMINE MALEATE, PHENYLPROPANOLAMINE HYDROCHLORIDE (ALLERGY RELIEF MEDICINE) ongoing since an unknown date at a dose of 180 mg once a day. On 18-Mar-2021, DYSPNOEA (shortness of breath), ASTHENIA (Weakness in her body, muscle and legs), PAIN (Intense pain), OROPHARYNGEAL PAIN (Sore throat), TREMOR (Shaking), DIZZINESS (Dizziness), CHILLS (chills), FATIGUE (Fatigue/ extreme fatigue), MYALGIA (Muscle pain), PYREXIA (fever), NAUSEA (Nausea) and HEADACHE (Headache) had resolved, ABDOMINAL PAIN UPPER (severe stomach cramps - PMS type) had not resolved. At the time of the report, PULMONARY CONGESTION (lung congestion), ILLNESS (sick), ABDOMINAL DISTENSION (bloated), CHEST PAIN (pain moved to the chest area), CHEST PAIN (chest pain), CHEST DISCOMFORT (chest tightness), TREMOR (shakes), HYPOKINESIA (trouble moving and walking), HYPERSOMNIA (sleeping on and off all day), PAIN (body pain), PREMENSTRUAL PAIN (extreme PMS), DECREASED APPETITE (loss of appetite), PALPITATIONS (irregular heart rate/palpitations), HEART RATE IRREGULAR (irregular heart rate/palpitations), FATIGUE (Fatigue), MYALGIA (body aches) and MYALGIA (so much muscle pain - Muscle pain throughout the body was intense) outcome was unknown and MUSCLE SPASMS (terrible cramping like menstruation), ABDOMINAL PAIN UPPER (had a painful stomach) and the last episode of DIARRHOEA (Diarrhea) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Blood pressure measurement: 193/75 mmhg (High) 193/75 mmHg. On 17-Mar-2021, Body temperature: 98.8 degree celsius (Inconclusive) 98.8 degree Celsius. On 17-Mar-2021, Heart rate: 60 breaths per minute (Low) 60 breaths per minute. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient took 2 papaya chewable tabs for stomach. The patient is taking allergy 10 -plus, refresh lubricant eye drops, refresh optive advanced eyedrops every 2-3 hours as needed for both eyes, trace mineral drops -8 drops(3-4 water bottles per day). Company Comment: Very limited information regarding this events has been provided at this time. Noting the history of reflux esophagitis, IBS and treatment with Prolia may remain as risk factors. However, notes from HCP evaluation, details regarding tests/diagnostics, diagnosis and treatment are required for further assessment. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Concomitant medication Prolia, Treatment medication Arnica tablets were added. New events severe stomach cramps - PMS type, extreme fatigue, too sick, so much muscle pain - Muscle pain throughout the body was intense were added. On 10-May-2021: Reporter's FAX number was added. On 10-Jun-2021: Treatment medication Imodium and Magnesium were added. New events were added. On 23-Jun-2021: Outcome, FAX number updated On 01-Jul-2021: event added, lab data, medical history, con-med added; Sender's Comments: Very limited information regarding this events has been provided at this time. Noting the history of reflux esophagitis, IBS and treatment with Prolia may remain as risk factors. However, notes from HCP evaluation, details regarding tests/diagnostics, diagnosis and treatment are required for further assessment. Further information has been requested.

Heart damage; Irreversible lung damage; She gets out of breath from walking across the floor/could not breathe; When she wakes up in the morning she has to force herself to function; She is always in pain; Pain in arm; Hard to lift arm off pillow; Weakness; Blurred vision; Pain behind eyes; Irregular heartbeat; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEART INJURY (Heart damage) in an 80-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 Allergy NOS (The patient stated she has a lot of allergies). On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 HEART INJURY (Heart damage) (seriousness criterion medically significant), LUNG DISORDER (Irreversible lung damage), DYSPNOEA (She gets out of breath from walking across the floor/could not breathe), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (When she wakes up in the morning she has to force herself to function), PAIN (She is always in pain), PAIN IN EXTREMITY (Pain in arm), LIMB DISCOMFORT (Hard to lift arm off pillow), ASTHENIA (Weakness), VISION BLURRED (Blurred vision), EYE PAIN (Pain behind eyes), HEART RATE IRREGULAR (Irregular heartbeat) and HEADACHE (Headache). At the time of the report, HEART INJURY (Heart damage), LUNG DISORDER (Irreversible lung damage), DYSPNOEA (She gets out of breath from walking across the floor/could not breathe), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (When she wakes up in the morning she has to force herself to function), PAIN (She is always in pain), PAIN IN EXTREMITY (Pain in arm), LIMB DISCOMFORT (Hard to lift arm off pillow), ASTHENIA (Weakness), VISION BLURRED (Blurred vision), EYE PAIN (Pain behind eyes), HEART RATE IRREGULAR (Irregular heartbeat) and HEADACHE (Headache) outcome was unknown. No concomitant medication information was mentioned by reporter No treatment medication information was mentioned by reporter Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications. Information regading the events is vague. Further information has been requested. This case was linked to MOD-2021-035954 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications. Information regading the events is vague. Further information has been requested.

Pt was accompanied by daughter, who drove pt to clinic. Pt was correctly identified, screened, given vaccine, monitored for appropriate time. Pt left clinic as passenger of vehicle and was being driven by daughter. Pt started complainingg of Shortness of breath and not feeling right.. Daughter brought pt to local emergency room, Pt was later transferred to higher care hospital. Information regarding symptoms and further medical care was relayed to clinic by family member.

Patient came in today for initial dose of COVID-19 Vaccination. Patient has denied exposure to COVID-19 and denies any sign and symptoms of COVID-19 (loss of smell, taste, cough, fever, fatigue and body aches) in last 14 days. After administration of injection patient reported" tightness in the neck area, compromised breathing, numbness and tingling on the face, and high Blood Pressure of 180/100, and Pulse of 110 bpms. Patient reported allergic reaction has occurred within first 10 minutes of the post vaccination during the observation period. She denies any known allergies to food, drugs, and prior vaccination. Attending Physician and Vaccination Coordinator called the Paramedics (911) immediately. Paramedics has arrived within first 5 minutes at the vaccination site. As per Paramedics the Patient Blood pressure was high (180/110), Oxygen Saturation was dropping fast from 99% to 92%. Paramedics notified Patient that they will be administrating BENADRYL (IV) in route to the hospital. The Follow up call has been made to the Patient Husband name and as per Husband she is doing well and has been discharged from the Hospital. Patient Husband has been advised to make follow up appointment with their personal PCP and discuss precaution to take second shot.

Patient states that the night of her vaccine she felt feverish, and had extreme shortness of breath for about 5-6 hours, and she has been exhausted ever since. She states there has been a few days she has not even been able to get out of bed.

Had very bad chest pains and hard to get my breath about 45 min after the shot and it lasted 30 mi or so. I feel ok now but do I still take the 2nd shot? Thanks

Patient was in 15 minutes observation after COVID vaccination when she started experiencing SOB at 4:18 pm. Started with O2 treatment at 3 ml flow rate, notified site lead immediately. Under site lead supervision, attempted to take VS : HR 90 irregular, RR 40 irregular, unable to take BP due to equipment malfunction. No T due to no thermometer in observation room. Patient is diaphoretic states SOB, dizziness. Denies Chest pain. No N/V. At around 4:20 pm, one dose ( 0.3 ml) of epi-pen adult was administered left lateral thigh and called Emergency service ambulance per protocol. At 4:30 pm, EMS ambulance and police were arrived. Detailed patient care information was provided and handed over the care to the team. At 4:40 pm, patient left with emergency ambulance team.

My parents do not have a smart phone so they cannot participate in the mobile app to report symptoms. I understand that there may or may not be a link between my mother's symptoms and the vaccine, but I want to make sure that it is looked into. Three days after dose, my mother woke up with shortness of breath. Over the last week, the shortness of breath has lingered and she has also had stomach issues. She has now been hospitalized since yesterday. These are not uncommon symptoms with her, but she has definitely been worse since the vaccine. Assuming she recovers, I am concerned about her taking the second dose, scheduled in two weeks. Her symptoms are very similar to those of a Physician in an article I read today.

11:30 Reports throat dryness s/p vaccination, during 15 minute monitoring; "throat feels restricted" w/no additional complaints Po hydration/ water given, 02 via NRM applied, continued monitoring; NAD, respirations unlabored; BP 140/90 P 65 RR 14 O2SAT 99%RA 11:45 "feels better"; BP 140/89 P 63 RR 14 O2 SAT 98% RA; released from facility w/ daughter

Two nights after injection, had terrifying nightmare, 3 nights a bad dream, nightmares, bad dreams waking me up with a rapid heart beat and fast pressured breathing, and vivid dreams continued for approximately 10 -12 nights had 2 nights with vivid dreams. On 2/5/21, woke at about 4:50 am with rapid heart beat that changed into AFib and elevated blood pressure. Heart beat reached 151 bpm and subsided about 30 minutes after getting out of bed.

Patient assessed and monitored by EMS on 2/4/2021 post vaccination: Chief Complaint: Difficulty breathing; tremors Secondary Complaint: Dizziness; full body weakness History of Present Illness: Patient was receiving COVID 19 vaccine. After injection, patient began experiencing labored breathing, full body tremors, and became extremely weak. Patient requested to be checked out. Medical History: Obtained From: Not Recorded Current Medications: None - Reported By Patient Allergies: Albuterol Lidocaine Sulfur Neurological Exam Level of Consciousness: Alert Loss of Consciousness: No Chemically Paralyzed: No Stroke Scale: Cincinnati Negative Mental Present: Oriented-Time, Oriented-Event, Oriented-Place, Oriented-Person, Normal Baseline for Patient Pupils Left, Right Size: Normal, Normal React: Reactive, Reactive Motor, Sensory LA: Normal, Normal RA: Normal, Normal LL: Normal, Normal RL: Normal, Normal Airway Status: Patent Performed By: Patient Outcome: Unchanged Respiratory Effort: Normal Sounds: L: Clear R: Clear Sounds: breath sounds clear all fields Cardiovascular JVD: Not Appreciated Cap. Refill: Less than 2 Seconds Edema: Not Appreciated Pulses Left, Right Carotid: Not Checked, Not Checked Radial: Strong, Strong Femoral: Not Checked, Not Checked Injury Details Reason for Encounter: Injury/Trauma Drugs/Alcohol?: None Initial Physical Findings Assessment Skin: Capillary Nail Bed Refill less than 2 seconds, Dry, Normal, Warm Skin Findings: Skin CTC normal, warm, dry, pink Left Shoulder Findings: Injection site of vaccine; no swelling noted Mental Status: Normal Baseline for Patient, Oriented-Event, Oriented-Person, Oriented-Place, Oriented-Time Impression / Diagnosis Symptoms: Breathing Problem, Tremor, unspecified, Weakness, Tachypnea, not elsewhere classified Impression: Dizziness, Weakness Initial Patient Acuity: Emergent (Yellow) Activity 15:40: HR=98, BP= 106/70, Alert, RA SpO2=99, Resp.= 22 Labored Crew was requested over to RN vaccine station to assess female patient presenting with labored breathing, slight tachypnea, full body tremors, and general body weakness. Patient had just received first dose of Moderna COVID-19 vaccine. Patient is AAOx4, (-)LOC, (-) signs of anaphylaxis. Patient is assisted onto stretcher, secured with straps x3 and side rails raised and brought over to ems triage area. Patient denies any pain, complains of uncontrolled full body tremors. 15:47: HR=78, BP=134/90, Alert, RA SpO2=98, Resp.=20 Labored, Cincinnati Negative Crew assesses, patient shows no signs of anaphylaxis, lung sounds clear in all fields. Patient feels light headed and is lowered to supine position. Patient states she has had an episode similar to present in doctors office a few years ago when administered albuterol, and event had subsided approx. 30 minutes later. 16:01: HR=78, BP=136/p, Alert, Resp.= 18 Labored, Cincinnati Negative Vitals reassessed. Still above normal baseline for patient. 16:10: HR=80, BP=120/p, Alert, RA SpO2=98, Resp.=18 Labored, Cincinnati Negative Vitals reassessed, patient now showing full body involuntary tremors and complains of extreme weakness when moved to fowlers. Patient Cincinnati negative, no signs of anaphylaxis. Patient moved back to supine position. 16:18: HR=76, BP=122/68, Alert, RA SpO2=97, Resp.=18 Normal Vitals reassessed, breathing no longer labored, patient states she feels better and wishes to go to bathroom. Patient is assisted to bathroom with assistance from RN. 16:35: HR=74, BP=126/68, Alert, RA SpO2=97, Resp.=18 Normal Vitals reassessed, patient wishes to walk around and see how they feel, crew monitors. No tremors are noted for several minutes, patient now sitting fowlers on stretcher. Patient is advised that at any time they can call 911 if they feel they don't feel right or are unsure of condition. Patient is always made aware that ems crew does not diagnose and does not have the ability to see and diagnose underlying conditions that a hospital would have the capabilities to do so. After several more minutes of walking and discussion of patient condition, patient wishes to sign RMA , and go home with husband, daughter was waiting at residence. patient signs RMS, AMA, RN signs as witness. Patient care diminished. 2/5/2021 at 11:08am: Public health nurse called patient at for follow-up. Patient stated she was ?not steady on feet for a while? on prior night. Patient stated she started to feel ?back to normal? today. The only symptom patient is reporting today is feeling tired. Received verbal consent from patient to update her HCP, Dr. , about her reaction post vaccine. , RN

pt stated that she has had difficulty breathing at night, congestion, thickness in her throat, chills, nausea, constant dizziness, has a rash around her neck, has fatigue and weakness. Pt also has had pain in her right knee the night of the vax. Pt just feels bad, raised blood pressure, has numbness in both hands and is very uncomfortable. Pt called her PCP and was told to her to take an extra HBP pill. Since pt is still having most of these symptoms she will call her PCP back for more medical advice.

I had some shortness of breath. I had chills. 99.4 temp. I was nauseated but never vomited. irregular heartbeat. very tired most of the day. 3 days later I broke out in a rash on my arm below the injection site and around my arm.

immediately after vaccine injection upper body went into convulsion, uncontrolled jerking and tremor of all extremities. Difficulty Breathing

Dizziness, lightheadedness, wheezing, chills, headache, body aches, sore arm - 6 to 8 hours Arm swelling, hard lump, redness near injection site - began on day February 15. Hardness lasted five days, redness lasted 13 days Sleep disturbances - difficulty getting to sleep, waking in middle of night with feeling of disorientation - began on February 15 and lasted for four nights. Eye pain with feeling of object in eye and red, itchy eyelids. Began February 17 and recurred intermittently for six days.

Ran a temperature of 100; Had to up my oxygen rate from 2.5 to 3 liters as was having trouble breathing; left arm got red over a wide area about the size of my hand, and is still a little pink. lost appetite for a day. Bruising seemed to increase some on my arms.

Symptoms: ulcers inside lower lip, mild swelling inside mouth, roof of mouth, tongue, throat, nasal swelling. Same reaction I've had to penicillin, etc. No rash. Same symptoms occur with ACE inhibitor reaction. 60 mg Allegra taken every 12 hours made symptoms milder, but didn't go away. Did not feel well in general, no appetite. Today, March 6, almost no symptoms, it has been more than 12 hours since the last Allegra.

Dizziness, difficulty breathing, swelling of face, rash on thighs and low back, slight tightness of chest. Symptoms continued to get worse. After 45 minutes went to ER Vital signs taken + EKG, observation. After approximately 3 hours breathing, dizziness, swelling of face improved. Some rash remains.

Patient presented to Hospital ED on 3/14/21 with respiratory distress. Patient was tested for COVID-19 and found to be positive on 3/14/21 in the hospital ED. Patient was a DNR. Hospice was consulted (this writer is employed by Hospice). The patient passed away on 3/15/2021. Per family patient had recently received COVID-19 vaccine. Vaccine information verified in portal.

Moderna COVID-19 Vaccine EUA: Fever, large swelling at injection site, dizziness and weakness, shortness of breath, headache, body ache (joint and muscle pain), chills

Cerebral occlusion in middle cerebral artery; Developed SOB which lingered; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of CEREBRAL ARTERY OCCLUSION (Cerebral occlusion in middle cerebral artery) in an 81-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 Diabetes mellitus, Hypertension and Hyperlipidemia. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced DYSPNOEA (Developed SOB which lingered). On 03-Mar-2021, the patient experienced CEREBRAL ARTERY OCCLUSION (Cerebral occlusion in middle cerebral artery) (seriousness criterion hospitalization). The patient was hospitalized from 03-Mar-2021 to 06-Mar-2021 due to CEREBRAL ARTERY OCCLUSION. At the time of the report, CEREBRAL ARTERY OCCLUSION (Cerebral occlusion in middle cerebral artery) and DYSPNOEA (Developed SOB which lingered) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Patient's advanced age, hypertension, diabetes Miletus, hyperlipidemia may remain as risk factors for this event. Further information is requested.

4/2020 presumed COVID-19 (not formally diagnosed, not hospitalized) 2/07/21 Moderna vaccine #1 (date per pt's daughter) 2/21/21 onset SOB/DOE, fever 2/24/21 Seen at Urgent Care: RML crackles and infiltrate on CXR, given azithromycin and Augmentin 2/27/21 Presented to ED with progression of SOB/DOE, fatigue, diarrhea. Hypoxemic requiring low-flow NC, B/L basilar crackles noted; started on CTX/azithro (2/27-3/3) for presumed CAP 3/08/21 Required HFNC; first seen by me personally: diffuse, distinct velcro crackles, lower > upper fields 3/12/21 Started on high-dose steroids without improvement; unable to wean from HFNC with progressively worsening hypoxemia; pt declined intubation. 03/22/21 Patient died in Palliative Care Unit Diagnosis: Interstitial lung disease of uncertain etiology, acute interstitial pneumonitis vs. undiagnosed connective tissue disease

Presented to ER with SOB and received diagnosis of COVID PNA. Admitted to floor where abx and steroids were given. Also given remdesivir. Completed remdesivr course ans still struggling with O2 saturation. Pt listed as DNR and wished to not be intubated. Remains hospitalzied with poor overall prognosis. Patient had first dose of COVID vaccine followed by a positive COVID test at the hospital 12 days later.

Increase ringing in right ear. Ringing started in left ear. Headaches & Dizziness. Cold like symptoms--some coughing, sneezing, runny nose. Shortness of breath.

Shortness of breath for about one week Saw DR who gave me referral to Community Radiology on April 1st. Pulmonary Embolism Diagnosed. Went to Emergency at Hospital. They sent me home with rx for Eliquis.

Patient received Moderna Dose #1 on 1/11/2021. Later that day, her armpit had a swollen lymph node. This was treated topically with clindamycin for hidrandenitis suppurative for about 2 weeks. Then patient received Moderna Dose #2 on 2/8/21. By 2/11/21, patient had some intermittent confusion noted. Vitals were mostly WNL. On 3/4, patient observed with SOB and restlessness. SPO2 was 86%, Temp 98.4, HR 59, BP 136/59. Oxygen started. Later on 3/4, patient had change in mental status, lethargy, SOB and SPO2 90% on PRN oxygen. Transferred to hospital. Patient was admitted to hospital on 3/4/21. She was readmitted to nursing home on 3/12/21. Discharge diagnosis included: altered mental status, acute expiratory failure, fever, atypical pneumonia, CHF exacerbation, HTN, DM, dementia, asthma/restrictive lung disease.

chill fever, cramps, headaches, couldn't breath, blur vision, disoriented, weakness, no appetite, had to pee every 10 min.

Shortness of breath, severe anemia. I don't know if these symptoms were caused by the vaccine. These symptoms ocurred 5-6 weeks after the 2nd shot (on Feb.10,2021)

flu like sxms, acute exacerbation of copd/pneumonia starting 02/08/21, headache, chx pain all night starting 02/13/21. Pt admitted to hospital 02/14/21. Performed lab work, elevated troponin level which continued to climb. Discovered two blockages and installed two stints to primary artery. Pt was discharged 02/16/21

Shortness of Breath and heart palpations on 1/27/21 at 4AM. another shortness of breath on 2/6/21 at 9AM. Had follow up of stress test and wore a heart monitor. Both test showed heart dysfunction (stiff heart and doesn't relax). Have had no problems since 2/6/21

01/22/2021- Chills, sore arm, fatigue 01/25/2021- That morning, I was walking up stairs that I walk up everyday, I could not breathe by the time I got to top of stairs, that never happens. Lasted through next day then got a little better as long as I was sedentary. I had continuing shortness of breath with any kind of physical activity. Still having shortness of breath to this day.

Within 24 hours, my mom's arms swelled up from shoulder to fingertips and she had never had swelling in her arms prior. She also was hanging her head as if she had fallen asleep, but actually was unable to lift her head. 4 days following the vaccine she started having breathing issues and was intubated, we had the ventilator removed (she was actually a DNR and was not supposed to be intubated). On January 19, 2021 she died. She went into this facility for rehab regarding an infection she had in her leg.

Patient admitted to Hospital for blood clot in lung after falling twice approximately 24 hours after 2nd COVID immunization

Death 4/18/2021 Causes of death listed on patient's death certificate: 1) Sequelae of SARS-Coronavirus 2019 Other: Rheumatoid Arthritis, Insulin Dependent Diabetes, Chronic Hypoxic Respiratory Failure, Morbid Obesity

On 4/7/21, she received the second dose of the Moderna COVID-19 vaccine. Then, around 5/1/21, she developed fevers to 102 with associated fatigue and poor appetite, but no other clear localizing symptoms, including no sore throat, cough, chest pain, SOB, abdominal pain, N/V/D, joint swelling/pain, rashes, or dysuria. She presented to an outside hospital ED where she had an infectious workup that included a CXR concerning for LLL pneumonia. She was prescribed doxycycline for 7 days with resolution of her fevers and subjective improvement. In early June 2021, the patient redeveloped fevers and chills, worst at nighttime, without localizing symptoms. Her appetite and energy level remained very poor despite several changes to antidepressants as an outpatient. She was treated with nitrofurantoin x 5 days for presumed UTI, but fevers persisted, still without associated cough, CP, or SOB. With going fevers, fatigue, and poor appetite resulting in ~18lb unintentional weight loss, she was admitted to Hospital on 6/22/21 for further evaluation. While at Hospital, she continued to have fevers to 102+ without localizing symptoms despite empiric doxycycline. A broad infectious workup returned negative. CT chest and CTAP were also unrevealing for a cause of fevers. She was found to have an elevated ferritin, LDH, and triglycerides, as well as a low fibrinogen, concerning for HLH (high H-score). She received high-dose dexamethasone. Bone marrow biopsy was performed that was negative for malignancy. However, peripheral flow cytometry returned with a clonal B-cell population, her soluble IL-2 was elevated, and she was found to have splenic enhancement on PET-CT, all concerning for occult lymphoma as the potential driver of her HLH. She remains admitted and is critically ill with complications of DIC and bleeding that preclude a splenic biopsy to confirm the suspected diagnosis of lymphoma. Since her fevers, malaise, and fatigue started less than 1 month after her second dose of the Moderna vaccine, and the patient was insistent that she "hadn't felt right" since she received that second dose of the vaccine, we decided to report this event in the VAERS system.

Patient was exposed to COVID in her home via her daughter from out of state. 07/11 she began experiencing nausea, vomiting, and diarrhea, as well as loss of taste and smell. She presented to the ED with these symptoms and fatigue. She was diagnosed with COVID pneumonia and dehydration and admitted to the COVID Unit. Problem list: -Severe Covid pneumonia with pulmonary infiltrates and new hypoxia. Symptom onset 7/11/2021 -Hypoxic respiratory failure secondary to above -mildly elevated troponin w/o chest pain -Nausea/vomiting/diarrhea, suspected to be secondary to coronavirus -Acute kidney insufficiency, suspect prerenal azotemia from volume depletion -History of hypertension, currently hypotensive -Weakness -new dx of DMII with steroid induced hyperglycemia Plan: -Continue inpatient level of care in the Covid unit -Dexamethasone (7/18/2021-) and completed remdesivir (7/17/2021-7/21), supplementary oxygen, Mucinex, albuterol, proning, is at the spirometry. CRP elevated at 19, D-dimer elevated at 1200 will trend CRP but currently not severely hypoxic enough to qualify for Tocilizumab. Troponin downtrended. TTE with right sided heart dyfxn, likely at least partially chronic as CTA does not show any evidence of pulmonary embolus. Would recommend repeat transthoracic echocardiogram after recovery from acute illness and consideration of right heart catheterization if right ventricle dysfunction appears to be persistent. -Sliding scale of insulin started given her history of borderline diabetes with the expectation of hyperglycemia on dexamethasone. 7.5. Continue lantus, medium dose SSI -Resume amlodipine. Continue holding ACE inhibitor given acute kidney insufficiency -Renal function improving, appreciate assistance -PT/OT consulted and rec -Acetaminophen and Zofran for symptomatic management

PATIENT DEVELOPED PROGRESSIVE NEW DYSPNEA, DIFFERENT FROM HER BASELINE. SHE HAS BEEN HOSPITALIZED TWICE FOR PERSISTENT DYSPNEA AND CENTRALIZED CHEST PAIN, WHICH HAS OTHERWISE HAD NEGATIVE WORK UP.

About 10 minutes after receiving the vaccine, pt began complaining of a tickle in her throat and mild SOB. After 13 minutes she began complaining of her throat feeling tight.

Pt received her vaccine and about 10 minutes later she began c/o of a tickle in her throat and then her throat felt like it was getting tighter and she had mild SOB. Treatment--- she was taken to ER for evaluation where she was given IV solumedrol and IV Benadryl and IV fluids. After being in ER for approximately 2 hours she was discharged to home.

Patient complained of shortness of breath, chest pain, and chest tightness after about 1 minute following vaccine. She was given Epi 0.3, Benadryl 25mg, and Solumedrol 125mg. She was transported to ER and was released after symptom resolution and normal EKG at the Hospital.

Patient states she experienced feelings of her throat closing up, states she took Benadryl and called her Physician and was advised to not receive second moderna injection.

Left shoulder injury. Unable to reach behind back with left arm. Started approximately 2/4/21. Still have pain & hard to reach behind back on 2/14/21. Noticed small dime-sized red spot on left shoulder on 2/11/21. On 2/14/21 red spot had grown to approximately 3 1/2? long & 2 1/2? wide. Is warm to the touch, but doesn?t seem to be swollen & not painful. Intermittent problem finishing a sentence without taking an additional breath. Started about 2/5/21. Not sure if heart murmur is related.

Fever by the next day, difficulty breathing, pneumonia, and then DEATH within a few days. (Died 02/01/2021)

Patient reported feeling weak, fatigue, fever (102), and loss of appetite. Patient subsequently went to the ER 2/6/2021 and tested positive for COVID-19 on 2/7/21 (collection date). See following discharge summary from ED: 82 y.o. female who initially presented to the ED with complaint of generalized weakness, fatigue, fever, and loss of appetite x at least 4 days since receiving Covid 19 vaccine. Her workup in the emergency room was significant for hypoxia with 02 saturation 88% on 2LPM (home nocturnal 02 requirement) with improvement to mid-90s on 4LPM. Blood sugar was 47, Cr 1.61. CXR showed extensive R lung and moderate left lung opacities. She was started on empiric ceftriaxone and azithromycin and admitted to the hospitalist service for further workup and mgmt. During her stay in the hospital, pt did test positive for Covid 19. She developed rapidly progressive respiratory failure, felt to be secondary to ARDS. There was also question of contributing pulmonary edema, however this was refractory to lasix and thus ARDS was felt to be the most significant factor. She had requested DNR/DNI status, thus as her 02 requirement escalated she was transitioned to 15LPM NRB and then to BiPAP support. Unfortunately, she continued to suffer greatly with the BiPAP in place, and therefore made the decision to transition herself to comfort measures only after visitation from her family. Her other medical issues were supported as appropriate during her stay, with dextrose infusion for hypoglycemia and AKI, also hyponatremia felt to be due to IVVF. Unfortunately, am unable to find any documentation regarding how pt was feeling when she received the vaccine compared to her baseline state of health. thus am unable to say whether the severity of her illness represents vaccine­ enhanced disease or the much more common cytokine release syndrome leading to ARDS. Regardless, she developed ARDS as result of her Covid 19 illness. Time of death: 1408 on 2/9/21. Cause of death: ARDS due to Covid 19 pneumonia.

Right after receiving the vaccine I had racing heartbeat for 2 hours. I was short of breath over the next few days. I developed a swollen and itchy arm. I developed dark bags under my eyes that made me look like I had "black eyes". My fingers turned purple. my veins in my hands and feet enlarged and looked green to me. I feel fine, I just have these funny things happening. everything started to go away after about 3 days and are almost normal except for the veins. I felt fine. then 3 days later on 2/15 I felt like I was going to faint, I felt a rush of heat like a fever and nausea. I felt fine by the end of the day. I am sleeping a lot. I also have a strange feeling in my foot that comes and goes for a few seconds.

Pt was hospitalized due to positive COVID 19 and hypoxia from 2/2/21 and 2/5/21. Pt had a 4 day history of weakness, abdominal pain, and shortness of breath. Pt tested positive for COVID 19 and was hypoxic requiring hospitalization. Pt was treated with Remdesivir and Dexamethasone in hospital and weaned off oxygen at discharge. Py had CT of chest showing groundglass opacity. Pt had received her first Moderna COVID 19 vaccine previously on 1/26/21.

Patient presented on 2/16 with SOB and cough over past 3 weeks. Patient treated with antibiotics, steroids and nebulizers.Patient improved and discharged 2/24 with plan for outpatient biologic treatment for eosinophilic asthma. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine. .

Patient called to report that her face got red and swollen within 45 minutes of vaccine and she had a rash on her face and she had a little bit of throat swelling and was speaking like a frog and it was hard to swallow. She said within 3 days her legs started to go numb and especially her thigh muscles and her veins in her left foot were engorged. She said she went to the ER and they rxed 40mg prednisone for 4 days and her papers from the ER read "allergy." When I spoke to her for the second time and advised her she does not qualify for a second moderna vaccine, patient said that when she went to the ER she went for abdominal swelling, leg swelling, leg numbness, and swelling of the left ankle and foot. I confirmed with her that her symptoms have all improved and she said "yes, tremendously." She said she spoke to her PCP and at least one additional doctor yesterday.

x2 ER visits 2/7/21, 2/8/21 c/o n/v/d; X2 inpatient admissions for small bowel obstruction 2/8/21, 2/16/21; admitted 3/18 swg bed for physical deconditioniong. 3/18/21 Swg Bed admission HPI: 82 y.o. female presents for direct admission to swing bed. Back in the middle of February the patient had a high-grade small-bowel obstruction ended up with laparotomy and lysis of adhesions. She was extremely deconditioned. She came to swing bed here and states here for about 2 weeks. She thought she was ready to go home and be successful at that time. Unfortunately, she has gotten home and found that she can barely take care of herself. She is extremely deconditioned. She thinks she just needs to be built up for another week or 2 and then could be very successful at home. She does have a friend that is helping her, but is worried about getting so weak that she end up hurting herself. I saw her yesterday in the office and thought that another swing bed stay a might be in order.

PATIENT RECIEVED VACCINE ON FEBRUARY 12, 2021. BEGAN FEELING VERY FATIGUED AND SHORT OF BREATH ABOUT ONE WEEK LATER. AFTER A WEEK OF FEELING UNWELL SHE DECIDED TO GO TO LOCAL CLINIC. THEY DID AN EKG AND SENT FOR A HEART MONITOR. SHE WAS SENT HOME AND WAITED FOR THE MONITOR TO ARRIVE BY MAIL. IN ABOUT ANOTHER WEEKS TIME SHE WAS RUSHED TO EMERGENCY AND WAS HAVING A MASSIVE HEART ATTACK. SHE PASSED AWAY MARCH 2, 2 1/2 WEEKS AFTER HER FIRST MODERNA VACCINE. I BELIEVE IT WAS THE VACCINE THAT CAUSED THE HEAT ATTACK.

Pt received first Moderna COVID shot 2/25/2021. Pt developed acute on chronic respiratory failure with hypoxia, presented to local hospital ED on 3/25 and transferred to our facility for higher level of care. Currently in ICU with covid related hypoxia and pneumonia.

Vaccine administered at 1816. Patient walked to the observation area and while in the observation area, got up to use the restroom. Patient exited the restroom and said she needed assistance. She indicated to the observation nurse that "this ain't good" or "this ain't right". Patient reported seeing spots and having chest pain. The time was approximately 1830. She was assisted to the floor. Help was summoned and 911 called at approximately 1834. Upon being lowered to the floor patient was breathing, she was not cyanotic, her eyes were open and she was not responsive. The patient had a pulse. Sometime after 1830, but before 1835, the patient was observed to have seizure like activity as bilateral

The patient received her FIRST dose of Moderna COVID vaccine on 1/26/21 and SECOND dose on 2/23/21. On 3/8, she first started to experience shortness of breath, which was attributable to cardiac etiology and diastolic heart failure at the time, but which in retrospect may have been her earliest symptom of new onset myasthenia gravis, which is the AE I am wanting to report. She was hospitalized from 3/8-3/13, and underwent extensive cardiac workup that was negative. She again developed shortness of breath on 3/17/21 and was re-admitted to the hospital on 3/18/21 for diuresis for presumed diastolic heart failure exacerbation, received diuresis from 3/18-3/22/21 but then developed new onset diplopia, at which pint I evaluated her in neurological consultation on 3/22. Her brain MRI disclosed an UNrelated incidental small left cerebellar infract, but her neurological exam showed a new R lateral rectus palsy and new moderate to severe left eyelid ptosis, suspicious for myasthenia gravis. Anti-acetylcholineseterase antibodies--- binding, blocking, and modulating, were all sent off and came back all strongly positive on 3/26-27/21. The patient then called stating she had developed recurrent shortness of breath, new onset dysphagia, and worsening double vision. I urgently re-evaluated her in outpatient follow-up in my office on 4/2/21 and sent her immediately to the hospital to be readmitted, where she remains as of this reporting date and she has been receiving IVIG with improvement in her symptoms. She did NOT have any previous known history of eyelid ptosis, dysphagia, diplopia, or muscle weakness. In retrospect, the patient states that her current symptomatology began around 3/7/21 with the benefit of hindsight. I am reporting this event because it is very unusual for an 82 year old WOMAN to develop new onset of myasthenia gravis, and it is a known autoimmune disease, and a vaccine would be a plausible trigger for its development, or trigger for its first symptomatic manifestation. I was also especially concerned because my fellow neurologist, ALSO had a patient develop myasthenia gravis about 2 weeks or so following their second dose of the Pfizer COVID vaccine. It would be an EXTRAORDINARY coincidence for two instances of new onset myasthenia gravis to occur 2 weeks post- vaccination at essentially the same time in an institution of our size, so we both felt obliged to report both cases ASAP to the VAERS. I was not able to reach the patient in her hospital room today to get additional specifics about where she got the vaccine, its lot number etc., however she is a retired and has indicated her willingness to provide you with any and all additional information you need, and I am also personally very willing to provide any additional information about her eventual outcome.

On 1/27/21, after receiving Dose 1 , I had some chest pains, shortness of breath and a pulse rate as high as 190. I (foolishly) did not do anything but suffered through these symptoms at varying degrees of pain/discomfort for about an hour and a half. Recently on 4/9/21, I experienced these same symptoms. My heart felt like it was pounding out of my chest; pulse rate was up to 170 and BP was 190/86. I also had intermittent chest pains at different levels of severity. Called 911, ambulance took me to healthcare facility where I was advised that I had Atrial Fibrillation. I don't know if this is related to the Covid shots but I feel it should be documented. While I have had high blood pressure for years and I am an older adult, I have never had any heart problems, per se. I also know it would not be unusual for someone with my characteristics to develop- Atrisl Fibrillation, however, it is suspicious that this occurred only after the covid vaccines were administered. Pregnancy History; 1 child.

Started feeling weak next day after shot. As days went by I became increasingly short of breath. This continued for over 2 weeks and then started having chest pain. Went to ER and admitted with pericarditis. 2 days later I went into Atrial fib. The next day I had a cardioversion. Home the following day. One week at home not feeling well, I was readmitted with increased chest pain and shortness of breath. Pulse very low and needed a pacemaker which was inserted Easter Sunday. Home now and still not feeling well.

Death Anasarca Hyperammonemia Altered mental status Pulmonary edema Hypermagnesemia ARF (acute renal failure) Anemia

During Hospitalization, patient tested positive for COVID-19 post vaccination. Patient experienced shortness of breath requiring supplemental oxygen

Pt. presented to ED. Was currently being treated for UTI. Husband states that she has had low oxygen saturations for the past week with any movement, statins she will do as low as the 60's% accompanied with SOB. Husband reports noticing more confusion than normal and reports being very anxious and delirious, poor appetite and lethargic. In ED pt. was found to have O2 saturation of 74% on RA. Weight was also noted to be up. Pt. usual weight in the 190 range and currently pt. is 207 range. Pt. was admitted from ED with diagnosis of Community acquired pneumonia, hypoxia requiring high flow O2 via Airflo, elevated d-dimer.

On 3/25/21, patient presented to the ED with several days history of nausea, vomiting, and upper abdominal pain, and 1 day history of shortness of breath and wheeze. Patient recently received her first dose of Moderna COVID vaccination on March 10. Patient's daughter first developed COVID symptoms approximately 1-2 weeks prior, and was tested positive. Patient developed nausea, vomiting, and upper abdominal pain 6 days prior on March 19. She was tested positive for COVID several days prior to admission (either the 22 or 23rd, patient not sure). On the morning admission, patient had significant worsening of shortness of breath and wheeze. Patient also became significantly more weak and fatigued, and was eventually brought to ED. Patient reported chills, but denied headaches, chest pain, or diarrhea. Patient admitted to the hospital on 3/25/21 with main diagnosis COVD-19 pneumonia and patient expired on 4/13/21.

2-27-21 Heart pain, transported to ER 2x in 2 days. Within 2 days, her Liver and Kidney function failed. and Acute Hypoxic Respiratory Failure and Cardiogenic Shock were listed as cause of death on 3-3-21

Patient was given the moderna vaccine and waited in clinic the requested 15minutes. Patient was fine when she left the office. She advised when she got home about 5 or so minutes later, she started to feel like her throat was swelling. Denied any trouble breathing, she kept drinking water to make sure her throat was still open. She took 2 large teaspoons of liquid benadryl. She never went to ER or called the office until 5/24/2021. After the benadryl started working she felt better and did not have any further symptoms.

1. Blisters all over back side of left hand, saw Dr. , resolved in a couple of days (occurred 2 days post Vax) 2. Baseball sized lump , iced, resolved (occured 2 days post Vax) 3. approximately 2 weeks post Vax - began difficulty breathing and chest pains, elevated heart rate. Went to clinic , was sent via ambulance to ER . Admitted with diagnosis of pneumonia, fluid retention /edema . Spent 6 days in the hospital. Was told by hospital staff to report to VAERS. Covid test was negative. 4. Today - 15 weeks post Vax, never recovered energy, has severe fatigue, weakness, unable to stand for long periods of time or walk more than a minute. Saw Dr. - look work showed severely elevated Ferritin levels 900+. Still battling and treating with home heath care 4 days a week / OT x2 and PT x2. Home bound. This is ALL since Vax #2....she was walking 30 minutes a day and completely self sufficient before this shot.

February 16 at night, I had temperature of 99 degrees, fever and chill. I have been taking my temperature reading every morning. On the 17th, chills and pain started. On the 18th, temperature was 100, chills and fatigue. On the 19th, temperature was 99 and I had trouble breathing, abdominal pain, chills and fever. On the 20th, temperature was 99, dizzy, chills, ache, pain and fatigue. On the 21st, all the way across. On the 22nd, temperature was 100 degrees and I was experiencing everything else. On the 23rd, I went to the emergency room at 6am. I was in the hospital through the 24th. They discharged me on the 24th. I had a nurse who told me about the diastolic heart failure so I made an appointment to see the cardiologist which I could see on the 4th of March. A nurse had pointed out the EKG test results indicating not heart failure but excess fluid in your lungs.

82 year old woman admitted to the ICU for management of worsening acute hypoxic respiratory failure secondary to severe COVID 19 pneumonia on 6/17/21. Patient was originally hospitalized for treatment of COVID 19 in the beginning of June 2021. She was discharged on 6/10/2021. She presented to the emergency room on 6/12/2021 for syncopal episode at home. Head CT was negative for any acute intracranial pathology. 12 lead EKG did not demonstrate any arrhythmias, nor any ST to T changes, and echocardiogram demonstrated EF=70% with no wall motion abnormalities. She was admitted to the hospitalist service continued work up for syncope.

Patient admitted to hospital on 04/20/2021 for significant shortness of breath; patent tested positive for COVID-19 despite being fully vaccinated against it. Patient died on 04/24/2021. Death Certificate Information: Part I: Cause of Death: A. Repiratory Arrest B. COVID-19 Part II Other Significant Conditions COPD; Multiple Myeloma

The day following the second Moderna imz, pt went to ER due to high fever, weakness and exacerbation of COPD with wheezing and difficulty breathing

Woke up with hives from waste up, shortness of breath, and took test to monitor if issues was going on with heart, bloodwork showed that she was allergic to (PEG) in vaccine

Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 025B21A) for COVID-19 vaccination. The patient's past medical history included Shortness of breath and Mastectomy (She has had a left mastectomy). On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jun-2021, the patient experienced DYSPNOEA (Shortness of breath) (seriousness criterion hospitalization). The patient was hospitalized from 19-Jun-2021 to 21-Jun-2021 due to DYSPNOEA. On 21-Jun-2021, DYSPNOEA (Shortness of breath) had resolved. No concomitant medications were mentioned. No treatment details were reported. Based on the current available information, the temporal association between the use of the product and the start date of the event appear unlikely, however, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information, the temporal association between the use of the product and the start date of the event appear unlikely, however, a causal relationship cannot be excluded.

admitted into hospital; admitted into hospital; tired; Very bad reaction after the first shot; breathing problems; close to death; Diarrhea; threw up - couldn't keep anything down for 2 days; was incapacitated, Weak; couldn't walk/could not get out of bed/couldn't sit and wait at the ER,unable to walk; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of the first episode of HOSPITALISATION (admitted into hospital), the second episode of HOSPITALISATION (admitted into hospital) and NEAR DEATH EXPERIENCE (close to death) in an 82-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 COVID-19 in August 2020. Concurrent medical conditions included Coronary artery disease, Peripheral arterial disease, Breast cancer, Heart failure (More events at night) and Heart disease, unspecified. Concomitant products included APIXABAN (ELIQUIS), LORATADINE, LOSARTAN, DILTIAZEM, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), FUROSEMIDE, POTASSIUM CHLORIDE (LASIX + K) and EZETIMIBE (ZETIA) for Heart failure, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid enlarged. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced ASTHENIA (was incapacitated, Weak) and GAIT INABILITY (couldn't walk/could not get out of bed/couldn't sit and wait at the ER,unable to walk). On 19-Feb-2021, the patient experienced DIARRHOEA (Diarrhea) and VOMITING (threw up - couldn't keep anything down for 2 days). On an unknown date, the patient experienced the first episode of HOSPITALISATION (admitted into hospital) (seriousness criterion hospitalization), the second episode of HOSPITALISATION (admitted into hospital) (seriousness criterion hospitalization), NEAR DEATH EXPERIENCE (close to death) (seriousness criterion medically significant), VACCINATION COMPLICATION (Very bad reaction after the first shot), DYSPNOEA (breathing problems) and FATIGUE (tired). The patient was hospitalized from 01-May-2021 to 06-May-2021 due to HOSPITALISATION, and then from 13-May-2021 to 21-May-2021 due to HOSPITALISATION. The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, last episode of HOSPITALISATION (admitted into hospital), NEAR DEATH EXPERIENCE (close to death), VACCINATION COMPLICATION (Very bad reaction after the first shot), DYSPNOEA (breathing problems) and FATIGUE (tired) outcome was unknown and DIARRHOEA (Diarrhea), ASTHENIA (was incapacitated, Weak), GAIT INABILITY (couldn't walk/could not get out of bed/couldn't sit and wait at the ER,unable to walk) and VOMITING (threw up - couldn't keep anything down for 2 days) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. 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 05-Jul-2021: Follow up received contain information about patient information, medical history, vaccine facility information, and concomitant medications, new serious events and updated out come of events.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded

patient went on hospice 7/16/21 and expired 7/17/21 developed sudden neuro degenerative disease unspecified with paralysis of lower extremities first then arms, neck and complained of shortness of breath, swelling left and then progressive swelling

problem breathing, prior to the vaccine, I was visiting another state and walked all over that was November 2020, yes I was a smoker and quit 7 years ago

about 20+ hours after vaccination resident was having hard time breathing, 911 was called. Resident coded multiple times at the facility after CPR she was taken to ICU. She coded again and was placed on life support. Due to her choice to not be on life support she passed on 11/26/2021.

fever, muscle aches, headache, shortness of breath, loss of appetite, fatigue sleep, Tylenol, cpap with oxygen, aspirin (Bufferin) 2.5 days I am up and dressed on 2/3 (third day), but very tired and sleepy.

My mother, received the 1st vaccine for COVID 19 last week on Tuesday, Jan 26th. On Friday, Jan 29th, she started having diarrhea and continues to experience the same. She feels bad all over, can't get up and move around. When she stands and walks, she said she feels pain in the back of her neck and head. She is out of breath and generally laid in bed all day today. She is not eating much on a daily basis, today just some cheese and crackers and orange juice.

2:30pm Received 1st dose of Moderna. Hx of SOB/swelling with allergy shots. 2:45pm c/o itching around lips. VS BP 166/19 P 90 o2 sat 97% RA, alert, ambulatory. 2:50pm Benadryl 50 mg IM stat LGM. 2:55pm BP 171/71 P 90 O2 sat 98% RA, reports itching resolved. 3:00pm BP 147/88 P 87 O2 sat 97% RA. 3:15pm ambulatory, but became unsteady, sat in chair. 3:19pm BP 153/75 P 77 3:24pm BP 148/78 P 80 3:25pm ambulatory to truck. 3:28pm husband returned to clinic to report wife's rash. Instructed to go to ER. Report called to ER. 01/21/21. F/U call. Pt reports observed in ER, no treatment. Instructed to take Benadryl 50 mg po bid x 2 days. No further problems.

pt first developed a swelling without redness, purple, that receded quickly with cold compress Pt within 5 minuted developed resp distress, sob, chest pain and crushing chest feeling along with lip tongue mouth tingling, difficulty swallowing, increasing anxiety and diaphoresis.

Extreme shortness of breath that lasted overnight and resulted in trip to ER, diarrhea the night of injection

Bad headache, very stuffy nose, I couldn't breathe and almost went to the hospital. Ears were ringing, my eyes were ready to pop out of my head. Temples hurt, lymph glands were swollen, sore throat. Mostly in upper part of anatomy above collar bone. It made me very weak, I had trouble getting out of rocking chair to answer phone. So I took another Tylenol. I usually only take 1-2 Tylenol a day and that was my second one by the middle of the day. I had to lay down and I live alone so I was nervous and had phone beside me and debated calling 911 which I have never done. I dozed and when I woke up about a couple of hours later it was much better. Still had headache and a little stuffiness but anybody can handle that. Also, I was very nauseated and couldn't eat but I did drink water.

Patient received the first dose of her covid vaccine by Moderna in her left arm at 1445. Lot number 023M20A. Exp. 8-10-2021. Patient had no pain with injection. Tolerated well. Approximately 30 seconds to one minute after injection patient reported to nurse that her mouth and throat felt dry. This nurse asked the patient if she was feeling anything else different and if her throat felt itchy. Patient reported that her throat did feel a little itchy. This nurse called for assistance. RN obtained Dynamap to take patient vital signs. This nurse stayed by patient's side at all times. NP responded and was by patient's side throughout event. Patient now reporting feeling very hot. Ice pack applied to back of her neck. Initial vital signs 184/87, Map 123, HR 119. Patient tachypnic and tachycardic. Pulse ox WNL at 99%. Lung sounds clear. Radial pulse obtained, rapid. First responder called for with overhead page. Next vital signs 189/79.map of 113. HR 116. Patient still tachypnic and tachycardic with a pulse ox of 99%. Patient reports she is feeling dizzy and hot still. Able to answer questions and was oriented at all times. Dr and first responder team arrived at scene. Patient able to answer questions. Is still dizzy and not feeling well. Patient transferred safely to cart and strapped in with safety straps. All patient belongings placed on cart with her. Patient taken to ED for evaluation.

4 hours after receiving vaccine she had dyspnea, low oxygen saturation levels. EMS called and she was transported to local hospital, then air flighted to Clinic. She was diagnosed with COVID when she was admitted.

Approximately 2 hours after the vaccination was given patient experienced shortness of breath, coughing, and decreased 02 stats with a pulse oximeter. Caregiver applied oxygen supplementation which improved 02 stats. Vaccinating pharmacist and home health nurse were notified and returned to facility. When pharmacist arrived patient was eating lunch and appeared to be normal. No observable breathing problems or swelling. Local inject site appeared normal with no rash or swelling. Patient tolerated 1st dose well previously. Nurse and caregiver attempted to measure oxygen while pharmacist was there but could not obtain a reading. Observed patient for an additional half an hour with no observable issues.

difficulty breathing, tightness in chest, dizziness, weakness, headache, rash-immediately after vaccination

On January 1, 2021, patient was admitted to Medical Center with COVID. Tested positive on January 2, 2021. Spent 10 days in hospital. Once recovered from pneumonia and fever gone, on January 10, 2021, she was transferred to Rehabilitation Center for continued treatment. She spent 16 days there. She developed UTI and CDIF infections and was on/off oxygen. She started physical therapy. She was scheduled to be released to go home on January 27, 2021. On January 26, 2021, the day before going home, Rehabilitation Center gave her the Moderna vaccine. On January 27, the day she went home, she started feeling very weak and couldn't walk. My dad tried lifting her and they both fell to the ground. My dad called 911 and she was taken to Medical Center, with high fever and possible stroke symptoms (which later was negative). Two days later, she had difficulty breathing and was put on a ventilator. She was on a ventilator for about three days. They took it off and she slowly started recovering. The doctors did all kinds of tests (blood clot in lung, heart, etc.) and all was negative. The only thing they could trace it to was an adverse reaction to the vaccine. After spending 11 days at hospital and treating her for various infections, her heart stopped and she passed away suddenly.

Got the vaccine and was feeling tired, and her arm hurt, an all she wanted to do was lay in bed with her heating pad. The following day she woke up with a headache, some nausea but nothing came up. She also had diarrhea and her arm was sore. She felt weak, and since she had COVID she has had shortness of breath. She stayed in the bed all day unless she had to as her arm felt like it was made of metal and was extremely tired. She was moving around upstairs and somewhere around 8:00 PM she went to the bathroom, was sweating profusely and wiping herself with tissue, and apparently turned out the light and apparently passed out as she woke up on the floor in the hallway and could not get up right away. She could not use the left arm, was able to get herself up with the help of the door to stand on her feet. She walked into her room and sat on the bed, and did not lay back down and greatful that she did not fall down the steps. She went back to bed, but in the morning she was terrified and her family heard her talking to the doctor on call who told her to go to the ER. In the ER they told her that she had syncope, seen by Dr. at Health Care. She was admitted at 11:11 AM on 2/27/21. She was given IV, had a CAT scan of her head, told her that it did not reveal any blood. After several hours they discharged her. She called her doctor and she has an appointment tomorrow morning. She is feeling tired, not sleeping well.

3/5/21 emergency roomHPI 83 y.o. female who presents with Complaints of nose bleed reports that she had a nose bleed this ongoing now for the past hour she could not stop at home and came for help she reports her symptoms are mild-to-moderate better with putting pressure on her nose worse without pressure denies any injury FINAL IMPRESSION ICD-10-CM ICD-9-CM 1. Hypertensive urgency I16.0 401.9 2. Epistaxis R04.0 784.7 2/22/21 Emergency room HPI 83 y.o. female who presents with SHORTNESS OF BREATH ONSET BEFORE ARRIVAL. EMS GAVE PT A DUONEB AND NOW SHE STATES SHE FEELS FINE. DAUGHTER STATES THAT PT HAD A YELLOW STOOL YESTERDAY. PT STATES THE SHORTNESS OF BREATH IS WORSE WITH LAYING FLAT. NO OTHER EXACERBATING FACTORS. FINAL IMPRESSION ICD-10-CM ICD-9-CM 1. Acute urinary tract infection N39.0 599.0 2. Shortness of breath R06.02 786.05

This patient developed a severe pneumonia, clinically diagnosed as COVID-19 pneumonia, with hypercapnic and hypoxemic respiratory failure, and expired. I am not sure if it was related to the vaccine, but the rapid antigen for Sars-CoV2 was positive and the PCR was negative. I am reporting this event because of the lack of clarity on this issue and the positivity of the Sars-CoV2 was beyond the parameters of 14 days in the phase three trials.

Day 1 No adverse affect. Day 2 about 7:15 pm suddenly pounding heart and panting to breath. Fitbit showed HR of 134. Weak. Layed down. Took extra Propanolol. Stopped after 5-10 minutes. Scary. Took BP and it was 175/89. Felt warm while sleeping poorly. Got up and BP was 105/40. Temp was 99. Fell asleep. Felt poorly all day but fine on Day 3

Date and time adverse event started: 2 weeks ago, caller unsure of exact time (3/18/2021) dizziness, wheezing, congestion, states lungs feels like "it is filled with fluid". Has taken neb tx to alleviate symptoms but has no relief. Recommended to see primary provider. Caller states will take patient to urgent care today, 3/18/21.

Patient complains of nausea. This is nausea, without vomiting. This has been present for the past 2 weeks. The frequency of episodes is several times daily. Associated symptoms include lightheadedness and weakness. Pt received her first Moderna COVID-19 vaccine on 3/11/21, she has been experiencing these symptoms since that date. ROS: CONSTITUTIONAL: Negative for chills, fatigue, fever, and weight change. CARDIOVASCULAR: Positive for tachycardia. RESPIRATORY: Positive for dyspnea and unusual chest pain. GASTROINTESTINAL: Positive for heartburn. MUSCULOSKELETAL: Positive for bilat leg pain. NEUROLOGICAL: Positive for weakness. PSYCHIATRIC: Positive for frustrated.

on 4/5/2021 patient started experiencing shortness of breath and pleuritic pain. Admitted to hospital 4/12 with bilateral PE's per diagnostic tests.

Approximately 1800, nursing staff reported patient had facial drooping and slurred speech. Patient vitals were stable. Symptoms resolved. 2/1/2021 Resident observed in the bedroom, unresponsive. No heartbeat or lung sounds upon auscultation. Pupils mid-dilated and fixated, no reaction to light. Carotid pulses were not palpable. Pronounced dead at 1422 by nurse practitioner.

Five days after receiving the Covid-19 vaccine, patient suddenly began having trouble breathing. We called 911 right away but, by the time EMS arrived, she was unconscious and didn't appear to be breathing. Patient was not sick at the time this occurred but she was hospitalized in December of 2019 and was diagnosed with pulmonary fibrosis and pulmonary hypertension which required her to go home with and continue on supplemental oxygen. However, she never experienced pulmonary distress after coming home and her SPO2 levels consistently ranged between 96 and 99% with supplemental oxygen. Patient's death was very sudden and unexpected.

This is an 83 years old lady who was presented to the emergency department because of increasing difficulty breathing, coughing, generalized body ache, and weakness. She was diagnosed with COVID-19 on April 9, 2021. The patient chest x-ray showed ill-defined bilateral opacities. She was hypoxic on presentation. 1. Bilateral COVID-19 pneumonia. Present on admission. Associated with hypoxia. The patient was diagnosed with COVID-19 on April 9th but her initial symptoms started even earlier

Presented to ED on 4/23/21 with weakness, malaise, poor appetite and nausea; elevated temperature, tachycardia, lactic acidosis, chest XRAY patchy infiltrates. COVID test positive. Respiratory failure and COVID19 pneumonia. Patient referred to hospice.

I went to doctor appt was having pain in my left lung right under rib cage. I was transferred t to ER cause of severe pain. I was hospitalized for two days for pneumonia received antibiotics. The next day I asked to go home to take care of my spouse on Oxygen and he also exp pneumonia after vaccine.

Extreme fatigue, lightheadedness, shortness of breath. Initial onset was rather sudden on 4/29/21 and seen at urgent care without definitive dx and DC'd without treatment and somewhat improved. Health did not resume to normal and deteriorated again with same sx on 5/1/21; presented to UC again and transferred to main ED. Again, DC'd without definitive dx or tx ordered and marginally improved at the time of DC. Sx worsened again prompting another visit to the ED on 5/3/21 and again DC'd without definitive dx or tx.

I am the epidemiologist reporting on behalf of patient who tested positive for COVID-19 via PCR on 5/14/21 after the completion of a full Moderna vaccine series (Dose 1 on 4/1 and Dose 2 on 4/29). The patient later died on 6/5/21 . Cause of Death is listed as cardiac arrest; hypoxic RF; Extensive PAD and ischemic leg/foot ulcers s/p bypass surgery. Pre-existing conditions listed as: OTHER CHRONIC DISEASES, CARDIOVASCULAR DISEASE, DIABETES MELLITUS, CHRONIC LUNG DISEASE (ASTHMA/EMPHYSEMA/COPD)

Death 4/7/2021 Causes of death listed on death certificate: 1) Acute respiratory failure 2) Chronic kidney disease 3) Diabetes mellitus 4) Atrial fibrillation Other: COVID 19

Mom woke me up with her pulse at 134, 140, her BP about 160/90, she was out of breath, complained of chest pain, refused going to the ER. I increased her Toprol b/c it had controlled her pulse when she developed A-fib in 2011. I was afraid to do it, so I increased it very little after I confirmed clinical protocol online, plus I know her condition well, but still I am not a physician. Very early in the morning with her cardiologist from home called me and told me to increase by half the Toprol dosage. He is her cardiologist when mom lives . It took almost a week to bring her pulse down to the 70's which is the ideal goal Dr. set. Her feet remained swollen for a few weeks. I am taking her to the clinic to see her cardiologists there as well on July 7th. PCP ordered two ekg's locally and her usual blood work-up for tikosyn (every 90 days). We go once a year because it was Doctor who stabilized her back in 2011 with tikosyn. I drove her from out of state then to the clinic. She had had an awful adverse response to multaq . It almost killed her. My brother was traveling abroad an took her to my home. I had her hospitalized to have her pulse stabilized and then arranged the clinic visit. Since then she has the yearly visits and her home cardiologist supervised her care. She is very lucky to have such amazing physicians. This year was a bit different because of online health care, but now that we are vaccinated we are driving in.

Shortness of breath (very) and heart palpitations (many)... diagnosis of congestive heart failure from a cardiologist

Death 04/23/2021 Causes of death listed on death certificate: 1. hypoxic respiratory failure 2. covid 19 3. diabetes mellitus 4. hypertension

URI signs and symptons began approx. 2-2-21 which did not respond to antibiotic, Predisone, inhaler, Nebulizer Tx. etc. After six office visits to PCP and severe shortness of breath Cat Scan was ordered on 3-09-2021 which revealed multiple Pulmonary Emboli in both lungs. Xarelto was perscribed.

Pt received vaccine 07/01/2021 in the afternoon and patient felt fine with no complaints that day. The following day the patient complained of SOB and the nursing staff found her O2 sat in the 50 so she was brought to the hospital. She was evaluated at the Hospital and discharged back to nursing facility the same day. Patients daughter brought patient back to facility from hospital. On 07/03 patient complained of congestion but "breathing better". On 07/04, patient stayed in bed all day. RN at facility administered tylenol and a soda and right after administration found the patient unresponsive. Nurse started CPR and 911 was called. EMS used defibrillator until the staff alerted EMS that patient was DNR. Patient passed away in room between 3-4pm.

Pt received both doses of the Moderna COVID-19 vaccine (on 3/1/2021 and 4/7/2021). She subsequently developed COVID, testing positive via PCR on 7/3/2021 and was admitted to our hospital on 7/3/2021. She was never ill enough to be in the ICU, instead staying in the general med/surg COVID unit until she was discharged on 7/7/2021. Her primary discharge diagnosis was "COVID-19 pneumonia with mild hypoxemic respiratory failure".

sharp pain inleft hand fingers; Left shoulder really hurt; Left arm skin on top was crinkled; Intermittent pain in entire left side of body; Pain in left arm/arm was sore from elbow to wrist/inner lower left arm was painful; Stayed in bed; Unable to go back to sleep/did not sleep well; loss of stamina; Shoulder make grinding sound; Anaphylactic shock; Felt terrible/felt miserable; Soreness; Throat started to swell; Left side of her head felt like a balloon; Felt like she had puffiness on the left side; Extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Fruit allergy (raw pineapple), Fruit allergy (coconut shredded) and Oil allergy (coconut oil). On 06-Feb-2021 at 6:01 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criterion medically significant), FEELING ABNORMAL (Felt terrible/felt miserable), ORAL PAIN (Soreness), PHARYNGEAL SWELLING (Throat started to swell), HEAD DISCOMFORT (Left side of her head felt like a balloon), SWELLING FACE (Felt like she had puffiness on the left side), ASTHENIA (loss of stamina), MUSCULOSKELETAL DISCOMFORT (Shoulder make grinding sound) and FATIGUE (Extremely tired). On 07-Feb-2021, the patient experienced BED REST (Stayed in bed), INSOMNIA (Unable to go back to sleep/did not sleep well) and VACCINATION SITE PAIN (Pain in left arm/arm was sore from elbow to wrist/inner lower left arm was painful). On 10-Feb-2021, the patient experienced PAIN (Intermittent pain in entire left side of body). On 11-Feb-2021, the patient experienced SKIN WRINKLING (Left arm skin on top was crinkled). On 12-Feb-2021, the patient experienced ARTHRALGIA (Left shoulder really hurt). On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (sharp pain inleft hand fingers). On 06-Feb-2021, PHARYNGEAL SWELLING (Throat started to swell), HEAD DISCOMFORT (Left side of her head felt like a balloon) and SWELLING FACE (Felt like she had puffiness on the left side) had resolved. On 07-Feb-2021, BED REST (Stayed in bed) had resolved. On 12-Feb-2021, FEELING ABNORMAL (Felt terrible/felt miserable), INSOMNIA (Unable to go back to sleep/did not sleep well), PAIN (Intermittent pain in entire left side of body), SKIN WRINKLING (Left arm skin on top was crinkled), ARTHRALGIA (Left shoulder really hurt) and FATIGUE (Extremely tired) had resolved. At the time of the report, ANAPHYLACTIC SHOCK (Anaphylactic shock), ORAL PAIN (Soreness) and VACCINATION SITE PAIN (Pain in left arm/arm was sore from elbow to wrist/inner lower left arm was painful) outcome was unknown and ASTHENIA (loss of stamina), MUSCULOSKELETAL DISCOMFORT (Shoulder make grinding sound) and PAIN IN EXTREMITY (sharp pain inleft hand fingers) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. Treatment medications were not provided. Reduced from dance four lessons consecutively to two lessons consecutively. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Updated Reporter address. Updated patient demographic details such as height, weight, race, ethnic group and Allergies(raw pineapple, coconut shredded, coconut oil). Added new Events like Loss of energy, Shoulder make grinding sound, Anaphylactic shock, Sharp pain in left hand fingers and crunchy sound in left upper shoulder.; 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.

SHORTLY AFTER RECEIVING HER VACCINE, MY MOTHER WENT TO A GRADUATION PARTY FOR HER GRANDCHILDREN. THE DAY FOLLOWING THIS PARTY, SHE STARTED TO COMPLAIN ABOUT SHORTNESS OF BREATH AND LEFT PLEURITIC PAIN., FEVER AND POOR PO INTAKE. SHE WAS ADMITTED TO THE HOSPITAL UNTIL JULY 7. SHE WAS DIAGNOSED WITH PNEUMONIA , SEPSIS AND MILD PLUERAL EFFUSION. HER D DIMER WAS ELEVATED AND SHE WAS TREATED WITH LOVENOX FOR SUSPECTED PULMONARY EMBOLISM. DUE TO HER POOR KIDNEY FUNCTION, SHE WAS UNABLE TO GET A CT SCAN WITH CONTRAST TO DETERMINE THE THE SEVERITY OF THIS CLOT. SHE HAS SINCE BEEN DISCHARGED HOME FROM HER REHAB DUE TO NOT BEING ABLE TO PARTICIPATE IN CARE, TO HOSPICE CARE.

At 4:27 pm client stated she was developing a rash on face. BP 220/110, P 80, R16. Epinephrine .5ml given IM at 4:31pm. Reported tongue felt thick and difficulty breathing, BP 210/100, P 64, R 18. Benadryl 50mg given at 4:34pm, rash on face less, BP 178/88, P 60, R 18. Transferred by private vehicle to Hospital at 4:45pm.

was seated and waiting for her 1:12 appointment. We administered the vaccine and approximately 2-3 minutes later she was turning red and calling me for help. I asked her what was going on and she said to help her, that she can't breathe, and that she thinks she is going to die. We administered a dose of Epinephrine and shortly after she said she was feeling better but she was shaky/jittery. EMS was called simultaneously and they arrived shortly after.

Patient was seated and waiting for her 1:12 appointment. We administered the vaccine and approximately 2-3 minutes later she was turning red and calling me for help. I asked her what was going on and she said to help her, that she can't breathe, and that she thinks she is going to die. We administered a dose of Epinephrine and shortly after she said she was feeling better but she was shaky/jittery. EMS was called simultaneously and they arrived shortly after.

Exactly 12 hours after receiving my vaccination, at 1:30 am, I had a horrific coughing spell that lasted for half an hour. In addition, I had wheezing and a feeling of "bubbles" in my chest. My arm was very hot and tender at the injection site. I slept through the rest of the night but awoke feeling extremely weak and confused. As a result, I spent the day in bed. I had no appetite, as well. The next day, I had coughing bouts off and on and still don't feel myself.

Poste vaccination resident was observed with respiratory distress within an hour. 911 called . Upon arrival Benadryl and Epinephrine administered . Resident was later intubated. Tranferred via 911.

Pt. felt fine after the vaccination. Waited in the clinic for the full 15 minutes without issues. Went home and approximately 1 hour later began to feel short of breath and "couldn't seem to catch" her breath at all. Episode lasted approx. 4-5 minutes. Over the course of the evening, she had a total of 4 such episodes of shortness of breath. Denies any itching, swelling, rash, or issues with her throat.

Patient reports shortness of breath ad her heart racing. EMS performed EKG which was abnormal - ST elevation. Patient was transported to ER. Daughter of patient reports that patient was at the ER 2 days prior due to blood pressure.

Patient presented to the ED where she received vaccination from Public Health. 20 minutes post vaccination became dizzy and experienced SOB. EMS transported. EMS EKG showed possible STEMI. EKG in ED showed t-wave inversions in V-5 and V-6. Patient complaining of SOB. Patient noted feeling better on arrival to ED. Troponin negative in ED. EKG normal. CT head normal. Information on vaccine administered not available as given at another facility. Submission provided by receiving facility for ER services.

CONFUSED, HEADACHE, PRONOUNCED WEAKNESS--UNABLE TO STAND OR SIT PROPPED UP FOR 5 DAYS, LOW O2 SATURATION, HIGH BLOOD PRESSURE

1/27/21 developed dime sized redness and soreness in arm. the next day was 2 inches the next day was 4 inches across and swollen and warm. Pt also having difficulty breathing, Went to Doctor and ER due to breathing distress. Was monitored but not admitted. Still continues to experience headaches, chills, and an increase in salivary secretions.

Patient reported that she felt like her throat was closing few hours after receiving her vaccine. She reported that she took Benadryl and she felt better. She reported that the next day the roof of her mouth and her lips started swelling and again took Benadryl and the swelling did not go away then she started taking prednisone 20mg along with Benadryl and she felt better.

The day following Moderna #2 (on 2/17/21) she had sudden onset of confusion. She thought the remote control was the telephone and speech was confused. No motor deficits. Was taken to ER and then admitted to Medical Center for stroke-like symptoms. Admitted 2/18/21, discharged 2/20/21 with diagnosis of Acute Encephalopathy (possible TIA) and Accelerated hypertension.

shortness of breath and n burning in center of chest. Like Lungs were hot. Call to Nurse Pract. recommended I go to Emergency room as could be heart attack. Went to Medical Center Emergency Dept as recommended. Took vitals and waited for additional tests. arrrived at Emergency Room of Medical CEnter

Pt stated that after she received the COVID-19 vax she had pain in her left arm. She started having swelling, redness, chills, muscle aches, pains, fever (99.3), SOB, and fatigue. Her SOB is requiring her use more O2 than normal. Today she still has swelling, redness and soreness around the injection site that is worse than on the first day. Her PCP came to see her yesterday on 3/2/2021 and they told her that her symptoms meant that her immune system was working. Care giver would recommend her to go to the ER if her symptoms persisted.

At about 11:00 am which was about 22 hours after receiving 2nd dose of Moderna patient exhibited difficulty breathing and soon breathing became more difficult to point where her shoulders were lifting to breathe. At 6:45 pm she passed away.

Patient recieved her first dose of Moderna vaccine today at 1033 am , Patient start coughing around 1048 am after her fifteen minutes wait expired. Daughter stated her mother do cough at times because of difficulty swallowing. Patient alert no other symptoms. nurse alert called at 1051 am. Nurse alert team arrived at 105 2am and assessed patient . Plan to monitor for an additional 15 minutes. Observed patient for an additional 15 minutes, no coughing her difficulty of breathing noted or any other reactions. Patient stable upon leaving the department at 1105 am via wheelchair with her daughter.

2/23/21 84 y.o. female who presents with complaint of syncopal episode that happened about 6:30 p.m.. Patient was working with a family member to has across the street for a visit when she started feeling dizzy with unsteady gait and shortly after passed out and was cut by the family member. Family member says she was out for about 10 min and then came around. The patient complained of some headache but denies chest pain, nausea vomiting, abdominal pain, cough or shortness of breath. Patient has not been eating or drinking because she has and lost some. Has some food after this episode but was brought in because of continued dizziness. 3/15/21 84 y.o. female who presents with a skin tear on the left forearm and abrasion on the left temporal area after she tripped at home prior to arrival. Patient states she has mobility issues and normally uses a walker but she did not. Patient is on home oxygen. Patient denies loss of consciousness or neck pain but is on Eliquis due to atrial fibrillation and stroke. She does have a pacemaker. Patient denies any other injuries..

difficulty in breathing; dizziness, light headed; A spontaneous report was received behalf of Consumer concerning a 84– Years-old elder female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events dizziness, light headed and difficulty in breathing. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the event as difficulty in breathing which considerable as seriousness and admitted in the hospital. On an unknown date, the patient experienced the events as dizziness, lightheaded. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. On an unknown date, the outcome of the events difficulty in breathing and dizziness lightheaded was UNKNOWN; Reporter's Comments: This case concerns an 84-year-old female who was hospitalized with a serious unexpected event of dyspnea along with NS unexpected dizziness and lightheadedness. Event onset occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. 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.

Blood clot in lung; fever; Difficult breathing; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Blood clot in lung) and DYSPNOEA (Difficult breathing) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). Concurrent medical conditions included Hypertension. 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) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced DYSPNOEA (Difficult breathing) (seriousness criterion medically significant). On 27-Feb-2021, the patient experienced PULMONARY EMBOLISM (Blood clot in lung) (seriousness criteria hospitalization and medically significant) and PYREXIA (fever). At the time of the report, PULMONARY EMBOLISM (Blood clot in lung), DYSPNOEA (Difficult breathing) and PYREXIA (fever) outcome was unknown. Treatment details included Heparin, Xarelto. Based on the current available information a temporal association between the use of the product and the onset date of the events, and with reoccurrence of blood clot with second vaccine use, causal relationship with the events cannot be excluded. Fever is consistent with the known safety profile of the vaccine.; Sender's Comments: Based on the current available information a temporal association between the use of the product and the onset date of the events, and with reoccurrence of blood clot with second vaccine use, causal relationship with the events cannot be excluded. Fever is consistent with the known safety profile of the vaccine

arm got sore 10 hours after shot,,,,,,,,bad headache at back of my head , check bone real sore, ,teeth hurt, tightmess in chest, felt like throat was closing up. That lasted for 4 hours, I took an asperin finally, and it started to subside,

hemoglobin levels were dropping – it was a 4 when it should be a 14; Body started bruising - started on her legs and then spread to other locations; she was bleeding everywhere on her body; experienced a little bit of shortness of breath; got tired very easily; This spontaneous case was reported by a consumer and describes the occurrence of HAEMOGLOBIN DECREASED (hemoglobin levels were dropping – it was a 4 when it should be a 14), INCREASED TENDENCY TO BRUISE (Body started bruising - started on her legs and then spread to other locations) and HAEMORRHAGE (she was bleeding everywhere on her body) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Scoliosis and Sciatica. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced DYSPNOEA (experienced a little bit of shortness of breath) and FATIGUE (got tired very easily). On 03-Mar-2021, the patient experienced INCREASED TENDENCY TO BRUISE (Body started bruising - started on her legs and then spread to other locations) (seriousness criteria hospitalization and medically significant). On 28-Mar-2021, the patient experienced HAEMOGLOBIN DECREASED (hemoglobin levels were dropping – it was a 4 when it should be a 14) (seriousness criterion hospitalization) and HAEMORRHAGE (she was bleeding everywhere on her body) (seriousness criterion medically significant). At the time of the report, HAEMOGLOBIN DECREASED (hemoglobin levels were dropping – it was a 4 when it should be a 14), INCREASED TENDENCY TO BRUISE (Body started bruising - started on her legs and then spread to other locations) and HAEMORRHAGE (she was bleeding everywhere on her body) had not resolved and DYSPNOEA (experienced a little bit of shortness of breath) and FATIGUE (got tired very easily) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: inconclusive (Inconclusive) Inconclusive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. After a few days, her body started bruising. It started on her legs and then spread to other locations. On 28-Mar-2021, she went into the hospital because of the bruising that kept expanding. The doctor there said that her hemoglobin levels were dropping – it was a 4 when it should be a 14. They did a couple of transfusions and discharge her on 30-Mar-2021. On 02-Apr-2021, she had to go back to the hospital, she had bruising on her hands, feet, and arms. Doctor told them that it was that her blood was thinning and that she was bleeding everywhere on her body. She was still at the hospital. They also said that it looked like her body was fighting the treatments - producing antibodies against them. They gave her plasma and steroids. They also did every test possible, CT scans, and the doctors still dis not know what is causing it. Based on the current available information and the temporal association of the product use and the start date of the events a causal relationship cannot be excluded. This case was linked to MOD-2021-071592 (Patient Link).; Sender's Comments: Based on the current available information and the temporal association of the product use and the start date of the events a causal relationship cannot be excluded.

My mother died in the hospital after being in the ICU for a week with severe breathing problems. Her symptoms matched that of a Covid patient but she tested negative for Covid twice (once was the 24 hour test).

Moderna COVID-19 Vaccine EUA: one day after vaccination patient presents to emergency department (ED) vomiting, tachycardic, and febrile with increased home oxygen use. Denies chest pain. Found to have positive blood cultures and diagnosed with NSTEMI, underwent heart catheterization and found to have severe ostial RCA stenosis, and admitted for medical management of CAD and antimicrobials. Patient discharged medically stable to home.

Felt dizzy the night of, pressure on chest, shaking, blood pressure elevated more than usual, blood glucose levels elevated more than normal, increased SOB, flushing of face. When walking very short distance about 5 feet would feel dizzy, winded (SOB), face would turn red and hot, and blood pressure would elevate. Treatments: 2/24/2021: EKG, Rapid & PCR COVID test, both negative. BW ordered for CBC w/autodiff, CMP, TSH 2/26/2021: Gabapentin D/C 3/04/2021: RX for Hydralazine 25mg, was too strong and D/Cd on 3/19 3/19/2021: UC visit for decreased urinary output, dizziness and elevated blood pressure. on 3/24/2021: follow up OV, patient is now feeling back to normal, but experiencing SOB with exertion 4/20/2021: follow up OV, patient is feeling normal, but experiencing SOB with exertion.

Patient reports that approximate at 4:00pm shortly after vaccine patient began to feel short of breath and having chest pain. Patient reports," I took Nitro and felt better, but chest pain and shortness of breath has continued to worsen. Patients vaccine card identifies Moderna as the brand, however computer report Pfizer. This also is a concern.

allergic reaction. mouth lips tongue and throat swelling. was still able to breathe and speak freely but lasted the entire day. gums tingling all day. (swelling was enough to smooth out upper lip wrinkles)

Pt p/w a 5 day hx of diarrhea, nausea chills, dry consistent cough w/some intermittent cramping of bilat lower abdomen. COVID test positive (4/28) despite receiving Moderna vaccines (2/4 & 3/3/21). Given drops in her O2 saturation, admitted for medical management of acute hypoxic respiratory failure secondary to COVID-19. Received dexamethasone, tocilizumab during admission and ceftriaxone for catheter-related UTI. Pt recovered and ultimately was discharged on 5/11 with followup.

Patient presented to Emergency Department on 4/10/21 with moderate SOB experienced in the middle of the night. She experienced SOB when she woke up in the middle of the night on 4/9/21 that made it difficult for her to walk back to her bed from the bathroom. Oxygen reached as low as 80% while in the hospital and she was discharged with oxygen for use at home. She received her first dose of Moderna COVID vaccine on 4/9/21. She was last hospitalized from 1/26/21 to 2/5/21 for tachybradycardia syndrome for which a pacemaker was placed. She also developed COVID19 infection while in the hospital at this time and was discharged with oxygen that was a returned back to supplier after 1 week.

COVID-19 positive 5/23/21 requiring 4-day hospitalization after vaccination in February. COVID antibody test returned negative. Presented to ED with SOB for 3-4 days prior, headache, fatigue, and cough. CTA positive for bilateral pulmonary groundglass opacities and small lung nodules. COVID PCR positive. Was maintained on 1L of NC. Received PO decadron 6 mg daily and lasixs in hospital.

Progressive SOB started around 3/20/21 leading to ER visit, diagnosed with bilateral pulmonary emboli on 3/23/21.

I developed a severe case of hives at the vaccine site 5 days after the inoculation. I also had arm pain. Then I developed brain fog, hallucinations, shortness of breath, worse a-fib, body pain , deep depression.

Patient presented to emergency department for increasing trouble breathing on 4/23/2021. She was previously diagnosed with COVID-19 infection on 3/3/2021. She was admitted to a different facility from 4/8/2021 to 4/20/2021 for management of COVID-19 infection where she also tested positive for COVID-19. She was admitted for further management of COVID-19 infection. Her symptoms did not improve and she was placed on comfort measures on 5/4/2021. Patient expired on 5/5/2021 due to complications from COVID-19 infection.

Received COVID vaccines (Moderna) on 3/16/21 and 1/19/21. Vaccines not administered, but found via immunization query. Presented to ED with leg pain and chest pain. CXR showed worsening heart failure. Because of tachycardia, tachypnea, keukocytotis, and lactic acidosis received 5 days of vancomycin and zosyn for possible sepsis. CPR prior to discharge positive for COVID. Currently not on any supplemental oxygen.

High blood pressure, never had previous, shortness of breath , at rest and on exertion, rash, exhaustion

Thursday and Friday my arm was red and sore and over the weekend on Monday I have terrible pains in the lungs I called the nurse and she said to go to the hospital. I have a pressure of 102 with terrible pain. They thought I was having a heart attack and they did an electro, echo cardiogram. They did a Ct scan and they found I have clots in the lungs. They admitted me into the hospital and stayed for 2 night and then on 3/11 they sent me home and they gave me a Blood thinner (take it twice a day).

Patient had an immediate reaction following the 1st Moderna COVID-19 Vaccine administration on 01/18/2021. S/S began immediately following the injection, and were scratchy, dry throat, dry cough, slight wheezing in upper bilateral lobes. Treated with 50 mg Benadryl, monitored for 30 minutes which included vital signs. Patient recovered- home with husband. Advised patient to follow up immediately with urgent care or primary care physician.

After 15 minutes of observation and no adverse reactions, patient went to the restroom, and went shopping. 30 minutes after administration, patient was extremely fatigued, unresponsive, unable to be aroused. Called 911. Blood pressure was 60/Error or blood pressure machine was not working properly. Began to gasp and vomit. Epinephrine was administered at that time. 45 minutes after administration, EMS arrived. Patient was discharged from hospital around 3pm and her diagnosis was syncope.

Patient observed for 15 m, left clinic was at a restaurant for a bit (~ 1 hr after) & developed throat swelling and shortness of breath & returned to clinic & was observed, vitals & EKG were stable & patient was discharged

Within a few days, my mother started reporting profound fatigue and shortness of breath while conducting routine household activities. She no longer had to energy for her daily exercise walks and became increasingly lethargic. She died in her sleep while taking an afternoon nap on Thursday, February 4th. I am highly concerned this could be a vaccine related.

2/7/2021 at 0630, resident found in recliner without pulse or respirations. Resident had not been found to have any adverse reactions to the vaccine between the time of the vaccine on 2/4 until found deceased on 2/7.

Patient started having shortness of breath and tingling in fingers shortly (approximately 10 minutes) after receiving vaccine dose.

24 hrs after injection i was hot hot, started getting weak, body weird, , feeling nauseous, went tto bed and woke up feeling sick, unsteady on my feet, hard time breathing. Went to the ER on the 10th but was not able to treat you. im getting better but slight nauseous still

Patient presented to the ED 2/15/2021 for shortness of breath and lightheadedness with near syncopal event. The pt reported 2 episodes of SOB and lightheadedness, with the second one as the more severe. On her second episode, she felt severe shortness of breath, tried to walk quickly to her bed with her walker, and fell into her bed. CT angio demonstrated acute saddle PE, mild right heart strain, RUL pulmonary infarct, and mild multifocal pneumonia with suspicion of COVID; IR was consulted and suggested thrombectomy due to the severity of the embolism. In the ED, she was started on heparin drip and put on low-flow NC oxygen without distress. Upon arrival to the emergency department her vital signs were significant for T 36.4, SBP 120/81, HR 95 bpm, NSR, RR 18, FiO2 94% on room air. Her oxygen increased to 98% on 2 L nasal cannula. Her laboratory values revealed WBCs 15.1, Hb 14.4, HCT 43.4, PLT 321, neutrophils 68.8%, D-dimer 4642, NA 134, K3.4, anion gap 9, BUN 17, creatinine 1.00, glucose 163, troponin elevated 0.12, 0.25, and 0.41, urinalysis is unremarkable, COVID-19 swab is positive. A thrombectomy was performed 2/16/2021. She tested COVID positive on 2/16/2021 and her SpO2 remains in the high 90s with dips to mid 80s while talking, but she does not currently experience any SOB.

Resident developed a 100.2 F temperature and shortness of breath. Fever noted at 7:45 pm, Oxygen level was not above 88%, On-call RN was notified at 7:45 pm. RN advised staff to recheck vitals at 9:30 pm and to continue to monitor resident. Family was notified at 7:45 pm also. At 9:30 pm, check of vitals was done. Temperature was 102.5F, SpO2 was 93%, BP 107/63, pulse 102. At 9:50 pm, Family member requested that resident be sent to Emergency Room. EMS was notified, patient transported to Hospital ER.

PATIENT CAME FOR HER FIRST DOSE OF COVID-19 VACCINATION. SHE WAS VACCINATED AT 9:30AM AND OBSERVED FOR 15 MINUTES. PATIENT HAD NO SIDE EFFECTS WHILE SHE SAT FOR 15 MINUTES AFTER BEING VACCINATED. SHE LEFT THE VACCINATION CLINIC WITH HER DAUGHTER IN LAW. AROUND 10:15AM, THE DAUGTHER IN LAW CAME TO THE PHARMACY AND STATED THE PATIENT WAS HAVING A HARD TIME BREATHING IN THE CAR. ONE PHARMACIST RAN OUT TO THE PATIENT AND CHECKED HER PULSE. PATIENT WAS GIVEN A BENADRYL 25MG TABLET TO TAKE. PATIENT ALSO HAD NITROGLYCERIN TABLETS WITH HER AND TOOK ONE TABLET WHILE THEY WAITED FOR PARAMEDICS TO ARRIVE. I CALLED THE PATIENT AROUND 6PM THAT EVENING AND SHE STATED SHE WAS HOME AND FEELING BETTER. SHE WAS A LITTLE TIRED BUT WAS FEELING BETTER AND HAD NO OTHER SYMPTOMS.

pt states that on 2/27/2021 she started getting nervous and dizzy. She fell on 2/27/2021 and 2/28/2021. On 2/28/2021 she started coughing and having trouble breathing so she went to Urgent Care. She was tested for flu and covid and then told she needed an EKG so was told to go to the ER. She did not go to the ER but went to a Cardiologist Dr. next morning on 3/1/2021. They took chest XRAY, EKG, Blood Work, and covid test. Dr. changed her prescription Carvedilol 6.25 mg x 2 daily and Furosemide 20mg once a day. Pt is expecting them to call her today w/ test results and will FU w/ regular Cardiologist.

Moderna COVID-19 Vaccine EUA 3/12/21: The patient was started on antibitoics outpatient Tuesday for bronchiolitis. Covid test was done, no results yet. Pt daughter stated got better yesterday today confused. 85-year-old woman who presented with 2 days history of cough, chest discomfort and shortness of breath. She reports insidious onset of symptoms 2 days ago cough which was initially dry, then productive of scanty whitish sputum. She also reported associated shortness of breath and pleuritic mid chest discomfort. She denies any fever, chills, nausea or vomiting. She denies any known contact with individual diagnosed with been tested with COVID-19 infection, reports compliance with masking directives. She is up-to-date with her COVID-19 vaccination, 2nd short of COVID-19 vaccine was administered last Saturday. Chest in her primary care physician yesterday and been diagnosed with bronchiolitis, prescribed oral Augmentin and Medrol Dosepak without any improvement in symptoms. She presented to emergency department today and was found to be hypoxic to 82% on room air. At present she has required supplemental oxygen at 5-8 liters/minute. She will be admitted to the hospitalist service for further treatment and evaluation. 3/20/21: She is s/p plasma, antibiotics (aztreonam, vancomycin), no remdesivir due to poor renal function. She has been on decadron 3/12 to date (to complete 10 day course) She was able to be weaned down to 1 L NC oxygen while on admission with improved symptoms. Plan is to discharge to rehab today.

Caller stated that 10 hours after she got her vaccine she started to have a severe headache, nausea, abdominal pain, weakness and shortness of breath. Stated all symptoms but the weakness and shortness of breath have resolved

Pt received her second dose Moderna shot. Had complaint of slight tightness in her throat. Pt was able to speak in full and unlabored sentences . Pt has history of high blood pressure but denies any history of adverse reactions to medications and had no reaction to her first vaccine. Offered PT diphenhydramine to assist with symptoms. 1545 administered 2.5ml and monitored PT.

Vaccination was on Wednesday, March 17, 2021 at 3 PM. Symptoms began 8 days later, and Emergency Room admission 3days later on Sunday, March 28, 2021, for Blood Clots in legs and lungs,(critical in Pulmonary Artery). Blood thinner started immediately was Zarelto, and continues daily. Pain, nausea, shortness of breath, and fatigue were the symptoms. The patient was admitted to hospital for 5 days and sent home to recuperate. 3 days later, on Sunday she was back into the emergency department with intestinal bleeding that had gone on for 2 days. She was admitted again and had a colonoscopy. Bleeding stopped and she went home after 3 more days. She is currently getting home health care.

When pt came home all joints muscle, back started hurting, seamed to keep getting worst after she had gotten some muscle relaxers and pain pills, Day 3 mom couldn't walk and was found on the floor, diff breathing and very week, EMS was called and taken to hospital for 3nights,

First DVT in an 85-year-old ambulatory female on daily ASA. Also found to have pneumonia at the same time. Presented afebrile with gradually progressive dyspnea over days and acute onset right lower extremity swelling and pain over hours. Normal O2 sat. Pt was evaluated and seen in memory care where she currently lives. Treatment: ASA discontinued, Eliquis and Levaquin started. Pt remained in memory care and is doing well with almost complete recovery 10 weeks later.

Patient reported SOB, chills, fatigue, muscle aches and red site reaction. Patient needed to use her oxygen.

Pt awoke on 02/28/2021 with increased lower extremity edema went to Urgent care had CXR and was told to increase Lasix to 40 mg daily for 4 days. Swelling became worse over next 2 days and patient became short of breath and on 03/02/2021 she went to Hospital and had a CT scan of chest which showed a pulmonary embolus and a bilateral lower extremity ultrasound which showed a right femoral DVT and popliteal occlusive thrombus and a posterior tibial and peroneal vein occlusive thrombus. She was started on Lovenox and admitted to the hospital . she was discharged on 03/05/2021 and had a right femoral thrombectomy as an outpatient on 03/ 08 2021 with complete resolution . She was discharged home on Lovenox and later switched to Eliqus. She is home and doing well at time ofreport.

Died unexpectedly in my arms. On the 15th. Could not breathe We tried to use inhaler and did not work.

headache, chest discomfort, dyspnea. Symptoms started approximately 18 minutes after her vaccination. she has continued to have dyspnea on exertion since. Vomited the first day after.

Patient received second COVId 19 vaccine on 4/9/21 @ Health Department. Was admitted to hospital on 5/18/2021 with SOB, Nausea, Vomiting, and Headache. Diagnosed with COVID 19 infection and COVID 19 Pneumonia. Patient expired on 5/19/2021 at hospital.

Around 2 am in morning after receiving vaccination 14 hours prior, subject experienced severe body tremors and flu-like symptoms including body aches, headaches and lethargy. within 3 days, headaches and body aches subsided however subject remained extremely fatigued and was unable to perform ADL's. Performance status declined. Sitting in chair/laying in bed 24 hours a day. Became short of breath on minimal exertion. On 6/6/21 patient taken to ER for c/o shortness of breath, cough and tachycardia. Was found to have large pulmonary emboli.

Died 4/24. Immediate cause of death acute hypoxic respiratory failure, underlying cause COVID-19 associated respiratory distress syndrome and COVID-19 viral pneumonia

Patient received vaccine on Jan 22nd at 1:42 pm. Patient stated she woke up at 2:00 am with severe shortness of breath and felt as if she had a cement brick on her chest. She struggled to breath all night, and paced the house. Patient states she felt as if she was going to die. Patient did not wake anyone up or tell anyone, so vitals or other information could not be obtained during the reaction. Patient felt better Saturday morning, but still very fatigued and very fearful.

I was talking on the phone and all of the the sudden I couldn't feel my cheekbone and all the way up to the eye socket and my tongue felt like a sponge, and I couldn't breathe very good. So I got my friend to take to me to the ER and they gave me oxygen, and the next my tongue was still swollen and had blisters on it. They recommended scheduling a follow appointment with PCP. They gave me a shot and three prednisone pills to take on a taper.

Top of head to bottom of feet for itching. difficulty breathing, lung pain, headache, dizziness, disoriented-unable to maintain balance, growly voice, body aches

Received 2nd COVID 19 vaccine 3/4/21. On 3/5/21, was tired, but otherwise did okay. On morning of 3/6/21, she awoke short of breath, felt hot, was a little nauseated, and did not take her medication. She has gradually grown more short of breath and distressed since then. She appears weak, distressed with tachycardia and hypoxemia. Bilateral pneumonia seen on xray. She arrived to the ED in A-fib with RVR HR 150's. O2 90% on 12L NRB. After IV access was obtained and labs drawn patient was transitioned to BiPAP setting 10/5 and 30% per MD at 1300. Her saturations were not maintaining above 90% and O2 was titrated up to achieve a O2 % > 90. She was given a loading dose of Diltiazem per protocol and started on a DilIazemt gtt, the drip was titrated up to max 15 to achieve target HR <100. Her BP remained stable during this course. She received a bolus of NS. 1 gram of Tylenol via IV. 1 gram of Rocephin infusing upon transfer. D5LR infusing at 200 upon transfer.During her course in the ED she was able to communicate with staff when asked questions.

JAN. 27, '21- NOTICED SHORTNESS OF BREATH DURING REGULAR EXERCISE ROUTINE FOR STRENGTH & FLEXIBILITY. JAN. 28, '21 WEAR A FITBIT ON WRIST- SAW READING OF REST. HEART DOCTOR. COULD NOT GET APPT. UNTIL FED. 2ND. WENT TO URGENT CARE- DIAGNOSIS OF SINUS BRADYCARDIA, DYSPNEA ELEVATED BP, CALF PAIN. REFERRED TO ER DEPT. WAITED UNTIL NEXT MORN. TO GO TO HOSPITAL.

Swelling in leg/edema; Facial tingling; numbness in lips; Shortness of breath; Weakness in leg; Weakness in leg and severe headache; A spontaneous report was received from an 86 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced facial tingling, numbness in lips, severe headache, shortness of breath, increased blood pressure, swelling and edema and weakness in leg. The patient's medical history included cellulitis in left leg. No concomitant medications were reported. On 21- Feb-2021, the patient received her first doses of mRNA-1273 (Lot number: 031M20A) intramuscularly for prophylaxis of COVID-19 infection. The patient reported that that she had facial tingling, numbness in lips, shortness of breath and blood pressure of 210/90 after getting her first Moderna vaccine. Patient also reported weakness in her leg and severe headache. Patient said facial tingling lasted for about 2 hours and lip numbness lasted for about 4 hours(21-FEB-2021). Patient also complained about swelling in her leg/edema but she said she has cellulitis in her left leg and she was not sure if the swelling had something to do with the vaccine or not. Patient did not take anything to treat symptoms but contacted her doctor and pharmacist. The patient reported that all other symptoms like weakness in her legs, Shortness of breath, and the headache lasted for about 4 days(25-FEB-2021). Patient said all she wanted the Moderna team to know that she reacted to the vaccine. Seriousness criteria for the event of swelling and edema was medically important. Action taken with mRNA-1273 was unknown. The outcome for all the events was considered as recovered/resolved. No further information was provided.; Reporter's Comments: Based on the information provided, a strong temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Headache is consistent with the known safety profile of the vaccine.

See started having shortness of breath on the night of 8/2/2021. He sends her to do tests, and she was taken to the hospital. She died in the hospital due to kidney and heart failure.

Pt started late in the day w/ CP and SOB, was transported to Hospital by EMS . Pt passed away once at the facility. Time of Death was: 2011 on 4/1/21; pt was discharged from ER on 4/2/21

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Additional Details: shortness of breath, drop in oxygen level, worsening of fibromyalgia

small bowel obstruction; shortness of breath; This spontaneous case was reported by an other caregiver and describes the occurrence of SMALL INTESTINAL OBSTRUCTION (small bowel obstruction) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Small bowel obstruction. Concurrent medical conditions included Emphysema. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced DYSPNOEA (shortness of breath). On an unknown date, the patient experienced SMALL INTESTINAL OBSTRUCTION (small bowel obstruction) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 04-May-2021 due to SMALL INTESTINAL OBSTRUCTION. At the time of the report, SMALL INTESTINAL OBSTRUCTION (small bowel obstruction) and DYSPNOEA (shortness of breath) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications included an unspecified inhaler for emphysema. Treatment for the events included use of a tube and relive the pressure of the small bowel obstruction without surgery and an unspecified steroid medication to treat the shortness of breath. 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.

could not keep balance; could not speak well; could not walk well; could not breath through nose; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of BALANCE DISORDER (could not keep balance), SPEECH DISORDER (could not speak well) and GAIT DISTURBANCE (could not walk well) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 12L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included HYDROCHLOROTHIAZIDE, VALSARTAN (VALSARTAN/HYDROCHLOROTHIAZIDE) for an unknown indication. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced DYSPNOEA (could not breath through nose). On 16-Feb-2021, the patient experienced BALANCE DISORDER (could not keep balance) (seriousness criterion hospitalization) and SPEECH DISORDER (could not speak well) (seriousness criterion hospitalization). 16-Feb-2021, the patient experienced GAIT DISTURBANCE (could not walk well) (seriousness criterion hospitalization). The patient was hospitalized on 23-Feb-2021 due to BALANCE DISORDER, GAIT DISTURBANCE and SPEECH DISORDER. The patient was treated with Surgery for Balance disorder; Surgery for Speech disorder and Surgery for Gait disturbance. At the time of the report, BALANCE DISORDER (could not keep balance), SPEECH DISORDER (could not speak well), GAIT DISTURBANCE (could not walk well) and DYSPNOEA (could not breath through nose) outcome was unknown. Treatment included acetaminophen after receiving injection. 911 was called on 23-Feb-2021 and patient taken to a medical center where she was admitted for an unspecified emergency surgery. Patient was on ventilator at time of report. This case was linked to US-MODERNATX, INC.-MOD-2021-132568 (E2B Linked Report). This case was linked to MOD-2021-132568 (Patient Link).; Sender's Comments: Very limited information regarding this event has been provided at this time. US-MODERNATX, INC.-MOD-2021-132568:Case for first dose

numbness in bilateral legs, SOB- states her GBS symptoms have slowly been progressively getting worse since Feb. after receiving the 1st dose of the COVID vaccine.

Got second dose of Moderna 4/19/21. Was having increasing shortness of breath since 5/24/21. Admitted 6/8. Increasing lower extremity edema. Is obese. Coughing up phlegm. No fever/chills/chest pain/abdominal pain. COVID negative. Found to have a saddle pulmonary embolism and DVTs in the lower extremities . Appears unprovoked. Started on Eliquis. Still currently admitted 6/11

heart became inflamed; lungs became inflamed; felt weak; Couldn't lay down / she couldn't do anything; hard for her to breath; Could hardly walk; Arm pain; Not like herself; felt wipe out; Nauseated; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDITIS (heart became inflamed) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced MYOCARDITIS (heart became inflamed) (seriousness criterion medically significant), PNEUMONITIS (lungs became inflamed), ASTHENIA (felt weak), MOBILITY DECREASED (Couldn't lay down / she couldn't do anything), DYSPNOEA (hard for her to breath), GAIT DISTURBANCE (Could hardly walk), PAIN IN EXTREMITY (Arm pain), FEELING ABNORMAL (Not like herself), FATIGUE (felt wipe out) and NAUSEA (Nauseated). On 07-Apr-2021, MYOCARDITIS (heart became inflamed), PNEUMONITIS (lungs became inflamed), ASTHENIA (felt weak), MOBILITY DECREASED (Couldn't lay down / she couldn't do anything), DYSPNOEA (hard for her to breath), GAIT DISTURBANCE (Could hardly walk), PAIN IN EXTREMITY (Arm pain), FEELING ABNORMAL (Not like herself), FATIGUE (felt wipe out) and NAUSEA (Nauseated) had resolved. Treatment medication were not reported. Concomitant products were not provided. After the second dose, the patient felt wiped out, weak, couldn't do anything, which was described as "not like herself". At the same time, the patient couldn't lay down. These symptoms lasted for about five weeks. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

No adverse effects noted after vaccination. Patient with cardiac history was found unresponsive at 16:45 on 1/6/21. Abnormal breathing patterns, eyes partially closed SPO2 was 41%, pulseless with no cardiac sounds upon auscultation. CPR and pulse was regained and patient was breathing. Patient sent to Hospital ER were she remained in an unstable condition had multiple cardiac arrest and severe bradycardia and in the end the hospital was unable to bring her back.

Resident reported shortness of breath, severe fatigue/weakness, new onset confusion, sore throat, body aches, runny nose

Day after vaccine patient reported headache, trouble breathing, numbness in hands and feet, and high fever. Patient states she does have COPD and it felt more of an exacerbation, but she states her COPD has been controlled for a while and has not had trouble breathing like this in a long time. Patient has recovered from all symptoms besides numbness in hands. Patient did not seek treatment becuase "she didn't want to".

soreness at the sight. red ring about 2 inches in diameter. shortness of breath (that could also be part of my COPD. However, it seems to be a little more so.

Just over 24 hours after vaccine patient states she developed systemic itching, racing heart, sob and fatigue which resolved in less than 24 hours. She did not seek care and was fine when she reported these symptoms.

Death; kidney failure (unable to urinate); shortness of breath; required oxygen; A spontaneous report was received from consumer concerning an 87-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shortness of breath, kidney failure and death. The patient's medical history included advanced kidney and heart disease. No relevant concomitant medications were reported. On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 17 Jan 2021, the husband reported that the patient experienced adverse events. Symptoms included shortness of breath and kidney failure (unable to urinate). The patient was admitted to the hospital and discharged to hospice. Oxygen was administrated for shortness of breath. Action taken with mRNA-1273 in response to the events was not applicable. On 20 Jan 2021, the patient died. The cause of death was unknown. Autopsy details were unknown.; Reporter's Comments: This case concerns a 87-year-old, female patient with the medical history of advanced kidney and heart disease, who experienced fatal unexpected event of dyspnea, renal failure and death. The events of dyspnea and renal failure occurred 12 days and the event of death occurred 15 days after the first dose of mRNA-1273 (Lot: unknown). The patient was admitted to the hospital and discharged to hospice. Oxygen was administrated for shortness of breath. The cause of death was unknown. Autopsy details were unknown. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the history of advanced kidney and heart disease may remain as confounder. Additional information has been requested.; Reported Cause(s) of Death: Unknown cause of death

She was fine the first day, on Wednesday she noticed her arm was red, and had difficulty breathing, but has COPD and used her medications. About 5:00 PM her mouth started watering and she got the drive heaves, and then about 15 minutes and then started having them bad. She laid down and after 15 minutes she could not breath, couldn't get any air. When she was able to get some air, her throat was sore and she was really hoarse. Later in the evening she laid down again and the breathing difficulty happened again and it was worse. She was scared to the point that she was afraid to lie down. She is fatigued. She finally fell asleep during the night and didn't sleep much and today is very tired. She called her doctor this morning, and talked to the nurse. They told her if it got worse to go to the ER. Told her to call the CDC.

The patient had immediate dyspnea and dizziness. When there was no immediate resolution, she was taken to the ER on campus. She was released home following ER evaluation.

The night she received the shot she developed pain, tenderness, redness and swelling at the injection site. The next morning had headache, chills, heart felt loud and fast, could not think, could not remember even normal things like how to turn on TV, insomnia. Went to store and became weak and breathing hard with minimal activity, had to sit down and rest before leaving. Symptoms lasted about 3-4 days and at this point have resolved.

10-15 minutes after vaccination patient complained of dizziness, blurred vision, and shortness of breath. Patient states she felt slightly short of breath walking into the clinic prior to vaccination but did not mention symptoms to staff. Patient was evaluated by clinic medical director and EMS staff. No objective signs of local or systemic reaction, only patient's subjective statements. Patient was transported to Hospital for further evaluation.

Patient had trouble breathing after vaccination. Assessed by on-site EMT who determined she could return to home.

After injection on Friday, headache, fever, tired, achy. Very tired through weekend. On Monday she developed painful deep breathing , tightness in chest, more achy, extremely low energy, warranted emergency visit for chest x ray and EKG. Still has debilitating exhaustion a week later.

Details of pt. symptoms following her MODERNA Vaccine Note: She has been and was perfectly healthy no health issues or symptoms of this nature until after receiving the Moderna COVID vaccination (1st dose). 26 Feb 2021 (Friday) 3:00 PM First dose Moderna vaccine given - no issues at time of vaccination. At approximately 7 hours post-dose ? severe whole body shaking, weakness, racing accelerated heart rate, difficulty walking- lasted throughout the night. 27 FEB 2021 (Saturday) Morning ? brain fog- very confused ? NO FEVER or shaking- however weak, unbalanced on her feet and confused in the afternoon we went about normal activities during the day so we thought she made it thru some acute reaction. Evening ? At approximately 9 PM ? whole body shaking, chills, weak, unbalanced. Her heart rate was not as accelerated (serious) as Friday night 28 FEB 2021 (Sunday) -seemed better but still brain fog (confusion), - by afternoon did normal things did a walk to get fresh air but she seemed to have labored breathing ? ?Huffing? and slow-she seemed better after the walk. 5 PM ? sudden and unexpectedly- she started whole body shaking, chills, difficulty walking, unsteady ? lasted about 1 hour ? unsteady on her feet needed assistance to walk. I put her to bed at 7:30 pm to rest and I was afraid she would fall because unsteady and shaking legs ? she had intermittent whole body shaking, chills, weakness 1March 2021 (Monday) ? around 10 am another episode - intermittent whole body shaking & chills, generalized weakness? developed respiratory symptoms, wheezing, deep croup- like coughing, weakness 2 March 2021 (Tuesday) ? respiratory symptoms seemed to be progressing. 3 March 2021 ( Wednesday) 3 PM Doctor evaluation ? fluid in lungs ? tested for Covid & prescribed antibiotics for lungs- 250 mg AZ ( 5 day treatment)

Patient was found by husband in respiratory distress on 3/3/21 with inability to arouse and agonal breathing. Intubated and sedated and brought to facility. Possible aspiration pneumonia, as patient vomited prior to intubation. Unknown if related to vaccine

Summary - ANAPHYLAXIS. Screened via medical questionnaire with no known hx of anaphylaxis after receiving injection. Less than 10 minutes after receiving injection, pt's son reported to staff that pt was overheated and not feeling well. After receiving ice water, pt became non-responsive to questions and developed tongue swelling, blocked airway and audible wheezing. 0.3mg IM epinephrine injected into L thigh. Pt was laid down in empty exam room. Blood pressure 130/80, pulse 96, temp 96.9. Pt able to sit up, answer questions and breathe comfortably without distress within few minutes of receiving epinephrine. Examined by EMS and declined transportation to ER. Called by physician 4 hours later; pt reported doing well.

DIAGNOSED WITH COVID 1/21/21; RECIEVED BAMLANIVUBAM INFUSION; HOSPITAL ADMISSION 1/23/21 WITH ACUT RESPIRATORY FAILURE DUE TO COVID. INTUBATED X 10 DAYS

Patient received vaccine at 10:18am and then went home with no reaction in the vaccination POD. EMS was called to the patients home shortly before 2:30 that afternoon. When EMS arrived patient was posturing with lower extremities extended in plantar flexion. Last seen normal 30 minutes prior. she was also tachycardic and in respiratory distress with sonorous respirations. Cranial nerve deficit present GCS 3.She was unresponsive and intubated. Airlifted after CT to hospital. She died at 1647 at Hospital from hemorrhagic stroke.

09MAR2021-Patient is a 87 y.o. old female with a history of receiving her second COVID vaccine this past Friday. For the previous 2 to 3 days she has had increasing fatigue and generalized weakness. Anorexia and nausea have been noted as well. Apparently has not been eating or drinking well at all. No vomiting or diarrhea. No new medication recently. No fever or chills. Patient was seen and evaluated in the ER tonight by the ER physician. Significant acute renal failure was noted. Urinalysis was unrevealing. Mild hyperkalemia and moderate metabolic acidosis were noted as well. Initial treatment in the emergency room included a 1 L bolus of normal saline and antiemetic therapy. The hospitalist service was then consulted for admission." Discharge Summary Written 20MAR2021-Patient was admitted and started on IV fluids. Nephrology was consulted. She was started on a bicarb drip for metabolic acidosis. Renal US was negative for hydronephrosis but with incidental biliary ductal dilatation which was stable compared to a previous imaging study in 2011. Unfortunately her renal function continued to worsen and require dialysis. She had a temporary dialysis catheter placed on 3/12. She had RRT started on 3/12 and again on 3/13. Her urine output, electrolytes, and azotemia started to improve slowly. Renal function continued to improve and she no longer required any RRT. Her temporary dialysis catheter was removed on 3/19. Her Foley catheter was also removed on 3/19 and she was urinating well prior to discharge. She will go home with oral Lasix. Patient felt much improved and is agreeable for discharge on this date- 20MAR2021 Second Admission- 02APR2021-05APR2021- INDICATION FOR ADMISSION: This is an 87-year-old female with history of COPD, hypertension, and chronic lung disease, who presented to the Emergency Department on April 2, 2021 with a chief complaint of shortness of breath.. Three days prior to this admission the patient had increasing shortness of breath. The patient also had a nonproductive cough but denied any fever or chills. The patient was started on IV Lasix and IV steroids in the ED. She also had elevated BNP. She was admitted to the hospital for further medical management. Discharge Summary Written 05APR2021- She was started on IV steroids, IV Lasix, nebulization, and she was monitored closely. The patient also had HGB dropping to 8.8 from 11.3 back in March 2021. The patient was started on proton pump inhibitor. Gastroenterology and cardiology eventually were consulted to see the patient. She did have an EGD done at this time which showed gastritis. She will continue Protonix for now. She was started on IV Lasix and she improved with the treatment. Now she remains on room air. She denied any respiratory issue. Her renal function still remains at baseline. Today creatinine is 1.5. The patient can be discharged home today and continue oral Lasix at home daily for now. She was instructed to follow up with her primary care physician and also her cardiologist as outpatient in 1 to 2 weeks.

Patient presented 3 days after her second DuoNeb vaccine with weakness dizziness chest pain or shortness of breath and was initially diagnosed with a pneumonia by chest x-ray obtained with antibiotics without improvement. Subsequently she was hospitalized and CT of the chest showed left lower lobe segmental pulmonary embolism. The patient never had history of venous thromboembolism in the past. She had weakly positive anticardiolipin antibody of IgG type of unknown significance. She was treated initially with antibiotics but after diagnosis of the blood clot she was started on anticoagulation with apixaban with improvement

Patient admitted 3/28/2021 with severe COVID 19 pneumonia. She progressed to acute respiratory failure and was intubated. During her hospitalization she was diagnosed with acute myeloblastic leukemia. Her family withdrew care and she died on 4/7/2021

With 1st vaccine on 1-9-21 I had severe chest pain, the NP diagnosed it as pleurisity, told to take Tylenol, on second vaccine 2-6-21 I had a very bad headache that went down my neck and right shoulder, and lower back, NP said it was arthritis, go to sports med. since that time the pain has covered all my joints, muscle spasms to the point of not being able to walk, completely bedridden at this time, severe pain, headache, insomnia

short of breath; a fast heartbeat; dizzy; nauseous; arm was sore at the injection site; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (short of breath) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (Medical history not provided). On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced DYSPNOEA (short of breath) (seriousness criterion medically significant), HEART RATE INCREASED (a fast heartbeat), DIZZINESS (dizzy), NAUSEA (nauseous), VACCINATION SITE PAIN (arm was sore at the injection site) and FATIGUE (fatigue). On 05-Mar-2021, FATIGUE (fatigue) had resolved. At the time of the report, DYSPNOEA (short of breath), HEART RATE INCREASED (a fast heartbeat), DIZZINESS (dizzy), NAUSEA (nauseous) and VACCINATION SITE PAIN (arm was sore at the injection site) outcome was unknown.

Only received one dose on 2/28/21, then on 3/7/21 - 3/22/21 and again 3/27-4/1, client was hospitalized for Shortness of breath (negative for covid, tested a total of 4 times in the hospital, all negative). Currently, client's SOB symptoms have resolved, no fever and no chills. Past medical history: CHF, pHTN, AoC renal failure, DM type 2. Current Medications: Lasix, nifedipine, isosorbide, gabapentin, aspirin, insulin Only side effect from vaccine reported is injection site pain that resolved after 24 hours.

Patient received Moderna COVID vaccine on 2/1/2021 and 2/22/2021. Pt. presented to Medical center within Health system with weakness and arm and leg swelling on 3/4/2021. Admitted for observation, tested negative for COVID and discharged on 3/5. Pt. presented to Medical Center, also within Health system on 5/2/2021 complaining of SOB. Stated that she has had non-productive cough for months, but felt it had worsened lately. Pt. found to be COVID positive with bilateral infiltrates. Pt. required 6L O2. Pt. was DNRCCA. Pt. not intubated but expired from cardiac arrest/COVID on 5/16/2021.

86-year-old woman with a history of COPD who presented with complaints of shortness of breath. She was admitted with an impression of acute on chronic hypoxic respiratory failure secondary to COVID-19 pneumonia. She was initially started on antibiotics which were stopped due to low procalcitonin level and no evidence of bacterial pneumonia. She qualified for remdesivir and finished it. She was also getting Decadron with vitamin C and zinc and bronchodilator. Patient continued to do well and has tolerated Remdesivir well and has finished it. She is back to her baseline oxygen requirements.

Anaphylactic like reaction started with dizziness sweating increased heart rate wheezing in and out of consciousness. administered 0.3 of epinephrine, O2 via NC at 3L. called EMS. EMS arrived with in 10 minutes and administered additional 0.5 of Epinephrine and transported patient to the ER

1-16: Cant take deep breath, 1-17-18: R hand swollen, painful - Advil, 1-21-23: Extreme pain in L wrist, Swollen. Advil pm, Advil, immobilized with stretchy bandage

Resident passed away unexpectedly on 01/19/21 after developing acute hypoxic respiratory failure on morning of 01/19/21. She was transferred to hospital via EMS where she was intubated, coded, and ultimately expired with uncertain underlying cause, potentially ACS.

2/2/21-1000-patient presented to the local emergency room with complains of fever, shortness of breath and decreased oxygen sats. temp 101.7, pulse 102, respirations 36, BP 141/92, oxygen 94%. Lung sounds crackles bilaterally with rhonchi on the left. patient worked up for sepsis, CXR shows mild atelectasis. blood pressure dropped, and continued to drop through treatment requiring levophed drop to be initiated. Patient POA determined that this would not be her sister's wishes and made the decision to make patient comfort care status. 2/3/21- patient lethargic throughout night. 0640-patient demise.

EARLY SUNDAY MORNING THE PATIENT BEGAN VOMITTING AND SHORT OF BREATH AND CHEST AND BACK PAIN. SHE CODED WHEN SHE GOT IN THE ER AND LATER PASSED AWAY THE MONDAY. DIAGNOSIS WAS PNEUMONIA AND HEART FAILURE PER STEP DAUGHTER.

after 15 minute observation, pt complained of dizziness upon standing, shorty after c/o of shortness of breath, chest tightness, heavinees to tongue.

Patient expired 2 days after receiving the vaccination. Patient had other signs of deterioration over the course of the previous month with worsening edema and difficulty breathing. Unlikely to be related according to our assessments, but wanted to err on the side of caution.

Following the vaccine the next day she had the normal discomfort, tiredness and the arm was sore for about a week. Then on 2/11/21 she had an ocular migraine, and as that ended she was hit with an intense pain in her head that she had never experienced before. It lasted for hours, for the rest of the day. She took Ibuprofen which did not do anything. She looked up online and the clinic had a report on what to do for the migraines, and she took Ibuprofen and strong coffee. She does that and was able to ward it off and stop it some. Then it continued to happen during the day and the pain is so intense. The day before yesterday, 3/9/21 the regimen of coffee and ibuprofen did not improve. It goes from the top of her head, down to her neck and sore to touch behind her ears. It is now a dull headache around her whole upper skull. She lives alone and her children do not live anywhere close to her. She is also having horrendous fatigue and is not able to get much done such as shopping, also shortness of breath and pounding heart beat generally is very active and some days she is not able to get dressed due to the symptoms. She went to UC and she had them do a COVID test, which was negative and sent to the ER at and her BP was 191/75, and was told to FU with her neurologist and internist and had no answers for her headaches.

3/13/21 ER HPI -> transferred to hospital 88 y.o. female who presents to the Hospital Emergency Department by private auto with her daughter. Apparently, the patient has a 2 day history of intractable nausea and vomiting. She states she has vomited more than 5 times over the last 2 days. She has become more and more weak. She states she has been having coffee-ground emesis. No definite fever. The patient had a similar episode to this a few months ago. The patient does take nightly ibuprofen. She also take iron on a daily basis because of chronic anemia. She is not on any blood thinners. When the patient did get to the ER she had an episode of vomiting and it did appear coffee-ground. She is having a little bit of epigastric abdominal pain. No history of GI bleed in the past 3/16 note from Hospital Hospital Course: 88 y.o. female with a past history significant for hypertension, renal artery stenosis, arthritis, skin cancer presented to hospital with nausea/vomiting and transferred to another hospital on 3/13/2021 for GI evaluation. Patient developed coffee ground emesis and had NG tube placed, yielding 1800 cc of coffee-ground emesis. She was also noted to be hypertensive. A CT done at the outside hospital revealed a large hiatal hernia with a significantly distended herniated portion of the stomach and a portion in the left upper quadrant compatible with a gastric outlet obstruction. Transferred to another hospital and GI consulted. Underwent EGD on 3/14 with results as noted below. Recommended to continue PPI, avoid NSAIDs if possible and repeat EGD in 8 weeks as outpatient. NG-tube removed and tolerated diet. No further bleeding noted. Hgb remained stable. Medically stable for discharge. Counseled on medication use and diet. Patient or daughter had no further questions or concerns on discharge.

He went to the hospital for cardiovascular problems and cholecystitis and was under treatment after the first dose. 2/26/2021 at around 11:00 pm she was complaining of high blood pressure, uncontrolled vital signs, uncontrolled sugar, at 6:00 am she has passed away. They certify respiratory failure.

Client was vaccinated at a community event. Twenty minutes after receiving the vaccination she began complaining of chest pain and difficulty swallowing. Her VS remained stable, however, she reported difficulty breathing and at that time emergency responders was called. She remained alert and responsive for the 23 minutes between symptom onset and EMS arrival. She was transported out of the facility.

3/26/21 ER to Inpt Admission: Patient was admitted to the hospital for comfort measures after patient suffered MI and did not want any life-prolonging therapies. Patient was started on comfort medications and symptoms were monitored closely. The patient passed peacefully before she could be fully assessed

pt stated she was fine when she got home after she got the vax. she woke up feeling terrible and was very ill. Her throat tightened up. She was warm, nauseas and shaking from head to toe, aching from head to toe. Her temp was 99.1, she was very fatigued and has loss of appetite. She took Tylenol for her symptoms. She slept for about 12 hours. Her symptoms lasted for days. She is still very weak and fatigued at this time.

Fell three times in home on May 15th. Was taken to Emergency Room by Ambulance. In hospital for two days and then released. Ordered Home Physical Therapy and Walker. Cleaned the wounds from the fall. Difficulty breathing and swallowing. Released and told to schedule echocardiogram with Primary Care to follow up on heart's pumping function. Still had difficulty breathing when home and walking. Started diarrhea on Monday 22 had appointment on the 24th with doctor, but died at home before she could make appointment.

Fatigue, dizziness, weakness. Issues with breathing caused hospitalization 3 days after shot. Blood clot located in lung and 2 in right leg. Hospital stay 11 days, step down facility roughly 2 weeks, PT/OT upon arrival home.

COVID-19 infection & hospitalization after completed vaccine series. First dose of Moderna 2/17/21, second dose received 3/17/21. Pt hospitalized 4/7 for shortness of breath and generalized weakness.

Muscular pain total body especially chest, back and neck. Large hematoma at injection site. Feeling of tightness in breathing.

Developed shortness of breath within 12hrs of 2nd Moderna dose along with heart palpitations and nausea. Admitted to hospital 3 days after shot and quickly developed pnemonia and died 4 days later after blood O2 fell below 80%. Had periods of mild improvements followed by more severe declines each time.

patient said 4 to 5 days after the vaccine, she went to the hospital and had blood clots in the lungs and legs. she said she's ok now and dr told her to get her second vaccine today. she is now on Eliquis.

Pt developed left side back pain two weeks after receiving her second dose. Pain persisted until June 10 when she went to the ER and was diagnosed with bilateral pulmonary blood clots. Pt hospitalized for two days and discharged on apixaban.

Pr received her Moderna covid 19 vaccines on 2/26 and 3/26/21 and per the daughter she went downhill since with progressive fatigue and not acting herself and failure to thrive with poor appetits. she was hospitalized from 6/9-6/19/21 with recurrent urinary tract infection despite appropriate treatment as an out pt, severe sepsis, diffuse pneumonia, acute metabolic encephalopathy, severe, persistent hypokalemia due to poor po intake and a pancreatic mass- possibly malignant with negative ca 19-9 incidentally found on imaging. She was sent home on comfort/hospice care on 6/19/21 as family opted for no further aggressive treatment for the pancreatic mass. she was treated with antibiotics for the sepsis, pneumonia and urinary tract infection during her hospital course.

Fully vaccinated patient admitted to hospital with detected COVID PCR test. Patient with positive COVID swab in ED on 05/31/21. Came to ED with leg swelling, weakness. Discharged home on 1 L/NC of O2 due to lower O2 sats 92-94%. Patient seen again in ED on 06/06/21 this time for increasing shortness of breath, increasing oxygen demand, and icnreased work breathing. O2 needs since last ED visit increased to 2-3 L. Admitted to hospital for COVID infection and CHF exacerbation. Treated with aggressive diuretics, remdesivir, and dexamethasone. Blood cultures tested positive and was started on IV ATB's. Patient discharged back to AFC with Hospice services.

Pt who resides in an assisted living facility w/multi comorbidities p/w SOB w/exertion, coughs and bodyaches. Was found to be COVID positive and O2 sats in the 80s. Was admitted for medical management of acute hypoxic respiratory failure 2ndary to COVID-19 viral PNA despite having received Moderna vaccines (1/26 & 2/23). She was initiated on dexamethasone and O2. Showed rapid improvements and was ultimately discharged 2 days later back to her assisted living facility w/follow-up.

Serious breathing problem; Feeling lousy all over; Upset stomach; Spitting up; Not interested in eating; Started having memory issue; Soreness at the injection; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Serious breathing problem), FEELING ABNORMAL (Feeling lousy all over), ABDOMINAL DISCOMFORT (Upset stomach), VOMITING (Spitting up), DECREASED APPETITE (Not interested in eating) and MEMORY IMPAIRMENT (Started having memory issue) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Serious breathing problem) (seriousness criterion hospitalization), FEELING ABNORMAL (Feeling lousy all over) (seriousness criterion hospitalization), ABDOMINAL DISCOMFORT (Upset stomach) (seriousness criterion hospitalization), VOMITING (Spitting up) (seriousness criterion hospitalization), DECREASED APPETITE (Not interested in eating) (seriousness criterion hospitalization), MEMORY IMPAIRMENT (Started having memory issue) (seriousness criterion hospitalization), PAIN IN EXTREMITY (Soreness at the injection) and FATIGUE (Tired). At the time of the report, DYSPNOEA (Serious breathing problem), FEELING ABNORMAL (Feeling lousy all over), ABDOMINAL DISCOMFORT (Upset stomach), VOMITING (Spitting up), DECREASED APPETITE (Not interested in eating), MEMORY IMPAIRMENT (Started having memory issue), PAIN IN EXTREMITY (Soreness at the injection) and FATIGUE (Tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The concomitant medications were not reported. The treatment information was not provided. The patient went to hospital 7 times in the past 2 months. The smallest time spent in hospital was three days and the longest time was nine days. The patient was scheduled for second dose on 28-FEB-2021. Limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.; Sender's Comments: Limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.

Patient said that she couldn't walk starting about 2 days after the shot. She had to go to the hospital and it was discovered that she had 3 blood clots, 2 in her legs and 1 in her lung.

Shortness of breath . Was sent to Hospital to have fluid drawn from lungs . patient has diagnosed with liver cirrhosis. patient was in the hospital for 14 days.

Patient presented to Vaccine clinic 1/12/21 to receive COVID vaccination. Patient denied any ill feeling, no fever, cleared for vaccination. Is chronically SOB due to COPD, but patient reported no different than usual. Presented to the ED the next day c/o SOB and weakness for the last week. Patients condition ultimately declined over the next few days and died 01/21/21 from pneumonia (not COVID). Patient did admit she lied about her symptoms on the day of vaccination to get the shot.

Patient experienced labored breathing, rails bilaterally, and a temp of 99.2. Labwork showed a critical sodium level of 163. She was started on D5/NS 2 liters and then sent to the hospital when her fever spiked to 101.3. She was also very lethargic. She was diagnosed with pneumonia / sepsis

On 1/27/21, resident experienced shortness of breath and felt some pressure on her chest. Systolic Blood Pressure was in the 200's and Diastolic Blood Pressure was in the 100's, HR 117. She was sent to Hospital and diagnosed with: St Elevation Myocardial Infarction due to occlusion of circumflex coronary artery, Acute Systolic Heart Failure, and Aspiration Pneumonia.

Patient is a 89 y.o. female with a history of a TAVR that presented to the emergency room few hours after having a 40 min episode of chest pain. The patient states she was just eating and suddenly started having sharp pain on the left side of her chest. There was a little bit of associated shortness of breath, but not much. She states it was sharp in nature and seem to stay about the same for about 40 min. She states that she does seem to get chest pain sometimes when she vacuums, but usually if she sits down it immediately goes away. She reports that she saw PAC about a week ago and was thought to be a little bit fluid overloaded. She was started on a little bit of oral Lasix and was supposed to come see provider later in the week. She states she has diuresed very aggressively the last few days and is feeling quite a bit less short of breath. In the ER, her EKG did not show anything acute. Troponin was normal. BNP was mildly elevated, but her imaging did not show any signs of acute congestive heart failure. Her D-dimer was elevated. However, she was not having any pain while she was in the emergency room. Her pulse was normal and her oxygen saturations were in the high 90s.

Vaccine was administered at Nursing Facility. Patient is an 89-year-old female with prior medical history of CVA with dysphagia, history of possible dementia, GERD, hyperlipidemia, and a pacemaker. She is a resident from town. She was sent for hypotension with a blood pressure of 90/52, tachypnea respirations of 54, possible aspiration pneumonia. Status post Covid vaccine earlier today. History is limited as patient is nonverbal on my exam. Death within 24 hours of vaccination

On 3/6/2021 the patient presented to the ED with dyspnea and substernal chest pain that pretty much resolved as soon as she came in. She was admitted to rule out any cardiovascular events (none were apparent). Reason for admission: chest pain.

Patient seen and evaluated by PA-C. with myself. We agreed on the clinical findings and implemented our plan together. Please see PA's note for details. All relevant procedures supervised. Patient arrived to the emergency department due to respiratory symptoms, hypoxic, reported that Wednesday he received his 2nd dose of COVID vaccine. His initial workup was concern for NSTEMI with elevated troponin and peaked T-waves, his chest x-ray concerning for COVID/pneumonia. Patient initially tolerated oxygen by nasal cannula and sepsis protocol was started including IV fluid resuscitation that was done cautiously due to the concern of COVID with respiratory failure. The biotics were given. PA-C readdressed code status with patient who confirmed that his DNR DNI, she so contacted his daughter. Patient had multiorgan failure including acute kidney injury, and pneumonia with respiratory failure +/- respiratory failure. Due to the concern of NSTEMI patient was initially going to be transfer to was hospital and transfer was started. Patient respiratory status started deteriorating and his blood pressure dropped slightly but improved after 500 cubic centimeters of IV fluid and he was also placed on a NIPPV. Around 6:00 p.m. patient has significantly desaturation and he discontinued himself NIPPV. Due to inability to intubate patient, he was ventilated with BVM, patient is slowly improved saturation levels and was opening his eyes, he was placed on a non-rebreather. At this point there is high concern of ARDS and due to inability to intubate or give for the respiratory support His daughter was at bedside and updated of current medical status and poor prognosis. Patient continued deteriorating and at this point he had agonal breathing. His daughter was at bedside and she was made aware of the futile prognosis of patient due to his respiratory failure. Patient rapidly became bradycardic and went into cardiac arrest. No CPR was done due to the DNI DNR status of the patient. Critical Care Procedure Note Authorized and Performed by: MD Total critical care time: Approximately 30 minutes Due to a high probability of clinically significant, life threatening deterioration, the patient required my highest level of preparedness to intervene emergently and I personally spent this critical care time directly and personally managing the patient. This critical care time included obtaining a history; examining the patient; pulse oximetry; ordering and review of studies; arranging urgent treatment with development of a management plan; evaluation of patient's response to treatment; frequent reassessment; and, discussions with other providers. This critical care time was performed to assess and manage the high probability of imminent, life-threatening deterioration that could result in multi-organ failure. It was exclusive of separately billable procedures and treating other patients and teaching time. Please see MDM section and the rest of the note for further information on patient assessment and treatment. PE: VITAL SIGNS: BP: 126/75 Pulse: (!) 122 Resp: (!) 40 SpO2: (!) 82 % Temp: 98.1 °F (36.7 °C) Height: 5' 8" (172.7 cm) Weight: 152 lb (68.9 kg) General: Alert, nontoxic, in no acute distress. Lungs: Clear to auscultation bilaterally. CLINICAL IMPRESSION: 1. Sepsis with acute hypoxic respiratory failure and septic shock, due to unspecified organism (HCC) 2. Suspected COVID-19 virus infection 3. NSTEMI (non-ST elevated myocardial infarction) (HCC) 4. Multifocal pneumonia 5. ARDS (adult respiratory distress syndrome) (HCC) 6. Acute kidney injury (HCC) Further care and disposition otherwise as outlined by PA. ED on 2/14/2021 Revision & Routing History Detailed Report Note filed date Mon Feb 15, 2021 8:46 AM

Patient woke up more disoriented than usual, dizzy, short of breath, chills, headache, congestion, and blurred vision. She was taken to the ER, but refused a CT scan. She was given a saline bolus. As of 03/19/21 her vision is still blurred and she is more disoriented than her baseline.

20 minutes s/p vaccination, patient began experiencing dizziness and stated that her throat felt "tight". She stated that she had not eaten anything yet that morning. This RN administered 25 mg PO Benadryl and gave patient water and a granola bar. Patient was observed for an additional 20 minutes. No further reactions or symptoms were observed or reported. Patient was AxOx4 and ambulatory. She left the clinic with a friend.

Nausea ,shortness of breath during the day . Heart stopped 7:45 pm. Death declared at 12:45 am March 09 2021.

Stroke with aphasia. Was in the hospital for shortness of breath, being evaluated. Woke up in the morning with acute onset of aphasia. Swallowing and motor strength good. Does have history of strokes in the past but didn't have residual deficits.

4/1 son arrived and she got sick - stomach and general feeling of unwell; couldn't eat. Increase in shortness of breath (she had this with COPD); 4/2 and 4/3 continued to feel sick as described above. 4/5 son drove her to the hospital; she was dx COVID + in the ED. (note that on 3/27 she shopped with her daughter in law and ate in restaurant)

While working at my desk @ 10:00 April 1st, felt a severe jaw pain, radiated around to back of neck, down back, around to chest. Became very SOB. Called 911. Ambulance took me to hospital ER then ICU. Developed exquisite headache. Given pain meds and slept. Dr saw me the next morning. I had not had a heart attack. They had no DX. I think I had a 23 day delayed reaction to shot #2.

Pt admitted on 04/05/20 with SOB and altered mental status. Was given steroids and supportive care throughout admission and transitioned to comfort care on 04/09/2021 and passed away the next day. Patient had received both doses of COVID vaccine and tested positive for COVID 41 days later

Pt w/hx of dementia brought to ED w/fevers and low oxygen saturation and worsening SOB and lethargic. CXR showed chronic appearing interstitial prominence and left basilar opacity. Pt was found to be positive of COVID-19 infection. Had received both Moderna vaccines (1/19/21 & 2/16/21). Pt admitted for additional management for acute hypoxemic respiratory failure, COVID-19 pneumonia and treated with dexamethasone, combivent nebs, remdesivir, and azithromycin/ceftriaxone empirically for secondary bacterial pneumonia. Pt ultimately was discharged 3 days later to an assisted living facility where she resides oxygenating well and more alert.

Patient was admitted for recent complaints of shortness of breath and back pain, patient was found to be anemic with low hemoglobin. Patient was given a transfusion and admitted to the floor.

S/P VACCINE, STARTED WITH FEVER OF 101.2, CHILLS, RESPIRATORY WHEEZING, AND BODY ACHES AT 2100. PRN TYLENOL GIVEN AT 2116, TEMP DECREASED TO 100.1. NURSE PRACTIONER MADE AWARE WITH NEW ORDER FOR DUONEBS. TODAY ON 5/21 SHE STATES SHE STILL FEELS ACHES, HAS NOT HAD ANY TYLENOL TODAY- MORNING TEMP WAS 99.1 AND CURRENTLY IT IS 98.4.

Pt developed SOB, presented to the ED and tested positive for COVID 19. She was admitted to inpatient care, non ICU.